2024年11月4日（一） 14:00 - 17:00
SC1: Developability of Bispecific Antibodies: Formats and Applications
Bispecific antibodies are a rapidly growing and clinically validated class of antibodies with marketed drugs and multiple candidates in clinical trials. Targeting multiple antigens in a synergistic manner can confer enhanced therapeutic benefit and potentially uncover novel biological mechanisms. However, multiple formats and a tedious candidate selection process to select functional and developable bispecific antibodies makes such programs cumbersome. This short course highlights the rapid growth in the field, therapeutic applications, and focuses on challenges with discovery and development of bispecific antibodies. We will use an approved bispecific antibody as a case study to understand the varied aspects of discovery and development of bispecific antibody programs.
14:00 Developability of Bispecific Antibodies: Formats and Applications
Nimish Gera, PhD, Vice President, Biologics, Mythic Therapeutics
Topics to be covered:
- Introduction to bispecifics and bispecific formats
- Therapeutic applications of bispecific antibodies
- Developability of bispecifics
- Case study: discovery and development of an FDA-approved bispecific antibody
INSTRUCTOR BIOGRAPHIES:
Nimish Gera, PhD, Vice President, Biologics, Mythic Therapeutics
Nimish Gera is the Vice President of Biologics at Mythic Therapeutics leading multiple projects to engineer and develop novel antibody and antibody-based drugs in oncology and immuno-oncology. Prior to Mythic, Nimish has over fifteen years of experience in antibody and protein engineering with five years leading bispecific antibody programs in several disease areas such as rare diseases, oncology, and immunology at Alexion Pharmaceuticals and Oncobiologics. Nimish received his PhD degree in Chemical and Biomolecular Engineering from North Carolina State University and a B.Tech degree in Chemical Engineering from Indian Institute of Technology, Guwahati.
SC2: Advanced Applications of SPR & BLI Biosensors for Drug Discovery and Development
The surface plasmon resonance (SPR) and bio-layer interferometry (BLI) biosensors stand as the cornerstone real-time label-free (RT-LF) platforms for characterizing protein-protein interactions. Traditionally used for determining critical antibody binding affinities in lead therapeutic molecule selection, these biosensors now face evolving demands. With advancements in protein engineering and regulatory agencies mandating deeper elucidation of mechanism of action, there is a continued need to design sophisticated SPR and BLI assays. This short course aims to unveil novel approaches in designing SPR/BLI assays that emulate biological processes on the chip, along with the challenges encountered in their development. Various assays instrumental in identifying multiple clinical molecules will be showcased, highlighting the importance of SPR/BLI assays. Innovative assays tailored specifically for assessing the mechanism of action of clinical candidates which has become an integral part of the IND filing process, will also be presented. Attendees will gain valuable insights into harnessing these cutting-edge techniques to bolster their research endeavors and regulatory submissions.
14:00 Advanced Applications of SPR & BLI Biosensors for Drug Discovery & Development
Vishal Kamat, PhD, Senior Director, Protein Sciences, Ampersand Biomedicines
Topics to be covered include:
- Introduction to SPR & BLI assays.
- Impact of capture antibody on the reliability of measured binding kinetic values.
- Blocking assays & limitations of different assay formats.
- High throughput pH screening of mAbs for extended half-life mechanism.
- Epitope binding assays and their limitations.
- Thermodynamics of binding interaction & its implication on lead selection.
- Case study: Discovery & development of multiple clinical candidates.
INSTRUCTOR BIOGRAPHIES:
Vishal Kamat, PhD, Senior Director, Protein Sciences, Ampersand Biomedicines
Vishal (Vish) Kamat is an innovative and collaborative leader with 17 years of experience in the field of biotherapeutics and biophysical characterization of antibodies and proteins. He has supported the discovery and development of antibodies for 150+ targets which yielded 20 clinical drug candidates and 3 market-approved drugs - DUPIXENT, LIBTAYO, and EVKEEZA. He also has extensive experience in high throughput screening of antibodies using diverse platforms such as SPR, BLI, KinExA, Gyrolab, MSD and Luminex. His scientific excellence is evident by multiple peer-reviewed publications in high impact journals, patent approvals and IND reports. After a 12-year career at Regeneron Pharmaceuticals where he held positions of increasing responsibility from postdoctoral candidate to Sr. Staff Scientist, he worked as a Director of Antibody Characterization at Twist Biopharma and is currently working as a Senior Director of Protein Sciences at Ampersand Biomedicine. Vishal holds a PhD in Biomedical Engineering from Drexel University and BS in Electronics Engineering from University of Mumbai.
