Skip to main content
ASCPT 2023 Annual Meeting Main banner
Back

Qi Liu, PhD (she/her/hers)

Associate Director for Innovation & Partnership
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 helped developing OCP’s capacity/portfolio on machine learning/artificial intelligence, real world evidence and digital health technologies, collaborating with internal and external experts to help keep the office stay abreast of current trends in innovative approaches. Dr. Liu leads OCP’s Innovative Data Analytics program and Machine Learning Review Team. 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 co-authored over 50 manuscripts and presented on many topics at FDA Advisory Committee meetings and scientific conferences. She worked on several working groups for FDA guidance documents and Manual of Policies & Procedures development. 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 of the Real-Time Oncology Review and Assessment Aid Pilot Programs.
Dr. Liu is a Fellow of the American College of Clinical Pharmacology. She is on the editorial board of the American Association of Pharmaceutical Scientists Journal, Clinical Pharmacology and Therapeutics, Clinical and Translational Science: Pharmacometrics and Systems Pharmacology, and of Clinical and Translational Science.
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. In addition, she has a Master's degree in Pharmaceutics and a Bachelors’ degree in Clinical Pharmacy from West China University of Medical Sciences.

Presentation(s):