Transporters in Drug Development ─ Discovery, Optimization, Clinical Study and Regulation

Membrane transporters can be major determinants of the pharmacokinetic, safety and efficacy profiles of drugs. This presents several key questions for drug development, including which transporters are clinically important in drug absorption and disposition, and which in vitro methods are suitable for studying drug interactions with these transporters. In addition, what criteria should trigger follow-up clinical studies, and which clinical studies should be conducted if needed. This book, written by leaders in the field, will consider the key elements in these areas , covering both pharma industry and FDA perspectives.

Yuichi Sugiyama had been the Professor, Department of Molecular Pharmacokinetics at the University of Tokyo since 1991, retired from the University of Tokyo, 2012. He is now working as the Head of Sugiyama Laboratory, RIKEN Innovation Center, RIKEN Research Cluster for Innovation, Yokohama, Japan. He is a coauthor of more than 580 publications in international journals as well as 270 book chapters and review articles. His research focuses on two areas: 1) Physiologically based pharmacokinetics (In vitro/in vivo extrapolation): 2) Molecular pharmacokinetics of drug transport in liver, kidney, intestine and brain. His work is internationally recognized by prestigious awards, including AAPS Distinguished Pharmaceutical Scientist Award, 2003, FIP Hoest Madsen Gold Medal in 2009, "Medal with Purple Ribbon" given by Government in 2010 and B.Brodie Award from ASPET in 2012. 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 (1997-2007). He served as the chairman of Board of Pharmaceutical Sciences in FIP (2000-2004). He was also the president of both “International society for the study of xenobiotics (ISSX)” and “Japanese Society for Xenobiotic Metabolism and Disposition (JSSX)”.(2006-2007). Bente Steffansen is Associate Professor in Transporters in ADME at The Faculty of Health and Medical Sciences, University of Copenhagen. She graduated with MSc (pharm) in 1989 from the Royal Danish School of Pharmacy and obtained her PhD in 1994 under the Danish Research Academy within the field of prodrug design aimed for improved drug delivery. During her PhD she was also a research scientist for 1? year at the University of Kentucky, USA. She vent to the University of Uppsala in Sweden as visiting scientist in 1996. Shortly hereafter in 1997 she initiated the Molecular Biopharmaceutics research group at the University of Pharmaceutical Sciences focusing in the beginning on designing prodrugs for the absorptive peptide transporter PEPT1. Her interest for membrane transporters has since then expanded to include many other transporters. Bente has more than 60 research publications, supervised more than 120 Master students for their final research degree and 15 PhD’s. In 2010 she edited a book in Molecular Biopharmaceutis, she is a member of the European BioSim network of excellence, and has received several research grants including honorable travel grant. She serves as the Program Director for the Pharmaceutical education at the University of Copenhagen and is a member of the Chemical Committee under the National Pharmacopea Board.