Learning Tracks

This breakout discussion will address the current regulatory thinking and considerations of MAM and non-clinical immunogenicity studies with a focus on:
• FDA expectations, analytical comparability, and feasibility for analytical comparability including MAM and relevance to clinical outcomes (safety, efficacy, and potency);
• Perspectives from industry on in silico/invitro immunogenicity in replacement of clinical requirements for a CES trial (Note: this bullet to be covered by industry in their presentation); and
• Perspectives from both the Agency and industry on the interpretation of BPCIA in regards to “U.S. licensed biologic”. (Note: more information to come on this last bullet as the panel develops content)

Moderator: Laura Harner
Associate Director, RA Biopharma, Sandoz

Diane McCarthy, PhD
Senior Director, Science and Standards, Global Biologics, USP

Andrew Graves, M.S., SCYM
Director, Immunogenicity Assessment, Teva Pharmaceuticals

Anita Krishnan, PhD
Associate Vice President and Head of Analytical Sciences, Biocon Biologics Ltd.

Sarah Rogstad, PhD
Senior Scientific Advisor, Office of Pharmaceutical Quality Research, OPQ, CDER, Food and Drug Administration