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Session 5 - Clinical Perspectives
Session Chair(s)
Stan Bukofzer, MD
Corporate Vice President and Chief Medical Officer
Hospira, Inc., United States
Speaker(s)
Constructs of Biosimilar Approval
Rachel Sherman, MD, MPH
Duke Margolis Center for Public Policy, United States
Senior Policy Fellow
FDA Draft Guidance Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
Darrell R. Abernethy, MD, PhD
FDA, United States
Associate Director for Drug Safety, Office of Clinical Pharmacology, CDER
Biosimilars - Totality of Evidence for Regulatory Approval
Vladimir Hanes
Amgen, United States
Medical Director
Extrapolation
Sumant Ramachandra, MD, PhD, MBA
Hospira, Inc., United States
Chief Scientific Officer & Senior VP of R&D and Medical Regulatory Affairs
Interchangeability
Stan Bukofzer, MD
Hospira, Inc., United States
Corporate Vice President and Chief Medical Officer
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
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