Kristen Nickens, PhD

Product Quality Team Leader Office of Biotechnology Products, Division of Biotechnology Review and Research-I, OPQ, CDER

Dr. Kristen Nickens is a Product Quality Team Lead in the Office of Biotechnology Products (OBP), Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA).  Her regulatory career began at the FDA in 2013 as a National Institutes of Health-FDA Interagency Oncology Task Force Fellow in the Center for Biologics Evaluation and Research (CBER), after which, she joined CDER/OBP as a product quality assessor in 2014. Throughout her tenure in the FDA, Dr. Nickens has acquired extensive regulatory expertise in the lifecycle management of biotechnology products from early-phase development through post-licensure for products under both 351(k) and 351(a) regulatory pathways.  Dr. Nickens received her Ph.D. in Molecular Medicine with a concentration in Oncology from The George Washington University’s Institute for Biomedical Sciences in Washington, DC and completed a post-doctoral fellowship at the Henry M. Jackson Foundation’s Center for Prostate Disease Research in Rockville, MD.

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