Keynote 2

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Keynote Session 2: Challenges and opportunities for rare disease drug development

Friday, Aug 14th, 2025

Speaker: Dr. Lei Nie, Division Director, FDA
FDA

Nie Lei Dr. Lei Nie is the Division Director of Division of Biometrics IV in the Office of Biostatistics, OTS/CDER/FDA. He is interested in developing and promoting innovative statistical methods in drug development.

Abstract

TBD