Dr. James M. Joly serves as a Preclinical Safety and Toxicology Consultant at Ceramedix, Inc. Bringing extensive expertise in pharmacology, toxicology, pharmacokinetics, and regulatory science, he provides invaluable guidance on the design and execution of nonclinical safety studies from IND through all phases of clinical development.
With over 35 years of industry experience, Dr. Joly has established an impressive track record of leading preclinical safety development programs for cutting-edge biopharmaceuticals. As President at Pharma-GPS, LLC, Dr. Joly has provided preclinical safety development guidance to clients spanning the United States, Canada, China, Japan, Israel, and Ireland. Moreover, he has performed technology evaluation for in/out-licensing, conducted GLP/GMP/GCP auditing of China-based CROs, and provided litigation support pertaining to safety issues. As an Adjunct Associate Professor at Wright State University, Dr. Joly lectured on pharmacokinetics and pharmacodynamics. He previously held leadership positions at Procter & Gamble Pharmaceuticals, where he directed preclinical safety development of the highly successful $2 billion+ brand Actonel® and several other approved products. He also played a pivotal role as the Chief Preclinical Safety Assessor for P&G’s in-licensing team, conducting technical due diligence on over 30 target opportunities.
Dr. Joly earned a PhD in pharmacology and toxicology from the University of Louisville and subsequently served as a postdoctoral fellow at Research Triangle Institute. He holds an MS in entomology/pesticide toxicology from Clemson University and a BS from the University of Kentucky.