Module 2: Drug Discovery and Development

August 21 (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 process,
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 (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
10:15-11:00 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 Sasaki, Nagasaki 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 (Day 3)

09:00-09:30 Investigational Phases of Clinical Research (I-IV) and Study Design
Professor Dr. Juntra Karbwang, Nagasaki University, Japan
09:30-10:30 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 (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)
ProfessorDr.Ichiro Arai, Nihon Pharmaceutical University, Japan
12:00-13:00 Lunch


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