Cara Fiore | Senior Regulatory Scientist
FDA

Cara Fiore, Senior Regulatory Scientist, FDA

Dr. Cara Fiore is a Senior Regulatory Reviewer and Microbiologist at the Food and Drug Administration/Center for Biologics Evaluation and Research/Office of Vaccines Research and Review (FDA/CBER/OVRR) since 2007. Vaccines and related products intended for human use that are used for infectious diseases indications in the US are reviewed by OVRR. Dr. Fiore reviews a broad range of vaccine files; including vaccines used for maternal health and immunization, biodefense, meningococci, and also bacteriophage products for clinical development and expanded access use. Dr. Fiore is active in several Agency, Federal Government-wide, and global working groups regarding pregnancy and lactation, regulatory development of vaccines and related products (including phage); frequently interfacing as a lead reviewer with external stakeholders on behalf of OVRR/DVRPA for phage therapy and vaccine development. Prior to joining the Office of Vaccines Research and Review, Dr. Fiore was a Senior Scientist at the Office of Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Service (HHS). Before her work in the federal government, she was a Senior Scientist, Supervisor in Fermentation Development (Vaccine Development), Process and Product Development, at Nabi Biopharmaceuticals, Rockville. Dr. Fiore received her PhD from the School of Medicine, University of Maryland, Baltimore, MD, in vaccine development. She received a BS Biology, and a BA Anthropology from Tulane University, New Orleans, LA prior to entering graduate school.

Appearances:



Day 2 - World Antimicrobial Resistance Congress & Disease Prevention Control Summit 2024 @ 14:50

Presentation: Regulatory considerations in the development of bacteriophage for clinical use

last published: 12/Jun/24 19:45 GMT
last published: 12/Jun/24 19:45 GMT

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