James Polli

James Polli, PhD, is a Professor and Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy's Department of Pharmaceutical Sciences. He leads 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). His research focuses on optimizing oral drug absorption through formulations and public quality standards for dosage forms.

Education:

• PhD in Pharmaceutics, University of Michigan
• BS in Pharmacy, Philadelphia College of Pharmacy and Science

Research Interests:

• Maximizing oral bioavailability via formulation strategies
• Development of biowaiver standards for oral drugs
• Advanced in vitro methods for predicting drug performance
• Complex generics and regulatory science

Awards:

• 14th Takeru Higuchi Research Prize
• 2024 Volwiler Research Achievement Award
• 2022 AAPS Global Leadership Award
• Fellow of the American Association for Pharmaceutical Scientists

Advising & Education: Directed 25 PhD graduates and oversees the online MS in Regulatory Science program. Active in training next-generation regulatory scientists.

Labs & Collaborations: Leads M-CERSI (FDA partnership) and CRCG, advancing regulatory science and complex generic drug research.