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FREE ROAD MAP TO FDA WHITE-PAPER
The ITC Transporter White Paper provides detailed guidance for transporter mediated DDI studies for the seven transporters recommended in the March 17, 2010 FDA Advisory Committee vote. Get the White Paper and a Road Map Summary to help navigate it.
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Optivia Scientific Advisory Board
Leslie Benet, Ph.D. Chairman of Scientific Advisory Board
Dr. Benet is a professor and former Chairman (1978-1998) of the Department of Biopharmaceutical Sciences, UC San Francisco. His research interests, more than 480 publications, 7 books and 11 patents are in the areas of pharmacokinetics, biopharmaceutics and the role of transporters in PK/PD. Dr. Benet is listed by ISI as one of the most highly cited pharmacologists worldwide. His most recent work has addressed the interplay of metabolic enzymes and transport proteins as related to oral bioavailability and hepatic elimination, with particular emphasis on immunosuppressive, anti-cancer, anti-AIDS and anti-infective drugs.
He is a Fellow of the Academy of Pharmaceutical Sciences and Research, the American Association of Pharmaceutical Scientists (AAPS) and of the American Association for the Advancement of Science (AAAS). In 1985, Dr. Benet served as President of the Academy of Pharmaceutical Sciences. He was the founding President of the AAPS. Dr. Benet is a member of the Institute of Medicine (IOM) of the National Academy of Sciences. He is the former Chair of the Pharmacology Study Section and the Pharmacological Sciences Review Committee for the NIH, the FDA Center for Biologics Peer Review Committee, the FDA Expert Panel on Individual Bioequivalence, the Board of Pharmaceutical Sciences of the FIP, the Organizing Committee for the Millennial World Congress of Pharmaceutical Sciences, the Congressionally mandated IOM/NRC Committee on Accelerating the Research, Development and Acquisition of Medical Countermeasures Against Biological Warfare Agents and as a member of the FDA Science Board and the Generic Drugs Advisory Committee. He presently serves as a member of the IOM Forum on Drug Discovery, Development and Translation, the FDA 100th Anniversary State of Science Review Committee and the Board of Directors of the American Foundation for Pharmaceutical Education.
Dr. Benet received his AB (English), BS (Pharmacy), M.S. from the University of Michigan and his PhD from University of California, San Francisco. In addition, he has received seven honorary doctorates from universities around the world.
Yuichi Sugiyama, Ph.D. Scientific Advisor
Professor Sugiyama is in the Department of Molecular Pharmacokinetics at the University of Tokyo. He is the coauthor of more than 550 publications, 270 book chapters and review articles.
Professor Sugiyama’s work focuses on two areas: 1) prediction of drug disposition from in vitro biochemical data. 2) Molecular pharmacokinetics of drug transport in liver, kidney, intestine and brain.
His work has been recognized by numerous prestigious international awards. According to a recent report of ISI Essential Science Indicators, Professor Sugiyama has been ranked as the top (#1) cited scientist in the field of Pharmacology & Toxicology.
He has served as the chairman of many organizations including ISSX and the Japanese Society for Xenobiotic Metabolism and Disposition (JSSX).
B. Michael Silber, Ph.D. Scientific Advisor
Dr. B. Michael Silber is a professor of Neurology, Bioengineering and Therapeutic Sciences, and Chief of Drug Discovery R& D at Institute for Neurodegenerative Diseases (IND) University of California School of Medicine.
Prior to joining the faculty at UCSF and the IND, Dr. Silber held senior executive R & D operating positions at leading pharmaceutical, biotechnology, or biopharmaceutical companies, including Roche, Johnson & Johnson, Pfizer, Cetus, and Lederle. He has contributed to the discovery, development, or regulatory approval of 23 medicines across a wide range of diseases.
Dr. Silber has over 170 research articles, book chapters, abstracts, and invited presentations at national and international meetings. He is a reviewing editor or reviewer for many national or international scientific journals. He is a principal or co-principal investigator on NIH funded program project grants, foundation and donor sponsored research being conducted at the IND. He was elected and serves on the UC Berkeley Bioengineering Council, was on the Keystone Symposia SAB for nine years, is a study-section reviewer for the NIH, and was formerly on the University of Washington School of Pharmacy Corporate Board. He is also a Board member of several biotechnology or life-sciences startup companies, and is a Senior Strategic and Scientific Advisor to life sciences, biotechnology, and VC companies focused on discovering new drug and drug-device combinations. He has made many contributions to scientific research and technology in drug discovery R & D.
Dr. Silber received his Doctor of Pharmacy degree from University of Southern California and his Ph.D. in Pharmaceutical Chemistry and Pharmacology from University of California, San Francisco.