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. Curriculum Vitae
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. Curriculum Vitae