Senior Staff Fellow- Product Quality & Immunogenicity
U.S. Food and Drug Administration, Maryland
João Pedras-Vasconcelos, Ph. D., Senior Pharmaceutical Scientist, DPQA15-OPQA3-OPQ-CDER-FDA
Dr. Pedras-Vasconcelos has been a biologics product quality and immunogenicity assessor with the now Office of Product Quality Assessment III (former Office of Biotechnology Products), Center for Drugs- FDA for 22+ years. He received his Ph. D. in Immunology in 1999 from Cornell University, Ithaca NY USA.
He joined the FDA in 2002, first with CBER’s Office of Therapeutics Research and Review, and then CDER ‘s Office of Biotechnology Products (now Office of Product Quality Assessment III) and has extensive regulatory experience, both CMC and immunogenicity in reviewing cytokines, monoclonal antibodies, fusion proteins, therapeutic toxins, hormones, and enzyme replacement therapies. Joao is a co-chair of CDER’s Integrative Immunogenicity Working Group and a member the coordinating committee for CDER Office of Pharmaceutical Quality Infectious Disease and Inflammation Center of Excellence. He is also a member of the AAPS Immunerdy, NAber, and ISI working groups and has been actively involved in immunogenicity stakeholder outreach since 2013.
Disclosure information not submitted.
Tuesday, October 22, 2024
2:30 PM – 3:30 PM MT