Trusted Expert Advice (TEA)
EpiVax has a new TEA service! This new service, Trusted Expert Advice, features one-on-one consulting with former FDA Division Director (Office of Biotechnology Products) and Immunogenicity expert Amy Rosenberg. Dr. Rosenberg has 30 years of experience in the immunogenicity field and was the principal author of the risk assessment guidance “Immunogenicity Assessment for Therapeutic Protein Products” (2014). She also was one of two US representatives to the ABIRISK Consortium’s Scientific Advisory Board and was a long-standing FDA consultant to the NIAID’s Immune Tolerance Network. She has a broad view on all aspects of the FDA regulatory process, having spent several years in CBER regulating cellular products and their selection devices, as well as a more recent stint in the clinical group regulating cell and gene therapies.
Amy is available to lend her expertise in the areas of pre-clinical and IND-ready immunogenicity risk strategies. Interested? Contact us here!