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 l To identify the genes or loci which are involved in determining the responsiveness to a given drug n to distinguish responders and non-responders by Dr. Jim Wei, FDA, 2000 KH symposium, October 23, 2001

Impacts of Pharmacogenomics on Medical Care l Delivery of high quality drug in short and reliable R&D process l Improvement of drug efficacies and reduction of adverse events l 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 l Lagging of the pharmacogenomic approach in drug research and development l Challenges on drug development in private sector l Immature environment Understanding and support of clinical investigators Public acceptance Reasonable and more flexible usage of the guideline for genome research l Fostering of bio-informatists and researchers KH symposium, October 23, 2001