IriSys Management Team

Gerald J. Yakatan, Ph.D., Founder
Chairman

“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.

Gina Stack, Co-Founder
President and Chief Executive Officer

Gina Stack co-founded IriSys Inc. in 1996 and has directed the Company as President and Chief Executive Officer since 2001 having previously served as Chief Operating Officer and as Vice President Business Development. Ms. Stack has led the growth of the Company from a small research laboratory specializing in formulation development to a cGMP compliant facility with the capabilities of moving a compound from discovery to the manufacturing of clinical trial materials for Phase I and Phase II studies. She has been responsible for the negotiation of the license for a patented pharmaceutical technology, Neurodex™ to a publicly traded company, Avanir Pharmaceuticals. Neurodex™ is currently under review by the FDA. Gina Stack has been an invited speaker on the subject of women in leadership roles and particularly on women in the position of Chief Executive Officer. From 2000 to 2003 she served as Chair, Women in Bioscience, San Diego; from 2003 to 2004 she served as Chair, American Association of Pharmaceutical Scientists (AAPS) San Diego Discussion Group and currently sits on the National AAPS Membership Committee. Ms. Stack is a member of the Board of Directors of the La Jolla Music Society.

Eli Shefter, Ph.D.
Chairman of the Scientific Advisory Board

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 and diagnostic).

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.

Douglas W. Taylor, Ph.D.
Vice President, Analytical Development & Quality Systems

Dr. Taylor was awarded a Ph.D. in Analytical Chemistry from the University of Illinois, Urbana, IL and has over 20 years experience in the pharmaceutical industry. He has been responsible for analytical methods development and validation at The Dow Chemical Company, Monsanto/Pharmacia and American Cyanamid and has led projects resulting in stability indicating methods for pharmaceutical substances. Dr. Taylor has significant experience in developing methods of analysis and characterization for a variety of molecules from synthetic organic molecules to monoclonal antibodies. These methods include HPLC, RP, IEC, SEC, SDS-PAGE, Western blot, ELISA, capillary electrophoresis, and spectroscopy. While at Dow and Monsanto/Pharmacia, he was involved in building a contract manufacturing business utilizing transgenic plants for the production of therapeutic proteins and peptides. He has also been responsible for the creation of CMC documentation for IN and NDA submissions. Dr. Taylor has over 10 years experience in project management in GMP environments and with regulatory approval processes. He joined IriSys in 2003.