2025年 演講者

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Raolat M Abdulai
Galvani Bioelectronics

Raolat M. Abdulai, MD, MMSc, Chief Medical Officer, Galvani Bioelectronics

From August 2024 Raolat Abdulai, M.D. is the Chief Medical Officer. In her role, she is leading Galvani’s clinical organization encompassing the clinical development, surgical, clinical operations, medical affairs, biostatistics, and disease biology-focused pre-clinical functions as well as the portfolio of current and future clinical studies. She joined Galvani Bioelectronics from Sanofi, where she most recently served as the Global Clinical Lead for dupilumab in Immunology and Inflammation. She played a pivotal role in shaping the clinical strategies for multiple indication expansions across disease areas, most recently with the approval of the first-ever biologic for chronic obstructive pulmonary disease (COPD), focusing on late-stage data to transform treatment paradigms and enhance patient outcomes. Raolat is a pulmonary and critical care physician with an extensive background in early and late clinical development, digital biomarkers, and technology in clinical operations. Raolat received a B.S. in from the University of Maryland and an M.D. from Howard University. She completed her Internal Medicine training at the Mayo Clinical and her fellowship Pulmonary and Critical Medicine at Harvard Medical School/Brigham and Women’s Hospital. She was also a fellow in the NIH-funded training program and completed her Masters in Medical Science in Biomedical Informatics at Harvard Medical School.

Andrea Abram
Eli Lilly

Andrea Abram, Eli Lilly

No bio available.

Desiree Abu-Odeh
Merck

Desiree Abu-Odeh, PhD, MPH, Senior Scientist, Global Trial Optimization, Merck

Desiree Abu-Odeh is a Senior Scientist in Merck's Global Trial Optimization (GTO) department. She has 15 years of research experience in academic, government, and clinical research settings. Desiree was with GTO from 2020 to 2022, then had the opportunity to lead diversity, equity, and inclusion work for a department in the City of Chicago enterprise. She returned to GTO in 2023 and remains committed to DEI in her work at Merck. Desiree has a BS in Neuroscience and MA in Bioethics from the University of Minnesota and an MPH and PhD in Sociomedical Sciences from Columbia University.

Rolando J Acosta Nuñez
Regeneron

Rolando J. Acosta Nuñez, PhD, Manager, Biostatistician, Regeneron Pharmaceuticals

Rolando was born and raised in Puerto Rico. He holds a Bachelor of Science in Computational Mathematics from the University of Puerto Rico at Humacao and a PhD in Biostatistics from Harvard University. His PhD work focused on developing statistical methods to assess population mobility and mortality after natural disasters. Rolando joined the Biostatistical Engineering group at Regeneron in July 2022 where he works on analyzing data stemming from wearable devices, developing machine learning models for the creation of prognostic factors, disease progression modeling research, among other things. More broadly, he is interested in statistical methods and computational tools to elucidate problems in medicine.

Monique R. Adams
Sanofi

Monique Adams, PhD, MS, Executive Director, Global Head Diversity & Inclusion in Clinical Trials, Sanofi

Monique Adams is Executive Director, Global Head Diversity & Inclusion in Clinical Trials She is a thought expert on identifying innovative ways to improve the clinical trial experience for patients, clinical sites and the clinical teams who design and run the studies. She also manages the innovation project leads. Monique has a broad understanding of clinical development, gained through years of experience across Medical Affairs and Global Clinical Operations in different market environments. Monique is also the Vice-President of Women of Color in Pharma (WOIP) a nonprofit professional society founded in March 2015. WOCIP is committed to providing an environment that nurtures and empowers Black and Latina women employed in the pharmaceutical industry to take charge of their professional and personal development.

Ryan Ahern
Truveta

Ryan Ahern, CMO & Co-Founder, Truveta

Dr. Ryan Ahern is Co-founder and Chief Medical Officer of Truveta and has more than a decade of experience in healthcare data and clinical research. At Truveta, Ryan leads the Life Science Partner team which focuses on developing new partnerships and ensuring those partners are successful in their research. He is currently a Clinical Assistant Professor of Medicine at the University of Washington School of Medicine and practices at Harborview Medical Center, Seattle’s large county hospital. Prior to this, he trained in internal medicine at the Massachusetts General Hospital and has served as a Clinical Assistant Professor of Medicine at Weill Cornell Medical Center and New York Presbyterian; attending physician at Massachusetts General Hospital; and instructor at Harvard Medical School.

Jodi Akin
Hawthorne Health

Jodi Akin, Founder, Hawthorne Health

Jodi is a healthcare executive, leader, innovator, advisor and serial entrepreneur. She has more than 20 years experience in clinical development, scientific and regulatory strategy, management and medtech market development from start-ups to S&P 500 companies. Prior to founding Hawthorne Effect, Inc., Jodi was Global VP Clinical Affairs at Edwards Lifesciences, LLC- where she led the seminal clinical trials and regulatory approvals for transcatheter heart valve therapy. Also a humanitarian, Jodi led international healthcare initiatives including Heart To Heart International Children's Medical Alliance, The Nahapetov Friendship Foundation and the China Heart Group, a joint venture with the United Nations Industrial Development Organization. She holds an undergraduate degree in Foreign Service from Georgetown University, Masters in Physiology and Nursing from Pace University, New York and 8 patents with a few more pending.

Dennis Akkaya
myTomorrows

Dennis Akkaya, Chief Commercial Officer, myTomorrows

Dennis Akkaya, myTomorrows Chief Commercial Officer, has worked with the BioPharma industry for over 15 years and has been with myTomorrows for 8. After a decade in European biotech companies, Dennis took an opportunity to use his experience to help those affected by disease after experiencing it within his own family.

Damalie Akuamoah
Merck

Damalie Akuamoah, Diversity Program Lead, Merck

Damalie Akuamoah is a Clinical Trial Diversity Program Lead at Merck & Co., driving the global strategy to enhance diversity and inclusion across atherosclerosis, cardiovascular, infectious disease, and vaccine clinical trials. Her mission ensures participant populations reflect communities the organization serves. Akuamoah leads Merck's Diversity in Clinical Trials Global Perspective Working Group, facilitating international collaboration on best practices and localized solutions for inclusive trials. With over a decade at Merck, Damalie has held roles as an Epidemiology Scientist and Clinical Scientist, leading and supporting global observational and clinical studies in various therapeutic areas including cardiovascular, diabetes, women’s health, and oncology. Damalie earned a Bachelor of Science from City College of New York, CUNY, and a Master of Public Health in Epidemiology from Drexel University.

Todd Albin
Cedar Health Research

Todd Albin, President, Cedar Health Research

Todd Albin launched Cedar Health Research following more than two decades of experience as an accomplished leader in the clinical research industry. He is an expert in the areas of clinical research site operations and patient recruitment. Cedar Health Research is a pioneer site and patient network in the development and utilization of AI/ML technology in support of expanding clinical research access to support accelerated recruitment of diverse populations. His past experience include executive roles with Synexus, PPD/Acurian, and Ora where he led global teams supporting operations, investigator site relations, and patient recruitment and retention. received is bachelors in business administration from the University of Miami and his MBA from Florida International University.

Whitley Albright
Sanofi

Whitley Albright, Clinical Innovation and Operations Strategy Lead, Sanofi

I thrive on optimizing processes, driving innovation, and lightening the load for all stakeholders. Known for my collaborative approach, I excel at strategic thinking and building strong relationships that drive success. I’m all about proposing creative solutions to enhance clinical trials and elevate the patient experience. Let’s innovate together!

Demissie Alemayehu
Pfizer Inc

Demissie Alemayehu, PhD, Vice President, Biostatistics, Pfizer Inc.

Demissie Alemayehu is Vice President of Biostatistics at Pfizer. He has over 25 years of leadership experience in the pharmaceutical industry. He has been influential externally, with decades of research and teaching experience at major institutions. He has held important offices at key professional societies and has served on editorial boards of major journals. Demissie has published extensively in refereed journals and has co-authored or edited three monographs. He is a Fellow of the American Statistical Association and holds a Ph.D. degree in Statistics from the University of California at Berkeley.

Adrelia Allen
Merck

Adrelia Allen, PharmD, PMP, Director, Clinical Trial Patient Diversity, Merck

Adrelia Allen is a 24-year veteran of the pharmaceutical industry working in sales and clinical research at Merck. She has held positions of increasing experience as a Clinical Research Associate, Clinical Trial Project Manager, and Clinical Research Manager (CRM). She is currently the Director of Clinical Trial Patient Diversity, where she is responsible for the strategy and execution of activities for the diverse representation of patients in clinical trials. Adrelia has a Doctor of Pharmacy degree from Florida A&M University College of Pharmacy.

Jodie T Allen
AstraZeneca

Jodie Allen, PhD, Senior Director, Clinical Trial Diversity, AstraZeneca

Dr. Jodie Allen leads Clinical Trial Diversity at AstraZeneca and is responsible for global strategy and capability building in clinical development and operations. A medical sociologist by training, Jodie has 15+ years experience working across academic public health, life science consulting, and in pharma (Commercial and R&D). The red thread in her work is delivering large scale organizational change to improve patient access, experience, and outcomes. Her background in human behaviour in clinical settings, experience in technology implementation, and impact measurement are currently being combined to ensure that clinical trial populations reflect disease state populations in AZ sponsored trials.

Nithiya Ananthakrishnan
Precision for Medicine

Nithiya Ananthakrishnan

Visionary executive with a distinguished track-record fostering an environment of continuous innovation and growth through people-centric strategies. Data sciences leader focused on data analysis, visualization, and solutions to solve key issues in clinical trials. On a personal level, deeply committed to supporting educational excellence, particularly for underprivileged children.

Gaynor Anders
Trialbee

Gaynor Anders, Chief Delivery Officer, Trialbee

Gaynor has over 20 years of experience in communications, leading patient recruitment and patient engagement strategy at Ogilvy, MMG and Labcorp Drug Development. Developing complex but tailored communications programs that are executed all over the world, Gaynor combines communications, clinical trial and therapeutic expertise with up-to-date unparalleled regulatory insight in over 70 countries. Gaynor combines industry knowledge of feasibility and patient recruitment/retention with outstanding healthcare communications expertise. Her therapeutic expertise spans women’s health, cardiology, gastroenterology, pain, CNS/Mental health, oncology and endocrinology to name but a few. In addition, her experience working within vulnerable patient populations (particularly paediatric and mental health) is well recognised within the industry. In 2012 she was named as one of Pharma Voice’s Top 100 of the Most Inspiring People in the Industry.

Dawn Anderson
Deloitte LLP

Dawn Anderson, Partner, Consulting, Deloitte LLP

Mike Andino
ICON

Mike Andino, Senior Director, Patient Recruitment & Retention, ICON

Mike brings 23+ years of industry experience with 19 of those years focused on clinical trial recruitment and retention. He joined ICON in 2017, with a focus on digital recruitment and various strategic account leadership roles in the space. Mike’s experience includes global CROs as well as patient recruitment agencies covering rare disease, oncology, vaccines, pediatrics, dermatology, neurology and infectious diseases. In a previous role, Mike was one of the founding members of a Patient Experience team for a mid-size CRO eventually acquired by ICON. Mike holds degrees in Mechanical Engineering and a Masters in Business Administration with a concentration on international marketing.

Kristen Andrews
LabCorp

Kristen Andrews, Head Research Site Enablement, Clinical Trial Enablement, Product Strategy, LabCorp

Kristen Andrews, Head of Research Site Enablement at Labcorp, has over 25 years of experience in the clinical trials industry. Starting as a clinical research coordinator, her career has progressed through increasing levels of responsibility and leadership first at research sites and then in site relationship and decentralized clinical trial programs at CROs. She is a passionate advocate for patients, investigators and sites and is dedicated to advancing relationships between industry partners. Kristen holds a BA from Northwestern University and maintains CCRC certification through ACRP.

David Apfel
Johnson & Johnson

David Apfel, Executive Director, Head, External Innovation, R&D Data Science and Digital Health, Johnson & Johnson

Denise H Archilla
Chronic Warrior Coaching, LLC

Denise Archilla, MSW, Founder, Chronic Illness Life Coach, Patient Advocate, Chronic Warrior Coaching, LLC

Denise Archilla, MSW, is a certified life coach, a former Licensed Clinical Social Worker (LSWC) and a Montessori certified teacher with over two decades of experience providing support and management tools to warriors - a term many like to use to acknowledge and describe those living with a chronic illness, rare disease, and/or disability. As a warrior herself (diagnosed with Ehlers-Danlos Syndrome/Hypermobility Spectrum Disorder (EDS/HSD) and Dysautonomia) and a mom to two young-adults that identify as warriors, her personal knowledge of long-term illness and disability has greatly informed her work and expertise. She assists people in developing the habit of finding joy alongside the pain. In this process, they are able to reclaim their identities, which often become entangled with a difficult and all-encompassing medical diagnosis. Denise has been an advocate for youth throughout her career. She believes their voices should be heard and included in all matters that include them. She is particularly passionate about coaching teen and young adult warriors and helping them build confidence, find and use their voice, and empowering them to take a leadership role in advocating for their own health and wellness. Most recently, Denise has been working with more and more women in their 30’s-40’s learning to live with the challenges of chronic illness/disability in the workplace. Her coaching supports them in self-advocacy, educating themselves around their rights under the ADA, possible career transitions, or, perhaps making an entire career change and redefining their value based on who they are and not what they do. Additionally, Denise is a huge proponent of peer support and truly enjoys facilitating small peer support groups that bring people together with similar experiences. There is great magic and power in being with others that truly “get it.” Whether in Individual Coaching, Group Coaching, Patient Advocacy, or Education, Denise’s philosophy and belief is her tagline: Because Chronic Doesn’t Mean Can’t!

Barbara Argibay Gonzalez
Anju Software

Barbara Argibay Gonzalez, Vice President & General Manager Data Division, Data Mgmt, Anju Software

With over 15 years of experience in Data and Clinical Research, Barbara Argibay leads the Data Division at Anju, overseeing TA Scan and Data Science Solutions. Barbara’s prior experience within operations, product development, and postdoctoral research puts her at the intersection of data, analytics, insights, and strategy to support the life sciences delivering impactful results.

Stacey Arrambide
Advanced Clinical

Stacey Arrambide, Sr VP Functional Svc Solutions, Functional Svc Solutions, Advanced Clinical

Stacey is an innovative solution provider with over 25 years of global clinical development experience across a broad range of therapeutic areas, clinical phases, and outsourcing models. Beginning his career in Biometrics, Stacey has held numerous leadership positions of increasing responsibility over various functional areas for Advanced Clinical and other contract research organizations (CROs). He enjoys partnering with and leading teams to make a positive difference and adding value. Stacey is passionate about improving lives and providing hope for all those involved in the clinical research and product development ecosystem.

Alicia Asgari
StudyKIK

Alicia Asgari, Dir Technology Solutions, Bus Dev, StudyKIK

Alicia Asgari is the Director of Technology Solutions at StudyKIK, a Syneos Health Company, where she advises on best practices for technology solutions for patient recruitment and retention. She has been serving clinical research for over 18 years in various capacities. Her passion for research began as a graduate research assistant and continued during her tenure at UC Irvine working in the central office for human research protections. Alicia also spent several years with the Department of Medicine at UC Irvine, where she expanded into general clinical research operations and clinic support. She has been a technical solutions consultant in e-clinical, regulatory, and life sciences for over 13 years, helping to implement thoughtful and functional technology practices that inspire long-term success and sustainability across all research indications.

Martha Azer
Johnson & Johnson Innovative Medicine

Martha Azer, PharmD, Associate Director, Regulatory Policy NA, Johnson & Johnson

Martha Azer is an Associate Director of Global Regulatory Policy and Intelligence within Global Regulatory Affairs at Johnson & Johnson. She leads the US policy work on Digital Health, Artificial Intelligence/Machine Learning, and Precision Medicine to help shape the regulatory policy landscape to advance innovation in product development to provide exceptional medicine to patients. Martha has more than 10 years of experience in the pharmaceutical industry and held various roles at both J&J and Pfizer, including a background in pharmacovigilance. Martha received her Doctor of Pharmacy from Ernest Mario School of Pharmacy - Rutgers University in New Brunswick, NJ. Upon graduating, she completed a managed care residency at Horizon Blue Cross Blue Shield of New Jersey and served her community as a retail pharmacist for over 6 years.

Solomon Babani
Syneos Health

Solomon Babani, Senior Vice President, Business Development, Syneos Health

Sol Babani is a seasoned biopharma executive with over 25 years industry experience. The last 10 years he has been on the CRO side of the business, while the 17 years before that he was on the “sponsor” side in a variety of roles including: bench scientist, finance, project management, outsourcing and alliance management. Sol has spent time in large pharma (Pfizer and Novartis), biotech (Regeneron), and virtual development organizations (Auven/Celtic Therapeutics) and has thus seen the industry from many viewpoints. Mr. Babani also has a passion for innovation and how to better apply technology to the clinical research space, and has spoken at industry conferences on the topic of, “The Role of the CRO in the Healthcare Model of the Future.” With this experience, Sol has established himself as an expert in building and maintaining strategic partnerships, alliances, and collaborations. In his current role as SVP, Business development at Syneos Health, Sol is responsible for leading the North American Biotech/SMID Business Development team.

Daniel Bachalis
Bristol Myers Squibb Co

Daniel Bachalis, MS, MBA, Senior Director, Engineering & Operations, Drug Development IT, Data, and Analytics, Bristol Myers Squibb Co.

No bio available.

Ankit Bajpai
ZS

Ankit Bajpai, Associate Principal, ZS

Ankit brings over 11 years of dedicated experience in the pharmaceutical industry, spanning multiple domains including supply chain, operations, and commercial domains. As the leader of ZS's clinical supply chain space, Ankit partners with pharma clinical supply chain teams to address complex clinical supply chain challenges, fostering agility and delivering innovative end-to-end solutions. Passionate about making clinical supply teams more agile and efficient, Ankit invests in developing new capabilities, adopting cutting-edge technologies, and creating thought leadership to enable clinical supply chain teams to achieve stronger trial outcomes and faster speed. His work supports delivering life-saving therapies to patients faster and more effectively, embodying his commitment to excellence and innovation in healthcare.

Jasbinder Bajwa
Roche

Jas Bajwa, Manager, Biosample Operations, Roche

Jasbinder (Jas) Bajwa holds the position of Operations Lead and Coach for Regulated Bioanalysis and Biosample Operations at Roche, located in Welwyn Garden City, UK. Bringing over a decade of specialized experience in Biosample Operations has been instrumental in executing biosample management activities across multiple disease areas and spearheading the modernization of biosample management processes in early phase R&D with industry peers. She is committed to the goal to "maximize the value of patient's biosamples on our clinical studies while maintaining their integrity through their entire lifecycle." Jas’s passion for people development is evident through coaching, mentoring, and supervisory roles. She manages the Early in Careers UK industrial placement program within her organisation, promoting alternative careers in Operationalizing Science. As a dedicated STEM Ambassador, Jas strives to debunk myths surrounding scientific careers and inspire the next generation to explore opportunities in STEM fields. Accumulating 20 years of experience in Pharma R&D and the NHS, Jas's expertise spans Clinical Operations, Data Management, and Portfolio Management, covering a range of disease areas and clinical trial phases.

Valerie J Balosso
GSK

Valerie Balosso, Director, Data Management, Infectious Diseases, GSK

Valerie Balosso is Director for Infectious Disease for GlaxoSmithKline with 15 years of experience in pharmaceutical industry and specifically in Data Management. She has a large experience in selection, set up and management of collaboration with CRO in the Data Management and ePRO area. Valerie has a specific interest for new technologies including Artificial Intelligence/Machine Learning, Decentralized Clinical Trail and Team engagement.

Lorenzo Balsamo
Tango Therapeutics

Lorenzo Balsamo, Director, Clinical Informatics & Innovation, Tango Therapeutics

Innovative IT Professional with experience as a Program Manager, Business Analyst, Project Manager, Solution Architect, Account Manager, Principal Instructor, Systems Engineer, Team Leader, and Manager.

Mohan R Bangalore
Summit Therapeutics

Mohan R. Bangalore, PhD, Head & Senior Director, Procurement & Vendor Management, Summit Therapeutics

Dr. Mohan Bangalore is currently the Head/Senior Director of Procurement & Vendor Management at Summit Therapeutics, a biopharmaceutical Oncology company. He is leading the procurement strategy and sourcing operations for R&D, manufacturing, and commercial at Summit. Previously, he was the Group Director in R&D Procurement & Supplier Management team at Organon, a Women's Health biopharma company. He supported the R&D outsourcing needs for Pre-Clinical studies, Early Clinical & Late Clinical trials, and also Outcomes Research. Dr. Bangalore has worked in the Pharma industry for over 20 years with companies such as GlaxoSmithKline, Bristol-Myers Squibb, and Wyeth/Pfizer. His expertise includes Strategic Sourcing, Vendor Management, Clinical Operations, Medical Affairs, Biomarkers/Labs, Biospecimen management, and Project/Change management. Dr. Bangalore is a scientist/virologist by training with a PhD in Molecular Biology from Iowa State University, Iowa. He later obtained an MBA from Temple University in Philadelphia, PA. Combining his scientific and technical expertise with business operations skills, Dr. Mohan Bangalore brings unique perspectives to this summit.

Katherine Barboza
Galderma Laboratories LP

Katherine Barboza, PhD, Associate Director, Process Development, Galderma Laboratories LP

Katherine Barboza drives operational and scientific excellence through data standards and process improvement in Galderma's Research & Development group. She oversees the development and implementation of new and updated clinical development processes, ensuring cross functional alignment and streamlining workflows.

Shelly Barnes
UCB, Inc

Shelly Barnes, Global Clinical Innovations and Digital Lead, UCB

Shelly Barnes is the UCB Global Innovations Lead based in Raleigh, NC USA. She is accelerating innovative strategies and solutions driving the improvement of the patient experience within the conduct of their clinical trials. Shelly is delivering solutions using novel technologies, transforming from traditional clinical trials to sustainable human-centric clinical trials while maintaining quality, compliance and stakeholder commitments. Shelly actively represents UCB on several industry consortiums including DTRA, CTTI, TransCelerate and IHI.

Tricia Barrett
Praxis

Tricia Barrett, CEO, Praxis

Tricia Barrett is the President of Praxis, leading the day-to-day management of the business. A member of the Praxis team since 2003, Tricia oversees all Praxis operations from proposal generation through completed, enrolled studies. Her experience encompasses a wide range of therapeutic areas and tactical strategies, which brings a unique approach to patient recruitment that focuses on both sound science and innovative execution.

Dorothee B Bartels
HeDa-Advisors, BBraun US

Dorothee B. Bartels, PhD, Associate Professor (Apl. Professor) for Public Health and Epidemiology, Medizinische Hochschule Hannover; Founder, HealthData-Advisors, Board BBraun US

Professor Dr. Dorothee B. Bartels is a trained epidemiologist (Harvard School of Public Health, PhD and Habilitation Hannover Medical School), senior thought leader in (pharmaco)epidemiology, Real World Data (RWD) strategies, and evidence generation, both, based on established methods and (gen)AI. After several senior global leadership roles in the pharmaceutical industry, she moved into the innovative-digital space, i.e. in the innovation hub of Boehringer Ingelheim as Chief Digital Science Officer, to X, Moonshot (Alphabet) as Clinical and Real World Strategy Lead, and to Aetion (a software company analyzing claims/EHR) as Chief Digital Officer. Dorothee is founder of HeDa (HealthData)-Advisors, providing strategic and execution advice for real world data insights and evidence generation. She holds several board positions and is teaching on a regular basis advanced pharmacoepidemiology in academia.

Sophie Bartram
Ohio State University

Sophie Bartram, Fourth Year Undergraduate Student, Health Sciences Studies, Ohio State University

Sophie Bartram is a fourth-year undergraduate student at The Ohio State University studying Health Sciences. During her undergraduate studies, she gained hands-on patient care experience through interning at a rehabilitation hospital and for a pediatric occupational therapy group. Over the summer, she worked as a Digital Health Sciences Intern for Takeda Pharmaceuticals. In this position, she focused on identifying and assessing the burden on patients and site personnel induced by digital health technologies in clinical trials.

Tuba Bas
Bristol Myers Squibb Co

Tuba Bas, PhD, Senior Director, Clinical Center of Excellence, Bristol Myers Squibb Co.

Tuba is a Senior Director at Clinical Center of Excellence (CCoE) team as Clinical Capabilities Lead, serving as Global Process Owner for Clinical Protocol Development Process. Some of the highlights from her work are leading cross-functional teams to success for process improvement activities and contributing to organizational excellence. Prior to her role at CCoE, Tuba was a Senior Clinical Development Scientist at BMS Melanoma Program providing scientific leadership and expertise to execute clinical trial activities. Before joining BMS Tuba served as Lead Clinical Scientist at Merck for the Keytruda Lung Program leading her teams to successful global approvals. She was also the Data Monitoring Committee (DMC) coordinator for the Oncology Lung Program. Before her career at Merck, Tuba served as a Postdoctoral Research Scientist at EMD Serono in Translational and Biomarker Research, and Research Fellow at two different academic institutions, the Albert Einstein College of Medicine Cancer Center and Biomedical Engineering Department at Worcester Polytechnic Institute. Tuba has a Bachelor’s degree in Chemistry and Master’s degree in Environmental Sciences from Bogaziçi University, and earned a PhD in Biomedical Sciences from the University of Massachusetts Medical School based on her work in the laboratory of Nobel Laureate, Craig C. Mello, identifying new components of the Wnt signaling pathway in C. elegans; and her work in Kobertz Lab on glycobiology that provided a new biogenic mechanism for channelopathies. In the course of her academic and pharmaceutical career, Tuba has published extensively over a variety of diverse topics including organic chemistry, intracellular signaling pathways, animal models, hematopoietic stem cell physiology, NSCLC, and melanoma. In her spare time, Tuba enjoys traveling, plenty of outdoor activities (hiking, swimming, playing tennis), gaming (computer and board), learning (clarinet, piano, new concepts/languages), reading Sci-Fi books, and socializing with friends and family. Tuba is a happy puppy mom; and she loves spending time with her pup, “Lucky.”

Luke Basta
Merck & Co Inc

Luke Basta, Assoc Dir Clinical Data Mgmt, IRT & COA Svcs, Merck & Co Inc

Luke specializes in the IRT space, driving innovative solutions to support clinical trial operations. Before transitioning to the industry, Luke spent nearly a decade in academia, conducting social science research, where he honed his analytical skills and developed a passion for data-driven insights. Luke earned a BA in Chemistry from Wesleyan University.

Alison Bawden
Veristat

Alison Bawden, Project Director, Regulatory Affairs, Regulatory Affairs, Veristat

Deirdre BeVard
CSL

Deirdre BeVard, Senior Vice President, R&D Strategic Operations, CSL Behring GmbH

Deirdre currently serves as SVP, R&D Strategic Operations for CSL. In this role she leads a multi-functional “nerve center” for R&D designed to leverage and connect capabilities across the organization to integrate the business management of R&D; enable data driven insights & decisions; provide operational excellence; enable high performing teams and embed patient focus into the delivery of a diverse and innovative portfolio. Strategic Operations includes Clinical Development Operations, R&D Project & Portfolio Management, Integrated Business Operations, R&D Enabling Technology, R&D Patient Partnerships, and R&D Japan. Previously Deirdre has led Clinical Development Operations organizations at Nektar Therapeutics, Endo Pharmaceuticals, and Otsuka Pharmaceuticals. She also held significant leadership roles establishing innovative models dedicated to bringing clinical trials to community physicians and their patients. Additionally, her background includes working in a CRO and a start-up software company. This diversity of experience has given her a broad and global perspective of the clinical research industry. Deirdre strives to be a servant leader who operates with humble confidence and a healthy curiosity about people, projects, and process. Her leadership expertise is in creating inclusive teams and environments that allow for innovation, performance excellence, and personal development. She has been awarded an HBA Rising Star and PharmaVoice 100 of the Most Inspiring People for Change Agent category. Deirdre’s professional passion is in partnering with patients and their providers for increased and optimized opportunities for clinical trials. Personal passions include family, travelling, a well-crafted cocktail, a good book, and any reason to laugh!

Maree Beare
Clinials

Maree Beare, CEO, Clinials

Liz Beatty
Inato, Inc.

Liz Beatty, Chief Strategy Officer, Inato

Liz Beatty is the Chief Strategy Officer at Inato, a clinical trials marketplace which flips the traditional model and allows sites to participate in the trials that are best aligned with their interests and that of their patients. She is focused on advancing Inato’s corporate strategy, developing partnerships and driving growth in North America. Previously, Liz was the Head of Digital Clinical Trials at Bristol-Myers Squibb where she led digital innovation efforts across Global Clinical Operations. Her team leveraged innovative approaches to increase clinical trial participation and enhance the clinical trial experience for sites, patients, and their care team. Liz previously held positions in clinical operations including managing a global patient recruitment team, and various positions in protocol management and site management.

Liz Beatty
inato

Liz Beatty, Co Founder & CSO, inato

Liz Beatty is the Co-founder and Chief Strategy Officer at Inato, where the company is building the world's first clinical trial marketplace to create greater visibility, access, and engagement across a more diverse population of doctors and their patients. She is focused on advancing Inato’s corporate strategy, developing partnerships and driving growth in North America. Previously, Liz headed digital clinical trials at Bristol-Myers Squibb, where she led digital innovation efforts across Global Clinical Operations.

Jimmy Bechtel
Society for Clinical Research Sites (SCRS)

Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)

Jimmy Bechtel is the Society for Clinical Research Sites' (SCRS) Vice President of Site Engagement. He brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum in previous positions as data specialist, patient recruiter, and operations manager. On the pharma side where he worked in innovation project management, Jimmy utilized his previous professional experience to encourage a site-centric environment and create ease for sites working with a major sponsor company. This multifaceted background allows Jimmy to bring a unique perspective to the work he does on behalf of the sites. At SCRS, Jimmy is in charge of developing and executing the company's site-facing initiatives, and works closely with key industry partners to build out various SCRS partnership programs. Additionally, Jimmy drives the implementation the Membership department’s site-focused operations as well as design and marketing.

Matt Becker
SAS Institute Inc.

Matt Becker, Advisory Life Sciences Industry Consultant, Life Science Industry R&D, SAS Institute Inc.

Becker has been a Principal Industry Consultant at SAS since 2013. Prior to joining SAS, he had been using SAS in the life sciences industry since 1988. He focused on clinical programming, data management and visualizations. Becker presented numerous papers and won best paper awards at DIA, PharmaSUG, SUGI and SAS® Global Forum, PHUSE, PharmaSUG China and numerous regional users group meetings.

Melissa Bencivengo
Bayer Pharmaceuticals

Melissa Bencivengo, Director, Alliance and Partnership Management, Bayer Pharmaceuticals

Melissa is a Senior Alliance Manager with 30 years industry experience. In her current role she oversees the partnership of two strategic Contract Research Organizations (CROs) focusing on governance, process management, and performance metrics to ensure successful collaboration and project outcomes. Her career began in regulatory affairs at Sandoz (now Novartis), and transitioned to the clinical outsourcing, vendor and project management space where she developed and managed outsourcing strategies, resource assignments, vendor training, negotiated contracts, budgets, and managed purchase orders.

Joanne Benedict
Gilead

Joanne Benedict, Senior Director, Clinical Operations, Head, Risk Based Quality Management, Gilead

Joanne Benedict is Head of Risk-Based Quality Management at Gilead. Joanne is a strategic leader in the pharmaceutical industry with a passion for industry collaboration and the tremendous value it offers. Joanne leads global cross-functional teams in designing and deploying innovative processes and technology to further transform clinical trial management and data surveillance.

Edward J Bentlyewski
Herbert Irving Comprehensive Cancer Center- Columbia University

Edward J. Bentlyewski, Assistant Director, Clinical Research Nursing & Quality Assurance, Columbia University

Assistant Director of research nursing and quality assurance and Nurse Practitioner with more than a decade clinical trial experience in all phases. Certified through American Academy of Nurse Practitioners (AANP), Oncology Nursing Society (AOCNP), and Society of Clinical Research Associates (CCRP). Experience overcoming barriers to access to care in underserved communities. Committed increasing to Diversity, Equity, and Inclusion in healthcare and clinical trials.

Stephanie Berger
Urology Clinics of North Texas

Stephanie Berger brings nearly two decades of clinical research experience to her role as Director of Clinical Research at Urology Clinics of North Texas and Cancer Clinics of North Texas. This care team features a multidisciplinary network of urologists, radiation oncologists, and medical oncologists, including 65 providers across 21 offices throughout North Texas. Stephanie's experience encompasses a wide range of clinical research environments, including large hospitals, academic institutions, consortiums, and community healthcare settings. Her work spans the continental US, Puerto Rico, the Dominican Republic, US Virgin Islands, India, and Eastern Europe. She enjoys optimizing operational workflows and enhancing site quality, transforming struggling sites into high-performing research centers.

Laurie S Berry
Pfizer

Laurie Berry, PhD, Director, Strategic Solutions, Pfizer Inc.

Director of Clinical Innovation & Strategic Partnerships at Pfizer's Global Product Development Operations Center of Excellence. With a Ph.D. in Analytical Chemistry from the University of Vermont and a BA/BS from St. Anslem College, I have been with Pfizer since 1994. In my current role I lead Pfizer's Clinical Trial Concierge as part of the Decentralized Clinical Trials Community of Practice, focusing on innovative ways to improve clinical studies. I have extensive experience in leading clinical study teams and BLA submissions for Global Product Development and Research & Development. I also served as a Clinical Supply Chain Lead for 10 years. My work has been instrumental in driving innovation and change within the biopharmaceutical industry, particularly in drug and clinical development. I am also a key contributor to Pfizer's Care Anywhere initiative, which aims to decrease patient burden and increase retention through the use of wearables, telehealth, at-home labs, home health, mobile clinics, and direct-to-patient drug delivery. Additionally, I lead the development and deployment of Mobile Units, which offer location flexibility and expand the reach of clinical trials to more diverse and underserved populations.

Erwin Berthier
Tasso Inc.

Erwin Berthier, CTO, Tasso Inc.

Dr. Erwin Berthier is the Co-Founder and CTO of Tasso. An adept innovator, the technologies developed under his leadership at Tasso are empowering patients and clinicians to realize virtual care, perform frequent monitoring, and improve health outcomes. In addition to his role at Tasso, Erwin is also an Affiliate Assistant Professor in the Department of Chemistry at the University of Washington in Seattle. Erwin received a Diplôme Ingénieur in Fluid Mechanics from ENSTA (Ecole Nationale Supérieure des Technologies Avancées) in Paris, an MS in Electrical Engineering from the University of Canterbury in New Zealand, and a PhD in Biomedical Engineering from the University of Wisconsin-Madison. He is the author of over 50 publications in peer-reviewed scientific journals and a co-author of the book “Open Microfluidics”.

Jimmy Betchel
Society for Clinical Research Sites (SCRS)

Jimmy Betchel, Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)

immy Bechtel is the Society for Clinical Research Sites' (SCRS) Vice President of Site Engagement. He brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum in previous positions as data specialist, patient recruiter and operations manager. On the pharma side where he worked in innovation project management, Jimmy utilized his previous professional experience to encourage a site-centric environment and create ease for sites working with a major sponsor company. This multifaceted background allows Jimmy to bring a unique perspective to the work he does on behalf of the sites. At SCRS, Jimmy is in charge of developing and executing the company's site-facing initiatives, and works closely with key industry partners to build out various SCRS partnership programs. Additionally, Jimmy drives the implementation the Membership department’s site focused operations as well as design and marketing.

Samit Bhatt
Myonex Inc

Samit Bhatt, VP, Clinical Trial Patient Solutions, Myonex Inc

Samit Bhatt has over 13 years of experience in the pharmacy and pharmaceutical industry managing successful formulary status and relationship management with payers. He has significant understanding of healthcare contracts, and knowledge of medical and pharmacy benefits including specialized knowledge across different therapeutic areas.

Siddhartha Bhattacharya
PwC

Siddhartha Bhattacharya, Life Sciences AI Leader, PwC

Sidd is a Partner in PwC's Healthcare Analytics and AI practice, serving as the Life Sciences Gen AI leader. With over 20 years of product engineering experience, Sidd has worked with market-leading organizations to launch innovative cross-industry solutions, specializing in Cloud Native & AI. He has dedicated over 10 years to serving the pharmaceutical, biotechnology, and medical device industries.

Relevant experience

  • Sidd has cross-functional expertise focused on the intersection between R&D strategy, operations, and technology. He has diverse experience ranging from ERP system implementation, operating model design, M&A post-merger integration, innovation, and digital strategy.

  • Sidd has conceptualized, designed, and built several industry first FDA validated Artificial Intelligence (AI)-enabled product enabling intelligent automation in the pharmaceutical R&D domain.

  • Sidd is a thought leader at PwC's life sciences digital/AI transformation practice and a speaker at top-tier industry conferences. He serves as a lead advisor to senior leadership at Fortune 500 companies, providing guidance on AI strategy and implementation. Sidd has co-led programs to expand AI capabilities, collaborating with third-party research labs, startups, and other specialty sources to enhance knowledge domains.

Rebecca Bichard
Insmed

Rebecca Bichard, Director, Clinical Process Excellence and Training, Insmed

Rebecca has over 25 years of pharmaceutical industry experience in varying roles. She has been a Study Coordinator, CRA, Clinical Trial Manager and Lead, Technical Writer, Trainer, Instructional Designer, and Quality Manager. She has led functional areas and departments at time managing up to 20 direct reports. She has successfully led company-wide initiatives including the implementation of a learning management system and establishing a new clinical study information repository usually meeting required deadlines. Rebecca attributes the majority of her success, including the recent implementation of her organization’s enhanced clinical study risk management process, to effective application of change management principles.

Karina Bienfait
Bristol Myers Squibb Co

Karina Bienfait, PhD, Executive Director, Consent, Biospecimen & Imaging Management, Bristol Myers Squibb Co.

Karina Bienfait, PhD, is the Executive Director and Head of Consent, Biospecimen & Imaging Management at Bristol Myers Squibb (BMS). In this role, Karina is responsible for end-to-end management of biological specimens, medical imaging and informed consent for all BMS-sponsored clinical trials. Since joining BMS, she has driven the implementation of a state-of-the-art specimen management system, developed policies and processes to ensure specimen and imaging oversight, and has strategically transformed end-to-end consent operations for specimens for both protocol-related and future-use testing. More recently, Karina has assumed responsibility for full informed consent management for all BMS-sponsored clinical trials as well as leadership of the R&D Data & Specimen Governance Council which oversees secondary use of clinical trial data and specimens. Prior to BMS, Karina was at Merck & Co. for 10 years, where she held positions of increasing responsibility within Clinical Pharmacogenomics and Clinical Specimen Management. Her last role was head of Global Genomic Policy, Process, and Compliance (GPPC), where was responsible for evaluating the impact of global genomic and biospecimen policies and laws/regulations on Merck’s research programs; developing Merck policies, processes, and consent related to genomics and biobanking; and ensuring the compliant use of biospecimens. In this role, Karina also implemented routine genotyping of patients participating in Merck’s clinical trials to identify genetic predictors of drug response. Karina is currently an Advisor to SCOPE for Biomarkers and Biospecimens and co-chair of the Industry Pharmacogenomics Working Group. She has also served as a member of the Genomics Roundtable of the National Academy of Sciences, Engineering, and Medicine. Karina completed an internship in Clinical Psychology at Nassau University Medical Center and a postdoctoral fellowship in Clinical Psychopharmacology in the Department of Psychiatry at Rutgers University - Robert Wood Johnson Medical School. She holds a PhD in Clinical Psychology from St. John's University and a B.A. in Psychology and French from New York University.

Angela Bilkhu
Roche

Angela Bilkhu, Senior Global Patient Partnership Director, Sickle Cell Disease and aHUS, Roche

Heidi Bjornson-Pennell
Chan Zuckerberg Initiative LLC

Heidi Bjornson-Pennell, Senior Program Manager, Science in Society and Lead, Rare As One Network, Chan Zuckerberg Initiative LLC

A graduate of Columbia University, Heidi attended law school in England at the University of Law and Inns of Court School of Law and began her career practicing criminal defense, immigration and asylum and human rights law as a barrister at One Pump Court and Doughty Street Chambers. Upon returning to the United States, Heidi requalified as a US attorney, practicing civil litigation at the premier litigation boutique, Keker, Vest and Peter, LLP, and then criminal defense law as a state public defender at the Office of the State Public Defender, representing clients on California’s death row for over a decade. Heidi’s life shifted course when, at ages 2 and 4 years old, her 2 youngest children were diagnosed with a rare, chronic and progressive disease, primary ciliary dyskinesia (PCD). Heidi joined the board of the PCD Foundation, supporting for many years the foundation’s efforts to improve diagnosis and the development of treatments and cures in PCD. In 2019, Heidi joined the Chan Zuckerberg Initiative, a philanthropy with the mission to build a more inclusive, just and healthy future for everyone. A Senior Program Manager in the Science in Society program, Heidi’s work includes leading the Rare As One Network, a network of nearly 100 patient-driven organizations working to catalyze efforts in research and towards the development of treatments and cures in rare disease.

Jen Blankenship
VivoSense

Jen Blankenship, Senior Research Scientist, Clinical Research & Development, VivoSense

Experienced digital health researcher aiming to develop better ways to measure aspects of life that matter to patients with wearable sensors across therapeutic areas including Alzheimer's disease, oncology, and rare disease.

Julie Blasingim
Univo IRB

Julie Blasingim, CEO & Institutional Official, Univo IRB

Julie Blasingim is a seasoned IRB executive with 20 years of extensive regulatory, operational, and compliance experience in human research protection and site operations of clinical research. She has served in a dozen senior leadership roles across multiple central IRBs including Independent IRB, Schulman, and Advarra. Routinely consulted for her extensive human research protection regulatory expertise, she has hosted countless FDA inspections at both the IRB and under site operations and has managed multiple accreditations and certifications through AAHRPP and ISO. Julie holds a master’s degree in business administration specializing in leadership.

Lynette Bojko
Pfizer

Lynette Bojko, Head, Sourcing Compliance Management, Pfizer

Lynette Bojko is an Executive Director working in Clinical Development & Operations at Pfizer. During her 27 year career at Pfizer, Lynette held roles in Data Management, Study Management, Project Management and Vendor Management. She is currently the Head of Sourcing Compliance Management, where she leads a team that is responsible for the design and monitoring of vendor engagement processes, sourcing strategy and governance framework.

Katie Bonner
AstraZeneca

Katie Bonner, Director of Strategic Feasibility, AstraZeneca

I am a seasoned professional in the field of clinical operations feasibility with over 12 years of experience. As Director of Strategic Feasibility and Analytics at AstraZeneca, I have been instrumental in driving the success of numerous clinical trials across biopharmaceuticals respiratory, inflammation, and autoimmunity. My expertise lies in feasibility analysis, site selection, and operational strategy, ensuring that trials are conducted efficiently and effectively. Throughout my career, I have demonstrated a deep understanding of the complexities of clinical trial operations, leveraging data-driven insights to optimize site performance and patient recruitment. I have a proven track record of collaborating with cross functional teams, regulatory bodies and key stakeholders to navigate the challenges of clinical research and bring innovative therapies to market. I hold a master's degree in developmental kinesiology from Bowling Green State University, a bachelor's degree in clinical psychology, and a bachelor's degree in kinesiology from Michigan State University. I am excited to share my knowledge and experiences on best practices in clinical trial feasibility and operations and am passionate about advancing clinical research and improving patient outcomes through meticulous planning and execution.

Nils Bottler
Angelini Ventures

Nils Bottler, Principal, Angelini Ventures

Nils is a Venture Capitalist currently working at Angelini Ventures. The focus is to invest in early-stage start-ups in the digital health and lifesciences field. His first work experience was in the banking industry working mainly on M&A projects as well as on a number of consulting projects in Germany, China, UK and the United Arab Emirates. He then moved to digital media and analysed, developed and executed new business models at the Axel Springer SE in Berlin before taking a deep dive into the german health care market as SVP RHÖN-Innovations and the premier hospital chain RHÖN-KLINIKUM AG and with Think.Health, where he is still involved as Venture Partner. Specialties: Venture Capital, Digital Health, eHealth, Medical Devices, Mergers and Acquisitions, M&A, financial analysis, equity capital markets, business development, strategic product development, start-ups, early stage, investing

Ariel Bourla
Johnson and Johnson

Ariel Bourla, MD, PhD, Senior Director, Data Science and Digital Health, Johnson & Johnson R&D

Dr. Ariel Bourla serves as Senior Director on Johnson & Johnson R&D's Data Science and Digital Health team, where she leads efforts to apply real-world data and other innovative technology solutions to advance and accelerate Oncology clinical programs. Dr. Bourla holds a strong background in Medical Oncology, Immunology, and Data Science. She spent 6 years at Flatiron Health as a Medical Director and Clinical Trials Lead. In this role, she led research teams executing prospective real-world studies, methodologic and observational research projects, and development of new technologies for sites and sponsors participating in clinical trials. Dr. Bourla received her MD/PhD training from the Mount Sinai School of Medicine, with a subsequent internship and residency at New York Presbyterian-Columbia University Medical Center, and a Medical Oncology fellowship at Memorial Sloan Kettering Cancer Center. She earned a BA in English Language and Literature from Yale University.

Danilo Branco
Fortrea

Danilo Branco, Director, Central Monitoring Operations, Fortrea

Danilo Branco, Director of Central Monitoring at Fortrea, is a passionate, optimistic, tech-savvy clinical trials Risk Based Quality Management, Central Monitoring, Project Management, and Clinical Operations professional with 21 years of experience managing complex studies in both big Pharma and CRO settings. He co-leads a team of 50+ employees globally in the mission of improving data quality while bringing efficiencies to Clinical Trials conduct. The last 10 years were dedicated to leading and encouraging process creation, continuous assessment, and enhancements to maximize the positive impact of the RBQM adoption in full alignment with regulatory expectations.

Mary B Brantner
Insmed Inc

Mary Brantner, Senior Director, Clinical Program Optimization and Innovation, Insmed

Mary Brantner is Senior Director, Head of Clinical Program Optimization and Innovation at Insmed Inc. In her role, she identifies opportunities to standardize processes and leverage technology to streamline and optimize conduct of clinical trials. She also leads creation of Patient Diversity Action Plans at Insmed. Mary has 35 years of experience in the Pharmaceutical and Device Industry, having worked at Daiichi Sankyo and Becton Dickinson along with other pharma companies before joining Insmed. Her recent roles have been in the Global Development Operations and Process and Systems areas where she has overseen Global Development Operations functions that include Clinical Operations, TMF Operations, Process Excellence and Training, Clinical Trial Disclosure and Transparency, Clinical Systems, and Medical Writing. Ms. Brantner holds an MS in Clinical Research Administration from New York Medical College and a BS in Biology from Ramapo College. She also holds certifications with ACRP as a CCRA and Prosci for Change Management.

Dan Brenner
1nHealth

Dan Brenner, CEO & Founder, Business Development, 1nHealth

Dan is the Founder & CEO of 1nHealth. Prior to starting 1nHealth, Dan led client and portfolio development at SPRIM and SPRIM Ventures, leading all online initiatives for SPRIM and its venture companies. Dan blended his perspective in clinical and consumer to launch 1nHealth. Prior to SPRIM, Dan was the CEO of several e-commerce ventures. In these roles, Dan was involved in launching hundreds of new products and direct marketing to a wide range of consumers and use cases. With a previous background in Life Sciences Consulting at SPRIM, Dan has blended his perspective in clinical and consumer to launch 1nHealth.

Dan’s prior start up experience included the launching of TriNova and leading the brand to acquisition by Gold Eagle Company in 2016, joining the acquiring Company’s board in 2017. As a passionate alumnus, Dan would like to note he earned his M.B.A. from UCF before their football team was good.

Katherine Broecker
Eli Lilly & Company

Katherine Broecker, Senior Director, Design Hub Data Insights, Eli Lilly and Company

Katherine Broecker is Senior Director, Design Hub Data Insights, Clinical Innovation & Optimization with Eli Lilly. With a background in both business management and biostatistics, her passion is using data and analytics to make the next business decision to drive clinical trial success and provide medicines to patients. Her current role is focused on global clinical trial allocation and novel ways to identify and reach target patients, including diverse populations.

Denise N Bronner
Empactful Ventures

Denise Bronner, PhD, Founder & CEO, Empactful Ventures

Denise N Bronner, PhD, has roughly 15 years of organizational thought leadership experience within the global healthcare space and has held various roles in academia, consulting, pharma, and venture capital. During her career, she has specialized in health equity, data-driven global therapy program strategy development, pitch and storytelling refinement, and identifying business opportunities within pharma. Beyond her professional endeavors, she's passionate about enhancing diversity in STEM fields, serving on advisory boards, participating as a judge in pitch/business competitions, and mentoring young professionals. She holds a bachelor’s degree in Biological Sciences from Wayne State University, a Ph.D. in Microbiology & Immunology from the University of Michigan-Ann Arbor, and certification from the Venture Capital Executive Program from UC Berkeley Haas School of Business. She is the founder of Empactful Ventures which currently consults healthcare-focused startups and venture funds, and she is a member of the Clinical Leader editorial board.

Randy Brown
Altimmune

Randy Brown, Vice President, Clinical Operations, Altimmune

Randy Brown is a seasoned Clinical Operations Leader with nearly 30 years of global drug development experience directing all aspects of clinical programs. Randy has served in leadership roles over the last 20 years in the biotech, pharmaceutical, and medical device sectors. Mr. Brown recently served as the Chief Operating Officer and Executive Vice President of Clinical Development and Operations for PAVmed and its subsidiary, Lucid Diagnostics. Prior to that he served as head of Clinical Operations at Baxter and Vice President of Clinical Operations at Lyric Pharmaceutical. Randy has played pivotal roles in leading large-scale phase 2 and 3 global clinical programs, helping secure multiple approvals across his career. Mr. Brown holds a BS and MS from George Washington University.

Wout Brusselaers
Deep 6 AI

Wout Brusselaers, CEO, Deep 6 AI

Wout Brusselaers is the founder and CEO of Deep 6 AI, a precision research company that empowers healthcare organizations and life sciences companies to de-risk and accelerate clinical research. Wout founded Deep 6 AI in 2016 to improve clinical trial outcomes through AI-driven software that mines electronic medical record (EMR) data to precision match patients to trials. Wout leverages his entrepreneurial experience and deep operational expertise to help address the industry’s patient recruitment and retention challenges. Wout holds a Masters in International Economics from the University College Dublin, and a Licentiate degree in Economics from Vrije Universiteit Brussel.

Dawn Buchanan
AffyImmune Therapeutics

Dawn Buchanan, Vice President, Clinical Development Operations, AffyImmune Therapeutics, Inc.

Dawn Buchanan is a seasoned Clinical Operations executive with over 25 years of experience at both small/large pharma and a CRO, and now is the Head of Clinical Development Operations at AffyImmune, a small start-up biotech developing autologous CAR T cell therapy for solid tumors. Dawn started at AffyImmune as the first Clin Ops hire and has built the function and her team from the ground up. She is passionate about cell therapy, with a unique CV having also been on the External Manufacturing side of cell therapy as an Operations Lead for establishing a CDMO in the EU while at Celgene/BMS. Her small biotech experience has allowed her to lean into a leadership role in new ways that she finds fulfilling, including building a high-performing team and working closely with other functions including QA, CMC, Clinical Development as part of senior leadership in establishing strategy for the first clinical program.

Tricia Buchheit
Alnylam Pharmaceuticals

Tricia Buchheit, Associate Director, Patient Recruitment, Alnylam Pharmaceuticals

Tricia Buchheit has over 25 years of Patient Recruitment, Retention, and Project Management industry experience through her work at agencies, CROs, core labs, and biotechnology companies. This vast experience provides a 360-degree perspective of the challenges key stakeholders encounter with recruitment and retaining patients into clinical trials. Currently, Tricia focuses on the development and implementation of thoughtful recruitment and retention strategies and solutions to bring much needed RNAi therapeutics to market.

Lee Buckler
Blood Centres of America

Lee Buckler, Senior Vice President, Advanced Therapies, Blood Centers of America

Lee is an experienced senior executive and corporate director with deep commercial expertise in the biotechnology sector. His management experience includes as CEO and VP of public and private biotech companies, as well as providing management and strategic consulting services to public and private bio-pharma companies in Canada, the United States, Middle East, Japan, and Europe. Lee’s deepest expertise is in the cell therapy and regenerative medicine sector having lead several transformative transactions including multinational investment and licensing deals involving companies in North America, Europe, and Asia. Lee has particular experience in Canada, the United States, and Japan. Lee holds a Bachelors of Education and a JD from the University of British Columbia.

Robert Buka
Medidata a Dassault Systemes Co

Robert Buka, Sr. Director, Product Management, Intelligent Trials, Medidata a Dassault Systemes Co

Christine P Bump
Penn Avenue Law & Policy

Christine P. Bump, JD, MPH, Principal, Penn Avenue Law & Policy

Christine P. Bump, Principal and founder of Penn Avenue Law & Policy, is an insightful regulatory attorney with two decades of experience developing and implementing FDA strategies for devices, diagnostics, digital health platforms, and genetic and genomic tests. She advises laboratories, large corporations, and emerging companies with an awareness and understanding of their business and strategic goals. Christine has served as regulatory counsel for a national diagnostic coalition, written several articles, and presented at numerous industry conferences. Before starting her firm, she practiced at Hyman, Phelps, & McNamara, P.C. and in the Life Sciences group at Goodwin. Christine earned a B.A. from Sweet Briar College, an M.P.H. from Emory University’s Rollins School of Public Health, and a J.D. from Emory University School of Law.

Stacey Burghdoff
ProPharma

Stacey Burghdoff, Exec Dir Strategic Alliance Mgmt, Strategic Alliance Mgmt, ProPharma

Wesley Burian
Retired

Wes Burian, Patient

Wes is a retired film art director who spent most of his career at Dreamworks Animation. He has participated worldwide in his field from industry to academia and has recently taken a more active role in legislative and health-care advocacy due to his own rare diease, Fabry. Wes lives near Portland, Oregon where he is currently participating in a gene therapy clinical trial in a mostly remote capacity.

Brian S Burkhardt
Oliver Patch Project

Brian Burkhardt, Co-Founder & Executive Director, Oliver Patch Project, Inc.

Brian Burkhardt is the Executive Director and Co-Founder of the Oliver Patch Project (OPP). His journey to OPP has been marked by a diverse array of creative experiences, all culminating in his current role. In 2020, Brian's son, Oliver, was diagnosed with Leukemia during the peak of the pandemic. Faced with the fear of Oliver's prognosis, Brian and his wife, Trisha, approached the diagnosis with positivity and love. Early in Oliver’s treatment, Brian initiated a simple request on Facebook for friends and family to "Send a Patch," encouraging Oliver to walk to the mailbox daily. This call to action garnered over 2,000 patches within the first month alone. Brian began sewing these patches onto Oliver’s jacket, transforming it into a symbolic suit of armor for his journey. As Oliver opened patches and sent thank-you videos, he suggested, "Mom, Dad, we should do this for other kids." This heartfelt moment sparked the beginning of their mission. The Oliver Patch Project collaborates with artists globally to create a fun, free, and engaging platform that aims to empower children battling cancer through the power of patches. Currently operational in over 260 hospitals across all 50 states, OPP has reached thousands of children, teenagers, and families. Oliver’s dream of extending this support to other children has become a reality and remains Brian’s driving passion. Driven by the vision to extend love and support to every child, teenager, and family participating in clinical trials, the Oliver Patch Project recently launched its Global Clinical Patch Support (Retention) Program. This initiative aims to unite participants in clinical trials, creating a cohesive community irrespective of trial specifics or organizers. OPP endeavors to build a comprehensive network that reassures every pediatric participant that they are not alone on their journey.

Colleen Butler
Lightship

Colleen Butler, VP, Clinical Operations & Delivery, Lightship

o Colleen Butler is a results-driven leader with a proven track record in process optimization, organizational development, and project delivery. Colleen has over 20 years of Clinical Operations experience, 18 of which have been in a management/senior management capacity working for leading clinical research organizations. Prior to joining Lightship, Colleen led a team of more than 150 staff across seven countries at PRA Health Sciences (ICON) in the delivery of accelerated site activation resulting in a 30% reduction in start-up cycle times. Colleen’s leadership is characterized by a commitment to service excellence, employee development, and continuous improvement, ensuring that both organizational and client objectives are met with precision and efficiency.

John Cai
Merck

John Cai, MD, PhD, Executive Director, Real-World Data Analytics and Innovation, Merck

John Cai, MD, PhD, FAMIA, is Executive Director, Real-world Data Analytics and Innovation, in the Merck Center for Observational and Real-World Evidence. He is leading a team of data scientists and outcomes researchers to generate real-world evidence and insights through innovative and advanced analytics. John has more than 20 years of experience in biomedical and clinical research across academic, biotech, and pharmaceutical settings. John received his medical training from China Medical University and his Medical Informatics training from Harvard Medical School. Pursuing a passion for both medicine and computing, John has co-authored peer-reviewed publications in the areas of medical informatics, machine learning, clinical trials, and cancer genomics. John is a Fellow of the American Medical Informatics Association (AMIA), and also serves in the AMIA Industry Advisory Council.

