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Ankit Shah, PhD

Senior Clinical Pharmacology Reviewer
US Food & Drug Administration

Dr. Ankit Shah is a senior clinical pharmacology reviewer in Division of Cancer Pharmacology I in the Office of Clinical Pharmacology at the U.S Food and Drug Administration.

Ankit received his PhD. in Pharmacology & Toxicology from University of Missouri Kansas City in 2013. During his PhD, he studied the interactions between HIV viral proteins and substance abuse to understand the mechanisms leading to neurotoxicity. He also developed keen interests in studying the role of CYP metabolizing enzymes responsible for potential drug-drug-interactions (DDIs) between substance abuse and anti-retroviral drugs. Upon completion of his PhD, he joined nanotechnology characterization lab at NCI (NIH), where he studied immunological properties of various nano-formulations and RNA nanoparticles for cancer therapy. He has published over 30 peer reviewed articles in journals such as Nano letters, Cell death & disease, and Journal of neuroinflammation.

Since joining the FDA as a reviewer in 2019, he has reviewed multiple applications to develop anti-cancer therapies, including both Oncology Products and Hematology Products. He has extensive experience dealing with regulatory issues that arise with small molecules and biologics from a clinical pharmacology perspective.

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