Amy Rosenberg

Amy Rosenberg is a prominent physician-immunologist currently serving as the Senior Director of Immunology and Protein Therapeutics at EpiVax, Inc., a position she has held since September 2021. Prior to joining EpiVax, Dr. Rosenberg had a distinguished career at the U.S. Food and Drug Administration (FDA), where she spent over 33 years, including 14 years as the Director of the Division of Therapeutic Proteins in the Center for Drug Evaluation and Research (CDER) .134

Education and Early Career

Dr. Rosenberg earned her Doctor of Medicine degree from Albert Einstein College of Medicine and completed further studies at New York University and the National Institutes of Health (NIH). She trained in basic immunology and specialized in Internal Medicine and Infectious Diseases .34

Contributions at the FDA

During her tenure at the FDA, Dr. Rosenberg was instrumental in overseeing the regulation and approval of numerous therapeutic products, including monoclonal antibodies and enzyme replacement therapies. She was also a key figure in developing guidelines for immunogenicity assessment for therapeutic protein products, notably authoring the guidance published in 2014 .23 Her leadership roles included serving on various committees, such as the NIH-FDA Immunology Interest Group Steering Committee and the Oncology Center of Excellence Science Council .13

Role at EpiVax

At EpiVax, Dr. Rosenberg focuses on immunogenicity risk strategies for therapeutic products, leveraging her extensive regulatory experience to provide expert consultation in pre-clinical and IND-ready phases .25 She leads initiatives like the "Trusted Expert Advice" service, aimed at assisting clients with immunogenicity assessments .45

Dr. Rosenberg's expertise positions her as a significant contributor to advancements in immunology and therapeutic development within both regulatory and clinical contexts.