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Clinical Research and Translational Research ___________________________________________________________________________ 2010/SOM3/LSIF/007 Life Science Innovation Submitted by: Japan Life Sciences Innovation Forum Sendai, Japan 18-19 September 2010 LifeLife ScienceScience InnovationInnovation Sep.18, 2010 Executive Member of Council for Science and Technology Policy Tasuku Honjo Agenda １. Council for Science and Technology Policy (CSTP): - Control Tower for Science and Technology Strategy - ２. Strategic Support to Clinical Research and Translational Research ３. The New Growth Strategy and the 4th Science and Technology (S&T) Basic Plan ４. Action Plan 1 1.Council for Science and Technology Policy (CSTP): - Control Tower for Science and Technology Strategy - 2 Science and Technology Administration in Japan Prime Minister Cabinet Office for basic policy and general coordination on important issues for cabinet Cabinet Office: Council for Science and Technology Policy (CSTP) ☆ S&T Basic Plan , Resource Allocation Policy …… (Cabinet Office for policy making) (Ministries for implementation) Ministry of Education, Culture, Sports, Science and Technology (MEXT) Ministry of Health, Labour and Welfare (MHLW) Ministry of Economy, Trade and Industry (METI) Coordination Other Ministries 3 Members of the Council for Science and Technology Policy Members of the CSTP (As of August, 2010) Chairperson Naoto KAN Prime Minister Minister of State for S&T Policy Tatsuo KAWABATA Minister of Education, Culture, Sports, Science and Technology Yoshito SENGOKU Chief Cabinet Secretary Cabinet Members Kazuhiro HARAGUCHI Minister of Internal Affairs and Communications Yoshihiko NODA Minister of Finance Masayuki NAOSHIMA Minister of Economy, Trade and Industry Masuo AIZAWA Former President, Tokyo Institute of Technology Tasuku HONJO Visiting Professor, Kyoto University Executive Members Former Representative Director and Executive Vice President, Naoki OKUMURA Nippon Steel Corporation, Ltd Former Vice President and Professor, National Graduate (academia/industry) Takashi SHIRAISHI Institute For Policy Studies Toyoko IMAE Professor Emeritus, Nagoya University Professor, Institute of Economic Research, Hitotsubashi Reiko AOKI University Ryoji CHUBACHI Vice Chairman, Sony Corporation Sci. Council Ichiro KANAZAWA President of Science Council of Japan 4 2. Strategic Support to Clinical Research and Translational Research 5 Decline of the Number of Developing Biotechnology-Based Medicine Number of Developing Biotechnology-Based Medicine USA UK Germany France Japan ◆ Research and Development Platform for Biotechnology-Based Medicine should be enhanced. 6 Issues of Research and Development for Innovative Medicine 【 Global Sales of Japan Origin Medicines （FY2007）】 Global Sales Patent Expire Rank Product Primary Use Company （Million $） （USA） 18 Actos diabetes Takeda 3,370 2011 22 Takepron/Prevacid ulcer Takeda 3,190 2009 27 Crestor cholesterol Shionogi 2,796 2016 32 Aricept alzheimer Eisai 2,459 2010 38 Cravit/Levaquin antibiotic Daiichi-Sankyo 2,398 2010 41 Abilify schizophrenia Otsuka 2,160 2015 44 Harnal/Flomax urinary Astellas 1,939 2009 46 Blopress/Atacand high blood pressure Takeda 1,896 2011 50 NeoRecormon/Epogin anemia Roche/Chugai 1,796 - 55 Prograf Immune suppressor Astellas 1,700 2008 58 Olmesartan high blood pressure Daiichi-Sankyo 1,593 2016 60 Luprin/Lupron anti-cancer Takeda 1,588 2011 63 Aciphex/Pariet ulcer Eisai 1,558 2013 90 Pravacol/Mevalotin cholesterol Daiichi-Sankyo 1,113 2006 ◆ Japan Origin Medicines: 14 Medicines / Top 100 Global Sales ◆ Y2010 Problem: Patents of 9 Medicines will be expired until 2011 in USA 7 Issues of Japanese Medical Device Industry 【Global Competitiveness Index* of Medical Devices】 0.8 0.6 Medical Device for Diagnostic 0.4 0.2 0 1999 2000 2001 2002 2003 2004 2005 2006 (year) -0.2 Medical Device ( Total ) -0.4 Medical Device for -0.6 Medical Treatment -0.8 -1.0 Medical Devices for Medical Devices for Medical Devices Diagnostic Medical Treatment (Total ) Global Competitiveness Good Bad Poor * Global competitiveness index = (Export – Import ) / ( Export + Import ) ( Ref.: Statistics on production dynamics of medical industries (MHLW) ) 8 Activity of Clinical Research is Weak in Japan Numbers of Published Reports in major 3 journals USA USA Germany UK Japan Canada UK Germany France Basic France Clinical 【Numbers of Published Reports 】 Canada Research Holland Research (in major 3 journals) Swiss Italy Italy Australia Clinical Research << Basic Research Holland Swiss Australia Belgium Sweden Sweden Austria Scotland China Spain Improve Clinical Research Spain Denmark Activity Belgium China Israel Norway Scotland Finland Ref. Thomson Reuters 2003 – 2007 Korea Japan th ( March 7 , 2010,Yomiuri Shimbun ) 9 Outline of 5-Year Strategies for