August 22, Monday (Day 1)
Session 1: Discovery
Describe the pharmacological process for drug discovery. Identify the process to protect intellectual property.
13:00-13:30 | History and overview of drug discovery process Dr. Nobuhiro Noro, GlaxoSmith Kline, K.K., Japan |
13:30-14:00 | The role of Genomics and bioinformatics Dr. Nobuhiro Noro, GlaxoSmith Kline, K.K., Japan |
14:00-14:30 | 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 |
14:30-14:45 | Break |
14:45-16:00 | 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 |
16:00-16:45 | 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 |
August 23, 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: Pre-clinical 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 |
10:15-11:15 | 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 |
11:15-11:30 | Break |
11:30-12:00 | Biopharmaceuticals - Development ofBiopharmaceuticals - Type ofBiopharmaceuticals - Issues Related to the useof Biopharmaceuticals(Antigenicity Stability Drug 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 |
14:00-15:00 | Pharmaceutical Development and CMC Professor Dr. Hiroshi Sasaki, Nagasaki University, Japan |
Session 3: Clinical Development
15:00-16:00 | Overview of clinical development Professor Dr. Juntra Karbwang, Nagasaki University, Japan |
August 24, Wednesday (Day 3)
9:00-10:00 | Patents in Drug Discovery: - Publication VS Patents - Patent system - Type of Patent Professor Dr.Hiroshi Kato, Nihon University, Japan |
10:00-11:00 | Regulatory Framework Dr. Hiroshi Yamamoto Nagasaki University, Japan |
11:00-11:30 | Investigational Phases of Clinical Research (I-IV) and Study Design Professor Dr.Juntra Karbwang, Nagasaki University, Japan |
11:30-12:00 | Clinical Development Plan Professor Dr. Juntra Karbwang, Nagasaki University, Japan |
12:00-13:00 | Lunch |
Session 4: Traditional Medicine
Underline the importance of traditional medicine in PRD
13:00-14:00 | Introduction of Traditional Medicine and guidance on herbal medicines Professor Dr. Kiichiro Tsutani, Tokyo Ariake university of medical and health ,Japan |
14:00-15:00 | Regulation for traditional medicine development ProfessorDr.Ichiro Arai, Nihon Pharmaceutical University, Japan |
August 25, Thursday (Day 4)
9:00-10:30 | 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 |
10:30-10:45 | Break |
10:45-11:15 | Pharmacokinetics in Clinical Development - Extrapolation from animal to human pharmacokinetics Dr.Shyh-Yuh Liou, Ono Pharmaceutical Company Limited Head Office, Japan |
11:15-12:15 | Pharmacokinetics Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand |
12:15-13:00 | Lunch |
13:00-14:00 | Rev and Exam 1 (Module2) Profeesor Dr. Hirayama or Professor Dr. Kesara |