James E. Polli

James E. Polli is a Professor and Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy, where he holds a primary appointment in the Department of Pharmaceutical Sciences. He serves as co-Director of the FDA-funded University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Center for Research on Complex Generics (CRCG), and directs the online MS in Regulatory Science program. His leadership spans regulatory science initiatives and complex generics research.

Dr. Polli earned his PhD in Pharmaceutics from the University of Michigan and BS in Pharmacy from Philadelphia College of Pharmacy and Science. His research centers on oral drug absorption, with dual emphases on maximizing oral bioavailability through formulation/chemical approaches and developing public quality standards for oral dosage forms. He has pioneered methodologies in biopharmaceutics classification, dissolution testing, and bioequivalence assessment.

His publication portfolio reveals a strong trend toward physiologically based biopharmaceutics modeling (PBBM), biowaiver monographs for complex drugs, and advanced dissolution-permeation systems. Recent work focuses on predicting food effects, surfactant-mediated dissolution, and quality standards for amorphous solid dispersions. His research bridges academic innovation with regulatory applications through FDA collaborations.

• Fellow of the American Association for Pharmaceutical Scientists (AAPS)
• American Pharmacists Association Takeru Higuchi Research Prize recipient
• 2024 American Association of Colleges of Pharmacy Volwiler Research Achievement Award
• 2022 AAPS Global Leadership Award
• 2021 TOPRA Education Award

Dr. Polli has advised 25 PhD graduates and secured significant FDA funding for M-CERSI and CRCG. His grant portfolio emphasizes regulatory science infrastructure, complex generics development, and educational initiatives. He served 12 years as editor of Pharmaceutical Research and contributes to FDA workshops on bioequivalence standards. His laboratory work integrates dissolution-hollow fiber membrane systems, biorelevant media modeling, and quality-by-design approaches for complex drug products.