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