Module 2 Drug Development
　　　

　　　　　Drug Discovery

3 October , 2006 Tuesday

0900-1100 History and overview of modern drug discovery
　　　　　　　Mr. Nobuhiro Noro, GSK, Japan

1100-1130 Tea Break

1130-1230 From drug target to drug lead
　　　　　　　Mr. Nobuhiro Noro, GSK, Japan

1230-1400 Lunch

1400-1530 Drug targets identification and validation in cardiovascular diseases
　　　　　　　Dr.Hisashi Ohta, Tsukuba Institute Merck Banyu Pharmaceutical, Japan

4 October, 2006 Wednesday

0900-1030 Overview of chemistry in drug discovery Hit/lead generation and optimization
　　　　　　　Dr. Prof. Tadashi Yoshimoto, Nagasaki University, Nagasaki, Japan

1030-1100 Tea break

1100-1200 Drug discovery for Prion disease
　　　　　　　Prof. Shigeru Katamine, Nagasaki University, Nagasaki, Japan

1200-1330 Lunch

1330-1430 Drug targets identification and validation in TB
　　　　　　　 Assoc. Prof. Dr. Prasit Palithapolkarnpim, BIOTEC, Thailand

1430-1530 Drug discovery for TB
　　　　　　　Dr. Mitsuyoshi Kinoshita, Otsuka pharmaceutical, Osaka, Japan

1530-1600 Tea break

1600-1700 Drug discovery for Trypanosomiasis
　　　　　　　Prof. Dr. Kiyoshi Kita, The University of Tokyo, Japan

5 October, 2006 Thursday

0900-1000 Publications, IPR and patents in drug discovery
　　　　　　　Mr. Kenichi Osawa, Merck Banyu Pharma, Japan

1000-1030 Tea break

1030-1130 Publications, IPR and patents in drug discovery (Cont.)
　　　　　　　Mr. Kenichi Osawa, Merck Banyu Pharma, Japan

　　　　　Chemical Manufacturing and Control (CMC)

6 October, 2006 Friday

0900-1000 Synthesis of active pharmaceutical ingredient
　　　　　　　Prof. Susumi Hatakeyama, Nagasaki University, Japan

1000-1030 Formulation
　　　　　　　Prof. Susumi Hatakeyama, Nagasaki University, Japan

1030-1100 Tea break

1100-1300 Methods for determination of concentrations in various media by means of spectrometric methods, HPLC, and biological methods
　　　　　　　Prof.Dr. Masaaki Kai, Nagasaki University, Japan

1300-1400 Lunch

1400-1530 Stability for drug substance and drug product
　　　　　　　Prof.Dr. Hiroaki Nagaoka, Nagasaki International University, Japan

1530-1600 Tea break

1600-1700 Development of specification
　　　　　　　Prof.Dr. Hiroaki Nagaoka, Nagasaki International University, Japan


７ October, 2006 Saturday

0900-1030 Quality assurance/quality control
　　　　　　　Prof.Dr. Hiroaki Nagaoka, Nagasaki International University, Japan

1030-1100 Tea break

1100-1200 Example: Antimalarial drug, dihydroartemisinin
　　　　　　　Assoc. Prof. Supornchai Matangkasobat, Mahidol University, Thailand

1200-1300 Lunch

1300-1530 Regulatory (with an example of a drug CMC requirement)
　　　　　　　Prof.Dr. Hiroaki Nagaoka, Nagasaki International University, Japan

1530-1600 Tea break

1600-1630 Naming the New Chemical Entity (NCE)
　　　　　　　Prof.Dr. Hiroaki Nagaoka, Nagasaki International University, Japan


　　　　　Pre-clinical Developmenｔ

Pharmacological development

9 October, 2006 Monday

0900-1100 Pharmacological data in new drug application
　　　　　　　Dr. Shunsuke Ono, University of Tokyo, Japan

1100-1130 Tea break

1130-1230 Methods in pharmacological R&D (1)
　　　　　　　Dr. Hiroyuki Itoh, Astellas Pharma Inc, Japan

