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Workshop I: Panel Discussion: Analytical
Date
January 22, 2024
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Panelists:
Emily English, Cartesian Therapeutics, Inc.
Phillip Kurs, CBER, FDA
Van Hoang, Spark Therapeutics, Inc.
Hetalben Patel, Pfizer, Inc.,
Da Ren, BioTherapeutics Solutions, Inc.
Session Chair
Speakers
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Workshop I: Analytical
PLATFORM TECHNOLOGIES DESIGNATION PROGRAM: HIGHLIGHTS OF STATUTORY LANGUAGE
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…
Workshop II: Process - Panel Discussion & Closing Remarks
Carl Frye & Ronan Kelly, _Eli Lilly and Company _
Workshop III: Product In-Use: Meeting Patient and User Needs
PATIENT AND USER-CENTRIC CONSIDERATIONS ON IN-USE STUDY DESIGN
