Lawrence X. Yu, PhD

Deputy Director of FDA’s Center for Drug Evaluation and Research’s Office of Pharmaceutical Quality
United States Food and Drug Administration (FDA)

Lawrence X. Yu, Ph.D., is the Deputy Director, Office of Pharmaceutical Quality, Food and Drug Administration, where he oversees new, generic, and biotechnology product quality review and inspection functions as well as the FDA CDER quality labs with over 1200 staff scientists. He is also adjunct Professor of Pharmaceutical Engineering at the University of Michigan.

Prior to joining the FDA, Dr. Yu had worked at Pfizer (Upjohn) and GlaxoWellcome for 8 years. Dr. Yu joined the FDA in 1999 and has served as Team Leader, Deputy Division Director, Division Director, Deputy Office Director, and Office Director. Dr. Yu’s research interests have centered on the prediction of oral drug delivery and the development of pharmaceutical Quality by Design. His compartmental absorption and transit (CAT) model has laid the foundation for the commercial software, GastroPLUSTM and Simcyp®, which are being widely used in the pharmaceutical industry.

Dr. Yu is a fellow and the past section Chair of the American Association of Pharmaceutical Scientists and an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 130 papers, and presented over 100 abstracts, and given over 200 invited presentations. He is a co-editor of the books entitled “Biopharmaceutics Applications in Drug Development”, “FDA Bioequivalence Standards”, and “Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, 2nd Ed.”

Dr. Yu is the winner of numerous awards including AAPS Regulatory Science Achievement award, AIChE PD2M Drug Product QbD Achievement Award, Japan Naigai Foundation Distinguished Lectureship, China Beijing University IPEM graduation commencement address, Department of Health and Human Service Outstanding Leadership Award, FDA Commissioner’s Special Citation, Outstanding Achievement, Group Recognition, and Team Excellence awards.