October 15, Thursday (Day 2)
Session 1: Discovery Phase
Describe the pharmacological process for drug discovery. Identify the process to protect intellectual property.
| 09:00-09:30 | History and overview of drug discovery process Dr. Nobuhiro Noro, GlaxoSmith Kline, K.K., Japan |
| 09:30-10:00 | The role of Genomics and bioinformatics Dr. Nobuhiro Noro, GlaxoSmith Kline, K.K., Japan |
| 10:00-10:30 | 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 |
| 10:30-11:15 | 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 |
| 11:15-12:00 | 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 |
| 12:00-13:00 | Lunch |
Session 2: Pre-clinical Development
| 13:00-14:00 | Patents in Drug Discovery: - Publication VS Patents - Patent system - Type of Patent Professor Dr. Hiroshi Kato, Nihon University, Japan |
| 14:00-14:45 | The role of Pharmacology - Pharmacological Evaluations (Selectivity screening, Pharmacological profiling, Testing in animal models of disease, Safety pharmacology) - Examples TBA |
Session 3: Traditional Medicine
Underline the importance of traditional medicine in PRD
| 14:45-15:30 | Introduction of Traditional Medicine and guidance on herbal medicines Professor Dr. Kiichiro Tsutani, The University of Tokyo, Japan |
| 15:30-16:15 | Regulation for traditional medicine development Dr. Ichiro Arai, Tsumura & Co., Japan |
| 16:15-17:15 | Pharmaceutical Development and CMC Professor Dr. Hiroshi Sasaki, Nagasaki University, Japan |
October 16, Friday (Day 3)
| 09:00-09:30 | Overview: Pre-clinical study requiments for human clinical studies Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
| 09:30-10:30 | 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 |
| 10:30-11:30 | Overview of clinical development Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
Session 4: Clinical Development
| 11:30-12:00 | Pharmacokinetics Professor Dr. Juntra Karbwang, Nagasaki University, Japan |
| 12:00-13:00 | Lunch |
| 13:00-14:00 | Regulatory Framework Dr. Mai Mikawa, Coordination Division Office of Planning and Coordination Pharmaceuticals and Medical Devices Agency |
| 14:00-14:30 | nvestigational Phases of Clinical Research (I-IV) and Study Design Professor Dr. Juntra Karbwang, Nagasaki University, Japan |
| 14:30-15:00 | Clinical Development Plan Professor Dr. Juntra Karbwang, Nagasaki University, Japan |
| 15:00-16:30 | Exercise Professor Dr. Juntra Karbwang, Nagasaki University, Japan |
October 17, Saturday (Day 4)
| 09:00-10:30 | Pharmacogenomics - Anticipated Benefits - Polymorphisms in Drug Targets - Polymorphisms in ADME - Pharmacogenomics Testing - Pharmacogenomics in Clinical Trials - Examples Dr.Shyh-Yuh Liou, Ono Pharmaceutical Company Limited Head Office, Japan |
| 10:30-11:00 | Pharmacokinetics in Clinical Development - Extrapolation from animal to human pharmacokinetics Dr.Shyh-Yuh Liou, Ono Pharmaceutical Company Limited Head Office, Japan |
| 11:00-12:00 | 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 |
| 12:00-13:00 | Lunch |
| 13:00-14:00 | Drug Discovery in Academia Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
| 14:00-14:45 | Rev and Exam 1 (Module 2) Profeesor Dr. Hirayama or Professor Dr. Kesara |