Pablo Caiceo
Thermo Fisher Scientific Inc

Pablo Caiceo, Director, Global Clinical Supplies, PPD Clinical Research Services, Thermo Fisher Scientific Inc

Alissa Calaway
Gladerma Labs LP

Alissa Calaway, RN, MSN, Manager, Medical Device Clinical Project Management, Galderma

Alissa Calaway oversees Clinical Project Managers working on Galderma medical device clinical studies globally to ensure programs are executed according to timelines, budget and meeting quality standards. She ensures compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and aligns with company strategies and goals. She has a long history of supporting and working in the medical device industry during her career including experiences as a CRC, FCRA, In-house CRA and CPM. Alissa is a master's prepared registered nurse in the state of Texas with a specialty in critical care nursing.

Dana Callow
Boston Millennia Partners

Dana Callow, Founder & Managing Partner, Boston Millennia Partners

Mr. Callow is the Managing Partner of Boston Millennia Partners. Prior to founding Boston Millennia Partners, Mr. Callow co-founded the predecessor fund of BMP in 1982. Before that, he worked as a Senior Consultant at Braxton Associates, an international strategic planning firm that was formed by professionals from Bain & Co. and Boston Consulting Group. He worked with Fortune 100 companies in strategic planning and implementing merger and acquisition strategies. Prior to working in the management consulting business, Mr. Callow worked in sales and marketing for Tymshare, Inc. (McDonnell-Douglas). He was formerly Lead Director and Chair of the governance committee of PAREXEL International Corporation (Formerly NasdaqGS:PRXL), a $2.5 billion revenue clinical trials management company sold on September 29,2017 for $5 billion. He is a lead investor in, or has served as, a Director of a number of other public and private companies, including ILEX Oncology, Inc. (Nasdaq: ILXO), a cancer pharmaceutical company acquired by Genzyme for $1 billion; MedAptus, Inc., a mobile computing provider of clinical, financial and administrative software solutions to the medical community; and COTA Healthcare, Inc., a precision medicine company that stores, tracks and analyzes longitudinal clinical and billing data of oncology patients with the goal of improving outcomes and reducing costs. Other investment responsibilities included Glycofi Inc., (acquired by Merck, NYSE: MRK); HotJobs, Inc. (acquired by Yahoo, NasdaqGS: YHOO); iVillage, Inc. (acquired by NBC Universal, a subsidiary of General Electric, NYSE: GE); and Tektagen, Inc. (acquired by Charles River Laboratories, NYSE: CRL) Mr. Callow is a member of the Advisory Board of the Dartmouth/Tuck Center for Private Equity and Entrepreneurship. He is also a member of the Board of Trustees and member and past Chairman of the Investment Committee at Tufts University and on the Board of Overseers at Tufts University Medical School. Mr. Callow is a National Board member for the Leukemia & Lymphoma Society where he chaired its Therapy Acceleration Program committee. Mr. Callow is a graduate of Tufts University and holds an MBA from the Amos Tuck School at Dartmouth

Jim Carroll
Walgreens

Jim Carroll, Head, Real World Evidence & Clinical Trials, Walgreens

Jim Carroll currently serves as the Head of Real-World Evidence for the Walgreens Clinical Trials business. Over the course of two years, Jim has led the build out of an integrated business unit that provides novel Real-World Evidence and Patient Recruitment solutions to sponsors. Underlying this build out is a core mission of improving patient access to clinical research. Jim brings more than twenty-five years of hands-on business unit management and functional leadership experience to the life sciences industry. He has managed numerous P&Ls aligned to the creation of novel services, digital platforms, and business entities while bringing unique value to biopharmaceutical sponsors across the product lifecycle. Jim has previously served in several executive and strategic advisory roles, including as Vice President of Life Science Solutions at OM1. He has also served as VP and Global Business Unit Leader for ICON Plc’s Real-World Evidence Strategy & Analytics unit where he was responsible for strategic direction, staffing and the establishment of ICON’s broader market positioning for their Real-World Evidence services. Prior to ICON, he was VP of Product Management and Marketing at Syneos Health. He has also held leadership roles at IQVIA, PharMetrics, Muro Pharmaceuticals and Cambridge Isotope Labs, a unit of Otsuka Holdings. Jim received an MBA from the Questrom School of Business at Boston University and a BS in Chemistry from the University of Massachusetts at Amherst.

Mia Carter
ICON Clinical Research LLC

Mia Carter, Senior Manager, Product Delivery IRT & CSM, ICON Clinical Research LLC

Mia is a Senior Manager of Product Delivery at ICON, where she leads the development and implementation of ICON’s RTSM, Flex Advantage. With expertise in integrating Flex Advantage with ICON’s proprietary clinical supplies management module and third-party systems, Mia brings valuable insights from both an IRT/RTSM and clinical trial logistics perspective. As a member of ICON’s IRT and CSM team, her comprehensive knowledge helps drive successful solutions for complex and simple clinical trials.

Suzanne Caruso
Citeline

Suzanne Caruso, General Manager, Clinical & Regulatory, Citeline

Suzanne Caruso is a senior business executive and clinical trial study start-up expert with over 15 years of experience in the pharmaceutical industry. As the General Manager of Clinical & Regulatory at Norstella, she leverages her expertise in data analytics and innovative trial operational models to drive efficiency for large pharma, biotech, and CRO companies. Suzanne has held roles at Veeva Systems, WCG, GSK, and Novartis and has served as a subject matter expert and adviser to over 50 organizations.

Lynne Cesario
Pfizer Global R&D Groton Labs

Lynne Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs

Lynne Cesario has more than 25 years of experience in clinical research and drug development in the pharmaceutical industry. She is currently an Executive Director in the Data Monitoring and Management department, leading the Global Risk Based Monitoring Program at Pfizer. As the overall business lead point of contact for RBM, Lynne coordinates and aligns all cross-functional project workstreams. Lynne also manages the global Central Monitoring teams, as well as a Data Science team that focuses on AI and automations that can be employed in the biometrics space. Lynne is an active member of Transcelerate and PhUSE where she co-led the RBM Workstream.

Meghana Chalasani
FDA CDER

Meghana Chalasani, Associate Director for Clinical Trial Innovation, Office of New Drugs, FDA CDER

Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). Previously, Meghana led OND's Advisory Committee Team and Science Strategies program, and worked closely on CDER’s Patient-Focused Drug Development program. Meghana holds a master’s in Health Policy and Management from Columbia University and a bachelor’s in Medicine, Health and Society from Vanderbilt University.

Joan A Chambers
Consultant

Joan Chambers, Senior Consultant, Tufts Center for the Study of Drug Development

Joan led the non-profit organization, Greater Gift, as CEO. The mission focuses on raising awareness of clinical research, fostering trust through celebrating and expressing gratitude for all participants, and contributing to the well-being of vulnerable children by paying forward the gift of health. A results-driven executive in health life sciences, known for implementing innovative strategies across diverse industries and demonstrating expertise in marketing and operations.

Janice H Chang
TransCelerate Biopharma Inc

Janice Chang, CEO, TransCelerate Biopharma, Inc.

Janice Chang is the Chief Operating Officer at TransCelerate BioPharma Inc. Ms. Chang has been involved with the organization since its inception. In her current position, Ms. Chang works closely with the CEO and the Board of Directors to shape the long-term strategic vision and priorities for the organization and its 30+ initiatives. Ms. Chang defines and guides TransCelerate’s overall external engagement strategy with global health authorities, governmental agencies, industry groups, and TransCelerate’s country network spanning across 30 countries. She has accountability overseeing TransCelerate’s corporate operations and works closely with her team to drive strategic delivery of TransCelerate’s portfolio. Ms. Chang also actively participates in various cross-stakeholder global discussions to help evolve our R&D paradigm. Most recently she joined the Advisory Council for HL7 International’s Vulcan Accelerator. Vulcan, which is a global strategic effort to bring together stakeholders across the translational and clinical research community to align on data exchange standards to bridge existing gaps between clinical care and clinical research, enabling more effective acquisition, exchange, and use of healthcare data in translational and clinical research. With a background of 20+ years of experience leading initiatives in large pharma and biotech companies, Ms. Chang has experience spanning across regulatory, clinical, and manufacturing. Ms. Chang is passionate in driving meaningful change across our ecosystem and not settling for the status quo. She believes in reimagining the way we advance innovative medicine and advocates for the power of open collaboration across stakeholder groups.

Rachel Chasse
AbbVie

Rachel Chasse, Associate Director, Digital Science Strategy, AbbVie

Rachel is the Associate Director of Digital Science Strategy at AbbVie. She integrates digital health technologies into evidence-generation strategies within AbbVie's neuroscience portfolio. Prior, she was the founding Director of Innovation at the Digital Medicine Society (DiMe) and worked on Pfizer's Digital Medicine team, digital health start-ups, consulted for pharma, and supported various other clinical teams for over a dozen years.

Scott Chavers
Walgreens Co

Scott Chavers, PhD, Senior Director, Epidemiology, Real-World Evidence Clinical Trials, Walgreens Co.

Senior Director with a demonstrated history of working in academia, hospital, and healthcare industry settings and over 27 years’ experience. Skilled in Pharmacoepidemiology, Oncology, Infectious Diseases, Immunology, Vaccines, Global Public Health, Clinical Trials, and Regulatory disciplines. Strong professional with a Ph.D. in Epidemiology from the University of Alabama at Birmingham (2003). Currently leads Walgreens Boots Alliance Pharmacoepidemiology, Real-World Evidence-Clinical Trials across all therapeutic areas.

Lauren Chazal
Headlands Research Inc

Lauren Chazal MBA, Chief Business Development Officer, Headlands Research

Lauren Chazal, MBA, is an expert in the clinical trials industry, with extensive experience in site operations, business development, and financial management. She spent the first five years of her career with traditional financial organizations and then pivoted to clinical research with a privately held multi-site clinical research organization. She has been instrumental in business development, mergers and acquisitions, and relationship management for global clinical research sites since 2012. This includes but not limited to Headlands Research where she holds the current title Chief Business Development Officer. Lauren joined Headlands Research, a KKR portfolio company, in October of 2018 as the first employee under the then CEO. She has been integral in building the business from concept to 18 research centers across the US/Canada and 550+ employees to date. In addition to KKR, Lauren has reporting experience with several mid/large sized private equity groups. Lauren's deep understanding of the dynamics between clinical research centers, CROs, and sponsors is complemented by her expertise in securing high-quality trial sites and patient recruitment solutions. Lauren earned a dual degree in Finance and Marketing from Lehigh University and an MBA from the University of Florida (UF). She is actively involved in the Healthcare Businesswomen’s Association (HBA) and serves on the board of the International Women’s Forum (IWF) Arizona Chapter. She has been a regular speaker at multiple industry conferences. Outside of her professional achievements, Lauren spends time with her two beautiful children, is an avid reader and is also a dedicated four-time marathon runner.

John D Chelico
CommonSpirit Health

John D. Chelico, MD, System Vice President & Chief Medical Information Officer, CommonSpirit Health

Dr. Chelico is a board-certified internal medicine and clinical informatics physician. His expertise is in the use of electronic health record systems for the improvement of clinical care, quality, research and financial strength. He is currently the System Vice President and Chief Medical Information Officer at CommonSpirit Health. Formed in 2019 through the alignment of Catholic Health Initiatives (CHI) and Dignity Health, CommonSpirit is the largest nonprofit health systems in the United States, with more than 1,200 care sites in 24 states, serving 25 million patients across America. Dr. Chelico is also currently an Assistant Professor of Medicine at the Zucker School of Medicine at Hofstra / Northwell and continues his clinical practice as an internal medicine hospitalist where he is a ward attending to house staff and medical students. Additionally, he is an Adjunct Assistant Professor of Population Health Sciences at Weill Cornell Medical School where he teaches a course focused on Clinical Informatics and Healthcare Quality since 2016. Dr. Chelico is a graduate of New York University, where he studied Computer Science at the Courant Institute of Mathematical Sciences. He completed his medical education at the State University of New York Downstate Medical Center, and finished residency training in Internal Medicine at North Shore University Hospital in Long Island, New York. Dr. Chelico went on to complete a National Institutes of Health (NIH) funded Post-Doctoral Fellowship and Masters Degree in Biomedical Informatics at the Columbia University Medical Center. During his fellowship, he became intricately involved with the strategy and re-architecture of the clinical data warehouse for the New York Presbyterian Healthcare System of Columbia University Medical Center and Weill Cornell Medical Center. Following his fellowship, Dr. Chelico joined the New York City Health and Hospitals Corporation as the Assistant Chief Medical Information Officer of Bellevue Hospital Center and the South Manhattan Healthcare Network. In the following years, he assumed the position as both the Director of Clinical Informatics at NYU Langone Medical Center and the Director of Data Warehouse Research at NYU Center for Health Informatics and Bioinformatics. At NYU Langone Medical Center he was a physician lead overseeing the Data Warehouse, Business Intelligence, and Epic Electronic Health Record System implementation across the enterprise. In 2011, he joined Northwell Health as the Chief Medical Information Officer at both cornerstone tertiary medical centers of North Shore University Hospital and Long Island Jewish Medical Center to oversee the electronic health information systems implementation and optimization. Starting in 2016 he took on a new role for Northwell Health, as the Vice President and Chief Information Officer of the Feinstein Institutes for Medical Research, where he is responsible for the Information Technology & Informatics that supports clinical research across the entire health system. In 2018 he was named the Vice President and Chief Informatics and Innovation Officer for the health system and founded the Northwell Health Center for Research Informatics and Innovation. This center concentrated on working with commercial partners looking to bring new technology into the health system and capitalize on the data assets that a large health system can provide to industry. Dr. Chelico is regularly invited to participate as a clinical informatics expert and health information technology consultant for industry and health care systems internationally.

Victor Chen
Kaiser Permanente Northern California

Victor Chen, Managing Director, Clinical Trials Program, Kaiser Permanente

Clinical executive with more than 20 years’ experience transforming clinical teams to clinical operations excellence in both industry and study sites. Developer of innovative study designs that successfully gathers data for both regulatory and commercial success. Strong clinical expertise in electrophysiology, pulmonology, surgery, oncology, and orthodontics that increases KOL engagement and participation. Negotiator of clinical regulatory strategies with US, EU, Canada, China and Japanese regulatory bodies. Expert in revamping and revitalizing clinical operations and execution of failing studies.

Su Chen
MITRE

Su Chen, MD, Clinical Science Principal, MITRE; Steering Committee Chair, CodeX HL7 FHIR Accelerator

Dr. Su Chen, MD, is a Clinical Science Principal at MITRE. She is an intrepid emergency medicine physician, computer scientist, and clinical informaticist with systems leadership experience in healthcare information systems optimization. Su currently co-chairs the Steering Committee for the CodeX HL7 FHIR Accelerator, a not-for-profit member community advancing open clinical specialty data exchange standards in cancer, genomics, cardiovascular health, and beyond. She serves on the Executive Committee and the Technical Review Group mCODE (minimal Common Oncology Data Elements), an open standard for cancer data exchange. Prior to joining MITRE, Su served as Director of Clinical IT in a nationwide health system, Steward Health Care, and Chief Medical Information Officer and Urgent Care Medical Director of the Greater New Bedford Community Health Care Center.

Sharon Chen
AlphaLife Sciences

Sharon Chen, Founder and CEO, AlphaLife Sciences

Sharon Chen is a visionary leader at the intersection of computer science and life sciences, boasting over 25 years of pioneering software development experience. As the Founder and CEO of AlphaLife Sciences, she drives innovation in generative AI-powered clinical development solutions, transforming the way the industry approaches drug development. Previously, Sharon served as the APAC General Manager at Verily Life Sciences, an Alphabet company, where she led groundbreaking initiatives integrating advanced technology with life sciences. As an Engineering Director at Google, she developed critical technological platforms and received prestigious accolades such as the "Founder's Award" and the "Outstanding Leadership Award" for her exceptional contributions. Her unparalleled expertise uniquely positions her as a leading figure in the industry. Sharon's visionary leadership and innovative spirit continue to profoundly impact AlphaLife Sciences and the broader life sciences sector.

James Chennells
Bayer Plc

James Chennells, Strategic Alliances Lead, Product Development & Performance Excellence, Clinical Development & Operations, Bayer

30 year industry experience across CROs & Pharma working in Clinical Operations, Business Development & Procurement. Following a Biology Degree I started my career as CRA working for Icon before moving into Business Development at Covance and subsequently Kendle (now Syneos). I joined Bayer in 2003 heading up a European Clinical Outsourcing function. As the outsourcing function developed and ultimately moved into the Global Procurement function at Bayer I assumed greater responsibility. Responsibilities have included leading regional teams across Europe & Asia for Pharma Development sourcing activities and Global teams responsible for Pharma Development Category strategy. During this time I was also heavily involved in the management of key supplier partnerships. I moved back into Bayer R&D to take a role leading an agile team to identify and manage a portfolio of future solutions supporting new approaches to clinical trial Planning and conduct to deliver faster, better, cheaper trials. Subsequently moving to the Alliance Management function in my current role as Strategic Alliances Lead, leading the Bayer's key strategic projects with external suppliers to enable the organizations ongoing transformation.

Scott Chetham
Faro Health

Scott Chetham, PhD, CEO & Co-Founder, Faro Health

Scott Chetham, PhD, is an experienced healthcare entrepreneur who is currently the CEO and co-founder of Faro Health. Scott leads the strategy for the Faro Health platform, which is designed to power clinical development by connecting data to decision making in a fundamentally new way. Previously, he was the Head of Clinical Research Operations and Data Management at Verily Life Sciences, formerly known as Google Life Sciences. This multi-faceted strategic and operational role involved leading the clinical strategy, clinical teams, process development and operations for all clinical projects of the company, including Google and Google[x]. Scott has also served as a Venture Partner at Versant Ventures, CTO and Co-founder of Intersection Medical (sold to ImpediMed), and VP Clinical Affairs (ImpediMed). In these latter two roles he was responsible for clinical research strategy and operations.

Amy Cheung
Deloitte Consulting LLP

Amy Cheung, Principal, Deloitte Consulting LLP

No bio available.

Christopher Church
Hawthorne Health

Christopher Church, Chief Commercial Officer, Hawthorne Health

No bio available.

Mark F Ciaccio
AbbVie Inc

Mark F. Ciaccio, PhD, Senior Biology Data Scientist, Platform Informatics & Knowledge Management, AbbVie, Inc.

Dr. Ciaccio uses Artificial Intelligence and Machine Learning to help accelerate Pharmaceutical Development at AbbVie Biopharmaceutical company. He is a member of the AbbVie RAIDERS (Rapid A.I. Developers) that are dedicated to the implementation of A.I. throughout the company. Mark specifically focuses on Clinical studies, currently working to simulate clinical trial enrollment, write chatbots to help answer regulatory questions, and design machine learning models to implement wearable devices in the clinic.

Chris Cirillo
Chemomab Therapeutics

Chris Cirillo, Senior Director, Clinical Operations, Chemomab Therapeutics

Chris Cirillo is a Clinical Operations Professional with 25+ years of progressive experience from Clinical Research Associate to Senior Director, Clinical Operations. He's made a career in small/midsize pharma serving as an advisor and leader in design, implementation, and closure of large-scale programs, specifically clinical trials in all phases of development. While thriving in small organizations, it's provided the opportunity to work closely with others in Regulatory, CMC, Clinical Supply, Medical Writing, Research, and Medical Affairs to understand the cross-functional aspects of Drug and Device Development.

Andrew I Coates
AbbVie Inc

Andrew Coates, Feasibility Director, AbbVie

Andrew Coates is a Director on the Study Feasibility team at AbbVie. Throughout his 20+ years with the organization, Andrew spent nearly two decades in clinical operations, with over ten years leading multiple clinical programs. He has spent the last four years in Study Feasibility working with study teams to develop better protocols for patients and sites, preparing data-driven study timelines, and optimizing country/site selection. Along with a cross-functional team of experts, he has spent the last two years developing CATALYST, an innovative clinical study planning tool enabling users direct access to machine-learning data to drive analytics-based decisions. Andrew earned his Bachelor’s Degree in Chemistry from Davidson College (NC) and his Master's Degree in Chemistry from the University of North Carolina.

Gary L Cobb
Boehringer Ingelheim Pharmaceuticals Inc

Gary Cobb, Head, Diversity & Inclusion in Clinical Trials, Boehringer Ingelheim Pharmaceuticals, Inc.

Gary Cobb serves as Boehringer Ingelheim's inaugural Head of Diversity, Equity & Inclusion in Clinical Trials and Patient Recruitment & Retention, U.S. Since joining Boehringer, he has been the driving force in launching, developing and managing the diversity in clinical trials division in the U.S. and infusing innovative, patient-centric approaches in their patient engagement strategies all while pushing the boundaries of what’s possible in healthcare. He is a member of the U.S. Clinical Development & Operations Leadership Team and supports the overall organization in diversity and community engagement strategy, growth, and innovation. Throughout his career as a passionate and progressive healthcare leader and advocate, Gary's focus has been centered on working to address critical challenges for patients and communities that continue to be underserved and underrepresented. He has a varied combination of expertise that enables him to uniquely bridge the gap between healthcare and innovation. Gary's clinical and healthcare experience, coupled with the personal and professional intersection of his community engagement and philanthropic efforts, bring a rich perspective in supporting the necessary work to achieve inclusive research and a human-centered culture.

Michael J Cohen
Thermo Fisher Scientific

Michael J. Cohen, Senior Director, Environmental Sustainability, Strategy & Innovation, Thermo Fisher Scientific

Michael J. Cohen, MSc, MBA is the Senior Director, Environmental Sustainability and Innovation at PPD. In this role, Michael leads PPD’s efforts to decarbonize clinical research at the study level through innovative solutions focused on key areas of carbon emissions. Prior to joining PPD in 2022, Michael helped start the CVS Health Clinical Trial Services business, developed pharmaceutical commercialization data programs at AETNA, worked in Medical Affairs at Johnson & Johnson and led a medical device startup. Michael is a bioengineer and materials scientist by training, with degrees from both University of California, Berkeley and Northwestern University, as well as an MBA in finance from Louisiana State University, Shreveport. Michael has published in both Science and Nature, presented medical videos at the Cannes Film Festival, previously served on the Dean’s Advisory Board at Harvard School of Dental Medicine and currently serves on the Northwestern University Alumni Admissions Council.

Cal Collins
OpenClinica LLC

Cal Collins, CEO, Engineering, OpenClinica LLC

Cal co-founded OpenClinica with colleague Ben Baumann in 2006. OpenClinica provides a comprehensive, best-in-class suite of data management and workflow solutions for clinical trials. Cal co-led a collaboration with an OpenClinica client and the FDA that won Bio-IT World’s 2022 Innovative Practice Awards for their work on an eSource initiative integrating EHR and EDC systems. He has been active in standards development work for many years, including as a member of CDISC’s Operational Data Model V2 feature team, the HL7 Vulcan Advisory Council and Steering Committee and the SCDM eSource Consortium.

Gina Conenello
US Dept of Health & Human Svcs

Gina Conenello, PhD, Interdisciplinary Scientist, DRIVe & BARDA, US Department of Health & Human Services

Gina Conenello, PhD, is a virologist who received her PhD from Mount Sinai School of Medicine. She joined BARDA/DRIVe in 2022 as a Program Manager to focus on de-risking cutting edge technologies, developing novel regulatory strategies, and facilitating decentralized care modalities for pandemic response. She currently leads the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program in BARDA DRIVe (Division of Research Innovation and Ventures), aiming to catalyze decentralized clinical studies and healthcare delivery at real world locations where patients are seeking care today. Prior to BARDA, she spent over 10 years at FDA as a lead reviewer and subject matter expert in point of care and home use diagnostics with a focus on microbiology diagnostics. During the pandemic she was instrumental in the EUA authorizations for the first home use tests for SARS-COV-2.

Camille Cook
LexisNexis Risk Solutions

Camille Cook, Sr Dir Strategy & Innovation, Risk Solutions, LexisNexis Risk Solutions

With 15+ years of experience, Camille has implemented innovative practices for Healthcare IT, Healthcare and Life Sciences organizations utilizing data, health informatics, epidemiology and human behavior patterns to create actionable insights that guide healthcare policy and meaningful use practices, and improve clinical care outcomes. Her recent experience includes evaluating syndromic infectious disease trends, healthcare operations, health economic outcomes research, and social determinants of health.

Anca Copaescu
Strategikon Pharma

Anca Copaescu, CEO, Strategikon Pharma

Anca Copaescu, CEO, is the powerhouse behind Strategikon's success and the driving force behind the company's revolutionary Clinical Maestro® platform. With over 15 years of experience in the clinical research industry, Anca's expertise in clinical outsourcing and analytics is second to none. As Head of Clinical Outsourcing and Analytics at BioMarin Pharmaceuticals, she managed and advanced the company's global outsourcing, vendor management and clinical analytics functions. Her passion for efficiency and innovation led her to relentlessly pursue improvements in clinical study planning, outsourcing, and financial management. And when she couldn't find a technology solution that met her standards, she decided to build a better one - the game-changing Clinical Maestro platform.

Sebastien Coppe
One2Treat

Sebastien Coppe, CEO, One2Treat

Sébastien Coppe, CEO of One2Treat, is an accomplished leader in clinical trial innovation, driving change and delivering impactful software solutions for a better biopharma industry. At One2Treat, he is motivated by a strong belief in the transformative power of digital solutions to address patient needs and streamline clinical research. He is committed to pioneering approaches that prioritize patient-centricity in clinical trial design, decreasing sample size and therefore enhancing biopharma productivity.

Mary Costello
Evinova An AstraZeneca Healthtech Co

Mary Costello, Evinova An AstraZeneca Healthtech Co

Mary Costello has spent over 30 years supporting commercial growth for companies in the healthcare and drug development sectors. She has worked across multiple functions in the clinical and post marketing services continuum from clinical to data management and logistics to digital tools with a particular focus on site services. She has served as an advisor and strategist to multiple start up groups and today is leading Evinova’s strategic marketing effort.

Jodi B Coughlin
Deciphera

Jodi Coughlin, Senior Director, Vendor Performance and Strategy, Deciphera Pharmaceuticals

With 20 years of experience and industry roles spanning across small to large CRO and Sponsor organizations, Jodi attributes developing budgets and proposals in her early CRO days to deepening her understanding of the critical relationship between CROs and Sponsors. As she progressed in her career, she transitioned to supporting Sponsor organizations in Outsourcing Management, developing processes and negotiating CRO budgets and contracts for Phase I-IV clinical trials. Her passion for developing effective communication and governance structures expanded as she discovered a gap in “true strategic partnerships” between cross-functional trial teams. With the addition of ICH E6 R2, Jodi found her niche as she began to lead and develop strategic and innovative vendor management and performance management oversight solutions between Sponsor and CRO matrix organizations. She is highly passionate about establishing internal and external cross-functional communication processes, effective issue escalation pathways and finds joy in building positive strategic partnerships that drive quality performance in support of clinical trial development.

Amy E Cramer
Johnson and Johnson Innovative Medicine

Amy Cramer, Founder and Director, Vulcan; Data Acquisition, eSource, Johnson & Johnson Innovative Medicine

Amy Elizabeth Cramer draws on her experience as a cardiac critical care nurse, clinical research coordinator, certified healthcare quality professional, and clinical research informaticist. Amy has worked in a community hospital, an independent academic medical center, and a world-class, academic medical institution. She is currently a Director of Data Acquisition-eSource for Johnson and Jonson Innovative Medicine. Amy is the founder of Vulcan, HL7 FHIR Accelerator dedicated to Translational and Clinical Research. She holds several previous leadership roles such as the Vice Chair for the Society for Clinical Data Management (SCDM) eSource Consortium, Co-Chair HL7 Clinical Interoperability Council and Board for the North Carolina Healthcare Quality. Throughout her career, Amy’s focus has been to determine improvements that provide better patient-centric care, whether that is in developing a visualization for a complex hypoglycemia protocol, developing a transplant quality program, or optimizing the use of the electronic health records for clinical research. Currently, Amy has been engaged in discussions about clinical trials solutions, which includes eSource; specifically, the secondary use of EHR data for clinical research. She is a TransCelerate member and reviewer for many professional journals. Amy received a Master in Management of Clinical Informatics from Duke University School of Medicine.

Gracy Crane
Roche Products Ltd

Gracy Crane, PhD, International Regulatory Policy Lead for RWD, Roche Products Ltd.

Building on a strong academic research background in pre-clinical molecular oncology at Oxford and MIT, I have also developed significant industry experience combining medical affairs, clinical development and trial design, health economics and health outcomes research. My industry experience spans UK and Europe, supporting pipeline, pre-launch and marketed products. I have been commended for my innovative and collaborative contributions for evidence generation to support products.

Roger A Craveiro
MSD

Roger Craveiro, Associate Director Specimen Lifecycle Management, Global Clinical Trial Operations, Merck Animal Health

Roger Craveiro is a Specimen Lifecycle Management, Associate Director with over two decades of experience in the pharmaceutical industry. Roger's career began at the bench in a molecular biology lab, screening human genomic libraries. Over the years, Roger transitioned into clinical operations and specimen management, applying his expertise supporting clinical trials and pharmaceutical drug development. Residing on the East Coast, Roger enjoys spending time outdoors where he finds balance and inspiration and an occasional round of discgolf with his family and friends.

Janeen Crawford
Merck

Janeen Crawford, Associate Director, Procurement, Research Procurement, Merck

Janeen Crawford brings over 30 years of experience in the healthcare industry, with a solid background in the pharmaceutical sector for over 22 years. Throughout her career, she has gained a diverse range of healthcare experiences, including Clinical Research, Sales, Medical Education, Expert Engagement, Operations, and Procurement. Currently, Janeen holds a crucial role as a manager for the Imaging services category in Merck's clinical research portfolio. Alongside her professional endeavors, Janeen actively serves her community in various capacities as a non-profit board member, Deacon, community advocate, and as a proud member of Delta Sigma Theta Sorority, Inc.

Jonathan Crowther
Pfizer Inc

Jonathan Crowther, PhD, Head Predictive Analytics, PRD (OARS), Pfizer Inc.

Strategic Visionary in Digital Transformation & Analytics Leadership with Proven Analytics Portfolio Management Expertise With a keen eye for Strategic Vision, I've been at the forefront of advancing analytical capabilities, particularly in site intelligence, operational metrics, and quality indicators. My prowess in Digital Transformation has been instrumental in the on-time delivery and precision of a diverse suite of predictive models, leveraging ML/AI and Generative AI technologies. My role extends beyond mere strategy. I've championed an analytical development portfolio including in-house data & analytics transaction platform serving >1400 users, generative AI, and advanced modeling for business intel, ensuring robust analytical methodologies are in place, which has been pivotal for leadership and governance decisions. My expertise in Business Analytics and Product Analytics has been the backbone of this success, coupled with a budget management responsibility of >$5M. Building and nurturing relationships is at the core of my approach. I've continuously influenced key organizational stakeholders, ensuring the seamless adaptation and implementation of analytics and intelligence strategies. My proficiency in Engagement Management and Data Governance has been crucial in maintaining positive vendor partnerships, emphasizing quality delivery and continuous improvement. As a people leader, I've instilled a performance-centric culture, emphasizing Business Planning and actionable metrics. My commitment to Data Strategies and analytical thinking has ensured project and portfolio deliveries are not just timely but also rooted in process improvement. I've coordinated work with an agile mindset, ensuring products are delivered with consistency and precision. My technical acumen extends to Natural Language Processing (NLP), Business Intelligence (BI), data visualization, and cloud platforms including AWS, positioning me at the intersection of strategy and technology.

Diana Cucos
Syneos Health

Diana Cucos, President FSP 360, FSP 360, Syneos Health

With over 25 years in the pharmaceutical and CRO industries, Diana Cucos leads Syneos Health's FSP 360 division, delivering tailored solutions to meet clients' evolving needs. Her leadership spans clinical operations, project management, and strategic planning, managing over 6,000 resources across 50+ countries. Recognized for her commitment to advancing clinical research, Diana was named one of PharmaVoice's 100 Most Inspiring People in 2021 and an HBA Luminary in 2017.

Leila Cupersmith
Choice ClinOps, LLC

Leila Cupersmith, Founder & CEO & Principal Consultant, Choice ClinOps LLC, Individual Consultant

Karina D'Angelo
Parexel Intl

Karina D'Angelo, Scientific Dir, Real World Data Strategy, Parexel Intl

P. Karina D’Angelo Ph.D. is a healthcare informatics professional with over twenty-five years of experience in working with real world data (RWD), medical informatics, and analytics. Dr. D’Angelo received her Ph.D. with distinction from Columbia University, where her research focused on data algorithms to facilitate stroke detection from radiological images and medical reports. Since receiving her degree, she has successfully led and managed numerous healthcare data-driven initiatives including value-based care and cohort-based outcomes analysis for multiple health systems including Montefiore Medical Center and Providence Health. She brings her leadership and informatics skills into her current role to develop strategy and processes for the delivery of global RWD in the execution of external control arms, retrospective, and safety studies.

Simon Dagenais
Pfizer

Simon Dagenais, RWE Lead, Internal Medicine, Pfizer Inc.

Business-minded researcher and team leader with strong clinical background, graduate training in epidemiology and health economics, and over 15 years of experience designing, conducting, and communicating scientific research to healthcare providers, hospital administrators, health plan executives, policymakers, and others. Extensive hands-on experience with study design, execution, data analysis, and scientific writing, as demonstrated by track record of publications and presentations. Skilled in development and synthesis of evidence in acute and chronic pain, spinal disorders, musculoskeletal conditions, neurologic disorders, rare genetic diseases, and other therapeutic areas.

Kourosh Davarpanah
Inato

Kourosh Davarpanah, CEO, Inato

Kourosh Davarpanah is co-founder and CEO of Inato, a global marketplace that matches community-based research sites with the right clinical trials. Kourosh spearheads Inato’s vision to empower each and every investigator to offer the right trial to their patients, making clinical trials more accessible, inclusive and efficient. Before founding Inato, he worked on the design of decentralized trust systems and co-founded a startup in the transportation industry. Kourosh is a graduate of Ecole Polytechnique and Columbia University.

Ashley Davidson
Advarra

Ashley Davidson, VP, Product Lead, Advarra

Ashley Davidson is the Vice President, Product Lead at Advarra. In this role, Ashley collaborates with current partners and the research community to understand their challenges and translates those challenges into solution-based enhancements to our product offerings. Ashley has over 20 years of expertise in site activation, clinical operations, data management, and clinical strategy. For the last 12 years, Ashley has held a variety of senior positions in life sciences technology organizations, both in Product Strategy and Product Management, where she has led GTM and customer adoption strategies, as well as product development and delivery.

Caroline J Davis
PCORI Patient Centered Outcomes Research Institute

Caroline Davis, MPP, Senior Program Associate, Public and Patient Engagement, PCORI Patient Centered Outcomes Research Institute

Caroline Davis is a Senior Program Associate in the Public and Patient Engagement team at the Patient-Centered Outcomes Research Institute (PCORI). In her role, Caroline assists in the management and planning for PCORI’s Science of Engagement funding initiative, and in other project management activities related to supporting Engagement in research in PCORI’s funded research portfolio, including the update of PCORI’s engagement guidance and release of the Foundational Expectations for Partnerships in Research. Before joining PCORI in 2021, Caroline worked in diversity, equity and inclusion training and tool development for a medical professional association. She received her master’s in public policy from George Washington University in 2019, where she focused on health economic policy.

Dominic De Bellis
Merck & Co., Inc.

Dominic De Bellis, PhD, Executive Director, AI Strategy & Operations Lead; Global Clinical Trial Operations, Medical Writing & Disclosure, Merck & Co., Inc.

Dominic De Bellis, PhD, is an established business leader with 30 years of experience in scientific and medical communications. Known for strong communication skills and extensive business development experience, Dom has transitioned into the realm of Artificial Intelligence (AI) projects as they apply to document writing and development. With a strong working knowledge of advanced technology and a specific focus on the intersection of AI with clinical study documents, he brings a unique blend of expertise to the table. Dr. De Bellis skillfully communicates complex concepts, making them accessible to diverse audiences.

Nancy DeFusco
Merck Sharp & Dohme, LLC

Nancy DeFusco, Director, Specimen Lifecycle Management, Merck Sharp & Dohme LLC

20+ years in the industry including positions in central lab supplier, EDC and sponsor roles. Currently, leading a new organization that has grown out of the goal for end to end management of biospecimens from collection to destruction.

Angela DeLuca
Amgen

Angela DeLuca, Associate Vice President, Global Study Operations, Amgen

Angela DeLuca is the Associate Vice President and Head of Global Study Operations at Amgen. In this role, Angela leads the Site Management and Data Management organizations, ensuring excellence and consistency in clinical trial execution across the portfolio. With 20 years of experience in the biopharmaceutical industry, Angela has extensive expertise in oncology and has lived and worked in both the US and Japan. She is recognized for her ability to drive global clinical development excellence through innovative operational strategies and the early adoption of digital health initiatives, optimizing the R&D landscape to accelerate products to the global market. Before joining Amgen, Angela was the Vice President of Oncology and Cell Therapy Clinical Operations at Takeda. She also held leadership positions at both AbbVie and Abbott, where she transformed clinical development operations and established a center of excellence that became an industry benchmark. As the Head of Strategy and Operations for Portfolio Program Management, Angela partnered with the R&D Leadership team to identify and implement innovative improvements across the organization. In her role as Head of Innovation, she led the Japan Design Lab team, integrating digital technologies, health technologies, big data, and predictive analytics to enhance clinical trial design and support strategic business decisions. Angela holds an MBA in Innovation from the University of North Carolina Chapel Hill, Kenan Flagler Business School, and a Bachelor’s in Chemistry from The Ohio State University. She is also a certified PMP.

Angela DeLuca
Takeda Pharmaceuticals Inc

Angela DeLuca, VP & Head, Oncology & Cell Therapy Clinical Operations, Takeda Pharmaceuticals Inc

Angela DeLuca is the Associate Vice President and Head of Global Study Operations at Amgen. In this role, Angela leads the Site Management and Data Management organizations, ensuring excellence and consistency in clinical trial execution across the portfolio. With 20 years of experience in the biopharmaceutical industry, Angela has extensive expertise in oncology and has lived and worked in both the US and Japan. She is recognized for her ability to drive global clinical development excellence through innovative operational strategies and the early adoption of digital health initiatives, optimizing the R&D landscape to accelerate products to the global market. Before joining Amgen, Angela was the Vice President of Oncology and Cell Therapy Clinical Operations at Takeda. She also held leadership positions at both AbbVie and Abbott, where she transformed clinical development operations and established a center of excellence that became an industry benchmark. As the Head of Strategy and Operations for Portfolio Program Management, Angela partnered with the R&D Leadership team to identify and implement innovative improvements across the organization. In her role as Head of Innovation, she led the Japan Design Lab team, integrating digital technologies, health technologies, big data, and predictive analytics to enhance clinical trial design and support strategic business decisions. Angela holds an MBA in Innovation from the University of North Carolina Chapel Hill, Kenan Flagler Business School, and a Bachelor’s in Chemistry from The Ohio State University. She is also a certified PMP.

Vivian DeWoskin
Faro Health Inc.

Vivian DeWoskin, Chief Strategy Officer, Strategy, Faro Health Inc.

Vivian is currently the Chief Strategy Officer at Faro Health, a healthcare technology company dedicated to driving innovation in Clinical Development. At Faro, she leads marketing and professional services, and works to maintain strategic alignment across the organization as the company scales. Previously, she was Chief Commercial Officer at NeuraLight, a digital biomarker and diagnostics company focused on neurodegenerative diseases. Prior to her role at NeuraLight, she was the VP of Strategy at Komodo Health, where she led a cross-functional team of market strategists to set corporate and segment-level revenue goals, direct product development strategy, and lead GTM operations for Komodo’s software and data products for Life Sciences and Healthcare customers. Before her roles in sales and segment leadership at Komodo, Vivian spent nearly a decade in life sciences strategy consulting at Trinity Life Sciences, supporting both small biotech and large pharma clients on everything from early commercial planning and portfolio strategy, to L&A opportunity assessments, to new product launch planning. Vivian holds a BA from Princeton University, where she studied cognitive and computational neuroscience, and an MBA from Berkeley-Haas.

Chris Decker
CDISC

Chris Decker, President & CEO, CDISC

Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development, clinical research, and consulting and his 20-year engagement with CDISC includes roles as a volunteer, implementer, and board member. Chris is passionate about leading CDISC towards a technology-based standards future and expanding the organization's global impact in clinical research standards.

Charmaine Demanuele
Pfizer

Charmaine Demanuele, PhD, Executive Director, Head, Quantitative Sciences for Digital Sciences & Translational Imaging, Pfizer Inc.

Dr. Charmaine Demanuele is an Executive Director in the AI/ML Quantitative and Digital Sciences group within Global Biometrics and Data Management, Pfizer Research & Development. She leads a team of statisticians and data scientists that bring end-to-end clinical trial innovation with digital health technologies, imaging and statistical, AI/ML methodologies. Her group works across Pfizer's portfolio to develop novel digital endpoints, and leverages models such as Bring-Your-Own-Device and Decentralized Clinical Trials to enable efficient, patient-centric trials and faster breakthroughs for patients. Prior to joining Pfizer, Charmaine was as a neuroscience research fellow at Harvard Medical School and Massachusetts General Hospital in Boston.

Danny Den Hamer
myTomorrows

Danny Den Hamer, Product Manager, Software Engineering, myTomorrows

Danny is a former pharmacist turned software engineer and product manager, leveraging his diverse background to revolutionize healthcare through AI. At myTomorrows, he leads the development of TrialSearch AI, a peer-reviewed, generative AI tool that simplifies clinical trial discovery and access for physicians and patients. With a passion for innovation, Danny showcases how the intersection of healthcare, technology, and design can create groundbreaking solutions that positively impact lives.

Jenny Denney
Parexel

Jenny Denney, EVP, Global Head Parexel FSP, Parexel

Jenny Denney is Executive Vice President and Head of FSP Clinical and Biometrics. In this role, she provides leadership and strategic direction to Parexel’s Clinical and Biometrics business leading diverse functional teams that span the globe. Jenny has more than 20 years of biopharmaceutical experience and has been at Parexel for 12 years. Her expertise spans clinical research and development, commercial strategy, and clinical and project leadership with experience working with CROs, large pharma, and biotech. More recently, as Senior Vice President and head of Strategic Clinical Leadership of Global Clinical Operations (GCO) at Parexel, she led the clinical strategy and oversight for the company’s top partnership accounts. This included developing the infrastructure to manage the complex transition of work from Full Service to FSP for a top global pharmaceutical company. During her career, Jenny was involved with multiple NDA submissions and regulatory authority inspections.

Robert A DiCicco
TransCelerate BioPharma Inc.

Robert DiCicco, Vice President, Portfolio Management, TransCelerate BioPharma, Inc.

As Vice President of Portfolio Management at TransCelerate, Rob's current role includes oversight of a portfolio of projects that include digital transformation, pragmatic trials, and real-world data. He is a member of the Vulcan Advisory Committee. From 2018-2021, Rob was the Deputy Chief Health Officer at IBM Watson Health, where he led external collaborations to implement digital COVID Trial screening tools and leveraged his industry experience to guide software developers working on life sciences offerings. He joined IBM after a long career in Pharmaceutical R&D spanning nearly 30 years; 25 with GlaxoSmithKline where he served in a variety of leadership positions. While at GSK, Rob was the Vice President of Clinical Pharmacology Sciences and Study Operations with a global footprint that included the US, UK, Australia, and China. Rob’s team designed clinical trials aimed at profiling new medicines, establishing proof of concept, and delivering critical data for product labeling. He also led the development of a number of late-phase oncology projects leading to successful product approvals. In 2015, Rob launched a Clinical Innovation and Digital Platforms Team at GSK where he focused on identifying, evaluating, and piloting emerging technical solutions to automate different areas of clinical trial design and implementation. Under his leadership, Rob’s team launched the first industry-sponsored Apple Research Kit Study to assess disease burden in rheumatoid arthritis patients in a real-world setting. He also led the Common Protocol Template and Digital Data Flow work streams sponsored by TransCelerate. He was also one of the team leads for the Clinical Trials Transformation Initiative (CTTI) sponsored Mobile Clinical Trials Novel Endpoints project. Rob received his Doctor of Pharmacy Degree from the University of the Sciences in Philadelphia. His areas of expertise and interest include clinical trial design, clinical operations, protocol quality, and ethics in research.

Abigail Dirks
Tufts University

Abigail Dirks, MS, Data Scientist, Center for the Study of Drug Development (CSDD), Tufts University

Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative site burden and experience, risk-based quality management (RBQM) adoption, clinical research associate (CRA) performance, decentralized clinical trials (DCT) use and impact, patient recruitment and retention and study volunteer participation burden. Abigail has published the results of her studies in peer-review journals including Therapeutic Innovation and Regulatory Science and Clinical and Translational Science. She has also presented at major industry conferences including Clinical Trials in Oncology Conference and the Xpectives Health Summit and as a keynote speaker at the Society for Clinical Research Sites Global Summit and the Citeline Awards. She received an MS in Health Informatics and Analytics from Tufts University School of Medicine, Boston, MA and a BS in Data Science and Mathematics from St. Michael’s College, Colchester, VT.

Sina Djali
Janssen R&D LLC

Sina Djali, Head, Data Management and Central Monitoring, Immunology and Medical Affairs, Johnson & Johnson

Sina Djali has over 25 years of experience in drug and clinical development in various companies and academia. Currently he is the head of Integrated Clinical and Operations Analytics at Jansen Pharmaceuticals. In this role Sina is responsible for incorporating Risk Management principles through applied analytics in the day to day R&D clinical operations. This includes managing both data engineering and analytics/data science teams to provide sustainable solutions in support of R&D clinical operations. Prior to this role, Sina was the head of Risk Management - Central Monitoring at Janssen R&D. Previously he has been responsible for Clinical Process and System Department at Tibotec Pharmaceuticals, where he developed and implemented a data driven Quality Risk Management System. He has also held several positions in research, regulatory affairs and R&D Quality Assurance departments at Wyeth and Aventis Pharmaceuticals.

Marissa Dockendorf
Merck

Marissa Dockendorf, Executive Director, Head of Digital Clinical Measures, Merck & Co., Inc.

Marissa Dockendorf, PhD, is the Executive Director and Head of the Digital Clinical Measures group at Merck. She has 18 years of experience in the pharmaceutical industry and has made significant contributions to the research and development of several pharmaceutical products. In her current role, she leads a team of scientists in identifying, developing, and implementing novel digital clinical measures in clinical trials across Merck's portfolio to enable more efficient and patient-centric drug development. She has played critical roles in driving innovation projects focused on modernizing clinical trials and has been instrumental in inclusion of blood micro- and outpatient sampling, digital medication adherence monitoring technologies, and wearable devices in clinical trials. Prior to her current position, Marissa spent 10 years in Merck's Quantitative Pharmacology & Pharmacometrics organization providing pharmacokinetic and pharmacometric expertise and scientific oversight for numerous programs across the drug discovery-development continuum, covering diverse therapeutic areas including cardiovascular, neuroscience, and ophthalmics. Marissa also worked at Johnson & Johnson Vision Care for 3 ½ yrs, where she contributed to the research & development of ocular drug-device combination products. Marissa has co-authored over 30 peer-reviewed manuscripts. She has a PhD in chemical engineering and a master’s degree in biomedical engineering from the University of Florida and an undergraduate degree from the Illinois Institute of Technology.

Martha Dockery
Exact Sciences

Martha Dockery, MS, Associate Director, Clinical Monitoring, Health Equity Champion Exact Sciences

Martha Dockery is a highly accomplished professional in the field of clinical research, currently serving as the Associate Director of Clinical Monitoring at Exact Sciences and a Health Equity in Clinical Trials Champion. With a wealth of experience in her role, Martha has successfully overseen and directed a diverse portfolio of clinical trials, demonstrating exceptional operational efficiency and strict adherence to regulatory standards. As a Health Equity Champion, Martha actively fosters a commitment to advancing health equity in clinical trials, spearheading initiatives that promote inclusivity and equitable representation in research. In addition to her leadership in clinical research, she also holds a Literacy Specialist Certificate, further showcasing her dedication to education and advocacy. In addition to her clinical expertise, Martha is deeply committed to advancing Diversity, Equity, and Inclusion (DEI) within the realm of clinical trials. Serving as a staunch DEI advocate, she actively promotes and showcases the importance of diverse representation in research studies. Moreover, Martha excels as a strategic leader and dedicated people manager, fostering an inclusive and supportive work environment that enables her team to thrive and achieve remarkable results. Martha's unwavering dedication to advancing DEI initiatives in clinical research exemplifies her steadfast commitment to social equality and her innovative approach to transforming healthcare practices.

Craig Dorer-Abadia
Worldwide Clinical Trials

Craig Dorer-Abadia, Executive Director, Project Management, Oncology, Worldwide Clinical Trials

Craig is a clinical research professional with over 20 years of industry experience. He started his career with a Dermatology specialization eventually broadened to include general medicine, rare/orphan diseases, and oncology. In his role at Worldwide, Craig is a leader within the oncology department where he has focused on mentoring and growing the project management team, and building and growing sponsor partnerships. His broad indication experience, as well as his experience having held roles at CROs ranging from niche to Top 5 largest globally have informed his management style and program oversight, and client relationships.

Donna Dorozinsky
Just in Time GCP

Donna Dorozinsky, Founder and CEO, Just in Time GCP

Donna Dorozinsky, President & CEO Just in Time GCP As the Founder and CEO of Just in Time GCP, Donna Dorozinsky leads a highly respected organization dedicated to supporting life sciences companies in maintaining Good Clinical Practice (GCP) compliance and optimizing clinical trial operations. Her company provides specialized clinical compliance and inspection readiness consulting and Trial Master File (TMF) management services. With over 30 years of experience in study operations, Donna possesses in-depth knowledge across a broad spectrum of functions, including clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. Her extensive experience working with a diverse range of stakeholders-from small biotech startups to large pharmaceutical companies, academic institutions, regulatory agencies, CROs, and investigator sites-enables her to effectively guide organizations toward achieving and sustaining GCP compliance. Donna’s career began at GlaxoSmithKline, where she spent 15 years focusing on Phase I Clinical Research Operations. In 2005, she founded Just in Time GCP, which has since evolved into an industry recognized leader in clinical compliance and operational optimization. Throughout her career, Donna has successfully led complex, large-scale projects, conducting operational gap analyses and driving process improvements for sponsors, CROs, and clinical sites. Her expertise in inspection readiness has helped numerous organizations successfully navigate regulatory inspections and implement remediation strategies for eClinical systems, quality management systems, and TMF services. A well-known speaker and dynamic educator, Donna has delivered numerous training programs on topics such as GCP compliance, Quality Management Systems (QMS), Inspection Readiness, and TMF Management. She is the Lead Editor of the 2024/2025 edition of Good Clinical Practice: A Question and Answer Guide and serves as a member of the TMF Reference Model Steering Committee. Donna’s leadership and entrepreneurial accomplishments have been recognized by Ernst & Young, which named her an Entrepreneur of the Year. Under her direction, Just in Time GCP has been included on the INC5000 list for four consecutive years. Donna holds a BSN from Gwynedd Mercy University, where she also serves on the Board of Trustees, and an MSN from Widener University.

Thomas Dougherty
Novo Nordisk

Thomas Dougherty, Lead, Data Science & AI Innovative Partnership, Novo Nordisk

Tom Dougherty is currently the Data Science & AI Innovative Partnership Lead at Novo Nordisk. He is responsible for developing external partnerships to accelerate the development of new assets across the portfolio. Prior to Novo Nordisk, Tom was the Director of RWE Partnerships & Innovation at Pfizer where he launched therapeutic area external data partnerships and novel technologies. Tom has over 18 years of experience in healthcare with Merck, GE Healthcare, Boston Scientific, and Premier. He received a bachelor’s degree in chemistry and an MBA from Villanova University.

Joseph Dustin
eClinical Consulting

Joe Dustin, Founder & Managing Partner, eClinical Consulting

Joe is an innovator sitting at the intersection of life sciences and technology with goals focused on making the whole drug development process faster for pharma and better for patients. Recent world events have brought the reality of how complex clinical trials are into the mainstream news and this pandemic has been a rallying cry for our industry resulting in the rapid acceptance of new ways to conduct clinical trials, designed with the patient experience at the center and technology that works smarter for all stakeholders. For almost 20 years, Joe has been a vocal and visible force in the Life Sciences industry specifically in the realm of eClinical Technology starting in the eCOA space, and most recently finishing up a 12-year run with Medidata. He has worked with top Pharmaceutical, Biotech, and CRO organizations on innovation, change management, implementation, product development, sales, and consulting. Joe is a graduate of Roger Williams University Gabelli School of Business with a degree in Computer Information Systems and Political Science. He is a member of the Drug Information Association’s Regional Advisory Council and the Leadership Council for the CNS Summit.

Dana Edwards
Endpoint Clinical

Dana Edwards, CCO, Endpoint Clinical

Dana Edwards is the Chief Commercial Officer at Endpoint Clinical, a leading provider of RTSM solutions for clinical trials. With over 20 years of experience in life sciences, Dana has a deep expertise in clinical trials and technology. She previously led commercial operations at Circuit Clinical, focusing on advancing patient engagement in clinical trials, and held leadership roles at IQVIA, managing global sales in Clinical Technology and Patient Recruitment. Earlier in her career, Dana gained foundational expertise in drug development and commercialization at Bausch & Lomb and Sanofi.

Sherrine M Eid
SAS Institute Inc

Sherrine M. Eid, Global Head, Real World Evidence & Epidemiology, SAS Institute, Inc.

Kevin Eisenfrats
Contraline, Inc.

Kevin Eisenfrats, Founder & CEO, Contraline, Inc.

Kevin co-founded Contraline and has been CEO since its inception. Contraline is a biotechnology company developing paradigm-shifting innovations in reproductive health, starting with the world's first long-lasting, reversible male contraceptive known as ADAM. Kevin has led Contraline from an idea to clinical-stage company, built a world-class team, and has brought in >$30M in funding. Prior to Contraline, Kevin was involved in drug development in immuno-oncology and non-hormonal female contraception. He is an inventor on over 50 patents relating to novel contraceptive drugs, medical devices, and biomaterials. He has a degree in Nanomedicine Engineering from the University of Virginia, and in 2017, was named on the Forbes 30 Under 30 in Healthcare. Kevin is also an active angel investor and startup advisor, with a focus on biotech, deep tech, and women's health companies.

Marie M Emms
Bristol Myers Squibb

Marie Emms, Head, Patient Engagement and Recruitment, Global Development Operations, Bristol Myers Squibb

Marie is Head of Patient Engagement & Recruitment at BMS. She is responsible for growing, developing and supporting a team to accelerate recruitment and enrollment through the creation of engagement programs globally. Prior to her role at BMS, Marie was the Global Head of Investigator & Patient Engagement at Johnson & Johnson. Marie specializes in the development and execution of strategic integrated communications programs to support sites and their patients through the clinical trial journey, from initial awareness and consent through to compliance and adherence. She has worked on a wide range of therapeutic areas across neonatal, pediatric, adult, and geriatric studies. Cross-functional collaboration is essential for the creation and delivery of effective strategies that drive enrollment and engagement in the clinical trials that enable sponsors to bring drugs to market faster and to the patients that need them. Marie’s unique Commercial and Clinical insight, as well as her spirit of partnership, encourages and ensures successful collaboration. Marie defines what it means to be a leader in today’s rapidly changing healthcare industry. She has a genuine and singular passion to improve the lives of patients-a passion that motivates and energizes her colleagues and everyone with whom she interacts.

Laura Engerman
ZS Associates

Laura Engerman, Principal, R&D, ZS Associates

No bio available.

Cassandra Erato
Spaulding Clinical Research

Cassandra Erato, CEO, Spaulding Clinical Research

Cassandra Erato’s comprehensive knowledge of early phase drug development is driven by her depth of experience within Spaulding Clinical Research, an early phase CRO. She joined at its inception in 2007 and was named CEO in 2020. Previously, she managed all facets of daily operations as COO and has always held a leading role in integrating new technologies in the operation. Her extensive experience in clinical operations and leadership within a pioneering clinical research organization positions her as an authoritative voice on the integration of technology in accelerating clinical trials.

Jonathan Ernst
PCM Trials

Jonathan Ernst, VP Business Development, Bus Dev, PCM Trials

Jonathan is the Vice President of Business Development at PCM Trials. Jonathan offers a unique blend of experience in operational and strategy roles, applying both to the design required for mobile visit services. Jonathan specializes in collaborative and consultative relationships to bring mobile visits to patients.

Andres Escallon
Suvoda

Andres Escallon, Vice President, eCOA Solutions Strategy, Suvoda

No bio available.

Thierry Escudier
Pistoia Alliance

Thierry Escudier, Portfolio Lead, Pistoia Alliance

A leader in Clinical Research with more than 30 years' experience in Corporate R&D pharma organizations, Thierry has been promoting patient engagement strategy across the Industry. Thierry is now acting as an independent consultant providing strategic consulting and is very much convinced that digital innovation and patient engagement are the key success factors in the drug development phase and will impact positively the medicinal product lifecycle. Thierry acts as a Portfolio Lead for the Pistoia Alliance, a global, not-for-profit members’ organization collaborating to lower barriers to innovation in life science and healthcare R&D.

