2026 FDA Presentations

Clinical Pharmacology Evaluation of Immunogenicity: Advancing Harmonization from Submission to Communication
Yow-Ming Wang, PhD, Associate Director for Biosimilars and Therapeutic Biologics, CDER, FDA

View Agenda

Comparative Immunogenicity Risk Assessment of CRISPR-Cas Proteins
Wojciech Jankowski, PhD, Commissioner’s Fellow, CBER, FDA

View Agenda

Understanding and Circumventing the Immune Responses to Approved Protein Therapeutics
Daniel LaGasse, PhD, Research Regulator, CBER, FDA

View Agenda

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

View Agenda

KEYNOTE PRESENTATION: Unveiling Sex Bias in AAV Vector Responses: From Pre-existing Antibodies to Innate Immunogenicity
Leila Abdelhamid, PhD, ORISE Research Fellow, Immunology & Gene Therapy, CBER, FDA

View Agenda

AAV2 Delivery of the SaCas9 Gene Results in Presentation of an HLA-A∗02:01-Restricted T Cell Epitope Potent to Induce T Cell Cytotoxicity
Susana Najera, ORISE Fellow, Office of Therapeutic Products, Gene Transfer and Immunogenicity Branch, CBER, FDA

View Agenda

FEATURED PRESENTATION: Scientific Considerations for Immunogenicity Assessment of Follow-On Products
Michael A Norcross, MD, Medical Officer, CDER, FDA

View Agenda

Preclinical Approaches for Immunogenicity Risk Assessment of Peptide Drug Products
Mohanraj Manangeeswaran, PhD, Senior Research Scientist, CDER, FDA

View Agenda