James Cloyd, PharmD
Professor and Lawrence C. Weaver Endowed Chair-Orphan Drug Development
Department of Experimental and Clinical Pharmacology
College of Pharmacy
University of Minnesota
Dr. Cloyd earned his BS in pharmacy from Purdue University in 1971. While at Purdue he
studied the biosynthesis of mitromycin by streptomyces verticillatus as a research assistant in
medicinal chemistry. Following 2 years in pharmacy practice, he entered the combined
PharmD/Hospital Pharmacy Residency Program at the University of Kentucky, with Don Perrier,
PhD (pharmacokinetics) as his advisor. His research project was the protein binding of
phenytoin in newborns. Upon graduation in 1976, he accepted an appointment as an assistant
professor in clinical pharmacy with the College of Pharmacy, University of Minnesota. From
1985-86, he completed a fellowship with Rene Levy, PhD (clinical pharmacokinetics) at the
University of Washington. His fellowship project dealt with the concentrations-dependence of
carbamazepine auto-induction. In 2005, Dr. Cloyd established the Center for Orphan Drug
Research for which he serves as director. The Center’s mission is the development of orphan
drugs for rare, pediatric neurological disorders.
Dr. Cloyd early academic career began with an emphasis on the clinical pharmacology of CNS
drugs. At the University of Minnesota he established a clinical practice in the Neurology Clinic
at St. Ramsay Medical Center, where he managed antiepileptic drug therapy for patients with
poorly controlled epilepsy; designed and taught a neurotherapeutics course in the College of
Pharmacy; and established a research program in conjunction with the NIH-funded
Comprehensive Epilepsy Program.
Dr. Cloyd’s research program focuses on the pharmacology (basic and clinical) and development
of orphan drugs for rare, pediatric neurological disorders. His research includes laboratory
investigations of drug solubility, stability, and pharmacology; pharmacokinetic and efficacy
studies in animals; drug safety, bioavailability and pharmacokinetic, pharmacogenomic, drug
interaction, and efficacy studies in healthy volunteers and/or patients including children and the
elderly. He holds 9 INDs and has served as principal or co-principal investigator for a number of
Phase I-Phase III trials, many of which have supported NDA applications. He co-authored the
orphan drug application for diazepam rectal gel (Diastat) and was a key leader in the successful
development of product. The National Institutes of Health, the Food and Drug Administration,
foundations, and the pharmaceutical industry have funded his research, which has led to100
papers in major medical and pharmacology journals as well as book chapters on various aspects
of CNS drugs.
Dr. Cloyd has trained 23 PhD and post-doctoral fellows, many of whom have pursued a career in
clinical pharmacology. He is actively involved in several international and national
organizations including the International Conference on Rare Diseases and Orphan Drugs and
the American Epilepsy Society, where he serves on the Board of Directors.
In addition, he has served on an NINDS clinical trials study section and is a newly appointed
member of the FDA Advisory Committee on Pharmaceutical Science and Clinical
Pharmacology.