Cheryle Evans
Advanced Clinical

Cheryle Evans, SVP, Global Clinical & Biometric Operations, Global Clinical & Biometric Operations, Advanced Clinical

Cheryle is a senior-level executive with extensive, progressive clinical research experience and is responsible for the strategic planning and tactile operations in project management, clinical monitoring, site activation, safety and document management. She has led global teams across multiple disciplines, successfully utilizing automation to improve quality and streamline operations. Prior to joining Advanced Clinical in 2013, Cheryle was the VP of Clinical Monitoring, NA, with inVentiv Health Clinical, where she led the optimization of three global strategic units: Global Study Start-Up, Expedited Safety Reporting and Document Management and Publishing. Prior to her tenure with inVentiv Health Clinical, Cheryle was part of a strategic team with Essential CRO, where she supported the transition and growth from a site management organization to a top-five, global, full-service CRO. Cheryle has therapeutic expertise in cardiovascular, urologic, dermatologic and women’s/men’s health clinical trials. A life-long Chicagoan, Cheryle is a registered nurse in the state of Illinois, with a specialty in critical care nursing, and she attended the University of Illinois at Chicago. She is a published thought leader on implementing risk-based monitoring for midsize pharma, biotech and device companies and a frequent speaker at industry conferences.

Jack Evans
EmVenio Research

Jack Evans, VP Site Operations, Site Operations, EmVenio Research

Jack Evans has more than a decade of clinical research experience that spans over 5 continents and is knowledgeable in a vast array of therapeutic areas and trial designs across all phases of clinical development. As Vice President of Site Operations at EmVenio, he is focused on developing infrastructure, client partnerships and leading operational delivery to deliver business growth and expansion. Jack has held senior positions at Pratia, PPD (AES), and Synexus Clinical Research. As a cross functional and operational delivery leader, he was part of the team that built Europe’s largest site network including full commercial accountability, implementing international frameworks for feasibility, contracts, and global project project management. He earned a BS in Pharmaceutical Science from the University of Wolverhampton, Faculty of Science & Engineering.

Mark Evans
Faze

Mark Evans, Managing Director, Faze

No bio available.

Michelle Everill
Alnylam Pharmaceuticals

Michelle Everill, Vice President, Global Trial Optimization, Alnylam Pharmaceuticals

Michelle Everill is a pioneer in the field of clinical trial optimization that includes the intersection of data science, technology, innovation, and process simplification and flexibility. She has worked in clinical research since 2000 in a variety of roles at sponsors, CROs, and sites, and has participated in trials as a patient. She strives to drive more effective trials in terms of scientific advancement, patient, site, and operational burden, and the time and cost trade off. Michelle has led feasibility, data science, and business operations organizations at three of the top-ten pharma companies, consulted for and advised many organizations, and recently joined Alnylam as VP, Global Trial Optimization to further strategic approaches to innovative and curative medicines research.

Matthew Failor
MAIA Biotechnology

Matthew Failor, Director & Head, Clinical Operations, MAIA Biotechnology

Matthew Failor is the Director and Head of Clinical Operations for MAIA Biotechnology. Currently he is responsible for the delivery and oversite of global Phase II/III multi-national clinical trials. Over his 13-year career, he worked and led key clinical trials that contributed to the FDA approval of several new therapies such as VEKLURY (Remdesivir), KEYTRUDA (Pembrolizumab), and ENTYVIO (Vedolizamab).

Diane Faraone
PurpleLab

Diane Faraone, Senior Director, Pharmacy Analytics, Clinical, PurpleLab

Diane Faraone is the Senior Director of Pharmacy Analytics at PurpleLab. Her professional training spans over 25 years in clinical pharmacy practice. She has held leadership roles in payer, provider, and pharmacy benefit management, consulting, product development for episode grouping methodologies, data analytics, payment integrity, and specialty pharmacy practice.

In her current role at PurpleLab, Diane is responsible for leading clinical content, product, and process development related to pharmacy and data analytics. She provides internal and external sales, advertising, and marketing clinical content and publication development. She has authored and contributed posts, blogs, podcasts, abstracts, and posters for presentation related to specialty pharmacy, data analysis, and emerging trends in drug development and utilization. She serves on various committees and expert panels in the development of specialty pharmacy adherence, quality measures and abstract reviews.

Diane received her Doctor of Pharmacy degree from the University of Rhode Island, a collaborative program with Brown University Medical School and completed course work in a doctoral program in pharmacology & toxicology at the University of Connecticut School of Pharmacy. Prior to that, she received her Bachelor of Science in Pharmacy from the University of Rhode Island.

Alyssa Farrell
SAS Institute Inc

Alyssa Farrell, Director, Health and Life Sciences Practice, SAS Institute Inc

Alyssa Farrell leads industry marketing for the SAS Global Health and Life Sciences Practice. In this role, she focuses on the SAS solutions that help optimize health outcomes for individuals and their communities. Alyssa is actively engaged in analyst relations, market research and influencer marketing to stay on top of industry trends and align SAS capabilities to customer needs. She has also supported the global energy and public sector teams during her career at SAS. Prior to joining SAS in 2004, Alyssa was a senior consultant in the Deloitte Public Sector practice. She earned her MBA degree with a concentration in Management Information Systems from the University of Arizona. She also holds a Bachelor of Arts degree with honors from Duke University.

Jessica J Federer
Angelini Ventures

Jessica J. Federer, Board Member, Angelini Ventures

Jessica Federer is a recognized leader in the global life sciences industry. She was the first Chief Digital Officer for the Bayer AG group, as well as the first woman to hold that role in the industry. She led Bayer’s digital transformation across the pharmaceutical, consumer care, crop science, material science and animal health businesses during record setting years for both sales and EBITDA. Reporting into the Bayer AG Group Management Board, Federer united the company’s digital strategy and investments across divisions to accelerate growth across the 118,00 employees. During her tenure, the company acquired and integrated Merck’s consumer care business and Monsanto, becoming, respectively, the second largest consumer health and the leading agriculture businesses on the planet, and floated their material science division into Covestro. With a focus on scalable digital enablers to business integrations and success, Federer streamlined investments, modernized capabilities, and upskilled the workforce. Prior to leading digital for the group business, Federer established a track record inside Bayer for delivery across regulatory affairs, market access, product launches, and business turnarounds. This includes the launch team for the record holding biologic EYLEA ®, an overhaul in the animal health business, and establishing the market access function globally. Federer regularly contributes to publications and events for the FT, Reuters Health, Bloomberg, and leading consultancies. Ms. Federer joined BMP as a Venture Affiliate in 2018, and is a Partner for the Opportunity Fund. She is a graduate of George Washington University and received an MPH from the Yale School of Public Health.

Olivia Feiro
CSL Behring

Olivia Feiro, Director, Clinical Risk and Document Management, CSL Behring

Olivia began her career as a clinical research associate at a contract research organization prior to becoming a lead clinical research associate and then a project manager, overseeing the operations of clinical trials in multiple therapeutic areas. After several years in project management, Olivia transitioned to the risk-based monitoring space. She supported the start-up of RBM within the CRO, including process design, procedural document development, RBM platform support and performing central monitoring activities. In 2019, Olivia joined CSL Behring to lead the central monitoring group and the implementation of Risk Based Quality Management practices.

Bryan Feldman
AbbVie

Bryan Feldman, Senior Director, Business Technology for Clinical Development, Regulatory Affairs, and R&D QA, AbbVie

Entered the industry nearly 25 years back now. Have led a wide range of technology and business organizations for 2 large pharmas throughout my career. Currently lead a team in AbbVie's Development Business Technology group with software development, data engineering, RPA and AI solutions for Clinical Development, Regulatory, Medical Affairs, Pharmacovigilance and Data Management business functions.

Christine M Fernandez
Cell & Gene Therapy

Christine M. Fernandez, Consultant, Cell & Gene Therapy

Christine Fernandez is an advanced practice nurse leader with over 30+ years of experience across a variety of cell and gene platforms. She has extensive experience creating treatment plans, developing protocols, and establishing collection requirements and cell processing center networks for both clinical and commercial programs. She is currently providing consulting services assisting with Strategic Planning, Resource Development and Patient Care Protocols to several start-up biotech companies globally. Christine serves on the Executive Board of the World Apheresis Association, is a member of the Qualification in Apheresis Exam Committee and is a Past President of the American Society for Apheresis. She is dedicated to ensuring patients and families have access to cutting-edge care while reducing disparities.

Macarena Fernandez
Pfizer

Maca Fernandez, Disease Intelligence Analytics Lead, Pfizer Inc.

Maca Fernandez holds a Bachelor’s degree in Veterinary Medicine and Surgery and brings over 17 years of diverse experience in the clinical research sector. With a robust background that spans site-facing roles to feasibility assessments, Maca has recently transitioned into strategic program-level initiatives. Passionate about integrating real-world evidence (RWE) into healthcare practices, Maca focuses on enhancing the patient journey and ensuring the patient perspective is at the forefront of decision-making. Her special blend of clinical and strategic expertise positions her as a key advocate for innovative approaches in improving patient outcomes.

Jay Ferro
Clario

Jay Ferro, Exec VP, Chief Information & Technology Officer, Clario

Always striving for excellence, Jay heads up Clario’s development, information technology and strategic sourcing initiatives. With over 25 years of experience of working as a global technology leader, Jay has a wealth of knowledge which helps drive changes that are critical to managing data protection. An expert in improving and implementing data policies, Jay is well placed to ensure the complete privacy and protection of data belonging to Clario’s customers and patients.

Reed Few
Johnson & Johnson

Reed Few, Director, External Innovation, Data Science & Digital Health, Research and Development, Johnson & Johnson

I am a passionate real-world-data & evidence enthusiast with 12 years of experience in the biotech industry. Most recently, I worked in the early days (employee #10) at ConcertAI in NYC. During my career at J&J, I have focused on the external innovation space (primarily oncology) for data science and digital health initiatives (primarily Phase II+). During this time, I have connected with small and mid-size companies (but mostly start-ups) all over the globe, and am super passionate making connections and creating opportunities in the industry.

Rosalie Filling
Endo Pharmaceuticals Inc

Rosalie Filling, Vice President, Senior Global Head, R&D Operations, Endo

For 25 years, Rosalie “Rosie” Filling has developed clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence-transforming R&D operations for pharmaceutical companies. As a member of the global R&D leadership team at Endo, she oversees the coordination and implementation of the company’s clinical development strategies, including clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness, and business operations. Endo’s active research programs span men’s health, orthopedics, and endocrinology, as well as focused development in the areas of sterile injectables and complex generic products. Rosie’s main focus at all times is on the end users-the patients. Bringing new life-enhancing and, at times, life-saving medications to patients drives Rosie’s sense of purpose. As a breast cancer clinical trial participant herself, she knows firsthand that her work and commitment can make a positive impact and improve patients’ lives. Guided by that tireless dedication, Rosie has earned a reputation as a powerful thought leader and mentor. She has participated as a keynote speaker at industry conferences, sharing her vision of how companies can shape the future of clinical trials; she regularly presents to Johns Hopkins University Ph.D. candidates about potential career paths; and within Endo, she supports team members both formally and informally, particularly as an executive champion for the company’s employee resource group for women, AWE (Alliance for Women at Endo). In previous roles, Rosie built teams and capabilities at Lupin Pharmaceuticals, Teva, and other respected life sciences companies. She earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

Marina Filshtinsky
Cambridge Healthtech Institute

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute; Co-Founder, ClinEco

In her current role as Co-Founder and Senior Vice President of Strategy and Product Development at ClinEco, Inc., Marina Filshtinsky is leading platform development and working closely with an offshore team of engineers. She is also leading and coordinating the work with advisors and investors on go-to-market strategy, business model, and positioning the platform within the clinical trials industry. At her "day job" Marina is working as executive conference director for several CHI’s events including SCOPE and SCOPE Europe.

Barbara Fink
Philips

Barbara Fink, Associate Director, Clinical Affairs, Emergency Care, Philips

Barbara Fink, MS, CCRP, EMR, is Associate Director of Clinical Affairs for Philips Emergency Care. She has over 15 years of clinical evidence generation experience in varying roles. She has been a Study Coordinator and Clinical Trial Safety Specialist in the hospital setting. In the medical device industry she has been a CRA, senior CRA, Clinical Study Manager, Clinical Operations Manager, and a Senior Manager prior to transitioning into her current role. She has successfully led initiatives implementing paperless systems, including an electronic Institutional Review Board submission system, an electronic patient recruitment database, and e-consent.

Gerald Finken
RXE2

Gerald Finken, CEO, RXE2

No bio available.

Wes Fishburne
Zelta by Merative

Wes Fishburne, Principal Product Manager, Zelta, Zelta by Merative

Wes Fishburne is a Zelta Senior Product Manager who brings over 20 years of expertise supporting software solutions for the clinical trial industry. With extensive experience supporting clinical sites with a clinical trial management system (CTMS) and now working with the Zelta team, he has been instrumental in the development of Zelta’s eConsent and eCOA modules, as well other core areas of the Zelta Clinical Data Management System (CDMS) and EDC platform.

Nasha Fitter
Citizen Health

Nasha Fitter, Co-Founder & CEO, FOXG1 Research Foundation

Nasha Fitter is a leader in the rare disease space through her work on utilizing patient data to accelerate treatments. She is also the mother of a child with the rare neurological condition, FOXG1 Syndrome, and co-founded and leads the FOXG1 Research Foundation.

Ashley Fitzgerald
Deciphera

Ashley Fitzgerald, Senior Manager, Vendor Performance and Strategy, Deciphera

Ashley has over 13 years of industry experience in both large CROs and Sponsor organizations, with a wealth of knowledge spanning from Clinical Operations, Quality Assurance, Project Management and Vendor Oversight. While working in these various areas within the industry she began to realize the importance of bridging the gap between sponsor and vendors and creating a 'One Team' mindset. Through her development of relationships with vendors she has been able to advocate for her employers while also empowering the vendor to bring forth their expertise to allow both teams to succeed. Ashley enjoys advancing the vendor relationships through partnership initiatives, recognition of superior work and open communication.

Mette Flindt Heisterberg
Novo Nordisk AS

Mette Flindt Heisterberg, PhD, Competency Development Specialist, Clinical Operations Office, Global Trial Portfolio, Novo Nordisk AS

Mette Flindt Heisterberg, Competency Development Specialist, Novo Nordisk. Mette has a background in academic research and has a PhD degree from Basic and Clinical Research in Musculoskeletal Sciences, Faculty of Health and Science, University of Copenhagen. Since 2017 Mette has worked at Novo Nordisk within Clinical Operations as trial manager and within the latest years as project manager on different innovative improvement projects.

Maria I Florez
Tufts University

Maria Florez, Senior Consultant, Tufts CSDD

Maria Florez is a research consultant affiliated with the Tufts Center for the Study of Drug Development. Her research looks at the impact of digital transformation in clinical research; practices, strategies, and incentives driving improvements in the pharmaceutical R&D process; and the economics of new drug development. Maria has been a researcher and strategist in the healthcare sector for more than a decade. She has held positions at Cleveland Clinic, New York-Presbyterian Hospital of Columbia, and Cornell Universities. Maria holds a bachelor’s degree in quantitative economics and master’s degree from The Fletcher School of Law and Diplomacy at Tufts University.

Tim Foley
Scailyte

Tim Foley, Chief Business Officer, Scailyte

With over two decades of experience in strategic leadership roles at Takeda, Astellas, and AI/ML life science startups, Tim is a seasoned industry veteran with a wealth of knowledge and expertise. His strong track record of successfully leading strategic initiatives and dedication to biomarker-driven drug development make him the perfect choice to drive Scailyte's growth strategy. As a result-driven executive with a background in business development, he specializes in creating value, providing guidance, resolving complex problems, and leading new technologies and product strategies. With a track record of executing transactions worthover $16B, Tim has a focus on helping novel life science startups secure funding and navigate the partnering paradigm to bring innovative solutions to the market. His strategic vision and hands-on approach are crucial in taking Scailyte to new heights.

Stephen Framil
Merck & Co, Inc.

Stephen Framil, Corporate Global Head Accessibility, Office of Corporate Accessibility, Merck & Co., Inc.

As the Corporate Global Head of Accessibility at Merck & Co., Inc., Dr. Stephen Framil has been an ardent advocate and practitioner of equitable access across the range of human experience: including the built environment, food sustainability, education, performing arts, and the digital landscape. With over 30 years of executive leadership in business strategy and innovation, policy and governance, procedure and operations, and portfolio management expertise, Steve continues to lead and champion accessibility in multinational corporations, non-profit education, and the performing arts. Steve resides in the Greater Philadelphia area with his wife Natalia, children Aren and Sasha, cats Mila and Jana, and dogs Benji and Joey. Steve maintains an active music career as the founding Executive & Music Director of Camerata Philadelphia and the Port City Music Festival (Wilmington NC), as well as Director of Orchestra & Strings at Eastern University PA. To make this all happen as a CRC Survivor (2024 NED), Steve energizes through marathons and triathlons, and is a 4X Ironman (2021-2024)-why be bad at one sport, when you can be bad at three!

Antoinette Frankum
ClinChoice Inc

Antoinette Frankum, VP & Head of Clinical Dev, N America Clinical Dev, ClinChoice Inc

As the Vice President, Head of Clinical Operations North America - ClinChoice, Antoinette leads and manages the delivery of high-quality clinical trials for biotech, pharma, and medical device clients in the US and Canada. She has over 30 years of experience in the clinical research industry, with a proven track record of operational excellence, strategic planning, and team development.

Antoinette is passionate about improving the lives of patients through science and innovation. She has extensive therapeutic expertise in rare diseases, oncology, respiratory, cardiovascular, diabetes, and women's health, among others. She is also a member of the Association of Clinical Research Professionals, and a graduate of the UCLA Anderson School of Management Executive Program. Antoinette's mission is to foster efficiency and effectiveness throughout the clinical research processes and systems, and to build high-performing teams that deliver value to the clients and the industry.

Magnus Franzen
Wavestone

Magnus Franzen, Partner, Wavestone

Magnus is a Partner with Wavestone (previously PEN Partnership), helping Life Sciences' companies reimagine how they engage their patients and partners in healthcare to deliver better experiences & outcomes. He has worked with AstraZeneca since 2019 to embed patient-centric operations and make science and clinical trials more accessible to all patients. Before Wavestone, Magnus was part of the Life Sciences' team at PA Consulting and Head of Research at eyeforpharma. He is a thought-leader in patient-centricity, digital health, and real-world evidence.

Cristin Freeman
Bristol Myers Squibb

Cristin Freeman, Head, Informed Consent Management, Bristol Myers Squibb Co.

Cristin Freeman is the Head of Informed Consent at Bristol Myers Squibb, where she is focused on the ethical use of clinical trial samples and data, adherence to global genomic and data policies, and informed consent process and technology. Cristin is approaching 20 years of experience in research, ethics, project management and trial operations in academia and industry, holding various positions managing large scale pharmacoepidemiologic studies, leading cross-functional teams to execute global studies, and managing and executing global processes regarding consent including global and country consent templates. Additionally, Cristin holds a Master of Public Health from the Medical College of Virginia and a Master of Bioethics from the University of Pennsylvania.

Amy Froment
Regeneron Pharmaceuticals

Amy Froment, Sr Dir & Head, Global Trial Optimization, Regeneron Pharmaceuticals

Amy is passionate about connecting data and expertise to inform clinical trial strategy, design and patient engagement. Focusing on operational excellence in trial planning that aligns the science with the perspectives of patients and trial sites. Amy is an established leader in data led strategic feasibility, site identification and patient engagement with a focus on diversity in clinical trials. Combined with a background in clinical trial and program management she also has extensive experience in complex global clinical trial delivery across a broad range of therapeutic areas and phases. She has been in the pharmaceutical industry for over 20+ years and is currently the Head of Global Trial Optimization at Regeneron.

Silvio Galea
WCG

Silvio Galea, Chief Data & Analytics Officer, WCG

Silvio Galea is the Chief Data & Analytics Officer of WCG, where he leads the overall data and analytics strategies to create competitive differentiation, improve business agility, and create operational efficiency across the enterprise. Silvio has over two decades of experience leading and managing software, data, & AI organizations across a range of industries including Healthcare, Finance and Publishing.

James Gallagher
Johnson & Johnson Innovative Medicine

James Gallagher, Senior Director, Innovative Health, Johnson & Johnson Innovative Medicine

James brings over two decades of distinguished leadership in the Life Sciences industry, demonstrating expertise in managing budgets exceeding $200 million and leading diverse teams of up to 700+ professionals. Renowned for building high-performance teams and navigating complex business transformations, James has dedicated his career to Biometrics and, more recently, immersed himself in clinical innovation and technology.

Chelsea Gallagher
Bristol Myers Squibb Co

Chelsea Gallagher, Sr Dir Drug Dev Innovation & Digital Health, Business Insights & Analytics, Bristol Myers Squibb Co

No bio available.

Laura Galuchie
Merck

Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck

Laura has a unique role which blends internal and external components. Laura is Merck’s assigned leadership to the Oversight Committee of TransCelerate BioPharma, Inc. The Oversight Committee is the primary governing body for decisions related to the operational direction of TransCelerate, including project direction and expected outcomes. Laura draws on her experience as Director of Clinical Operations for a busy therapeutic area and Head of Clinical Performance, Analytics, and Innovation to provide this perspective. Within Merck, she has responsibility for driving internal engagement with key stakeholders. She facilitates adoption and internalization of TransCelerate solutions in alignment with Merck's objectives. Finally, she watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.

Sergio Garcia
Hackensack Meridian Health
Genoa Garcia
Avantor

Genoa Garcia, Sr Bus Dev Mgr, US Clinical Svcs, Avantor

Genoa Garcia, Senior Business Development Manager at Avantor Sciences, specializes in supporting diagnostic labs and bio pharma companies from R&D to commercialization. Leveraging her expertise to support customers with end to end solutions, she specializes in implementing protocol solutions that help create, advance, and result in the adoption and accuracy needed for formal submission to governing bodies. She has a focus in early-stage diagnostic labs from conception through commercialization. She received her MBA from the University of California Davis and went on to support many successful clinical trials.

Drew Garty
Veeva Systems

Drew Garty, Chief Technology Officer, Clinical Data Management, Veeva Systems

Drew’s career in pharmaceutical technology spans over 25 years and includes significant experience in eClinical system architecture, design, and development, as well as process design, solution validation, and international implementation and support. In his role as CTO, Drew collaborates with customers, partners, and the industry to set vision and direction of Veeva Clinical Data products.

Rachael A Geedey
Cluepoints

Rachael Geedey, Director, Customer Success, Cluepoints

With 16 years in the CRO space and a deep expertise in clinical technology across various platforms, I have specialized in RBQM technology training, adoption, and implementation since 2018. Currently, I’m the Director of Customer Success at CluePoints, where I leverage my extensive background to drive impactful outcomes and enhance client experiences.

Lisamarie Georgen
MacroGenics Inc

Lisamarie Georgen, Senior Director Clinical Supplies Operations, MacroGenics, Inc.

Lisamarie is entering her 24th year working in the pharmaceutical industry, focusing on Clinical Operations and Clinical Supplies. She has held many different roles within her career, including various positions of increasing responsibilities at BioMerieux, Hospira, and Thermofisher. Lisamarie is currently the Senior Director of Clinical Supplies at MacroGenics. She was sought out to form the company's first Clinical Supply Department. Lisamarie is known for her mentoring of colleagues and direct reports. With her extensive technical skills and mentoring mentality, Lisamarie has successfully created a robust and dynamic clinical supply department and team contributing to the success MacroGenics.

Brittany Gerald-Lewis
Moderna Inc

Brittany Gerald-Lewis, Associate Director, Clinical Trial Health Equity, Moderna, Inc.

Brittany brings over 16 years of global clinical operations experience working at various pharmaceutical companies and CROs and 7 years of entrepreneurial experience. Her expertise includes global study management, global site management, monitoring, and clinical trial diversity and inclusion. In her current role, she leads the strategy for implementing inclusive clinical trials, leads the cross-functional Clinical Trial Health Equity Working Group, and represents her organization on clinical trial diversity matters internally and externally. With a passion for clinical trial diversity and inclusion, she is eager to apply successful solutions to advance clinical trial diversity globally and address health disparities. She has a special interest in digital health solutions for underrepresentation populations in clinical trials and maternal and infant health.

Ryan Gifford
CTI

Ryan Gifford, VP, Global Laboratory Services, Laboratory Services, CTI

Ryan Gifford is an accomplished executive in clinical research operations, with over 20 years of experience leading high-performing teams and managing advanced laboratory functions. Ryan has a proven track record of overseeing large-scale CRO operations across diverse sectors, including clinical research, pharmaceutical development, and healthcare.

After two decades working in various roles within a global CRO, Ryan is now leading a global central laboratory. CTI Labs is the first new, full service central laboratory in over a decade. CTI Labs is changing the expectation for central labs, focusing on customer service, attention to detail and data integrity.

Jeremy P Goldberg
Arsenal Capital Partners

Jeremy P. Goldberg, Operating Partner, Healthcare, Arsenal Capital Partners

Mr. Goldberg is an Operating Partner of Arsenal where he focuses on networking and sourcing transactions for the healthcare team. Prior to joining Arsenal in 2014, Mr. Goldberg was a Managing Director, Corporate Development of Endo Pharmaceuticals. Previously, he was a founding Partner of ProQuest Investments and the founding CEO or founder of three biotechnology companies that were acquired or taken public. In addition, he also held executive positions at Becton Dickinson and at GSK. He serves on Dana Farber Cancer Institute Visiting Committee and board of NIH/Cambridge/Oxford Scholars program.

Norman M Goldfarb
Site Council

Norman M. Goldfarb, Executive Director, Site Council

Norman M. Goldfarb is Executive Director of the Site Council and the Clinical Research Interoperability Standards Initiative (CRISI). He is also Managing Director of Elimar Systems, which is developing a technology platform to transform clinical research into a collaborative, learning enterprise. Previously, he was Chief Collaboration Officer of WCG Clinical, founded and led the MAGI conferences, and published the Journal of Clinical Research Best Practices.

Jennifer S Goldman
GeniMed

Jennifer Sydney Goldman, Clinical Business Operations, Consultant

Jennifer Sydney Goldman is a seasoned professional with extensive experience in the biotech industry, specializing in Finance and Business Operations. With a career spanning multiple organizations, Jen has developed deep expertise in Financial Planning and Analysis, focusing on both short and long-term budgeting and forecasting of clinical trials. She is also skilled in vendor relationship management, clinical operations, site contracts and budgets, and site payments. Jen began her career at Genetics Institute (now part of Pfizer) and has since contributed to the success of several notable biotech companies, including AVEO, Millennium, FORUM, Karyopharm, and Deciphera. Most recently, she has been providing valuable support to a number of small and startup biotechs, including Day One Biopharmaceuticals, Breathe Biomedical, Verismo Therapeutics, and Vigil Neuroscience. In addition to her professional work, Jen loves to speak about all things finance and clinical business operations, and has presented at several key industry conferences, , including Outsourcing in Clinical Trials New England (Boston 2024), the Association of Biotech Finance Officers (ABFO) National Conference (Boston 2024), ClinBiz (2023), and multiple SCOPE and MAGI conferences. Outside of her work in biotech, Jen is an accomplished musician with recent performances at renowned venues such as Boston’s Symphony and Jordan Halls, as well as the Hatch Memorial Shell on Boston’s Esplanade. A passionate advocate for teamwork, Jen believes that biotech, like music, is a collective effort-there are no soloists. She is always eager to connect with colleagues on topics related to Finance and Business Operations.

Robert S Goldman
Contraline, Inc

Robert Goldman, Head of Clinical Operations, Contraline

As the Head of Clinical Operations, I oversee, manage, and analyze the project performance of all global clinical trials, ensuring they are executed as per scope, timeline, budget, and quality standards. With over 15 years of clinical research experience at the site/CRO/Sponsor level, I have acquired extensive therapeutic knowledge and skills in various areas, such as analgesia, GI, pulmonary, hepatology, cardiovascular, dermatology, endocrinology, rare disease, oncology, women's health, men's health, infectious disease and CNS disorders.

Gretchen E Goller
Seagen

Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.

Gretchen Goller leads the Patient Recruitment and Retention Solutions group at Seagen with a focus on oncology-specific solutions resulting in a holistic, patient centered approach ensuring that patients and their families have the most positive experience. Ms. Goller has over 20 years’ experience gained in pharma and CRO industries. Prior to Seagen, she was the Global Head of the Patient Recruitment and Retention team at ICON. Previously, Ms. Goller was the Patient Recruitment and Retention leader at sanofi-aventis. Other roles included Clinical Trial Manager, Medical Affairs at Wyeth and Study Manager at Astra Zeneca. She has held positions at the University of Pennsylvania including Study Coordinator and Site Director working on a range of therapeutic areas including vaccines, cardiovascular, cardiology, ophthalmology, women's health, HIV, and endocrinology. Ms. Goller has a BA from the University of Massachusetts and an MSW from the University of Pennsylvania and is located outside of Philadelphia, PA.

Melanie L Goodwin
Immunocore LLC

Melanie Goodwin, Director, Clinical Outsourcing, Immunocore

Melanie has been part of the clinical trial industry for 20+ years focusing on trial enrollment and supplier relationships in a variety of therapeutic areas. Her most recent role is with Immunocore supporting Relationship Management across all Clinical Operations suppliers.

Adam Gottesman
Flatiron Health

Adam Gottesman, Principal, Clinical Research Partnerships, Flatiron Health

Adam Gottesman is a Principal of Clinical Research Partnerships at Flatiron Health, where he collaborates with global biopharma companies to identify strategic opportunities for integrating novel real-world evidence and clinical research technology into their near- and long-term priorities. Since joining Flatiron in 2018, Adam has played a key role in driving commercial, go-to-market, and partnership strategies across the company's real-world evidence and clinical research businesses. Before Flatiron, he was a life sciences strategy consultant at ClearView Healthcare Partners, where he advised biopharma clients on pipeline development, corporate strategy, and innovation initiatives. Adam graduated with honors from Brown University, earning an Sc.B. in Biochemistry and Molecular Biology.

Vaishali Goyal
AstraZeneca Pharmaceuticals

Vaishali Goyal, MS, AI Lead, Development, AstraZeneca Pharmaceuticals

Vaishali Goyal is a dynamic IT leader with extensive experience in the pharmaceutical industry, known for her transformative impact since joining AstraZeneca R&D IT in November 2018. She has driven significant advancements across multiple domains, including medical evidence, real-world evidence, digital health, software as a medical device, R&D transformation programs, and AI initiatives. Vaishali's proactive leadership has been instrumental in spearheading transformative change, and her collaborative efforts with cross-functional IT business teams have propelled AstraZeneca's digital transformation to new heights. In addition to her industry role, Vaishali is an Adjunct Professor at George Mason University, where she passionately teaches graduate-level courses on Big Data, demonstrating her commitment to continuous learning and education.

Bola Grace
University College London

Bola Grace, PhD, MBA, Senior Director, Digital Biomarkers, GSK; Professor, University College London

Professor Bola Grace has decades of leadership experience across multiple sectors across pharma, biotech, and academia, providing strategic, commercial and technical direction to highly skilled cross-functional teams on complex programmes; and delivering numerous innovative award-winning products. She enjoys collaborative research and development as well as the application of data science across therapeutic areas. She was worked extensively on digital measures, devices and digital endpoints in clinical trials. She has a PhD from University College London and an Executive MBA from the University of Cambridge Judge Business School.

Matt Graffeo
GCI Group

Matt Graffeo, Managing Director, Clinical Trial Communications, GCI Group

Matt Graffeo is a recognized leader in digital healthcare communications nearly 20 years of experience, working in the U.S. and Europe with major Fortune 500 companies and distinguished NGOs. He currently serves as the Global Head of Digital and Clinical Trials Communications at GCI Group. Matt oversees a global team of digital strategists showcasing his global expertise and visionary leadership. Matt has pioneered GCI Group's clinical trial recruitment offering, the agency's fastest-growing offering, focusing on social and digital media for clinical trials recruitment. He has led recruitment initiatives on behalf of major pharmaceutical clients. Matt is unwavering in his commitment to improving diversity within clinical trials, using digital communication creatively to ensure diverse representation. He has led several award-winning projects and earned industry recognition, including Sabre Awards, MM+M Awards, IDEA Awards and Cannes Lions. He is a respected industry speaker, sharing insights on digital media and diversity in clinical trials recruitment. He holds a BA in Communications and Art History from Tulane University in New Orleans and an MFA in Digital Media Production from The Savannah College of Art and Design.

Bianca J Green
Takeda Pharmaceuticals Inc

Bianca Green, Lead, Diversity & Inclusion in Clinical Trials, Takeda

Catherine Gregor
Florence Healthcare

Catherine Gregor, Chief Clinical Trial Officer, Thought Leadership, Florence Healthcare

Catherine Gregor is an expert in clinical research operations and e-clinical solutions. With nearly two decades of clinical research experience, she has honed a deep understanding of clinical trial design, conduct, and patient outcomes. As the Chief Clinical Trial Officer for Florence Healthcare, she is at the forefront of designing and implementing technology solutions to support the mission of faster cures for everyone.

Zahiah Gueddar
IQVIA Technologies

Zahiah Gueddar, Sr Director & Commercial Lead Financial Strategy, IQVIA Technologies

Zahiah (Zee Zee) Gueddar leverages over 17 years of diverse industry expertise encompassing delivery, finance, operational effectiveness, and the commercial sector. Zee Zee offers invaluable insight into the challenges encountered by sponsors, CRO’s, sites and patients. In her role leading IQVIA’s Financial Technology offerings, she serves as an innovative partner for clients seeking transformative outcomes and growth opportunities. Known as a strategic thinker and problem solver, Zee Zee is responsible for driving growth and differentiation, product go-to market & ensuring innovative and competitive offerings. Zee Zee is based in Southern California and is a graduate of San Diego State University.

Tobias Guennel
QuartzBio

Tobias Guennel, Sr VP Product & Chief Architect, Data Mgmt & Systems Integration & Innovation, QuartzBio

Senior Vice President of Product & Chief Architect, QuartzBio A translational informatics visionary and creator of SaaS solutions supporting clinical sample inventory and biomarker data management, Tobi drives technology innovation across data-centric spaces from complex biomarker signatures for patient selection to enterprise software solutions for pharmaceutical and biotechnology companies. At QuartzBio, Tobi leads innovation for product management, product development, software engineering, product support, technical professional services, and solutions engineering.

Sofia Guerra
Bessemer Venture Partners

Sofia Guerra, Vice President, Bessemer Venture Partners

Sofia is an investor in the Cambridge office, where she focuses on healthcare and biotech. Sofia began her career as a consultant at Bain and Company, where she worked on strategy, operations, and due diligence projects across healthcare and technology. Prior to joining Bessemer, she was an investor at BoxGroup Ventures and the co-founder and President of Nucleate Bio, a national life sciences entrepreneurship program helping PhDs, Post-docs, and students commercialize scientific projects. Sofia earned her MBA from Harvard Business School and her BA with high honors in Chemistry from Harvard University. While in school, she conducted research alongside Bob Langer, a serial entrepreneur and one of 12 Institute professors at MIT widely recognized for his contributions to drug delivery and tissue engineering fields.

Maria Gujral
Bristol Myers Squibb Co

Maria Gujral, Senior Director, Biospecimen & Imaging Management, Bristol Myers Squibb Co.

Maria Gujral is the Head of Biospecimen & Imaging Management at Bristol Myers Squibb (BMS), bringing over 20 years of experience in biospecimen and vendor management. In her current role, she supports biospecimen and imaging management for hematology, oncology, and cell therapy trials. Her team ensures the timely and efficient delivery of all biospecimen and imaging operational aspects across all stages of dynamic clinical studies, from start-up to conduct and close-out. Maria has led and participated in several continuous improvement initiatives aimed at enhancing end-to-end specimen tracking oversight. She has also overseen multiple strategic BMS vendor partnerships with Central and Specialty labs. Maria holds a BS from The College of New Jersey (NJ, USA) and an MS in Quality Assurance and Regulatory Affairs from Temple University (PA, USA).

Manuri Gunawardena
HealthMatch

Manuri Gunawardena, CEO, Exec, HealthMatch

Manuri is the Founder and Chief Executive Officer at HealthMatch. Since 2017, her mission has been to change the future of medicine by putting patients first.

At HealthMatch, she has built an active and engaged community of over 1.8 million patients who seek to participate in clinical trials, and is in constant dialogue with sponsors, clinical research organizations, trial sites, and others across the industry to understand their challenges and create new solutions.

Her pathway to change the future of medicine began during her final year of medical school, where she witnessed patients’ challenges in engaging with clinical trials and the inequity inherent in accessing them. She became determined to find a solution that empowered patients and connected them to tomorrow’s treatments, no matter their background or resources. Since then, she has developed partnerships with leaders across the industry and earned a place on Forbes’ 30 under 30 lists amongst other awards.

To Manuri, changing the future of medicine is bigger than patient recruitment. She is constantly seeking opportunities for innovation across the drug development cycle, and is led by the voice of the patient in this work.

Arkady I Gusev
Novartis Institutes for BioMedical Research Inc

Arkady Gusev, PhD, Head, Lab Excellence & Operations in Biomarker Development, Novartis Institutes for BioMedical Research, Inc.

Dr. Arkady Gusev is the Executive Director of Laboratory Excellence and Operations in Biomarker Development/Translational Medicine at Novartis Institute for Biomedical Research. In his current role, he is responsible for the scientific and operational leadership of clinical biomarkers, assay outsourcing, sample operations, central laboratory setup, and vendor management. Previously, Arkady Gusev led the Business and Technology Operations units in the Department of Pharmacokinetics, Dynamics, and Metabolism in Pfizer Global Research Division. Arkady Gusev received his PhD (1992) in mass spectrometry from the Institute of Space Research, Russian Academy of Sciences. Following his PhD, he joined the Department of Chemistry, University of Pittsburgh as a postdoc and held a Research Assistant Professor position in the Department of Chemistry at Vanderbilt University before joining the industry in 1997. Arkady Gusev is the author and co-author of 60+ peer-reviewed publications in different areas of bioanalytical technologies, bioanalysis, biomarkers, and clinical operations. Arkady Gusev’s recent research interests include patient-centric technologies, bioanalytical and biomarker assay outsourcing, vendor management, clinical operations, and the art of operational excellence and portfolio management.

Allison Guy
AstraZeneca

Allison Guy, Senior Regulatory Affairs Director, AstraZeneca

Over the past two decades, Allison Guy has established a strong track record of following the science to develop and deliver life-changing medicines with a focus on patient-centricity and use of innovative tools to expedite patient access to safe and effective treatments. She has led regulatory strategies for biologics and small molecules in different therapeutic areas at various stages of their life cycles and has published on multiple regulatory topics. Allison is currently a Regulatory Affairs Director in the Oncology Regulatory Science, Strategy and Excellence group at AstraZeneca and a recurring guest lecturer at the Leslie Dan Faculty of Pharmacy.

Shwen Gwee
(Former) Bristol Myers Squibb

Shwen Gwee, Founder & Chief Disruptor, Health Disruptors, Inc.

Shwen is a recognized pioneer in digital health and corporate innovation, as well as a respected biopharma industry thought leader who was named a Top 40 “Healthcare Transformer” by MM&M, a PR Week "Health Influencer 50", listed on the Constellation Research "Business Transformation 150" and has been recognized in Medika's list of "Fifty of the Most Influential Voices in Healthcare". Over the last 20 years, he has held leading roles in digital strategy and innovation within the biopharma industry. Most recently, he was the VP/Head of Global Digital Strategy at BMS, where he led innovation across the enterprise. Prior to that, he was the Co-Founder and Global Head of Open Innovation for the Novartis BIOME-a global network of innovation hubs. Currently, he is an independent consultant, investor, advisor, and mentor to various digital health start-ups.

Sheila Gwizdak
Halloran Consulting Group

Sheila Gwizdak, Vice President, Head of Consulting, Halloran Consulting Group

With over 25 years of expertise in the life sciences, Sheila serves as a senior leader and trusted advisor to organizations in regulated industries. As Vice President and Head of Consulting at Halloran Consulting Group, she leads a dynamic team of experts dedicated to designing and implementing innovative solutions that drive impactful business results and create a competitive edge for our clients.

Her expertise spans management consulting, quality and compliance, business process optimization, risk management, and organizational transformation. She is passionate about fostering a culture of quality, continuous improvement, and innovation within life sciences organizations, empowering them to achieve their strategic objectives. Sheila has a proven track record of spearheading initiatives that enhance organizational performance, elevate client satisfaction, and ensure regulatory excellence.

Ann M Hake
Eli Lilly & Co

Ann M. Hake, MD, Executive Director, Digital Health Research and Development, Eli Lilly & Co.

I am a board-certified Neurologist with fellowship training in neurodegenerative diseases and postgraduate training in medical informatics. In my current role at Lilly, I am a clinical research physician in the Digital Health Research and Development group, as well as the Vice Chair of the Lilly Bioethics Advisory Committee. Previously at Lilly I have led late- and early-phase clinical trials and have provided medical leadership in Medical Affairs in neurodegeneration and in migraine. Prior to joining Lilly, I was an Associate Professor of Clinical Neurology at the Indiana University School of Medicine, where I now continue to hold an adjunct faculty position, serve on the Institutional Review Board, and see neurology outpatients twice monthly.

Duncan Hall
Triumph Research Intelligence Ltd

Duncan Hall, CEO, Exec, Triumph Research Intelligence Ltd

Duncan has over 20 years of experience in the life sciences technology sector. Duncan started TRI in 2013 with the specific aim of making Risk-Based Quality Management (RBQM) simple and accessible for all clinical trials. He has overseen the development of OPRA, an industry leading RBQM platform that integrates risk assessment, risk management and central monitoring. Duncan’s extensive knowledge of RBQM in clinical trials means he’s a sought-after expert speaker at industry events.

Catherine Hall
Egnyte Inc

Catherine Hall, Head of GXP Quality Assurance, Sales, Egnyte Inc

Dynamic leader with a proven track record of success in developing and implementing strategic plans to drive organizational goals. A critical thinker who excels at asking probing questions to deliver exceptional results through highly proficient mechanics. A highly respected and influential thought leader and communicator, adept at building strong relationships and garnering project support and consensus.

Catherine is currently Head of GXP Quality at Egnyte, Inc.

Her previous experience and volunteer work includes: ISPE, NECSO Steering Committee, Endpoint Clinical, Sunovion Pharmaceuticals, Biogen, Millennium Pharmaceuticals and Pfizer. She holds a Master's from University of Houston - Clear Lake and Baylor College of Medicine and Bachlor's from University of Maine.

Seth Halvorson
WCG

Seth Halvorson, GM, Site & Clinical Research Solutions, WCG

Seth Halvorson is the General Manager of WCG’s Site Solutions business unit that includes WCG’s study start up teams, site network, CTMS, recruitment and retention services, study acceleration, and site augmentation solutions. Seth started at WCG in 2018 as the General Manager of WCG ThreeWire. Prior to joining WCG he was Vice President and Assistant General Counsel at Syneos Health. Seth worked at Syneos Health for 9 years through the i3/PharmaNet merger that created inVentiv Health and the INC Research Merger that created Syneos Health. During that time, Seth was responsible for leading the clinical division’s global contracting teams and providing legal counsel for the clinical division. Seth was a member of the inVentiv Health Patient Centricity task force.

Seth devotes his energy to developing and deploying realistic and effective solutions that connect the keys clinical trial stakeholders of sponsor, site, and participant.

Troy Hamilton
CaRe Clinic

Troy Hamilton, Director of Operations, CaRe Clinic

Troy Hamilton serves as the Director of Operations at CaRe Clinic, bringing a wealth of experience from medical research roles at the University of Calgary and senior management positions in private clinics. Renowned for his ability to transform significant initiatives into measurable outcomes, Troy leverages his background in biological sciences and project management, along with his CCRP designation from SoCRA. He excels in business operations, quality control, process optimization, stakeholder engagement, financial forecasting, resource allocation, and KPI development within the clinical research sector. As a recognized expert, Troy is frequently invited to speak at provincial, national and international conferences and events. He is also a co-author of the ACRC Research Glossary. Outside of his professional life, Troy enjoys hiking, gardening, and exploring culinary arts.

Janie Hansen
Daiichi Sankyo Inc

Janie Hansen, Business Systems Transformation, Global Development Information Management, Daiichi Sankyo Inc

Janie Hansen is a seasoned professional in Business Systems Transformation within Global Development Information Systems at Daiichi Sankyo, Inc. With over 20 years of experience as a business and integration architecture consultant in clinical systems, she has a proven track record of turning concepts into reality. Her expertise lies in delivering successful technology solutions and maximizing the value of technology investments in the pharmaceutical industry. Most recently, she has focused her efforts on leading transformative initiatives that leverage the potential of Generative AI.

Donna Hanson
Advanced Clinical

Donna Hanson, VP Strategy & Optimization, Strategy & Optimization, Advanced Clinical

Donna Hanson, Vice President, Strategy & Optimization, has over 20 years of experience in the clinical research industry spanning site management and contract research organizations (CROs), patient recruitment, and functional service provider offerings. Seasoned in clinical development strategy, Donna’s focus has been in executing and leading teams in patient recruitment, feasibility, site identification/engagement, and proposals. Her therapeutic expertise spans most major areas, including oncology, and includes all Phases; her passion is in rare disease and pediatrics, and she continually looks for ways to support Sponsors in ensuring patient and site centricity. Donna is located in Wisconsin, US.

Meghan N Harrington
Medidata a Dassault Systemes Co

Meghan Harrington, Vice President, Clinical Trial Financial Management, Medidata, a Dassault Systemes Co.

Meghan serves as the Vice President, Clinical Trial Financial Management at Medidata, driving roadmap and strategy across our Grants Manager and Payments products. Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. It was through this privileged relationship with patients facing devastating diagnoses that Meghan witnessed first-hand the life-saving and life-enhancing effects of medical and therapeutic intervention thus piquing her interest in the drug development process. Meghan joined a CNS-focused start up in RTP and has spent the last 20 years working in the life science technology industry. The last decade of this time has been solely focused on the clinical trial financial domain driving product strategy and leading teams responsible for complex system implementations.

Melissa Harris
Fortrea

Melissa Harris, Global Head, Patient Recruitment & Engagement, Fortrea

Melissa has 23 years of industry experience dedicated to accelerating patient recruitment from all possible feeds including site EHRs, AI and data enabled recruitment channels, digital and online media and community engagement programs. Melissa works to harness the benefits of applying innovative solutions toward successful patient recruitment and retention campaigns while driving health literacy, diversity and inclusion and patient access equity to reduce study burden and facilitate enrollment into everyday life. Melissa heads up Fortrea’s Voice of Patient program to drive patient insights into every step of the drug development paradigm and is a Co-Lead of Fortrea’s Site Advisory Board.

Suzanne Harris
SubjectWell

Suzanne Harris, Senior Vice President of Marketing, SubjectWell

Suzanne Harris serves as the Senior Vice President of Marketing at SubjectWell, provider of the most accurate, diverse, predictable, and patient-centric platform that connects patients and caregivers to breakthrough healthcare opportunities. Suzanne’s personal involvement in clinical trials and patient advocacy drives her passion for advancing clinical technology and improving the patient experience.

Christopher Hart
Foley Hoag LLP

Christopher Hart, Partner, Co-Chair, Privacy and Data Security Group, Foley Hoag LLP

Chris Hart is a litigation partner and co-chair of the Privacy and Data Security group at Foley Hoag LLP, a leading law firm with a global reach and a reputation for excellence. With nearly two decades of civil litigation and human rights experience, Chris helps clients navigate complex and evolving data privacy and cybersecurity challenges, from compliance and incident response to government investigations and litigation. As a certified privacy professional and a recognized leader in the field, Chris advises clients across various industries and geographies on their data management and governance practices, including their obligations under comprehensive data protection laws (such as CCPA, GDPR, PIPEDA), and other domestic and international frameworks (such as the TCPA). Chris has extensive teaching experience as a part-time lecturer at Northeastern University School of Law, where he designed and taught courses on data privacy regulation and compliance. Chris has a vibrant pro bono practice, for which he has received significant recognition. Chris is a passionate advocate for diversity, equity, and inclusion, and leads the firm's practice in counseling clients on their DE&I practices and managing investigations relating to DE&I.

Karen Hartman

Karen Hartman, Vice Chair, Research Administration, Mayo Clinic

No bio available.

Michelle Hartmann
South Broward Research

Michelle Hartmann, CCRP, is the Director/Owner of South Broward Research which is located in SE Florida. She started with South Broward Research in 2006. South Broward Research is a community based, independent site. She is dedicated to the pursuit of advancing healthcare by ensuring integrity and quality in the work performed at South Broward Research. She feels fortunate to be a part of an incredible team. She attended The Florida State University where she received both her Bachelor of Science and Master of Science. She has continued her education in the field of research by attending research seminars and conferences, participating in panels with sponsors and industry organizations, and becoming a Certified Clinical Research Professional. She enjoys spending time with her family, traveling, and can often be found reading a good book.

T. Hephner
Inspire

T. Hephner, CRO, Inspire

T. Hephner is a highly experienced business development and sales leader with a proven track record in the healthcare and clinical research industries. He currently serves as the Chief Revenue Officer (CRO) at Inspire, where he has been instrumental in driving revenue and strategic growth. Previously, T. held leadership roles including Head of Partnerships and Business Development at Crescendo Health, Chief Commercial Officer at Curebase, and Vice President of Global Business Development at THREAD Research. He has consistently demonstrated expertise in building partnerships, expanding market reach, and creating innovative solutions to enhance patient engagement and clinical research outcomes. With a diverse background spanning roles at Signant Health, Praxis Communications, and West Pharmaceutical Services, T. has a deep understanding of the clinical research landscape. His entrepreneurial spirit is reflected in his co-founding of Praxis Communications and his leadership of Healthy U, LLC, a pioneer in promoting healthy snack alternatives. T. Hephner’s career reflects his commitment to advancing clinical research and patient engagement through strategic innovation and effective leadership.

Christopher Herrick
Mass General Brigham

Christopher Herrick, Vice President, Research Technology, Mass General Brigham

As the Vice President of Research Technology at Mass General Brigham, Chris leads a team of over 60 professionals who provide cutting-edge informatics and analytics solutions to support the research mission of one of the largest and most prestigious healthcare systems in the world. With over 20 years of experience in the hospital and healthcare industry, he has a proven track record of delivering value to stakeholders, partners, and customers through strategic vision, operational excellence, and business development. He has been involved from the start in the development of the Mass General Brigham Research Patient Data Registry (RPDR) as well as i2b2 (Informatics for Integrating Biology and the Bedside), an open-source informatics platform used at over 300 academic institutions worldwide. He is passionate about advancing biomedical research and innovation through the use of data and technology with a goal of empowering researchers to discover new insights, improve patient outcomes, and transform health care.

David Herron
Perceptive Inc

David Herron, Grp CEO, Perceptive Inc

No bio available.

Lisa Hersh
Regeneron

Lisa Hersh, Senior Manager, Precision Medicine, Regeneron

Lisa Hersh is a Senior Manager focused on developing new tools and technologies to support Regeneron's Precision Medicine department. Starting her Regeneron career in the laboratory, she moved to Precision Medicine in 2016 and has been instrumental in developing standards, streamlining processes and reducing the manual burden of sample tracking. Lisa has an MS in Biology from NYU and an MS in Forensic Molecular Biology from George Washington University.

Joshua Hershelman
AstraZeneca Pharmaceuticals Inc

Joshua Hershelman, Director, US Site Engagement, Site Management & Monitoring, AstraZeneca

Josh Hershelman has 18 years of experience in the pharmaceuticals industry. He started in field sales and worked with multiple large sponsor organizations before joining AstraZeneca. After a few years in field sales with AZ he decided to transition to the R&D side of the business. His unique industry experience over the past 18 years in global patient insights, clinical operations analytics, sales, monitoring, and feasibility provides a wholistic view of the drug development process. Today he leads the US Site Engagement Partners in Care Network team supporting the growth of AZ's strategic footprint across the US.

Bradley Hightower
Hightower Clinical

Brad Hightower, CEO, Hightower Clinical

Brad has worked at the site-level in clinical research for almost 15 years and is the former Executive Director of the Oklahoma Heart Hospital Research Foundation. Brad has since started his own integrated site network, Hightower Clinical, and hosts the Note to File podcast - a podcast for clinical research sites.

Jenn Hill
Vertex Pharmaceuticals

Jenn Hill, Director, Clinical Site Contracting and Payments, Vertex Pharmaceuticals

Jenn Hill is a site contracts and payments expert, with more than 15 years' experience working in pharmaceutical companies and contract research organizations of all sizes. At Vertex Pharmaceuticals, Jenn leads a global team responsible for global clinical site contracting.

Jolene Hill
Nurocor

Jolene Hill, Vice President Solutions Consulting, Solutions Consulting, Nurocor

Jolene Hill is a results-oriented Business Consultant with over 20 years of experience leading global initiatives in the pharmaceutical industry. She specializes in driving innovation by aligning technological solutions with business objectives, leveraging her expertise in process improvement, change management, and digitalization strategies. As a subject matter expert in Specimen Management, Jolene applies her deep knowledge of content standardization, data modeling, translational medicine sample management, clinical development, and drug retention programs to streamline operations and enhance efficiencies. Her diverse skill set and leadership have been instrumental in advancing digitization and optimizing workflows across the pharmaceutical sector.

Jennifer Hillner
Care Access

Jennifer Hillner, Vice President, Strategic Accounts, Care Access

Jennifer Hillner, Vice President of Strategic Accounts at Care Access, works with our top sponsor partners to build solutions that accelerate clinical research as well as improve the diversity of clinical trials. Jenn helps create new innovative offerings for our sponsors. She is passionate about bringing research to historically underrepresented populations and removing the bottlenecks that slow the process of getting critical treatment to the patients that need them.

Laura Y Hilty
HealthX Ventures

Laura Y. Hilty, Principal, Investments & Growth, HealthX Ventures

I am passionate about creating new paradigms that create meaningful change through innovation in healthcare and clinical research through investing, strategy, M&A and partnerships. I have held a variety of roles in my ~17 years in healthcare technology (EHR and clinical trial tech) in leadership roles spanning corporate strategy, product strategy, product management, and partnerships across stages from company start-up to scale. Through that time I launched six technology products, driving M&A strategic evaluation and processes including completing six strategic acquisitions, developing corporate strategy, and developing and launching partner programs. I have been on the sell side of company exits twice, helping develop a strategic thesis for growth that has continued to be the path the company follows. I have a Bachelor’s in Molecular / Cell Biology from Vanderbilt University, am a mentor to start-up entrepreneurs in Madison, active in helping improve healthcare in Africa, and spend my free time negotiating with my young daughter or outdoors hiking or kayaking.

Kelly Hoang
Gilead

Kelly Hoang, Associate Director, Data Scientist, Gilead

Jesse Hoffman
Alliance For Multispecialty Research LLC

Jesse Hoffman, Chief Business Officer, Business Development, Alliance For Multispecialty Research LLC

With over 20 years of experience in the clinical research industry, Jesse has held significant site and CRO roles, including 12 years at Syneos Health, a global Contract Research Organization (CRO), and 4 years at Advanced Clinical Research, with 2 sites in Utah and Idaho. Since 2019, Jesse has been the Chief Business Officer at AMR, a prominent clinical research site company with over 30 locations across the United States.

Henry Hoffman
BASE Life Science

Henry Hoffman, Senior Vice President R&D at Base life science, BASE Life Science

Entrepreneur with capability to take balanced risks in new, interesting ventures. Successful and accomplished Sales and Marketing Manager, seasoned Project Manager; experienced in various industries including Life Sciences, Telecommunications and Aeronautics; proven track record both in sales and implementation of complex solutions in various business areas. Cross-functional background, including sales and marketing, global program management, project management and project work in companies of different sizes. Distinct ability to build and lead teams and provide strong leadership; strong motivation skills. Superior communication and interpersonal skills, including management experience of small to medium size team; international work experience in all major markets, e.g. Europe, US, South Africa and AsiaPac

Kyle Hogan
Datacubed Health

Kyle Hogan, Chief Executive Officer, Datacubed Health

Kyle has been dedicated to advancing the voice of the patient through the promise of ePRO/eCOA since 2007, in that time helping deliver over 500 successful trials for CROs and Pharmaceutical companies globally. He is a recognized expert for implementing innovative and patient centric ePRO/eCOA solutions with an aim to achieve sponsor confidence and study success across all phases of clinical trials.

Faith Holmes
Elligo Health Research

Faith Holmes, CMO, Medical Affairs, Elligo Health Research

Dr. Faith Holmes brings over 30 years of patient care experience and 11 years in medical practice management to her role as Elligo’s Chief Medical Officer. Her background in Family Medicine, and Hospice and Palliative Medicine across various practice settings enhances her ability to build Elligo’s network of Research Ready physician practices. Dr. Holmes has served as Principal Investigator on 15 optimized trials in the virtual and hybrid models, in addition to trials at the local site, Elligo Clinical Research Center, in Austin.

Angela Holmes
OmniScience

Angela Holmes, CEO, OmniScience

Jen Horonjeff
Savvy Cooperative

Jen Horonjeff, PhD, Founder & CEO, Savvy Cooperative

Jen Horonjeff, PhD, is the Founder & CEO of Savvy Cooperative, and was named one of the 50 Most Daring Entrepreneurs by Entrepreneur Magazine for her work at Savvy, the first patient-owned co-op that helps companies get input and insights from diverse patients. Jen grew up with juvenile idiopathic arthritis, survived a brain tumor, holds a PhD in Environmental Medicine, and previously worked as a health outcomes researcher, human factors engineer, and FDA advisor. Jen serves on the Board of Directors for The Sequoia Project, the Advisory Board of Trialbee, and numerous other committees to ensure the patient voice is included.

