Michael Day has 20+ years of experience in the pharmaceutical/biopharmaceutical industry. He earned his Ph.D. in Pharmaceutical Sciences and Chemistry from the University of Missouri-Kansas City.

Mr. Day provides both regulatory strategy and chemistry, manufacturing, and controls (CMC) consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced therapies. He previously served as Managing Director of CMC/Global Regulatory Affairs at Cardinal Health Regulatory Sciences.

In addition to his consulting, Michael currently serves as adjunct faculty for the University of Missouri-Kansas City’s School of Pharmacy and as Vice President of the Pharmaceutical Technical Exchange Association.

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William R. Kelce has more than twenty-five years of experience in the pharmaceutical and biopharmaceutical industry as an executive providing regulatory strategy and non-clinical development expertise. His Ph.D. and Post-Doctoral training in toxicology were completed at the University of Missouri-Columbia and The Johns Hopkins University, respectively.

Dr. Kelce has secured over $20 million in grant funding through 2020 for clients in the wound healing field with the following areas of expertise:

• Drug discovery and development program design focused on go/no-go decision-making.
• Due diligence assessments for potential in-licensing and out-licensing candidates.
• Diverse therapeutic area expertise including dermatology and wound healing.

Dr. Kelce has been an active Fellow of the Academy of Toxicological Sciences since 1999.

Video: Animal Rule, Priority Review Vouchers

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