The 27^th Workshop of the Japanese Society for the Study of Xenobiotics

Chair: Toshiyuki Kume
(Drug Metabolism and Pharmacokinetics Research Laboratories, Mitsubishi Tanabe Pharma Corporation)

 The 27^th Workshop of the Japanese Society for the Study of Xenobiotics (JSSX) will be held at Gakujutsu Sogo Center : National Center of Sciences Building (Hitotsubashi Hall) on May 9^th (Thu) and 10^th (Fri), 2013. Theme of this workshop shall be, “From human PK prediction to efficacy/safety prediction - A roadmap of the revolutionary period for drug Metabolism and pharmacokinetic research -”. In the previous 6^th Short Course of JSSX, we chose “Strategies to predict human PK in drug development in pharmaceutical companies” as a theme, and its participants shifted the utmost interest to efficacy/safety prediction. In response to this, we will focus on the efficacy/safety prediction this time even though this is a step forward and challenging topic for us.

 It is needless to say the importance of accuracy of human PK prediction. However, on the other hand, the Valley of Death lies mostly in Phase II study in drug development, where efficacy is assessed. Development of the translational research, which is the bridge to cross this valley, is what determines the fate of the pharmaceutical industry, and also is where spreads new fields of activities for DMPK researchers. We are pleased to have the opportunity to provide presentations of study cases at once. Heading the list of presentations is “variation in drug transporters at clinical condition”, in which there are still many unknown points, by Dr. Masuda of Kyoto University Hospital, followed by clinical and non-clinical cases that each pharmaceutical company has actively studied. Furthermore, we look forward to listening to a visionary research in a case of Alzheimer's disease by Dr. Hisaka of the University of Tokyo Hospital.

 I think that “individual differences”, “biomarkers”, and “Modeling & Simulation (M&S)” are keywords for efficacy/safety prediction. Therefore, as keynote addresses on the first day, Dr. Sugiyama of RIKEN will deliver a speech on the methodology of PK/PD prediction with consideration of individual differences, and Dr. Yokoi of Kanazawa University will introduce micro-RNA research which has been getting more notice as a safety biomarker. Also, Dr. Uyama of PMDA will speak from the standpoint of drug evaluation. Since we intend this workshop to be a place for researchers from industry, government, and academia to get together, share information on the current status, and discuss the future, we would like to have as much participation as possible

 It is easy to imagine that DMPK research will drastically change in ten years’ time. The reason why is that I believe that everyday measuring objects for instrumental analysis will extend from “drug” to include “endogenous substance”, and “PK analysis” will just be a clue for “PD prediction”.

 Where are we going? Where should we be going? I hope this two-day workshop will provide a roadmap of the direction for DMPK researchers.