Daoying Hu
Johnson & Johnson Innovative Medicine

Daoying Hu, PhD, MBA, Director, Data Science and Digital Health, Johnson & Johnson Innovative Medicine

Daoying Hu has 17 years experience in pharmaceutical and CRO industry. She developed her career through several functional roles including biomedical research, project management, site network management, and clinical data solutions. She focuses on clinical planning and analytics in the recent years. Currently she leads Strategic Feasibility group at UCB, which support clinical operational teams to plan and start up clinical trials using big data/predictive analytics and innovative strategies. Daoying received her PhD from Baylor College of Medicine, and MBA from Duke University.

Ann-Marie Hulstine
Alpheus Medical

Ann-Marie Hulstine, Vice President, Clinical Operations, Alpheus Medical

Ann-Marie started her pharma/biotech career over 20 years ago and has found a love of the unique challenges that biotech and start-ups bring. Ann-Marie serves as the Vice President of Clinical Operations at Alpheus Medical, leading a drug device combination program. She has spent the majority of her career in, and has a passion for, oncology drug development.

Stacy Hurt
Parexel Intl

Stacy Hurt, Chief Patient Officer, Patient Engagement, Parexel International

A globally recognized advocate within the patient community, Stacy champions Parexel’s patients-first culture. She ensures that patients and caregivers have a seat at the table to translate their lived experience and recommendations into improvements in the drug development process at its earliest stages. Stacy champions accessibility to clinical research by expanding the definition of diversity to ensure that people with disabilities have an equitable chance at better treatments, improved outcomes, and cures. Stacy is an award-winning 25-year pharma executive with experience in functional areas such as sales, marketing, training, operations, and physician practice management. She is a frequent conference speaker and industry influencer, always championing patient involvement in clinical research, for example, as a member of the Global Annual Meeting Program Committee for Drug Information Association (DIA). Stacy is also co-chair of the board of the American Cancer Society Northeast Region (Pittsburgh market).  Stacy holds a bachelor’s degree in labor and industrial relations from Penn State University and master’s degrees in health administration and business administration from the University of Pittsburgh.

Mike Hutton
Almac Group

Mike Hutton, Director - Strategic Partnerships and Commercializ, Clinical Technologies, Almac Group

Mike Hutton graduated from the University of East Anglia with a PhD in Biochemistry and spent 18 years as an academic in Scientific and Medical Research. In 1999, he joined a leading London central laboratory provider and then moved to ICTI in 2002, prior to its acquisition by Almac. After 20 years with Almac, Mike is currently the Head of Strategic Partnerships & Alliances developing new opportunities globally for Almac’s world-class IRT solution.

Brigham Hyde
Atropos Health

Brigham Hyde, CEO, Atropos Health & Venture Partner, Audere Capital LLC, Atropos Health

Dr. Brigham Hyde is CEO and co-founder of Atropos Health since August 2022. He provided funding and support for Atropos Health’s official launch in late 2020. Hyde has a significant track record of building businesses in the health tech and real-world data (RWD) space and most recently served as President of Data & Analytics at Eversana. Prior to that role, Mr. Hyde served as a healthcare partner at the AI venture fund Symphony AI, where he led the investment in, co-founded, and operated Concert AI, an oncology RWD company - most recently valued at $1.9B. Hyde held previous roles as Chief Data Officer at Decision Resources Group, which was acquired by Clarivate for $900M in 2020. He has also served on the Global Data Science Advisory Board for Janssen, as a research faculty at MIT Media Lab, and served as adjunct faculty at Tufts Medical School.

Sameera Ibrahim
Bristol Myers Squibb Pharmaceuticals Ltd

Sameera Ibrahim, Senior Director, Quality Strategy & Business Operations, Bristol Myers Squibb Pharmaceuticals Ltd.

No bio available.

Muhammed Idris
Morehouse School Of Medicine

Muhammed Idris, PhD, Co Director, Digital Health & Medicine, Morehouse School Of Medicine

Dr. Muhammed Y. Idris is an Assistant Professor in the Department of Medicine aat Morehouse School of Medicine (MSM), where he is also an Associate Director leading digital transformation in the Clinical Research Center and serves the Founding Co-Director the Center of Excellence for the Validation of Digital Health Technologies and Clinical Algorithms. Trained as a computational social scientist his work combines machine learning and community-based research to design more accessible and adaptive digital health tools and interventions for use in clinical research. Prior to joining MSM, Dr. Idris held several roles leading interdisciplinary teams building, deploying, and maintaining machine learning solutions in industry as well as startups and venture capital. His work has been presented on various academic, policy, and industry platforms and encompasses a TED talk on AI-driven social service delivery that garnered around 1.8 million views. Dr. Idris graduated from the University of Washington and the Pennsylvania State University.

Margaret Ikpoh
NIHR

Margaret Ikpoh, National Settings Lead for Primary Care, NIHR Clinical Research Network; Vice-Chair, Professional Development & Standards, Royal College of General Practitioners

Margaret Ikpoh is a GP Partner at Holderness Health. She is the current Royal College of General Practitioners Vice Chair for Professional Development. She is the practice lead for research and has had previous roles with the NIHR Yorkshire and Humber as a research champion for First5 GPs and AITs. She is the current National NIHR Settings lead for Primary Care She is also the former Associate Director for Primary Care for Hull York Medical School and is a GP Trainer. In 2021 she was voted the Fellow of the year at the RCGP Inspire awards. She is the former co-Chair for the regional Primary Care Workforce Group with NHS England & Improvement for the North-East and Yorkshire Regional People Board and is still an active member. In 2022 she was voted one of HSJ’s top 50 most influential Black, Asian and minority ethnic figures in health. In 2024 she was awarded the Caribbean and African Health Network Special Recognition Award for Leadership in Primary Care.

Anne Marie L Inglis
GSK

Anne Marie L. Inglis, PhD, Senior Director & Asset Lead, Clinical Operations, GSK

Anne Marie Inglis has over 25 years of experience in clinical research, spanning all phases and therapeutic areas, but specializes primarily in Clinical Operations. She spent most of her career at GSK, and up until 2020 represented GSK on TransCelerate Biopharma workstreams, leading both the Site Qualification and Training team as well as the Patient Experience Team. She is passionate about improving the patient experience in clinical research and in particular, increasing the diversity of participants in clinical trials. She left GSK in 2020 to move into smaller biotech and at Mallinckrodt Pharmaceuticals developed a Risk Management framework that ensured compliance to ICH E6(R2). She moved to Affinivax and was responsible for developing the innovative operational strategy for an early-phase vaccine asset. In 2022, Affinivax was acquired by GSK, and Anne Marie is back as a Clinical Operations Asset Lead. She remains committed to employing innovative strategies to ensure clinical trials are available to all patients who could benefit, while improving quality and speeding delivery of new medicines to the marketplace.

Vladimir Ivanov
Pfizer

Vladimir Ivanov, PhD, Director, Group Lead, AI/ML Quantitative Data Sciences, Pfizer Inc.

Director, Group Lead, AI/ML Quantitative Data Sciences, Pfizer Focus on multi-modal molecular and clinical data to inform clinical development and trial design with the emphasis on artificial intelligence and machine learning (AI/ML).

Leslie Ives
Parexel Intl

Leslie Ives, Senior Director, Patient Recruitment, Patient Strategy and Insights, Parexel Intl

Leslie is a Senior Director leading Patient Recruitment operations at Parexel. Leslie has more than 18 years’ experience in the pharmaceutical and clinical trials industries, primarily in clinical operations roles and driving innovative patient recruitment and retention campaigns for many of the world’s leading pharmaceutical companies. Working with key site stakeholders, disease specific physician consultants and patient partners, Leslie’s work is centered on making clinical trials efficient for sites and easier to navigate for patients. Leslie holds a bachelor’s degree in English and Biology and a master’s degree in Health Communications.

Venky Iyer
Pfizer

Venky Iyer, Director, Data Strategy & Enablement, Pfizer Inc.

Venky Iyer is Director of Data Strategy & Automations within Information Management Group at Pfizer. He has over three decades of experience in the pharmaceutical sector delivering key enablers for multiple clients to drive business value. Currently, he is actively involved in several AI/ML strategic initiatives partnering with key stakeholders and driving key concepts for enablement. He holds a master’s degree in Mathematics and has been with Pfizer since 2019.

Paul Jacobs
Regeneron Pharmaceuticals

Paul Jacobs, Associate Director, Development Innovation, Regeneron Pharmaceuticals, Inc.

Paul Jacobs is Associate Director of Global Development Innovation at Regeneron. He is part of a function responsible for enabling clinical trials innovation by bringing innovative thinking, tools and techniques to the table through an innovation pipeline process. Before joining Regeneron in 2021, Paul worked in innovation roles at LEO Pharma as Head of Innovation, helping to establish and grow the R&D Data and Analytics function and, before that, as a founding member of the LEO Pharma Innovation Lab. Paul has also held roles in consultancy with Frog (Capgemini Invent) as Head of the UK Life Science Practice and various Medical Editing, Digital Strategy and Client Service roles at Publicis Healthcare, Sonic Boom and Nucleus Group companies. Paul received his Masters Degree in Biomedical Sciences from King’s College, London and his Bachelor’s degree in Biological Sciences from The University of Salford.

Nitin Jain
Intrinseque Health

Nitin Jain, President & CEO, Intrinseque Health

With experience of 22+years, Nitin Jain has worked extensively in Business Development, General Management, Strategic Alliances and Operations in the Drug Development, Pharmaceuticals & Central Laboratory industries in Asia Pacific, US, EU and the Indian Sub-Continent. Nitin has worked with organizations such as; Covance & INC Research as Head Business Development. At Theorem Clinical Research, as Vice President & General Manager, Nitin has effectively managed all activities of the company in Asia Pacific region including, Operations, General Management, Global Staffing business and Business Development. Nitin Jain completed his Higher Secondary education from David Game College, London, UK. He obtained his Bachelor in Administration degree from AMLA, LA, USA and Master of Business Administration degree from ACL, London, UK. An effective problem solver and decisive leader, Nitin Jain wishes to continue pursuing his career in the Drug Development industry.

Aamir Jaka
Saama

Aamir Jaka, VP Life Science Strategy, Commercial, Saama

Aamir Jaka leads Saama’s Customer Success team, which is focused on helping Saama customers achieve their business goals using Saama’s AI-driven SaaS platform, as well as product based industry solutions and accelerators for customers. He has over 20 years of experience in technology, consulting, and software organizations working to solve complex business challenges with technology-enabled, data-driven business insights. His ability to bridge technical and business topics within executive and end-user communities allows Aamir to work closely with Saama customers to drive digital transformation initiatives that generate measurable value-based outcomes. Aamir joined Saama as part of the company’s 2019 acquisition of Comprehend Systems, Inc., where he led the Professional Services and Customer Success teams. Prior to Comprehend, Aamir led services and consulting teams at Adaptive Insights (a Workday company), Perficient and PwC. A graduate of the University of Southern California, Aamir holds a BS in Business Information Systems and an MBA from the Haas School of Business at the University of California, Berkeley.

Kelsey Jakee
PA Consulting

Kelsey Jakee, Managing Consultant , Global Life Sciences, PA Consulting

Kelsey Jakee, managing consultant with PA Consulting, has an established track record of leading and managing transformation in pharmaceutical R&D. Over the past 14 years, she has advised Top 20 BioPharma and industry consortia on clinical innovation, new service and business model development, R&D technology strategy, digital transformation, improving the patient experience, and leveraging novel data sources across preclinical, clinical, and drug safety. Her mission is to drive high-impact and lasting change in clinical research to help us all live our best lives

Usama Javed
Merck & Co

Usama Javed, PharmD, Associate Principal Scientist, Regulatory Digital Health, Merck & Co.

Usama is a dedicated pharmacist with a Master's in Health Informatics, blending clinical expertise with a passion for digital innovation in healthcare. With a career spanning from frontline patient care in retail pharmacy to shaping regulatory strategies in digital health at Merck, Usama leverages unique insights to drive impactful change. His diverse background fuels his commitment to improving patient outcomes through technology, making him an engaging thought leader at the intersection of pharmaceuticals, health technology, and regulatory innovation.

Christina L Jenkins
Convergent Ventures LLC

Christina L. Jenkins, Co-Founder & General Partner, Convergent Ventures LLC

I am a early-stage venture investor, board director, and a trusted advisor to healthcare leaders, offering a unique perspective spanning patients, providers, and US payers. My expertise is grounded in finance training at GE, clinical medicine, health systems executive leadership, and health plan governance. I'm a cofounder and General Partner at Convergent Ventures, a Seed/A firm investing in health and sustainability. I lead our health/life sciences strategy and look primarily for relentless teams building science-driven platform companies that help take the "art" out of medicine. They transform the way we diagnose, monitor, or treat, leading to better outcomes for all. I am a board director of for-profit companies ranging from $0 to $26B in revenue, where I use my "sonar hearing" and ability to pose the right first questions in service to growth. As a former CEO in the provider setting, I respect the challenges of executing within opaque, fast, or resource-constrained contexts -- I serve as a trusted advisor to C-suite leaders seeking to redesign for better clinical value or innovate their care models. I'm invited often to share my views on AI in health, the health of women, the life sciences investing landscape, and more. Some places I've recently done so: NYSE, HLTH, SXSW, NY BIO, Google/Techstars, NAM / NY Fed, Forbes, BioFutures, and Commonwealth Fund.

Donald G Jennings
Eli Lilly & Co

Donald Jennings, Senior Advisor of Systems, Tech@Lilly Clinical Design and Operations, Eli Lilly and Company

Don Jennings currently serves as a Senior Architect in Eli Lilly’s technical organization where he is responsible for defining, evolving and driving innovation in Lilly’s Clinical Trial Design & Operations capabilities. Don also participates in the Transcelerate Digital Data Flow (DDF) workstream as Vendor Engagement subteam lead where he advocates for industry-scale data system interoperability using USDM and its associated APIs. Previously, Don was a Lilly Digital Health technology advisor leading engineers in developing SaMD solutions to improve delivery of therapy for complex disease states (2018-2023). Don also led Lilly teams in development of eSource technologies, automated clinical information exchange, PK/PD simulation and genomic analytics (2007-2018). Prior to his roles at Lilly, Don participated in the original sequencing of the human and rat genomes at Celera Genomics (2000-2007) and delivered science ground segments for several NASA and ESA high energy astrophysics missions (1989-2000). Don holds an MBA from Butler University, an MS in Physics from Iowa State University, and bachelor’s degrees in Physics and Computer Science from the University of Missouri.

Lisa Jennings
Catalyst Clinical Research - Catalyst Flex

Lisa Jennings, Senior Director, Business Development, Business Development, Catalyst Clinical Research - Catalyst Flex

Lisa Jennings, Senior Director, Catalyst Clinical Research

Although clinical research continues to increase in its complexity, relationships among biopharma companies and their outsourcing remain a constant. Having experience with relationship development and ensuring the small biopharma client’s voice is heard by internal stakeholders is essential. Lisa navigates complex science, regulatory, and organizational landscapes, ensuring creative and collaborative solutioning aligns to client and patient needs. Being able to communicate to all levels throughout an organization, helps Lisa to connect and integrate the right resources to deliver all phases of global clinical trials.

LaQuinta Jernigan
mdgroup

LaQuinta Jernigan, COO, Operations, mdgroup

LaQuinta Jernigan currently serves as the Chief Operating Officer for mdgroup. mdgroup is a global patient health services company that provides a patient-first approach to clinical research. They support all sizes of pharma and biotech to attract, engage, and maintain patient participation in healthcare research. With a pioneering global ecosystem of clinical trial solutions, streamlined patient reimbursements, safe patient transport and in-home health visits - to personalised patient support, clinical equipment logistics and top-tier healthcare professional staffing placements.

Yugang Jia
Verily

Yugang Jia, PhD, MPH, Director, AI & Data Science, Verily

Yugang Jia, PhD, MPH, has been the Director of AI & Data Science at Verily Life Sciences since 2020, focusing on leveraging machine learning and artificial intelligence techniques to drive innovation in clinical research and digital health settings. Prior to this, he led the Health AI team at Fidelity Investments (2017-2019) and spearheaded various key innovations at Philips Research (2006-2017). Dr. Jia has authored over 20+ peer-reviewed papers and holds 7 granted US patents along with 20+ patent applications. Since 2021, he has also been affiliated with the Laboratory for Computational Physiology at the Massachusetts Institute of Technology, conducting research on health equity and AI safety in the critical care domain.

Otis Johnson
Trial Equity

Otis Johnson, PhD, MPA, Principal Consultant, Trial Equity

Dr. Otis Johnson is the Founder of Trial Equity, whose purpose is to ensure that medicines are safe and effective for all people by providing solutions for diverse patient recruitment in clinical trials. Recognized for his leadership by Pharmavoice, Informa Connect and Mogul, he has served on the diversity advisory boards of the Association of Clinical Research Organizations (ACRO) and the Association of Clinical Research Professionals (ACRP). He is also on the advisory board of Wake Forest University’s Master’s Degree Program in Clinical Research Management and a Global Advisory Board Member of the Healthcare Businesswomen's Association (HBA).

Paris Johnson
AstraZeneca

Paris Johnson, Senior Local Study Associate Director, AstraZeneca

Tom Johnson
Exostar

Tom Johnson, Senior Director, Life Sciences & Health IT, Life Sciences Solutions, Exostar

Tom Johnson is a seasoned professional who has devoted the last decade to optimizing the clinical study process for life sciences companies, focusing on reducing technical burdens and enhancing efficiency in study start-up and application access management.  Exostar's expansive community includes half of the world’s largest pharmaceutical companies, over 30,000 organizations, 100+ connected applications, and over 700,000+ individuals working in thousands of sponsors, CRO and site locations worldwide. With a Bachelor of Science in Industrial Engineering from The Georgia Institute of Technology, Tom brings a unique blend of academic expertise and practical experience to his role, driving impactful solutions within the life sciences industry.

Jill M Johnston
WCG Clinical

Jill Johnston, Chief Innovation Officer, WCG Clinical

Jill Johnston is the Chief Innovation Officer at WCG Clinical, where she drives cutting-edge innovation and integration initiatives across the organization. Focusing on business transformation and strategic exploration of new technologies, processes, and solutions, Jill ensures that WCG Clinical remains at the forefront of the industry. Bringing extensive experience from the Clinical Trial sector, Jill has previously served as President of WCG’s Study Planning and Site Solutions. Her professional journey includes significant roles such as Vice President of Clinical Strategy at Veeva Systems and Global Vice President of Business Transformation at Covance, where she spent more than 20 years leading pivotal clinical trials in oncology, cardiovascular, metabolic, and neurology. Jill’s remarkable contributions to the industry have been recognized through several prestigious awards, including the Excellence in Process Award and the Chairman’s Award-received twice during her tenure at Covance. She holds certifications as a Six Sigma Black Belt, certified Project Management Professional, and a certified Clinical Research Associate from ACRP. Jill earned a BSc in Biology from SUNY College of Environmental Science and Forestry. An active contributor to the academic community, she taught clinical monitoring and coordination to support Drexel University’s Clinical Development Master’s program. Jill was also a founding member and former Chapter President of the Association for Clinical Research Professionals (ACRP) in Greater Philadelphia.

Brandie Jonas
Geron Corporation

Brandie M. Jonas, MS, Senior Director, Program Management, Geron Corporation

I am a Program Management leader with over 20 years' experience in overseeing projects and programs for CMC, preclinical, and clinical research. My expertise is in developing program management tools, processes, and teams for small pharma and biotech companies.

Michelle Joseph
Mural Oncology

Michelle Joseph, Director, Clinical Data Management, Mural Oncology

In my role, I am skilled in collaborating with diverse stakeholders to enhance operational efficiency and propel clinical development programs forward. Excel in implementing best practices and ensuring the quality and integrity of clinical trial data. I oversee all aspects of clinical data management, from protocol development to study design and data collection, analysis, and reporting. By leveraging my expertise in regulatory requirements and industry standards, I ensure compliance with applicable guidelines and drive efficient and effective data management processes. My leadership style is characterized by collaboration, innovation, and a commitment to excellence. I foster a culture of teamwork and continuous learning, empowering my team to achieve their full potential and deliver high-quality results that meet or exceed stakeholder expectations. As a strategic thinker and results-oriented leader, I thrive in dynamic environments where adaptability and agility are essential. I am dedicated to delivering measurable outcomes and exceeding business objectives while maintaining a focus on patient safety and regulatory compliance. Let's collaborate to advance clinical data management practices, drive innovation in healthcare, and improve patient outcomes, while connecting and exploring opportunities to make a meaningful impact together.

Tim Joy
Pfizer

Tim Joy, Head of Strategic Solutions, Information Mgmt, Pfizer

No bio available.

Naveen KK
Labcorp

Naveen KK, Vice President & Global Head, CMR, CM & Safety Services, Fortrea

Dr. Naveen KK has worked in Healthcare, CRO & ITES industry for 18+ years, he has experience working across Pharmacovigilance, Risk-Based Monitoring, Cardiac Safety Services and Connected Devices. Physician with Master's in Business Administration degree & Lean Six Sigma Black Belt Certification. He is currently working as Executive Director & Global Head, Central Monitoring, Medical Data Review, and Clinical Trial Safety in Labcorp.

Andrew D Kaczorek
Eli Lilly & Co

Andrew D. Kaczorek, Data Engineer, Eli Lilly & Co.

Andrew has worked across many areas of Eli Lilly over a sixteen year career. With expertise in architecture, cloud computing, software development, data engineering, high-performance computing, and clinical trial analysis, he currently serves as a technical lead for MagnolAi, our custom data platform. Andrew's work focuses on integrating advanced AI techniques to enhance the platform’s capabilities, including automation of data acquisition pipelines, parallel processing systems, database solutions, and cloud computing resources. He has led efforts to evaluate and incorporate innovative sensor technologies into our workflows, conducted analyses related to subject compliance and digital biomarker research, and spearheaded initiatives to enhance the platform's real-time data ingestion and processing capabilities.

Hassan Kadhim
Vertex Pharmaceuticals

Hassan Kadhim, Head of Clinical Operations and Development Business Capabilities, Vertex Pharmaceuticals

Hassan Kadhim is the Global Head of Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations at BMS. In his current role, Hassan's team owns the technology stack and capabilities within Global Development Operations, and drives change and innovation towards better outcomes for clinical trial stakeholders. Hassan is very passionate about transforming the clinical research arena in the pharma industry through the use of technologies and patient-centric clinical trials, and is a firm believer of the need for clinical innovation grounded in strong business practices for sustainability, change management and adherence to compliance and regulatory commitments. Hassan regularly appears and speaks at industry events around improving the clinical trial experience with digital tools, and wrote “The Remote Clinical Trials Model” whitepaper in 2016, to formalize a new patient-centric clinical trial research model leading to what we know today as Decentralized Clinical Trials. Beyond BMS, Hassan actively collaborates across industry collaborations such as Transcelerate and others to advance relevant and high-value industry challenges. He has a degree in bioinformatics and a graduate degree in pharmaceutical sciences, both from the University of Montreal in Canada.

Nadia Kallu
AstraZeneca Canada Inc.

Nadia Kallu, Strategic Feasibility Associate Director, AstraZeneca

As a seasoned professional in the pharmaceutical industry, I have amassed a wealth of experience as a Local Study Associate Director, overseeing the operational intricacies of clinical trials at AstraZeneca. In this pivotal role, I successfully managed the execution of clinical studies, ensuring adherence to regulatory standards, maintaining study timelines, and fostering collaboration with diverse stakeholders to achieve study objectives. Building on this foundation, I made a strategic transition into the realm of Feasibility, where I harnessed my operational expertise to evaluate the viability and practicality of conducting clinical trials on a broader scale. This shift empowered me to assess potential sites, forecast patient recruitment capabilities, and provide valuable input into study design by leveraging my comprehensive understanding of operational considerations. My journey from Local Study Associate Director to a Strategic Feasibility professional has equipped me with a holistic perspective on clinical trial management, blending operational acumen with strategic foresight to contribute meaningfully to the planning and execution of clinical studies at AstraZeneca.

Aaron Kamauu
Ikaika Health LLC

Aaron W. Kamauu, MD, MS, MPH, CEO, Navidence LLC

Dr. Aaron Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) is an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to support a variety of clinical research, informatics, clinical trials, and drug development activities, including pharmacoepidemiology, outcomes research, protocol design, site identification, data-driven patient recruitment, and the use of RWD to support evidence generation & submission to regulatory agencies (e.g., FDA). He has this experience across the spectrum of pharmaceutical/biotech, entrepreneurship, and large CRO businesses.

Dhvanil Karia, PhD
Credible Planning

Dhvanil Karia, PhD, Director, Clinical Solutions, Credible Planning

Dhvanil is a highly experienced and results-driven healthcare IT leader with over 12+ years of experience in the clinical drug development domain and exclusively last 7+ years in the pharmaceutical/CRO industry. He is adept at driving new technology solutions, building relationships and managing complex engagements with a proven ability to lead the development, delivery and deployment of clinical technology solutions in large matrix IT environments.

Numan Karim
AbbVie Inc

Numan Karim, MS, Associate Director, Data Science & Analytics, AbbVie, Inc.

Numan Karim is an Associate Director of Data Science & Analytics at AbbVie. He has 8 years of experience in the pharmaceutical industry, with a focus on enabling analytics capabilities across Clinical Development. Numan's current work involves developing fit-for-purpose analytics and data science capabilities for healthcare professionals and scientists in Clinical Operations and Patient Safety. Combining visual analytics, statistics, and modern data engineering tactics, he has deployed multiple data science products at scale. Numan is passionate about data science leadership and the intersection of analytics, technology, and medicine. Numan received a BS in Statistics & Integrative Biology from the University of Illinois at Urbana Champaign in 2016, and received an MS in Applied Data Science from the University of Chicago in 2020.

Christina Karunaratne
Karuna Integrated Clinical Services

Tina Karunaratne, Executive Advisor, Biopharma Relations, ClinEco

Tina is the Founder and CEO of Karuna Integrated Clinical Services (KICS), a niche Clinical Research Organization. She also serves as a Consultant to startup biotech/pharma companies. Tina also serves on the Board of Directors for two non-profit organizations - Children Across America (CAA), which focuses on enriching the lives of minority children in STREAM (Science, Technology, Reading, Engineering, Arts, and Mathematics) and, more recently, Pathways to Trust. This organization focuses on the needs of patients and families battling rare diseases and facing hurdles to care. She is an Adjunct Instructor at Northeastern University’s Masters in Biotechnology Program. Tina has a Doctoral degree in Law and Policy (Northeastern University) and a Master of Science in Regulatory Affairs (Regis College).

Asma Kasuba
Johnson and Johnson Innovative Medicine

Asma Kasuba, Senior Director, R&D Data Science Global Development, Johnson and Johnson Innovative Medicine

Asma Kasuba is Senior Director, Global Development Data and Science and Digital Health at Johnson and Johnson Innovative Medicine. Her career in the pharmaceutical industry spans across all phases of clinical development and multiple therapeutic areas, enabling a diverse and broad lens to drug development. Asma has held roles in increasing responsibility across Regulatory Affairs, Program Management, Strategy, and Operations and Data Science in R&D, Medical Affairs and Commercial. In her current role, Asma is leading a team of Data Science PMs to build and utilize RWD, RCT, and AI/ML modeling capabilities to optimize clinical trial design, site selection and accelerate trial execution, and scaling these capabilities for greater impact across the portfolio. Asma has a Bachelor's Degree in Biochemistry from Rutgers University and an MBA in International Business. She is a PMP Certificated and a Stanford University Certified PM. Prior to joining Johnson and Johnson, Asma has prior experience at Pfizer and Biomatrix.

Nechama Katan
Pfizer Inc

Nechama Katan, Director, Innovative Analytics, Data Monitoring and Management, Pfizer Inc.

Nechama Katan, is a Wicked Problem Wizard working at Pfizer as a Director of Data Science. She helps organizations understand technical processes and problems and then works to build trust and innovative solutions. Nechama has been supporting Pfizer’s Risk Based Monitoring team for over 6 years. Nechama has worked in multiple industries and organizations of all sizes, including high and low tech, finance, and pharmaceuticals. Nechama’s education includes an MSc from NYU/Courant Institute in Mathematics and an MA from Columbia University in Statistics.

Konstantina M Katcheves
Teva Pharmaceuticals

Konstantina Katcheves, Senior Vice President, Business Development, Alliance Management and Acquisitions, Teva Pharmaceuticals

Konstantina Katcheves is Senior Vice President of Business Development at Bristol Myers Squibb (BMS). She has over twenty years of business development, corporate strategy and intellectual property experience. In her role at BMS, Konstantina is responsible for all business development activities for new technologies including early discovery partnerships, platform collaborations, digital innovation, precision medicine and cell and gene therapy technologies. She also leads a global team responsible for business development in Japan and China and innovation search and evaluation outside the U.S. Prior to joining BMS, Konstantina served as Vice President of IP and Licensing at Agilent Technologies and prior to Agilent was Vice President of Global IP and Licensing at Lonza. Konstantina holds a M.S. from the Johns Hopkins University, J.D. from the University of Oklahoma and B.S from the University of California at San Diego.

Jeffrey A Kaye
Oregon Health & Science University

Jeffrey A. Kaye, MD, Director, ORCATECH (Oregon Center for Aging & Technology), Oregon Health & Science University

Dr. Kaye is the Layton Professor of Neurology and Biomedical Engineering at Oregon Health and Science University (OHSU). He directs the Layton Aging and Alzheimer’s Disease Center, ORCATECH (the Oregon Center for Aging and Technology), and ORCASTRAIT (the Oregon Roybal Center for Care Support Translational Research Advantaged by Integrating Technology). His long-standing research focus has been to advance methods to sustain healthy aging and treat conditions associated with aging. This work has been facilitated by a remarkable cadre of interdisciplinary colleagues and collaborators within OHSU, as well as many others at research centers around the world. Through these many associations, He has enjoyed extensive experience in team-building, designing, conducting and analyzing studies of aging and diseases of aging across a wide spectrum of environments (e.g., clinics, community residences, assisted living and nursing facilities, "smart" homes), designs (e.g., program projects, longitudinal natural history studies, proof-of-concept studies, randomized controlled trials, online surveys), and approaches (e.g., cognitive and behavioral testing, genetics, neuroimaging, biomarkers, in-home continuous assessment technologies). He leads or has led several longitudinal studies on aging and clinical trials including: The Oregon Brain Aging Study (OBAS), Intelligent Systems for Detection of Aging Changes (ISAAC), Ambient Independence Measures for Guiding Care Transitions, EVALUATE-AD (Ecologically Valid, Ambient, Longitudinal and Unbiased Assessment of Treatment Efficacy in Alzheimer’s Disease), DETECT-AD (Digital Evaluations and Technologies Enabling Clinical Translation for Alzheimer’s Disease), and the Collaborative Aging Research using Technology (CART) Initiative studies, all using pervasive computing and sensing technologies for assessment and interventions. He serves on many national and international panels and boards in the fields of geriatrics, neurology and technology. He is listed in Best Doctors in America. He has authored over 450 scientific publications and holds several major grant awards from federal agencies, national foundations and industrial sponsors.

Dan Kearney
CNS Healthcare

Dan Kearney, CEO, CNS Healthcare

In over 30 years of leading teams at clinical trial sites, my focus has always been on empowering our people to provide our patients with the best trial experience possible. My goal is to ensure our clinicians and research teams have the resources and infrastructure they need to successfully operationalize a wide variety of clinical trials without ever losing sight of the importance of patient care. I wholeheartedly believe in the transformative power of partnerships across sites, sponsors, CROs and technology providers. Through collaboration, we can innovate in all aspects of clinical research to make better treatment options available to those who need them most.

Lindsay S Kehoe
Clinical Trials Transformation Initiative

Lindsay Kehoe, Project Manager, Clinical Trials Transformation Initiative

Lindsay Kehoe manages the development and implementation of projects at the Clinical Trials Transformation Initiative (CTTI). Lindsay has 10 years of experience coordinating clinical research. Prior to joining CTTI, she served as a clinical trial lead at Children’s National Medical Center in Washington, DC, coordinating both physician-driven and industry-sponsored trials. She also served on the hospital's Institutional Review Board. Lindsay is a genetic counselor with extensive experience in both pediatric and adult genetic counseling. Early in her career, Lindsay worked in the pharmaceutical sector, first in early-phase drug development at Millennium Pharmaceuticals (now Takeda Oncology) and then in post-marketing laboratory surveillance at Sanofi Genzyme. Lindsay is a proud alumnus of the University of Virginia and master’s graduate alumnus of Boston University School of Medicine.

Jean Kelly
Rochester Clinical Research

Jean is the Head of Clinical Operations and a Sub-Investigator at Rochester Clinical Research in Rochester, NY. She is a Physician Assistant by training and has several years of both outpatient and inpatient site research experience. Jean has a passion for site operations and the patient experience, because they are the core of what makes clinical research possible!

Istvan Attila Kerekes
Gedeon Richter Plc

Istvan Attila Kerekes, PharmD, Senior Clinical Project Manager, Global Medical Division, Global Clinical Operations, Gedeon Richter Plc

Pharmacist by profession but became a Clinical Project Manager to drive innovation in the pharmaceutical industry. With several years of on-site monitoring and clinical project management experience, I gained in depth knowledge about the full lifecycle of the clinical drug development process from Phase I to phase III on a wide range of therapeutic areas and different study designs. Involved in the set-up, monitoring and management of several hybrid clinical trials in the past 10 years.

Scottie Kern
Critical Path Institute

Scottie Kern, Executive Director, eCOA Consortium, Critical Path Institute

Mr. Kern is a patient-based clinical technology expert with over 25 years of clinical research experience and serves as the Executive Director of the eCOA Consortium at C-Path. Beginning his career in clinical data management roles at several CROs and pharmaceutical companies, Scottie was first exposed to Electronic Patient Reported Outcome (ePRO) technology back in 2003. Enthused by the potential of this technology and its direct interaction with patients, Scottie took a role as the functional lead for ePRO at Wyeth’s Vaccine Research Unit in 2004, one of the earliest dedicated enterprise-level ePRO ownership roles in the industry. Establishing himself as an industry SME and thought leader on ePRO and Electronic Clinical Outcome Assessments (eCOA), he went on to serve as the Head of Patient Technologies and Global Head of ePRO at Pfizer. Scottie launched his own consulting company in 2013, via which he supported a range of pharmaceutical companies with eCOA strategy and implementation. Scottie joined C-Path in 2021.

Kianta Key
GCI Health

Kianta Key, Group Sr VP Digital & Head of Identity Experience, Digital Healthcare, GCI Health

No bio available.

Irfan Khan
Circuit Clinical

Irfan Khan, CEO, Circuit Clinical

Dr. Irfan Khan is the founder and CEO of Circuit Clinical. Dr. Khan is a cardiologist who served as a principal investigator on both therapeutic and device clinical trials for more than a decade and is passionate about improving access and equity in clinical trials, community engagement, and patient education and empowerment. Over the last six years, he has overseen Circuit Clinical’s growth to more than 2.5 million patients, involving 30+ partner locations including multi-specialty physician practices, Accountable Care Organizations, and Federally Qualified Health Centers. His work at Circuit Clinical has also included the creation of TrialJourney™, the first-ever ratings and reviews platform for clinical trial participants and people seeking clinical research as a care option. Under Dr. Khan's leadership, Circuit Clinical was awarded a "World Changing Ideas" recognition from Fast Company™, as well as being named an Inc. Magazine™ Best Workplace 2021, and a Fast Company™ Best Workplaces for Innovators 2021.

Sheraz Khan
Pfizer

Sheraz Khan, PhD, Director, Operational AI & Data Sciences, Pfizer Inc.

With over two decades of experience leading the development and deployment of digital solutions in the pharmaceutical industry, I have spearheaded data science initiatives that optimize every stage of the clinical trial lifecycle. My expertise includes leading teams to harness machine learning for improved patient recruitment, integrating novel digital endpoints for deeper insights into drug efficacy, employing ML techniques for risk-based data monitoring, and automating regulatory document authoring using generative AI. At Biogen and through my consultancy, I have integrated digital technologies into clinical trials to streamline processes and enhance outcomes. At Harvard and MIT, I developed open-source Python tools for digital health and fostered industry-academia collaborations. I have published over 60 high-impact papers with over 2,000 citations and hold two patents in digital health technologies. Adept at leading cross-functional teams, I seamlessly merge technology and healthcare to accelerate clinical trials and drive strategic objectives.

Garo Kiledjian
SGM Alliance

Garo Kiledjian, Founder & CEO, SGM Alliance

Garo Kiledjian is the Founder, President, and CEO of SGM Alliance, a 501c3 nonprofit that focuses on educating and advocating for inclusive Sexual and Gender Minority (SGM) participation in clinical trials, life sciences, and the evolution of healthcare. Garo also serves as the Chief Operating Officer for Trialogic, a Site Network for one of the largest global LGBTQIA+ healthcare providers. Having served in multilevel roles within administration, research, pharmacy, operations, and finance, Garo brings a versatile skill set to his leadership role. He also serves on the Membership Planning Committee for Society for Clinical Research Sites (SCRS) and is on the Executive Committee for the National LGBTQ Task Force-one of the oldest social advocacy groups that focuses on legislative and policy changes at the grassroots level in Washington, DC. He is passionate about DEI and offers a unique perspective on how the intersectionality of race and ethnicity overlap with gender and sexuality. Garo earned his Bachelor’s from UCLA and studied Leadership and Global Strategy at Woodbury’s Graduate School of Business.

Tamy E Kim
FDA CDER

Tamy Kim, Director for Regulatory Affairs and Policy, Oncology Center for Excellence (OCE), FDA

Tamy Kim is the Director for Regulatory Affairs and Policy in the Oncology Center of Excellence (OCE) at the FDA. She also has a dual role as the Associate Director for Regulatory Affairs within the Office of Oncologic Diseases within CDER. Dr. Kim is responsible for developing policies and procedures affecting the review of products under the OCE across CDER, CBER and CDRH. She is also responsible for providing guidance to oncology review divisions and sponsor for complex regulatory issues. During her time with FDA Oncology, Dr. Kim helped established the OCE and formed policy and procedures for Breakthrough Therapy, Accelerated approval, Real-Time Oncology Review (RTOR), expanded access, master protocols, seamless trials designs and more.

Joseph Kim
ProofPilot Inc

Joseph Kim, Chief Strategy Officer, ProofPilot Inc

As Chief Strategy Officer, Joseph Kim brings over 25 years of pharmaceutical expertise to ProofPilot. Finishing his Pharma career in 2022 as the Senior Advisor in Lilly’s Digital Health Office, he brings a wide array of pharmaceutical research industry knowledge, integrating his experience working for a wide variety of organizations, including multiple Sponsors such as Merck and Takeda (Shire), as well as CROs, and technology vendors. He has a robust combination of experience across all phases of clinical research, and a well-known history of innovation in the industry, recognized as one of the “Top 100 individuals on the 2015 MedicineMakers Power List,” and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch. He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova.

Adam Kinsey
Merck & Co Inc

Adam Kinsey, Assoc VP Clinical Operations & Regional Head, N America, Merck & Co Inc

No bio available.

Jesper Kjaer
Novo Nordisk AS

Jesper Kjaer, Global Director Public & Private Partnerships, Strategic Operations Global Medical Affairs, Novo Nordisk; Co-Chair, Vulcan Advisory Committee

Global Director for Public Private Partnerships at Novo Nordisk. Former head of The Data Analytics Centre at the Danish Medicines Agency, co-chair for HMA / EMA Big Data Steering Group. 20+ years’ experience in data management, analyses and data visualisation having previously worked in academia and pharmaceutical industry. Has headed up activities in EU Framework Programmes (large HIV observational studies), TransCelerate Biopharma, co-chair for HL7 Vulcan advisory board. Co-founder of PHAIR: Pharmacovigilance by AI Real-time analyses, applying FHIR resources to health care data in DK for real time safety surveillance. Previously involved in EHDS pilot work and DARWIN EU advisory board.

Brett Kleger
Inspire

Brett Kleger, CEO, Inspire

Brett Kleger is a nationally recognized executive leader with deep strengths in sales, marketing, corporate development, and product management. He has extensive experience building healthcare technology and services companies and divisions, and bringing new offerings and capabilities to market. He is particularly interested in data-driven digital solutions. Prior to Inspire, Brett was CEO of Datacubed Health, where he transitioned the company during the pandemic from early-stage concepts to a major contender in the eCOA and decentralized clinical trial platform categories. Prior to Datacubed, Kleger was Chief Commercial Officer and Chief Operating Officer at DrugDev, where he led the company’s market success to become the leading provider of site-facing technologies, resulting in an acquisition by IQVIA. He remained at IQVIA for several years post-acquisition to consolidate and lead the commercialization for all of IQVIA’s clinical trial technologies. Brett holds a business degree from the University of Maryland and a juris doctorate from the Villanova School of Law. In 2018, he was named to the PharmaVoice 100 in recognition of his considerable career achievements.

Lew Klein
AstraZeneca

Lew Klein, IT Clinical Lead, R&D IT, AstraZeneca

No bio available.

Olgica Klindworth
Medidata a Dassault Systemes Co

Olgica Klindworth, Vice President, Data Quality and Risk Management Solutions, Medidata a Dassault Systemes Co.

Olgica Klindworth is a Vice President, Medidata R&D spearheading development of data quality and risk management capabilities/Clinical Data Studio. Prior to joining Medidata, Olgica spent 17 years at PPD, 10 years in data management leading Data Management teams, building Data Management capabilities and overseeing execution of a number of clinical trials across various therapeutic areas. Olgica has also spearheaded development of Data Analytics and Centralized Monitoring processes and capabilities at PPD. She has participated in or led a number of data management, innovation and RBQM initiatives and served as a subject matter expert or speaker in a number of industry conferences. Olgica received her Bachelor of Science in Microbiology from University of Texas at Austin and Master of Science in Analytics from Texas A&M University.

Sven Knapinski
CSL Vifor

Sven Knapinski, PhD, Director, Site Partnerships, Clinical Development, CSL Vifor

Sven Knapinski leads the newly established Site Partnerships Team at CSL. He and his team are excited to make a difference by deepening the relationship with key clinical research sites and institutions, expanding CSL’s site network, centralizing internal knowledge, and fostering streamlined internal and external information exchange. Sven has 18 years of Clinical Development experience most of it linked to Clinical Trial Management. After his PhD in Biology, he stared his career in a CRO and gained some experience in the medical device industry before he joined CSL (Vifor) 10+ years ago.

Evan Ko
SGM Alliance

Evan Ko, Strategic Operations Manager, SGM Alliance

Evan Ko is the Strategic Operations Manager at SGM Alliance, a pioneering 501(c)(3) nonprofit dedicated to advancing Sexual and Gender Minority (SGM) inclusion in clinical research, life sciences, and the evolving healthcare ecosystem. With a strong technical background and a deep commitment to fostering inclusive healthcare and educational systems, Evan bridges gaps between communities and capital through culturally competent initiatives. They are passionate about empowering underrepresented groups, believing that serving the most marginalized ultimately benefits everyone. A recognized advocate and leader, Evan brings authenticity and their lived experiences to every space. Their background in engineering education research and clinical operations informs their efforts to address access barriers and inclusivity for SGM communities. Evan also serves as the Founding Director of the Out for Undergrad Life Sciences Conference, supporting hundreds of high-achieving LGBTQ2+ undergraduates in reaching their fullest potential. Originally from the Midwest, Evan holds a Bachelor’s degree in Bioengineering from the University of Illinois at Urbana-Champaign. They currently reside in Portland, Oregon, with their partner and dog, living a happy little life.

Cheryl Kole
Almac Group

Cheryl Kole, VP Strategy & Commercialization, Clinical Technologies, Almac Group

Cheryl Kole has over 20 years experience in the pharmaceutical technology field, joining Almac in 2000. Cheryl is responsible for the solution strategy and commercialization for Clinical Technologies products and services as well as overseeing the product management and marketing teams.

Chris Komelasky
SiteBridge Research Inc

Chris Komelasky, CEO & CoFounder, SiteBridge Research Inc

Chris Komelasky is the CEO and Co-founder of SiteBridge Research. Chris has extensive experience as a management consultant and healthcare executive in the areas of strategy, operations, data analytics, commercialization, and business transformation in Pharmaceutical and CRO organizations. Chris was previously the Executive Director of PPD’s Site and Patient Access group driving the innovation agenda and a portfolio of strategic initiatives helping to enable a move towards more data-driven decision making, where he also led the Global Investigator Services and Strategic Site Collaboration teams. Prior to joining PPD, was at GSK in global strategy, business transformation and commercialization and in management and strategy consulting at Accenture and ZS Associates.

Michael J Koren
ENCORE Research Group

Michael Koren, Medical Director & CEO, Jacksonville Center for Clinical Research, Encore Research Group

Michael J. Koren, MD, practices cardiology and serves as the Chief Executive Officer at ENCORE Research Group. He founded ENCORE which has conducted over 2500 clinical trials at 8 locations in Florida since 1997. He received his medical degree cum laude at Harvard Medical School, and completed residency in internal medicine, chief residency and fellowship in cardiology at New York Hospital/Memorial Sloan-Kettering Cancer Center/Cornell Medical Center. Dr. Koren is a fellow of the American College of Cardiology. He is a fellow and two-time past president of the Academy of Physicians in Clinical Research and past president of the regional chapter of the American Heart Association. As an ACRP Certified Principal Investigator, Dr. Koren has led more than 500 clinical trials on hypercholesterolemia, cardiovascular disease, and heart failure. He participates in the Cholesterol Treatment Trialist Collaboration based in Oxford. Dr. Koren’s research has been published in peer-reviewed journals including Nature, Journal of the American College of Cardiology, Circulation, New England Journal of Medicine, and The Lancet. He has lectured nationally and internationally on topics such as lipid-lowering therapy and preventive cardiology.

Anna Kosenko
BioNTech US Inc.

Anna Kosenko, Associate Director, Biomarker Operations, BioNTech US Inc.

Anna Kosenko currently holds the role of Associate Director, Biomarker Operations within iVAC Platform Team at BioNTech US Inc. Anna joined BioNTech US Inc. in July 2024. Anna previously worked at Takeda between 2022 and 2024 as Team Lead, Sample Management and Data Operations, playing a critical role in building a biomarker operations team with clinical sample and data operations capability to support Takeda’s oncology and cell therapy portfolio of Phase I through III global studies. Before joining Takeda, Anna worked in Oncology Biomarker Sample and Data Management role at Seagen (formerly Seattle Genetics). Anna spent 7 years at Parexel International, where she gathered a wealth of experience in clinical operations across therapeutic areas by supporting clinical trials for 20+ pharmaceutical and biotechnology companies. Anna holds an MS in Bioinformatics from Freie University of Berlin (Germany).

Jennifer Krohn
Gilead

Jennifer Krohn, MS, Associate Director, RBQM, Clinical Operations, Gilead Sciences. Inc.

Jennifer Krohn, MS, has over 17 years of experience in the pharmaceutical industry across a range of functions, with the last decade dedicated to risk-based quality management (RBQM) and a special focus on centralized monitoring (CM). She has extensive experience in developing and implementing CM tools and processes as well as leading data analyst teams at a large CRO. Recently, Jennifer transitioned to the pharmaceutical side at Gilead, where she serves as a Risk Advisor, helping to build RBQM capabilities and advising study teams on the development of strategic monitoring approaches. She also serves as a PHUSE RBQM Working Group lead for Central Monitoring and as a contributor to the QTL project. Jennifer holds a Master of Science degree in Biochemistry and Physiology. She resides in Wilmington, NC, with her husband of 16 years and their 10-year-old daughter.

Marie Kromplewski
Bristol Myers Squibb Co

Marie Kromplewski, RN, MSN, Associate Director, Clinical Capabilities Manager, Clinical Center of Excellence, Bristol Myers Squibb Co.

Marie is a Registered Nurse with over 25 years of clinical research experience. She began her passion for clinical research at academic centers, working with pediatric and adult oncology patients on Phase 1-3 research studies. Then transitioned to the pharmaceutical industry to better understand and influence the clinical protocol development before it reaches the patients. At Bristol Myers Squibb, she has held several roles within drug development spanning across all phases of drug development and always striving to improve and streamline processes. She is involved in leveraging new innovative technology to improve our ways of working.

Tobias Kruse
Trials24 GmbH

Tobias Kruse, Managing Director Europe, Trials24 GmbH

Dr. Tobias Kruse is the Managing Director of Europe at SubjectWell. He is the founder and former CEO of Trials24, a company that supports biotech and pharmaceutical companies, as well as CROs, in accelerating patient recruitment. Trials24 was acquired by SubjectWell in September 2024. Before founding Trials24, Tobias co-founded ImevaX, a biotech company focused on vaccine development, where he developed and executed the out-of-site databases patient recruitment strategy. Tobias earned his PhD in Molecular Biotechnology from the Technical University of Munich, where he developed a vaccine against Helicobacter pylori. He holds numerous patents and has published papers in journals such as Nature and EMBO.

Sylvie Kruyner
Bayer Pharmaceuticals

Sylvie Kruyner, Director, DCT Operations, Bayer Pharmaceuticals

Sylvie Kruyner serves as Director, DCT Operations at Bayer Pharmaceuticals. Her primary focus is to support clinical and operational teams to evaluate the implementation of Decentralized Clinical Trial elements and to support with operationalization of these elements. Up until today, Bayer has implemented DCT in multiple global clinical trials, inclusive of hybrid and fully remote designs. Ms. Kruyner joined Bayer in 2014. She has more than 10 years of operational and trial management expertise within CRO and sponsor organizations, holding different roles on both local and global levels in Europe and the US. Next to this, Ms. Kruyner has also been involved in creating and providing intra-company trainings, several taskforce initiatives (related to customer-centricity, change management, monitoring, resourcing) and end-user-insight activities. She holds a Masters in Health Care Management and Policy from Ghent University, Belgium. She currently lives in Kansas, US.

Sunny Kumar
GSR Ventures

Sunny Kumar, Partner, GSR Ventures

Sunny Kumar is a Partner at GSR Ventures, where he primarily invests in early-stage companies deploying emerging technologies to transform healthcare delivery, including lead investments in Medable, Deep 6 AI, and Osso VR. Sunny is a physician as well as a published medical researcher with a focus on applying informatics and artificial intelligence to translational medicine in the fields of neurosurgery and gene therapy. He is a serial entrepreneur and most recently founded a company to reduce readmissions for high-risk patients with chronic diseases using voice-enabled natural language processing technology. Sunny received a BS in Molecular Biology from Yale University, an MD from Stanford University School of Medicine, and an MBA from Stanford University Graduate School of Business.

Mary Jo Lamberti
Tufts Univ

Mary Jo Lamberti, PhD, Director and Research Associate Professor, Tufts Center for the Study of Drug Development (CSDD)

Dr. Mary Jo Lamberti manages multi-sponsored and grant-funded research projects at Tufts CSDD. She has extensive experience conducting market research on pharmaceutical industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts CSDD, Dr. Lamberti was Director of Market Research at CenterWatch. She has also worked on federally funded research studies in science education reform. Dr. Lamberti holds a B.A. from Wellesley College and a Ph.D. in Psychology from Boston University.

Kavita Lamror
Maxis Clinical Sciences

Kavita Lamror, Partner, RWE & Digital Transformation, Maxis Clinical Sciences

Dr. Kavita has more than 16 years of experience in the healthcare industry, with prominent roles in big pharma organizations as well as consulting firms. Responsible for establishing de-novo units for value evidence generation in multiple organizations and providing strategic inputs and insights for integrated evidence generation plans across the drug development lifecycle. She provides guidance on multiple RWE & HEOR deliverables including global RWE studies, in-house RWD products, HEOR models, value dossiers, market access insights, and regulatory submissions across multiple therapy areas.

Rogier Landman
Pfizer

Rogier Landman, PhD, Associate Director, Digital Medicine Data Science, Pfizer Inc.

Rogier Landman is Associate Director Data Science at Pfizer and is based in Cambridge, MA. He has worked on a wide variety of data science projects. His latest work is on using large language models for facilitate clinical trial documentation, including strategies for evaluation of model output.

Kai Langel
DEEP Measures

Kai Langel, CEO, DEEP Measures

Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal decentralized clinical trial platform. In 2019 Kai co-founded the DEEP initiative to co-create a novel integrated ecosystem for the development, validation and acceptance of digital measures. Kai continues to contribute in an advisory role with DEEP, which is now an independent company. Through his involvement in technical, operational and scientific roles, he has gained deep and holistic understanding of the clinical trial process and the key mechanisms of our ecosystem. Kai brings his entrepreneurial spirit and creative mindset to support Janssen’s global regulatory policy work across a range of topics. Kai has a passion for broad pre-competitive collaboration and is motivated to modernize the ways our broader ecosystem works together to advance the adoption of novel tools and methods to support efficient and patient-centric pharmaceutical R&D.

Patrick M Lank
AbbVie

Patrick Lank, Medical Director, Specialty Development, AbbVie

Dr. Lank is an emergency physician with additional specializations in medical toxicology and addiction medicine. As a faculty member at Northwestern University's Department of Emergency Medicine for more than a decade, Dr. Lank focused his research and teaching on the care of patients who had overdosed and those with substance use disorders. In 2022, Patrick joined AbbVie to take on two major roles -- both as a medical director in clinical development (Specialty Medicine focusing on infectious diseases) and as the medical director for the AbbVie Research Collaborative. The AbbVie Research Collaborative is an innovative program and platform to build cohorts of people with disease who are interested in engaging directly with AbbVie to share their health journey and insights -- elevating the patient voice in scientific research to shape the medicines of the future.

Bjorn Larsson
Novo Nordisk A/S

Bjorn Larsson, Director, Clinical Learning & Training, Novo Nordisk AS

Bjorn Larsson is Director of Clinical Learning and Training, Global Trial Portfolio, at Novo Nordisk. He is responsible for the strategy and execution of learning initiatives across clinical operations at Novo Nordisk. Bjorn has a broad understanding of learning and change gained through 20+ years of experience of leading strategic learning programs across a variety of industries. Prior to joining Novo Nordisk, he has successfully combined an end-user-focused approach with risk-oriented regulatory transformation across financial services, automotive, and professional services industries. Bjorn Larsson received a master’s degree in organisational development from Lund University, Sweden.

Nicole Latimer
Medrio Inc

Nicole Latimer, CEO, Exec, Medrio Inc

Nicole Latimer is Medrio's Chief Executive Officer. As CEO, Nicole carves out her time in three equally and critically important areas: studying the life sciences industry, making decisions about how Medrio can have a greater impact on that industry, and then focusing on the best way to communicate those decisions to staff and customers. She brings 25 years of impressive and broad-based healthcare experience, including stints at The Advisory Board Company (now part of Optum) and Deloitte Consulting, where she focused on population health management, health system growth strategies, patient and employee education, and SaaS development and delivery. Most recently, in her role as CEO of Staywell, she drove the company’s mission to be the premier provider of lifestyle risk management programs for the entire healthcare ecosystem leveraging behavioral science as the foundation for improving health outcomes. She shines at redesigning processes, increasing efficiency, and reducing costs.

Manny Lazaro
Kailera Therapeutics

Manny Lazaro, Senior Vice President, Clinical Development Operations, Kailera Therapeutics

Manny currently holds the position of Senior Vice President, Clinical Development Operations at Kailera Therapeutics, where he is responsible for clinical strategy, planning and execution. Kailera Therapeutics is a clinical stage biotech company in Waltham, MA, dedicated to developing the next generation of therapies in chronic weight management and diabetes. Manny started his industrial career 32+ years ago with positions of increasing responsibility at small, mid-size bipharma and large pharma. Manny holds a Master’s of Science in Drug Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and a Bachelor’s of Science in Biology from the University of Massachusetts at Boston. Before working in the device and biopharmaceutical industry, Manny served in the United States Air Force for 6 years as a Staff Sergeant.

Tran Le
Grove AI

Tran Le, Grove AI

Andrew Lee
Merck & Co

Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.

Andrew (Andy) Lee is Senior Vice President and Head, Global Clinical Trial Operations (GCTO) at Merck. In this role, Andy leads and manages all operations related to the conduct of Merck clinical trials, with particular focus on global, in-patient clinical trials, designed and executed to meet cost, speed, and quality standards. Andy is also responsible for the design and study/data management of clinical protocols in all regions and countries, as well as the tools, systems, and processes used in clinical trial executions. Andy joined Merck in September 2014 from Sanofi, where he served as Senior Vice President and Deputy Head of Clinical Sciences and Operations (CSO), and Head of the CSO Clinical Operations Cluster. In addition to directing the CSO, Andy led the integration of Sanofi with Genzyme, where he had been Senior Vice President, Global Clinical Operations. Earlier in his career, he spent more than 16 years in a range of positions of increasing responsibility at Pfizer. Andy holds leadership positions in a number of professional societies, including the role of Treasurer of TransCelerate Biopharma, Inc., a non-profit organization that comprises the world’s leading pharmaceutical and biotech companies. He received his M.S. in Bioenergetics and Physiology from Ball State University in Indiana, and two undergraduate degrees from Rhodes University in South Africa.

