The Immunogenicity Conference Stream brings together the FDA, industry leaders, and academic experts to explore key factors influencing immunogenicity and strategies for early prediction. Discussions will cover immunogenicity assay development, drug and target interference, pre-existing antibodies, and clinical relevance. With a focus on both traditional biologics and novel modalities—such as cell and gene therapies, RNA therapies, bispecifics, and ADCs—attendees will gain insights into immune response manipulation for therapeutic advantage while addressing safety concerns. Join us to stay at the forefront of immunogenicity research and innovation.

Conferences Include:

Keynote Presentation: Immunogenicity Strategy for Complex and Emerging Modalities
Mohsen Rajabi Abhari, PhD, Director, Scientific Governance PK Sciences Drug Disposition, Novartis

Featured Presentation: Scientific Considerations for Immunogenicity Assessment of Follow-On Products
Michael Norcross, MD, Medical Officer, CDER, FDA

Keynote Presentation: New Approach Methodologies (NAMs) in the Assessment of Immunogenicity
Zuben Sauna, PhD, Director, Division of Hemostasis, CBER, FDA

Featured Presentation: Immune Reset—Addressing Autoimmune Disease, Allergy, and Novel Indications
Amy Rosenberg, MD, Senior Director, Bioanalytical Sciences, Regeneron Pharmaceuticals