Jim Joly

Biography

 Dr. Joly founded Pharma-GPS, LLC after spending 17+ yr as a toxicologist and pharmacokineticist with Procter & Gamble Pharmaceuticals. His broad-based technical skills contributed to the development of the 2 billion dollar brand Actonel®, strategic life-cycle management of many of P&G's marketed products, commercially successful co-development projects with several external partners (US, Korea, Japan, France), and technical assessments for licensing & acquisitions. Most recently, he was the chief assessor for preclinical safety assessment of P&G's technical due diligence team (for in-licensing opportunities) from 2004-2009, identifying risks and developing contingency plans to strengthen negotiating positions for acquisitions and partnering opportunities. Dr. Joly has global regulatory toxicology expertise in development of small molecules, biologics, and botanical products, and experience in submissions and addressing concerns with filings to FDA, EMEA, JMHLW, and several other country-specific agencies (German BfArM, French AFSSAPS, Swedish MPA, and UK MHRA). His familiarity with the customs and business practices in Japan and China was achieved over the course of several projects and extensive travel in these countries over the last 15 yr. Dr. Joly received his Ph.D. in Pharmacology and Toxicology from the University of Louisville. He continues to serve as Adjunct Associate Professor in the Department of Pharmacology and Toxicology, Wright State University School of Medicine. He has presented several invited talks in the US, China, and Japan on a variety of drug development topics.

Research Interest

 pharmacy and pharmacology