William Kelce, MS, PhD, Fellow ATS
Volunteer Professor and Principal Consultant, PAREXEL Consulting
Post-Doc, The Johns Hopkins University, 1991
Ph.D., University of Missouri-Columbia, 1989
M.S., University of Missouri-Columbia, 1985
A.B., Washington University- St. Louis, 1981
Special Interests: Development of Regenerative Medicine Advanced Therapy products (eg, stem cell therapeutics, immuno-oncology cell therapy, CAR-T cells); orphan drug applications; FDA expedited development programs; nonclinical IND/NDA regulatory submissions; IND/NDA gap analyses; drug substance and drug product impurity and excipient qualifications; animal rule submissions; and development of small and large molecules.
I continue to lead nonclinical development programs from discovery to approval, providing gap analyses and grant writing support, and authoring Common Technical Document (CTD) Investigational New Drug (IND) application and New Drug Application (NDA) regulatory submissions. I have led development programs in ophthalmology, metabolic disease, dermatology, wound healing (partial- and full-thickness wounds and burns, and wound-microbial burden), cancer, gastroenterology, pain and inflammation, neuropharmacology, cardiology and medical devices.
Prior to joining PAREXEL Consulting, I 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; President of Leading Edge PharmTox; and Director and Executive Consultant at Cardinal Health. In addition to nonclinical development, I have led Phase 1 pharmacokinetic and pharmacodynamic, Phase 2, and multi-site Phase 3 clinical trials.
On the academic side, I have published 13 book chapters; 52 original research articles in scientific journals (ie, Nature, Journal of Biological Chemistry, Journal of Molecular Medicine, and Endocrinology); and, have been invited to speak at scientific conferences worldwide including the United States, Europe, Japan and Australia.
While not active in research anymore, I stay current by serving on three scientific editorial boards (Toxicology and Applied Pharmacology, Birth Defects Research and Environmental Health Perspectives), as Associate Editor of Toxicology and Applied Pharmacology and as past Chairman of the Board of Publications for the Society of Toxicology. I 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 EPA Gold Medal for scientific research on environmental endocrine disruptors.
I am happy to join the Department of Pharmacology, Toxicology & Therapeutics and look forward to interacting with students and faculty on issues related to pharmaceutical development, life in industry and government, and any topic where I may be able to provide some hard-earned insight.