Arlene Lee
Medidata

Arlene Lee, Director, Product Management, Data Quality and Risk Management Solutions, Medidata

Arlene Lee is a Director of Product Management for Data Quality and Risk Management solutions at Medidata, where she leverages her in-depth industry experience to advance innovative data quality and centralized monitoring systems. Prior to joining Medidata, Arlene brought over 23 years of experience in the pharmaceutical industry, with more than 17 years in Clinical Data Management and Centralized Monitoring across CRO, pharmaceutical, and biotech sectors. She has led the execution of Phase I-IV clinical trials across multiple therapeutic areas, with particular expertise in oncology and vaccines. Arlene has also been instrumental in establishing data management practices and advancing data quality solutions for global studies. She holds a Bachelor of Science degree in Chemistry from the University of Missouri - Columbia.

Disa Lee Choun
Johnson and Johnson

Disa Lee Choun, Head of Integrated Clinical and Operational Analytics (ICOA), Johnson & Johnson

Disa has 15+ years of experience working in technology and innovation, especially in the pharmaceutical industry. She is the Head of Integrated Clinical and Operational Analytics at Johnson & Johnson. She was previously at UCB as the Head of Innovation and held other leadership roles. Prior to joining the pharma, she was a co-founder of an IT company. She has an EMBA and B.S. in Pharmaceutical Chemistry. In 2017, Disa started a consortium, a cross-industry collaboration on blockchain via PhUSE. She was awarded Top 100 Women in Technology, Financial Times' top 100 most influential BAME Leader, and featured on the cover of CIO Look celebrating Women in Tech 2019. Recently, she co-authored a book titled 'Digital Health and Patient Data, Empowering Patients in the Healthcare Ecosystem'. Her passion is closing the gap for patients with unmet needs and exploring the right digital capabilities to accelerate the implementation of end-to-end patient solution.

Susan M Leister
Technical Resources Intl Inc

Susan M. Leister, MBA, PhD, CQA, CSSBB, Vice President, Quality & Compliance, Technical Resources International, Inc.; Senior Trainer, Barnett International

Susan M. Leister, MBA, PhD, CQA, CSSBB, has over 20 years of experience covering the pharmaceutical, medical device, and clinical arena, including extensive working knowledge of GCP, cGMP, GLP, ICH E6 GCP, and HSP. She has managed various inspections including ISO, CE Mark, Health Canada, MHRA, EMA, DEA, Maryland Board of Pharmacy, and FDA. Dr. Leister provides QM oversight to multiple government and commercial clients from large pharma to the small biotech startup. She currently oversees a QA auditing team comprised of ~ 20 FTEs who verify monitoring performance and internal audits with a global reach, conduct quality trend analysis including analysis of reports and associated data, and provides recommendations and quality consultative services. She is experienced in managing NIH drug repository and stability lab for domestic and international clinical trials and is skilled in developing plans for resolutions to deviations and CAPAs, analyzing QA/QC results, and recommending process improvements with 6 Σ. Dr. Leister is seasoned in mock inspections and overall inspection readiness.

About Barnett International:
Barnett International is a leader in training and resources for clinical research professionals. The Barnett approach is unique in that it combines content development expertise with a high level of subject matter experience, engaging instructional design and a multi-platform approach. Our education and training portfolio offers diverse options for all types of learners. Barnett helps clients get the most out of their research and development dollars by managing change effectively, improving organizational performance, and enhancing staff knowledge. The "Barnett Difference" is evident in our deep understanding of the clinical research process and in the rapid and tangible performance improvements we deliver.

Steve Lesser
Optum

Steve Lesser, Optum

Dr. Steve Lesser, PhD, serves as the Vice President of Growth for Clinical Trial Solutions at Optum Life Sciences. With a robust career spanning over two decades, Steve has dedicated himself to the advancement of the clinical trial industry through application of innovative eClinical and data solutions. His extensive experience includes pivotal leadership roles at innovative, notable organizations such as Pluto Health, Medable, Medidata, INC Research (now Syneos), and IBM Life Sciences. In each position, Steve's primary focus has been collaborating with customers and partners to fundamentally enhance clinical trial processes and outcomes.

Holding an MS and PhD in Neurobiology from Duke University, Steve's academic background equips him with a deep understanding of the scientific and technical complexities inherent in clinical trials.

Patrick Leung
Faro Health Inc.

Patrick Leung , CTO, Development, Faro Health Inc.

Patrick is the Chief Technology Officer at Faro Health, applying large language models and other forms of AI to optimize clinical trial development. Previously he was co-founder of Earthshot Labs, an NSF-funded deep tech company applying geospatial AI to predicting tropical ecosystem growth and carbon financing. Previously Patrick was CTO of Two Sigma's $4B AUM Private Investments division, pioneering the application of AI, data science, and alternative data to private equity and venture investing. Earlier Patrick spent 11 years at Google in engineering leadership positions including the Google Duplex conversational AI system. Patrick was also a founding employee and SVP Engineering at an early E-Commerce platform that IPOed in 1999.

Jennifer Levin Carter
Medzown

Jennifer Levin Carter, CEO, Medzown

Jennifer Levin Carter, MD, MPH, MBA is the Founder and CEO of Medzown, Inc., a Precision Medicine Management at Scale Company. Dr. Carter was formerly a Managing Partner and Venture Partner at Sandbox Industries and Blue Venture Fund. The Blue Venture Fund is a unique collaboration between BCBS companies, BCBSA, and Sandbox. Dr. Carter is a healthcare executive, investor, board member, and entrepreneur with a successful track record of developing and investing in innovative strategies and solutions at the intersection of healthcare IT and services, digital health and machine learning, precision medicine, genomics and its application to healthcare delivery, and life sciences including novel clinical trial delivery and drug development. Dr. Carter has deep expertise in creation and implementation of systems and platforms using next-generation data and technology to support patient and physician access to improved therapeutic strategies. Prior to Sandbox and Blue Venture Fund, she was Managing Director of JLC Precision Health Strategies. Prior to this, Dr. Carter was VP and Head of Precision Health at Integral Health (now Valo Health), a Flagship Pioneering company. In 2018, she founded a novel clinical trials company in stealth and was CEO until its pre-launch acquisition by Integral Health in March 2019. Prior to the clinical trials company, Dr. Carter was the Founder and President of N-of-One, Inc. She served as CEO from 2008-2012, and President and Chief Medical Officer from 2012 until its acquisition by Qiagen (Market Cap $8B) in 2019. At N-of-One, Dr. Carter led the creation of award-winning solutions that still deliver novel treatment strategies to hundreds of thousands of patients with cancer globally.  Dr. Carter serves on multiple public, private, and not-for-profit boards and is an advisor to healthcare companies in genomics, tech-bio, pathology, digital health, and other AI applications to healthcare.

Carrie Lewis
Endo Pharmaceuticals

Carrie Lewis, Executive Director, Clinical Program Optimization, Endo

Carrie Lewis is the Executive Director of Clinical Program Optimization at Endo, since June 2020. Carrie manages multiple teams of people to implement industry standard processes and practices across the organization to prepare Endo for advancement and expansion in both domestic and global clinical programs. Prior to Endo, Carrie was the Director of Project Delivery at PRA Health Sciences overseeing global clinical studies and operational strategy of new bids. Carrie has over 20 years of industry experience, holding various high level roles in clinical operations across both Branded and Generic programs and has experience working with academia, clinical sites, CROs and Pharmaceutical companies. Carrie has a BA in Psychology from West Virginia University and a MS in Clinical Research Administration from George Washington University.

April Lewis
Johnson & Johnson Innovative Medicine

April Lewis, Head, Innovative Health, Global Development, Johnson & Johnson Innovative Medicine

April brings 25 years of experience in clinical R&D, demonstrating a proven track record of leading global teams to innovate and disrupt clinical trial operations. She has played a pivotal role in major transformational initiatives, including the Quintiles/IMS merger and GSK’s “Future Ready” initiative. Currently, April is the Senior Director of Innovative Health at Johnson & Johnson Innovative Medicine. In this role, she oversees the introduction, testing, development, and scaled delivery of novel capabilities, processes, and solutions aimed at enhancing patient and site experiences, increasing operational efficiencies, and setting new standards of excellence.

Micah Lieberman
Cambridge Healthtech Institute

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

Micah has 20 years of experience in the biopharma industry. He is an Executive Director at Cambridge Healthtech Institute (CHI) where he is a producer, content developer, and facilitator of the Summit for Clinical Ops Executives (SCOPE), the leading event in the US and Europe for biopharmaceutical industry executives focused on driving innovation in clinical trials and digital health. On a daily basis, he builds a broad community of clinical research stakeholders and industry thought leaders, performs market research, and ascertains ever-changing industry trends in clinical trial optimization, clinical innovation, patient recruitment, digital health, drug development, clinical trial technology, and population health. He is also the Co-founder and Vice President of Community and Business Development of ClinEco. ClinEco unites sponsors, CROs, service providers, and sites on the world's first B2B global clinical trial marketplace so each can expand clinical partnerships. SCOPE and ClinEco are owned by Cambridge Healthtech Institute (CHI). Please join our SCOPE and ClinEco communities! https://clineco.io/; www.SCOPEsummit.com; www.SCOPEsummiteurope.com

Holger Liebig
Parexel

Holger Liebig, Executive Director, Partnership Center of Excellence, Parexel

Holger Liebig is an Executive Director, Partnership Center of Excellence at Parexel. In his role, Holger creates infrastructure and intellectual property to support Parexel’s Strategic Partnerships. He is an active member of the core partnership teams including involvement in both internal and external governance, KPI definition, change management and process alignment. Holger is a certified Lean Six Sigma Black Belt with 33 years of industry experience. He worked on Phase I-III clinical research in various positions. This included line-management of geographically disparate project management groups and various roles with accountability for operational processes and systems. Holger is also responsible for the general management of Belgium as a country within Parexel.

Stacey Limauro
Deciphera Pharmaceuticals

Stacey Limauro, Executive Director, Clinical Operations, Deciphera

Stacey Limauro, Executive Director of Clinical Operations at Deciphera Pharmaceuticals, has over 25 years of industry experience across all Phases of clinical development in both small and large Pharma organizations. In her current role, she provides leadership and oversight for the entire clinical development operations team and portfolio at Deciphera, including contributing to the operational strategy and implementation of process development and improvement within the department. One of Stacey’s most influential accomplishments was leading the successful approval of Deciphera’s first drug, QUINLOCK in 2020 for the treatment of GIST. She enjoys working with high-performing cross-functional teams to bring therapeutic treatments to patients in need. She received her BS in Chemistry from Trinity College in CT, and an MS in Biochemistry from Boston College in MA.

Shaheen Limbada
WEP Clinical

Shaheen Limbada, Chief Operating Officer, Operations, WEP Clinical

Shaheen is a seasoned executive in the CRO and pharmaceutical industry, with over 23 years of experience in drug development, clinical operations, innovation and strategy, pharmacovigilance and post trial access solutions. He has worked in large pharma and CROs settings including AstraZeneca, LEO Pharma, Veristat and Topstone Research. Shaheen is a visionary leader who combines scientific expertise, business acumen, and operational excellence to deliver outstanding results for WEP clients and stakeholders. He is passionate about advancing clinical research and improving patient outcomes through innovation, collaboration and patient access.

Craig H Lipset
Decentralized Trials & Research Alliance DTRA

Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)

Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is the founder of Clinical Innovation Partners, working as an advisor and board member with pharma, tech and venture capital to bring vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig is also the Co-Chair for the Decentralized Trials & Research Alliance, the leading non-profit collaboration focused exclusively on improving access for research participation. Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University, and Adjunct Instructor in the Center for Health + Technology at University of Rochester. He serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Previously Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures. He has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who's Who in eHealth.

Trevan Locke
Duke Univ

Trevan Locke, PhD, Assistant Research Director, Duke-Margolis Institute for Health Policy

Trevan Locke, PhD, is an Assistant Research Director at Duke-Margolis working on issues related to biomedical innovation. He oversees Duke-Margolis' involvement as a founding member of the Advancing Clinical Trials at the Point of Care Coalition and workstreams on evidence generation for Duke-Margolis' Real-World Evidence Collaborative. Previously, he worked as a Regulatory Science and Policy Analyst at the American Association for Cancer Research on regulatory issues impacting cancer care and the development of cancer therapies, including considerations for equitable clinical trial enrollment. Dr. Locke completed a Bachelor of Engineering in Chemical and Biomolecular Engineering at Vanderbilt University and a PhD in Chemical and Biochemical Engineering at Rutgers University, where his research focused on the development of nanoparticles for the delivery of chemotherapy to treat cancer.

Robert Loll
Praxis

Robert Loll, Sr VP, Business Development & Strategic Planning, Praxis

Robert Loll is SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies. Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 15 years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.

Neha Londono
Seagen

Neha Shah Londono, Director, Global Clinical Trial Diversity, Equity, and Inclusion, Pfizer

Neha Shah Londoño has twenty-four years industry experience within the Sponsor, CRO, and biotech environment. She has extensive knowledge of the clinical trials process through career advancement and has driven industry-wide efforts to increase health equity and develop solutions for diversification of clinical trial participants across the ecosystem. Neha is currently supporting oversight enterprise mission, vision, and strategy for clinical trial diversity, equity, and inclusion at Pfizer, where she leads cross-functional teams and partners with patient organizations to meet the needs of diverse medically underserved communities.

Rana Lonnen
Novartis

Rana Lonnen, Managing Director, Novartis

Rana Lonnen is a healthcare technology investor, entrepreneur, and molecular biologist. At Novartis, she leads strategic investments in technology companies, on a mission to transform the healthcare ecosystem and make positive impact on people’s lives. Previously, Rana was Head of Preclinical Development at a UK biotech, Auspherix; investment consultant to IP Group in London; Founder and CSO of a UK-based Biotech, Axendos therapeutics. Prior to this, she was a Wellcome Trust-backed principal investigator in drug discovery in the field of Infection, Immunity, and Inflammation, author and inventor on high impact peer-reviewed publications and patents; before this, Rana worked at Bristol-Myers Squibb, in sales and marketing. Rana holds a PhD in molecular biology and an MBA from Imperial College London. She personally cares about equitable healthcare, social justice, sustainability, and the future of antimicrobial resistance. In her downtime, Rana likes to make culinary experiments, be in nature, and read. Rana is a board observer at Aktana, Cota Healthcare, H1 Insights, Koneksa, Mekonos, NuvoAir, and Dopavision. She is based out of Basel, Switzerland.

Gary Lubin
Ledger Run Inc

Gary Lubin, CEO, Ledger Run Inc

Gary is a recognized industry expert with a long record of achieving success. Gary has a long track record of successful launching, and running new businesses, managing a venture capital fund, leading transformative initiatives at Fortune 50 companies. He is a CPA, CGMA, CITP, and earned a BS from Washington University in St. Louis and an MBA from the Harvard Business School.

Mike Luker
Eli Lilly and Company

Mike Luker, VP, Data & Analytics Clinical Design & Delivery, Eli Lilly and Company

Mike joined Eli Lilly and Company in 1989 and for the past 35 years has provided leadership in clinical data and analytics, clinical development, information technology, and human resources. Mike currently helps to lead collaborative efforts driving efficiency in clinical development using AI and process automation and improving patient and investigator experience in clinical data collection.

Mike holds a degree in Business Administration and Information Technology from Hanover College and an MBA from The University of Alabama.

Aline Lutz
Segmed, Inc.

Aline Lutz, Vice-President of Medical Affairs, Medical Affairs, Segmed, Inc.

Dr. Aline Lutz is a physician-scientist specializing in healthcare technology, population health, and medical imaging research. At Segmed, she leads real-world imaging data (RWiD) initiatives, providing high-quality data for clinical trials and creating a meaningful impact on the healthcare ecosystem. Previously, Dr. Lutz practiced as an ophthalmologist and conducted clinical research. She worked with Johnson & Johnson Vision and served as a key opinion leader for ophthalmic medical devices and pharmaceuticals. She also held a position at the Telehealth Center in the Epidemiology Department of the Federal University of Rio Grande do Sul, Brazil, where she used technology to address large-scale public health challenges. Dr. Lutz holds an MD and earned a PhD in Ophthalmology and Visual Sciences from the Federal University of São Paulo, Brazil. Her doctoral research focused on developing artificial intelligence algorithms for ocular biomarkers. Personally, she cares about health equity, technology-driven diagnostics, and building a sustainable future for clinical care.

Sean Lynch
Novartis Pharmaceuticals

Sean Lynch, Clinical Innovation Head, Innovative Trial Operations, Novartis Pharmaceuticals

Sean Lynch has been working in clinical research for over 17 years with a heavy emphasis on the role of technology and vendors in the very changing landscape of clinical innovation. He started as a data managed at Quintiles before progressing into project management roles at software companies. CROs and start-ups. He has even dabbled in consulting and business development and has lots of tales to tell. Today he is the Innovation Capability Head for Innovative Trial Operations at Novartis.

Xin Ma
Bayer

Xin Ma, Senior Vice President, Head, Integrated Evidence Generation & Business Innovation, MA&PV, Bayer

Based in Wuppertal Germany, Xin served as the SVP and Head of Integrated Evidence Generation & Business Innovation, Bayer AG. During her tenure at Bayer, Xin held a diverse number of roles around the globe, including VP Head of New Product Commercialization & Portfolio Strategy, Strategic Marketing in Berlin, Head of Global Drug Discovery-Innovation Center China in Beijing, Strategic Project Lead/Manager Bayer AG Corporate Development in Leverkusen, and Project Lead in pharma R&D in the US. Prior to joining Bayer, Xin was a scientist at Procter & Gamble Pharmaceuticals. Xin brings extensive experience along the pharma value chain across many therapeutic areas. She will be transitioning into a new role as of Jan. 1, 2025. Xin holds a Ph.D. in Organic Chemistry (Germany/USA) and a M.S. in Chemical Engineering (China).

Cristin MacDonald, PhD
WCG

Cristin MacDonald, PhD, Vice President, Client Delivery, WCG

As the leader of Avoca’s integrated consulting and research solutions, Cristin MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has over 12 years of pharmaceutical industry experience with expertise in clinical research, process development, and strategic management.

David MacMurchy
Lightship

David MacMurchy, CEO, Lightship

o David is focused on developing better access to healthcare and improving patients’ well-being. David is a leader in the health & life sciences sector with over two and a half decades of experience working for leading organizations. Prior to joining Lightship, David led a team of more than 9,000 delivering clinical trials across Europe, Asia and Africa at PRA Health Sciences (ICON). David helmed the Life Sciences practice as a Partner for EY (Ernst & Young) in Europe supporting pharmaceutical and biotechnology companies, focusing on growth, planning and technology capabilities. His career of collaborating with the world’s leading healthcare providers in the United States, Europe and China includes over 10 years with IMS Health (IQVIA) and Pfizer.

Andrew Mackinnon
Medable Inc

Andrew Mackinnon, Sr VP & Exec GM, Customer Value, Medable Inc

With 20 years of experience in managing clinical trials at large Pharma, Biotech and CRO companies, Andrew Mackinnon, Executive GM, Customer Value at Medable, leverages his broad operational expertise to improve how the deployment of modern, digitally enabled clinical trials are utilized. From his involvement in one of the earliest deployments of decentralized methodologies, he has been passionate about the benefits that this approach can bring in reducing the burden of clinical research on both sites and patients.

Marcin Makowski
GlaxoSmithKline

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline

Marcin Makowski is the Head of Centralized Monitoring and Data Analytics at GSK. Previously Marcin held similar positions at AstraZeneca and UCB. Last 10 years of Marcin’s career was revolving around establishing and improving Risk Based Monitoring models including centralized monitoring and quality tolerance limits. Marcin holds MD and PhD degrees from the Warsaw Medical University.

Marina A Malikova
Boston Medical Ctr

Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine

Dr. Malikova is an Assistant Professor of Surgery at Boston University, School of Medicine, and an Executive Director of Research at the Department of Surgery at Boston Medical Center. Dr. Malikova has PhD in Biochemistry with strong background in biomedical sciences. She also holds a Master’s Degree in Clinical Investigation and Master’s of Business Administration in Health Sector Management from Boston University. She has over 18 years of experience in the biomedical product R&D, clinical development, operations and regulatory compliance fields; with the past 11 years on executive level. In her current role as Executive Director, Dr. Malikova macro-manages research programs in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations and compliance, strategic planning and execution oversight of clinical trials; safety and risk management. She is a member of International Society of Pharmacovigilance (ISoP), and currently serves as the Vice-President of NASoP.

Paul Mancinelli
WCG

Paul Mancinelli, CTO, WCG

Dr. Paul Mancinelli is the Chief Technology Officer of WCG where he leads technology overall, including infrastructure, software engineering, and application development across the organization to support WCG’s strategy and enhance productivity, efficiency, and synergy throughout the enterprise. Paul previously served as Cigna's Chief Data and Analytics Engineering Officer where he was responsible for Cigna's enterprise authoritative data assets as well as the advanced analytics ecosystem and reporting solutions. Under Paul’s leadership, the Data & Analytics Engineering team was a catalyst for the use of Big Data, Machine Learning and Open Source technologies in support of Cigna’s Personalization and Affordability strategies. Paul also served as Vice President of IT Data and Analytics leading Cigna’s Data and Analytics software engineering team and was Informatics Senior Director leading Information Management in IT since starting at Cigna in 2014. He also served as a board member of the Gartner Data & Analytics Research Board. Prior to joining Cigna, Paul served as Chief Technology Officer at CoreOne Technologies in New York, where he was responsible for enterprise software development, technical support, operations, corporate IT, and information security. Prior to that, Paul served as Global Head, Research and Development Data/Systems/Tradebook at Bloomberg L.P where he worked for more than 16 years. Paul holds a BS in Physics from Rensselaer Polytechnic Institute and a PhD in Astrophysics from the State University of New York Stony Brook.

John Manlay
Pfizer Inc

John Manlay, Senior Director, Clinical Data Sciences, Pfizer

Data management professional with over 25 years' experience managing oncology clinical trials from ph1 to phIV as well as registrational clinical research collaboration studies.

Jessica Marer
Teva Pharmaceutical Industries Ltd

Jessica Marer, Director, Global Clinical Operations, Trial Optimization and Planning, Teva Pharmaceutical Industries Ltd.

Jessica Marer is the Director of Trial Optimization and Planning at Teva Pharmaceutical Inc. She holds a Bachelor of Science in Biological Science and an MBA in Healthcare Innovation. Jessica has been in industry for over 15+ years starting at a clinical site where she honed her skills in clinical trial execution, quality assurance and staff education and operational oversight. Over the past six years, she has transitioned to the pharmaceutical sector, where she focuses on supporting patient-centered planning and optimizing clinical trials.

Kwame Marfo
Komodo Health

Kwame Marfo, Senior Director, Product Strategy, Clinical Dev, Komodo Health

Kwame Marfo is a Product Strategy Lead at Komodo Health. He is focused on informing the company’s product roadmap and go-to-market strategy to successfully meet customers’ current and future needs. He champions the customer voice across different market segments and develops new use cases for Komodo’s technology to drive value for customers.

Kwame has 15+ years of experience in the biopharma industry, working in strategy and operations leadership roles across manufacturing technical operations, commercial analytics, and R&D.

Prior to Komodo, Kwame was Director of Insights and Analytics for Genentech’s Global Clinical Operations. Kwame graduated with a BS in Chemical Engineering from Stanford University and an MBA from the University of California, Berkeley.

Brian S Martin
AbbVie Inc

Brian Martin, Chief AI Product Owner, BTS; Head of AI, R&D Information Research; Senior Research Fellow, AbbVie, Inc.

Brian joined AbbVie in 2018 as the head of the newly formed RAIDERS team within Research & Development’s Information Research division, focused on accelerating, scaling, and amplifying the work of AbbVie’s R&D community using Artificial Intelligence technologies like machine learning, deep learning, graph computation, and cognitive computing. Brian is a part of the leadership team building and directing the AbbVie R&D Convergence Hub (ARCH) as part of the R&D Convergence initiative and a member of the ACOS Scientific Innovation Council. Brian came to AbbVie after spending five years in technology consulting across many industries, and over a decade of additional experience before that working in trading and financial markets technology. During his consulting time, Brian was the architect of the United States’ Common Securitization Platform and the technology founder of Publicis.Sapient’s AI practice. While his primary focus is AI technologies, he was also a co-founder of the QuPharm quantum computing community and the Pistoia/QED-C Quantum Community of Interest. He is a frequent presenter at conferences on topics as diverse as optical networking, quantum computing, blockchain, cognitive architecture, and other emerging technologies that are all part of digital transformation. Brian holds a B.S. degree in Computer and Cognitive Science from Alma College and a M.S in Computer Science from the University of Chicago. He is a board member for the Chicago Innovative Executives League and for the Mundelein High School Business Incubator program. He has been involved with the Creative Destruction Lab at the University of Toronto’s Rotman School and as a panelist/reviewer for the National Science Foundation Secure and Trusted Cyberspace grant division. Brian lives in Lake Bluff, Illinois with his wife and four children.

Craig Martin
The Orphan Therapeutics Accelerator

Craig Martin, Founder, CEO, The Orphan Therapeutics Accelerator

Craig is a deeply experienced executive, founder, board director, and advisor to biotech, pharma, health tech, and healthcare organizations. He has worked extensively with companies advancing novel technologies and treatment modalities including genomic sequencing, mRNA, gene editing, and the first approved gene therapy. Craig’s focus in emerging innovations and desire to make an impact in areas of high unmet need led to a particular emphasis in rare disease-including serving as CEO of Global Genes, a leading non-profit that brings together patient groups, research institutions, and industry to drive innovation across rare diseases. He was previously a Global Principal with Ogilvy Consulting and, prior to that, CEO of Ogilvy’s Feinstein Kean Healthcare. He’s held leadership positions with firms based in Cambridge, MA, Washington, D.C., New York, and Brussels, Belgium. Craig is a frequent commentator and panelist on key issues affecting patients and influencing health innovation.

Steven Martin
WCG

Steven Martin, Vice President, Product Management and Strategy, WCG

Steven Martin is the Vice President of Product Management and Strategy at WCG. In this role, he leads the development of the product portfolio, identifies market opportunities, defines product-level strategies, and introduces modern product development processes across the organization. Steven brings over 20 years of experience in medical device and MedTech product management, marketing, and sales, spanning clinical trials, healthcare, and medical devices. Prior to joining WCG, he held positions of increasing responsibility at Medable, ZS Consulting, and Philips.

Trejeeve Martyn
Cleveland Clinic

Trejeeve Martyn, MD, Cardiologist, Advanced Heart Failure and Transplant, Director, Heart Failure Population Health, Cleveland Clinic

Dr. Martyn is a staff Cardiologist in the section of Heart Failure and Cardiac Transplantation at Cleveland Clinic. He serves as the Director of Heart Failure Population Health for the Cleveland Clinic Health System. In this role, he is focused on scaling efforts to improve heart failure care across a large integrated system. He is a staff physician in the Cleveland Clinic Amyloidosis Center. His research and clinical interests include medical therapy for heart failure, amyloidosis, implementation science, and novel technology in the diagnosis and management of heart failure. He is also actively involved in clinical trials in the areas of heart failure therapeutics, novel devices, and remote monitoring technology. He is a recipient of multiple grants aimed at novel approaches to EHR-based screening for cardiac disease. He has been invited to speak on optimizing heart failure care, regionally, nationally, and internationally. He serves on the older populations committee for the American Heart Association (AHA) and is a member of the Heart Failure Collaboratory (HFC), serving on their digital health committee. A Phi Beta Kappa graduate of Bowdoin College, he attended Harvard Medical School and completed his internal medicine residency at the University of California San Francisco (UCSF). He completed his general cardiology and Advanced Heart Failure fellowships also at Cleveland Clinic where he served as chief fellow. During his training he completed his Masters in Clinical Research at Case Western Reserve University.

Dharmesh Mashru
Credible Planning

Dharmesh Mashru, CEO, Credible Planning

Dharmesh is a seasoned business head with a proven track record in spearheading organizations, nurturing them & taking them from start up phase up to full maturity in the healthcare and engineering manufacturing space. With the right combination of technical expertise, eye for continuous improvements & innovative mindset, commercial acumen, strategic vision and, leadership skills he has applied his success formula to more than 5 organizations over the past 30 years growing them immensely.

Natasha Massias
Datacubed Health

Natasha Massias, Solutions Architecture Director, Datacubed Health

Natasha is a seasoned, dynamic learning development and eCOA/ePRO professional with ten years in the clinical trials industry. Her expertise within the field is technical product training, and she has facilitated hands-on, instructor-led trainings to over 300 sites throughout her career.

Brian Matesic
Norwest Venture Partners

Brian Matesic, Principal, Norwest Venture Partners

Brian is an experienced life sciences investor who focuses on early to mid-stage companies. Prior to joining Norwest, Brian worked at Blackstone Life Sciences, where he helped lead over $1.5B of investments across biotech, medical devices, and diagnostics. He was a Board Observer or Alliance Committee Member at 5 companies, working closely with management teams on clinical trials, FDA approval process, and commercial strategy. Brian was previously an Engagement Manager at McKinsey & Company, where he advised companies across the healthcare industry. Brian has a medical degree from Stanford and MBA from Harvard. His research on prostate cancer, diabetic macular edema, and patient safety has been published in multiple peer-review journals.

Lydia Matombo
Merck & Co., Inc.

Lydia Matombo, Director, Risk Evaluation & Adaptive Integrated Monitoring, Merck & Co., Inc.

Lydia Matombo is a Director, Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In her role, she establishes technical and cross-functional business needs, aligns with stakeholders, and oversees data integration activities between Merck and Suppliers resulting in the build-out, testing, implementation, and maintenance of business-critical Key Risk Indicators (KRI)s in support of Adaptive Integrated Monitoring (AIM), Global Clinical Trial Operation’s (GCTO) risk-based initiative to further the organization’s risk-based quality management (RBQM) approach through advanced analytics. She ensures that supplier systems are ready and maintained throughout the study life cycle to enable the execution of central analytics and monitoring activities, including Quality Tolerance Limit analysis, Key Risk Indicator analysis, and Central Statistical Analytics. This enables each Clinical Trial Team to support the effective identification of important study issues that require monitoring, management, and adaptation of study plans. Lydia collaborates with other functions, Quality Assurance, Ethics’, and compliance, to ensure that systems and any outlined processes are compliant and Inspection ready. BACKGROUND Lydia has more than 20 years of clinical database management expertise, leading end-to-end clinical trial conduct and execution, strategic implementation of quality-by-design data collection systems, building and leading high-performing teams across many therapeutic areas, and is now in the role of Risk Systems Data Integration Lead. Lydia is committed to creating a diverse and inclusive work environment. She is a member of the GCTO’s Diversity, Equality, and Inclusion Ambassadors and Merck’s League of Employees of African Descent (LEAD). Lydia holds a BSN (Honors) from Fairleigh Dickinson University in New Jersey, is a Registered Nurse, and is Project Management Professional (PMP) certified.

Marland May
AbbVie

Marland May, Associate Director, Clinical Trial Diversity & Inclusion, AbbVie

Marland May is the Associate Director of Clinical Trial Diversity & Patient Inclusion at AbbVie. He specializes in supporting territory development and new clinical investigator acquisition strategies. Through his efforts, AbbVie has established a streamlined process for identifying, training, and onboarding new investigators across the globe. Marland has over a decade of experience in the pharmaceutical industry, with leadership roles in global site management, clinical study leadership, and diversity and patient inclusion. He is committed to paving the way for a more equitable healthcare ecosystem for all. Marland first started his career in the mental health field as a clinical therapist and has worked at all levels of education, from elementary to college. He is an advocate for ensuring diverse perspectives are reflected in drug development and promoting inclusivity in clinical research.

Dagmar McCaughey
Vertex Pharmaceuticals

Dagmar McCaughey, Senior Director, Head of Study Start-Up, Vertex Pharmaceuticals, Inc.

Dagmar McCaughey is Senior Director and Head of Study Start-Up within Vertex Pharmaceuticals’ Global Clinical Operations team. With over 20 years of experience in clinical research and pharmaceutical development, she has built deep expertise across the drug development lifecycle, blending operational leadership with technological innovation. Dagmar has worked both across Europe and globally, consistently driving teams to deliver on strategic business goals. She is passionate about leveraging cutting-edge technologies to enhance the efficiency of clinical operations. Before joining Vertex, Dagmar filled various roles at ICON Clinical Research, GlaxoSmithKline, and Parexel. She holds a medical degree (MD) and has a proven track record in advancing clinical trials with a focus on operational excellence.

Mark McClellan
Duke-Margolis Center for Institute Policy

Mark McClellan, MD, PhD, Director, Duke-Margolis Institute for Health Policy; Former Commissioner, FDA

Mark McClellan, PhD, is Director and Robert J. Margolis, MD, Professor of Business, Medicine and Policy at the Duke-Margolis Institute for Health Policy at Duke University. He is a physician-economist who focuses on quality and value in health care, including payment reform, real-world evidence and more effective drug and device innovation. At the center of the nation’s efforts to combat the COVID-19 pandemic, the author of COVID-19 response roadmap, and co-author of a comprehensive set health policy strategies for COVID vaccines, testing, and treatments, Dr. McClellan and his Duke-Margolis colleagues are now focused on health policy strategies and solutions to advance the resilience and interconnectedness of 21st Century public health and health care. Mark is a former administrator of the Centers for Medicare & Medicaid Services and former commissioner of the US Food and Drug Administration, where he developed and implemented major reforms in health policy. Dr. McClellan is an independent board member on the boards of Johnson & Johnson, Cigna, Alignment Healthcare, and PrognomIQ; co-chairs the Guiding Committee for the Health Care Payment Learning and Action Network; and serves as an advisor for Arsenal Capital Group, Blackstone Life Sciences.

Emily McCormack
New York Blood Center

Emily McCormack, Social Media Director, New York Blood Center Enterprises

In the digital world with shortened attention spans and demand for feel-good content, I have an empathetic approach to creating swipe-stopping collateral to cut through the clutter. During my 12+ year career in social media, spanning positions at the Cystic Fibrosis Foundation, Memorial Sloan Kettering Cancer Center, and New York Blood Center Enterprises, I find the opportunity to connect with patients in the online community a privilege. The patient voice and reported outcomes are vital to improving healthcare across the board, and meeting those patients where they are, often in the social space, is essential to all improvements and innovation.

Amy McCormick
Regeneron Pharmaceuticals Inc

Amy McCormick, Associate Director, Global Trial Optimization, Regeneron

Amy McCormick is a Senior Manager, Global Trial Optimization - Patient Engagement at Regeneron. In her role, Amy leads the development of patient engagement strategies for clinical trials ensuring the patient voice is considered in strategic study planning and execution. She has more than 12 years of experience in the pharmaceutical industry. Prior to her work in pharmaceuticals, Amy worked in various capacities as a Registered Nurse. While working as a Pediatric Bone Marrow Transplant Nurse, she cared for many patients who participated in clinical trials. This opened her eyes to a whole new career path outside of bedside nursing. Shortly thereafter, she began working as a Clinical Research Nurse at a US Oncology site in Arizona. Amy’s passion for oncology clinical trials and patient engagement grew rapidly with a goal to ensure all patients understood their treatment options, including investigational treatments. In pursuit of this passion, Amy eventually transitioned from working directly with patients to working "behind the scenes" at Eli Lilly, first as an Oncology Pharmaceutical Project Manager and later as an Associate Director - Patient & Site Experience before eventually joining Regeneron in 2022. Her work in Patient Engagement at Regeneron supports multiple therapeutic areas including oncology, with a special focus on diversity, equity, and inclusion (DEI).

Thomas McDonald
Consultant

Thomas J. McDonald, MS, Consultant-Clinical Trials, Biospecimen & Vendor Relationship Management

Tom has over 20 years of industry experience in various roles within clinical trial supply and execution. Nearly half of this time has focused on the clinical supply chain-including raw materials, investigational supplies, lab kits, and biospecimens. When not concentrating on optimizing global logistics, Tom enjoys spending time with his family, boating and music.

Kelly J McKee
Evinova

Kelly McKee, Head of Innovative Patient Recruitment, Evinova; Co-Creator of the SCOPE Participant Engagement Award

Kelly McKee serves as vice president of Decentralized Clinical Trials (DCTs) in Patient Cloud at Medidata. She is responsible for creating new solutions to engage clinical trial patients pre-trial, in-trial, and post-trial, as well as developing patient and product communications around all Patient Cloud Products for decentralized and hybrid clinical trials. Kelly is a proven clinical trial leader and trailblazer in operationalizing global patient-focused solutions across organizations including innovations in clinical trial awareness, access, and improvements in patient experiences. Prior to Medidata, she spent over 20 years within clinical operations and patient recruitment at top-tier pharmaceutical companies including Sanofi, Merck, Eli Lilly and Co., and Vertex Pharmaceuticals. Kelly is passionate about celebrating the role that clinical trial participants bring in making new medicines and vaccines possible and was named one of Life Sci Voice’s Top Industry Leaders in 2022, PharmaVoice’s 100 Most Inspiring Leaders in 2020, Centerwatch’s Top 20 Innovators of 2018, and PharmaTimes’ Clinical Researcher of the Year, Clinical Research Teams, in 2012.

Kelly McKee
AstraZeneca Pharmaceuticals

Kelly McKee, Head, Innovative Patient Recruitment Evinova, AstraZeneca Pharmaceuticals

Melodi McNeil
Abbvie Inc

Melodi McNeil, Director, Regulatory Policy & Intelligence, AbbVie, Inc.

Ms. McNeil is a Director, Regulatory Policy and Intelligence, at AbbVie. She has more than 25 years of Regulatory Affairs experience gained from a variety of roles in both the pharmaceutical industry and at the United States Food and Drug Administration. Currently, Ms. McNeil supports regulatory activities for AbbVie by identifying, analyzing, and commenting on proposed regulatory policies, and ensuring that appropriate AbbVie personnel are aware of emerging and final regulatory policies; in addition, she provides regulatory advice and strategic support to global project teams. Melodi has a Bachelor’s degree in Pharmacy and a Master’s degree in Management, with an emphasis in health care administration.

Scott T Megaffin
Adiso Therapeutics

Scott T. Megaffin, CEO, Adiso Therapeutics

Proven C-level leader with deep experience running global Fortune 500, start-up, and emerging pharmaceutical businesses, possessing the unique ability to blend, build, and strengthen performance from the ground up. Broad understanding of market strategy development within clinically diverse programs that achieve meaningful product differentiation. Significant accomplishments creating profitable business development and investment community partnerships within the C-suite. Strategy/Vision: Deep start-up, transaction and capital raising success through the establishment and guidance of Adiso, Adastra, and Churchill; creation and execution of clinical development and business strategy to lead the companies from formation; with the identification and advancement of multiple first-in-class drug product assets; negotiated and managed lucrative business development partnerships; business development and licensing with Baxalta, transaction to Cothera Bioscience and Sun Pharma FZE. Change Leadership: Adaptable and insightful leader instrumental in the cultural and team transformation of Onconova from a private 16-person medicinal chemistry company into a commercially prepared 67-employee Nasdaq listed company executing a successful Initial Public Offering (IPO). Commercial Innovation: Directly involved in numerous successful product development/co-development programs and commercial launches within oncology and specialty therapeutics. Demonstrated ability to employ unique approaches to value pricing and contracting within competitive markets. Execution/Implementation: Ability to visualize and articulate both long-term and near-term goals while promoting excellence through organization design, leverage of key functional areas, with clear decision making and process application. Global M&A: Marshalled Churchill Pharma through nine-month transaction process and successful sale of assets prior to product approval by FDA, while simultaneously preparing for a Churchill launch. While at Onconova, initiated and negotiated two separate license agreements for Japan/Korea and Europe

Michael Mehler
AstraZeneca

Michael Mehler, Director, Cell Therapy Operations, AstraZeneca

Michael works in the Cell and Gene Therapy Group at ZS focusing on designing a seamless C> treatment experience in order to define and shape the future commercialization of products. Working cross-functionally across site operations, supply chain, clinical and commercial operations, Michael leads the process of streamlining C> product delivery to provide a best-in-class customer and patient experience. By facilitating, supporting, and simplifying the end-to-end operations of C> products in a clinical trial setting, Michael prepares customers for commercial planning and launch when bringing transformative cell and gene therapies to market. Michael has spent 10+ years in the cell and gene therapy industry helping C> organizations operationalize products, build global site footprints, develop supply chain strategies, lead patient and customer engagement, and prepare for commercialization and product launch. Working for cell therapy biotech startups as well as global pharmaceutical companies such as Adaptimmune, Immatics and GSK, Michael has unique hands-on experience helping companies shape the clinical trial experience with C> products. With his rare and versatile experience, Michael has pioneered innovative C>-specific roles, such as the Cell Therapy Patient & Site Operations Lead, serving as a cross-functional C> subject matter expert.

Rachel Melloul
CISCRP

Rachel Melloul, MPH, Project Manager, CISCRP

Rachel Melloul is a Project Manager at the Center for Information and Study on Clinical Research Participation (CISCRP). Rachel has a strong dedication to ensuring the patient voice is heard and assisting clinical trial sponsors in creating a more patient-friendly participation experience. Rachel has previous experience working in a hospital environment to implement operational initiatives, and the local county health department leading a team with investigations focusing on COVID-19 mortalities. Rachel manages a variety of projects, including both quantitative and qualitative patient voice projects, to gather patient insights and feedback toward optimizing and improving clinical trial participation experiences. She holds a Master of Public Health from UTHealth Houston and a Bachelor of Science from The University of Arizona.

Mark Melton

Mark Melton, Co-Chair, Biospecimen Management Consortium

Accomplished biopharmaceutical professional with 10 years of experience spanning biotechs, pharmaceutical companies, CROs, biomarker and bioanalytical labs, and clinical research sites. Co-chair of the Biospecimen Management Consortium.

Mary Lynn Mercado
Novartis Pharmaceuticals

Mary Lynn Mercado, PhD, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis Pharmaceuticals

Mary Lynn Mercado is the Global Head of Protocol Delivery and US Site Head for Regulatory Writing and Submissions at Novartis. She has 12 years of research experience in academic and pharmaceutical settings and 15 years of experience in the Regulatory Writing and Clinical Operations spaces. For TransCelerate BioPharma, she is the co-workstream lead for the TransCelerate Clinical Content & Reuse initiative and supports Protocol Digitization efforts across initiatives. She is also the Deputy Topic Lead for PhRMA on the ICH M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) Expert Working Group. Mary Lynn received her Bachelor of Science from Brown University and her PhD from Rutgers University.

Liza C Micioni
Tris Pharma, Inc.

Liza Micioni, Senior Director, Head of Clinical Operations, Tris Pharma

Over 24 years of leadership experience in clinical operations, project management and medical affairs which includes clinical development strategy, protocol design, training and development, vendor management, and stakeholder relationships. Therapeutic experience includes pulmonary, rare disease, central nervous system, dermatology, gastrointestinal, nephrology and oncology.

Dmitri Mikhailov
Novartis Institutes for BioMedical Research Inc

Dmitri Mikhailov, PhD, Director & Global Head, Biomarker Coordination, Novartis Institutes for BioMedical Research, Inc.

Dmitri Mikhailov is the Global Head of Biomarker Study Coordination, Translational Medicine at Novartis. Dmitri’s team is responsible for clinical biomarker study setup across multiple therapeutic areas, and for developing new processes and technologies to improve clinical study conduct. As part of his role, Dmitri represents Novartis on the Patient Centric Sampling IQ consortium, developing best practices for new generation clinical trials. Dmitri is also the global lead for Novartis Human Tissue Network, the company wide effort to develop risk-based strategy and efficient processes to enable translational research using human samples. Dmitri joined Novartis in 2003 and had several positions of increasing responsibility in early biology, lead discovery, safety pharmacology and drug repositioning. Dmitri Mikhailov holds a Ph.D. in Biology and M.S. in Physics & Applied Math.

Muzafar Mirza
Pfizer

Muz Mirza, Senior Director, Senior Group Lead, Oncology, Pfizer

No bio available.

Shawn Mishra
Regeneron Pharmaceuticals Inc

Shawn Mishra, PhD, Senior Lead, Digital Biomarkers, Regeneron Pharmaceuticals

Dr. Shawn Mishra is a senior lead on the Digital Biomarkers team at Regeneron Pharmaceuticals. He holds a Ph.D. in Biomedical Engineering, along with M.S. and B.S. degrees in Mechanical and Biomedical Engineering from Northwestern University. Dr. Mishra specializes in developing biosensors and algorithms for wearable devices, focusing on biomechanical design, AI/ML applications, and time series analysis. His work has resulted in several patents, including a real-time sweat sensor and neural networks optimized for edge hardware. These innovations have advanced the field of digital biomarkers and led to commercialized technologies. Dr. Mishra's research contributes to improving patient monitoring and developing more personalized healthcare solutions.

Tashan K Mistree
GSK

Tashan K. Mistree, MS, Senior Director Business Operations, GSK

Tashan Mistree is an experienced professional with over 12 years in Quality Assurance, Quality Management, and Auditing at GSK. In her previous role as Head of Audit Conduct in Clinical Quality Assurance, she led the execution of both internal and external audit programs. Tashan's work passions include the embedding of critical concepts such as Quality Risk Management, Critical Thinking, and Quality by Design into processes to ensure Fit-for-Purpose clinical trials. Currently, Tashan co-leads the TransCelerate workstream on Interpretations of Clinical Guidances & Regulations, for ICH E8 R1 and ICH E6 R3, which focuses on the challenges in implementing and operationalizing new guidance revisions by developing solutions to support stakeholders.

Cilla Mistry
GSK

Cilla Mistry, Central Monitoring Process Manager, Central Monitoring and Data Analytics, GSK

Cilla Mistry is a seasoned professional in the pharmaceutical industry, with a career spanning over two decades. She is currently a key member of the Central Monitoring and Data Analytics group at GSK, a position that allows her to leverage her extensive experience and deep understanding of the industry. In the past five years, Cilla has honed her expertise in Risk-Based Quality Management (RbQM) for both in-house and outsourced trials. Her work in this area is driven by a passion for revolutionizing the management of complex clinical trials, a testament to her commitment to innovation and excellence in her field. In addition to her work in RbQM, Cilla also brings to the table substantial experience in Data Management across various therapy areas. This diverse skill set makes her a valuable asset in the pharmaceutical industry, as she continues to contribute to advancements in the field.

Grant Mitchell
Every Cure

Grant Mitchell, MD, Co-Founder & CEO, Every Cure

Grant Mitchell, MD, MBA, is Co-Founder and CEO of Every Cure. He is a seasoned entrepreneur, operator, and investor in the areas of health, technology, and machine learning. He has launched multiple health tech companies and operated in the CEO role in life science and tech organizations. Previously, Dr. Mitchell was a Principal in Analytics at McKinsey & Company’s artificial intelligence division, QuantumBlack. There he led teams that pioneered the use of machine learning algorithms and real world evidence databases to predict health outcomes in subpopulations by drug type. Dr. Mitchell was an integral part of the effort to support Dr. Fajgenbaum in the search for the cure of his own rare disease, and further collaborated with Dr. Fajgenbaum on the CORONA project. Every Cure is the culmination of Dr. Mitchell and Dr. Fajgenbaum’s experience in rare disease research, drug repurposing, and advanced analytics. Dr. Mitchell earned a BA in economics from New York University, MD from the University of Pennsylvania, and MBA from the Wharton School.

Donna Mongiello
YPrime

Donna Mongiello, Sr VP eCOA Strategy, Commercial, YPrime

Donna’s diverse career in healthcare began in nursing and evolved to focus on technologies that support patients in clinical research. With nearly 20 years in the clinical trials space and expertise in patient centricity, improving enrollment success, eCOA, BYOD, and more, Donna is a published author and presents regularly at pharmaceutical industry conferences. In her current leadership role at YPrime, she is the subject matter expert for eCOA, providing strategic direction that drives key partnerships through innovation.

Suzanne E Montanye
Endo

Suzy Montanye, Site Relationship Manager, Endo

With over 25 years of experience in the clinical research industry, I have dedicated 19 years as a Site Director at a private research clinic, where I successfully oversaw the completion of more than 150 clinical trials across 50 indications. Currently, I serve as a Site Relationship Manager, where I support both seasoned and novice sites in navigating the complexities of running clinical trials. My role involves close collaboration with site teams and sponsor clinical teams to ensure that the site’s perspective is integrated into every aspect of the trial, fostering smoother and more effective study execution.

Melissa Mooney
IQVIA Technologies

Melissa Mooney, Dir eCOA Solution Engineering, Solution Engineering, IQVIA Technologies

Melissa Mooney, Director, Solutions Engineering, IQVIA Patient Suite Melissa Mooney has over 19 years of experience in the development of eCOA solutions for use in clinical trials. Melissa’s area of expertise is eCOA solution design where she has supported clients and eCOA vendors in developing robust and usable eCOA software solutions that meet eCOA protocol requirements. She also brings a plethora of experience in eCOA requirement gathering, leading eCOA User Acceptance testing, eCOA data management, and BD support.

David F Morra
Merck

David Morra, Senior Director, Regulatory Digital Health, Merck & Co., Inc.

David joined Merck in January of 2022. During that time, he provided his technical expertise and leadership to the validation of DHTs, resolving global agency concerns regarding use of a digital algorithm paving the way for EU approval. David was also instrumental in leading several change initiatives including ensuring the right experts are available at the right time for project teams, and an IFU optimization initiative, ensuring synergies across MRL to create IFUs more efficiently when our products require them. Externally, David has chaired several industry conferences for digital health and has provided his leadership and expertise to several industry groups. David came to Merck with over a decade of experience developing complex combination products and home use digital solutions within large, medium, and start-up organizations. David has led R&D, Regulatory, and Quality organizations through product development, clinical testing, FDA approval and clearance, and ultimately commercialization of these solutions in a variety of disease states and risk profiles.

Eileen Murphy
Cambridge Healthtech Institute

Eileen Murphy, Conference Producer, Production, Cambridge Healthtech Institute

Jane E Myles
Decentralized Trials & Research Alliance (DTRA)

Jane Myles, Co-Lead, Priority Initiative 3B, DCT Playbook, Decentralized Trials & Research Alliance (DTRA)

Jane has focused on improving clinical trials and patient experience for more than 25 years. Her passion is driving innovation into the trial design and execution to get medicines to patients faster. Jane switched from molecule focus to portfolio focus about 13 years ago, first focused on patient recruitment, then patient voice and input, then patient-facing technology and its adoption. She’s able to merge them all together in her current role as VP of Innovation at Curebase, building DCT technology and services to drive access and inclusion to trials. She’s also an initiative co-lead and a member of the DTRA leadership committee. She worked at Roche / Genentech for 17 years in many roles, including operational program manager for hematology ultimately working on driving patient-facing technology into global trials. In prior lives, she held various roles in DCT optimization at LabCorp and ran global trials at Lilly and Sanofi. She’s a Canuck who loves San Francisco and the ocean.

Srivatsan Nagaraja
Vidya Seva

Srivatsan Nagaraja, Founder, Vidya Seva

Srivatsan has over thirty years of experience in growing businesses in the Digital, Data, AI, Analytics, IT, Product and Operations management areas across several industry verticals. Currently he is helping companies unlock exponential growth opportunities to scale their businesses by leveraging the power of AI. Previously as Chief Digital Officer for R&DS Technologies, IQVIA he was responsible for driving growth and leading product development and operations of R&DS Technologies. Prior to that, as Chief Growth Officer for EXL he oversaw the Sales & Marketing, Consulting and Strategy functions helping EXL become a Strategic digital transformation partner to its customers. Before that, as Venture partner, he grew Cognizant’s foray into Digital & Platforms. He identified, incubated and grew innovative digitally enabled ventures across the Healthcare & Life Sciences value chain. Early on, He was responsible for growing Cognizant’s Life Sciences business unit to be a Tier one provider. He has worked with the many of the top 50 global Life Sciences organizations providing them comprehensive end-to-end consulting, analytics, business process and IT solutions. He has provided strategic leadership in helping life sciences organizations leverage technology and the global delivery model to effectively transform their businesses. Srivatsan was recognized as the top 100 most inspiring people in the life sciences industry award by PharmaVOICE publication in 2010 and 2021. Srivatsan holds a bachelor's in electrical engineering from B.I.T.S. in India and a master's degree in electrical engineering & computer science from Northwestern University.

Radhesh B Nair
AbbVie

Radhesh Nair, Director, Data Science and Analytics, Clinical Development, AbbVie

Radhesh Nair focuses on democratizing access to clinical data and creating analytics-driven pan-R&D insights and solutions.

Karthik Nakkeeran
Abbott Labs

Karthik Nakkeeran, Senior Data Scientist, Lingo, Abbott Labs

Karthik Nakkeeran has excelled as a Data Science Researcher and Engineer, boasting two patents and two publications. His systematic approach has enabled him to thrive in demanding work settings, where he's adept at steering intricate projects. Committed to upholding exemplary work standards, Karthik leverages his expertise in Management Information Systems, Data Science, and Computer Science engineering. With over 15 years in senior roles at Abbott, SAS, and Accenture, he's proficient in Statistics, Analytics, Data Modeling, Data Mining, Machine learning, Artificial intelligence, and Predictive Modeling, with competence in GenAI and deep learning techniques.

Rohit Nambisan
Lokavant

Rohit Nambisan, CEO & President, Exec, Lokavant

Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most recently the Head of Digital Product at Roivant and the Head of Product at Prognos Health. Rohit holds an M.S in Management and Engineering from MIT, an M.A. in Neuroscience from Boston University, and a B.A in Cognitive Neuroscience from UC Berkeley.

Sharmin Nasrullah
Salesforce.com Inc

Sharmin Nasrullah, GM Life Sciences and Clinical, Salesforce.com Inc

Sharmin Nasrullah is the GM of Life Sciences, Clinical at Salesforce. As General Manager, Sharmin leads the overall product strategy and go-to-market strategy for the R&D clinical suite of applications and products on Life Sciences Cloud, leveraging the best of the Salesforce platform and ushering in a new wave of innovations in clinical development. Before Salesforce, Sharmin held several leadership positions across the industry including leading digital health enterprise architecture at AstraZeneca, leading product and sales strategy in clinical data management at Veeva Systems, and leading clinical operations at Stanford University’s academic research organization. Sharmin holds a Master of Science in Bioengineering from Stanford University and a Bachelor of Science in Electrical Engineering from the University of Waterloo.

Kannan Natarajan
Pfizer Inc

Kannan Natarajan, PhD, Head, Global Biometrics & Data Management, Pfizer Inc

Kannan Natarajan, PhD Senior Vice President, Biometrics & Data Management Since 2016, Kannan has been with Pfizer as the Global Head of Biometrics and Data Management and Chief Statistical Officer within Research and Development. Kannan is a member of the Pfizer Research and Development Leadership team and is also currently the Chair of the Clinical Development and Access Board, a governance body that provide strategic, scientific advice and oversight of global clinical development strategy and payor access of medicines, across all therapeutic categories. Kannan is a passionate drug developer and an accomplished leader in data sciences with over 30 years of pharmaceutical industry experience across multiple therapeutic areas and vaccine development. His career aspiration is to further enhance the efficiency and effectiveness of clinical trials through application of disruptive technologies such as AI/ML and Quantum computing to help drive the development of groundbreaking therapies. He has extensive peer-reviewed publications and has presented at various global conferences. Kannan holds a PhD in Statistics from the University Florida, Gainesville; Masters in Statistics from the Indian Statistical Institute, Kolkata, India; and Bachelors in Statistics from Loyola College, Chennai, India.

Melissa Nezos
Firma Clinical Research

Melissa Nezos, Exec VP, Clinical Operations, Firma Clinical Research

Melissa Nezos is Executive Vice President of Clinical Operations at Firma Clinical Research where she leads the Clinical and Project Management teams responsible for delivery of mobile nursing. Melissa has 25 years of experience contributing to a number of global organizations within Clinical Operations, Project Management, and Process Change departments. Her experience spans both large and mid-sized CROs, overseeing large, multi-continent clinical operations teams. Melissa has brought her extensive clinical knowledge and expertise into the decentralized clinical trials arena and has been invited to speak at multiple conferences to present. Recognized within the industry as a champion for progression, Melissa has been instrumental in delivering global organizational change initiatives. She has been an Executive Steering Committee member for several external organizations, advocating progression and promoting change within the industry. As an advocate for data driven and technology led solutions, she has leveraged her ability to work across operational functions to successfully implement innovative clinical monitoring and data quality strategies. Melissa lives in Cary, North Carolina with her husband and 2 children. When her twins are not keeping her busy, she is an active volunteer for several local organizations within the Triangle.

Samar Noor
Bristol Myers Squibb

Samar Noor, Vice President, Head of Statistical Programming, Global Biometric Sciences, Bristol Myers Squibb Co.

With a passion for people, innovation, and simplification, Samar T. Noor brings over 20 years of experience in leadership, vision, and technical knowledge. She currently holds and has held multiple roles in technical leadership, most recently heading Statistical Programming and Technologies at Bristol Myers Squibb, focusing on data, innovation, automation, and building high-performing teams. Before her current role, Samar served as Head, Data Management and Clinical Development Standards at Johnson & Johnson. While at Johnson & Johnson, Samar led organizational transformation in Data Management, Statistical Programming, and Clinical Development Standards, realizing 80% reusability of standards, increasing consistency and quality while reducing total cost of operational delivery. Samar introduced analytical innovation as a discipline and design-thinking in process improvement. Prior to the role at Johnson & Johnson, Samar worked for Novartis Pharmaceuticals, serving as Head of Data Analytics and Process Improvement in the Oncology division. In this role, she was accountable for driving the data warehousing and data analytics solutions for the Oncology division. In addition, she was accountable for business operations, process improvement, and quality across Biostatistics, Statistical Programming, and Data Management. While at Novartis, she also spearheaded the technology and processes integration workstream in the GSK Oncology acquisition. Samar holds a Bachelors and Masters degree in Computer Science from New Jersey Institute of Technology with minors in Applied Mathematics and Legal Studies. Time away from work is spent with her three daughters and her husband.

