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Pharmacogenomics in Japan Hiroshi Gushima Director R&D Planning & Administration Department Yamanouchi Pharmaceutical Co., Ltd. From reports, “Pharmacogenomics” and “Observation on genomics-based medicine” issued by the Japan Health Sciences Foundation Application of Pharmacogenomics  To identify the genes or loci which are involved in determining the responsiveness to a given drug  to distinguish responders and non-responders by Dr. Jim Wei, FDA, 2000 KH symposium, October 23, 2001 Impacts of Pharmacogenomics on Medical Care  Delivery of high quality drug in short and reliable R&D process  Improvement of drug efficacies and reduction of adverse events  Development and evolution of healthcare services to be tailor-made medicine KH symposium, October 23, 2001 Construction of Infrastructure for Pharmacogenomics by Government  Millennium Project   Therapeutic related gene and genome-wide SNPs Post genome project: protein structural and functional analyses  Ethical considerations in genome research   Basic principles for human genome research Ethical guidelines for human genome and gene research KH symposium, October 23, 2001 Pharmacogenomics by Private sector in Japan  Challenging  in the Millennium Project led by government  in the Pharma SNP Consortium led by JPMA  with venture enterprises  Establishment of ethics committees on genome research  Fostering of bio-informatists and researchers KH symposium, October 23, 2001 Issues of Pharmacogenomics in Japan  Lagging of the pharmacogenomic approach in drug research and development  Challenges on drug development in private sector  Immature environment  Understanding and support of clinical investigators  Public acceptance  Reasonable and more flexible usage of the guideline for genome research  Fostering of bio-informatists and researchers KH symposium, October 23, 2001