October 28, 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 & Cellbased 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 29, 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.Yoshimasa Tanaka, 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) Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
| 10:15-10:30 | Break |
| 10:30-11:30 | Drug Discovery in Academia Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
| 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 Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
| 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 Professor Dr. Juntra Karbwang, Nagasaki University, Japan |
| 09:30-11:00 | Investigational Phases of Clinical Research (I-IV) and Study Design Professor Dr. Juntra Karbwang, Nagasaki University, 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 Professor Dr. Juntra Karbwang, Nagasaki University, 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
| 15:15-16:10 | Introduction of Traditional Medicine and guidance on herbal medicines Professor Dr. Kiichiro Tsutani, The University of Tokyo, Japan |
| 16:10-17:00 | Regulation for traditional medicine development Dr. Ichiro Arai, Tsumura & Co., Japan |
| 17:00-17:45 | Rev and Exam 1 (Module 2) Profeesor Dr. Hirayama or Professor Dr. Kesara |
October 31, Thursday (Day 4)
| 10:00-17:00 | Field Trip to Hisamitsu Pharmaceutical Co.,Inc Mr.Hideyuki Nakano,Hisamitsu Pharmaceutical Co.,Inc |