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May 9 (Thu) 13:30~16:45, Rm.327
Co-Located 10. Manufacturing and RA Strategy in Developing ADC and Multi-Specific Antibodies
Strategic Development of ADC and Multi-Specific Antibodies
   In order to support ADC & Multi-specific Ab developing company by providing know-how in manufacturing by sharing experience from a CDMO, Shanghai OPM Bioscience, and updated information on ICH Q5A
    Global trend of regulatory acceptance of the molecules and US FDA's point-of-view are also shared by key experts from Certara.
  • Session Chair
  • Julie YI Managing Director, MedClaris Inc.
  • Optimizing the Biomanufacturing Landscape: A Chemically-Defined Media Approach to Achieve Cost-Effective and High-Yield Production of Biotherapeutics
  • Zhihua XiaoCEO, OPM Biosciences Ltd., Co.
  • 13 : 30 ~ 14 : 00
  • Characterisation and Release tests for ADC and Multi-Specific Antibodies
  • LucAlain SavoyGlobal Head Biologics, Health Science - Drug Development, SGS Société Générale de Surveillance SA
  • 14 : 00 ~ 14 : 30
  • Biosafety Testing of Biologics, with Consideration to Recent Changes to ICH Q5A Viral Safety Evaluation
  • Nicola SillarsTechnical Project Manager, SGS Vitrology Ltd
  • 14 : 30 ~ 15 : 00
  • Bispecific and Genetic Therapies Towards Orphan Drug Development in Context of Regulatory and Unmet Market Demand
  • Hailin ZhaoChief Development Officer, Division of Corporate Development, EYEGENE
  • 15 : 15 ~ 15 : 45
  • How QSP Brings Insights and Accelerates Bispecific Antibody Drug Development 1
  • Piet van der GraafVice President of Modeling and Simulation Services, Quantitative Systems Pharmacology, Certara
  • 15 : 45 ~ 16 : 00
  • How QSP Brings Insights and Accelerates Bispecific Antibody Drug Development 2
  • Fei HuaVice President of Modeling and Simulation Services, Certara
  • 16 : 00 ~ 16 : 15
  • FDA Expectations for Biologics Drug Development to Support IND and BLA
  • Geoff FatzingerVice President, Regulatory Strategy, Certara
  • 16 : 15 ~ 16 : 45
 

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