Amy Rosenberg, MD

Amy Rosenberg, MD is a physician-immunologist who trained in basic immunology in Al Singer’s lab in the Experimental Immunology Branch of the NCI, NIH, following medical residency and specialty training in Internal Medicine and Infectious Diseases. Dr. Rosenberg then established a laboratory and performed regulatory duties at the FDA where she regulated an array of biotechnology products including cellular and protein therapeutics and cell-device combination products. Dr. Rosenberg served at the FDA for 33 years, with 14 years as Director of the Division of Therapeutic Proteins and then Division III in the Office of Biotechnology Products.

Dr. Rosenberg served on the NIH-FDA Immunology Interest Group Steering Committee and the Oncology Center of Excellence (OCE) Science Council, as well as FDA consultant to the Immune Tolerance Network Steering Committee and as Advisor to the ABIRISK Consortium. Dr. Rosenberg was principal author of “Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products,” published in 2014. Since September 2021 has served as Senior Director of Immunology and Protein Therapeutics at EpiVax, Inc.