Learning Tracks

This panel would include topics such as (i) FDA recommendations for designing a development program without a Clinical Efficacy study (CES) (ii) regulatory and industry perspectives on global convergence; and (iii) considerations for biosimilar development and regulatory assessment as analytical methods advance. Panelists will discuss the use of phase 3-style confirmatory efficacy studies and its implications for other regulatory assessments such as pharmacokinetic studies, the acceptance of global comparators, and other ways to streamline the development of biosimilars.

Speaker: Elena Wolff-Holz, M.D., PhD
Global Head Clinical Development, Biocon Biologics Ltd.

Panelists:
Nina Brahme, PhD, MPH
Clinical Analyst, OTBB, OND, CDER, FDA

Shanthi Rajendra, PhD
Associate Director, CMC – Biosimilars & Specialty, GR&D, Apotex Inc.

Martin Schiestl, PhD
Global Head Regulatory Affairs Policy, Sandoz

Moderator: Cory Wohlbach
Global Vice President, Biosimilars Regulatory Affairs, Teva Pharmaceuticals