Gordon Amidon, Ph.D., University of Michigan, Ann Arbor, Michigan

Dr. Gordon Amidon is internationally recognized for his research in the field of solubility, transport phenomena, prodrugs, and drug absorption. He is actively involved in developing the Biopharmaceutics Classification System (BCS) with the FDA, which will serve as a basis for international drug regulation.

Gordon received his B.S. degree from the State University of New York, Buffalo (1967), his M.A. degree in mathematics (1970), and his Ph.D. in pharmaceutical chemistry (1971) from the University of Michigan. From 1971 to 1981 he was a member of the faculty at the University of Wisconsin. In 1981 he became director of Pharmaceutical Research at Merck/INTERx, in Lawrence, Kansas. He was appointed Professor of Pharmaceutics at the University of Michigan in 1983 and was named the Charles R. Walgreen, Jr., Professor of Pharmacy in 1994.

Gordon has published extensively in journals, with over 170 published papers and 250 abstracts. He has contributed chapters to over 30 books and monographs. He is co-editor of three books, The Chemical Stability of Pharmaceutics, Peptide-based Drug Design: Controlling Transport, and Metabolism and Pharmacokinetic Analysis, A Practical Approach.

Gordon received the Ebert Prize of APhA in 1974 and 1981, and was co-recipient in 1984. In 1996 he received the Scheele Award of Swedish Academy of Pharmaceutical Sciences for outstanding contributions to the field of oral drug delivery and biopharmaceutics. He is a fellow of AAPS (and served as president in 1998), APhA/APS, and AAAS. He is also a member of the Controlled Release Society (and served as president in 1994), AACP, ACS, and the American Peptide Society.

Marival Bermejo, Ph.D., Universidad de Valencia, Spain

Dr. Marival Bermejo is currently Associate Professor of Pharmaceutics at the University of Valencia (Spain). She earned her B.Pharm and Ph.D degrees at the same University under the supervision of Prof. Plá-Delfina with a grant from Spanish Government. She got a position as Assistant Professor in 1993 and was promoted to her actual position in 1998. She performed two research stages at the Institut of Topology and System Dynamics in Paris VII University, collaborating with Prof. Christiane Mercier and at the University of Michigan, working with Prof. Gordon Amidon. Dr. Bermejo research was centered on biophysical absorption models and their use in the study of the influence of surfactants on intestinal absorption.

Her last research projects have been focused on the validation of in situ and in vitro models for oral permeability predictions and their application to the biopharmaceutical development of new fluoroquinolones. Marival Bermejo is member of the “BIOSIM Network of Excellence” and she is the coordinator of the project “MEMTRANS”, both projects funded by the European Commission and devoted to the improvement of in vitro methods for drug absorption predictions and the use of modeling and simulation as tools in drug development. She has been co-author of thirty papers, five of them in Spanish journals, four books chapters and is co-author along with Gordon Amidon of the English and Spanish versions of Modern Biopharmaceutics, a CD-Rom teaching tool.

She has co-advised seven PhD. thesis and seven PhD. dissertations since 1998. Dr Bermejo was member of the team of translators of European Pharmacopoeia into Spanish. In 2001 her team was awarded with the Research Prize of “Liconsa-Chemo Ibérica” for their work on fluoroquinolones absorption. She is member of the Board of Directors of the Drug Delivery Foundation (www.ddfint.org). Dr. Bermejo is member of SEFIG and EUFEPS and external assessor of the Spanish Agency of Medicines (AGEMED) and EMEA.

Jack A. Cook, Ph.D., Pfizer Global Research and Development, New London, CT

Dr. Jack Cook is a Vice President Clinical Pharmacology Specialty Care at Pfizer, Inc. Prior to joining Pfizer in 1990, he was a group leader at Sterling Drug, Inc. and served as an adjunct faculty member at Albany College of Pharmacy. He also currently serves as an Adjunct Associate Professor at the University of Michigan. His current interests include improving therapy by optimizing drug delivery and the use of modeling and simulation to make rational decisions in the development of drugs.

