IriSys Management Team
Gerald J. Yakatan, Ph.D., Founder
“Jerry” Yakatan has served in academic and industrial
environments, directing pharmaceutical product development efforts
at every phase from discovery to commercialization. His academic
career began in 1971 at the University of Texas, Austin where he
served as a Professor and later as Chairman of the Pharmaceutics
Department. In 1980 he joined Warner Lambert as Director of Pharmacokinetics
and Drug Metabolism and later served as Vice President of Product
Development Worldwide where he participated in the development
of several drug products including Lopid®, Lipitor®, Eryc® Accupril®,
Neurontin® and the Benadryl® cough line.. In 1987 he joined
Immunetech Pharmaceuticals, San Diego, CA as Executive Vice President
Research and Development and in 1990, Tanabe Research Laboratories,
USA as President and Chief Executive Officer. Dr. Yakatan founded
IriSys in 1996 recognizing the need for a West Coast pharmaceutical
product development contract services organization to serve the
growing California biomedical industry. In 1998, Dr. Yakatan began
his tenure at Avanir Pharmaceuticals, San Diego as President and
Chief Executive Officer where he led the development efforts of
Neurodex™, the NDA of which is currently under review by
the FDA and where he was responsible for the regulatory approval
and commercialization of Abreva®. Dr. Yakatan is a Fellow of
the American Association of Pharmaceutical Scientists and of the
American College of Clinical Pharmacology; he has received distinguished
alumnus awards from Temple University and from the University of
Florida. He is currently involved at the Board level with the American
Technion Society, La Jolla Music Society, and BIOCOM, San Diego.
Eli Shefter, Ph.D.
Chairman of the Scientific
Dr. Shefter most recently served as Professor of Pharmaceutics
at the School of Pharmacy, University of California, San Diego.
Eli Shefter is a renowned expert in the areas of pharmaceutical
product development with comprehensive knowledge and expertise
in formulation/drug delivery of classical and biotechnology derived
therapeutics; strategic and tactical planning for product development;
and regulatory requirements for drugs, biologics and devices (therapeutic
Dr. Shefter has been a member of the faculty at State University
of New York at Buffalo, from 1966 to 1981; the University of Colorado
from 1990 to 1992, and as Adjunct Professor, University of Colorado
from 1996 to the present. He has a variety of industrial experience
including E.I. DuPont Nemours, Genentech, Access Pharmaceuticals,
and Cytel Corporation. Dr. Shefter has served as Chief Scientific
Director and Senior Science Fellow at IriSys since the Company’s
founding in 1996.
Dr. Shefter is a member of the United States Pharmacopoeia, a
member of the committee of revision; and has served on the Board
of a number of scientific journals in pharmaceutics. Dr. Shefter
is a Fellow of the American Pharmaceutical Association (APA) and
of the American Association of Pharmaceutical Scientists (AAPS).
Dr. Shefter was awarded a Ph.D. from the University of Wisconsin.
Robert P. Giannini, Ph.D.
Chief Scientific Officer
Robert Giannini was awarded a Ph.D. in Industrial Pharmacy from
the University of Maryland at Baltimore for research in the area
of solid dosage form design. During 20 years industry experience,
Dr. Giannini has expanded his breath of knowledge to include development
of all dosage forms including controlled and extended release products.
He has been responsible for the preformulation studies, formulation
development and analytical methodology for products currently on
the market. In 1981 he joined Wyeth Laboratories as Unit Supervisor,
Novel Drug Delivery Systems. In 1985 he joined Key/Schering Plough
as Section Head, Solid Dosage Form Development which was followed
by a position as Vice President, Pharmaceutical Research and Development
at Himedics. In 1991 Dr Giannini joined Watson Laboratories as
Director of Product Development where he was responsible for the
development of generic products from early preformulation studies
to submission of the ANDA. Dr. Giannini joined IriSys in 1996 as
a member of the Scientific Advisory Board. He has served as Chief
Operating Officer since 2003.