Lawrence X. Yu, Ph.D., is the Director of the Office of Product Quality Assessment II at the Food and Drug Administration and the Rapporteur for the ICH M4Q(R2) Expert Working Group. Dr. Yu has been instrumental in implementing the Biopharmaceutics Classification System at the FDA and in defining Pharmaceutical Quality by Design (QbD). He played a key role in inaugurating the FDA’s modern review system, Integrated Quality Assessment (IQA), and in introducing the FDA’s Emerging Technology Team (ETT) program. He also developed the FDA’s historic concept of operations agreement, integrating review and inspection processes, and originated the Knowledge-aided Assessment and Structured Applications (KASA) initiative.

Dr. Yu serves as an adjunct professor at the University of Michigan. His Compartmental Absorption and Transit (CAT) model laid the foundation for commercial software such as GastroPLUSTM and Simcyp®, widely utilized in the pharmaceutical industry, academia, and regulatory agencies. He is a fellow and past section chair of the American Association of Pharmaceutical Scientists and an Associate Editor of the AAPS Journal. Dr. Yu has authored or co-authored over 150 papers and delivered more than 400 invited presentations. He is also a co-editor of the books “Biopharmaceutics Applications in Drug Development,” “FDA Bioequivalence Standards,” and “Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, 2nd Ed.”