2017 Hepatitis Debrief

Insook Kim, PhD is a clinical pharmacology team leader for gastroenterology and hepatology products in the Office of Clinical Pharmacology at FDA. Since she joined FDA as a clinical pharmacology reviewer in 2007, she has been involved in numerous IND and NDA review and has provided regulatory and scientific guidance for product development in the areas of gastroenterology, hepatology, and inborn errors of metabolism.  She served as a planning committee member for the public workshops on the clinical pharmacology and drug development for liver diseases, and the assessment of PK in hepatic impairment. Dr. Kim is a member of a guidance working group for hepatic impairment study.  Prior to joining FDA, Dr. Kim received a doctoral degree in Pharmaceutics from the University of Michigan and conducted post-doctoral research on nuclear receptors including FXR using transgenic animal models at the National Cancer Institute. She earned a master’s degree in Pharmacy from Seoul National University, and a bachelor’s degree in Pharmacy from Ewha Womens University in Korea.  Her area of interest is translational clinical pharmacology to optimize the drug development and therapeutics.