1230-1330 Lunch

1330-1430 Methods in pharmacological R&D (2)
　　　　　　　Dr. Hiroyuki Itoh, Astellas Pharma Inc, Japan

1430-1500 Discussion
　　　　　　　Drs. Shunsuke Ono and Hiroyuki Itou

1500-1530 Tea break

1530-1630 The cure oriented therapeutics for chronic renal failure with gene therapy
　　　　　　　Dr.Tsutomu Kurosawa, Osaka University, Japan


Toxicology

10 October, 2006 Tuesday

0900-1000 Principles of toxicology
　　　　　　　 Assoc. Prof.Dr. Wongwiwat Tassaneeyakul, Kon Kaen University, Thailand

1000-1100 Toxicological tests: in vitro & in vivo: acute, subacute, chronic, special organ toxicology, reproduction toxicology, teratogenicity, mutagenicity, carcinogenicity studies
　　　　　　　Assoc.Prof.Dr. Wongwiwat Tassaneeyakul, Kon Kaen University, Thailand

1100-1130 Tea break

1130-1300 Scheduling of toxicological studies in the development plan, the registration requirements, human & animal pharmacology, the proposed clinical application and the forms of administration.
　　　　　　　Dr. Soisanwan Satarug, University of Queensland, Australia

1300-1400 Lunch

1400-1530 Continuous monitoring of the correlation between new toxicological findings and the unwanted events observed in humans up till now.
　　　　　　　Dr. Soisanwan Satarug, University of Queensland, Australia


Pre-clinical Pharmacokinetics

11 October, 2006 Wednesday

0900-1030 Principles of pharmacokinetics: ADME processes
　　　　　　　Assoc. Prof.Dr. Wongwiwat Tassaneeyakul, Kon Kaen University, Thailand

1030-1100 Tea break

1100-1230 Pharmacokinetic data analysis & pharmacokinetic parameters
　　　　　　　Assoc. Prof.Dr. Wongwiwat Tassaneeyakul, Kon Kaen University, Thailand

1230-1330 Lunch

13:30-1530 Transferability of the pharmacokinetic findings in animals to humans Investigating toxicological problems - practices and pitfalls
　　　　　　　Dr. Soisanwan Satarug, University of Queensland, Australia


12 October, 2006 Thursday

1000-1200 Visit animal facility for medical research
　　　　　　　　Dr. Kazuki Osawa, Nagasaki University, Japan

1500-1630 Evaluation of viability (risk and benefit) for further development (case study)
　　　　　　　Dr.Tadaaki Taniguchi, Japanese Association of Pharmaceutical Medicine (JAPHMED), Merck Banyu Pharma, Japan


Clinical Trial

13 October, 2006 Friday

0900-1100 Overview of clinical development
　　　　　　　・Assessment of pre-clinical information
　　　　　　　・Clinical development plan
　　　　　　　・Application of pharmacokinetics and pharmacodynamics in drug development
　　　　　　　・Dose selection and regimen
　　　　　　　Dr. Tadaaki Taniguchi, Japanese Association of Pharmaceutical Medicine(JAPHMED), Merck Banyu Pharma, Japan

1100-1130 Tea break

1130-1200 The various investigational phases of clinical research (Phases I-IV)
　　　　　　　Dr. Tadaaki Taniguchi, Japanese Association of Pharmaceutical Medicine (JAPHMED), Merck Banyu Pharma, Japan

1200-1300 Lunch

1300-1500 Human pharmacokinetics:
　　　　　　　・Definition and significance of pharmacokinetic parameters (absorption, bioavailability, binding to proteins, distribution, clearance, elimination half life, AUC)
　　　　　　　・Special human-pharmacokinetic studies e.g. bioavailability studies of multiple-dose, interaction studies, pregnancy, liver disease etc.
　　　　　　　 Assoc. Prof. Dr. Wongwiwat Tassaneeyakul, Kon Kaen University, Thailand


14 October, 2006 Saturday

0900-1000 Therapeutic exploratory (with example)
　　　　　　　Dr. Kenji Nonaka, Japanese Association of Pharmaceutical Medicine(JAPHMED), Merck Banyu Pharma, Japan

