Dr. James E. Polli is Professor and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy. He received a BS in Pharmacy from the Philadelphia College of Pharmacy and Science and a PhD in pharmaceutics from the University of Michigan. He is also co-director of the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), an FDA-funded collaborative agreement with the agency, and director of the online MS in Regulatory Science program. His two main research interests are: (1) maximizing oral bioavailability through formulation and chemical approaches and (2) developing public quality standards for oral dosage forms. He has published in the areas of dissolution, drug intestinal permeability, transporter substrate requirements, prodrug design, oral bioavailability, in vitro – in vivo correlation, and bioequivalence. Dr. Polli is a fellow of the American Association of Pharmaceutical Scientists, an editorial board member of several journals, an editor of Pharmaceutical Research, and a member of the FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee. He teaches professional pharmacy students and graduate students, and has served as advisor to 19 PhD graduates.