[MPWG] Floyd E. Leaders, Jr., PhD

F Hoffman - HeteroGeneity, LLC fhoffman at heterogeneity-LLC.com
Sun Feb 26 20:32:06 CST 2006


To the Botanical Community:  

 

RE:   For further distribution

 

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.    

 

A brief biographical sketch is below (and attached).

  

 

Most sincerely, 

 

Freddie Ann Hoffman, MD

_________________________________________________

 

Freddie Ann Hoffman, MD 
HeteroGeneity, LLC 
5611  16th Street, NW 
Washington, DC  20011 
Tel.:  202-545-6843 
Fax:  202-545-6844 
 <mailto:fhoffman at heterogeneity-LLC.com> fhoffman at heterogeneity-LLC.com

 <http://www.heterogeneity-LLC.com> www.heterogeneity-LLC.com

 

 

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 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. 

 

 

 

 

 

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