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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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PLATFORM TECHNOLOGIES DESIGNATION PROGRAM: HIGHLIGHTS OF STATUTORY LANGUAGE
Workshop III: Product In-Use: Meeting Patient and User Needs
PATIENT AND USER-CENTRIC CONSIDERATIONS ON IN-USE STUDY DESIGN
CASSS Welcome and CMC Strategy Forum 2024 Introductory Comments
Platform technologies are used extensively across the biopharmaceutical industry to develop drugs efficiently and effectively. The application of prior knowledge and platforms from established products lays a strong foundation to guide development and advance new medicines to the patients…
