2024 FDA Presentations (as of 5/1/24):
Epitope in the Capsid of an Adeno-Associated Virus
Sojin Bing, PhD, Staff Fellow, Office of Tissues & Advanced Therapies, FDA CBER
Guidance on Immunogenicity in Drug Product Labeling
Eric Brodsky, M.D., Associate Director, Labelling Policy Team, CDER, FDA
Understanding and Circumventing the Immune Responses to Approved Protein Therapeutics
Daniel LaGasse, PhD, Research Regulator, CBER, FDA
What Information Can MHC Associated Peptide Proteomics (MAPPs) Assays Provide during Immunogenicity Risk Assessment of Therapeutic Proteins and Novel Modalities?
Zuben Sauna, PhD, Director, Division of Hemostasis, CBER, FDA
Immunogenicity Assessment of Gene Therapy Products
Anurag Sharma, PhD, Gene Therapy Reviewer, CBER, FDA
The Role of Clinical Pharmacology and Clinical Relevance of Immunogenicity
Yow-Ming Wang, PhD, Associate Director for Biosimilars and Therapeutic Biologics, CDER, FDA
Chairperson: Ronit Mazor, PhD, Principal Investigator, CBER, FDA