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
Director, Biologics Pipeline Development, USP

Andrew Graves
Director, Immunogenicity Assessment, Teva Pharmaceuticals

Anita Krishnan PhD
Head Analytical Sciences, Biocon Biologics

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