Immunogenicity Expert and FDA Alum Dr. Amy Rosenberg Joins EpiVax
AsiaNet 90490
PROVIDENCE, R.I., July 6, 2021 /PRNewswire=KYODO JBN/ --
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.
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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:
FDA Senior Science Council
NIH-FDA Immunology Interest Group Steering Committee
Oncology Center of Excellence Science Council
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 (
https://www.nature.com/articles/s41598-021-89016-7 ).
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."
About EpiVax:
EpiVax is a biotechnology company with expertise in T cell epitope prediction,
immune modulation, and rapid vaccine design. EpiVax's immunogenicity screening
toolkits for therapeutics (ISPRI) (
) and vaccines (iVAX) (
), are employed in advancing the research of a global roster of companies.
Press Contact:
Katie Porter, Business Development Manager
EpiVax
kporter@epivax.com
SOURCE EpiVax Inc.
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