was founded in 1996 by James W. Harris, PhD and Robert A. Baugher
as a limited liability company incorporated in Maryland. The company's
goal was to pursue the identification and commercialization of active
anti- First Pass Effect components in grapefruit. In 1997 Dr. Harris
successfully isolated compounds from grapefruit demonstrated to be highly
active through in-vitro tests as human CYP 3A inhibitors. The compounds
are complex molecules containing an unusual spiro-ortho-ester (SOE) substructure.
The structure of the SOE class of inhibitors was elucidated in May 1997
and the first of a series of patents was filed.
In 1998 and 1999 human clinical trials were conducted under dietary
supplement protocols on the co-administration of a refined grapefruit
extract with the HIV protease inhibitor saquinavir in healthy volunteers.
These trials established proof of concept for the enhancement of the
oral bioavailability of saquinavir with the observation of an average
40-fold increase of the blood concentration of saquinavir. The improvement
in oral bioavailability was much higher than could be reasonably expected
by drug delivery formulation technologies prevalent in the pharmaceutical
industry. An investigation of synthetic chemical methods was commissioned
that resulted in the first synthesis of these compounds. This success
provided additional intellectual property related to methods of synthesis
now pursuing development of SOEs as pharmaceutical products in a number
of applications in association with approved pharmaceuticals
where oral bioavailability boosting will provide therapeutic and pharmacoeconomic
benefit. A lead drug candidate has been selected. Initial clinical studies
are scheduled for 2007.
F. Sellers, PhD, CEO and COO
Sellers has extensive management experience in the pharmaceutical chemical
industry and commercial contacts
with both the emerging and established
pharmaceutical sectors. He has experience with chemical technology and
business development, the licensing in and out of novel technology, as
an R&D Director, as a sales and marketing team manager, and in the
design and negotiation of supply contracts to the pharmaceutical industry.
Previous roles have included Vice President & General Manager of Great
Lakes Fine Chemicals and Vice President of Sales & Marketing
for Catalytica Pharmaceuticals. Dr. Sellers earned his
PhD in organic chemistry from the University of Birmingham, UK in 1979
and a MBA from the University of Florida, 1996.
James W. Harris, PhD, Founder and Chief Scientific Officer
Dr. Harris is a co-founder of BAS and the sole inventor of all BAS patents
except the synthetic chemistry series. In 1996, Dr. Harris left the FDA
in order to found Bioavailability Systems with Mr. Baugher, a lifelong
friend and former employer. From 1991 to 1996, Dr. Harris worked for the
FDA, Center for Drug Evaluation and Research, ultimately becoming a key
member in clinical pharmacology research. During that time he published
papers on the elucidation of the metabolism
of Taxol™ by CYP 3A and the isolation of the principal Taxol™ metabolite. He
became aware of the literature
on the grapefruit effect and was sufficiently fascinated to seek a means
of participating in the commercialization of the effect. Dr. Harris earned
an MS and a PhD in Toxicology from the University of Rochester School of
Medicine and Dentistry in 1989 and 1991 respectively, and a BS in Chemistry
from Vanderbilt University in 1987.
A. Baugher, Founder, Chairman of the Board and Managing Partner
Mr. Baugher has been the sole investor in BAS and is the majority shareholder.
He has thirty years of business experience in a variety of retail, advertising,
hotel industry and real estate development settings. Mr. Baugher served
as a Director of the Prime Bank of Titusville, Florida from 1989 to 1998.
In 1994, the Governor of Florida appointed him to the Florida International
Trade and Commerce Committee. He earned a BA in Economics/Management from
the University of South Florida in 1972.
C. Craig Tisher, MD, Chairman of the Medical Advisory Board
Dr. Tisher is an eminent nephrologist and Dean of the College of Medicine
at the University of Florida. He is the Chairman of the BAS Medical Advisory
Board and is in the process of recruiting three additional members with
a strong level of transplant and clinical expertise. He holds the Folke
H. Peterson Distinguished Professorship at the University of Florida. He
is also the Director of the University of Florida Center for Clinical Trials
Research. He was Chief, Division of Nephrology, Hypertension and Transplantation
at the University of Florida from 1980 to 1997. Previously Dr. Tisher held
positions at Duke University School of Medicine, Walter Reed Army Institute
of Research and Washington University School of Medicine, St Louis. He
was President of the American Society of Nephrology from 1990 to 91 and
served as Editor of the Journal of the American Society of Nephrology from
1996 to 2001. Dean Tisher earned his MD from the Washington University
School of Medicine in 1961. He is the author or co-author of more than
two hundred articles, reviews and editorials.
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