Informa
TIDES USA: Oligonucleotide & Peptide Therapeutics
2025年5月19-22日
美國加州聖地牙哥, Manchester Grand Hyatt San Diego

Pre-Conference Day (May 19)

7:30am - 8:30am60 mins
Registration
    8:30am - 9:00am30 mins
    Breakfast Spotlight Presentations 1
    CMC Best Practices and Lessons Learned in Manufacturing from Sequence to IND for a Gene Editing Program
    • Melanie Cerullo - Cheif Quality and Regulatory Officer, ReciBioPharm
    8:30am - 9:00am30 mins
    Breakfast Spotlight Presentations 2
    Purification of Oligonucleotides Using Reverse Phase and Anion Exchange Resins
    • Hadi Fares, PhD - Senior Scientist, DuPont Water Solutions
    8:30am - 9:00am30 mins
    Breakfast Spotlight Presentations 3
    Wave Your Way to Success: Unboxing Long RNA Synthesis Aiming for Scale-up
    • Gregory Farlow - Senior Oligonucleotide Product Sales Specialist, Cytiva
    9:00am - 12:30pm210 mins
    Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
    Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
    • Mike Webb, Ph.D. - Founder and CEO, Mike Webb Pharma
    9:00am - 9:10am10 mins
    Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
    Workshop Leaders’ Welcome and Opening Remarks
    • G. Susan Srivatsa, PhD - President, ElixinPharma
    • Fran Wincott, PhD - President, Wincott & Associates, LLC
    9:00am - 9:05am5 mins
    Workshop AM3: Introduction to Genome Editing and Delivery
    Workshop Leaders’ Welcome and Opening Remarks
    • Steven Wolk, PhD - President, Siniwali Biotechnology Solutions
    • John Zuris, PhD - Director of Delivery and Editing Technologies, Editas Medicine
    9:00am - 9:10am10 mins
    Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
    Workshop Leader’s Welcome and Opening Remarks
    • Dave Garman, PhD - VP of Translation and Development, ProteinQure
    9:05am - 9:45am40 mins
    Workshop AM3: Introduction to Genome Editing and Delivery
    The History and Evolution of Genome Editing
    • John Zuris, PhD - Director of Delivery and Editing Technologies, Editas Medicine
    9:10am - 9:40am30 mins
    Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
    Evolution of Oligonucleotide Therapeutics: Impact on Manufacturing and CMC Strategy
    • James Powell - SVP, Manufacturing, Dicerna Pharmaceuticals
    9:10am - 9:45am35 mins
    Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
    Introduction to Fast Tracking to First in Humans and CMC Requirements and Considerations
    • Dave Garman, PhD - VP of Translation and Development, ProteinQure
    9:40am - 10:10am30 mins
    Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
    Oligonucleotide Solution API: Navigating the Regulatory Landscape
    • Chris Chorley - Associate Director, Regulatory Affairs CMC, Biogen
    9:45am - 10:30am45 mins
    Workshop AM3: Introduction to Genome Editing and Delivery
    Genome Editing Modalities and Their Applications
    • John Zuris, PhD - Director of Delivery and Editing Technologies, Editas Medicine
    9:45am - 10:30am45 mins
    Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
    ADME of Peptides to Support First in Human Studies
    • Jennifer Martin - Senior Advisor, ADME, Eli Lilly and Company
    10:10am - 10:40am30 mins
    Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
    The Impact of Manufacturing Innovation on Clinical Development: Manufacturing Controls and Regulatory Strategy
    • Martin Johnson, PhD - Vice President, Engineering, Eli Lilly
    10:30am - 11:00am30 mins
    Workshop AM3: Introduction to Genome Editing and Delivery
    Networking Refreshment Break
      10:30am - 11:00am30 mins
      Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
      Networking Refreshment Break
        10:40am - 11:10am30 mins
        Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
        Networking Refreshment Break
          11:00am - 11:45am45 mins
          Workshop AM3: Introduction to Genome Editing and Delivery
          Optimizing Ex Vivo and In Vivo Applications
          • Steven Wolk, PhD - President, Siniwali Biotechnology Solutions
          11:00am - 11:45am45 mins
          Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
          Toxicity and Safety Pharmacology Studies to Support First in Human Studies
          • Peter Korytko, Ph.D. - President, Preclinical GPS
          11:10am - 11:40am30 mins
          Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
          Establishing an RNAi Production Strategy for Large Indications
          • Kurt Vagle - Senior Director - Chemical Development RNAi CMC, Novo Nordisk
          11:40am - 12:10pm30 mins
          Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
          A Ligation Platform Approach to Enzymatic Oligonucleotide Assembly
          • Doug Fuerst - Executive Director, GSK
          11:45am - 12:30pm45 mins
          Workshop AM3: Introduction to Genome Editing and Delivery
          The Current Status Genome Editing Applications in the Clinic
          • Steven Wolk, PhD - President, Siniwali Biotechnology Solutions
          11:45am - 12:30pm45 mins
          Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
          The Importance of CMC and Safety Studies in the Design and Execution of First in Human Studies
          • Bruce Morimoto, PhD - Drug Development Advisor, Alto Neuroscience
          12:10pm - 12:30pm20 mins
          Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
          Panel Discussion with Workshop Speakers
            12:30pm - 12:45pm15 mins
            Close of Workshops and Transition to Luncheon Spotlight Presentation Rooms
              12:45pm - 1:15pm30 mins
              Spotlight Presentation Luncheon 1
              Feasibility of GAP-PS Technology for GLP-1 Peptide Synthesis
              • Cole Seifert, PhD - Research & Technology Specialist, Croda Inc.
              12:45pm - 1:15pm30 mins
              Spotlight Presentation Luncheon 2
              Available for Sponsorship. Contact Jennifer.Wickett@informa.com for details.
                12:45pm - 1:15pm30 mins
                Spotlight Presentation Luncheon 3
                An Enhanced Processing Approach for TFF
                • Martin Leuthold, PhD - Head of PD Filtration and Chromatography Consumables, Sartorius
                1:15pm - 1:30pm15 mins
                Short Networking Break
                  1:30pm - 1:35pm5 mins
                  Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
                  Workshop Leader’s Welcome and Opening Remarks
