October 29, Monday (Day 1)
Session 1: Discovery Phase
Describe the pharmacological process for drug discovery. Identify the process to protect intellectual property.
| 14:00-14:30 |
History and overview of drug discovery process Dr. Nobuhiro Noro, GlaxoSmith Kline, K.K., Japan |
| 14:30-15:00 |
The role of Genomics and bioinformatics Dr. Nobuhiro Noro, GlaxoSmith Kline, K.K., Japan |
| 15:00-15:30 |
High throughput screening: Pre-requisite of HITS systems, Assay Development & Validation, Biochemical & Cell-based assay, Assay Readout & Detection Dr. Nobuhiro Noro, GlaxoSmith Kline, K.K., Japan |
| 15:30-15:45 | Break |
| 15:45-16:15 |
The role of Chemistry in Drug Discovery:-Lead Identification, -Lead Generation Libraries (Combinatiorial Chemistry, Computational Approches), -Lead Optimization Dr. Nobuhiro Noro, GlaxoSmith Kline, K.K., Japan |
| 16:15-16:45 |
Pharmacokinetic Issues in Drug Discovery: - Designs and Purposes of DMPK Profiles of Lead & Drug Candidates - DMPK studies in Drug Discovery (Late lead identification & Early lead optimization, Mid lead optimization, Late lead optimization) - Prediction of DMPK and PKPD Correlation - Prediction of Toxicity Dr. Nobuhiro Noro, GlaxoSmith Kline, K.K., Japan |
October 30, Tuesday (Day 2)
| 09:00-09:45 |
The role of Pharmacology - Pharmacological Evaluations (Selectivity screening, Pharmacological profiling, Testing in animal models of disease, Safety pharmacology) - Examples Professor Dr. Hiroshi Ueda, Nagasaki University, Japan |
| 09:45-10:15 |
Biopharmaceuticals - Development of Biopharmaceuticals - Type of Biopharmaceuticals - Issues Related to the use of Biopharmaceuticals (Antigenicity, Stability, Drug delivery) Dr. Hiroyuki Itoh, Astellas Pharma Inc., Japan |
| 10:15-10:30 | Break |
| 10:30-11:30 |
Drug Discovery in Academia Professor Dr. Takayoshi Okabe, University of Tokyo, Japan |
| 11:30-12:30 |
Patents in Drug Discovery: - Publication VS Patents - Patent system - Type of Patent Professor Dr. Hiroshi Kato, Nihon University, Japan |
| 12:30-13:30 | Lunch |
Session 2: Pre-clinical Development
Describe the process of pharmacological development
| 13:30-14:00 |
Overview: Pre-clinical study requiments for human clinical studies Dr. Hiroyuki Itoh, Astellas Pharma Inc.Japan |
| 14:00-15:00 |
Assessing of Drug Safety: the role of toxicology - Objective and Type of Toxicology - Exploratory Toxicology - Regulatory Toxicology - Toxicity Measures and Toxicity Test Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
| 15:00-15:15 | Break |
| 15:15-16:15 |
Pharmacokinetics Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
| 16:15-17:15 |
Pharmaceutical Development and CMC Professor Dr. Hitoshi Sasaki, Nagasaki University Hospital, Japan |
October 31, Wednesday (Day 3)
Session 3: Clinical Development
| 09:00-09:30 |
Overview of clinical development Dr. Hanako Mihara, Abbott Diagnostics. Co., Ltd., Japan |
| 09:30-11:00 |
Investigational Phases of Clinical Research (I-IV) and Study Design Dr. Hanako Mihara, Abbott Diagnostics. Co., Ltd., Japan |
| 11:00-11:15 | Break |
| 11:15-12:15 |
Regulatory Framework Dr. Shimokawa Masafumi, Coordination Division Office of Planning and Coordination Pharmaceuticals and Medical Devices Agency |
| 12:15-13:30 | Lunch |
| 13:30-14:00 |
Clinical Development Plan Dr. Hanako Mihara,Abbott Diagnostics. Co., Ltd., Japan |
| 14:00-14:30 |
Pharmacogenomics - Anticipated Benefits - Polymorphisms in Drug Targets - Polymorphisms in ADME - Pharmacogenomics Testing - Pharmacogenomics in Clinical Trials - Examples Dr.Shyh-Yuh Liou, Takeda Pharmaceutical Company Limited Head Office, Japan |
| 14:30-15:00 |
Pharmacokinetics in Clinical Development Extrapolation from animal to human pharmacokinetics Dr.Shyh-Yuh Liou, Takeda Pharmaceutical Company Limited Head Office, Japan |
| 15:00-15:15 | Break |
Session 4: Traditional Medicine
Underline the importance of traditional medicine in PRD
| 15:15-15:45 |
Introduction of Traditional Medicine Professor Dr. Kiichiro Tsutani, The University of Tokyo, Japan |
| 15:45-16:30 |
Regulation for traditional medicine development Dr. Ichiro Arai, Tsumura & Co., Japan |
| 16:30-17:00 |
Guidance on herbal medicine Professor Dr. Kiichiro Tsutani, The University of Tokyo, Japan |
| 17:00-17:45 |
Rev and Exam 1 (Module 2) Professor Dr. Hirayama or Professor Dr. Kesara |
November 1, Thursday (Day 4)
| 10:00-17:00 |
Field Trip to Hisamitsu Pharmaceutical Co.,Inc Mr.Hideyuki Nakano,Hisamitsu Pharmaceutical Co.,Inc |