Alminaz Noorani
Ultragenyx Pharmaceutical Inc

Alminaz Noorani, Associate Director Clinical Systems, Ultragenyx Pharmaceutical, Inc.

Alminaz brings over 10 years of clinical trial experience with a unique combination of working on very niche trials on the sponsor side along with extensive experience on the vendor side supporting diverse therapeutic areas for sponsors needing unique solutions. Alminaz currently oversees the IRT and eCOA systems at Ultragenyx and collaborates closely with all functions to ensure the systems are accurately developed and supported from study start-up to close out.

Jonathan Norman
YPrime

Jonathan Norman, Dir Localisation Services, Linguistic Validation & eCOA SME, YPrime

With 7 years of experience in localizing paper and electronic COAs, Jonathan today leads translation and questionnaire licensing strategies for YPrime. He develops innovative approaches to ensure quality and accuracy in translated clinical trial materials, focusing on reducing translation burdens and increasing trial diversity. Throughout his career, Jonathan has progressed from Project Manager to Director roles in linguistic validation and quality assurance. He's a trusted SME in localization best practices, maintaining strong relationships with eCOA providers, pharma sponsors, and copyright holders across the clinical research industry.

Carrie A Northcott
Pfizer Inc

Carrie A. Northcott, PhD, Head of Digital Sciences, Biomeasures, Endpoints and Study Technologies (BEST), Pfizer

Carrie Northcott, PhD is a Director/ Project Lead within Digital Medicine and Translational Imaging (DMTI), Early Clinical Development (ECD) at Pfizer. She leads a driven and diverse team that is evaluating and validating the use of wearable digital devices to more fully understand and characterize physiological endpoints, such as quantitatively measuring night-time scratch and sleep. Carrie has a diverse scientific background in Pharmacology, Toxicology, and Physiology which provides unique insight into understanding how these novel digital endpoints provide meaningful information to patients, doctors, and researchers to better treat and understand diseases.

Sophia Nuijens
Bristol Myers Squibb Co

Sophia Nuijens, Director, Data Product, Drug Development Operations & Real World Evidence, Bristol Myers Squibb Co

Data Thought Leader, Strategic Business Partner & Maximizer who looks at the familiar with a differentiated perspective to position data as an asset in the attainment of company P&L objectives.

Kimberly O'Day
Eli Lilly & Co

Kim O'Day, Senior Director, Emerging Technology Operations, Clinical Trial Foundations, Eli Lilly & Co.

Kimberly O'Day is Senior Director of Emerging Technology Operations, at Eli Lilly and Company. Kimberly leads a dynamic team dedicated to accelerating and scaling technology to both advance drug development and access to clinical trials. With a healthcare and pharmaceutical career spanning over two decades, Kimberly has held several positions within the sponsor and site domains. Having a strong passion for health advocacy, she also serves as a health and safety committee chair and serves on two external committees. Kimberly has a B.S.N and MSAHS from Indiana University.

Richard O'Hara
Endo Pharmaceuticals Inc

Richard O'Hara, Director, R&D Business Operations, OncoC4, Inc.

Rick O’Hara has been an Associate Director of Project Management and Business Operations at Endo Pharmaceuticals since February of 2012. Prior to this role, Rick spent about 13 years at Johnson & Johnson in various clinical outsourcing roles. His experience at J&J spanned across many therapeutic areas and all phases of clinical research. He also worked on J&J’s FSP models. Before J&J, Rick spent 2 years at Covance as a Business Manager and 4 years at the University of Pennsylvania as a Business Administrator. The early part of Rick’s career was spent performing various financial management roles within the banking industry. Rick holds both a BS and an MBA from St. Joseph’s University in Philadelphia and he lives in Rydal PA.

Peter M O'Neill
TuHURA Biosciences

Peter O'Neill, Vice President, Clinical Operations, TuHURA Biosciences

"Work Hard, Stay Calm, and Cure Cancer." This guiding principle defines Peter O'Neill, a leader in oncology clinical trials with over 25 years of experience at Sponsors, CROs, and Hospitals. Recognized as one of PharmExec’s Emerging Pharma Leaders in 2020, Peter specializes in transforming complex clinical operations into patient-focused processes. His passion for fostering high-performing teams and a culture of collaboration drives breakthroughs in cancer treatment. Outside of work, Peter finds balance and inspiration through cooking, photography, and music

Joe O'Rourke
Walgreens

Joe O'Rourke, Head, Commercial Development, RWE Clinical Trials, Walgreens

Joseph “Joe” O’Rourke serves as the the Head of Commercial Development. He brings 20 years of experience in the clinical trials space and has a passion for increasing patient access and diversity to clinical trials. Joe recently served as the Strategic Alliance Lead and Vice President of Business Development at WCG Clinical. Over the course of 7.5 years, he was responsible for the growth of strategic partnerships, clinical trial enabling technologies, growth of endpoint solutions in CNS diseases, as well as the commercial integration of several acquisitions by WCG. Prior to WCG, Joe spent 8 years recruiting patients at Acurian (now Accelerated Enrollment Solutions, a part of PPD/Thermo Fisher Scientific) where he spent 4 years in operational delivery in a variety of roles and 4 years in business development. Joe personally delivered and oversaw more than 100 patient recruitment campaigns and helped to accelerate to market blockbuster new medicines in Diabetes and COPD. Joe has a MBA from Villanova University and a Bachelors in Kinesiology from West Chester University.

Kalyan Obalampalli
Clin.AI

Kalyan Obalampalli, Founder & President, Clin.AI

Terry L Oehler
Terry Oehler DPM

Terry Oehler, MD, Founder, Colorado Clinical Research

Dr. Oehler has been a dedicated podiatrist in the Denver metro area for over 25 years. Recently, he founded Colorado Clinical Research, driven by his passion for clinical research. He is now looking to expand his research business and partner with sponsors to develop innovative treatments for both chronic and acute foot and ankle conditions. Dr. Oehler holds a BS in Biology with a pre-med emphasis from Iowa State University and a Doctorate in Podiatric Medicine from Des Moines University. He also completed a two-year surgical residency program.

Casey Orvin
Alcanza Clinical Research

Casey Orvin, CCO, Alcanza Clinical Research

With nearly 25 years of experience in the research site space, Casey has a long and exemplary career history in pharmaceutical research site services including serving as past President of the Society for Clinical Research Sites (SCRS), a global organization representing nearly 10,000 clinical research sites in 47 countries within the pharmaceutical industry. Casey began his career leading a large pharmaceutical research site network, Research Solutions. In 2007, he was recruited to join Clinical Research Advantage/Radiant as EVP of BD and successfully led a network of over 75 research sites conducting clinical trials for pharmaceuticals, vaccines, and medical devices. In 2015, Casey and the executive team at Radiant merged with Synexus, a division of PPD. With Casey’s guidance, Synexus (now AES) continued to expand to 215 global clinical sites in 4 continents and over 15 countries. Casey also served as SVP of Pharmaceutical Relationships at StudyKik, and recently was the CCO for CenExel. Casey now serves as the CCO of Alcanza - a large owned and integrated network of research sites conducting inpatient and outpatient studies with a dedication to reducing barriers to clinical research with sites located in underrepresented patient populations across the US and Puerto Rico. Casey is passionate about representing the site voice within the industry while ensuring every research patient’s journey is a positive one. As a thought leader in the industry, Casey is regularly invited to be a keynote speaker and panelist and is often quoted by the leading publications covering the clinical research landscape. In 2020, he was recognized in PharmaVoice as one of the 100 Most Inspiring People in the industry.

Tamara Oyejide
Apnimed

Tamara Oyejide, Senior Director of Patient Recruitment, Apnimed

Tamara Oyejide is the senior director of patient recruitment for Apnimed, a biopharma company located in Cambridge, MA. Tamara has over 16 years of experience in the patient recruitment and retention space, supporting phase I-IV clinical trials on a global basis. Prior to joining Apnimed, Tamara held positions at Kendle (now Syneos), Parexel, ICON and Janssen. Tamara is passionate about teaching others about the value and importance of clinical trial participation. She also holds a special interest in the area of increasing trial participation among traditionally under-represented populations.

Andrea Paraboschi
Takeda

Andrea Paraboschi, PhD, Associate Director, Digital Solutions, Takeda

Andrea Paraboschi serves as the Associate Director of Digital Solutions at Takeda. With more than ten years of experience in digital strategy and implementation, his expertise ranges from media and consumer discretionary to industrial and digital health technologies. Andrea is passionate about devising methods to gather continuous data without imposing a burden on patients and site staff. He earned a PhD and a Master's degree in Innovation Management from Scuola Superiore Sant'Anna, as well as a dual Master's degree in Media and Computer Engineering from Politecnico di Torino.

Lamisa Parkar
Oracle

Lamisa Parkar, GVP, Business Planning and Development, Oracle

Lamisa Parkar, MD, is GVP of Strategy and Research Services for Oracle Life Sciences. A physician by training, she is passionate about cutting-edge technologies that enhance patient access, care delivery, and health outcomes. Lamisa has worked across provider and biopharma services in a variety of roles including corporate strategy, product and portfolio strategy, technology and data strategy, and is also a Limited Partner at Neythri Futures Fund, an historic first fund with a mission to increase the diversity quotient in the venture capital ecosystem. Most recently, Lamisa was VP of Real-World Evidence and Digital Engagement at Mirati Therapeutics, an oncology biotech based in San Diego, where she led digital innovation and evidence generation efforts to accelerate time to market and drive market development. She earned her medical degree in India from Maharashtra University of Health Sciences and her MBA from The Fuqua School of Business, Duke University. A former Bay Area native, Lamisa recently moved to the greater Atlanta area where she lives with her husband, two kids and dog.

Ralph Passarella
Care Access

Ralph Passarella, Co-Founder, Care Access

Ralph Passarella is the Co-founder of Care Access, where he and his team are working to make the future of health better for all, helping people learn more about their health, access health resources they need, and participate in research to help find new medicines and cures. Ralph also co-founded Signal Vine, an education technology company helping students navigate the administrative parts of higher education, where he currently serves on the Board of Directors. Prior to starting both companies, Ralph graduated from Vanderbilt University with a BA in Molecular and Cellular Biology and completed the first two years of the MD/PhD program at Johns Hopkins University School of Medicine. Ralph’s work as an entrepreneur and researcher has been recognized nationally by the National Cancer Institute, the American Medical Informatics Association, and the Clinical Global Initiative.

Alexander Pastuszak
Paterna Biosciences

Alex Pastuszak, MD, PhD, Co-Founder & CEO, Paterna Biosciences

I am an experienced physician-scientist-entrepreneur focused on starting, leading, and building companies that will positively impact healthcare across the spectrum of services, therapeutics, and devices. Chief Medical Officer, Contraline President, Clinical Care, Chief Medical & Scientific Officer, Vault Health Founder & CMO, Woven Health Associate Professor in Andrology / Male Infertility at University of Utah Entrepreneurial Endeavors: Chief Medical Officer, Contraline (2021) President, Clinical Care and Chief Medical & Scientific Officer, Vault Health (2019) Founder & CMO of Woven Health Inc. (2013), a digital health company developing the mobile platform for patient care team engagement, designed to enhance the productivity of healthcare professionals, improve the quality and safety of patient care, and reduce costs for healthcare institutions. Conception and development of "Vas Reverse" iPhone app (2012) to guide decision-making by patients seeking vasectomy reversal and urologic surgeons who perform these procedures. Clinical / Research Accomplishments: Successful clinical and basic science researcher?- Basic science interests focused on genetics of Peyronie's Disease and male infertility Over 140 peer-reviewed publications, 2 textbooks

Timil Patel
FDA

Timil Patel, MD, Clinical Team Leader (Acting), Thoracic, Head & Neck Oncology, FDA

Timil Patel is a medical oncologist and currently a Clinical Team Leader (Acting) in the Division of Oncology 2 at the US Food and Drug Administration. In this role, he leads a team of oncologists and scientists who evaluate drug development programs for thoracic and head and neck cancers, from first-in-human trials to approval. His research focuses on modernizing cancer trials, particularly through decentralized and pragmatic approaches. Dr. Patel serves on the White House Cancer Moonshot's Data and Innovation Task Force and the FDA's Decentralized Trials Guidance Working Group. He completed hematology/oncology fellowship at Yale before joining the FDA.

Medha Patel
Amgen

Medha Patel, Clinical Design Analytics Director, Amgen

Medha A. Patel is a seasoned leader in clinical development with over 20 years of expertise in data management, Biostatistics and Statistical Programming. As the Director of Strategic Development Design and Analytics at Amgen, she spearheads innovative data strategies that enhance clinical trial efficiency and drive impactful patient outcomes. Recognized as Amgen R&D People Leader, Medha has a proven track record in fostering team excellence, optimizing processes, and leading transformational initiatives. Her expertise spans data lifecycle management, and cutting-edge solutions for data acquisition and integration. Medha’s commitment to diversity and inclusion complements her technical acumen, making her a trailblazer in driving change and advancing the field of clinical development. She holds master’s degrees in Applied Statistics and Biostatistics and is an active member of the Healthcare Businesswomen’s Association. Medha’s passion for innovation and collaboration continues to shape the future of data-driven healthcare solutions.

Charlie Paterson
PA Consulting

Charlie Paterson, Associate Partner and Clinical Development Expert, PA Consulting

Charlie Paterson is a clinical development expert and associate partner at PA Consulting. He has a background in physics and extensive knowledge of lab technology, clinical trials design and execution, and provider operations. Mr Paterson drives the development and adoption of breakthrough technologies with leading organizations across the clinical trials continuum using data-driven approaches.

John R. Pavletic
Lilly Ventures

John R. Pavletic, Executive Director, Lilly Ventures

John Pavletic leads Lilly Ventures’ Tech investing strategy globally. This strategy focuses on next generation technologies and business models that can advance drug discovery and development as well as healthcare delivery. Prior to joining the Lilly Ventures team, he led early-stage product strategy for Lilly’s Digital Health group. Prior to Lilly, he held sales, marketing, and finance roles at Abbott across its Animal Health, Molecular Diagnostics, and Health IT business units.

Narayanarao Pavuluri
Merck

Narayanarao Pavuluri, Senior Director & Global Head, Clinical Database Services, Merck

Narayanarao (Rao) has been working in Pharmaceutical R&D and Consulting for the past 30+ years in the areas of Clinical Development, Statistical programming, and Submission preparation. Worked in and developed processes and software systems for all the functional areas. He has a passion for streamlining processes and systems to improve the quality of the work and outcomes, increase speed, and reduce cost at the same time.

Kimberly Payton
Alnlyam

Kimberly Payton, Senior Director, Vendor Management-Operations, Alnlyam

Kimberly Payton brings over 25 years of industry experience in Client Relationship Management, Study Management, and Project Management, accumulated through her roles at CROs and biotechnology companies. Presently, Kimberly is dedicated to leading teams across diverse therapeutic areas, striving to achieve effective Key Performance Indicators (KPIs), cultivate positive partner relationships, and ensure high performance in clinical trials.

Jill Pellegrino
AutoCruitment

Jill Pellegrino, Chief Executive Officer, AutoCruitment

As AutoCruitment's Chief Executive Officer, Jill brings over 15 years of leadership experience in patient recruitment, real world evidence and clinical research site operations. Jill is passionate about growing businesses that rely on innovative, data driven methods to reach patients to provide them with opportunities to participate in research opportunities. Most recently Jill was at CVS Health where she was responsible for establishing and growing the Real World Evidence and Patient Recruitment businesses. At CVS Health her businesses were successful in placing 35,000 patients into research opportunities in both clinical trials and research settings, drastically increasing diversity participation in research studies. Prior to CVS Health, Jill was General Manager of Accelerated Enrollment Solutions, which was comprised of 2,000 employees across 11 countries and encompassed a patient recruitment offering and clinical research site network of 160 sites. Jill received her Bachelors degree from LaSalle University in Mathematics and Computer Science.

Elisabeth Piault-Louis
Evinova An AstraZeneca Healthtech Co

Elisabeth Piault-Louis, Scientific Lead, Digital Science, Evinova

Sara Pierson
Pfizer Inc

Sara Pierson, Senior Director, Participant Ecosystem Group Lead, Pfizer Inc.

Sara Pierson is the Participant Ecosystem Group Lead at Pfizer Inc., leading the clinical trial infrastructure supporting information seekers through clinical trial alumni. She has a passion for clinical trial awareness, participant engagement and representation, and data driven recruitment-creating pathways and tools to help support people connect with clinical trials in a meaningful way.

Gino Pirri
PPD Part of Thermo Fisher Scientific

Gino Pirri, VP Product & Technology, Product & Technology, PPD Part of Thermo Fisher Scientific

Gino Pirri is the Vice President of Product & Technology Strategy at PPD, a part of Thermo Fisher Scientific, bringing over 25 years of leadership experience in the clinical research technology sector. A visionary leader and driving force for innovation, Gino leads the development and deployment of advanced technology, data, and digital solutions-leveraging AI, advanced analytics, and emerging technologies-to optimize the execution of clinical trials and expedite the delivery of life-changing therapies to patients. Throughout his career, Gino has held key product and technology leadership roles, where he has successfully advanced a wide array of clinical platforms, including EDC, eCOA, imaging, RWE, safety systems, wearables, eSource, CTMS, IRT, AI, and predictive analytics. Passionate about overcoming the fragmented technology landscape that often challenges sites, patients, and operational staff, Gino is dedicated to improving user experiences and driving operational efficiencies across the entire clinical trial process.

Claire Plewes
Parexel Intl Corp

Claire Plewes, Senior Director, Head of Strategic Feasibility, Global Strategic Feasibility, Parexel Intl Corp

Claire has 20+ years of experience in clinical research spent across top pharmaceuticals and CROs with expertise in clinical strategy & study feasibility. She currently heads global strategic feasibility department for Parexel.

Steve Polyak
Clinical Ink

Steve Polyak, SVP, Head of Global Production Innovation, Engineering, Clinical Ink

Steve Polyak is Senior Vice President, Global Head of Product Innovation at Clinical ink where he leads innovation, architecture and product design for new clinical trial capabilities. His organizational scope includes an innovation lab staffed with engineers, designers and scientists working on connected device integrations, wearables, sensors and digital biomarkers for therapeutic areas including diabetes, weight management, movement disorders such as Parkinson's disease and ALS. Steve received a PhD in Artificial Intelligence from Edinburgh University in Scotland and a Master's degree in Computer Science in Chicago. Steve has many years of experience building solutions for large scale assessments in both health and education markets. Previous work includes innovation at the college entrance exam company ACT, state assessments with Pearson Education, bringing the Encyclopaedia Britannica online and software consulting at Accenture and Computer Sciences Corporation.

Cory Potts
Bayer

Cory Potts, Senior Manager, Site Engagement, Diversity Lead, Bayer

Cory has worked in clinical research for 20 years from conducting research as a coordinator to managing clinical trial programs for pharma. He is currently a US Site Engagement Manager tasked with study feasibility and maintaining investigator relationships for Bayer, as well as a lead for diversity across all US trials. Cory calls central Texas home and lives on a ranch near Austin with his spouse, 13-year-old twins, and a GSP pointer named Kimber.

Caroline Potts
Medical Research Network

Caroline Potts, General Manager - MRN Site and Patient Services, MRN Site and Patient Services, Medical Research Network

Caroline Potts, MSc Health Sciences, MSc Healthcare and Design

Before joining MRN, Caroline worked in the public sector for 15 years supporting research in hospitals and the primary care setting, as well as providing support to research academics by writing funding applications, making submissions to regulatory authorities and running a large portfolio of studies to ICH-GCP requirements in clinical specialties such as stroke medicine, Parkinson’s disease, orthopedics, gastrointestinal medicine and respiratory medicine. During this time Caroline was one of the founding members of the UKRD group as well as an Executive member of the RD Forum providing R&D Directors and research staff working in the public sector with strategic guidance in supporting high quality research in the NHS.

In her current role, Caroline leads the development and expansion of MRN's global site network, site training programs, and on-site support services.

Gian Prakash
AbbVie Inc

Gian Prakash, Director, Data & Analytics, Information Research, AbbVie, Inc.

Gian Prakash is the Director of Data and Analytics supporting Global Therapeutics at AbbVie. With a wealth of experience in data and analytics coupled with a deep understanding of the pharmaceutical industry, Gian is instrumental in shaping the vision and strategy for data-driven initiatives within the organization. In his role, Gian leads efforts to integrate data, analytics and technology into AbbVie's global therapeutic endeavors, ensuring that data is leveraged effectively to enhance decision-making and drive successful business outcomes. Under Gian's leadership, the Data and Analytics team at AbbVie thrives on a culture of collaboration and innovation, continually seeking to enhance the impact of their work across the global therapeutic landscape. His dedication to excellence ensures that AbbVie remains at the forefront of leveraging data to deliver tangible benefits to patients and the healthcare community at large.

Megan Preovolos
Everyday Health Group

Megan Preovolos, Director, Patient Recruitment, Bus Dev, Everyday Health Group

Megan co-founded the patient recruitment business for the Pregnancy and Parenting division of Everyday Health Group, home to BabyCenter and What to Expect. She currently leads the execution of patient recruitment campaigns for women’s health and pediatric clinical studies. Megan has 16 years of experience in program and partnership management with a focus on maternal and global health. She holds a Masters in Public Administration from Columbia University’s School of International and Public Affairs, and a BA in Anthropology from Skidmore College. A passionate mom, choral singer, cook, and camper, she lives in the Bay Area with her husband, son, and two cats.

Lauren Price
Medidata a Dassault Systemes Co

Lauren Price, Director, CTMS Product Management, Product Management CTMS , Medidata a Dassault Systemes Co

No bio available.

Jarod Prince
Amgen

Jarod Prince, Senior Manager, R&D Operations, Amgen, Biospecimen Strategy and Operations

Jarod is a Senior Manager at Amgen with over 10 years of experience in multiple aspects of both academic and industry-sponsored clinical trials including clinical site recruitment and management, central lab management, and specimen management. Jarod is currently responsible for managing biospecimens for Amgen’s active clinical trials and oversight of Amgen’s specimen management vendors.

Akhil Rachamadugu
ServiceNow

Akhil Rachamadugu, Dir Life Sciences Industry Solutions, ServiceNow

Akhil is passionate about the use of technology in helping patients throughout the world. He has worked in the life sciences industry for over 15 years and has a wealth of expertise across the LS value chain including in preclinical/bench, clinical, manufacturing, and commercial. Akhil has spent many years in the pharmaceutical and medical device space helping to bring new product to market, drive clinical trials successes, and improve patient and site experiences. Having spent the majority of his career in in the intersection of technology and biopharma, Akhil has helped drive the adoption and evolution of innovative software solutions for the life sciences industry. He is a thought leader in the generative AI space and continues to work closely with leading AI and GenAI companies such as NVIDIA. Akhil has been published in several journals across multiple arenas including those in the scientific, operational, and process technology improvement spaces. Prior to joining ServiceNow, Akhil served as The Head of Strategy and Operations for Medidata Solutions.

Akhil is based in Raleigh NC where he enjoys spending time outdoors, cooking for friends and family, and attempting to perfect his fishing technique.

Maha Raheb
AstraZeneca

Maha Raheb, MD, Associate Director, Risk-Based Quality Management, AstraZeneca

Maha is an Associate Director, Risk-based Quality Management at AstraZeneca Canada. She drives RbQM process in assigned AZ sponsored studies. Maha is a Physician by education and holds a Master's degree in Internal Medicine with 15+ years of experience as a specialist in Internal Medicine. When Moved to Canada in 2009, Maha pursued her career in Clinical Research. Prior to Joining AZ, Maha worked for CROs and held positions of Medical Research Associate, Quality Control Specialist and Senior Quality Assurance Auditor. In her free time, Maha loves to bake desserts, read books, and spend quality time with family and friends.

Joan Ramella
Endo Inc

Joan Ramella, Associate Director, Oversight & Training, Endo

Prasanna V Rao
Saama

Prasanna Rao, Chief Products and Innovation Officer, Saama

Prasanna Rao is a distinguished AI practitioner and industry thought leader, currently serving as the Chief Products and Innovation Officer at Saama Technologies. With over 30 years of experience in information technology and analytics, including more than a decade in healthcare and life sciences, Prasanna brings a wealth of knowledge and expertise to his role. Previously, as Global Head of AI/ML, Clinical Data Sciences at Pfizer Research & Development, Prasanna worked closely with stakeholders, vendors, business SMEs, machine learning developers, and data scientists to foster innovation and advance the adoption of AI in clinical data sciences. His tenure at IBM Watson as a Watson Solution Architect was marked by significant achievements in implementing AI systems for a diverse range of clients. An accomplished speaker, Prasanna regularly presents at major industry conferences, including SCDM, DIA, SCOPE, DPharm, Tufts University CSDD, and Outsourcing Clinical Trials (OCT). He is also the holder of an IBM patent titled "Monitoring Clinical Research Performance," further cementing his status as a leading authority in leveraging technology for clinical development in the pharmaceutical industry. Prasanna continues to drive transformative advancements in AI and machine learning, delivering groundbreaking solutions to accelerate clinical research and development.

Mitesh Rao
OMNY

Mitesh Rao, MD, Founder & CEO, OMNY

Dr. Mitesh Rao is the Founder and CEO of OMNY, a venture-backed company revolutionizing how healthcare data is shared and valued. A Board-Certified Emergency Medicine Physician, Dr. Rao practices clinically as an Assistant Professor of Emergency Medicine at Stanford. Most recently, he served as the Chief Patient Safety Officer at Stanford Healthcare where he led Patient Safety, Quality, and System Redesign for the Enterprise. Dr. Rao began his career as a Fellow in the Robert Wood Johnson Clinical Scholars Program. As a physician leader and executive, he has helped implement systems-level improvements for quality and safety in institutions across the country and overseas that have had lasting effects on patient care provision. He has also led multiple campaigns and initiatives to improve healthcare quality on a national level. Throughout his career, Dr. Rao has helped implement and scale new technologies within the clinical venue. He also serves as a mentor to multiple startups and accelerator groups across the country in order to help guide the development of innovative solutions that can sustainably impact patient care.

Helene Raptis
Chiesi

Helene Raptis, Head of Feasibility Intelligence, Chiesi

Hélène is an accomplished leader in the pharmaceutical industry, recently appointed as the Head of Feasibility Intelligence at Chiesi Farmaceutici. With over 20 years of experience in clinical project management, Hélène has a proven track record of driving successful clinical trials and delivering innovative solutions to complex challenges. In her previous role as head of clinical project management, she was instrumental in overseeing the planning, execution, and completion of numerous high-profile clinical studies. In her new role, Hélène is leveraging her extensive knowledge and experience to enhance the company's capabilities in assessing the feasibility of clinical trials by implementing advanced analytics and AI-driven tools to improve the accuracy and efficiency of feasibility assessments.

Ratan L Ratnesh
Taiho Oncology Inc.

Ratan Ratnesh, Senior Director, Outsourcing & Vendor Management, Taiho Oncology, Inc.

Ratan Ratnesh is a Senior Director and Head of Outsourcing & Vendor Management at Taiho Oncology. Prior to joining Taiho/Otsuka, Ratan worked at Wyeth and Novartis where he managed different categories related to clinical outsourcing. Ratan has broad experience in strategic sourcing, clinical outsourcing, operations and supply chain improvements in Fortune 500 and growth companies. He started his career in management consulting specializing in supply chain across different industries and moved to clinical outsourcing in early 2000. He received his Bachelors in Mechanical Engineering from National Institute of Technology, India and an MBA from University of Louisiana.

Bobby Reddy
Pi Health

Bobby Reddy, CoFounder & COO, Pi Health

Dr. Bobby Reddy, MD is the Chief Operating Officer and Co-Founder of Pi Health. At Pi Health, he leads global operations, business development, and commercial activities with the mission of driving equal access to innovative medicines and clinical trials for patients around the world. Previously, he served in leadership positions at BeiGene and AstraZeneca. At BeiGene, he was Executive Director of Applied Innovation, a technology incubator in the Office of the CEO, which developed novel technologies to improve R&D and commercial capabilities. In this role, Dr. Reddy was the co-inventor of multiple patented technology applications which have successfully undergone enterprise adoption. He also built and managed multidisciplinary, global teams who led strategy, business development, global operations, and legal activities to drive development, implementation and growth of incubated technologies and companies. At AstraZeneca, Dr. Reddy was Head of Oncology Regulatory Science and Innovation, where he was a member of the global Oncology Regulatory Science and Strategy leadership team. Previous to his roles in pharma and biotech, Dr. Reddy was faculty of Harvard Medical School and a physician scientist and clinical dermatologist at Massachusetts General Hospital. His research focused on investigating the role of genetic and immunologic factors in melanoma development and progression, along with the development of novel therapeutic strategies. He is also an alumnus of the Howard Hughes Medical Institute - National Institutes of Health Research Scholars Program, through which he conducted research at the National Cancer Institute. He completed an Internal Medicine internship at Brigham and Women’s Hospital, during which he was given the Dunne Award for Humanism in Medicine by Harvard Medical School. He subsequently completed a Dermatology residency at Columbia University Medical Center, where he served as a Chief Resident during his final year of training. After residency, he completed a Melanoma Fellowship at Massachusetts General Hospital/Harvard Medical School. He obtained his M.D. with Alpha Omega Alpha honors from Rutgers-New Jersey Medical School. Dr. Reddy is a board-certified dermatologist and maintains an active clinical practice caring for patients at Massachusetts General Hospital, where he also teaches and mentors medical students and trainees.

Caroline Redeker
Advanced Clinical

Caroline Redeker, Senior Vice President, Corporate Development, Advanced Clinical

Clinical Research Innovator, Leader, and Mentor with 30+ years of experience in creating new solutions and adding value to clinical programs. Passionate about developing meaningful and authentic relationships with all stakeholders in the clinical trial process. Responsible for corporate strategy, innovation, and study optimization, including site and patient engagement strategies as well as global feasibility in order to deliver predictable timelines and deliverables. Driven to find new and better solutions that create efficiencies and offer opportunities to improve the clinical research process. Expertise in strategic consulting, clinical development planning, global project feasibility, site start-up and management, patient recruitment, innovative technologies, and a full suite of CRO services. Key experiences in study rescue and transition programs, with processes and strategies for both full CRO study management transition as well as functional service provider (FSP) programs. Responsible for developing and managing key strategic relationships across the globe. Current member and Deputy Director of Midwest Mentoring Program for Healthcare Businesswomen's Association (HBA); Co-Lead for Crowdsourcing Evidence Workstream and on Content Council for Decentralized Trials Research Alliance (DTRA); Led Site Budgeting for DCTs workstream for ACRP. Key awards include PharmaVoice 100, HBA Luminary award, President's Club at Inventiv Health, and President's Club 10 years in a row at Advanced Clinical. Advanced Clinical is the premier mid-sized CRO, offering full global contract research organization (CRO) services, dedicated functional teams/services (FSP), and strategic resourcing solutions. We are extremely proud of the success of our privately-held organization and its culture, which includes being voted year after year in the top 100 companies to work for in the Chicago area. Most importantly, from the top down and at all levels, we strive to make a better clinical experience for our clients, partners, vendors, sites, and patients each day.

Rose Redfield
Daiichi-Sankyo

Rose Redfield, Director, Support & Optimization Biosample Management, Daiichi-Sankyo

Rose Redfield is a seasoned biorepository/biospecimen professional with 25 years' experience in collection, storage, and governance of specimens for clinical research. Starting her career in the laboratory, her curiosity gravitated towards the “freezer of left-over samples” back in the corner. This led her on a journey within different roles of specimen management supporting clinical trials. Her career path at central labs, CROs and multiple Pharmaceutical Companies helped her developed best practice’s regarding specimen utilization for the benefit of future therapies.

Roy Reese
Ichor Strategies

Roy Reese, Sr Advisor & Head, Healthcare Practice, Ichor Strategies

No bio available.

Michel Reid
GSK

Michel Reid, Senior Director & Head, Global Demographics & Diversity, GSK

Michel’s team supports the entire GSK R&D portfolio (medicines and vaccines) to enhance diversity in clinical trials, to ensure GSK delivers against corporate ESG objectives by being ambitious for patients. Under his leadership, the team has been instrumental to promote health equity and to help improve health outcomes for a diverse population of underrepresented patients. To lead with transparency, he published a peer-reviewed retrospective study for GSK clinical trials over a span of 17 years that investigated the historical representation of U.S.-based participants and compared demographics with real-world disease epidemiology data. Prior to this role, Michel served as Director in GSK’s US Pharmaceuticals Commercial Insights team focusing on Vaccines. There, he was responsible for leading the design and execution of purpose-built market analysis and market research, producing innovative insights that continue to drive the commercial organization. Before joining GSK in 2018, Michel spent over 15 years in marketing agencies and consultancy, providing business strategy, and communications design, strategy, and analysis for clients in a variety of industries and across a wide range of pharmaceutical therapeutic areas and customer groups. Michel holds a degree in Mechanical Engineering from Carnegie Mellon University. Michel lives in Burlington, NJ with his wife Jennifer and three daughters, Azarin, Bonnie, and Piper. Talk to him about cars, computers, or cryptocurrencies, as those are his favorites.

Jie Ren
Merck & Co Inc

Jie Ren, PhD, Director, Data Science, Global Digital Analytics & Technologies, Merck & Co., Inc.

Jie Ren is the Director of Data Science in the Global Digital Analytics & Technologies group at Merck. In this role, she leads the digital health data analytics team and focuses on leveraging data science for digital endpoint development. Jie earned her PhD from Duke University in 2013 and her Bachelor’s degree from Peking University in 2007.

Valerie L Reynaert
Immuncore

Valerie Reynaert, Vice President, Global Clinical Operations, Immunocore

Valerie Reynaert serves as the Head of Global Clinical Operations at Immunocore. She joined Immunocore in April 2023. Valerie has more than 20 years in clinical development and operations in a variety of leadership roles in Vaccines and Pharmaceuticals development in both Europe and the US. Valerie has a Masters in Medical and Social Sciences from the Catholic University of Leuven, Belgium. She lives in the Philadelphia area.

Erin Reynolds
AbbVie, Inc.

Erin Reynolds, Associate Director, Clinical Trial Diversity & Inclusion, AbbVie

Erin Reynolds is an Associate Director on the Data Science and Analytics team at AbbVie. Throughout her 10 years at AbbVie, Erin has been working with study teams and functional area leaders to find ways to use clinical, operational, and real-world data to transform drug development while improving clinical trial operations and access for both patients and sites. Her recent work has focused primarily on AbbVie’s diversity and patient inclusion efforts to ensure that AbbVie’s strategy has the data and insights needed to inform decisions. Erin earned her Bachelor’s in Biology from Loyola University Chicago and her Master's in Applied Probability & Statistics from Northern Illinois University.

Tom Rhoads
Spencer Health Solutions LLC

Tom Rhoads, CEO, Spencer Health Solutions LLC

Kim Ribeiro
AbbVie

Kim Ribeiro, Head, Diversity and Patient Inclusion, AbbVie

Kim Ribeiro is the Head of Diversity & Patient Inclusion. Within this role, Kim Ribeiro is responsible for operationalizing a vision and enterprise strategy for AbbVie’s intentional approach to attracting underserved and diverse populations of investigator sites and patients into our clinical trials. Kim joined AbbVie in August 2014 after working as a patient recruitment and retention strategist delivering diverse enrollment for the top 50 pharmaceutical companies. During her tenure at AbbVie, Kim held positions in clinical recruitment strategy and patient centricity. Her collective experience has uniquely positioned her to be a leading voice in clinical trial diversity and patient centricity. Since stepping into the role of Head of Diversity & Patient Inclusion, Kim has been featured in DiversityPlus Magazine and represented AbbVie at a number of industry roundtables as a thought leader. In 2022, Kim was recognized as a Top 15 Champion of Diversity. In 2023, Kim had the distinction of being included in the PharmaVoice 100 list. As a licensed Medical Laboratory Scientist, Kim has been recognized by the ASCP as a 40 under 40 clinical professional. She completed studies in biotechnology and biotechnology management.

Kevin Richards
AstraZeneca

Kevin Richards, Head, Quality Investigations & Analytics, AstraZeneca

Kevin has made a career of overhauling analytics strategies at organizations across multiple industries including manufacturing, healthcare and now pharmaceuticals. He was brought into AstraZeneca 2 years ago to overhaul the Quality Management System analytics strategy bringing an approach that has led to the successful implementations of inspection readiness, quality and process compliance reporting and solutions. Kevin is passionate about uplifting the capabilities of the industry to deliver safe and effective clinical trials to patients through effective and transformative strategy in the quality space.

Catherine Richards
OM1 Inc.

Catherine Richards, President and COO, OM1 Inc.

Catherine Richards is the President & COO at OM1, inc. In her role as president Catherine is responsible for leading OM1’s four business units: Data & Insights, ASPEN, Research Services and PhenOM, as well as leads technology and compliance, all with the goal of ensuring a thriving company culture that delivers significant value to customers. Prior to OM1 Catherine was the Chief Data Officer & General Manager of the Real World Evidence business unit at ConcertAI, where she was responsible for a 600+ person global team that created and delivered data products, custom data solutions and outcomes science services to the pharmaceutical industry. Before ConcertAI, she was the Senior Vice President of Analytics & Scientific Engagement at Panalgo, where she led data integration, data operations and scientific engagement, including training and supporting users of Instant Health Data (IHD). Previous to Panalgo she was the Director of User and Scientific Engagement for Aetion, supporting the use and adoption of the Aetion Evidence Platform and working as the scientific lead for five of the top 20 pharmaceutical companies. Preceeding Aetion she was a staff scientist at the Hutchinson Institute for Cancer Outcomes Research (HICOR) at Fred Hutch in Seattle, Washington. While there the main focus of her research and academic activities was on improving the quality of cancer care while reducing the economic burden for patients and society. Catherine received her MPH and PhD in Cancer Epidemiology from the Mailman School of Public Health At Columbia University.

Claire Riches
Citeline

Claire Riches, Vice President, Clinical Solutions, Citeline

Christopher Riley
H1

Christopher Riley, Director, Strategic Insights, Solutions, H1

Chris Riley is a leader on the Strategic Insights team at H1, specializing in addressing the unique needs of clients across the pharmaceutical product lifecycle. In his role, Chris serves as a key liaison between clients and product teams, ensuring that H1’s clinical platform, Trial Landscape, leverages the latest advancements in AI and DE&I performance data to drive more diverse and effective clinical trials.

With over 15 years of scientific expertise, Chris now focuses on bringing clinical solutions to market that promote equitable patient access to trials, spanning areas such as protocol optimization, site selection, and principal investigator identification.

Chris holds a Bachelor of Science in Biochemistry from the College of Charleston and a Ph.D. in Biochemistry from the University of Texas at Austin.

Amy Ripston
Slope

Amy Ripston, Executive Director, Biospecimen Management Consortium

Amy Ripston is the Executive Director of the Biospecimen Management Consortium (BMC), is a clinical trial industry partnership dedicated to driving sample excellence in clinical research. Founded in June 2024, the BMC mission is to raise awareness of the importance and criticality of biospecimen management, develop industry standards and best practices, and advocate for change within the clinical trial ecosystem through standardization, policy, and thought leadership.

Gaelan Ritter
Bristol Myers Squibb

Gaelan Ritter, Executive Director, Innovation and Digital Health Analytics, Bristol Myers Squibb Co.

As the head of Analytics Innovation and Digital Health, Gaelan and his team are responsible for leading cutting edge real-world data alliances and most importantly creating and developing innovations across R&D. He co-leads the BMS digital initiative for global drug development, which is enabling a spectrum of digital solutions, including several types of decentralized trial capabilities. Gaelan is an industry leader in the development and infusion of digital innovation solutions to enable optimization of pharma drug development. In past roles Gaelan has led and developed strategic partnerships with large academic medical centers and networks. He has also supported trial design and start-up for the BMS oncology and immunology programs. This experience led him to develop industry leading trial design software and processes that create digital protocols and feed downstream systems and processes. He is passionate about not only the ideation and creation, but the development and business change that creates lasting advancement in the industry. Gaelan holds an MBA from Temple University along with MS in human physiology and biophysics from Georgetown. Outside work, Gaelan lives in southeastern Pennsylvania with his wife, enjoys traveling around the globe, cooking, and restoring their historic home.

Claire Rivera
Merck & Co Inc

Claire Rivera, Assoc Dir Delivery Mgmt, Delivery Mgmt, Merck & Co Inc

Claire leads a team responsible for data management study start-up and maintenance activities. She plays a critical role in driving innovation projects aimed at modernizing clinical trials and optimizing data integration. With nearly 20 years of experience, Claire has also earned her BA from the University of Pennsylvania and MS from Drexel University College of Medicine.

Holly Robertson
Medidata a Dassault Systemes Co

Holly Robertson, PhD, Head of Advisory Services, Professional Svcs, Medidata a Dassault Systemes Co

LaShell Robinson
Takeda Pharmaceutical Limited

LaShell Robinson, MS, Senior Director Diversity, Equity & Inclusion in Clinical Research, Takeda

LaShell Robinson is the Director of Diversity, Equity & Inclusion in Clinical Research at Takeda Pharmaceutical Company, Ltd. Here she leads the company’s strategic vision for increasing the diversity of Takeda’s clinical research programs by fostering partnerships & implementing strategies focused on education, awareness, access, and operational excellence. LaShell brings her experience from Janssen Research & Development, a Johnson & Johnson Pharmaceutical Company where she held the position of Clinical Operations Lead, Diversity & Inclusion in Clinical Trials (DICT). In this role, she supported the vision to ensure that all patients have access to innovative, high-quality care and the best possible health outcome regardless of race or ethnicity. LaShell was responsible for providing D&I strategic and tactical support to trials, including the COVID-19 vaccine and treatments trials. LaShell’s previous roles centered on Patient Recruitment & Retention and Site supporting global clinical trial programs with disease-focused strategy to expedite trial enrollment. Her specializations included training clinical teams, facilitation of site & patient engagement workshops, managing small to large scale investigative site support programs all of which focused on highlighting the patient experience to enable a better clinical trial experience. LaShell is a proud alumna of Tuskegee University where she obtained a Bachelor of Science in both Biology & Physics. Here she saw firsthand the impact history has on the patient’s perception of clinical research. This continues to fuel and influence her passion for educating others about clinical research and the diversity of the patient experience. LaShell has a Master of Science in Biomedical Engineering from the University of South Florida. LaShell and her family currently reside in Maryland.

Isaac R Rodriguez-Chavez
4Biosolutions Consulting & EEE, Clinical Trial Technology Modernization Network

Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc, CEO, 4Biosolutions Consulting (Sci/Clin/Reg Affairs) & Co-Chair, EEE-SA, Clinical Trial Technology Modernization Network (CTTMN)

I am a scientific and regulatory leader with expertise in all facets of scientific research, clinical trials, drug, therapy, vaccine, and medical device development and regulatory approval. With my broad knowledge and skills with the lab and clinical trial development and operations, I am able to effectively test cutting-edge novel medical products for infectious diseases, virology, microbiology, immunology, vaccinology, and oncology. I am also skilled in managing research projects, programs, functional areas, and Clinical Research Organizations (CROs). I have experience in directing cross-functional teams across multiple platforms while successfully accelerating the development and regulatory approval of innovative medical products and digital health technologies. I lead scientific affairs, clinical affairs, Qa/Qc, regulatory affairs, and policy development and implementation for the successful conduct of modern trials such as Decentralized Clinical Trials using innovative Digital Health Technologies. I am an a biomedical innovator, strategist, influencer and communicator who successfully leads organizations’ functional areas, programs and projects with P&L over $1B.

Peter Ronco
Emmes

Peter Ronco, CEO, Emmes

Peter is an accomplished drug developer and innovative senior pharmaceutical executive who is currently the CEO of Emmes as well as advising boards, private equity investors, and leaders across the pharmaceutical and biotech industry. In his current role as CEO of Emmes, he is responsible for setting both the strategic direction and the day-to-day operations of the full service CRO operating in 30+ countries and across multiple disease areas including ophthalmology, vaccines, rare disease, cell & gene therapy, and neuroscience. Emmes is collaborating with more than 210 sponsors, within the pharmaceutical/biotech industry, government, including over a dozen institutes of the National Institutes of Health (NIH), academic organizations, and non-profit foundations. Prior to Emmes, Peter was the Head of Global Development at Janssen R&D where he was responsible for leading the Global Development organization (including statistics, clinical pharmacology, clinical operations, data operations, project and portfolio management, etc.) in support of delivering a broad ranging portfolio of 450+ studies across all therapeutic areas and all phases from PhI -IV. In this role he managed a 10,000+ globally distributed organization and a $2bn+ operating budget to support the design of innovative drug development programs and the implementation of innovative approaches to trial design and execution including trial virtualization, digital health, patient-centered research, and diversity in clinical trials.

David Rosa
Summit Clinical Research

David Rosa, Director, Business Development, Summit Clinical Research

Dave Rosa has been in the clinical trial services area for nearly 40 years. He has spent the majority of those years within the CRO industry and the remainder in the clinical technology space. In his current role at Summit, he is responsible for working with study sponsors to align Summit's IRO services with their site needs.

Dave has his M.S. in Biostatistics from UMASS Amherst and, though he resides in Florida, remains an avid Boston sports fan.

Josh Rose
Hawthorne Health

Josh Rose, CEO, Hawthorne Health

Josh Rose, CEO, Hawthorne Health, is a clinical research industry veteran with more than 20 years of experience. Hawthorne Health is pioneering the way clinical trials are delivered in the patient’s home or community to drive better study outcomes. Prior to Hawthorne, Josh led the clinical trial delivery and site solution business at CVS Health, providing patient-first research within designated MinuteClinic locations, Home Research Services and virtually. Before joining CVS Health, Josh was Vice President and Global Head of Strategy for the clinical research business at IQVIA, while also launching and leading its decentralized clinical trial (DCT) and home research nursing service businesses. Josh has an MBA from Duke University and a Bachelor of Science in chemical engineering from the University of Illinois. He lives near RTP in NC.

Patricia Roselle
Sanofi

Patricia Roselle, Global Head, Patient Stakeholder Engagement, Sanofi

Patricia Roselle is the Global Head of Patient Stakeholder Engagement within R&D, at Sanofi. Pat co-leads the PALADIN Consortium Skills, Training and Frameworks Workstream and serves on the PALADIN Consortium Executive Committee.

Len Rosenberg
LLS/Beat AML

Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS

Dr. Rosenberg is a 35-plus-year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical, and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions, and new product/licensing evaluations, he brings tremendous hands-on insights to optimizing the drug development cycle, from the early start-up stage to global product registration. Dr. Rosenberg is Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society, and also Managing Partner of eP2Consulting, Inc. since 2001.

Julie A Ross
Advanced Clinical

Julie A. Ross, President & CEO, Advanced Clinical

Julie is a tenured executive leader responsible for all aspects of strategic planning, corporate alliances, sales and marketing, operations, financial management and regulatory compliance for Advanced Clinical and is a long-time active member of Healthcare Businesswomen’s Association (HBA) currently serving as vice-chair of the global board. She has been instrumental in leading the growth, profitability and overall success of multiple companies and has held positions in executive leadership and corporate officer roles including at a top-five CRO. Her oversight of global functional areas focuses on innovative methods for reducing the time and cost within clinical trials. With over 25 years of clinical research experience, Julie has participated in fundraising, mergers and acquisitions, authored many clinical research articles and is a well-known industry speaker. She is a change management expert and industry thought leader who has successfully led multiple company integrations, implemented a variety of cutting-edge technologies and platforms, and served six years as board president for a non-profit community group where she navigated a headquarter change twice and raised money through angel investors. Personally, Julie is a wife and Mom to four grown children, a graduate of the University of Wisconsin, La Crosse, with a bachelor’s degree in nuclear medicine technology and received the coveted HBA Chair Award in 2019 and the PharmaVoice 100 Red Jacket award in 2020.

Mike Rossi
ConcertAI

Mike Rossi, VP, Translational Science & MM RWE Solutions, RWE, ConcertAI

Michael R. Rossi, PhD, FACMG is the Vice President of Translational Science and Multi-Modal Real World Evidence Solutions at ConcertAI. Prior to ConcertAI, Mike was the Division Head of Molecular Oncology for Solid Tumors at Sema4 and an Associate Professor in the Department of Genetics & Genomic Sciences at the Icahn School of Medicine at Mount Sinai in New York. Mike has extensive expertise in genomics applications for clinical diagnostics, cancer research, and oncology clinical trials, and has authored or co-authored over 65 peer review publications focusing primarily on genomic mechanisms that drive human cancers and response to therapy. At Sema4, he developed a New York State validated comprehensive tumor/normal whole exome/whole transcriptome clinical diagnostic assay for all cancer types that was integrated with real world clinical data from Mount Sinai and external pediatric and community practice cancer centers. Prior to Sema4, had a dual appointment as an Assistant Professor at Emory University in the Department of Radiation Oncology and the Department of Pathology and Laboratory Medicine. There he developed many of the first molecular and NGS based clinical and research assays for solid tumors and hematological malignancies.

Melinda M Rottas
Pfizer Inc

Melinda M Rottas, Head of Optimization, Analytics & Recruitment Solutions, Clinical Development & Operations, Pfizer Inc.

Melinda Rottas is the Head of Optimization, Analytics & Recruitment Solutions (OARS), a team that aims to transform clinical trials at Pfizer, establish a new standard for clinical trial experience and deliver analytics and insights for optimized R&D performance. OARS is a talented global team delivering core capabilities spanning clinical trial country & site feasibility; protocol insights & optimization; recruitment & retention strategies; clinical trial investigative site partnerships & site experience; clinical trial participant experience & patient engagement and decision-making analytics & benchmarking. Melinda has over 23 years of experience at Pfizer, starting her career as a Medicinal Chemist in Drug Discovery, followed by additional roles in research including Business Operations and Portfolio Reporting & Forecasting prior to moving to the clinical development space. Melinda holds a BS in Chemistry from the University of Connecticut as well as an MBA from Rensselaer Polytechnic Institute.

Jonathan Rowe
ZS

Jonathan Rowe, PhD, MS, MA, Principal, ZS

Jonathan Rowe has 25 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Head of R&D Quality and Operations Risk Management at ZS. In this role he partners across the industry to design and implement advanced approaches to identifying and mitigating clinical development risk, and improving end-to-end process, study, site and vendor quality. From 2014-2019 Jonathan was the Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities included monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for both Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

Jonathan Rowe
ZS Associates Inc

Jonathan Rowe, Principal & Head, R&D Quality Operations & Risk Mgmt, ZS Associates Inc

Jonathan joined ZS’s Research and Development Excellence organization in January 2020 after 24 years of working across clinical, strategy, operations, and Quality in pharma. Within ZS, Jonathan established and leads the R&D Quality, Operations and Risk Management vertical. Jonathan has held leadership roles in both large and start-up pharma. His breadth of experiences and accountabilities crosses clinical development, medical affairs, intellectual property strategy, portfolio management, business development and pharmaceutical sciences. He was an author on Transcelerate’s key papers entitled “Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development” and a contributing author on, “Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development.” Jonathan has multiple peer reviewed publications and is an inventor on eight patents.

Arnab Roy
ZS

Arnab Roy, Associate Principal, R&D , ZS

Arnab Roy is an Associate Principal at ZS, leading cross-functional teams in R&D transformational programs for life sciences. With over 10 years of experience, he specializes in clinical development, real-world data, evidence generation, and market access analytics. Arnab has advised pharmaceutical and medical device companies on various issues, including driving clinical operations strategy, patient & site engagement transformation for clinical trials and integration of digital health tools and technologies in clinical development. He regularly contributes to ZS’s thought leadership on digital health innovations and decentralized research methods in clinical trials.

Sean Roy
Oracle

Sean Roy, Sr Director of Consulting, Life Sciences, Oracle

Sean has 13 years of IRT/RTSM domain expertise and 17 years in the services delivery of clinical trial software. Sean holds a BS in Management from Bentley University, a MS in Leadership from Northeastern University, and a Ph.D. in Organizational Leadership from Indiana Wesleyan University.

Todd Rudo
Clario

Todd Rudo, CMO & Executive Vice President, Clario

Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety. Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.

Brandon Rufino
Sanofi

Brandon Rufino, Computational Science Manager, Sanofi

Brandon leads the Integrative Clinical Data group in Digital R&D, a team of computational scientist, engineers, program managers and analysts focused on using ML/AI to integrate clinical and real-world data for several drug development applications, including drug repurposing, proxy endpoint identification, safety prediction, and simulation of novel mechanism of actions on a target cohort. Prior to joining Sanofi, Brandon worked as a Data Scientist building large language models at a healthcare company in Toronto. He was also a lead Data Scientist developing end-to-end software applications which derived cohort insights to inform combination drug treatments at a biotech company.

Stephen Ruhmel
Sanofi

Stephen Ruhmel, Director, Clinical Strategy Lead for Digital Endpoints, Sanofi

Stephen is an Associate Director at The Janssen Pharmaceutical Companies of Johnson & Johnson currently working in Janssen Clinical Innovation (JCI), a team dedicated to delivering clinical trial efficiencies and innovation for patients, investigators and the industry at large. He has worked across teams at Janssen and J&J for over 14 years in Global Public Health, Global Development, Digital Health, R&D, and IT. With a proven record of improving business performance as a technologist, researcher, and public health advocate, Stephen’s career mission is to dramatically improve healthcare for underserved populations globally by leveraging the latest healthcare technology. Stephen has worked with internal and external partners to develop speech-based capabilities in clinical trials, including conversational AI and speech biomarkers, with the objective of creating novel clinical outcome measures in the areas of Neuroscience and Alzheimer’s. He has also led projects in geofencing for safety event detection and digital measures for immundermatology, among others. Prior to his current role, Stephen developed and launched a SXSW-award-winning crowdfunding platform, CaringCrowd, which has raised over $4 million across 600+ nonprofit-led public health projects. Globally, he has contributed to projects throughout Africa, including a six-month secondment with Aga Khan University in Nairobi, Kenya, where he led a mixed methods cross-sectional study to evaluate a five-year nursing and midwifery program across Kenya, Uganda, and Tanzania. Stephen received a bachelor’s degree in Information Sciences and Technology from Penn State and a Master of Public Health from Rutgers.

Krista L Russell
Takeda

Krista Russell, Head Digital Health Solutions, Takeda Pharmaceuticals

Krista Russell is eager to bring digital capabilities to solve complex challenges. She is passionate about improving health outcomes for patients through the adoption of the right technology solutions. She is the Head of the Digital Health Solutions team at Takeda. Her team is focused on assisting clinical teams with taking on fundamental challenges to further the vision of streamlining Digital, Data, and Technology in clinical trials. Prior to Takeda, Krista developed, validated, and managed business and clinical technology tools. Krista’s passion for technology began with her career in the United States Navy. Her career passion for the use of high-quality, safe technology for patient care began while working with Veterans at high risk for suicide. It was through this effort she gained an understanding of the important of patient and site experience as a part of clinical research. She has worked extensively with patients, sites and teams on developing new and better solutions for complex issues in Research and Development. She is a certified clinical research coordinator and clinical project manager. Krista's experience includes managing hundreds of clinical trials and many large system implementation projects with SDLC validation.

Laura Russell
Advarra

Laura Russell, SVP, Head of Data and AI Product Development, Advarra

Laura Russell is a visionary leader in the life sciences and technology sectors, with expertise in product development and operational excellence. As SVP, Head of Data and AI Product Development at Advarra, she defines and oversees the company’s business transformation through the responsibly guided integration of AI, delivering advanced analytics solutions and novel applications of AI across Advarra’s portfolio of services and technologies.

Previously, Laura held transformative leadership roles at Verily and 23andMe, where she launched impactful products and built scalable operational frameworks. Holding a Master of Science in Clinical and Translational Research from Georgetown University, Laura combines deep industry knowledge with a commitment to advancing healthcare through data-driven and AI-powered solutions.

Stephanie Russell
Medidata a Dassault Systemes Co

Stephanie Russell, Sr. Director RTSM Solution Services, Professional Services, Medidata a Dassault Systemes Co

Stephanie Russell is a seasoned clinical operations professional specializing in biostatistics and Randomization and Trial Supply Management (RTSM) solutioning. With a strong passion for accelerating drug development, she excels in helping clients integrate Rave RTSM seamlessly into their organizations. Stephanie is dedicated to addressing consulting challenges and providing tailored solutions that optimize clinical trials processes. She remains well-versed in industry trends, particularly the rise of personalized medicine, while remaining pragmatic about its potential challenges around cost and implementation. In her consultations, Stephanie offers a comprehensive assessment, providing clients with viable options, clear pros and cons, and actionable insights into potential roadblocks, helping them navigate the complexities of the evolving clinical trial landscape.

