The 27th Workshop of the Japanese Society for the Study of Xenobiotics
From Human PK Prediction to Efficacy/Safety Prediction- A roadmap of the revolutionary period for drug metabolism andpharmacokinetic researchHitotsubashi Hall (Gakujutsu Sogo Center), Tokyo
May 9 - 10, 2013
May 9th (Thu)
14:50～15:00
Opening Remarks
Toshiyuki Kume, DMPK Research Laboratories, Mitsubishi Tanabe Pharma Corporation
15:00～15:50
Prediction of pharmacokinetics taking disease states and interindividual differences into accountYuichi Sugiyama, RIKEN Innovation Center, RIKEN
15:50～16:40
MicroRNAs as potential biomarkers for drug safety and efficacy
Tsuyoshi Yokoi, Drug Metabolism and Toxicology Faculty of Pharmaceutical Sciences, Kanazawa
University
16:40～17:10（Break）
17:10～18:00
A value of biomarker/M&S data in regulatory review for drug approval
Yoshiaki Uyama, Pharmaceuticals and Medical Devices Agency
18:40～20:30（Banquet at Gakushi Kaikan）

May 10th (Fri)
Theme 1: Pharmacokinetics in Disease States and Prediction of Drug Efficacy and Safety
9:40～10:25
Clinical Pharmacology of Drug Transporters: Influence of Disease on Functional Change
Satohiro Masuda, Department of Pharmacy, Kyoto University Hospital
10:25～11:00
Pharmacokinetics and Pharmacodynamics of Tolvaptan in the heart failure patients
Seong Ryul Kim, Division of Clinical Research & Development, Clinical Pharmacology, Otsuka
Pharmaceutical Co., Ltd.
11:00～11:35

Population pharmacokinetic (PPK) analysis of S-1 in Western patients with solid cancer
Ken-ichiro Yoshida, Pharmacokinetics Research Laboratory, Taiho Pharmaceutical Co., Ltd.
11:35～13:00（Lunch break）(11:55～12:40：Luncheon seminor)
Theme 2: Prediction of Drug Efficacy using M&S and Biomarkers
13:00～13:45
Issues in Disease Modeling: A Case for Alzheimer's Disease
Akihiro Hisaka, Pharamcology and Pharmacokinetics, The University of Tokyo Hospital
13:45～14:20
Pre-clinical M&S that is useful for clinical development: clinical M&S perspective
Kazutaka Yoshihara, Translational Medicine & Clinical Pharmacology Dept., Daiichi Sankyo Co.,Ltd.
14:20～14:40（Break）
14:40～15:15
Recent Advance in Translational Modeling and Simulation
Peter Bonate, Global Head Clinical PK and M&S, Astellas Pharma Inc.
15:15～15:50
A Novel Pharmacodynamic Modeling Approach to Determine Long Term Disease Progression
Rates in Japanese Type 2 Diabetes Patients: Pioglitazone vs. Conventional Therapy
Fran Stringer, Clinical Data Science Dept. Takeda Development Center Japan, Pharmaceutical
Develop. Div. Takeda Pharmaceutical Co. Ltd
15:50～16:10（Break）
Theme 3: Prediction of Drug Safety using M&S and Biomarkers
16:10～16:45
Assessment of safety and DDI in human using PBPK models
Hidenori Matsushita, Pharmacokinetics Research Laboratories, Dainippon Sumitomo Pharma Co.,Ltd.
16:45～17:20
Pros & Cons for biomarkers: Focusing on renal transporters related to TK and DDI estimation
Yuichiro Imamura, Drug Metabolism & Pharmacokinetics Research Laboratories, Daiichi SankyoCo., Ltd.
17:20～17:55
Current activity and challenges of JPDSC, an approach to personalized medicine
Shyh-Yuh Liou, Clinical Pharmacology, Clinical Data Science Dept. Takeda Development Center
Japan, Pharmaceutical Develop. Div. Takeda Pharmaceutical Co. Ltd

17:55～18:00
Closing Remarks
Toshiyuki Kume, DMPK Research Laboratories, Mitsubishi Tanabe Pharma Corporation