Lawrence Yu, PhD U.S. FDA

Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu implemented Biopharmaceutics Classification System at the FDA, described the Pharmaceutical Quality by Design (QbD), inaugurated the FDA modern review system - Integrated Quality Assessment (IQA), developed the FDA historic concept of operations agreement to integrate review and inspection, and originated the Knowledge-aided Assessment and Structured Applications (KASA) initiative. Dr. Yu is also an adjunct Professor at the University of Michigan. 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 150 papers and given over 400 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.