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DIA 2021 Global Annual Meeting


Scientific Advances in Biosimilar Development

Session Chair(s)

Rachel  Turow, JD, MPH

Rachel Turow, JD, MPH

  • Associate General Counsel, Regulatory Law & Policy; Head, U.S. Regulatory Policy
  • Teva Pharmaceutical Industries Ltd., United States
Current biosimilar development timelines are long and ultimately require a clinical study, even though the clinical study is confirmatory. This session will discuss the need for better science to limit the need for clinical data.
Learning Objective : Discuss the challenges to demonstrating biosimilarity without clinical data; Describe the future of biosimilar development and advancing science to speed these products to market.

Speaker(s)

Stacey  Ricci, DrSc

FDA Update

Stacey Ricci, DrSc

  • Director, Scientific Review Staff, OTBB, OND, CDER
  • FDA, United States
Denis  Arsenault, MA

Health Canada Update

Denis Arsenault, MA

  • Manager, Policy Development
  • Health Canada, Canada
Martin  Schiestl, PhD

Industry Update

Martin Schiestl, PhD

  • Global Head Regulatory Affairs Policy
  • Sandoz GmbH, Austria
Leah  Christl, PhD

Can a Biosimilar Be Unique? Differentiation Opportunities for Biosimilars

Leah Christl, PhD

  • Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
  • Amgen, United States
Gopinath  Ranganna, FFPM

Industry Update

Gopinath Ranganna, FFPM

  • Associate Vice President, Global Clinical Development
  • Viatris, India