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Workshop II: Process
Date
January 22, 2024
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Session Speakers:
Incorporation of Platform Based Approaches and Prior Knowledge Leveraging Into the Recently Revised ICH Q5A (R2) Guideline
Kathryn King, CDER, FDA
Power of Platform to Accelerate Therapies Beyond a Pandemic
Ronan Kelly, Eli Lilly and Company
Leveraging Platforms to Accelerate ADC Formulation and Drug Product Development
Karen Rutherford, Pfizer Inc.
Continuous Platform Improvement to Propel Drug Substance Development,
Heather Nunn, Amgen Inc.
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