David N Sall
Patient Enrollment Advisors LLC

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

David Sall is a marketing and engagement specialist with a focus on the healthcare industry. He was graduated with honors from The George Washington University with a Bachelor of Arts in Communications and a concentration in Business Marketing. David started his career in national broadcasting sales by representing hundreds of the nation’s top radio properties. As the media industry hit the technology revolution, David continued his career by building and managing the New York office of Hiwire, one of the original pioneers in digital streaming technology. With the opportunity to bring this knowledge to the traditional media space, David joined CBS Broadcasting’s management team and handled the flagship terrestrial radio news properties as well as the many digital assets of the Tiffany network. David is now the CEO and President of Patient Enrollment Advisors, which focuses on the recruitment and retention of qualified participants in medical clinical trials. This venture was born out of a clear need for the industry to approach the business of clinical trials with a unique set of eyes. “Our company takes a patient-focused strategy to help the healthcare industry quickly and safely bring products to market for those in need. Patient Enrollment Advisors not only finds qualified patients, but we also listen to them.” This humanistic approach makes the clinical trial process a better experience than ever before - for everyone involved - which ultimately helps pharmaceutical companies meet their research goals. Patient Enrollment Advisors reaches qualified trial candidates, retains them, and ensures they fulfill all requirements to bring a clinical trial to a successful, complete end. David is very excited to be a partner with SCOPE for the Participant Engagement Awards, and especially excited to highlight the innovation of engagement with study participants. He lives and works in New York City with his wife and two children.

Michael D Salvatore
Merck & Co

Michael Salvatore, Director, Process & Systems, Merck

With a solid foundation in science and a doctorate in business administration, I am driving innovation through low-code strategies to streamline operations and improve patient lives and outcomes. I have over 20 years of clinical trial and investigator-initiated study experiences, and I am eager to share many of my learnings from my journey in life. Currently, I am a Director for Process & Systems at Merck & Co., where I actively support the investigator-initiated studies and lead process improvements.

Leslie Sam
Leslie Sam & Associates LLC

Leslie Sam, President, Leslie Sam & Associates LLC

Leslie Sam, President of Leslie Sam and Associates, LLC, is a recognized leader in clinical trial research and quality management with over 30 years of experience. A Six Sigma Black Belt and a trusted partner to pharmaceutical companies and global health organizations, Leslie specializes in transforming clinical quality management systems to meet the evolving needs. Her innovative approach focuses on collaboration, change management, and risk-based strategies, ensuring regulatory compliance and operational excellence. Leslie’s industry contributions include co-developing a pioneering clinical quality management and issue management frameworks with TransCelerate and reviewing its global risk management guidelines. These efforts are examples of her commitment to driving industry standards forward. Leslie's expertise has been sought globally, including her leadership in applying Risk-Based Quality Management (RBQM) to a Mass Drug Administration, Decentralized Clinical Trial in Kenya, involving nearly 25,000 participants. As a speaker and consultant, she is highly regarded for her ability to guide organizations in adopting strategic, data-driven approaches to clinical operations.

Adam L Samson
Walgreens Co

Adam L Samson, Head Clinical Delivery Operations, Real World Evidence Clinical Trials, Walgreens Co

John Samuelsson
Pfizer

John Samuelsson, PhD, Senior Data Scientist, Artificial Intelligence & Machine Learning Quantitative & Digital Sciences, Pfizer Inc.

John is a senior data scientist at Pfizer, based in Cambridge, MA. Being a part of the operational AI group, his work focuses on enhancing operational efficiency and quality across the spectrum of drug development. Prior to joining Pfizer, John earned his PhD in computational medical engineering and medical physics from MIT and Harvard. He is passionate about teaching and mentoring students.

Fabian Sandoval
Emerson Clinical Research Institute

Fabian Sandoval, PhD, President & CEO, Emerson Clinical Research Institute

Dr. Fabian Sandoval, President & CEO, has over 30 years of bench to bedside research experience. His diversified research career has been in academia, healthcare systems and the public sector. He received his Bachelors of Science in molecular and cellular biology from Marymount University, and his Doctorate of Medicine from the Autonomous University of Guadalajara, School of Medicine. Dr. Sandoval is an international expert, key note speaker and presenter on the topic of Diversity and the rule it plays in clinical research among all cultures and races. Before opening the doors to Emerson Clinical Research Institute (ECRI) Dr. Sandoval’s research activities have included bench research at the National Institutes of Neurological Disorders and Stroke (NINDS) where he focused his work on Early Onset Alzheimer’s Disease, and Cretzfelt-Jakob Disease. At the NIHs’ Clinical Center conducting research in the outpatient Oncology unit, followed by his successful support of an NIH RO1 grant on preventing epilepsy in post-traumatic brain injury patients in adults and children, simultaneously run at the Washington Hospital Center, and Children’s National Medical Center. Dr. Sandoval served as the Supervisory Research Integrity & Compliance Officer in the Army Human Research Protections Office in the Office of the Army Surgeon General. Responsibilities included establishment, and oversight of Human Research Protection Programs across Army commands. His input has been instrumental in the review, development, and selection of protocols, in addition to education and training for resident and hospital faculty. Dr. Sandoval holds the following esteemed positions in the following community areas: • Four time Emmy Winner; Host of a one of kind weekly medical TV show “Tu Salud Tu Familia” (Your Family Your Health) • Medical Contributor for Telemundo, NBC, WZDC Washington D.C News, as well as Telemundo and Univision National. • Leadership Council member, Society for Clinical Research Sites (SCRS), • External Advisor to Genentech Roche • Renowned Invited Key Note speaker/presenter to multiple pharmaceutical and clinical trial organizations; on the topic of increasing minorities’ engagement, diversity education and participation, in clinical trials. Lastly he started the Emerson Community Clinic, in order to support un-insured patients across the DC metro area, as well as starting the Emerson Diversity Health Foundation, who’s mission is to educate patients and providers in the importance of participating in clinical research and accesses to care.

Kristopher Sarajian
Trialbee

The Bachelor: Kristopher Sarajian, Vice President, Marketing, Trialbee

Kris is a communicator, brand builder, and sales partner for clinical research technology. Currently VP of Marketing at Trialbee, Kris brings more than 20 years of experience to help build awareness of the emerging Patient Recruitment Platform (PRP) industry. Previously, Kris created and launched the Signant Health brand following the merger of Bracket and CRF Health, built the marketing team at DrugDev (an IQVIA company), and helped bring eCOA to life at PHT Corp. (now Clario). Kris and his wife Amanda live in Boston and love to travel with their young twin boys (and a crazy dog) who keep them busy, laughing, and happy.

Briana Sargent
Astellas

Briana Sargent, Associate Director, Biosample Management, Astellas

Briana Sargent is the Head of Biosample Management Operations at Astellas Pharma Global Development, where she has been instrumental since 2021 in building capabilities and overseeing the planning, initiation, and execution of biosample management activities. With a strong focus on operational excellence, Briana leads a dedicated team in implementing biosample management strategies that ensure high-quality delivery and standardization across projects. She holds a deep commitment to advancing the field of biosample management and is recognized for her leadership in this area. She brings with her nearly 20 years of industry experience having successfully managed complex global FiH Oncology trials, clinical pharmacology studies, and late stage/registrational studies. Briana has a proven track record of developing and mentoring staff and fostering a culture of excellence in both biosample management and clinical operations.

Anamika Sarkar
Regeneron Pharmaceuticals Inc

Anamika Sarkar, PhD, Intelligent Automation Lead, Global Development Solutions, Regeneron Pharmaceuticals, Inc.

Anamika joined Regeneron Pharma in 2017 and currently the Lead of Intelligent Automation group in Global Development Solutions. Prior to Regeneron she worked at Paragon Solutions (currently CGI) where she was strategy consultant in Clinical and Regulatory Operations spaces for both Biotechs and CROs. Some of her past experience in consulting includes as IT consulting role at Daiichi Sankyo Pharma and Domain Consultant for big pharma companies at Wipro Technologies. She is passionate about bringing right drug to right patient. Anamika is a PhD and MBA (Pharma Industry Management from Rutgers University), who started her scientific career as Computational Biologist, after her PhD, in the same field, from IITD (Indian Institute of Technology Delhi, India). She has worked as scientist both in academia (University of Washington Seattle, Memorial Sloan Kettering Cancer Center, Mt. Sinai School of Medicine) as well as pharma industry (Novartis, Inc.). She had been consulting as a bridge between business, technology, and science since 2012 'til she joined Regeneron in 2017.

Miruna Sasu
COTA Inc

Miruna Sasu, President and CEO, COTA, Inc.

Miruna Sasu currently serves as President and CEO at COTA Inc., an innovative oncology real-world data and solutions company. She is known for developing technology companies with a deep focus in understanding life science/drug development value drivers and aims to advance complex objectives that help lengthen and enhance human lives. In 2023, Miruna was awarded the MedTech Breakthrough award for ‘Best MedTech CEO’. In 2022, she was recognized as one of the top 25 women leaders in biotechnology for her trailblazing work in the invention and application of innovative next-generation solutions to solve tangible problems across a variety of healthcare industry sectors. In past roles, Miruna has led organizations at Johnson & Johnson and Bristol-Myers Squibb, where she revolutionized company-wide use of technology for minimizing cost of drug development, use of real-world data for faster drug development, and application of data sciences across enterprise drug portfolios from drug discovery all the way to commercialization and post-marketing. Miruna holds a Ph.D. in biology and statistics from Penn State University and an MBA from Temple University.

Scott Sawicki
SJS Consultative, LLC

Scott Sawicki, SJS Consultative LLC, Consultant

He has 30 years' career experience having predominantly worked in senior positions for large multi-national corporations, mostly as an R&D Sourcing professional. His varied industry experience with both sponsors and CROs includes R&D Sourcing & Procurement, Supplier Relationship Management, and Business Development, with sponsor companies ADC Therapeutics, Adare Pharmaceuticals, Novartis Pharmaceuticals, Aventis, and CROs Crovelis, Syneos Health, and Covance.

Kenna W Sayers
Merck

Kenna Sayers, Director, Vendor Management, Integrated Biomarker Operations, Merck

Currently responsible for a team of biomarker operations vendor managers at Merck, working primarily within the oncology space. Previously a 22 year professional at Q2 Solutions, and formerly Quest Diagnostics Central laboratories, in various roles from Global team manager in project management, global key account director, customer liaison/QA manager specializing in anatomic pathology operations, as well as project manager in a variety of therapeutic area, but primarily oncology.

Richard A Scaife
VectivBio AG

Richard Scaife, Head, Outsourcing, Windward Bio AG

Richard is currently employed by VectivBio, a Swiss Biotech focused on rare disease treatments, having originally joined the company when it was Therachon before acquisition by Pfizer and its subsequent spinout. Originally working as an Intensive Care Unit Nurse in the UK and Saudi Arabia, Richard managed a British Aerospace Medical Centre in Saudi, returning to the UK in 1990 to join Ciba-Geigy in Pharma sales roles, Sales Management, and ultimately CNS portfolio Brand Management. He moved to the CRO sector in 1997 with Covance, then Fisher Clinical Services in Health Economics/Reimbursement and Marketing roles, then leading a BD and Proposals unit at Quintiles before joining Daiichi-Sankyo in 2005. The following thirteen years in clinical development outsourcing (moving to Mitsubishi Tanabe Pharma in 2009 to become Global Outsourcing Lead) have included EU and global level achievements ranging from creating a new outsourcing and contracts function, negotiating global CRO agreements whilst building long-term, effective, CRO working relationships. In January 2017, Richard set up an outsourcing Consultancy OM360Ltd working with with financial, pharma and biotech companies on a broad range of clinical outsourcing projects until going FTE in 2021. Richard has been a member of PCMG, the Pharma and Biotech Outsourcing association, since 2006. He was Committee Chair from 2013 -21, awarded the PCMG Lifetime Achievement award in 2022 and continues to support PCMG activities as Committee Member and Director.

Peter Schaeffer
GSK

Peter Schaeffer, Digital & Process Optimization Leader, Digital Analytics & Performance, GSK

Pete Schaeffer has worked in the pharmaceutical industry for over 20 years in both the Pre-Clinical and Clinical areas. In his current role of Digital Operations and Process Optimization at GSK, Pete is focused on finding plus implementing digital health solutions supporting patients, sites, and sponsors on clinical trials. As a member of Transcelerate he has worked on both the Patient Technology and Patient Experience workstreams aiming to improve participant experience on trials.

Doug Schantz
Asklepios BioPharmaceutical Inc

Doug A. Schantz, Senior Vice President, Clinical Operations, Asklepios BioPharmaceutical, Inc.

Drug development executive with over 30 years of experience leading people and projects in a wide variety of positions within drug development including clinical project management, study management, data management, regulatory submission coordination and international clinical trials.

Steve Schlachter
Quest Diagnostics Inc

Steve Schlachter, Dir Product Portfolio, Healthcare Analytics Solutions, Quest Diagnostics Inc

Steve is the Director of Product Portfolio in the Healthcare Analytic Solutions group at Quest Diagnostics. He has been in healthcare for over 20 years bringing products and services to life by blending the balance of customer needs with the ever-evolving capabilities of technology. He currently focuses on developing data backed actionable insights to address big challenges across life sciences. Steve has Bachelor of Business Administration from the University of Cincinnati and MBA from Xavier University. His past experiences include maturing an EHR product thru the initial Meaningful Use certification, as well as, developing the first iPhone app for lab and prescription ordering.

Eirini Schlosser
Dyania Health

Eirini Schlosser, Founder & CEO, Dyania Health

Eirini is a serial tech entrepreneur with over a decade of experience in building NLP applications in addition to her years in M&A at Morgan Stanley and early foundation in biochemistry. She holds degrees from the Ohio State University and London Business school as well as professional certifications from MIT in machine learning and AI. Eirini is currently the Founder and CEO of Dyania Health, a fast-growing healthcare AI company that trained Synapsis AI, a medically specialized Large Language Model (LLM) to automatically and accurately read, understand, and deduce clinical conclusions from electronic medical records for use in clinical research, quality, and reporting. Eirini's mission has been to replace manual bottlenecks in healthcare and life sciences, which Synapsis AI has achieved at higher accuracy than individual human clinicians in institutions such as Cleveland Clinic. Her multidisciplinary team includes experts from prestigious institutions like NYU Langone, Memorial Sloan Kettering, UCLA Health, Amazon, BloombergAI, Flatiron Health, and McKinsey. Together they bridge the gap between medicine, engineering, and applied AI research. This unique blend of experiences is what powers Dyania Health on its mission to revolutionize the healthcare and life sciences industries.

Chris Schneiderman
AbbVie Inc

Chris Schneiderman, MPH, Director, Global Epidemiology, AbbVie, Inc.

Chris Schneiderman is an epidemiologist, earning his Master's degree in Public Health from the University of Illinois. He currently serves as the Director of Partnerships & Evidence Platforms at AbbVie Pharmaceuticals where he has spent nearly two decades in roles of increasing responsibility. Chris provides epidemiologic expertise for pipeline and marketed products across diverse therapeutic areas.

Shane C Senior
Crosstree Capital Partners Inc

Shane C. Senior, Managing Director & Owner, Crosstree Capital Partners, Inc.

Prior to co-founding Crosstree, Mr. Senior was Vice President of Corporate Finance at William R. Hough & Co. where he provided mergers and acquisition and equity financing advisory services to middle-market companies. Prior to joining William R. Hough & Co., Mr. Senior spent six years with Smith Barney's middle-market investment banking subsidiary, specializing in sell-side mergers and acquisitions and change-in-control growth recapitalizations. Mr. Senior has advised more than 150 companies and has managed or participated in more than 30 successful transactions. Mr. Senior is a graduate of the University of Florida where he received a B.S. in Business. Mr. Senior is a Chartered Financial Analyst charter holder and member of the Chartered Financial Analyst Institute. Specialties: Mergers and Acquisitions, Venture Capital Advisory for Pharma Outsourcing Companies.

Christine Senn
Advarra

Christine Senn, Senior Vice President, Site-Sponsor Innovation, Advarra

Christine Senn, PhD is the SVP of Site-Sponsor Innovation at Advarra, a global company offering services and technology solutions to safeguard trial participants and enable collaboration across all industry domains. She has worked in clinical research since 2005, starting at the University of Vermont College of Medicine then spent 16 years building the site network that became Centricity Research, where she served in various business roles across strategic growth initiatives, project planning and execution, and continuous process improvement. Senn has a PhD in psychology and master’s degrees in clinical psychology and advertising and public relations. She was the 2023 Chair of the Association of Clinical Research Professionals (ACRP), is an ACRP Fellow (FACRP), and is double certified as a Certified Clinical Research Coordinator (CCRC) and Certified Principal Investigator (CPI).

Craig Serra
Flatiron Health Inc

Craig Serra, Head of Clinical Research , Scientific and Technical Engagement, Flatiron Health Inc

Craig Serra is the Head, Clinical Research Scientific and Technical Engagement for Flatiron’s Clinical Research business unit, where he is accountable for shaping solutions using Flatiron’s suite of clinical research data and technology. Craig was previously the Global Head, Strategy and Innovation for Data Operations at Novartis and has held senior leadership roles at IQVIA and Pfizer, as well as served in a multi-faceted executive role at a niche CRO (DSP Clinical). Craig is recognized industry leader and was named Pharmaceutical Executive's "2020 Emerging Pharma Leaders" and PharmaVOICE “100 Most Inspiring People” for both 2017 and 2020. Craig earned a BA in Psychology from Rutgers University, an MBA in Management and an MS in Information Systems from Fordham University, and an MS in Pharmacology and Toxicology from Michigan State University.

Melissa Sesi
Merck & Co Inc

Melissa Sesi, MBA, Associate Director, R&D Sourcing & Procurement, Merck & Co., Inc.

Melissa Sesi has been working for Merck & Co., Inc. for over 17 years. She began her career at Merck as a Global Procurement intern supporting Supplier Diversity. She then joined full-time and has had roles of increasing responsibility within procurement categories including fleet, travel, card and meetings, HR External Workforce, and Functional Clinical Outsourcing. She was also the lead for Strategic Programs where she was Chief of Staff to the Vice President of Indirect Sourcing & Operations. Melissa’s current role is Associate Director of Clinical Services in Research and Development Sourcing and Procurement and supports clinical trials for MRL. Melissa holds a Bachelor’s degree in Supply Chain Management from Michigan State University and an MBA from La Salle University.

Sema Sgaier
Surgo Health

Sema Sgaier, CEO & Co Founder, Surgo Health

Dr. Sema Sgaier, CEO and Co-Founder, Surgo Health Sema Sgaier, Ph.D., is the CEO and Co-Founder of Surgo Health, a healthcare technology company whose mission is to personalize health to improve outcomes and reduce inequities. Sema is a serial entrepreneur with close to 20 years of experience in healthcare. She co-founded and led Surgo Foundation and Surgo Ventures, where she led the development of analytic products that solve health problems with greater precision. She was Initiative Lead at the Bill & Melinda Gates Foundation, where she brought innovations in data, consumer insights, and product introduction into large-scale health programs globally. She has over 60 publications and is a frequent OpEd contributor to The New York Times and prestigious media outlets. She is an adjunct assistant professor at the University of Washington. She completed her fellowship in Genomics at Harvard University, Ph.D. in Neuroscience from New York University, and M.A. in Neuroscience from Brown University. Sema is a member of the Board of Directors of the United States of Care. She was selected as a rising talent by the Women's Forum for Economy and Society.

Siddharth H Shah
BeiGene

Siddharth Shah, Executive Director, Product Management, Data Science and Digital Innovation, BeiGene

Siddharth is an Executive Director, Product Management in the data science and digital innovation at BeiGene. With 21 years of experience, he is passionate about digital led solutions to make affordable treatments available to patients in time.

Paresh Shah
Clinilink Health

Paresh Shah, Founder and CEO, Clinilink Health

Samantha Shaw
TriNetX

Samantha Shaw, Director, Product Management, TriNetX

Samantha Shaw, MHA: Director, Product Management - I’ve worked at TriNetX for 5 years supporting different initiatives including EHR to EDC, linking EHR and claims, oncology, RWD/RWE datasets to support protocol feasibility/optimization along with site outreach. I have almost 15 years of experience in the healthcare space ranging from clinical trial EDC development, to EHR implementation and finally to software development. My passion is in creating solutions for the “big” healthcare problems to ultimately impact better, more informed patient care and patient access.

Katie Shaw
IQVIA

Katie Shaw, Senior Director Patient Recruitment & Enablement, Global Patient and Site Services, IQVIA

Jie Shen
AbbVie Inc

Jie Shen, PhD, Research Fellow, Digital Science, AbbVie, Inc.

Jie Shen, PhD is an innovative leader with a track record of building innovative solutions to address various drug discovery and medicine development problems. He is a Research Fellow and Director of Digital Science at AbbVie, leading the digital health technology development, validation, and digital data analytics. Prior to his current role, Jie has led data science and advanced analytics capability development and execution for precision medicine, clinical trial optimization, digital health, and drug discovery at AbbVie and Eli Lilly and Company. Jie has published 50+ papers with more than 6000 citations.

Ming Shen
Deloitte Consulting LLP

Ming Shen, Managing Director, Deloitte Consulting LLP

Deborah A Shepard
Pfizer Inc

Deborah Shepard, PhD, Director, Group Lead-Biomarkers Clinical Data Acquisition, Pfizer Inc.

Deborah Shepard is Director, Group Lead-Biomarkers Data Acquisition in Clinical Data Sciences at Pfizer. She oversees development of biomarker data transfer specifications across the Pfizer portfolio to ensure timely, standardized, and high-quality transfer of data from laboratory partners. She is a subject matter expert for biomarker data standards and is a CDISC volunteer. She joined Pfizer Clinical Data Sciences in 2023 from the Pfizer Oncology Clinical Assay Group, where she had provided scientific and technical oversight of laboratory partners involved in clinical trial biomarker specimen analyses as a Biomarker Clinical Assay Lead. Prior to joining Pfizer, she held positions of increasing responsibility in project management, lab management, and data management at Quintiles. Deborah holds a PhD in biochemistry from the University of Wisconsin at Madison.

Heather H Shih
BioNTech US Inc.

Heather Shih, PhD, MBA, Senior Director Biomarker Operations, Global Clinical Development Operations, BioNTech US, Inc.

Heather Shih is currently Senior Director Biomarker Operations in Global Clinical Devleopment Operations at BioNTech US Inc. Heather joined BioNTech in 2024 to lead a global biomarker operations team to support the company's entire clinical pipeline consisted of Phase I through III global studies. Prior to BioNTech, Heather held a number of leadership positions at Takeda Pharmaceuticals, Bill & Melinda Gates Medical Research Institute, EMD Serono (a US subsidiary of Merck KGaA), and Pfizer. Heather has 22 years of experience in pharmaceutical and biotech industry, with a broad spectrum of experience in drug discovery and development. She was a member of the clinical team at EMD Serono that brought the anti-PD-L1 therapeutic antibody Avelumab (BAVANCIO) to the market. During her scientific career, she authored 22 publications and 2 book chapters. Heather holds a BS in Chemistry from the University of Massachusetts at Lowell, a PhD in Biochemistry from Tufts University School of Medicine, and an MBA from the University of Massachusetts at Lowell.

Danielle (Dee-Dee) Shiller
AbbVie

Dee-Dee Shiller, DO, Medical Director, AbbVie, Inc.

Dr. Shiller was the Chief of Gynecology at Good Samaritan Hospital in Baltimore and then the founding director of the Women's Wellness Center at Northwest Hospital. She was previously a practicing gynecologist who specialized in pelvic and sexual pain and minimally invasive surgery. In 2009, she became the first robotic surgeon at her hospital, and then in 2019 was the first surgeon in Maryland to offer Acessa, an innovative laparoscopic treatment for fibroids. In 2015, Dee-Dee included in her practice pharmaceutical medicine and began participating in Phase 2 and 3 clinical trials as principal investigator. She was involved in studies that helped to discover new products for contraception, pelvic pain, fibroids, and hot flashes. In 2021, Dee-Dee joined AbbVie as a medical director and principal investigator where she oversees the direction, planning, execution, and interpretation of clinical trials and research activities for Phase 1 studies at the AbbVie Clinical Pharmacology Research Unit. In addition, she participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. She is also responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for complying with these. In addition to routine responsibilities, she has volunteered to be the physician development program coordinator, where she has developed syllabus, education plan, and training schedule for physicians considering embarking in full-time pharma careers. She is also an active member of the international project with the Institute of Healthcare Improvement (IHI) Conception project. The purpose of the project is to provide documentation to describe and define the core data elements for optimal assessment of in-utero exposures to medicines.

Akiko Shimamura
TriNetX, LLC

Akiko Shimamura, Senior Vice President, Trial Design & Optimization, Trial Design & Optimization, TriNetX, LLC

Akiko Shimamura is an experienced leader in the life sciences industry, having held a range of senior roles. As Senior Vice President at TriNetX she is responsible for developing products and managing teams focused on trial design and optimization. Her wealth of experience and knowledge make her an invaluable asset to TriNetX.

As the former Vice President of Medidata, she has overseen products across RWE, Commercial Analytics, and tokenization. Akiko has a wealth of experience in consulting having previously worked at McKinsey & Company, where she provided advice to companies on life sciences and analytics.

Tricha Shivas
Foundation for Sarcoidosis Research

Tricha Shivas, Chief of Staff & Strategy, Foundation for Sarcoidosis Research

Tricha Shivas joined the Foundation for Sarcoidosis Research (FSR) in December of 2020. As the Chief of Staff and Strategy, she works with various stakeholders including individuals living with sarcoidosis and their loved ones, academic researchers, clinicians, industry partners, regulators, and policy-makers to advance FSR’s mission to support patients and accelerate sarcoidosis research in the search for a cure. Tricha is a collaborative and strategic leader with over 15 years of non-profit results-driven experience. Tricha has dedicated her career to improving the lives of those with complex chronic illness and rare diseases. Tricha has served patients in her roles with the Washington Regional Transplant Community, The Muscular Dystrophy Association (MDA), The National Quality Forum (NQF), WomenHeart-the National Coalition for Women with Heart Disease-and The Myositis Association (TMA). In these roles, she helped build comprehensive patient engagement and awareness programming, developed robust diversity, inclusion, and equity programming, worked with the NIH, FDA, and industry to expand therapeutic pipelines and to increase patient centricity in drug development, and worked with the CDC, HHS, regulators, and state and federal legislators to improve national health policy strategies, patient access to care, and healthcare quality measures.

Wanda Shoer
Sanofi

Wanda Shoer, Chief Learning Officer, Sanofi

Wanda Shoer is currently serving as the Chief Learning Officer at Sanofi, bringing over 20 years of experience. Prior to joining Sanofi, Wanda held various leadership positions across multiple functions, including Human Resources, IT, and Talent Development. During her tenure at Johnson & Johnson spanning over a decade, she led strategic operations in Research & Development, Drug Safety, and Talent Management. Before J&J, Wanda accumulated a decade of experience in both in-house and consulting roles focused on organizational change and process improvement within the pharmaceutical and investment banking sectors. Wanda earned her BA in Italian Studies and Economics from Wheaton College and an MBA from Simmons University. In her leisure time, she enjoys reading, fitness, and spending quality moments with her family. Active in the Latinx community, Wanda contributes her time to various organizations, supporting community building, mentoring, and educational initiative.

Noble Shore
Emmes

Noble Shore, VP Technology Strategy & Product Adoption, Customer Success, Emmes

Noble Shore has been leading efforts to develop and integrate innovative technologies in clinical research for nearly 20 years. Noble has led groundbreaking projects including: (a) one of the first RBM/EDC integrations on the market first used in the H1N1 pandemic response, (b) an automation engine for SDTM transformations used in over 200 studies, (c) an eClinical platform that can capture traditional and real-world data in a single database. Today, Noble is focused on technology strategies for acceleration of clinical trial timelines. Noble holds an B.S. in Computer Science from Carnegie Mellon University

Jonathan Shough
Parexel Intl

Jonathan Shough, CIO, PAREXEL International

Jonathan E. Shough is Chief Information Officer for Parexel. In this role he provides global leadership for the company’s Data and Information Technology (IT) strategic plan, including the development of innovative technologies and solutions to accelerate drug development initiatives in a constantly evolving and growing clinical trial landscape. Jonathan brings more than 30 years of experience in FinTech, Telecommunications, and Data & Technology with deep expertise in both the development and commercialization of innovative, award-winning technology solutions. Jonathan has been an innovator in the Pharmaceutical Sciences technology arena bringing hyperautomation (AI, RPA, and related technologies) including ground-breaking analytics and clinical operations technologies to the forefront of the industry.

Vimi A Shukkoor
Eli Lilly & Co

Vimi A Shukkoor, Advisor, Medical Quality Systems, Eli Lilly & Co

No bio available.

Pankaj Shukla
Clario

Pankaj Shukla, Senior Director, Strategic Accounts, Clario

I have been associated with the life sciences industry for 20+ years with strengths in both strategic account management and industry solutions practice development. Developing strong relationships with customers and helping them solve complex business problems has been key to my success.

Elena Sinclair
FlexPoint Bio

Elena "Ella" Sinclair, President and Founder, FlexPoint Bio

As a founder of FlexPoint Bio, Ella leads the company's efforts to optimize clinical trials through strategic biomarker selection, biospecimen management, and tactical clinical outsourcing. Her company is leading the efforts for thoughtful AI implementation in the clinical development space. Before FlexPoint Bio, she spearheaded transformative initiatives, including establishing an oncology biorepository in an academic center and developing and leading the Biomarker and Biospecimen Division at a cell and gene therapy company. She has a background in integrative biology and neuroscience from the University of Texas, business administration and project management from Louisiana State University, and applied data science and AI implementation from MIT.

Meenakshi Sinha
PwC

Meenakshi Sinha, Pharmaceutical and Life Sciences, PwC

Meenakshi specializes in R&D automation, product design, and agile delivery using emerging technologies to help businesses transform processes and enhance efficiency. She holds a Master’s in Information System Management from Carnegie Mellon University, a Bachelor’s in Electrical Engineering from Vellore Institute of Technology, India, and 10+ years of experience in the Pharma & Life Sciences industry.

Kyle Skillins
Regeneron

Kyle Skillins, Associate Director, Clinical Drug Supply & Logistics, Regeneron Pharmaceuticals, Inc.

Driver of change towards efficiency and alignment through speed to actionable data and technology supported processes.

Anne Smith
Regeneron Pharmaceuticals Inc

Anne Smith, Director, Central Monitoring, Regeneron Pharmaceuticals, Inc.

Anne is the Head of the Central Monitoring Team at Regeneron where she is responsible for both central monitors and data analysts, along with leading an RBQM implementation project with-in clinical development. She has been at Regeneron for 5 years. Anne has worked on both the Pharma and CRO side of the industry in RBQM, project management and data management roles in her career, often with a focus on technology implementation of some kind. Anne has a bachelors degree in Nursing from Indiana University.

Kelly L Smith
Viracta Therapeutics Inc

Kelly L. Smith, AD, Operations, Viracta Therapeutics, Inc.

With over 20 years of buy and sell experience in the industry, I have helped lead teams and companies to attain better KPIs, cost savings, and delivery of study results. In being able to see outside of the standard process(es), I have been able to be creative in my negotiations, assure a specific spend, and avoid downstream delivery issues.

Jay B Smith
TransPerfect

Jay Smith, Head, Product & Trial Interactive, TransPerfect

William B Smith
Alliance For Multispecialty Research LLC

William Smith, CEO, Alliance for Multispecialty Research

Dr. William Smith is the Founder, President, and Principal Investigator of clinics formerly known as VRG and NOCCR, the AMR centers in Knoxville, TN, and New Orleans, LA. He is also one of the original founders of Alliance for Multispecialty Research, LLC (AMR). Dr. Smith is board certified in Internal Medicine, Critical Care Medicine, Nephrology and Cardiology. He has been involved in more than 2,000 clinical trials over the past 40 years. He is a frequent lecturer at industry conferences and author and publishes extensively.

Delmonize Smith
Acclinate

Delmonize Smith, PhD, Co-Founder & CEO, Acclinate

Dr. Del Smith is the CEO and Co-founder of Acclinate, a company leveraging sustained engagement and AI-driven insights to empower communities to take actions for better health. His experience in business, healthcare, IT, government, and academia drives his unique approach to health equity. Del has pulished extensivley on the topics of entrepreneurship and minority business growth. A U.S. Army veteran, he holds a Ph.D. in Management from the University of Alabama.

John Smutko
GSK

John Smutko, Head of Specimen Management Oncology, GSK

BioPharma professional with a strong background in Genomics, Technical Support, Training, and Clinical Biomarker Operations. Currently Director of Oncology Scientific Operations at GSK, 30 years of experience in BioPharma from the Bench to Bioinformatics and Distributed Computing, to Assay and Reagent Commercial Teams and now Clinical Trials.

Walker Smythe
Keyrus

Walker Smythe, Life Sciences Practice Lead, Keyrus

Walker Smythe is a Senior Manager with Keyrus EPM Americas. Walker has over 10 years of consulting experience in the Software and SPM space. He has worked with various industries such as Medical Device, High Technology, Pharmaceuticals, Cyber-Security, and Financial services to implement financial planning and analysis, gross-to-net, clinical trial forecasting, demand planning and sales planning solutions. Walker has successfully implemented and consulted on over 40 different Anaplan Projects. Walker is also a certified Anaplan Model Builder, Anaplan Solutions Architect, and Master Anaplanner.

Andy Smythe
Keyrus

Andy Smythe, Global VP, Keyrus

No bio available.

Debora S Sobral
ClinBiz

Debora Sobral, Director, Site Budget Management, Kyowa Kirin

Débora S. Araujo has over a decade of experience in the pharmaceutical industry working and consulting for Fortune 500 companies. During her time in this industry her special focus has been on the business aspects of clinical trials including: clinical contracting and financial management, clinical outsourcing and CRO/vendor management, global clinical trial budgeting and forecasting, clinical financial analytics and metrics/KPIs, site budget development and negotiations, Fair Market Value (FMV) and global investigator site payments. She has also utilized her expertise and knowledge to drive practical change in this industry via thought leadership material, conference presentations, and consulting engagements. Débora’s passion for driving practical change in the industry led her to launch ClinBiz (www.clinbiz.com), an online platform with a dedicated YouTube channel, podcast, blog, and much more where clinical research professionals can stay connected and updated on the latest topics, trends, and technologies related to the business aspects of clinical trials. Débora has also recently published a book on clinical trial agreement negotiations named ‘The Four Villains of Clinical Trial Agreement Delays and How To Defeat Them’ which quickly became Amazon’s #1 New Release in the pharmaceutical and biotechnology category.

Erik Sokolowski
Alnylam Pharmaceuticals

Erik Sokolowski, Senior Director, Global Trial Optimization, Alnylam Pharmaceuticals

Erik Sokolowski is an innovative and influential Clinical Operations leader with 20+ years of experience in the pharmaceutical industry. Erik is currently a Senior Director of Global Trial Optimization at Alnylam Pharmaceuticals, focused on Study Start-up and Patient Recruitment and Retention across multiple therapeutic programs. Throughout his career, Erik has achieved positions of increasing responsibility as a result of driving productivity in pursuit of business objectives, identification for process improvement and contributing to team and organizational goals. Erik has held prior roles in Site Monitoring, Global Trial Management, Patient Advocacy, and Early Access Programs. Erik prides himself on fostering strong working relationships and building cohesive teams. He thrives on collaborating with cross-functional teams and key stakeholders to align on trial objectives, strategies, and timelines to maximize efficiency, effectiveness, and acceleration in Alnylam’s operational execution of clinical trials. Erik is committed to connecting data and expertise to inform protocol design to lessen the burden on sites and patients, with a strong focus on diversity within the clinical trials.

Dawn Sorenson
Daiichi Sankyo, Inc

Dawn Sorenson, Director, IRT Center of Excellence, Innovation Management, CSP & O, Daiichi Sankyo, Inc.

Dawn is a clinical systems and device professional with 20 years’ experience across numerous service spaces such as IRT, eConsent, EDC, eCOA, wearables, and remote source data verification. She started out her professional career at Amgen working with IRT and eCOA. She then gained experience with other services spaces at Theravance BioPharma. She has since moved to Daiichi Sankyo, Inc. concentrating in IRT and eConsent.

Sean Soth
Society for Clinical Research Sites (SCRS)

Sean Soth, Senior Vice President, Strategy and Global Business Partnerships, SCRS

Mr. Soth helped to launch the Society for Clinical Research Sites to unify and amplify the voice of clinical research sites globally. Inspired by SCRS Founder Christine Pierre, Sean works to improve collaboration within the clinical research ecosystem while focusing on site success. With over nearly 2 decades in life sciences, Sean is a regular speaker, panelist and host, leading the SCRS Global Impact Partner program, Sites NOW, and several Site Solution Summit programs.

Matt Sowards
Scout

Matt Sowards, Chief Innovation Officer, Executive Leadership, Scout

Matt joined Scout in 2013 and is the Chief Innovation Officer, overseeing sales and technology. With 15 years of experience across a range of industries, he excels in enhancing technology, operations, and finances. Matt's strategic management of finance and partnerships, combined with his commitment to leveraging technology, ensures Scout remains agile in addressing the dynamic needs of clients, sites, and patients.

Nick Spittal
Velocity Clinical Research

Nick Spittal, COO, Exec, Velocity Clinical Research

Mark Springer
Regeneron

Mark Springer, Director, Global Trial Optimization, Regeneron

Mark brings over 25 years of experience in new drug development and has been with Regeneron since 2019. He is a recognized leader in data-driven strategic feasibility, country and site identification, and enrollment planning. Mark excels in driving change by leveraging speed to actionable data and implementing technology-enabled processes to optimize outcomes.

Sam Srivastava
WCG

Sam Srivastava, CEO, WCG

Sam K. Srivastava is the chief executive officer of WCG, a global leader of clintech solutions that improve the quality and efficiency of clinical research conducted in over 130 countries and enables biopharma, CROs, and institutions to accelerate the delivery of new treatments and therapies to patients. He is a transformative leader with a proven track record of driving growth and innovation in healthcare. Prior to WCG, Sam served as chief executive officer of NeueHealth, a tech-enabled, risk bearing care delivery company with over 1M consumers across 17 states through owned clinics, partnered affiliates and high performing value-based networks. Sam was also chief executive officer of Magellan Healthcare, a leading behavioral, specialty and pharmacy management company serving 50M consumers worldwide. During his tenure, the company doubled in size by launching the nation’s first health plan for the seriously mentally ill, developing digital therapeutics and advanced illness programs. Prior to that, he worked at Cigna Healthcare as president of the national employer and Medicare businesses. He also led US strategy and development, that included the acquisition of HealthSpring and the launch of Cigna Ventures. Sam has held executive positions at UnitedHealth Group and HealthNet (Centene). He also served as a management consultant in the US and Europe, developing integrated delivery systems for providers, insurers, and governments. Sam serves as the Yale School of Public Health advisory council chair and Recovery Centers of America board director. He is a frequent national speaker and has testified to Congress regarding the opioid crisis aiding in the passage of the bipartisan Support Act. Sam graduated from Kent State University with Bachelor of Arts in medical science and humanities and completed graduate work at Yale University in health care management.

Lindsay Stahl
Citeline

Lindsay Stahl, VP, Global Head of PE&R, Citeline

As the VP, Global Head of PE&R, Lindsay leads Citeline's Patient Engagement and Recruitment division and is responsible for helping guide and grow our Patient Engagement and Recruitment solutions. She has over 15 years in scientific and clinical research & development, and real-world data strategy and solutioning for clinical investigation. Lindsay holds an MS in Epidemiology from Columbia University, an MA in Biopsychology from the City University of New York, Hunter, and a BA in Psychology from the University of Rhode Island.

Kristin Stallcup
Takeda

Kristin Stallcup, MS, Director, RBQM Operations, Takeda

Kristin leads the dynamic RBQM Operations team at Takeda, drawing upon her extensive experience in clinical trials operations and technology. For Kristin, the most rewarding aspect of her role is spearheading significant quality enhancements and fostering cross-functional collaboration through RBQM methodology. Beyond her professional life, Kristin and her family like traveling, kayaking, playing escape games, and pickleball together.

Shivi Stanley
Astellas Pharma US Inc

Shivi Stanley, Director, Study Optimization, Recruitment and Diversity , Astellas Pharma US Inc

Shivi Stanley is a Director/Portfolio Lead in Astellas’ Study Optimization, Recruitment and Diversity department. She has 20 years of clinical research experience at academic medical centers, community-based health systems and industry. At Astellas, she leads clinical operation teams in ensuring trials are designed to optimize patient and site experience while balancing the demands of the portfolio. Shivi has a BS in Human Kinetics from the University of Guelph and a MS in Health and Movement Sciences from Virginia Commonwealth University.

Nicole Stansbury
Premier Research

Nicole Stansbury, Senior Vice President, Global Clinical Operations, Premier Research; Co-Lead, Risk-Based Monitoring Working Group, Association of Clinical Research Organizations (ACRO)

Nicole Stansbury, Senior Vice President, Global Clinical Operations, is responsible for oversight of clinical operations which includes clinical strategy and delivery, study start up, central monitoring, and site management and risk-based monitoring at Premier Research. She leverages an innovative, data-driven approach and more than 25 years of industry experience to help sponsors address the rapidly evolving demands of the clinical development industry. In her role, Stansbury is focused on finding ways to simplify process and improve technology adoption to decrease the time, cost, complexity, and risk of delivering clinical research. Prior to joining Premier Research, Stansbury held various CRO leadership positions where she was instrumental in the strategic implementation of risk-based monitoring, central monitoring and continuous improvement of clinical operations processes. Stansbury has been co-lead for the Association of Clinical Research Organizations Risk-Based Monitoring (ACRO RBM) Working Group working with TransCelerate and the FDA since 2014. She holds a Bachelor of Science from Texas A&M and a Lean Six Sigma - Yellow Belt certification.

Brad Stefanovic
Simulations Plus

Brad Stefanovic, Simulations Plus

Brad Stefanovic is a seasoned Life Sciences professional with a wealth of experience spanning over 17 years in the domains of Clinical Trial management, clinical technology implementation, vendor management, business operations, development, and strategy. Before joining SLP, he held the esteemed position of Head of Clinical Operations (Vice President) at Ocugen, a pioneering biotech company specializing in gene and cell therapies for Ophthalmology, Orthopedics, and Vaccines. He has also previously held the role of Vice President, Clinical Operations at Aura Biosciences, another prominent biotech firm, where he led a team focused on utilizing Virus Like particles for the treatment of Ocular Oncology and Solid Tumor indications. His leadership extends to various biologics areas, including his role as Senior Director of Clinical Operations and program lead of the Clinical Team for the Injectable Biologics, Orthopedic, Pain Management, and Sports Medicine program at TissueTech Inc. (Now Bio-Tissue), a world-leading Regenerative Medicine company.

His expertise in Life Sciences is the result of his multifaceted career, which encompasses consulting, academic, non-profit, and commercial ventures, including overseeing outsourced full-service clinical trial management activities for large multinational medical companies. Brad is widely recognized as an outstanding scientific communicator in the life sciences industry, with a proven track record of successfully leading large teams through various phases of the medical product lifecycle. His international experience is noteworthy, having relocated from Australia to the USA 10 years ago and effectively managing multiple international clinical programs. In 2022, he earned the prestigious title of alumni of the year at his former institution, the University of the Sunshine Coast, in recognition of his exceptional foresight, strategic engagement, and innovative leadership in the Biotechnology field.

Brad brings a unique blend of clinical trial expertise, safety management, scientific and technology consulting and possesses strong team-working, leadership, communication skills and attention to detail. He is enthusiastic and excited about furthering the cause of clinical research.

Rene Stephens
Danforth Advisors

Rene Stephens, Managing Director, CBO, Danforth Advisors

Réne Stephens is a biopharmaceutical research and development industry consultant with over 25 years of business operations, outsourcing, and relationship management experience. He has worked within large and small pharma/biotech, CRO, SMO, medical imaging, and academic CRO companies, fulfilling roles ranging from individual contributor to global functional head. Réne understands the critical path of development and has a wealth of experience in outsourcing/procurement strategies and practices; vendor oversight, governance, and strategic relationship management; budget and contract negotiations (vendor and site level); clinical operations and finance management; process development and improvement; and technology solutions. Réne holds a BA in Corporate & Organizational Communications (WKU), and an MSHS in Clinical Research Administration (GWU). He has been providing outsourcing and relationship management consulting services to various R&D companies since 2018. While at Astellas Pharma Global Development as Executive Director and global head of Contracts & Outsourcing, Réne also served as the Global Procurement Lead for TransCelerate Biopharma, Inc., acting on behalf of and supporting the 20 biopharmaceutical company consortium for vendor selection, negotiation, and governance. He is the standing moderator for the quarterly Linking Leaders Outsourcing Roundtable meeting, where current issues are discussed among development outsourcing heads; and is a regular speaker at conferences and symposia on business operations topics related to drug development, outsourcing, and vendor negotiation, management, and oversight/governance.

Kevin Stephenson
Karyopharm Therapeutics Inc

Kevin Stephenson, MBA, MS, Executive Director, Data Management, Karyopharm Therapeutics

Kevin Stephenson is Executive Director and Head of Data Management at Karyopharm Therapeutics with over 20 years of experience in various areas of data management. He is responsible for leading a data management team focused on delivering high quality deliverables and being strong, collaborative partners within the organization. Kevin has extensive knowledge and expertise in data management operations, vendor management, EDC systems, metrics and analytics, DM quality, and risk-based data management. He holds a B.S. in both Physics and Aeronautical Engineering, as well as a M.S. in Physics from the University of Connecticut.

David Stevenson
Merck

Dave Stevenson, Managing Director, Merck Global Health Innovation Fund

Dave Stevenson is COO & Managing Director and a founding partner of Merck GHI Fund since inception in 2010. GHI Fund invests venture capital in start-up companies that improve health care as well as those that improve pharmaceutical operations specifically. Dave is responsible for identifying opportunities in clinical trials and also manages the GHI portfolio and operations. Dave brings more than 25 years of healthcare strategy and operations expertise to the GHI team. Dave started his career with Novartis where he built their first clinical trial management system. He holds an MBA from Vanderbilt University and a BA from Washington University.

Jean Stimola-Sposaro
Bristol Myers Squibb Co

Jean Stimola-Sposaro, Director, Global Clinical Trial Industry Collaborations, Global Drug Development & Global Development Operations, Bristol Myers Squibb Co.

Master of Jurisprudence in Healthcare Pharmaceutical Law & Policy. Patient advocate, educator, and care provider with over 30 years of experience in Pharmaceutical R&D and healthcare. Focused on ensuring bioethical best practices, compliance with ICH, and privacy laws to improve global public health equity and scientific innovation. Facilitating inclusive multi-stakeholder collaboration to accelerate the development of high-quality, safe, and effective treatments to address the unmet health needs of patients by enabling the development of solutions which will provide equal access to relevant health data to help patients and their care partners make informed decisions about their care options, including clinical trials.

Mike Stocks
Medrio

Mike Stocks, CTO, Executive Leadership, Medrio

Mike brings tremendous experience adopting emerging technologies, including robotic process automation, machine learning, and artificial intelligence, to accelerate product development, integration, and deployment to his role as Medrio’s Chief Technology Officer. Before joining Medrio in 2023, Mike served as Division CTO and SVP of Technology with digital health company Sharecare, where he accelerated cross-platform integrations and expanded the company’s machine learning, automation, and analytics capabilities. Mike has over ten years of experience in healthcare and medical device development. He is a veteran in technology with over 25 years of experience. He has held progressive technology transformation and leadership roles with Align Technologies and Deutsche Bank and holds a Bachelor’s degree from East Carolina University.

Tate Stubbs
HealthMatch

Tate Stubbs, Chief Operating Officer, Executive, HealthMatch

Tate is the Chief Operating Officer and Head of Strategic Partnerships at HealthMatch. He believes that putting patients first - embedding their interests and perspectives across the industry - is the best way to change the future of medicine. HealthMatch is a partner to sponsors and innovators across the biopharma industry working to change the future of medicine. Since 2017, HealthMatch has built an active community of over 1.8 million patients seeking clinical trials; and offers recruitment services and patient insights to solve commercial and trial-design challenges.

Tate’s background in funds management and M&A has given him a deep appreciation for the importance of end-customer (patient) outcomes in achieving commercial success.

Mike Sullivan
Bristol Myers Squibb Co

Mike Sullivan, Exec Dir Global Dev Operations, Drug Dev IT, Bristol Myers Squibb Co

Mike Sullivan is an Information Technology Executive with more than 25 years of experience with global, multi-national companies. Mike is a seasoned leader with a deep understanding of how technology adds value across the drug development life cycle and a strong track record of building cross-functional teams to deliver strategic capabilities across complex ecosystems. Mike is currently responsible for driving the strategic partnership between IT and Development Operations globally at Bristol Myers Squibb. Mike earned his MBA from Northeastern University with a dual concentration in High Technology and Innovations Entrepreneurship and a Bachelor of Science in Information Systems Analysis & Development from Drexel University.

Lauren Sutton
Verily

Lauren Sutton, Head of Product, Clinical Trial Recruitment & Site CTMS, Verily

Lauren Sutton is currently the Head of Product, Site CTMS and Recruitment at Verily where she partners with engineers and clinicians to deliver technologies that support operations teams in accelerating study execution. Prior to Verily, Lauren was Head of Clinical Research Product at Flatiron Health where she built solutions that leveraged real-world data to drive clinical research efficiencies for sponsors and CROs. Prior to Flatiron, Lauren worked in clinical operations at IQVIA focused on the execution of oncology trials. She holds a BS in biology from UNC Chapel Hill and an MBA from NC State.

Zachary Taft
IgniteData

Zach Taft, CEO, IgniteData

Healthcare Executive with a record of accomplishment leading business development and growth at Fortune 500 companies, entrepreneurial success through three acquisitions, including M*Modal by 3M for $1.1B, and academic medical center thought leadership shown through the co-founding of MSK’s Clinical Research Innovation Center. Visionary Innovator motivated by developing strategies and delivering industry-first products that enable clinical efficiencies and improve patient care within the healthcare arena. Product Expert with recognized ability in creating and maintaining partnerships with large tech companies, and healthcare systems across every market. Driven Leader known for developing and empowering high-performing, autonomous teams that consistently exceed objectives and expectations.

Sameer Tandon
BMS

Sameer Tandon, Senior Director & Strategic Transactions Lead, R&D Procurement, Bristol Myers Squibb Co.

Sameer is an experienced alliance and strategic sourcing executive with broad drug development and clinical trial operations experience in all phases of development responsible for engaging internal and external stakeholders to establish innovative partnerships, influencing decisions, leading, and managing multi-disciplined, cross-functional teams that create collaborative solutions supporting break-through performance in developing medicines for patients with high unmet medical need.

Michael Tanen
Merck & Co

Michael Tanen, Director, Head of Laboratory Operations and Logistics, Merck

Michael Tanen is the director of the Clinical Biomarker Specimen Management group at Merck Research Laboratories. Michael leads a group that is responsible for collection, tracking, and storage of clinical biomarker specimens collected in clinical trials. During his 20 years at Merck he has been involved in the utilization of clinical biomarker specimens from the prospective of discovery research through the usage for diagnostic development. His team has established an industry leading specimen management solution that support data integration between clinical data and specimens, improving how we make utilization decisions in the complex area of biomarker research.

Kindra Tatarsky
Cerity Partners Ventures

Kindra Tatarsky, Partner, Cerity Partners Ventures

Kindra is a results driven executive, working with corporations to leverage external innovation and drive growth. A people-first leader, Kindra's expertise in venture investing, corporate strategy, and market research enables her to deliver results for clients and partners while positively impacting culture. She enjoys partnering with ambitious thinkers who are passionate about the intersection of scale and innovation and its power to change the world.

Georges Tavares
Sanofi

Georges Tavares, Clinical Translation Services Global Manager, Sanofi

A seasoned Clinical Translation Services Global Manager with extensive experience in the pharmaceutical industry. Demonstrated expertise in vendor governance, project management, and team leadership. Adept at improving translation processes, defining strategies, and managing budgets and resources. Fluent in English, Spanish, and Portuguese, with a passion for continuous learning and professional growth.

Sylvia M Taylor
AstraZeneca

Sylvia M. Taylor, PhD, Executive Director, Head, Medical & Payer Evidence, Vaccines & Immune Therapies, AstraZeneca

Sylvia Taylor, PhD, MPH, MBA, is an infectious disease epidemiologist and currently Head of Medical and Payer Evidence Strategy for AstraZeneca’s Vaccines and Immune Therapies Unit that was formed in November 2021. She is passionate about vaccines and preventive interventions for infectious diseases and has spent more than 20 years working on related global health initiatives in both the private and public sector. She initially joined AstraZeneca in 2020 as the lead epidemiologist for AstraZeneca’s COVID-19 vaccine program, playing a key role in the distribution of >3 billion vaccine doses worldwide. She was previously also a senior epidemiologist for GlaxoSmithKline Vaccines, leading epidemiology strategy/activities for late and early-stage vaccines, including HIV, Ebola, TB, HPV, RSV, and Streptococcus Pneumoniae, over a period of 8 years. She has additionally worked as a Senior Technical consultant for the United Nations' International Organization for Migration, collaborating with the US Centers for Disease Control on community-based surveillance among Venezuelan migrants in Colombia, and as a research scientist at the Institut Pasteur in Paris, with focus on epidemiology and prevention of HIV, TB, and Hepatitis C. Originally from the United States, she has spent the last 17 years working/living abroad, including in Belgium, Cameroon, Cambodia, Colombia, Egypt, England, France, and Peru. During 2017-2019, while on sabbatical in Cameroon, she completed a TRIUM Global Executive MBA-a joint program with the London School of Economics, HEC Paris, and New York University Stern School of Business-and worked on several business development projects in Cameroon, China, and Europe.

Stacy Tegan
TransCelerate Biopharma Inc

Stacy Tegan, Program Director, TransCelerate Biopharma, Inc.

Stacy Tegan is the Program Director at TransCelerate Biopharma, Inc., a not-for-profit organization collaborating to converge clinical research and clinical care. In her current role she oversees efforts to digitize clinical trial protocols, increase the integration of EHRs into clinical research processes, and enable pragmatic trials to be conducted at the point of care. She has 20+ years of experience improving regulatory and clinical processes, and expertise in project management, strategic planning, digitization, and change management. Stacy is passionate about taking improving the community, with a history of volunteerism at the Drug Information Association (DIA), youth organizations, and she currently serves on her local Environmental Advisory Council.

Pamela Tenaerts
Medable

Pamela Tenaerts, MD, MBA, CSO, Medable

Pamela Tenaerts is Chief Scientific Officer at Medable, Inc. Dr. Tenaerts leads efforts to drive responsible adoption of decentralized research methodologies with evidence-based metrics and best practices. Dr. Tenaerts joined Medable from Duke University, where she led the Clinical Trials Transformation Initiative’s (Public Private Partnership co-founded by Duke University and the Food and Drug Administration) efforts to develop and drive adoption of practices that increase the quality and efficiency of clinical trials. She is a member of the Drug Forum at the National Academies of Science, a Dime Founding Members Council member and a Board Member of the MedStar Research Institute. Tenaerts is one of the leading advocates for innovation in clinical trials, with an emphasis on protocol design and QbD, patient engagement, responsible evidence generation and clinical trial methodology improvements. With more than 30 years’ experience in the conduct of clinical trials across a number of stakeholders, she practiced medicine in both the emergency department and as a family practitioner in the private practice setting before embarking on a career in research. She received her MD from Catholic University of Leuven, Belgium, and a MBA from the University of South Florida. She speaks multiple languages.

Michele Teufel
AstraZeneca Pharmaceuticals Inc

Michele Teufel, Site Management & Monitoring Therapy Area Strategy & Portfolio Delivery, Development Operations, AstraZeneca

Senior Director, Therapy Area Strategy & Portfolio Delivery within Development Operations, over 20 years in various roles within Clinical Operations, where I delivered early and late phase clinical studies across different therapeutic areas. I was responsible to ensure project standards and scientific requirements from study design concept through study closeout. Currently, I am working within our Site Management and Monitoring Organization. In this role, I ensure consistent communication and collaboration across clinical operations, study management, and the country teams across the globe.

Donald Thampy
Merck

Donald Thampy, Executive Director, Merck

Currently in pharmaceutical industry, working with the leaders to pivot to the patient by implementing transformative frameworks while challenging the ways of working to breed the culture of continuous improvement.

Becky Thompson
Parexel

Becky Thompson, Sr Dir, Solutions Consulting - Real World Research, Real World Evidence & Market Access Solutions, Parexel

With over 12 years experience in real-world evidence & market access programs with a focus on globally managed access programs in oncology and rare disease, Becky Thompson’s expertise encompasses observational studies, registries, post-authorization safety, interventional Phase IIIb - IV studies and pediatric programs. She helps to develop global, real-world evidence solutions for clients to demonstrate product value and ensure successful market access and commercialization. •Becky is a subject matter expert for managed access programs, including oversight of ongoing programs and member of managed access program committee and writes Parexel SOPs and best practices and speak at and attend conferences. Her therapeutic areas of experience include respiratory, oncology, neurology, obesity, chronic pain, cardiovascular, endocrine, diabetes & infectious disease. Becky Thompson has a BS (Highest Honors) Biology & Chemistry, University of North Carolina.

