Dr. Amy Rosenberg is a physician immunologist with over 30 years of experience in the development and immunogenicity of therapeutic protein and cellular products. During her tenure at the FDA, Amy played a pivotal role in the regulation and approval of numerous therapies, including hematopoietic stem cells, therapeutic proteins, enzyme replacement therapies, immunomodulators, and combination device-biologics. She also served on the FDA’s Oncology Center of Excellence Science Council and consulted for the Immune Tolerance Network and the ABIRISK consortium.

Currently, Dr. Rosenberg leads the EpiVax TEA (Trusted Expert Advice) consulting service, offering her extensive regulatory expertise to clients addressing immunogenicity risks in their pipeline projects.