Learning Tracks

This session will consider the challenges for biosimilars development and regulatory assessment and the need for a paradigm shift towards reducing the need for human clinical trials. Science continues to evolve, and analytical, comparative methods continue to improve; with this, this panel will explore ideas on how to, and why we should, rely less on human clinical trials to develop biosimilars. This element of streamlining will save time and cost and, more importantly, permit patients to access to biosimilars at a greater pace. Panelists will discuss how and why regulators, patients, and healthcare providers should move in the direction of accepting analytical data to support biosimilarity and interchangeability.

Moderator: Sarah Brown, PharmD
Associate Director, Regulatory Affairs Strategy and Science, Biosimilars, Sandoz

Stacey Ricci, Meng, ScD
Director, Scientific Review Staff, OTBB, OND, CDER, Food and Drug Administration

Martin Schiestl, PhD
Global Head Regulatory Affairs Policy, Sandoz

Cory Wohlbach
Global VP, Biosimilars Regulatory Affairs, Teva Pharmaceuticals

Elena Wolf-Holz, M.D., PhD
Global Head Clinical Development, Biocon Biologics Ltd.