Daniela Verthelyi, M.D., PhD
Chief, Laboratory of Immunology, Division of Biotechnology Review and Research III, Office of Biotechnology Products (OBP), OPQ, CDER
Daniela Verthelyi, Ph.D., currently heads the Laboratory of Innate Immunity and chairs CDER’s newly formed Center for Excellence in Infectious Diseases and Inflammation. She directs a lab focused on developing tools to monitor and control innate immune and inflammatory responses including potential impurities in therapeutic products that may foster unwanted immune responses therapeutic proteins reducing their life-saving potential. Dr. Verthelyi received her M.D. from the University of Buenos Aires and a Ph.D. from Virginia Tech in the United States, and then completed a fellowship training in Immunology at the Section in Retroviral Immunology in the Center for Biologics Evaluation and Research at FDA before joining the Office of Biotechnology Products in CDER as a principal investigator. She has Chaired the FDA-NIH Immunology Interest Group, the NIH-FDA Cytokine Interest Group, and served on the Advisory Boards for the NIH Human Immunology Group. She has authored over 80 peer-reviewed articles, holds several patents, and has received FDA’s, CBER’s, and CDER’s “Excellence in Laboratory Sciences” awards, among other honors.