Learning Tracks

This panel would include topics such as (i) FDA recommendations for designing a development program without a Clinical Efficacy study (CES) (ii) convergence; and (iii) strategies for communicating streamlined development to other stakeholders (e.g., providers and patients). This session will also touch on considerations for biosimilars development and regulatory assessment as analytical methods advance and cost-benefit calculations evolve for investing in clinical trials. Panelists will discuss the use of phase 3-style confirmatory efficacy studies, 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

Fabrice Romanet
Senior Vice President, Innovation and Development Biosimilars, Fresenius Kabi

Martin Schiestl, PhD
Global Head Regulatory Affairs Policy, Sandoz

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