alexa William Reed Kelce | Cardinal Health Regulatory Science

World Journal of Toxicology
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William Reed Kelce

William Reed Kelce William Reed Kelce
Cardinal Health Regulatory Sciences
United States of America
Biography

Dr. Kelce leads drug development programs from discovery to approval, provides gap analyses and grant writing support, and authors Investigational New Drug (IND) and New Drug Application (NDA) (or equivalent) regulatory submissions worldwide. He has led development programs in, ophthalmology, metabolic disease, dermatology, wound healing, cancer, gastroenterology, pain and inflammation, neuropharmacology, cardiology, medical countermeasures using the animal rule, and medical devices. Dr. Kelce has published 13 book chapters; 52 original research articles and has been invited to speak at scientific conferences worldwide including the United States, Europe, Japan and Australia. He currently is Associate Editor of Toxicology and Applied Pharmacology and was past Chairman of the Board of Publications for the Society of Toxicology (2007-2008). He was elected to the Academy of Toxicological Sciences (ATS) in 1999, the Pharmacia Science Fellow Program in 2002, and was awarded the US EPA Gold Medal for scientific research on environmental endocrine disruptors.

Research Interest

• Orphan drug applications
• FDA expedited development program applications
• Nonclinical (CTA, IMPD)/NDA (BLA, MAA) regulatory submissions
• IND (CTA, IMPD)/NDA (BLA, MAA) gap analyses
• Animal rule approval strategies
• Development of small and large molecules
• Development and strategy for cellular and gene product therapies

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