Jack received an A.A.S. degree in industrial chemistry in 1978 and B.S. degrees in Pharmacy and in Applied Mathematics in 1981 from Ferris State College. He received his Ph.D. from the University of Michigan in 1990.

Peter Langguth, Ph.D., Johannes-Gutenberg University, Mainz, Germany

Dr. Peter Langguth is a pharmacist by training and currently Professor of Biopharmaceutics and Pharmaceutical Technology at the School of Pharmacy, Johannes Gutenberg-University in Mainz, Germany. He received a Ph.D. in Pharmacology (1985) from the Johann Wolfgang Goethe-University in Frankfurt with Prof. Ernst Mutschler. From 1986 until 1988 he was Post-doctoral Research Fellow in Pharmacokinetics in the group of Prof. Edward R. Garrett at the University of Florida in Gainesville and from 1989 until 1995 he was Senior Research Fellow at the Department of Pharmaceutical Technology, Swiss Federal Institute of Technology (ETH) in Zürich, Switzerland. In 1995 he received the Venia legendi (Habilitation) in Pharmaceutical Technology and Biopharmaceutics from the ETH. From 1985 until 1995 he was also Visiting Scientist in various institutions including Alza Corporation, Palo Alto, STADA AG Dortelweil, and the University of Michigan (Prof. Gordon Amidon). In 1996 Prof. Langguth joined the Department of Pharmacokinetics and Drug Metabolism at Astra Hässle AB in Mölndal, Sweden, as Group Leader in Drug Absorption Research. In 1998 Dr. Langguth accepted a call to the University of Mainz as Head of the Department of Biopharmaceutics and Pharmaceutical Technology. His research interests include formulation and absorption of pharmaceuticals including bioavailability, pharmacokinetic and drug targeting aspects.

Hans Lennernäs, Ph.D., Uppsala University, Uppsala, Sweden

Dr. Hans Lennernäs is a full professor of Biopharmaceutics at Uppsala University since 1 July 2000, Sweden and he also holds an adjunct professor of Biopharmaceutics at Royal Danish School of Pharmacy in Copenhagen, Denmark since 2000. His research interest is focused on clinical significance of mechanisms and regulation of membrane transport and metabolism of drugs/metabolites in the gastrointestinal tract, hepatobiliary system and cancer tissues. This work is performed in vivo with clinical models in humans and in various tissue and cell culture models. His research aims to develop novel strategies of tissue drug targeting and delivery that aims to improve the clinical use and efficacy of drugs in various disease states, such as metabolic and cancer diseases. Hans Lennernäs has together with gastroenterologists developed and validated two new clinical intestinal perfusion techniques for investigations of intestinal transport and metabolism of drugs and nutrients.

He has been the Principal Investigator in an extensive collaboration with Food Drug & Administration, USA, University of Michigan, USA, and Medical Product Agency, Sweden during several years to develop a new guideline for the Biopharmaceutics Classification System. He has established an extensive human permeability database (45 compounds) that today is widely used in academia and pharmaceutical industry. Dr. Lennernäs has been the chairman for numerous international conferences. He serves as reviewer for several scientific journals in clinical pharmacology and pharmaceutical science. His work had led to more 140 publications, 190 invited lectures and more than 300 submitted presentations at scientific meetings. He has supervised 16 doctorial theses and acted as co-supervisor for two neurologists. He has obtained several national and international research grants.

Dr. Lennernäs has received a Glaxo Wellcome Achievement Award in 1997, an Annual Award from the Industrial Pharmacy Section of Fédération Internationale Pharmaceutique (FIP) in 1998, and an Honourable Mentions at EURAND AWARD 2000. He has been elected the AAPS Fellow 2004 and received the AAPS Meritorious Manuscript Award 2004. Dr. Lennernäs is on the board of the non-profit Drug Delivery Foundation, which promotes research and education in this area all around the world. He is also one of the innovators to a novel sublingual drug delivery system for the treatment of various acute pain conditions (Abstral, Rapinyl). He has invented seven patent/patent applications, which have resulted in drug products in pre-clinical phase and in preparation for phase I, II and III clinical trials. Abstral (Rapinyl) has been approved in Europe. He is also working with pharmaceutical development of novel strategies for replacement therapy of oral hydrocortisone in adrenal insufficiency and focal hormonal treatment of prostate cancer and BPH. His research team is currently composed of 7 Ph.D. students, and has an extensive national and international interdisciplinary collaboration with both universities and national and international pharmaceutical companies.