Creation of Innovative Drugs and Medical Devices CAO, MEXT, MHLW, METI Formulation in April, 2007, May 2008 (revised), February 2009 (revised) The drug/medical devices industries as Providing world’s best drugs and the driving force for the growth of medical devices to the public Japanese economy Measures aimed at most advanced R&D in Japan and worldwide R&D challengers which Japan plays important roles [1] Intensive Investment of Research Funds [2] Nurturing of Venture Companies [3] Improvement of Environments of Clinical Research/Clinical Trials [4] Collaborations with Asian Nations [5] Speed-up and Improvement of Quality of Reviews [6] Proper Evaluation of Innovation [7] Public-Private Dialogues for Innovative New Drugs and Medical Devices 10 Issues of Clinical Research in Japan “Clinical Trial” of New Medicines “Clinical Research” by Using In accordance with Pharmaceutical Affairs Act Candidates of New Medicines in House Approval and National Application of Health Insurance Price Advanced Medical Care ） Listing for Medicine (MHLW) (MHLW Evaluation and Approval Limited Usage of Clinical Trial (PMDA ） (not all Japan ) Contract Research Application to MHLW Private Sector of Medicines (Private Sector) (Pharmaceutical Affairs Act） as Special Medical Treatment Clinical Trial by Development in Private Sector or Universities or Institutes Clinical Trial by MD Research Seeds (Drug Candidates） ～ “Clinical Trial” and “Clinical Research” in Japan ～ 【 Issues of Clinical Research 】 ・ Quality of Research Protocol Necessary to Improve ： ・ Intellectual Properties （For example: Revision of Japanese GCP ・ Research Data and Results and unification of system） ・ Application of Research Results 11 Improvement of Infrastructures for Clinical and Translational Research ・ Keio University ・ National Cancer Center ・ National Cardiovascular Center ・ National Center for Child Health and Development ・ National Hospital Organization ・ Kitasato University ・ Oita University ・ International Medical Center of Japan ・ National Center Hospital of Neurology and Psychiatry ・ Chiba University Budget(FY2010) : 6.61 billion Yen ・ Sapporo Medical School. ・ Hokkaido University. 【MEXT 】 ・ Asahikawa Medical College ・ Tohoku University Coordination, Support and Training Program ・ Tokyo University for Translational Research： 2.4 b Yen ・ Kyoto University ・ Osaka University 【MHLW 】 ・ Foundation for Biomedical Research and Innovation Promotion of the Preparation of Clinical ・ Kyushu University Research Platforms ： 1.66 b Yen 【METI 】 Development of Technology to Promote Bridging Basic and Clinical Research ： 2.55 b Yen 12 Examples of Super Special Consortia Super Special Consortia: Deregulation and Financial Support for Clinical Research Center Networks 1. iPS Research Prof. Yamanaka’s Group: ▲ Hokkaido Univ. ・ Kyoto Univ. ・ Osaka Univ. ・ Institute of Medical Science, Tokyo Univ. Kyoto Univ. National Agriculture and Food ・ Riken < Prof. Yamanaka > Research Organization ・ Tokyo Univ. Tokyo Univ. Osaka Univ. Institute of Medical Science, Tokyo Univ. Riken ▲ 18. Next-Generation Vaccine ▲ ▲ Research ▲ ▲ Dr. Yamanishi ‘s Group: Institute of Medical ・ National Institute of Biomedical Science, Tokyo Univ. Innovation ・ Osaka Univ. National Institute of ・ Institute of Medical Science, Infectious Diseases. Tokyo Univ. ・ Tokyo Univ. Osaka Univ. ・ National Agriculture and Food National Institute of Research Organization Biomedical Innovation ・ National Institute of Infectious < Dr. Yamanishi > Diseases 13 Focusing of S&T Budgets (FY2010) S&T Budgets*：３５７２.３ billion Yen Basic Research R&D for Policy-Oriented Subjects System Reform (Universities, etc ） 1５３１.９ billion Yen １６６３.９ billion Yen ３７６.５ billion Yen ﾗｲﾌｻｲｴﾝｽLife 情報通信 環境 エネルギー 社会基盤 ﾌﾛﾝﾃｨｱ 19.0% ICT9.2% 7.0% 26.3% Infrastructure Frontier14.0% Energy 17.4% 1228 3315Science億円 1613 億円 億円 4598 億円 2446 億円 8.4% 3044 億円 29.4% 18.7% 19.8% 139.2 10.6% ﾅﾉﾃｸﾉﾛｼﾞｰ・材料 489.6billion Yenものづくり技術 330 billion Yen billion5.0% 865 億円 2.0% 356311億円 billion Yen 176.4billion Yen Yen Nano Tech.・ Environment Manufacturing Materials Technology 4.6 % 6.7% 1.8% 111.2billion 75.9billion 30.6billion Yen Yen Yen * Cabinet office assembled the data provided by ministries. 14 Major S&T Programs in Life Science (FY2010) Research for Child Health ○ Japan, Eco & Child Study （MOE）【3.1 billion Yen】 ・ Large Scale Cohort Study (Babies and Parents: 10 thousand pairs) ・ Study relationship between environmental factor and child disease Research for Disease Control Health Research ○ Program for Founding Research ○Project of Research and Development of Centers for Emerging and Reemerging Early Diagnostics and Medical Devices Infections Diseases (MEXT) for Cancer (METI) 【1.2 billion Yen】 【1.9 billion Yen】 ベトナム 中国 《 長崎大学 》 国立衛生疫学研究所 ・ 《東京大学 》 Promotion of R&D on New Medical 中国科学院 生物物理研究所
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