Course managers for the MS in Regulatory Science program are nationally and internationally renowned experts in their areas of interest.
James Polli, PhD
Professor of Pharmaceutical Sciences
James Polli is a professor of pharmaceutical sciences, as well as the Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy. He is co-director of the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), an FDA-funded collaborative agreement with the Food and Drug Administration (FDA). He received a BS in pharmacy from the Philadelphia College of Pharmacy and Science and a PhD (pharmaceutics) from the University of Michigan. Dr. Polli's research interest revolves around the performance and pharmaceutical quality of orally administered medicines. 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 drug absorption, bioavailability, bioequivalence, pharmaceutical quality, transporter substrate requirements, and prodrug design. He is a fellow and member-at-large of American Association of Pharmaceutical Scientists (AAPS), an editorial board member of several journals, an associate editor of pharmaceutical research, former vice-chair of the USP Expert Committee on Biopharmaceutics, and a member of the FDA Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology. He teaches professional pharmacy students and graduate students, and has served as advisor to 17 PhD graduates. He has lectured around the world on public drug standards in the area of pharmaceutical quality. Dr Polli's father, Gerald, co-wrote one of the first formal CMC sections for an NDA in the early 1960s for the Merck product Clinoril (sulindac). Dr. Polli is the graduate program director of the MS in Regulatory Science program and course manager of REGS 603 Drug, Biologic, and Device Regulation, as well as REGS 631 Drug and Biologics Development.
Berhanu Kibret, BPharm, MS, PhD
Instructor of Pharmaceutical Sciences
Berhanu Kibret, BPharm, MS, PhD, is an Instructor in the Department of Pharmaceutical Sciences (PSC) at the University of Maryland School of Pharmacy. His research focuses on the endocannabinoid system (ECS) in neuropsychiatric and neurodegenerative disorders, with particular emphasis on the roles of neuronal and glial type 2 cannabinoid (CB2) receptors in the neuroimmune and behavioral effects of drugs of abuse. Specific areas of interest include neuroimmune signaling, behavioral pharmacology, and the mechanistic interplay between drugs of abuse and the ECS. His work spans both preclinical behavioral models and molecular approaches aimed at understanding how CB2 receptor modulation may influence central nervous system pathology. Dr. Kibret has authored peer‑reviewed publications on cannabinoid pharmacology, neuroimmune interactions, and the physiological effects of substances such as alcohol, cannabis, and khat. Dr. Kibret will serve as the course manager for REGS 603 and REGS 614.
Alexander MacKerell, PhD
Grollman-Glick Professor of Pharmaceutical Sciences
Alexander MacKerell is the Grollman-Glick Professor in the Department of Pharmaceutical Sciences (PSC) at the University of Maryland School of Pharmacy. He is also the director of the Computer-Aided Drug Design (CADD) Center. His research involves computational and theoretical studies of biological, pharmaceutical and chemical systems. Specific areas of interest include structure-function relationships of proteins, carbohydrates and nucleic acids; computer-aided drug design targeting cancer, opioids and immunosuppression; and the development of empirical force fields for biological and pharmaceutical compounds. Empirical force field development is done in conjunction with the CHARMM molecule modelling program and novel CADD methodologies developed by MacKerell and co-workers include the Comformationally-Sampled Pharmacophore (CSP) and Site Identification by Ligand Competitive Saturation (SILCS) approaches. Dr. MacKerell is the course manager for REGS 614 Drug and Biologics Discovery.
Fadia Shaya, MPH, PhD
Professor of Pharmaceutical Health Services Research
Fadia Shaya serves as professor in PHSR, director of research for the Center of Innovative Pharmacy Solutions (CIPS), and associate director of the CDPP at the University of Maryland School of Pharmacy. Dr. Shaya has experience developing clinical, economic, policy, decision analyses, and budget impact models, as well as advanced training and expertise in formulary development and management. She works with Medicare and Medicaid, as well as commercial insurance plans, to guide drug formulary management and coverage decisions. During her time at the School, Dr. Shaya has built the research capacity to support all stages of drug development and policy, from pre-clinical trials to post-marketing surveillance. She is the course manager of REGS 641 Regulated Products in the Marketplace.
Yan Shu, MD, PhD
Associate Professor of Pharmaceutical Sciences
Yan Shu is an associate professor in the Department of Pharmaceutical Sciences at the University of Maryland School of Pharmacy. Dr. Shu has a PhD in pharmaceutical sciences and pharmacogenomics from the University of California, San Francisco, and obtained an MD degree from Xiangya Medical School, Central South University, China. Dr. Shu's group focuses on the genetic mechanisms of drug response and the roles of membrane transporters in pharmacokinetics and in clinical drug response. In particular, research is focused on genetics and epigenetics of drug effects on body's metabolic homeostasis. Research is also specifically directed to explore the regulatory mechanisms of drug transporters and their clinical implication. Dr. Shu is the course manager of REGS 621 Clinical Research.