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Katherine Tyner, PhD

U.S. Department of Health and Human Services

2021 fellow

Dr. Tyner is the Acting Associate Director for Science in the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER) within the Food and Drug Administration (FDA). In this capacity, she coordinates the intersection between science, review, and policy in OPQ.

As part of her portfolio, Dr. Tyner led the OPQ Extramural Research Program; developed key performance indicators and research metrics programs for OPQ; established new inter-office processes and workflows to support the launch of congressionally-mandated programs; and directed the Science Staff, an agile rapid response team that helped foster and maintain an innovation-friendly environment in OPQ.

Dr. Tyner is an expert in complex drug formulations. She leads the CDER Nanotechnology Working group, and represents CDER in a variety of national and international for a on the use of nanomaterials in drug products. Prior to joining OPQ, Dr. Tyner served as a principal investigator studying the quality, safety, and efficacy of complex drug products. Dr. Tyner has authored multiple book chapters, journal articles, and guidances on the appropriate characterization and biological impact of nanoparticle therapeutics and other complex products.

Dr. Tyner is an alumnus of Carleton College, where she received a B.A. in chemistry, and Cornell University, where she received a M.S. and PhD in chemistry. She completed a postdoctoral fellowship at the University of Michigan in a joint appointment in the Chemistry Department and the Toxicology Program. She is also a graduate of the Partnership for Public Service Excellence in Government Fellows Program.

As a WHLDP fellow, Dr. Tyner’s focus is on the Lab-to-Market CAP Goal and works closely with key Office of Management and Budget and agency stakeholders.

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