Bruce Merchant, M.D., Ph.D., Co-Founder & Principal, with graduate degrees from the University of Chicago, was formerly Director of the FDA's Immuno-hematology branch (the Center for Biologics Evaluation and Research), Chairman of the FDA's Hybridoma Committee, and FDA spokesperson for monoclonal antibody policies (1980-1984). Dr.Merchant next entered private industry as Director of Medical and Regulatory Affairs for Hybritech, Inc. He also served as Vice President of Regulatory Affairs and Clinical Development, for Viagene, Inc., and founded Clin/Regs Associates before forming Merchant-Taylor International. He has more than 30 years experience as a Researcher at the National Institutes of Health, as an FDA Regulator, as an Industrial Clinical and Regulatory Director and as a Biopharmaceutical Consultant.
James A. Taylor, Ph.D., Co-Founder and Principal, with advanced degrees in Biochemistry from Purdue University, was formerly Corporate Vice President and Chief Regulatory Officer for ImmunoGen, Inc, Vice President of Regulatory Affairs for Carter-Wallace, North American Director of Drug Regulatory Affairs for ICI Pharmaceuticals (now Astra-Zeneca) and a Senior Research Scientist and Regulatory Liason Officer for Pfizer, Inc. In 1992, Dr. Taylor founded Taylor Associates, a regulatory consulting firm before forming Merchant-Taylor International. He has extensive experience in Pharmaceutical Regulatory Affairs, GMP Compliance, Quality Assurance and Project Management with large and small pharmaceutical companies as well as vendors and contract manufacturers.