Immunogenicity
Monday, October 27, 2025
2:30 p.m. - 3:30 p.m.
This session will explore the evaluation of immunogenicity risk in generic peptides, oligonucleotides, and biosimilars, focusing on innovative assessment techniques and evolving regulatory frameworks. Participants will learn about the latest advancements in predictive modeling and risk mitigation strategies to enhance patient safety. Through case studies and expert insights, the session aims to provide a thorough understanding of current practices and future trends in immunogenicity evaluation. Discussions in this session will also touch on innate immunogenicity studies for synthetic peptides and adaptive immunogenicity studies for synthetic peptides.
Participants:
Jessica Greenbaum, JD
Director, Regulatory Affairs Policy U.S., Sandoz
Susan Kirshner, PhD (invited)
Division Director, Division of Product Quality Assessment XV, Office of Product Quality Assessment III, OPQ, CDER, FDA
Arunasree Lanka, PhD
Biocharacterization Specialist, Dr. Reddy’s Laboratories
Eric Pang, PhD (invited)
Senior Chemist, Division of Therapeutic Performance I, Office of Research Standards, OGD, CDER, FDA
Stacey Ricci, Meng, ScD (invited)
Director, Scientific Review Staff, OTBB, OND, CDER, FDA
Moderator: Anita Krishnan, PhD
Biocon Biologics