Module 2: Drug Discovery and Development

Session 1: Discovery
Describe the pharmacological process for drug discovery. Identify the process to protect intellectual property

August 20, Monday (Day 1)

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
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)
- Examples
Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand

August 21, Tuesday (Day 2)

9:00-9:45 The role of Pharmacology
- PharmacologicalEvaluations (Selectivityscreening, Pharmacologicalprofiling, Testing in animalmodels of disease, Safety pharmacology)
- 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 human clinical 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
Assistant Prof. Supatra Porasuphatana, Khon Kaen University, Thailand
11:00-11:15 Break
11:15-12:15 Pharmaceutical Development and CMC
Professor Dr. Hitoshi Sasaki, Nagasaki University, Japan
12:15-13:15 Lunch
13:15-14:45 Patents in Drug Discovery:
- Publication VS Patents
- Patent system
- Type of Patent
Professor Dr. Hiroshi Kato, Nihon University, Japan

Session 3: Clinical Development

14:15-15:15 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 22, 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
14:15-14:30 Break
14:30-16:30 Case studies (Group Exercise)
Professor Dr. Juntra Karbwang, Nagasaki University, Japan
16:30-17:00 Biopharmaceuticals
- Development of Biopharmaceuticals
- Type of Biopharmaceuticals
- Issues related to the use of Biopharmaceuticals
(Antigenicity, Stability, Drug delivery)
Assistant Prof. Supatra Porasuphatana, Khon Kaen University, Thailand

August 23, 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)
Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand
12:00-13:00 Lunch


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