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Qi Liu, PhD

Associate Director for Innovation & Partnership, Office of Clinical Pharmacology
US Food and Drug Administration

Dr. Qi Liu is currently the Associate Director for Innovation & Partnership in the Office of Clinical Pharmacology (OCP) at the US FDA. She leads OCP’s innovative initiatives through strategic partnership. She has helped developing OCP’s portfolio on machine learning/artificial intelligence, real world evidence and digital health technologies, collaborating with internal and external experts. She had the experience leading/co-leading OCP’s Physiological Based Pharmacokinetic Modeling and Simulation Oversight Board and Biologics Oversight Board. She was a co-lead initiating the Real-Time Oncology Review and Assessment Aid Pilot Programs. During her career at the FDA, she also contributed to over 200 NDA/sNDA reviews, 20 BLA/sBLA reviews, and numerous IND reviews to support drug development. She worked on several working groups for FDA guidance documents and Manual of Policies & Procedures development. She is an Associate Editor of Clinical Translational Science and on the editorial board of five scientific journals. Before joining FDA, Dr. Liu was a senior pharmacokineticist at Merck & Co. Inc. She obtained her Ph.D. degree in Pharmaceutics and a concurrent Master's degree in Statistics from the University of Florida in 2004.

Disclosure(s): No financial relationships to disclose

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