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Qi Liu, PhD

US Food and Drug Administration

Qi Liu, Ph.D., M.Stat., FCP is the Associate Director for Innovation & Partnership in the Office of Clinical Pharmacology (OCP)/ Office of Translational Sciences, CDER, FDA. She has helped developing OCP’s portfolio on artificial intelligence/machine learning (AI/ML), real world evidence and digital health technologies, collaborating with internal and external experts. She helped establishing the OCP Innovative Data Analytics Program and AI/ML review team, and currently serves as the lead. She is a co-chair of CDER's AI Council. She had the experience leading OCP’s Physiological Based Pharmacokinetic Modeling and Simulation Oversight Board and co-leading Biologics Oversight Board. She is also on the executive board of CDER’s Quantitative Medicine Center of Excellence. 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. She worked on 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.

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