EpiVax, Inc. (“EpiVax”) is pleased to announce that Dr. Amy Rosenberg is leaving the FDA’s Division of Therapeutic Proteins, CDER, which she led for over 20 years, to join EpiVax as Senior Director of Immunology and Protein Therapeutics.
Dr. Rosenberg’s work has focused on immune tolerance induction and immunogenicity. At the FDA, she oversaw the regulation and approval of numerous protein therapeutics and served as expert consultant to the National Institute of Health’s Immune Tolerance Network. Other notable appointments include:
EpiVax CEO/CSO, Dr. Annie De Groot, is looking forward to Rosenberg’s start: “Dr. Rosenberg is a key opinion leader for many ‘classical’ biologic products such as erythropoietin, G/GM-CSF, mAbs, as well as cellular therapies, and has been exploring novel biologics such as CAR-T and TIL cell therapies. Amy and I look forward to sharing her vast experience with EpiVax aficionados during our ‘Fearless Science World tour’ this fall and winter.”
Dr. Rosenberg’s years of regulatory experience will strengthen EpiVax’s ability to support clients developing vaccines and biologics for regulatory review. Dr. Rosenberg will also work with EpiVax scientists on a range of internal research programs, listed below:
Personalized Immunogenicity Assessment for Biologics (PIMA): Immune Tolerance-Adjusted Personalized Immunogenicity Prediction for Pompe Disease. EpiVax applied in silico tools (EpiMatrix and JanusMatrix) to identify immunogenic and tolerogenic epitopes that are recognized by individual Pompe patients and predicted based on their acid alpha-glucosidase (GAA) gene and HLA DR haplotype. De Groot AS et al., Frontiers in Immunology, 16 June 2021.
Personalized vaccine immunogenicity assessment using iTEM and J-iTEM: Identification, Selection and Immune Assessment of Liver Stage CD8 T Cell Epitopes from Plasmodium falciparum. Tucker KD et al., Frontiers in Immunology, 07 May 2021. The same approach accurately predicted outcomes for individual patients with cancer, Multi-step screening of neoantigens’ HLA- and TCR-interfaces improves prediction of survival. Richard G et al., (Nature) Scientific Reports, 11 May 2021.
Novel Tregitopes identified in non-IgG proteins: Identification of a potent regulatory T cell epitope in factor V that modulates CD4+ and CD8+ memory T cell responses. De Groot AS et al., Clinical Immunology, 04 January 2021.
Regarding her move to EpiVax, Dr. Rosenberg said, “I am thrilled to join this pioneering immunologically focused company exploring the range of applications of novel immunoinformatic technologies for evaluating and improving immune based outcomes for the most pressing issues and diseases of our time: infectious diseases, cancer, and autoimmunity as well as to find the means to deimmunize or tolerize to gene and protein therapeutics in the context of enzyme/gene replacement therapies for rare diseases.”