Module 2: Drug Discovery and Development

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


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