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October 3, 2002
The 3rd Kitasato University - Harvard School of Public Health Symposium
Pharmacogenomics in Japan
Hiroshi Gushima
Scientific Advisor
BioFrontier Partners, Inc.
and
Yamanouchi Pharmaceutical Co., Ltd.
Pharmacogenetics and
pharmacogenomics in Japan - 1

Government Millennium Project


Pharma SNP Consortium (42 pharmaceutical companies
belonging to JPMA)


Frequency of SNPs, Research on expression and function of
mutant proteins encoded by SNPs, Database, Immortal cell lines
Creation of Exploratory Clinical Research Center


Progress in SNP projects
Tokyo University, Kyoto University, Kurume University and
others
Ethics



Basic principles for human genome research (6/2000)
Ethical guidelines for human genome and gene research
(4/2001)
– Establishment and management of the Ethical Review Board
 141 research organizations (as of August 23, 2002)
Ethical guidelines for epidemiological research (6/2002)
Pharmacogenetics and
pharmacogenomics in Japan - 2




PI: Clinical pharmacokinetic studies stratified subjects
based on genetic polymorphisms of CYP isozymes
are increasing.
PII: Some PII studies are being conducted after the
approval by the IRB and/or EC.
PMS: Post-marketing clinical trials of proton pump
inhibitors (Omeprazole, Lansoprazole) are ongoing.
Activities toward the practical use:

Trastuzumab : IHC and FISH examinations
 Imatinib Mesilate, Iressa : prediction of the efficacy by gene expression
 Irinotecan : discrimination of adverse reactions by SNP-Invader assays
 Interferon : prediction of the efficacy by DNAchip
CIOMS
The Council for International Organizations of Medical Sciences


Established by WHO and UNESCO in 1949
Activities :
 Bioethics
 Health Policy, Ethics and Human Values - An
International Dialogue
 Drug Development and Use
– Safety requirements for the use of drugs
– Assessment, monitoring and reporting of adverse drug
reactions
– Reporting and terminology of adverse drug reactions
– Ethical criteria for drug promotion
– Surveillance and assessment of drug safety data from
clinical trials
– Pharmacogenetics and Pharmacoeconomics

International Nomenclature of Diseases
CIOMS Working Group
on Pharmacogenetics and Pharmacoeconomics

Membership
Academia (2), drug regulatory agencies (13) and
the pharmaceutical industry (11)
 University of Tokyo, MHLW, Yamanouchi

Targets
Terminology, impact, cost, regulation, ethics etc.
of pharmacogenomics and pharmacogenetics

Working Group Meeting



February 2002, EMEA, London
August 2002, BfArM, Bonn
February 2003, FDA, Washington DC
Conditions in Europe and USA

Europe



Report of The Society of Pharmaceutical Medicine’s
Working Party on Pharmacogenetics. International
Journal of Pharmaceutical Medicine 2001, 15:53
DIA Workshop on Ethical & Practical Complexities of
PGx Research, Basel, Switzerland, 5 March 2002
USA

Workshop on
Pharmacogenetics/Pharmacogenomics in Drug
Development and Regulatory Decision-Making, Univ.
of Maryland, Rockville Maryland, 16-17 May 2002
– Sponsored by FDA, PhRMA DruSafe and PWG