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 Presentations:

Immunogenicity Assessment Strategy for Peptides by Development Stage
Linlin Luo, PhD, Senior Director, Regulated Bioanalytics, Merck

CAR T Approaches to Treatment of Autoimmunity and Prevention of ADA to Biological Therapeutics
Amy Rosenberg, MD, Senior Director, Immunology and Protein Therapeutic, Epivax, Inc.

Risk to Readiness: Integrating Risk Assessment Outputs to Inform IND Bioanalytical Strategies
Vibha Jawa, PhD, Executive Director, Nonclinical Disposition and Bioanalysis, Bristol Myers Squibb