August 21, Monday (Day 1)
Session 1: Discovery
Describe the pharmacological process for drug discovery. Identify the process to protect intellectual property
| 13:00-15:30 | History and overview of drug discovery, The role of Genomics and bioinformatics, High throughput screening: Pre-requisite of HITS systems, Assay Development & Validation, Biochemical & Cell-based assay, Assay Readout & Detection, The role of Chemistry in Drug Discovery: -Lead Identification, -Lead Generation Libraries (Combinatiorial Chemistry, Computational Approches), -Lead Optimization Professor Dr.Yoshimasa Tanaka, Nagasaki University, Japan |
| 15:30-15:45 | Break |
| 15:45-17:00 | Drug Discovery in Academia Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
August 22, Tuesday (Day 2)
| 9:00-9:45 | The role of Pharmacology - PharmacologicalEvaluations (Selectivityscreening, Pharmacologicalprofiling, Testing in animalmodels of disease, Safetypharmacology) - Examples Professor Dr.Yoshimasa Tanaka, Nagasaki University, Japan |
Session 2 : Preclinical Development
Describe the process of pharmacological development
| 9:45-10:15 | Overview: Pre-clinical studyrequiments for humanclinical studies Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
| 10:15-11:00 | Assessing of Drug Safety:the role of toxicology - Objective and Type ofToxicology - Exploratory Toxicology - Regulatory Toxicology - Toxicity Measures andToxicity Test Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
| 11:00-11:15 | Break |
| 11:15-11:45 | Biopharmaceuticals - Development ofBiopharmaceuticals - Type ofBiopharmaceuticals - Issues Related to the useof Biopharmaceuticals(Antigenicity Stability Drug Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
| 11:45-12:45 | Lunch |
| 12:45-13:45 | Pharmaceutical Development and CMC Professor Dr. Hiroshi Kato, Nihon University, Japan |
| 13:45-14:45 | Patents in Drug Discovery: - Publication VS Patents - Patent system - Type of Patent Professor Dr. Hiroshi Kato, Nihon University, Japan |
Session 3: Clinical Development
| 14:45-15:15 | Overview of clinical development Professor Dr. Juntra Karbwang, Nagasaki University, Japan |
| 15:15-15:30 | Break |
| 15:30-16:30 | Regulatory Framework Dr. Hiroshi Yamamoto Nagasaki University, Japan |
August 23, Wednesday (Day 3)
| 9:00-9:30 | Investigational Phases of Clinical Research (I-IV) and Study Design Professor Dr. Juntra Karbwang, Nagasaki University, Japan |
| 9:30-10:30 | Clinical Development Plan Professor Dr. Juntra Karbwang, Nagasaki University, Japan |
| 10:30-10:45 | Break |
| 10:45-12:15 | 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 |
| 12:15-13:00 | Lunch |
| 13:00-14:15 | Pharmacokinetics (Non-clinical & Clinical) Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
| 14:30-16:30 | Case studies Professor Dr. Juntra Karbwang, Nagasaki University, Japan |
August 24, Thursday (Day 4)
Session 4: Traditional Medicine
Underline the importance of traditional medicine in PRD
| 09:00-10:00 | Introduction of Traditional Medicine and guidance on herbal medicines Professor Dr. Kiichiro Tsutani, Tokyo Ariake university of medical and health ,Japan |
| 10:00-11:00 | Regulation for traditional medicine development ProfessorDr.Ichiro Arai, Nihon Pharmaceutical University, Japan |
| 11:00-12:00 | Rev and Exam 2 (Module 2) Profeesor Dr. Hirayama or Professor Dr. Kesara |
| 12:00-13:00 | Lunch |