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Final Program


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Insook Kim, PhD

Team Lead, Clinical Pharmacology
US Food & Drug Administration

Insook Kim, PhD, is Master Scientist in the Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, US Food & Drug Administration. Dr. Kim has been leading the clinical pharmacology reviews of INDs, NDAs, and BLAs for the Division of Hepatology and Nutrition and the Division of Gastroenterology in the Center for Drug Evaluation and Research. Dr. Kim also has review experience in the inborn errors of metabolisms for the then Division of Gastroenterology and Inborn Errors. Dr.Kim has participated in the Guidance Working Groups on the hepatic impairment study, drug interactions with gastric acid reducers, labeling for organ impairment, and pediatric inflammatory bowel diseases. Prior to joining FDA, Dr. Kim conducted post-doctoral research on regulation of bile acid homeostasis at the National Cancer Institute. She graduated with a PhD in Pharmaceutics from the University of Michigan, a master’s degree in Pharmaceutics from Seoul National University and a bachelor's in Pharmacy from Ewha Womens University. Dr. Kim is interested in optimizing drug development by leveraging clinical pharmacology.

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