                  • Swagatam Mukhopadhyay, PhD - Co-founder & Chief Scientific Officer, Creyon Bio
                  1:30pm - 5:00pm210 mins
                  Workshop PM2: Introduction to Analytical Control Strategies for Therapeutic Oligonucleotides
                  Workshop PM2: Introduction to Analytical Control Strategies for Therapeutic Oligonucleotides
                  • Mike Webb, Ph.D. - Founder and CEO, Mike Webb Pharma
                  1:30pm - 1:35pm5 mins
                  Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
                  Workshop Leaders' Welcome and Opening Remarks
                  • Jan Nickolaus, PhD - Head of Quality Control, BioSpring GmbH
                  • Claus Rentel, PhD - Vice President, Analytical Development/QC, Ionis Pharmaceuticals, Inc.
                  1:30pm - 1:35pm5 mins
                  Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
                  Workshop Leader’s Welcome and Opening Remarks
                  • Marc Jacob, PhD - Head of Strategic Development, Chromatography Products, YMC America
                  1:35pm - 2:05pm30 mins
                  Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
                  Foundation Models: A New Hope for Emergent Drug Discovery Intelligence
                  • Brendan Frey, PhD - Founder and Chief Innovation Officer, Deep Genomics
                  1:35pm - 2:15pm40 mins
                  Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
                  Structure, Detection, Formation, and Potential for Purging of Impurities in ASO and siRNA Oligonucleotides
                  • Brandon Bock - Associate Director, Analytical Development/QC, Ionis Pharmaceuticals
                  1:35pm - 2:10pm35 mins
                  Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
                  Continuous Manufacturing of Tirzepatide Using Online UHPLC-Based PAT: An Enabling Technology for Commercialization of a Synthetic Peptide
                  • Stephen Groskreutz, PhD - Senior Director of Analytical Development in Bioproduct Research and Development, Eli Lilly and Company
                  2:05pm - 2:35pm30 mins
                  Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
                  Advancements in DNA-to-RNA Modeling and Implications for Oligo Design
                  • Kalin Vetsigian, PhD - Senior Director, AI & Machine Learning, GSK
                  2:10pm - 2:45pm35 mins
                  Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
                  Process Intensification in Large Scale Peptide Manufacturing
                  • Olivier Ludemann-Hombourger, PhD - Director, Global Innovation and Technology, PolyPeptide Group
                  2:15pm - 3:00pm45 mins
                  Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
                  Elucidating guide RNA Purity and Impurities through NGS and LC-MS(/MS) Technologies
                  • Jan Nickolaus, PhD - Head of Quality Control, BioSpring GmbH
                  2:35pm - 3:05pm30 mins
                  Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
                  Modeling Nucleic Acids at Creyon Bio
                  • David Pekker, PhD - Senior Director, Theory, Creyon Bio
                  2:45pm - 3:20pm35 mins
                  Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
                  Breaking with Traditions: Supporting Next Generation Peptide and Oligonucleotide Drugs with Intensified Processes
                  • Ralf Eisenhuth, PhD - Principal Scientist, Bachem AG
                  3:00pm - 3:30pm30 mins
                  Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
                  Networking Refreshment Break
                    3:05pm - 3:30pm25 mins
                    Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
                    Networking Refreshment Break
                      3:20pm - 3:50pm30 mins
                      Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
                      Networking Refreshment Break
                        3:30pm - 4:00pm30 mins
                        Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
                        Machine Learning Designs New GCGR/GLP- 1R Dual Agonists with Enhanced Biological Potency
                        • Anna Puszkarska, PhD - Machine Learning Lead, Sanofi
                        3:30pm - 4:15pm45 mins
                        Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
                        LC and MS Strategies for Streamlined Digested Oligo Mapping of RNA Based Therapeutics and Vaccines
                        • Martin Gilar, PhD - Research Fellow, Waters Corporation
                        3:50pm - 4:25pm35 mins
                        Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
                        Evolve Flow Chemistry into Liquid Phase Peptide Synthesis Technology
                        • Eric Fang, PhD - General Manager and Site Head, Snapdragon Chemistry, a Cambrex Company
                        4:00pm - 4:30pm30 mins
                        Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
                        Peptide Hit Discovery and Optimization Using Machine Learning and Small Peptide Arrays
                        • Ewa Lis, PhD - Founder and CEO, Koliber Biosciences
                        4:15pm - 5:00pm45 mins
                        Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
                        Validation and Use of Platform Methods for Oligonucleotide Therapeutics
                        • Jonathan Chan - Assistant Director, Analytical Development/Quality Control, Ionis Pharmaceuticals
                        4:25pm - 5:00pm35 mins
                        Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
                        Continuous Peptide Synthesis via Flow Mechanochemistry
                        • Frederic Lamaty, Ph.D. - Director of Research, Head of Green Chemistry Team, University of Montpellier
                        4:30pm - 5:00pm30 mins
                        Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
                        Exploring Chemical Giga Spaces for New Drug Candidates with Complex Target Profiles
                        • Ruben Abagyan, PhD - Professor, University of California, San Diego
                        5:00pm - 5:05pm5 mins
                        Close of Workshops
                          NextMain Conference - Day 2 (May 21)

                          * 活動內容有可能不事先告知作更動及調整。