William R. Kelce, MS, PhD

Principal Scientist, Regulatory Affairs and Product Development

William R. Kelce, MS, PhD, Fellow ATS, is Principal Scientist, Regulatory Affairs and Product Development for Cardinal Health Regulatory Sciences.

Role responsibilities

Dr. Kelce leads nonclinical development programs from discovery to approval. He provides gap analyses and grant writing support and authors Common Technical Document (CTD) Investigational New Drug (IND) application and New Drug Application (NDA) regulatory submissions. He has led development programs in ophthalmology, metabolic disease, dermatology, wound healing, cancer, gastroenterology, pain and inflammation, neuropharmacology, cardiology and medical devices. 

Professional experience

Dr. Kelce has more than 25 years of experience as a regulatory toxicology professional and senior executive in pharmaceutical research and development. Prior to joining Cardinal Health, he was a Science Fellow and Director of Safety Sciences at GD Searle, Pharmacia and Pfizer; Vice President of Preclinical Development and Clinical Operations at Pozen, Inc; Vice President and Chief Scientific Officer at the Drug Discovery Center of Innovation; Vice President of Nonclinical Development at Novan Therapeutics and President of Leading Edge PharmTox. Dr. Kelce has led Phase 1 pharmacokinetic and pharmacodynamic, Phase 2 and Phase 3 clinical trials.
Dr. Kelce has published 13 book chapters and 50 original research articles in scientific journals, including Nature , Journal of Biological Chemistry and Journal of Molecular Medicine and Endocrinology . He has presented at scientific conferences, symposia and workshops in the United States, Europe, Japan and Australia on environmental endocrine disruptors.

Professional affiliations and awards

Dr. Kelce holds an adjunct professorship at The University of North Carolina-Chapel Hill, Department of Pediatrics, School of Medicine. He serves on three scientific editorial boards (Toxicology and Applied Pharmacology, Birth Defects Research and Environmental Health Perspectives), is Associate Editor of Toxicology and Applied Pharmacology and is past Chairman of the Board of Publications for the Society of Toxicology. He was elected to the Academy of Toxicological Sciences (ATS) in 1999 (recertified in 2005, 2010 and 2015), the Pharmacia Science Fellow Program in 2002 and was awarded the US Environmental Protection Agency Gold Medal for scientific research on environmental endocrine disruptors.

Education

Dr. Kelce received a master’s and doctorate degree in pharmacology/physiology and toxicology from the University of Missouri-Columbia and completed a post-doctoral fellowship at The Johns Hopkins University in toxicology.

Areas of Expertise


Nonclinical drug development

Toxicology

Nonclinical gap analysis

Regulatory agency meetings

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