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It is with profound sadness that ABC informs its members of the death of a true friend and ally to the herbal medicine movement, Floyd E. Leaders, Jr., PhD.
Dr. Leaders was instrumental in helping create a significant bridge of communication and understanding between the herb industry and botanical researchers, on the one hand, and many scientists and policy makers at the U.S. Food and Drug Administration on the other - especially at a pivotal time in the development of the herb movement, i.e., just after the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Dr. Leaders was instrumental in helping to organize a significant conference on the regulatory and research challenges related to botanical dietary supplements in 1995, sponsored by the National Institutes of Health.
Dr. Leaders was particularly interested in improving the prospects for companies interested in pursuing the drug approval avenue (investigational new drugs, INDs) for botanicals and he mentored numerous clients in this direction, including large pharmaceutical companies as well as small-venture startups.
ABC received an e-mail notice of Dr. Leaders death from Freddie Ann Hoffman, MD, a friend and colleague of Dr. Leaders last night, Feb 26, the day Dr. Leaders passed over after a lengthy illness. Dr. Hoffman, a former FDA official and a consultant on botanical drug approvals, wrote, “It is with deepest sorrow that I post the announcement of the passing of Dr. Floyd E. Leaders, Jr. Floyd was a monumental figure in the research and drug development of botanical products in the United States. He was a mentor and colleague, and most importantly--a friend.”
Dr. Hoffman included the following biographical information that she assembled about Dr. Leaders, which we share with ABC members, stakeholders, and friends. We are grateful to Dr. Hoffman for allowing us to share this with ABC’s members.
--Mark Blumenthal.
FLOYD E. LEADERS, JR, PHD
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 [now the National Center for Complementary and 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 U.S. 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.
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