SC3: Tools for Cell Line Engineering and Development
Where are we heading to? We are heading to the future of tools for Cell Line Engineering and Development. The first question we ask is "how early can we go to clinic"? Then, we move to look at landing pads-are they really the future? This course will also address genetic engineering and new biologics platforms.
14:00 Tools for Cell Line Engineering and Development
Mario P. Pereira, PhD, Director of Technology & Business Development, ATUM
Where are we heading to?
1) Pool MCB for early stages clinical work-how early can we go to clinic?
2) Landing-pads-are they really the future?
3) Genetic engineering
- Which Technologies can I use?
- What to engineer and how to find it?
- Which problems can it solve?
- How to identify
4) New Biologics platforms
- Cell Line Development platforms for rAAV and Lentiviral production
- What can we learn from producing protein biologics and where are we heading to?
INSTRUCTOR BIOGRAPHIES:
Mario P. Pereira, PhD, Director of Technology & Business Development, ATUM
Mario Pereira has a diverse work experience history. Mario is currently the Director of Technology and Business Development at ATUM since March 2023. Prior to this, they worked at Horizon Discovery from 2016 to 2023 in various roles including Strategic Account Manager, Field Application Scientist, and Senior Scientist. At Horizon Discovery, they were responsible for commercial activities, technical input in pre and post-sales, and development of the CLD platform. Mario also worked as a Principal Scientist at FUJIFILM Diosynth Biotechnologies from 2015 to 2016, focusing on developing recombinant CHO cell lines. Mario Pereira completed their Biotechnology PhD at the University of Manchester from 2011 to 2015, where their research focused on genomic environment for recombinant gene expression. Mario has also been involved in various outreach and community activities, including roles at PARSUK and Oxbridge Biotech Roundtable.
Mario Pereira began their education in 2005 at the Universidade de Coimbra, where they obtained a Bachelor of Science degree in Biochemistry in 2008. Following this, they pursued a Master of Science degree in Biochemistry from the same institution, completing their studies in 2010. Mario then continued their academic journey at The University of Manchester, where they enrolled in a Doctor of Philosophy program in Biotechnology. Mario successfully completed their PhD in 2015, thus furthering their expertise in the field.
SC4: In silico and Machine Learning Tools for Antibody Design and Developability Predictions
In silico developability predictive platforms offer promising screening support to identify optimal properties of a candidate biotherapeutic at early stages. Predicting your biologic’s developability can help avoid instability problems during later development and impede significant economic consequences.
14:00 In silico and Machine Learning Tools for Antibody Design and Developability Predictions
Rahmad Akbar, PhD, Senior Data Scientist, Antibody Design, Novo Nordisk
Philip M. Kim, PhD, Professor, Molecular Genetics & Computer Science, University of Toronto
Shipra Malhotra, PhD, Senior Scientist, Biologics, Computational Biology and Machine Learning, Takeda
In silico developability predictive platforms offer promising screening support to identify optimal properties of a candidate biotherapeutic at early stages. Predicting your biologic's developability can help avoid instability problems during later development and impede significant economic consequences.
Topics to be covered include:
- Revealing a Global Biologics Research Informatics
- Platform integrating in silico prediction and lab experiment data to fast-forward biologics drug design and development
- Putting the platform into practice with biologic discovery use cases
- Elucidating process development best practices with use cases from Takeda
INSTRUCTOR BIOGRAPHIES:
Rahmad Akbar, PhD, Senior Data Scientist, Antibody Design, Novo Nordisk
At Novo Nordisk, Rahmad enables patients to realize their greatest potential by catalysing antibody design. He leverages experimental data, molecular simulation, and artificial intelligence to build computational oracles and to design antibody therapeutics faster, smarter, and cheaper.
