Biography

Dr. Qi Liu is currently the Acting Director for the Office of Computational Sciences/ Office of Translational Sciences, CDER, FDA. Prior to this role, she was the Associate Director for Innovation & Partnership in the Office of Clinical Pharmacology (OCP)/ Office of Translational Sciences, CDER, FDA. She is a co-chair of CDER's AI Council and the lead of CDER AI Review Rapid Response Team. She is a member of the FDA-Wide AI Policy Coordination and Planning Council. She is also on the executive board of CDER’s Quantitative Medicine Center of Excellence. She helped establishing the OCP Innovative Data Analytics Program (focusing on AI, Real-world data and digital health) and AI review team, and serves as the lead. She had the experience leading OCP’s Physiological Based Pharmacokinetic Modeling and Simulation Oversight Board and co-leading 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 contributed to over 200 NDA/sNDA reviews, 20 BLA/sBLA reviews, and numerous IND reviews. She has been on many working groups for FDA guidance documents and Manual of Policies & Procedures development. 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.