Dr. Leaders received a Bachelors of Science in Pharmacy from Drake University in 1955. He went on to receive a Masters of Science in Pharmacology, and later a Doctorate in Pharmacology from the State University of Iowa in 1962. His first professional position was as an assistant professor of pharmacology at the University of Kansas Medical School in Kansas City. In 1967 he left academia to join Alcon Laboratories (Fort Worth, TX), and he continued to move up through the ranks of the pharmaceutical industry, serving as Director of Research Services at Schering-Plough, and then Director of R & D at Pennwalt Corporation. By 1977, Dr. Leaders had founded Technical Evaluation and Management Services, Inc., a Dallas-based contract research organizations, one of the first CROs to run clinical trials for the pharmaceutical industry to meet the FDA’s regulatory standards.
In the early 1990’s he also formed his own consultancy group, The Leaders Group, Inc., from which he served as consultant to the newly established Office of Alternative Medicine at the National Institutes of Health. In this role, he assisted researchers, clinical investigators, federal agencies and the industry to understand not only the need for carefully designed studies and data management, but also the rigorous requirements for US drug development and approval. Through his patience and powerful negotiation skills, Dr. Leaders was successful in assisting sponsors in filing Investigational New Drug applications for heterogeneous botanical products with the FDA Center for Drug Evaluation and Research. He also co-chaired more than a half dozen workshops on botanical drug development, sponsored by the Drug Information Association, the Food and Drug Administration, and the National Institutes of Health.
An outgrowth of his work with both federal and private sector colleagues was the development of the scientific underpinnings for the FDA CDER Guidance document on Botanical Drugs. In 1997, Dr. Leaders formed yet another entity - Botanical Enterprises, Inc. (BEI), located in Rockville, Maryland. As Chairman and CEO, he entered into commercial agreements with potential companies and drug sponsors with the purpose of developing botanical drug products.
Following a protracted illness, Dr. Floyd Leaders passed away on February 26, 2006. He is survived by his wife, Madeline van Hoose, and his daughter.