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 IND-ready 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)
Amy Rosenberg is a physician-immunologist who, for 33 years, regulated biologics including cellular and protein therapeutics and cell-device combination products at FDA. 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 regulated diverse protein therapeutics, including monoclonal antibodies, fusion proteins, enzyme replacement therapies, hematologic and somatic cell growth factors, and immunomodulatory agents. She is currently the Senior Director and Consultant, Immunology, at EpiVax.
Amy is available to lend her expertise in the areas of pre-clinical and IND-ready immunogenicity risk strategies.