1000-1100 Therapeutic confirmatory (with example)
　　　　　　　Dr. Kenji Nonaka, Japanese Association of Pharmaceutical Medicine(JAPHMED), Merck Banyu Pharma, Japan

1100-1130 Tea Break

1130-1230 Therapeutic use (with example)
　　　　　　　Dr.Kimihiro Kasamo, Japanese Association of Pharmaceutical Medicine(JAPHMED), Merck Banyu Pharma, Japan

1230-1330 Lunch

1330-1500 Safety monitoring and reporting in clinical trials
　　　　　　・Basic principles and evaluation of investigational results (Phase-I and early Phase-II), with a view to further Development
　　　　　　・Basic principles for decisions regarding further development or discontinuation of a development project
　　　　　　　Dr.Kimihiro Kasamo, Japanese Association of Pharmaceutical Medicine(JAPHMED), Merck Banyu Pharma, Japan

1500-1530 Tea Break

1530-1630 Pharmacogenomics
　　　　　　　Dr. Shyh-Yuh Liou, Japan Section GlaxoSmithKline, Japan


Study design

16 October, 2006 Monday

0900-1030 Study design
　　　　　　　・Possible study designs taking into account ethical aspects, indication, controls, patient population, location of the trial centers
　　　　　　　・Trial design (parallel group design, cross over design, factorial design, group sequential design)
　　　　　　　・Design techniques to avoid bias (blinding, randomization)
　　　　　　　Prof. Dr. L. Jeyaseelan, Christian Medical University, Vellor, India

1030-1100 Tea break

1100-1230 Study design (Cont.)
　　　　　　　・Multi centers trials
　　　　　　　・Type of comparison
　　　　　　　・Outcome measurements
　　　　　　　Prof .Dr. L. Jeyaseelan, Christian Medical University, Vellor, India 1230-1330 Lunch

1230-1330 Lunch

1330-1500 Statistical considerations
　　　　　　　・Biostatistics in the planning phase (estimate of number of cases, randomization, statistical models, definition of end-points, planning of the subsequent evaluation)
　　　　　　　・Statistical analysis plan
　　　　　　　・Analysis sets: full analysis set, per protocol set, missing values and outliers
　　　　　　　Prof. Dr. L. Jeyaseelan, Christian Medical University, Vellor, India

1500-1530 Tea break

1330-1500 Statistical considerations (Cont.)
　　　　　　　・Data transformation
　　　　　　　・Method of statistical analysis (estimation, confidence intervals, hypothesis testing, evaluation of safety and tolerability)
　　　　　　　・Statistical analysis report
　　　　　　　Prof. Dr. L. Jeyaseelan, Christian Medical University, Vellor, India


Regulatory Issues

17 October, 2006 Tuesday

0900-1030 Regulatory aspects of clinical development
　　　　　　　Prof.Dr. Koji Kawakami, Kyoto University, Kyoto, Japan

1030-1100 Tea break

1100-1230 Special topics:
　　　　　　・Genetic engineer product
　　　　　　・Gene therapy and stem cells
　　　　　　　Prof.Dr. Koji Kawakami, Kyoto University, Kyoto, Japan

1230-1330 Lunch

1330-1500 Example of Clinical Drug development in Inida - Miltefosine trial
　　　　　　　Prof. Dr. Juntra Karbwang, WHO/TDR, Switzerland


Traditional Medicine

18 October, 2006 Wednesday

0900-1030 Introduction of Traditional Medicine: Alternative but rational approach Professor
　　　　　　　Professor. Kiichiro Tsutani, University of Tokyo, Japan

1030-1100 Tea break

1100-1200 Guidance on herbal medicine
　　　　　　　TBA

1200-1300 Lunch

1300-1500 Regulation for traditional medicine development
　　　　　　　Japan: Dr. Ichiro Arai, Manager, R&D Strategy Dept. Tsumura & Co.
　　　　　　　China: Professor Dr. Luping Qin, China

1500-1530 Tea break

1530-1700 Example: Herbal medicine to modern medicine
　　　　　　　Example: traditional medicine development
　　　　　　　Professor Dr. Luping Qin, Second Military Medical University, China


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