Philip M. Kim, PhD, Professor, Molecular Genetics & Computer Science, University of Toronto
Philip M. Kim is a Professor at Donnelly Centre at the University of Toronto. He leads a research laboratory that integrates machine learning, physics-based modeling and wet/experimental methods for engineering of biologics. He is a Co-founder of Resolute Bio, a drug development startup company. He authored over 70 publications, 7 invention disclosures and 3 patent applications. Before to setting up his lab in 2009, he was a postdoctoral fellow at Yale University where he pioneered structural analyses of protein interactions networks and an associate with McKinsey & Co. He holds a Ph.D. from the Artificial Intelligence Laboratory and Department of Chemistry at the Massachusetts Institute of Technology and a B.S. in Biochemistry and Physics from the University of Tuebingen.
Shipra Malhotra, PhD, Senior Scientist, Biologics, Computational Biology and Machine Learning, Takeda
PhD in Computational Biology from the University of Kansas, with a focus on data collection, analysis, and interpretation, as well as the development and implementation of cutting-edge in silico tools for drug discovery and design. Currently, as a Senior Scientist at Takeda Pharmaceuticals, I spearhead the design, characterization, and optimization of therapeutic candidate drugs through computational analysis of protein sequence and structure, computational protein design, and engineering. I'm deeply engaged in pioneering AI-driven approaches to generate human-like proteins, particularly in the domain of antibody-based therapeutics.
SC5: Best Practices for Targeting GPCRs, Ion Channels, and Transporters with Monoclonal Antibodies
Complex membrane proteins are important therapeutic targets and together represent the majority of protein classes addressed by therapeutic drugs. Significant opportunities exist for targeting complex membrane proteins with antibodies, but it has been challenging to discover therapeutic antibodies against them. This course will examine emerging technologies and strategies for enabling the isolation of specific and functional antibodies against GPCRs, ion channels, and transporters, and highlight progress via case studies.
14:00 Best Practices for Targeting GPCRs, Ion Channels, and Transporters with Monoclonal Antibodies
Ross Chambers, PhD, Vice President, Antibody Discovery, Integral Molecular, Inc.
Complex membrane proteins are important therapeutic targets and together represent the majority of protein classes addressed by therapeutic drugs. Significant opportunities exist for targeting complex membrane proteins with antibodies, but it has been challenging to discover therapeutic antibodies against them. This course will examine emerging technologies and strategies for enabling the isolation of specific and functional antibodies against GPCRs, ion channels, and transporters, and highlight progress via case studies.
INSTRUCTOR BIOGRAPHIES:
Ross Chambers, PhD, Vice President, Antibody Discovery, Integral Molecular, Inc.
Ross Chambers is the Vice President of Antibody Discovery at Integral Molecular. He pioneered the use of DNA immunization for antibody production and developed Integral Molecular’s MPS system for isolating antibodies. Dr. Chambers earned his PhD from the University of Otago, New Zealand, and did post-doctoral studies at UC Davis and Berkeley. Before joining Integral Molecular, he was the Director of R&D at SDIX and directed the discovery of thousands of commercial antibodies.
SC6: Introduction to Immunogenicity of Biotherapeutics
This session provides clear definitions of the unwanted immune responses due immunogenic drugs, the workshop will cover how to appropriately collect, analyze, and report potential immunogenic adverse events; assessment and management strategies in alignment with regulatory agencies immunogenicity guidelines. Researchers and clinicians will effectively identify, evaluate, report, analyze, and manage potential immunogenic adverse events, ultimately ensuring the safety and well-being of individuals receiving the treatment.
14:00 Introduction to Immunogenicity of Biotherapeutics
Sophie Tourdot, PhD, Immunogenicity Sciences Lead, BioMedicine Design, Pfizer Inc.
Maria-Dolores Vazquez-Abad, PhD, Vice President, Clinical Immunogenicity, Pfizer Inc.
