Module 2:Drug Development
Drug Discovery
2 October, 2007 Tuesday
0900-1100 History
and overview of modern drug discovery
Dr. Nobuhiro Noro, Glaxo SmithKlein KK,Tokyo, Japan
1100-1130 Tea Break
1130-1230 From drug target to drug lead
Dr. Nobuhiro Noro, Glaxo SmithKlein KK,, Japan
1230-1330 Lunch
1330-1500 Drug targets identification and
validation in cardiovascular diseases
Dr. Hisashi Ohta, Tsukuba
Institute Merck
1430-1500 Tea break
3 October,
2007 Wednesday
0900-1030 Overview
of chemistry in drug discovery
Hit/lead
generation and optimization
Dr.
Prof. Tadashi Yoshimoto,
1030-1100 Tea break
1100-1200 Drug discovery for HIV
Prof.
Dr.Kobayashi,
1200-1330 Lunch
1330-1430 Drug
discovery for TB
1430-1450 Tea break
1450-1550 Drug discovery for
Trypanosomiasis
Prof.
Dr. Kiyoshi Kita, The
1550-1650 Drug targets identification and validation
in TB
Assoc.
Prof. Dr.Prasit Palittapongarnpim, BIOTEC,
4 October, 2007 Thursday
0900-1000 Publications, IPR and patents in drug discovery
Mr. Kenichi Osawa, Merck Banyu Pharma,
1000-1030 Tea break
1030-1130 Publications, IPR and patents in drug discovery (Cont.)
Mr. Kenichi Osawa, Merck Banyu Pharma,
Chemical Manufacturing and Control (CMC)
5 October,
2007 Friday
0900-0930 Introduction to CMC
Prof. Dr.
Hitoshi Sasaki,
1030-1130 Formulations
Prof.
Dr. Hitoshi Sasaki,
1130-1230 Methods for
determination of concentrations in various media by
means of spectrometric methods, HPLC, and biological methods
Prof. Dr. Masaaki Kai,
1230-1330 Lunch
1330-1430 Stability for drug
substance and drug product
Assoc.
Prof. Supornchai Kongpatanakul,
1430-1500 Tea
break
1500-1600 Example: Antimalarial
drug, dihydroartemisinin
Assoc. Prof. Supornchai Kongpatanakul,
6 October,
2007 Saturday
0900-1000 Development of
specification
Prof.
Dr. Hiroaki Nagaoka,
1000-1100 Quality
assurance/quality control
Prof. Dr. Hiroaki
Nagaoka,
1100-1115 Tea
break
1115-1230 Regulatory (with an
example of a drug CMC requirement)
Prof. Dr. Hiroaki
Nagaoka,
1230-1300 Naming the New
Chemical Entity (NCE)
Prof. Dr.
Hiroaki Nagaoka,
1400-1530 Synthesis
of active pharmaceutical ingredient
Prof. Dr.Masakatsu Shibasaki, University of
Tokyo, Japan
Pre-clinical Development
Pharmacological
development
8
October, 2007 Monday
0900-1100 Pharmacological data in new drug
application
Assoc. Prof. Dr.
Shunsuke Ono, University of Tokyo,
1100-1130 Tea break
1130-1230 Methods
in pharmacological R&D (1)
Dr. Hiroyuki Itoh, Astellas Pharma Inc,
1230-1330 Lunch
1330-1430 Methods
in pharmacological R&D (2)
Dr. Hiroyuki Itoh, Astellas Pharma Inc,
1430-1500 Discussion
Drs. Shunsuke Ono and Hiroyuki Itou
1500-1530 Tea break
1530-1700 R&D
for Medical Devices and Alternative to Animal Experiments
Dr.
Tsutomu Kurosawa,
Toxicology
9 October, 2007 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,
1100-1130 Tea break
1130-1300 Principles of pharmacokinetics: ADME processes
Assoc. Prof. Dr. Wongwiwat
Tassaneeyakul,
1300-1400 Lunch
1400-1530 Pharmacokinetic data
analysis & pharmacokinetic parameters
Assoc. Prof. Dr. Wongwiwat
Tassaneeyakul,
Pre-clinical
Pharmacokinetics
10 October, 2007 Wednesday
0900-1030 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,
1030-1100 Tea break
1100-1230 Continuous monitoring of the correlation between new toxicological findings
and the unwanted events observed in
humans up till now.
Dr. Soisanwan Satarug,
1230-1330 Lunch break
1330-1530 Transferability of the
pharmacokinetic findings in animals to humans Investigating toxicological problems - practices
and pitfalls
Dr. Soisanwan Satarug,
11 October, 2007 Thursday
900-1000
Participants'
Report on Drug discovery
1000-1200 Visit animal facility for medical research
Dr. Kazutaka 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
Clinical Development
Clinical
Trial
12 October, 2007 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,
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
1200-1300 Lunch
1300-1500 Human pharmacokinetics:
· Clinical Application of PKs
·
Special human-pharmacokinetic studies e.g. bioavailability studies
of multiple-dose, interaction studies,
pregnancy, liver disease etc.
Prof. Dr. Kesara Na-Bangchang,
1500-1530 Tea break
1530-1630 Pharmacogenomics
Dr. Shyh-Yuh Liou, Takeda Pharmaceutical Company Limited
,
13 October, 2007
Saturday
0900-1000 Therapeutic exploratory (with example)
Dr. Kenji Nonaka, Japanese Association of Pharmaceutical Medicine
(JAPHMED), Merck
1000-1100 Therapeutic
confirmatory (with example)
Dr. Kenji Nonaka, Japanese Association of Pharmaceutical
Medicine(JAPHMED), Merck
1100-1130 Tea Break
1130-1230 Therapeutic
use (with example)
Dr.Kimihiro
Kasamo, Japanese Association of
Pharmaceutical
Medicine(JAPHMED), Merck
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
1500-1520 Tea Break
Study design
15 October, 2007 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,
1030-1100 Tea break
1100-1230
Study
design (Cont.)
· Multi centers trials
· Type of comparison
· Outcome measurements
Prof. Dr. L. Jeyaseelan,
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,
1500-1530 Tea break
1530-1700 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,
Regulatory Issues
16 October, 2007
Tuesday
0900-1030 Regulatory aspects of
clinical development
Prof.Dr. Koji Kawakami,
1030-1100 Tea break
1100-1230 Special topics:
· Genetic engineer product
· Gene therapy and stem cells
Prof.
Dr. Koji Kawakami,
1230-1330 Lunch
1530-1700 Participants's report on Drug Development
Traditional Medicine
17 October, 2007 Wednesday
0900-1030 Introduction
of Traditional Medicine: Alternative but rational approach
Professor
Dr. Kiichiro Tsutani,
1030-1100 Tea break
1100-1200 Guidance on herbal medicine
Professor
Dr. Kiichiro Tsutani,
1200-1300 Lunch
1300-1400 Regulation for traditional medicine
development
Dr. Ichiro Arai, Manager, Tsumura Drug Information Library, Tsumura & Co.
1400-1500 Example: Herbal medicine to modern medicine
Dr. Nasir Shuaibu, NEKKEN,
1530-1700 Example of Clinical Drug development
Dr.Takayama,Eisai , Japan