Partner with Experts in Immunogenicity Strategy.
Introducing Trusted Expert Advice (TEA), a personalized consulting service designed to support growing biotech companies navigating the complex world of immunogenicity risk strategy.
Through one-on-one consultations, TEA offers a collaborative partnership that leverages decades of experience in pre-clinical and clinical immunogenicity risk strategies. Our seasoned consultants possess a profound understanding of regulatory agency requirements and are able to provide tailored recommendations and assistance to enhance your biologic therapeutic pipeline and mitigate clinical failure risks.
Partner with EpiVax to confidently advance your biotech innovations and achieve your next milestones with expert guidance.
Why TEA?
Meet Amy Rosenberg, MD
Sr. Director of Immunology and Protein Therapeutics
(Formerly FDA)
Dr. Amy Rosenberg consults with biotechnology and pharmaceutical companies regarding immunogenicity considerations as they approach an IND filing or while strategizing immunogenicity mitigation and monitoring approaches for clinical trials.
A physician-immunologist, Amy oversaw the regulation of biologics, including cellular and protein therapeutics and cell-device combination products, at the FDA for 33 years. She directed the Division of Therapeutic Proteins in CBER/CDER and subsequently, the Division of Biotechnology Review and Research III in the Office of Biotechnology Products in CDER, FDA which regulates diverse protein therapeutics, including monoclonal antibodies, fusion proteins, enzyme replacement therapies, hematologic and somatic cell growth factors, and immunomodulatory agents. Dr. Rosenberg was a principal author of the 2014 FDA guidance titled “Immunogenicity Assessment for Therapeutic Protein Products” and served as an expert consultant to the National Institute of Health’s Immune Tolerance Network.
Dr. Rosenberg is available to lend her expertise in pre-clinical and clinical immunogenicity risk strategies through TEA.