This hands-on workshop will provide attendees with clear examples of how to characterize anti-drug antibody (ADA) results in clinical trials and how to evaluate their impact on significant clinical outcomes in alignment with regulatory agencies' expectations and immunogenicity guidelines. Attendees will work in teams to discuss the examples provided and will then present the summary of each team’s discussion on how the data should be analyzed, what the interpretation of the results is, and how to articulate the key message related to immunogenic risk identified in each protocol, as well as integrating the immunogenicity clinical data for the dossier. Attendees will effectively understand how the risk of immunogenic responses analyzed from clinical trials is reported and what the potential immunogenic adverse events identified are, ultimately ensuring the safety and well-being of individuals receiving the treatment. Join us to learn about:
- Clinical Trial Design: How and when to collect samples to characterize anti-drug antibodies (ADA). How to analyze and report the results of ADA from clinical trials, in alignment with regulatory agencies' immunogenicity guidelines
- Statistical Analysis Plan: Examples on how to assess the impact of ADA on clinically meaningful outcomes.
- Collection of Data: How to collect Injection Site Reactions (ISR) and/or Infusion Related Reactions (IRR) for each administered dose, and how to use the data in the programmed algorithms for analyses and reporting
- Medical Evaluation: Utilizing standardized assessments to evaluate all safety events and identify if they are potential acute or delayed immunogenic reactions against the therapeutic drug
- Assess if presence of ADA had a clinically significant impact on potential Immunogenic Adverse Events
- Identify the risk of potential Immunogenic Adverse Events and their significant impact on clinical outcomes for each program to inform risk-benefit considerations
INSTRUCTOR BIOGRAPHIES:
Sophie Tourdot, PhD, Immunogenicity Sciences Lead, BioMedicine Design, Pfizer Inc.
Sophie received her PhD in T cell vaccine immunology from the Université Paris Cité, France. Following her postdoctoral trainings at Imperial College London, she worked at the Pasteur Institute on HIV vaccine design, then progressed to Stallergenes-Greer and ITS. There, she led the pre-clinical immunology teams, assessing respiratory allergic diseases desensitization immunotherapy and vaccines for infectious diseases, respectively. She transitioned to the French National Research Institute for Health and Medical Research in 2012 as a key leadership member of the IMI-funded ABIRISK project, a consortium focused on the analysis of underlying biological mechanisms, clinical relevance, and prediction of unwanted immunogenicity of biopharmaceuticals. Sophie joined Pfizer’s BioMedicine department in 2017 where she now leads the Immunogenicity Sciences group, in charge of immunogenicity risk assessment of Pfizer biologics portfolio at all stages of development. She also acts as Director of Scientific Affairs for the European Immunogenicity Platform.
Maria-Dolores Vazquez-Abad, PhD, Vice President, Clinical Immunogenicity, Pfizer Inc.
Dr. Vázquez-Abad is recognized as a skilled teacher and mentor; through over two decades at Pfizer she has created and presented educational materials to colleagues at Pfizer and to external audiences covering topics such cytokine signaling, immunogenicity, drug development process, immuno-oncology, and mechanism of action of drugs. Some of her talks are available in her YouTube Channel.
Dr. Vázquez-Abad graduated as a medical doctor from the National Autonomous University of Mexico (UNAM). She began her career providing patient care in socially marginalized communities around Mexico City’s “poverty belt” and later she spent a year as a resident in the Southeast Jungle of Mexico, living among and treating underserved communities. She did her residency in Internal Medicine at the Hospital de Petróleos Mexicanos in Mexico City and her rheumatology fellowship at the National Institute of Cardiology in Mexico. She further trained in cellular, humoral, and molecular immunology at University of Texas Southwestern, and Cold Spring Harbor Laboratories, NY USA completing a post-doctoral fellowship in rheumatology at the University of Connecticut Health Center in the USA, where she became an Assistant Professor until joining Pfizer in 1998 as clinical lead and in 2007 she was the Inflammation Therapeutic Area Clinical Lead, managing a portfolio of over 15 compounds. From 2009 to 2014 she became the development lead of the inflammation portfolio for the Emerging Market countries. In 2014 she became Vice President, Chief Medical Officer of the Immunoscience Research Unit in Pfizer at Cambridge, Massachusetts, and later Chief Medical Head of Clinical Research, at the Immunology and Inflammation Research Unit. In 2015, she joined the Biosimilars teams as Head of Clinical and in 2019, she became the I&I Global Clinical Lead across the Biosimilars portfolio; in 2022 she became Medicine Team Leader, Clinical Immunogenicity, Pfizer, Cambridge, MA, leading the Immunogenicity Clinical Interpretation and she co-chairs Immunogenicity Advisory Council at Pfizer.
