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Yvonne Knight, MS

Sr Regulatory Health Project Manager
US Food and Drug Administration

Yvonne Knight, MS is a Senior Regulatory Health Project Manager on the Executive Program and Project Management team in the Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER). With over 10 years of regulatory experience, she serves as the regulatory and administrative lead in CDER for the Model Informed Drug Development (MIDD) Paired Meeting Program.

Prior to her tenure in OCP, Yvonne served as a Regulatory Business Process Manager in the Office of Pharmaceutical Quality as well as a Regulatory Health Project Manager for the Office of New Drugs and Quality Assessment (ONDQAA) at the FDA. She worked with colleagues in the OND Review Divisions to facilitate the receipt and response to Chemistry Manufacturing Control (CMC) submissions for both pre and post-market applications.

Prior to working at the FDA, Yvonne was a Lead Research Associate at Human Genome Sciences researching autoimmune disease models. In addition, she administered pharmacokinetic and biodistribution studies for novel compounds under consideration. Yvonne received her M.Sc. in Biotechnology from the University of Maryland Global Campus (UMGC).

Disclosure information not submitted.

Presentation(s):