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

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

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

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

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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

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

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

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

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