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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, Inc., 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)
The Mission of the New Initiative on Clinical Trial Innovation (C3TI) at FDA
ShaAvhree Y. Buckman-Garner, MD, PhD
FDA, United States
Director, Office of Translational Sciences, CDER
Regulatory Updates on Several Statistical Topics
Gregory Levin, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Current Science and Considerations in 2025
Sarah Yim, MD
FDA, United States
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
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