Senior Director of Immunology
Epivax
Providence, Rhode Island
A physician immunologist with extensive expertise in development and immunogenicity of therapeutic proteins and cellular products. I was involved in the regulation and approval of numerous FDA regulated products including hematopoietic stem cells and their selection devices, therapeutic proteins including monoclonal antibodies and fusion proteins, enzyme replacement therapies, immunomodulators, hematologic and somatic cell growth factors, and combination device-biologics. I have extensive knowledge of product quality issues as well as clinical aspects of experimental investigations and am a leading expert in clinical risk assessment and mitigation strategies of immunogenicity of therapeutic proteins (Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products) . I served as FDA expert consultant to NIAID's Immune Tolerance Network and to the ABIRISK Consortium and co-edited the AAPS/Springer Book “Biobetters: Protein Engineering to Approach the Curative”. After 33 years at FDA, I left the Agency and now am Senior Director, Immunology at EpiVax, Inc a powerhouse immunoinformatics and vaccine development company based in Providence, RI. I received an M.D. from the Albert Einstein College of Medicine, trained at NYU in Internal Medicine and Infectious Diseases and in immunology in the Laboratory of Alfred Singer in the Experimental Immunology Branch of the NCI before joining the FDA.
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Monday, October 17, 2022
3:30 PM – 4:30 PM ET
Monday, October 17, 2022
4:15 PM – 4:30 PM ET