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Opening Remarks and Session 1: Regulatory Updates and Experiences
Session Chair(s)
Maria Vassileva, PHD
Chief Science and Regulatory Officer, DIA, United States
Tamei Elliott, MS
Director, Global Scientific Content, DIA, United States
Satrajit Roychoudhury, PHD
Executive Director, Statistical Research and Innovation, Pfizer, United States
Yun Wang, PHD
Deputy Division Director, CDER/OTS/OB, FDA, United States
Opening Remarks and Session 1: Regulatory Updates and Experiences
Speaker(s)
ShaAvhree Y. Buckman-Garner, MD, PHD
Director, Office of Translational Sciences, CDER , FDA, United States
The Mission of the New Initiative on Clinical Trial Innovation (C3TI) at FDA
Gregory Levin, PHD
Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA, United States
Regulatory Updates on Several Statistical Topics
Sarah Yim, MD
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA, United States
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Current Science and Considerations in 2025
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