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.
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.
Frank Palumbo, BSPharm, MS, PhD, JD
Professor of Pharmaceutical Health Services Research
Frank Palumbo is a professor in the Department of Pharmaceutical Health Services Research (PHSR) and executive director of the Center on Drugs and Public Policy (CDPP) at the University of Maryland School of Pharmacy. He is a member of the Maryland and District of Columbia Bars and a licensed pharmacist. He has practiced both pharmacy and law, serving as principal investigator on major federal research grants and as a member of a NIH study section for more than four years. In addition to law, he maintains a strong interest in public policy, pharmacoeconomics, pharmacoepidemiology, and health services research. He has many journal articles and presentations to his credit, covering a wide range of topics including law and public policy. He also co-authored a book on containing costs in third party drug programs. Dr. Palumbo has been very active in several national professional organizations, including the American Pharmacists Association. He is the course manager of REGS 641 Regulated Products in the Marketplace.
Fadia Shaya, MPH, PhD
Professor of Pharmaceutical Health Services Research
Fadia Shaya serves as professor and vice chair of academic affairs 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.
Julia Slejko, PhD
Assistant Professor of Pharmaceutical Health Services Research
Julia Slejko is an assistant professor in PHSR at the University of Maryland School of Pharmacy. She holds a bachelor's degree in molecular, cellular, and developmental biology from the University of Colorado, Boulder and a doctorate in pharmacoeconomics from the University of Colorado School of Pharmacy. Her research focuses on innovative approaches for decision-analytic modeling for economic and health outcomes assessments -- methods that she has applied to model medication adherence and translate pharmacometric findings to cost-effectiveness analyses. Before returning to academia, she worked in the field of drug discovery at Array BioPharma in Boulder. She is very active with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and maintains close connections with collaborators in industry and academia alike. 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.
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