Nicola Thorne
Worldwide Clinical Trials

Nicola Thorne, Vice President, Oncology Project Management, Worldwide Clinical Trials

Nicola Thorne is a seasoned leader in the realm of clinical trial management with a specialization in oncology. As the Vice President of Oncology Project Management at Worldwide Clinical Trials, she brings a wealth of experience that combines a rich history of project management expertise in the pharmaceutical and CRO industry with a focus on oncology and hematology. Nicola is renowned for her strategic vision and leadership, ensuring the operational and financial delivery of projects aligns with the highest standards and client expectations. She champions the integration of strong governance, clinical best practices, and team leadership to advance therapeutic innovations. Nicola is committed to nurturing talent within her teams, emphasizing the importance of training and development. She believes in the power of effective communication and the need for clear and concise roles within project teams. Her approach to project management is characterized by a consistent focus on operational and financial delivery, strategic planning, and risk management. Nicola’s expertise extends to developing impactful client relationships, driving business strategies, and leading high-performing project management teams to deliver consistent results. Her expertise is pivotal in steering project teams towards achieving strategic objectives while fostering robust relationships with clients and stakeholders.

Aman Thukral
AbbVie Inc

Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc.

Aman Thukral is the Head of Clinical Systems & Digital Operations at AbbVie. He has over twelve years of experience in clinical development, technology planning & business-technology alignment. In his current role, he is responsible for eCOA operations, wearables and sensors, piloting new technology initiatives. Before this position, he had worked in Deloitte, Cognizant & GlaxoSmithKline at various levels.

Kara L Titus
DragonFly Therapeutics

Kara Titus, Senior Director, Procurement, Dragonfly Therapeutics

Kara has over 18 years of experience in the Pharmaceutical/Biotech industry, with 12 of those being in various roles overseeing clinical vendor relationships. Her passion is for developing internal and external relationships to help serve the organizational needs, leading and developing individuals in a motivational, empowering way, building trust to help the business thrive.

Lora Todd
Eli Lilly and Company

Lora Todd, VP Emerging Tech and Information Management, Eli Lilly and Company

No bio available.

Eva Topole
Chiesi Farmaceutici SpA

Eva Topole, Lead, Clinical Digital Health & Innovation, Chiesi Farmaceutici SpA

No bio available.

Daniel Tortora
Pfizer

Daniel Tortora, Pfizer

No bio available.

Thanh Tran
Astellas Pharma US Inc

Thanh Tran, Director, Immuno-Oncology Primary Focus Lead, Data Management, Astellas

Thanh Tran, Director of Immuno-Oncology Primary Focus, Data Management; currently at Astellas for the past 10+ years and has been in industry for 25+ years; is passionate, pragmatic, and patient-centric in the Data Management processes and technology. Thanh's motivation to get medicines to patients faster drives his passion to constantly evolve Data Management to deliver best in quality, technology, and processes.

Quynh "Quin" Tran
Cystic Fibrosis Foundation

Quynh Tran, Director of Patient Activation, Cystic Fibrosis Foundation

As Director of Patient Activation, I help people with cystic fibrosis manage this complex disease, in close collaboration with their interdisciplinary care teams. CF is a progressive, genetic condition that primarily affects the lungs, requiring hours of daily treatments with lung transplant as a treatment option. Critical to this care model for a rare disease is active participation in clinical trials, which the CF Foundation promotes and facilitates through therapeutic development at its accredited care center network.

Oanh Tran Stephan
BeiGene

Oanh Stephan, PhD, Executive Director, Head, Global Medical Writing, BeiGene

As a leader with over 15 years of experience in regulatory writing, coupled with an unwavering passion for team building, I have been fortunate to witness the profound impact that effective leadership can have on both individuals and organizations. Guided by a deep understanding of regulatory requirements and driven by a genuine desire to foster growth and collaboration, I am searching for an opportunity to create and be a part of high-performing teams that consistently deliver exceptional results. With a focus on collaboration, growth, and ethical leadership, I am committed to making a lasting impact not only within the regulatory landscape but also in the lives and careers of those I have the privilege to lead. As a leader with over 15 years of experience in regulatory writing, coupled with an unwavering passion for team building, I have been fortunate to witness the profound impact that effective leadership can have on both individuals and organizations. Guided by a deep understanding of regulatory requirements and driven by a genuine desire to foster growth and collaboration, I am searching for an opportunity to create and be a part of high-performing teams that consistently deliver exceptional results. With a focus on collaboration, growth, and ethical leadership, I am committed to making a lasting impact not only within the regulatory landscape but also in the lives and careers of those I have the privilege to lead. https://www.linkedin.com/in/phuong-oanh-tran-stephan/

Jennifer Trevor
Astellas Pharma US Inc

Jennifer Trevor, PhD, Director and Global Category Lead, Development and R&D Procurement, Astellas Pharma US Inc

Jen Trevor, PhD, has navigated a dynamic career shaped by her ability to pivot and thrive in diverse roles across both scientific and business landscapes. With a PhD in Chemistry from the University of Illinois at Chicago, her early work in biosensor research at Argonne National Laboratory laid a strong foundation for her technical expertise. Starting as a Forensic Chemist at the Drug Enforcement Administration, Jen quickly rose to a leadership position, managing teams and projects before transitioning into the private sector. Her adaptability was showcased when she joined Amylin Pharmaceuticals (now part of Bristol-Myers Squibb) as the API Development Manager, where she was responsible for critical tasks such as selecting manufacturers, managing tech transfers, and overseeing clinical contract negotiations. This marked a key pivot in her career toward the intersection of science and business. Jen’s journey continued at Ferro Corporation in a Business Development role, where she successfully merged her technical knowledge with commercial strategies, focusing on licensing and the sales of APIs. Her ability to manage complex technical transfers and build strong industry partnerships was further demonstrated at Astellas Pharma Inc., where she transitioned from a Strategic Sourcing Manager in Finance to an Ambassador role at the company's headquarters in Japan. Currently, as Global Category Lead for R&D Procurement Development, Dr. Trevor leverages her multi-faceted background in scientific research, business development, and strategic sourcing. Her ability to navigate and adapt to evolving technologies like AI in clinical contracts underscores her talent for integrating innovation with operational efficiency. With her unique blend of skills, she continues to drive forward-thinking approaches in managing strategic partnerships and global cross-functional teams.

Laura Trotta
CluePoints SA

Laura Trotta, Vice President, Research, Research Operations & Statistical Innovation, CluePoints SA

Dr Laura Trotta joined CluePoints in 2015 and moved into her current role as Vice President of Research in January 2022, where she leads a team of research scientists responsible for developing new statistical and machine learning algorithms to assess the quality of clinical trial data. Laura holds a Master’s degree in Biomedical Engineering and a PhD in Applied Mathematics from the University of Liège, Belgium.

Daniel Truxler
Regeneron

Daniel Truxler, Associate Director, Clinical Supply Systems, Regeneron Pharmaceuticals, Inc.

Daniel Truxler has over 25 years of experience in people leadership, process improvement, and technology. Born in Bronx, NY, he moved to Elizabeth City, NC, at age 13. Initially pursuing Aerospace Engineering at North Carolina State University, Daniel discovered his passion for computer technology and software programming, leading him to complete Bachelor's degrees in Computer Science and Business Management at St. Leo University. He furthered his education with a Master’s in Information Technology from Virginia Polytechnic Institute and State University. Daniel began his career in a marketing and publications organization and has since worked for Fortune 500 companies across the technology, retail, and multimedia industries. Currently, he is the Associate Director of Clinical Supply Operations at Regeneron Pharmaceuticals, where he leads a team focused on Clinical Drug Supply and Logistics and designs systems and processes to ensure the availability of clinical trial supplies for doctors and patients globally. Daniel, along with his wife of 27 years, enjoys raising their three children and mentoring others. His interests include reading, solving complex problems, and sharing his faith. Daniel aspires to inspire future generations to pursue education and careers in the sciences.

Renee Tschoop
Perceptive Inc

Renee Tschoop, Perceptive Inc

No bio available.

Edward Tumaian
Cyclo Therapeutics Inc

Ed Tumaian, Senior Vice President, Clinical Operations, Cyclo Therapeutics, Inc.

For more than 25 years, Ed has been working in the life sciences and healthcare industries, building and leading teams in clinical operations as well as portfolio and partnership management. At several large pharma companies, he managed products and teams in CNS, GI, CVM, and Gen Med therapeutic areas. He also held several leadership roles and several global CROs with focus on global end-to-end solutions across Phase I to post-approval trials and Real World Evidence. Currently serves as Vice President, Clinical Operations at Cyclo Therapeutics, Inc., managing a portfolio of CNS and Rare Disease studies. His areas of focus are Clinical Development and Operations, Technology Solutions, Customer Value & Collaboration, Strategic Partnerships, Portfolio/Product Management, Productivity, and Innovation.

Serpil Tutan
Baylor College of Medicine

Serpil Tutan, Director, Clinical Research, Baylor College of Medicine

Serpil Tutan is a Director of Clinical Research at the Center for Research Advancement, Baylor College of Medicine/Texas Children’s Hospital. She has more than 25 years of nursing and clinical research experience. Some of her current responsibilities include, protocol development, feasibility reviews, budget negotiations, and direct oversight of the clinical trial finance, regulatory and QA/QC teams. She had successfully completed institutional launch of the Clinical Trial Management System, financial module at Texas Children’s Hospital. One of her passions is protocol development and project management for all aspects of investigator initiated and/or rare disease trials.

Pirinka G Tuttle
Pfizer, Inc.

Pirinka Tuttle, Associate Director, Clinician, Biomeasures, Endpoints & Study Technologies, Pfizer Inc.

Pirinka Tuttle is a Clinician in the Biomeasures, Endpoints, and Study Technologies (BEST) group within Translational Clinical Sciences (TCS) at Pfizer. As a clinical researcher, she focuses on designing innovative protocols, which include the utilization of digital health technologies (DHTs) for novel digital endpoint (NDE) qualification and development in clinical trials across the disease portfolio. Pirinka has also been instrumental in the implementation of patient-centric microsampling for the quantification of various biomarkers through the design and conduct of concordance and feasibility studies.

Sasha Tyndale
AbbVie

Sasha Tyndale, Director, Diversity & Patient Inclusion, AbbVie

Sasha is the current sitting Head of Diversity & Patient Inclusion within AbbVie, overseeing implementation of AbbVie’s strategy for clinical trial inclusion. In her most recent role, Sasha was responsible for building foundational capabilities to integrate patient, care partner, and site insights into the clinical trial development process. Building and overseeing the implementation of AbbVie’s R&D strategy to intentionally and systematically integrate the diverse perspectives of our patients, their care-partners and sites into strategic decisions, at critical stages of the clinical drug development process in order to enhance clinical trial design to optimize patient and site experiences in AbbVie clinical trials. Sasha joined AbbVie in February 2015 and has held multiple roles within Clinical Development Operations and Aesthetics Clinical Development leading patient recruitment strategy, clinical innovation, and patient centricity during her tenure.

Caro Unger
Asher Biotherapeutics

Caro Unger, Clinical Trial Strategy & Management Leader, Asher Biotherapeutics

Oncology clinical operations professional with over 15 years of industry experience providing oversight on all phases of studies: global phase III confirmatory to phase 1 heathy volunteer. Have worked in melanoma, prostate, ovarian, solid tumor, AML, myelofibrosis, CLL/SLL, pancreatic, CRC, RCC, NCSCL, HCC, pediatrics, basket, and platform trials.

Gazal Vakili
Sumitomo Pharma

Gazal Vakili, Director, Digital Health Innovation, Sumitomo Pharma

Gazal Vakili, MSHS, is an experienced leader in digital health and clinical research, serving as the Director of Digital Health Innovation at Sumitomo Pharma America (SMPA) and the head of the US division of FrontAct, a digital health focused subsidiary company of SMP. She has a robust background in clinical trials and a career that spans senior positions at Sunovion Pharmaceuticals and other pharmaceutical/clinical research companies, where she drove trial management for over 15 years. Gazal is committed to advancing innovative health solutions through strategic leadership and clinical expertise.

Eduardas Valaitis
PwC

Eduardas Valaitis, Managing Director, Pharma R&D Analytics, PwC

At PwC, I lead a large team of data scientists and management consultants who develop strategy for and implement transformational programs and platforms at leading pharma companies for analyzing and deriving insights from clinical, RWE and operations data. I oversee the implementation of advanced statistical, machine learning, AI and automation methods on the deployed platforms to help clients maximize the value from their internal and external data assets and drive business strategy. Through my work, I routinely collaborate with senior leaders from various functions including clinical, HEOR, safety, biostatistics, site oversight and audit.

In addition to working with pharma companies, I have also developed data and analytics solutions for leading oil and gas, entertainment and media, telecommunications, and financial services companies. Further, I have lent my technical expertise in large class action settlement and litigation matters.

Throughout my career, I have actively recruited, developed, and mentored data and analytics talent; and have focused on diversity and inclusion efforts to provide a safe and productive environment for my team and other colleagues.

Sarah Valentine
Digital Medicine Society (DiMe)

Sarah Valentine, Partnerships Lead, Life Sciences, Digital Medicine Society (DiMe)

Sarah Valentine leads partnerships across life sciences at the Digital Medicine Society (DiMe). In her role, she thinks critically about the challenges we face in drug development and commercialization to drive strategy, prioritization, and concept development across areas of unmet need where there's an opportunity at the intersection of healthcare and technology to deliver unprecedented value to patients and other stakeholders across our industry. She convenes teams of interdisciplinary thought leaders and subject matter experts to tackle some of the biggest challenges we face as a field in order to advance the ethical, effective, equitable, and safe use of digital medicine to redefine healthcare and improve lives. Prior to her role at DiMe, Sarah was a digital implementation lead at Eli Lilly & Company, where she led efforts at the intersection of clinical development and digital health to leverage innovative digital technologies including digital measures, combination products, and other DDTs in clinical research.

Kees Van Ooik
Almac Group

Kees Van Ooik, Vice President - eClinical Development, Almac Group

A visionary entrepreneur with over a decade of experience driving digital transformation in life sciences and healthcare, Kees Van Ooik is renowned for his contributions to advancing clinical research technology. As co-founder of Your Research, Kees played a pivotal role in developing and delivering leading eCOA and CTMS solutions, enabling study teams to streamline operations, optimize outcomes, and embrace innovative approaches to clinical trials. Before Your Research's successful acquisition by Almac, Kees spearheaded strategies that empowered research teams worldwide, fostering greater control, efficiency, and predictability in their studies. A passionate advocate for innovation, he continues to champion the adoption of advanced eCOA and IRT technologies, empowering researchers to unlock new possibilities in clinical research. Now as part of the Almac Clinical Technologies's Executive team, Kees's dedication to transforming the clinical research landscape positions him as a thought leader and catalyst for change, inspiring the industry to embrace technology-driven solutions that enhance both speed and quality.

Luis Vargas
Genmab US Inc

Luis Vargas, IRT Manager, Global Clinical Drug Supply, Genmab US, Inc.

An accomplished IRT (Interactive Response Technology) Manager with over a decade of experience in the Life Science industry. Gained experience working with the IRT Supplier and Sponsor side to better understand the clinical trial protocol lifecycle and how it translates to the IRT system. Responsible for technical oversight, compliance, qualification, and validation of IRT systems used in clinical trials. Experienced with planning and coordinating the IRT implementation (initial/amendments), design requirements, UAT, integrations, and training in accordance with trial timelines and the relevant cross-functional internal stakeholder and external stakeholders.

Michelle Verhaeghe
Parexel International

Michelle Verhaeghe, Vice President, FSP Clinical Operations, FSP Leadership Team, Parexel International

With nearly 25 years of industry experience, Michelle brings extensive knowledge of clinical trial delivery, spanning project and program management, study start-up, monitoring, and managerial and leadership positions across clinical delivery.

She has 17 years of experience within FSP delivery models, holding positions of increasing responsibility throughout her tenure with ExecuPharm prior to its acquisition by Parexel in 2017. Earlier career roles included work in clinical development for a large pharmaceutical organization. Michelle has led multiple large FSP programs, building and growing client partnerships from inception to execution at scale.

Michelle holds a Master’s of Science degree in Biotechnology, Business Enterprise from John Hopkins University and a Bachelor’s degree from University of North Carolina.

Barbara Versage
Immunocore LLC

Barbara Versage, Senior Manager, Supply Chain Sourcing, Immunocore LLC

The Senior Manager, Clinical Supply Chain Sourcing and Vendor Relations is responsible for establishing strong relationships with external vendors assuring ongoing collaboration and providing a point for escalation. This role is also responsible for the purchase and management of commercial drug required for the clinical studies. She acts as a subject matter expert to lead internal teams (e.g. clinical supply chain, clinical operation, regulatory and strategy, portfolio & project management colleagues) in developing strategies for sourcing services and goods for IMMUNOCORE clinical studies, in line with related regulatory requirements and internal quality processes. Prior to joining Immunocore, Barbara was the Director of Client Services at ThermoFisher Scientific, Clinical Trial Division. There she managed a global team who had responsibility for the commercial drug supply chain including vendor performance and client experience. Barbara is a registered nurse who started her career caring for oncology patients and working in an academic research facility. Barbara lives in a quiet residential area on the Chesapeake Bay, enjoying shore activities. Her main hobby now is exploring the effects sound frequencies have on individuals.

Alyssa Vincze
Milliman IntelliScript

Alyssa Vincze, Principal & Director, R&D, Milliman IntelliScript

Alyssa is an actuary serving as Principal and Director of R&D at Milliman IntelliScript, a company with a long history of disruptive innovation in the life and health insurance sectors. She leads new product development and recently launched Irix®, a trial eligibility tool that leverages IntelliScript’s proprietary data network and deep interpretation expertise.

Viral Vyas
Bristol Myers Squibb Co

Viral Vyas, Dir IT, Global Clinical Dev, Bristol Myers Squibb Co

Viral Vyas is a highly accomplished IT executive with a unique blend of science, information technology, and management expertise. With a profound understanding of pharmaceutical research and development, Viral is deeply committed to enhancing patients' lives by aligning IT and business strategies. As the Director of IT for Global Clinical Development at Bristol Myers Squibb (BMS), Viral is at the forefront of digitalizing clinical protocols using standards and generative AI technologies. He is leading teams that implement digital protocol solutions, specimen management, and risk-based quality management systems for clinical teams. Viral holds a Master’s in Business Administration, Master’s in Information Management, and Bachelor’s Microbiology.

Suzanne Vyvoda
Ensho Therapeutics

Suzanne Vyvoda, Independent Consultant

Over the past 20 years working in Drug Development and Clinical Operations in biotech and pharma, I have established and led operations for companies including Gilead, Telavant, AbbVie and AMT implementing and managing all phases of human subject research including pre-clinical, Phases I-V, and post-market clinical trials.During this time, I have worked across a wide variety of therapeutic areas, including oncology, inflammation, neurology/CNS, infectious disease, rare disease and internal medicine in pediatric, adult, elderly and special populations.

Sanjiv Waghmare
Signant Health

Sanjiv Waghmare, Chief Product Officer, Signant Health

Sanjiv Waghmare serves as the Chief Product Officer of Signant Health focused on the strategy and development of all solutions in the portfolio. He leads a team of product managers and experience designers who are experts in the work our customers do as well as their respective functional roles. Sanjiv focuses on delivering a portfolio of market leading solutions that enable our customers to achieve efficiency in their work while maintaining the highest level of data integrity. Sanjiv has extensive leadership experience in product management and strategy development. Prior to joining Signant Health, Sanjiv led product management teams at Intuit, Finastra and Wolters Kluwer. He also served as the general manager for Intuit Health Group. Prior to entering the field of product management, Sanjiv was with McKinsey & Company where he served clients in multiple industries addressing challenges in business strategy and operational effectiveness. Sanjiv has a Bachelor of Engineering degree with honors in Electrical and Electronics Engineering. He earned his MBA from Kellogg School of Management at Northwestern University.

Rachel Wagner
Care Access

Rachel Wagner, VP Business Development, Business Development, Care Access

Rachel Wagner is the Vice President of Business Development at Care Access, a role she has held since 2022. In this capacity, she oversees global sales for Care Access’s expansive network of over 200 research sites, community-based patient pre-screening initiatives, and global site staffing solutions.

Before joining Care Access, Rachel served as Senior Director of Global Business Solutions at StudyKIK, a leading patient recruitment and retention technology company. Prior to that, she held the position of Director of Global Business Development at Synexus, a large global site network.

Rachel’s career began outside the clinical research industry as the co-founder and Chief Operating Officer of a pioneering tech marketing company specializing in automotive financial services, a role she held for 12 years.

With a passion for innovation, Rachel is dedicated to advancing transformative solutions in the clinical research field and is proud to contribute to Care Access’s mission of accelerating medical breakthroughs through health resource access for everyone.

Emmanuel Walckenaer
Yseop

Emmanual Walckenaer, CEO, Yseop

High tech Entrepreneur with a demonstrated history of working in the IoT, Artificial Intelligence and wireless industry. Strong sales professional skilled in Business Planning, Go-to-market Strategy and Mergers & Acquisitions. YSEOP CEO, a world leading Artificial Intelligence solution provider powered by Natural Language Generation.

Chris Walker
Alimentiv

Chris Walker, Director of Data Sciences, Alimentiv

Chris Walker is the Director of Data Sciences at Alimentiv, where he has cultivated a 12-year career dedicated to advancing clinical research through data-driven solutions. With a strong foundation in Clinical Data Management, his expertise lies in the successful implementation and optimization of eClinical technologies to drive efficiency and insights within the clinical trial process.

Wayne Walker
Medidata a Dassault Systemes Co

Wayne Walker, SVP, Rave Platform Technology, Rave Platform Technology, Medidata a Dassault Systemes Co

Wayne is Senior Vice President, Rave Platform Technology (including Rave EDC, Medidata Clinical Data Studio, Medidata Designer, Rave Imaging, Rave RTSM, Rave Coder, and Rave Safety Gateway) at Medidata. His responsibilities include the strategy, development, and delivery of these products across all Research & Development disciplines. Before joining Medidata, Wayne spent 12 years overseeing Product Management for clinical technology used by Data Management and Biometrics at PRA Health Sciences, which included oversight of Platform as a Service, Software as a Service, on-premise deployed environments, and in-house developed solutions.

Jasmine Walker
RWS Group

Jasmine Walker, Director, COA Partnership, Linguistic Validation, RWS Group

Jasmine Walker is a dedicated advocate for language diversity and cultural inclusion in the clinical trial field. Jasmine's passion for languages and cultures began in childhood and blossomed into a professional journey starting in 2010. She holds a Bachelor's degree in Linguistics, which laid a strong foundation for her career. Over the years, she has gained extensive experience in the usage of Clinical Outcomes Assessments (COAs) with a strong focus on enabling global diversity in clinical trials. From managing translation projects and coordinating licensing agreements with copyright holders to shaping COA licensing and localization strategies with eCOA partners, strong partnerships have become the name of her game. Currently, she serves as the COA Partnership Director at RWS, where she combines her diverse skills and experience to foster innovation and collaboration.

Karin Wallace
Cogstate

Karin Wallace, AVP, Client Solutions & Strategic Accounts, Portfolio Mgmt, Cogstate

Clare L Wallis
Worldwide

Clare Wallis, Executive Vice President, Global Clinical Development, Worldwide Clinical Trials

No bio available.

Simon Walsh
Johnson & Johnson Innovative Medicine

Simon Walsh, Head, Data Acquisition and Coding, Johnson & Johnson Innovative Medicine

Simon Walsh is an established leader currently serving as the Senior Director of Data Management and Central Monitoring at Johnson & Johnson, where he manages EDC and External Clinical Data Acquisition, Medical Coding, and Central Monitoring Reporting groups that support Johnson & Johnson Innovative Medicine portfolio. Leading a group of over technical 100 experts spanning multiple technical capabilities, Simon and his organization are pivotal in ensuring elevated levels of quality and integrity in data acquired for clinical trials. With more than 20 years of experience, including significant roles at Novartis and Covance, Simon has a proven record in strategic and organizational leadership, process optimization, and innovation in multiple domains including Statistical Programming, Clinical Data Standards, and Clinical Data Management and Central Monitoring. His career reflects a commitment to driving excellence and innovation in the management, central monitoring, and reporting of clinical trial data within the pharmaceutical industry.

Kailey Walsh
Alnylam

Kailey Walsh, Manager, Clinical Operations, Alnylam Pharmaceuticals

Suzin Webb
Velocity Clinical Research

Suzin Webb, Site Director, Velocity Clinical Research

Suzin Webb is the Site Director for Velocity Clinical Research’s Binghamton, NY site working with Principal Investigator Frank Eder, MD. Originally a laboratory scientist, Suzin has a strong background in the use of genetic and other biomarkers to assess disease state and progression, as well as patient safety and response to therapeutics, in a clinical trial setting in both human and veterinary medicine. Since transitioning to a site-level role, Suzin has learned about the clinical operational challenges that both patients and research sites face as we move into an era of precision medicine. Velocity Clinical Research is the largest global research site organization conducting sponsor studies across all therapeutic areas.

Dan E Webster
AbbVie

Dan Webster, PhD, Director, Digital Sciences, AbbVie, Inc.

Dan Webster, PhD, is a Director of Digital Science at AbbVie. Dan leads the Rheumatology and Oncology portfolios, focusing on implementing digital endpoints and software as a medical device in the clinical development portfolio. His scientific training spanned from the University of Wisconsin-Madison (Genetics) to Stanford University (Cancer Biology), followed by postdoctoral work in cancer genomics in Louis Staudt’s laboratory as a Damon Runyon Fellow at the National Cancer Institute. Prior to joining AbbVie, Dan led a collaborative effort with Apple, OHSU, and Sage Bionetworks to create the fully remote Mole Mapper Melanoma Study, and he founded the pre-competitive Psorcast Digital Biomarker Consortium with PPACMAN, Novartis, UCB, Pfizer, and Janssen to develop and validate digital biomarkers of psoriasis and psoriatic arthritis.

Jenny Wei
Kite Pharma

Jenny Wei, PhD, Senior Director, R&D Informatics and Technology, Kite Pharma

Jenny Wei is the Head of R&D Informatics and Technology at Kite Pharma. She has over 23 years of experience in the pharmaceutical industry delivering innovative digital solutions and advanced analytics for small molecule, biologics, and cell therapy R&D, real-world evidence generation, process development, clinical manufacturing, and supply chain. Trained as a biologist and a computer scientist, she holds a master’s in Computer Science from Rutgers University and a Ph.D. in Pharmacology from the University of Washington.

Henry Wei
Regeneron Pharmaceuticals Inc

Henry Wei, MD, Executive Director, Development Innovation, Regeneron

Henry Wei, MD, is the Head of Development Innovation at Regeneron, focused on accelerating clinical research. Previously, he worked at Google, the White House, Aetna, and McKinsey. He has authored patents on artificial intelligence, real-world data systems, and drug safety. He completed his M.D. and Internal Medicine residency at Cornell, additional informatics training at Stanford and Harvard, and oncology integrative medicine training at Memorial Sloan Kettering Cancer Center. He earned both his graduate & undergraduate degrees at Harvard University and published research on human neuroelectrophysiology and circadian biology. Dr. Wei is adjunct faculty at Weill-Cornell Medicine in Health Policy & Research.

Neil Weisman
Continuum Clinical

Neil Weisman, President, Continuum Clinical

As president of Continuum Clinical and Spectrum's Clinical Trial Experience pillar, Neil is responsible for leading the talented team of global clinical trial experts focused on elevating interest, increasing access and enhancing experiences for patients - while helping pharma and biotech companies achieve their drug development milestones critical to advancing new therapies. For 25 years, Neil has helped drive the company vision and craft its unique value proposition that addresses a wide range of therapeutic areas and indications, establishing Continuum Clinical as the industry’s go-to service provider. Neil is passionate about identifying and solving the bottlenecks and challenges that impact successful clinical trial enrollment - from protocol development through study completion - that often derail development and limit access to potentially life-saving treatment options. Neil is a proud graduate of the University of Michigan, Ann Arbor. He is a former radio DJ, food explorer and experience seeker. But what’s most important to him are his wife, two daughters, son and Lab.

Chris Weiss
OpenClinica LLC

Chris Weiss, Vice President, Sales, OpenClinica LLC

No bio available.

Ria Westergaard
Evernorth Health Services

Ria Westergaard, Director, Product Strategy, Clinical Trial Solutions, Evernorth Health Services

Ria Westergaard, PharmD, is the Director of Product Strategy for Evernorth Clinical Trial Solutions. Ria is an experienced leader with background in clinical research and pharmacy benefit management. At Evernorth, the health services division of The Cigna Group that serves more than 190 million people, Ria's role focuses on designing solutions that use integrated health data to meet market needs, such as clinical trial patient recruitment and regulatory-grade real-world evidence generation. Her 20+ years of pharmacy experience include direct patient care, utilization management policy development, presenting to pharmacy and therapeutics committees, managed care product development, research and mentoring.

Dana Wheeler
Merck & Co Inc

Dana Wheeler, Associate Principal Scientist, Global Trial Optimization, Merck

Dana Wheeler is an Associate Principal Scientist within the Global Trial Optimization group. She has over 10 years of research experience that spans from bench to bedside. Dana has been with the Global Trial Optimization team at Merck for 4 years and currently functions as the Indication Lead for Leukemia and Pediatric Oncology. Dana specializes in data-driven enrollment forecasting and recruitment and retention strategies for realistic and achievable study milestones. Dana has a BA in Human Biology with biopsychology and neuroscience concentration from the University of Kansas.

Kelly A White
Merck

Kelly White, Senior Director, Head, Global Trial Optimization, Oncology, Merck & Co.

Kelly White leads the Merck Oncology feasibility and trial optimization function. She has a track record of data driven problem solving and execution planning success. She has continued to evolve and expand the strategic approach of her team and draws on her prior experience in clinical nursing, academic and community based clinical research practice. She has a unique focus on both patient and site experience in oncology clinical trial participation and has significant experience in deploying novel and strategic initiatives to support these critical stakeholders.

Brook White
CRIO

Brook White, Vice President of Marketing/Commercial Operations, Marketing, CRIO

Brook has more than 20 years working in various aspects of drug development including work for CROs (clinical and preclinical), CDMOs, and eClinical technology companies. In addition to extensive experience building and leading marketing and sales teams, Brook has also filled roles in project management and technology.

Kendal Whitlock
Walgreens Co.

Kendal Whitlock, Head, Digital Optimization, RWE Clinical Trials, Walgreens Co.

Kendal K. Whitlock is the Head of Digital Optimization, RWE Clinical Trials, with Walgreens Boots Alliance. This role leverages data assets and partnerships to advance culturally responsive approaches to clinical research. In her role, Ms. Whitlock focuses on digital solutions to drive access and opportunities that are both flexible and convenient for participants. Ms. Whitlock brings nearly 25 years of pharmaceutical industry experience to this new role. During her tenure, she has worked globally in digital clinical trials, and in both medical and commercial roles. Ms. Whitlock holds a Master of Public Health degree in Sociomedical Sciences from Columbia University and is currently working toward a doctorate. She earned a BA with honors from Spelman College. Ms. Whitlock has published in peer-reviewed journals, speaks internationally, is a Co-Lead of the 3C Decentralized Clinical Trials (DCT) Research Curriculum Initiative for the Decentralized Trials Research Alliance (DTRA), Chair of the Product Development and Clinical Research Sub-committee for the Med Tech Color Collaborative Community, and a member of the Personalized Medicine Coalition (PMC) Health Equity Task Force.

Nick Whitney
IQVIA Technologies

Nick Whitney, Sr Director, Trial Management, Site Suite, IQVIA Technologies

Nick Whitney has 17+ years of experience in the life sciences and is currently Senior Director, Site Suite and is responsible for overseeing technologies that improve sptudy planning, feasibility, study start up and conduct. Nick has been involved with the delivery of these solutions for 10 years and is focused on guiding customers with the implementation of technological innovations to deliver value in trial operations. In prior roles, Nick has worked with a broad array of RWE/RWD stakeholders across industry, academia, payers, government, disease foundations, and patient advocacy organizations supporting the design and delivery of patient registries, observational studies, and clinical trials.

Scott Whitt
Triad Clinical Trials

Scott Whitt, General Manager, Triad Clinical Trials

Healthcare entrepreneur and medical research leader who co-owns a strong, profitable clinical trial site. With over 35 years in healthcare leadership roles, I look for profitable opportunities to improve healthcare for everyone.

Carrie Williams
McKesson Ventures

Carrie Williams, Vice President & Partner, McKesson Ventures

Carrie Williams brings 20 years of experience in healthcare from several vantage points within the industry. Prior to joining McKesson Ventures in 2017, Williams served as vice president of strategy and business development for digital health provider Omada Health, having held roles within McKesson’s strategy and business development team previously, working to advance strategies aimed at innovation within hospital pharmacy and clinical trial patient recruitment. She began her career in drug development, where she managed oncology clinical trials in both large pharmaceutical and biotech settings. Williams holds an MBA from the Haas School of Business at the University of California at Berkeley and an undergraduate degree in biology from the University of Massachusetts Amherst.

Kemi K Williams
AstraZeneca

Kemi Williams, Senior Director, Patient Science, AstraZeneca

Kemi Williams is Senior Director, Patient Science at AstraZeneca where she leads the development and implementation of AstraZeneca’s Clinical Trial Diversity initiatives, with an immediate focus on building out the US R&D trial diversity strategy and landscape. Kemi is a seasoned clinical research executive with over 24 years of successive clinical trials leadership experience in the biotechnology industry, spanning pharmaceutical, implantable medical devices, and in vitro diagnostic medical products. Her leadership experience includes building clinical and regulatory affairs functions from the ground-up at a precision medicine startup, launching a profitable CRO business unit within a biopharma, and developing high performing teams to manage trials (phases I-IV, PMA, 510k) that supported the successful launches of molecules and medical devices across multiple disease areas to include oncology, cardiovascular, women's health, autoimmune, and infectious diseases.  In her previous role as VP, Clinical & Regulatory Affairs at a precision medicine start-up, Kemi established the company’s clinical and regulatory affairs strategies, structure, and processes for its genetic research and development activities across Africa. Prior to that, Kemi led corporate-wide initiatives in major biopharma such as Roche, Abbott, & Medtronic to promote clinical excellence and operational efficiency in the design and conduct of US and global clinical studies. Some of Kemi’s accomplishments include crafting the European trial strategies for a company’s flagship cardiovascular device to expand the device’s clinical claims and support its addition to the European Society of Cardiology Heart Failure guidelines. At Roche, she led the design and conduct of the company’s first CLIA-waived studies to launch Roche’s point-of-care test system.

Kate Wilson
Biogen

Kate Wilson, Head of Clinical Trial Diversity, Global Clinical Operations, Biogen

Kate Wilson is the Head of Clinical Trial Diversity at Biogen. Kate has over 22 years of experience in clinical research with an undergraduate degree in Chemistry. She’s held multiple roles within Clinical Operations and worked across many therapeutic areas including multiple sclerosis and Alzheimer’s disease. Currently at Biogen, Kate is leading Biogen's clinical trial diversity strategies and goals to increase the awareness, access, and participation of diverse and representative participants in their clinical trials.

Krista Wilson
ICON Plc

Krista Wilson, Director, Clinical Operations, ICON

Krista is an experienced clinical research professional with over 20 years of experience focused primarily in the CRO setting, with extensive knowledge of both the full service and FSP CRO Models. Her expertise includes staff and department management, training, change management, budget and quality oversight, performance management, decentralized clinical trial set up and implementation, and process improvement.

David H Windley
Jefferies LLC

David Windley, Managing Director, Jeffries LLC

Dave Windley is a managing director and founding member of Jefferies’ Healthcare Equity Research team. Over a 25-year career in investment research, Mr. Windley has covered a broad range of healthcare product and service sectors, including managed care, healthcare information technology, pharmaceutical services, and specialty pharmaceuticals. Dave is a five-time Wall Street Journal Best on the Street honoree and a 6-time Starmine award recipient. Dave is involved in the Nashville financial and healthcare community, serving on boards of the CFA Society of Nashville and Owen Graduate School of Management. Dave also enjoys mentoring start-up companies and young finance professionals. Mr. Windley earned his Masters of Business Administration from the Owen School at Vanderbilt University and his BA from Transylvania University. Dave is a CFA charter holder and certified public accountant (inactive).

Marion Wolfs
Bristol Myers Squuibb

Marion Wolfs, Executive Director Clinical Oversight and Risk Management, Bristol Myers Squibb Co.

Marion Wolfs is a senior leader within the Integrated Data Analytics and Reporting (IDAR) organization from Janssen Pharmaceutical Companies of JnJ. In this role she is responsible for the oversight, execution, and management of the Analytical Risk-Based Monitoring (ARBM) processes including beyond trial level risk analysis at Janssen. She has been an RBM workstream co-lead for TransCelerate from 2016 to 2019 and is currently co-leading the RBM working group at PHUSE. Marion joined the pharmaceutical industry in 2007 and worked in various clinical operations roles until joining the Risk Management-Central Monitoring Group in October 2014. Marion holds a Master of Science degree in Biomedical Sciences from the Maastricht University and an International Certificate in Enterprise Risk Management from IRM.

Cara Woodruff
IQVIA Technologies

Cara Woodruff, Director, Product Management, IT Design & Development, Clinical Technologies, IQVIA Technologies

A highly motivated, experienced IT Product Management professional with over 26 years of experience in the biopharmaceutical service industry. Executes product strategy, defines product vision and roadmaps, develops customer-driven product requirements incorporating human-centered design, drives product release cycles using Agile methodologies, and collaborates with cross-functional teams to deliver high quality solutions on time. Prior roles include IT Product Owner, IT Business Partner, Integrated Processes and Technologies POC Project/Product Manager, Predictive Analytics Lead SAS Developer, Biostatistics Senior SAS Statistical Programmer, Statistical Programming Manager, Clinical Data Programmer, and Associate Biostatistician.

Aneta Woroniecka-Osio
Bayer Healthcare

Aneta Woroniecka-Osio, MD, Decentralized Clinical Trial (DCT) Strategy Development Lead, Bayer

Aneta Woroniecka-Osio has obtained her Medical Doctor degree from Medical University in Wroclaw, Poland. Upon completing her postgraduate training in Clinical Research she has joined Medical and Scientific Affairs at Bayer Canada. Aneta has over 15 years of industry experience, has held global roles of increasing responsibilities leading large phase III programmes in Clinical Development and Operations. Aneta also has experience in ICH-GCP study audit and regulatory inspections. In her current role Aneta leads development of operational framework focusing on DCT metrics; DCT implementation and advancing acceptance of DCT globally. She is passionate about science and innovative solutions to enable broader participation in clinical trials.

Alicia Worrall
AbbVie Inc

Alicia Worrall, Associate Director, Centralized Monitoring and TA Analytics, Data & Statistical Sciences, AbbVie, Inc.

Alicia Worrall joined AbbVie in 2015 after earning a master's degree in Applied Statistics. She is an associate director on a Data Science and Analytics team within Data and Statistical Sciences and leads analytics regarding Centralized Monitoring and TA analytics. This includes clinical trial execution, risk based quality management, and enabling data insights into clinical trial data to the broad clinical trial study team.

Amanda Wright
Javara

Amanda Wright, Vice President, Partnership Development, Javara

Amanda has over 20 years of experience across multiple functions in the clinical research industry, beginning her career as a Clinical Research Coordinator at an integrated network of clinical research sites, PMG Research. She has served in leadership roles that include operations, patient engagement, business development and marketing. Currently, Amanda leads Integrated Solutions where she applies her expertise and passions on intersecting strategic partnerships and collaborations that serve to innovate business process, patient engagement, and predictive modeling. In addition, Amanda has previously served for 10 years as the Executive Director of a clinical research non-profit, Greater Gift (501c3) designed to celebrate clinical trial participation and global health and well-being. Amanda is a graduate of UNC-Chapel Hill as well as various leadership programs.

Teri Wright
Eli Lilly & Co

Teri Wright, Director Clinical Lab Sciences & Devices Innovation, Clinical Trial Lab & Diagnostic Design, Eli Lilly and Company

Teri Wright is a Director in Clinical Trial Lab and Diagnostic Design at Eli Lilly and Company with over 25 years of experience in the field of clinical research. Teri has experience in a broad range of therapeutic areas, with particular focus on Oncology. Teri has played a key role in the design and execution of numerous clinical trials. Her commitment to excellence and innovation is evident in her leadership in clinical trial design and passion for mentoring the next generation of researchers.

Collier Wright
TruTechnologies

Collier Wright, VP of Solutions, Sales, TruTechnologies

Collier Wright, Vice President of Solutions at TruTechnologies, brings a unique blend of leadership and enterprise software expertise to his role. With an MBA from Duke University's Fuqua School of Business, Wright has held key roles at OakNorth Credit Intelligence and Abrigo, focusing on data-driven solutions and customer success. A former US Army officer, he also brings a proven track record of adaptability and leadership. Wright is passionate about leveraging technology to solve complex challenges, particularly in advancing clinical trials and medical therapy development. At TruTechnologies, he leads efforts to revolutionize clinical trial oversight, accelerate timelines, and improve outcomes in healthcare research.

Blake Wu
New Enterprise Associates NEA

Blake Wu, Partner, Healthcare Team, New Enterprise Associates NEA

Blake joined NEA in 2014 and focuses on investments in digital health, healthcare services, and biopharmaceuticals. At NEA, Blake co-manages the firm’s digital health and healthcare services practice, across both venture and growth investing verticals. Additionally, Blake also co-manages the firm’s public biopharma investing practice and is also a member of the Asia investing team and is involved with the firm’s healthcare investments in the region. Prior to NEA, Blake was a member of the private equity group at Ares Management, focused on investments in healthcare. Blake’s prior work experience also includes investment banking at Moelis & Company, where he was focused on transactions in healthcare, as well as equity research at Barclays Capital. Blake graduated from The Wharton School at the University of Pennsylvania, with a B.S in Economics with concentrations in finance, real estate and management.

Jeremy Wyatt
ActiGraph

Jeremy Wyatt, CEO, ActiGraph

my Wyatt is the CEO of ActiGraph, a leading global provider of wearable digital health technology (DHT) solutions for clinical research. With two decades of embedded hardware systems development and related cloud technology expertise, Jeremy has a uniquely well-rounded perspective on the challenges and opportunities of deploying wearable technologies to capture accurate and meaningful patient-centric digital measures. He is considered an industry thought leader and expert in the clinical biosensor space and is a frequent representative and contributor at clinical drug development commercial events, scientific consortiums, and FDA/EMA regulatory meetings. He has an undergraduate degree in electrical engineering from the University of Florida and an MBA from the University of West Florida. Jeremy is a member and contributor to the Digital Medicine (DiMe) Society and participates in various digital biomarker efforts with the Clinical Trial Transformation Initiative (CTTI).

Stephanie Wylie
Takeda Pharmaceuticals, Inc

Stephanie Wylie, Senior Scientist, Sample Management, Bioanalytical and Biomarker Sciences and Technologies, Takeda Pharmaceuticals, Inc.

Stephanie is a Senior Scientist in Bioanalytical and Biomarker Sample Management at Takeda Pharmaceuticals, where they lead a team to ensure the regulatory compliance and lifecycle management of bioanalytical and biomarker samples for oncology and cell therapy clinical programs. With expertise in project management and cross-functional collaboration, Stephanie has driven the development of biomarker sample management platform implementation and streamlined processes to support high-quality translational data. Previously, as a Project Manager at NeoGenomics Laboratories, Stephanie led complex multi-modality programs for global pharma and biotech orginizations, generating $40 million in revenue. Stephanie’s experience spans lab operations at Covance and the University of Michigan, where she managed complex research projects and developed strategies for operational efficiency. Known for mentoring teams and fostering collaboration, Stephanie excels at navigating technical challenges and ensuring timely, high-quality results.

Bartosz Wylot
AstraZeneca

Bartosz Wylot, PhD, Associate Director, Risk Based Quality Management, AstraZeneca

No bio available.

Tai Xie
CIMS Global

Tai Xie, Founder & CEO, CIMS Global

Dr. Tai Xie, Founder and CEO of CIMS Global, boasts 20+ years' expertise in clinical trial design, data management, statistics, and reporting. Prior to CIMS, Tai held leadership positions in top-5 U.S. pharmaceutical organizations and led as CEO in biotech and data companies. He is also an adjunct assistant Professor of Biostatistics, School of Public Health at the Rutgers University and an active researcher, publishing papers

Lily Xu
Vertex Pharmaceuticals

Lily Xu, PhD, Senior Principal Data Scientist, Data Science, Vertex Pharmaceuticals, Inc.

Lily is a Senior Principal Data Scientist in the corporate data science team at Vertex Pharmaceuticals. Since joining the group 4 years ago, she has been focusing on building innovative data science solutions for trial operations in multiple pipeline disease areas with cross-functional teams. She is recognized as an expert super user of Real-World Data (RWD) in Vertex. Before coming to Vertex, Lily was a Research Scientist at Philips Research North America, where she worked on building clinical solutions for managing healthcare-acquired infections using genomic sequencing and data science. Lily completed her PhD from MIT and the Broad Institute on developing novel single-cell genomics technologies and obtained her bachelor’s degree in Bioengineering from UC Berkeley.

Shuai Steve Xu
Northwestern Memorial Hospital

Shuai Steve Xu, Assistant Professor of Dermatology & Medical Director, Querrey Simpson Institute for Bioelectronics, Northwestern Memorial Hospital

As a physician-engineer, Dr. Xu is interested in the translation of breakthrough electrical engineering, materials science, and health information technology towards addressing major unmet clinical needs. As Medical Director of the Center of Bio-Integrated Electronics, he has expertise within flexible device platforms, specifically phototherapy systems, addressing a wide range of dermatological and non-dermatological clinical needs. Previously, he has developed several medical device technologies across multiple medical fields including dermatology, orthopedics, cardiology and patient non-adherence that have raised competitive funding from government grants and private investors. As a health economist, his work focuses on the role of FDA regulation on medical device innovation and the development of policies that facilitate breakthrough innovation in healthcare. More recently, he has developed an interest in social media, cosmetics, and consumer healthcare. This work, naturally, has direct relevance to the public with his publications garnering press coverage from sources such as The New York Times, CNN, The Washington Post, and The Los Angeles Times

Hua Xu
Yale University

Hua Xu, PhD, Robert T. McCluskey Professor and Vice Chair for Research and Development, Department of Biomedical Informatics and Data Science; Assistant Dean for Biomedical Informatics, Yale School of Medicine

Dr. Hua Xu is Robert T. McCluskey Professor and Vice Chair for Research and Development, Section of Biomedical Informatics and Data Science at Yale School of Medicine (YSM), as well as Assistant Dean for Biomedical Informatics at YSM. He received his Ph.D. in Biomedical Informatics from Columbia University. His primary research interests include biomedical natural language processing (NLP), data mining, and generative AI, as well as their applications in secondary use of electronic health records data for clinical and translational research. His research is funded by multiple agencies (i.e., NLM, NCI, NIGMS, NIA, NIMH, AHA, and CPRIT), and methods/tools developed in his lab have been widely used to support diverse biomedical applications. He served as the Chair of American Medical Informatics Association (AMIA) NLP Working Group and now leads the Observational Health Data Sciences and Informatics (OHDSI) NLP Working Group. Dr. Xu is a fellow of both the American College of Medical Informatics (ACMI) and the International Academy of Health Sciences Informatics (IAHSI).

Jeffrey S Yablon
Ubuntu Research Inc

Jeffrey S. Yablon, Head Business Development & Strategic Operations, Ubuntu Research, Inc.

Dynamic Senior Level Life Science Executive with 20+ years experience in myriad aspects of life science management. Expansive skill set with direct functional responsibility in general management consulting, business development, budget, and financial analysis, marketing, mergers, and acquisitions, proven entrepreneur, educator, and significant international experience. Expertise in laboratory management, BioBanking, clinical research, medical imaging, and clinical technology to include: electronic data capture, interactive voice recognition systems, laboratory information systems, and clinical trial management systems. Successfully sold and marketed pharmaceutical and biotechnology products on a global basis. Specialties: I have over 20 years of experience in sales, marketing, operations, and general management with full P&L responsibility. I have held leadership positions in Pharmaceutical, biotechnology, and clinical research companies. Central laboratory management, BioBanking, IVRS (Interactive Voice Response Systems), EDC (Electronic Data Capture), ePRO (Electronic Patient Reported Outcomes), Clinical Supplies and Distribution, ECG, medical imaging services, Pharmacovigilance, Biometrics, BPO.

Brenda L Yanak
Clinical Transformation Partners

Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder, Clinical Transformation Partners LLC

Ms. Yanak is a Pharmaceutical & Central Lab executive known for successfully translating scientific strategy into clinical operations, via technology and innovation. She developed an Innovation Operating Model to pilot digital health and other ideas to transform drug development, and envisioned and led a multi-year strategic program to operationalize Precision Medicine at a Top 5 pharma, including transformation of the end-to-end specimen management policy, process, and technology infrastructure: standardizing protocols, digitizing informed consent, developing virtual specimen tracking, and using artificial intelligence to automate clinical study reports to expedite creation of big datasets for mining new biomarkers. Brenda has led transformative initiatives at several major companies, and acts as an Advisor to the Summit for Clinical Operations Executives (SCOPE).

Anna H Yang
Genentech Inc

Anna H. Yang, PharmD, Clinical Innovation & Technology Leader, Genentech, Inc.

Anna Yang, PharmD, is a Principal Clinical Innovation and Technology Leader in the US Medical Affairs Evidence Generation Team at Genentech. Anna leads discussions related to DCT strategy and implementation with study teams across the portfolio, infusing insights and best practices from industry partners. Anna cares deeply about inspiring change in the lagging adopters by sharing important lessons learned and reshaping assumptions. Anna is also curious about quantifying the value of DCT approaches and is actively involved with DTRA and the Tufts PACT cross-industry collaborations. Anna received her PharmD at the Rutgers Ernest Mario School of Pharmacy.

Rita P Yankyera
Elligo Health Research

Rita Yankyera, Assistant Medical Director, Elligo Health Research

Rita Yankyera is a highly skilled Clinical Research Professional with a rich background in healthcare. Originally from Ghana, West Africa, Rita obtained her bachelor's degree in nursing from the University of Cape Coast, Ghana before pursuing her Masters in Science (Family Nurse Practitioner) degree at Vanderbilt University in Nashville, Tennessee. With over 10 years of experience in nursing and clinical trial/research, Rita has developed expertise and made significant contributions to the field through her work in various therapeutic areas, including Nephrology and Kidney transplantation, Endocrinology, Cardiology, Rheumatology, Dermatology, Vaccines, and Infectious diseases. Her extensive experience spans working with both adult and pediatric patients from diverse ethnic and racial backgrounds. Rita is a Certified Clinical Research Coordinator (CCRC), demonstrating her commitment to maintaining the highest standards of professionalism and expertise in clinical research, and further highlighting her dedication to advancing the field of clinical research and ensuring the highest quality of patient care.

John R Yannone
Johnson & Johnson Innovative Medicine

John Yannone, Director, Feasibility Strategy, Innovative Health Engagement and Advocacy, Johnson and Johnson

John Yannone is a biochemist by education, holds a PMP certification as well as an M.B.A., and is speaking from over 18 years of experience spanning product manufacturing and development, project management and clinical trial feasibility. After a successful career of almost 20 years across companies including AstraZeneca and Novartis, John began working with J&J Innovative Medicine in 2016 and has held roles with increasing responsibility across global development. In his current role, John leads feasibility strategy across Innovative Medicine’s R&D - driving the process, business ownership for the feasibility tools and platforms and driving the adoption of the tools, as well as embedding the process into new ways of working.

Amy Yarker
NIHR Clinical Research Network

Amy Yarker, Senior Business Development Manager, Life Sciences Partnership & Growth, NIHR Clinical Research Network

Amy Yarker is a Senior Business Development Manager for the National Institute of Health and Care Research (NIHR), with extensive experience in the life sciences sector. In this role, Amy develops and maintains strategic relationships with stakeholders across commercial and non-commercial domains, fostering trust and collaboration to support research initiatives. As a key account manager, Amy provides tailored support for large study portfolios, enhancing the UK's reputation as a leader in clinical research. Amy partners with NIHR's industry collaborators, government departments, and strategic partners to promote the UK's research capabilities and facilitate access to NIHR infrastructure. By driving continuous service improvement, Amy meets customer needs and contributes to the strategic development of research capacity. Representing NIHR at national and international conferences, Amy advocates for the UK's research environment and delivers high-level briefings and policy recommendations. With a strong background in operational and financial management, Amy has led cross-functional teams to enhance patient engagement and drive commercial clinical research initiatives, ensuring the UK remains at the forefront of the life sciences industry.

Emily Zacherle
Novo Nordisk Inc

Emily Zacherle, Senior Director, Healthcare Data Strategy, Novo Nordisk, Inc.

Emily Zacherle, MS is an Associate Director, Real-World Evidence Partnership Studies at Novo Nordisk Inc. She is responsible for leading real-world evidence (RWE) studies in type 2 diabetes in collaboration with external partners. She has led the pilot evaluation and implementation of tokenization and data linkage within randomized pragmatic clinical trials and other clinical studies. Prior to Novo Nordisk, Inc., Emily had various roles within RWE and health economics and outcomes research teams at Ipsos and Precision Health Economics. She is currently pursuing her Doctor of Health Science in Population Health at Thomas Jefferson University and previously completed her MBA in Pharmaceutical and Healthcare Marketing at St Joseph’s University and MS in Applied Physiology at the University of North Carolina at Charlotte.

Demetris N Zambas
Pfizer Inc

Demetris Zambas, Vice President & Global Head, Clinical Data Sciences, Pfizer Inc.

Demetris is currently VP and Global Head of Data Monitoring and Management at Pfizer. Demetris started his career as a Laboratory Scientist in 1991 and transitioned into the Clinical Development space where he held roles of increasing responsibilities in Trial Management and Monitoring and led the implementation of the company’s first Clinical Trial Management system. In 2000, Demetris was a member and eventually the leader of the team which executed the industry’s first Tech-Transfer of a web based EDC system. He eventually led the Data Management and Standards organization and continued on to Merck & Co. following the merger in 2009. Subsequently Demetris was Vice President of Data Management at Novartis AG from 2014 to 2017. Since 2017 Demetris leads Pfizer’s Data Management and Risk Based Monitoring line functions in a new transformation; developing and transitioning into an internal operating model across multiple geographic sites in support of Pfizer’s portfolio. He also leads the Data and Automation work stream as part of Pfizer’s Development-wide transformation effort. He currently serves on multiple Boards, including SCDM’s Advisory Board, has served on the Board of Trustees and was the 2016 Chair.

Marjorie Zettler
Conjugate Group

Marjorie Zettler, PhD, MPH, Consultant, Clinical Sciences, Conjugate Group

Marjorie Zettler, PhD, MPH is Consultant, Clinical Sciences with the Conjugate Group and a 2022 Woman Worth Watching in STEM. An award-winning industry veteran with two decades of experience in clinical research, drug development, and regulatory strategy, she has published over 100 abstracts, manuscripts, book chapters, and patents.

Sheng Zhong
AbbVie Inc

Sheng Zhong, PhD, Director of Statistics, Data and Statistical Sciences, AbbVie, Inc.

Dr. Sheng Zhong is a Director of Statistics at AbbVie Inc. He received his Ph.D. in Statistics from the University of Chicago. At AbbVie, he led multiple innovative predictive modeling projects across different fields such as clinical trial enrollment duration forecasting, virtual controls based on targeted learning in single-arm trials, and predictive clinical safety monitoring based on structured and text data. His recent works have led to multiple publications and manuscripts under review. Before joining AbbVie in 2016, Dr. Zhong worked at a big data analytics start-up for heavy machine equipment maintenance, where his work led to 3 US patents.

Kelly H. Zou
Viatris

Kelly H. Zou, PhD, Head, Global Medical Analytics and Real-World Evidence, Viatris; Founder, AI4Purpose

Kelly H. Zou, Ph.D., PStat is Founder, AI4Purpose Inc. and Head of Global Medical Analytics, Real World Evidence, and Health Economics and Outcomes Research, Viatris Inc. She is an elected Fellow of the American Statistical Association and an Accredited Professional Statistician. Previously at Pfizer Inc, she was Vice President and Head of Medical Analytics & Insights; Senior Director of Real World Evidence, Group Lead of Methods & Algorithms and Analytic Science Lead; Senior Director of Statistics. She was Associate Professor of Radiology at Harvard Medical School, as well as Director of Biostatistics at its affiliated teaching hospitals. She was Associate Director of Rates at Barclays Capital. She received both MA and PhD degrees in Statistics from the University of Rochester. She completed her Postdoctoral Fellowship at Harvard. Her research interests include health policy, real world evidence, signal detection, and artificial intelligence, with over 150 professional articles and 5 books. She was featured as an Outstanding Woman in Data Analytics by Forbes, an Inspirational Women in Statistics & Data Science by Wiley, and an Accomplished Woman in Statistics and Data Science by the American Statistical Association. She was the winner of the Chief Data and Analytics Officers’ Forum’s Future Thinking Award, AI100 Award, as well as Reuters Events Pharma USA’s Most Valuable Data & Insights Initiative Team Award, a Trailblazing Woman in Pharma.

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2025年 方案

Sunday Golf, Kick-Off Keynote & Participant Engagement Award
週一高爾夫、開球主題演講、與會者參與獎

SCOPE’s Kickoff Reception
SCOPE的開幕酒會

Pre-Con User Group & Workshops
會前使用者群組及研討會