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Pharmacogenomics in Japan
Hiroshi Gushima
Scientific Advisor BioFrontier Partners, Inc.
and Yamanouchi Pharmaceutical Co., Ltd.
October 3, 2002The 3rd Kitasato University - Harvard School of Public Health Symposium
Pharmacogenetics and pharmacogenomics in Japan - 1
Government Millennium Project Progress in SNP projects
Pharma SNP Consortium (42 pharmaceutical companies belonging to JPMA) Frequency of SNPs, Research on expression and function of mutant pr
oteins encoded by SNPs, Database, Immortal cell lines Creation of Exploratory Clinical Research Center
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 phar
macogenomics 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 W
orking 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 i
n Drug Development and Regulatory Decision-Making, Univ. of Maryland, Rockville Maryland, 16-17 May 2002
– Sponsored by FDA, PhRMA DruSafe and PWG
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