James E. Polli, Ph.D., University of Maryland, Baltimore, MD

Dr. James E. Polli is Professor and Vice-Chair of Pharmaceutical Sciences at the University of Maryland School of Pharmacy. He received a B.S. in Pharmacy from the Philadelphia College of Pharmacy and Science and a Ph.D. (pharmaceutics) from the University of Michigan. Dr. Polli’s research interest evolves around the performance and pharmaceutical quality of orally administered medicines. His two main research interests are 1) maximizing oral bioavailability through formulation and chemical approaches and 2) developing public quality standards for oral dosage forms. He has published in the areas of dissolution, drug intestinal permeability, prodrug design, oral bioavailability, in vitro - in vivo correlation, and bioequivalence. He is an Editorial Board member of several journals and is Vice-Chair of the USP Expert Committee on Biopharmaceutics. He is a licensed pharmacist and teaches professional pharmacy students and graduate students.

Ikumi Tamai, Ph.D., Kanazawa, Japan

Dr. Ikumi Tamai is Professor of Department of Membrane Transport and Pharmacokinetics, Faculty of Pharmacy, Institute of Medical, Pharmaceutical, and Health Sciences, Kanazawa University since April 2008. He received his B.S. from Kanazawa University in 1982, and Ph.D. in Pharmaceutical Sciences from University of Tokyo in 1988. He studied the carrier-mediated transports of drugs with Prof. Akira Tsuji at Kanazawa University. From 1989, he studied P-glycoprotein with Prof. Ahmad Safa at University of Chicago and intestinal transporters at University of Michigan with Prof. Amidon. In 1991, he joined Prof. Tsuji’s laboratory in Kanazawa University as assistant and associate professor till 2002 and contributed to the researches on the role of P-glycoprotein as the BBB, characterization of PEPT1, molecular cloning and functional characterization of OCTNs and OATPs transporters. In 2002, he was promoted as Professor in Tokyo University of Science, Faculty of Pharmaceutical Sciences, Tokyo, Japan and continued researches on the roles of membrane transporters in drug absorption and disposition. Then, he moved to Kanazawa University in 2008. He has published over 190 original articles related to transporters.

He is studying relevance of transporters to the efficacy and toxicity of drugs as well as to pharmacokinetics of drugs and application to drug delivery by mainly focusing on tissues such as small intestine, liver, kidney and lung. He is also studying physiological transporters such as uric acid, vitamins and amino acids to clarify the roles of transporters for the regulation of nutrients and physiological compounds for the purpose of finding novel pharmacological targets and biomarkers of any diseases. The targeted transporters are OATPs, OCTs, OATs, PEPTs, URAT, PGT, SGLTs, OCTNs, P-gp, MRPs, and others.

Shinji Yamashita, Ph.D., Setsun University, Osaka, Japan

Dr. Shinji Yamashita is a Professor of Faculty of Pharmaceutical Sciences at Setsunan University, Japan. After receiving Master degree of Pharmaceutical Science in 1982 at Kyoto University, he was employed by Jyosai University as Associate Researcher of Pharmaceutical Sciences. In 1985, he moved to Setsunan University and promoted to Assistant Professor (1989), Associate Professor (1995) and full Professor (2001). He received his Ph.D. degree in 1987 from the Kyoto University under Prof. Hitoshi Sezaki. From 1992 until 1993 he did post-doctoral research work in college of pharmacy, the University of Michigan under Prof. Gordon L. Amidon.

His research interests include pharmacokinetics, drug absorption, drug metabolism and drug delivery systems. Especially, he has been focusing on the screening of intestinal drug absorption by in vitro method using Caco-2 cultured cells. He has published over 50 original research articles and book chapters.