October 10, Monday (Day 1)
Session 1: Drug Discovery
To describe the pharmacological process for drug discovery and to identify the process to protect intellectual property.
13:45-14:15 History and overview of drug discovery process
Dr. Nobuhiro Noro, Head, Clinical Research/Biologicals,
Alliance and Rare Diseases, Development & Medical Affairs Division,
GlaxoSmith Kline, K.K.
14:15-15:15 The role of pharmacology in drug discovery
Dr. Nobuhiro Noro, Head, Clinical Research/Biologicals,
Alliance and Rare Diseases, Development & Medical Affairs Division,
GlaxoSmith Kline, K.K.
15.15-15.30 Tea break
15:30-16:30 Genomics and bioinformatics
Dr. Nobuhiro Noro, Head, Clinical Research/Biologicals,
Alliance and Rare Diseases, Development & Medical Affairs Division,
GlaxoSmith Kline, K.K.
October 11, Tuesday (Day 2)
9:00-10:00 High throughput screening
Dr. Nobuhiro Noro, Head, Clinical Research/Biologicals,
Alliance and Rare Diseases, Development & Medical Affairs Division,
GlaxoSmith Kline, K.K.
10:00-10:15 Tea break
10:15-11:30 The role of chemistry in drug discovery
Dr. Nobuhiro Noro, Head, Clinical Research/Biologicals,
Alliance and Rare Diseases, Development & Medical Affairs Division,
GlaxoSmith Kline, K.K.
11:30-13:30 Lunch
13:30-14:45 Drug development for neglected tropical diseases
Professor Dr. Kiyoshi Kita, Department of Biomedical Chemistry,
Graduate School of Medicine, The University of Tokyo, Japan
14:45-15:00 Tea break
15:00-16:30 Publications, IRP & patents
Dr. Kenichi Osawa, President, OSAWA IP LAW FIRM, Japan
October 12, Wednesday (Day 3)
Session 2: Chemistry, Manufacturing and Control (CMC)
Objective: To describe different processes of CMC.
9:00-9:30 Formulation of drug products
Professor Hitoshi Sasaki, Nagasaki University Hospital, Nagasaki, Japan
9:30-12:45 Overview of CMC, development of specifications, QA/QC,
Regulatory, naming the new chemical entity,
Stability for drug substance and drug product
Professor Hitoshi Sasaki, Nagasaki University Hospital, Nagasaki, Japan
12:45-13:45 Lunch
Session 3: Pre-clinical Development
Objective: To describe the process of pharmacological development.
13:45-14:30 Overview, pharmacological data in new drug application
Dr. Hiroyuki Ito, Senior Director, Pharmacology Research Labs.
Drug Discoversy Research,Astellas Pharma Inc., Japan
14:30-15:30 Methods in pharmacological R&D
Dr. Hiroyuki Ito, Senior Director, Pharmacology Research Labs.
Drug Discoversy Research,Astellas Pharma Inc., Japan
15:30-15:45 Tea break
15:45-17:00 The role of pharmacokinetics and drug metabolism
Professor Dr. Eiji Uchida, Showa University, Japan
October 13, Thursday (Day 4)
Session 4: Toxicology
Objective: To describe the toxicological methods.
9:00-10:00 Overview
Associate Professor Dr. Wongwiwat Tassaneeyakul, Dean,
Faculty of Pharmaceutical Sciences, Khon Kaen University,
Thailand
10:00-11:00 Toxicological tests: in vitro & in vivo
Associate Professor Dr. Wongwiwat Tassaneeyakul, Dean,
Faculty of Pharmaceutical Sciences, Khon Kaen University,
Thailand
11:00-13:00 Tea break & Lunch
13:00-14:30 Necessary facility to toxicology
Visit animal facility for medical research
Professor Dr. Kazutaka Ohsawa, Laboratory Animal Center for
Biomedical research, Nagasaki University
Session 5: Traditional Medicine
Objective: To underline the importance of traditional medicine in PRD.
14:45-15:45 Introduction of traditional medicine
Professor Dr. Kiichiro Tsutani, Graduate School of
Pharmaceutical Science, The University of Tokyo, Japan
15:45-16:00 Tea break
16:00-17:00 Regulation for traditional medicine development
Dr. Ichiro Arai, Manager, Tsumura Drug Information Library,
Tsumura & Co., Japan
17:00-18:00 Guidance on herbal medicine
Professor Dr.Kiichiro Tsutani
October 14, Friday (Day 5)
Session 6: Clinical Development
Objective: To explain the different phases for clinical trials, explain the critical role of pharmacokinetics/pharmacogenomics and safety monitoring, and explain the regulatory aspects for Clinical Trials
9:00-10:00 Overview of clinical development
Dr. Hanako Mihara, Medical Director, Health Economics and
Outcomes Research (HEOR), Division of Medical Affairs,
Japan/Asia-Pacific, Abbott Diagnostics. Co., Ltd.
10:00-10:15 Tea break
10:15-11:45 Investigational phases of clinical research (Phases I-IV)
Dr. Hanako Mihara, Medical Director, Health Economics and
Outcomes Research (HEOR), Division of Medical Affairs,
Japan/Asia-Pacific, Abbott Diagnostics. Co., Ltd.
11:45-12:45 Lunch
12:45-13:45 Study design (ethical aspects, control, patient population,
design techniques to avoid bias)
Dr. Hanako Mihara, Medical Director, Health Economics and
Outcomes Research (HEOR), Division of Medical Affairs,
Japan/Asia-Pacific, Abbott Diagnostics. Co., Ltd.
13:45-14:45 Statistical consideration
Dr. Hanako Mihara, Medical Director, Health Economics and
Outcomes Research (HEOR), Division of Medical Affairs,
Japan/Asia-Pacific, Abbott Diagnostics. Co., Ltd.
14:45-15:00 Tea break
15:00-16:00 Safety monitoring and reporting in clinical trials
Dr. Mitsuyoshi Hara, Senior Research Fellow,
Pharmacovigilance Area, Japan Development, MSD KK
October 17, Monday (Day 6)
9:00-10:00 Human pharmacokinetics
Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand
10:00-11:30 Pharmacogenomics
Dr. Shyh-Yuh Liou, Director, Takeda Pharmaceutical Company
Limited Head Office, Japan
12:00-13:00 Lunch
13:00-14:30 Regulatory aspects of clinical development
Mr. Kenichi Mikami, Division Director, Coordination Division
Office of Planning and Coordination Pharmaceuticals and
Medical Devices Agency
15:30~17:00 Drug discovery in academia
Professor Dr. Takayoshi Okabe, Open Innovation Center for
Drug Discovery, University of Tokyo, Japan
17:00-18:00 Review and exam (Module 2)
Professor Dr. Kenji Hirayama and Professor Dr. Kesara Na-Bangchang
October 18, Tuesday (Day 7)
10:00-17:00 Field trip to Hisamitsu Pharmaceutical Co., Inc
Mr. Hideyuki Nakano, Manager, Clinical Development Dpt.,
Hisamitsu Pharmaceutical Co., Inc, Japan