Life Science Innovation

Transcription

1 2010/SOM3/LSIF/007 Life Science Innovation Submitted by: Japan Life Sciences Innovation Forum Sendai, Japan September 2010

2 Life Science Innovation Sep.18, 2010 Executive Member of Council for Science and Technology Policy Tasuku Honjo

3 Agenda 1 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 4 th Science and Technology (S&T) Basic Plan 4. Action Plan

4 2 1.Council for Science and Technology Policy (CSTP): - Control Tower for Science and Technology Strategy -

5 Science and Technology Administration in Japan Prime Minister Cabinet Office: Council for Science and Technology Policy (CSTP) S&T Basic Plan, Resource Allocation Policy (Ministries for implementation) Cabinet Office for basic policy and general coordination on important issues for cabinet (Cabinet Office for policy making) Ministry of Education, Culture, Sports, Science and Technology (MEXT) Ministry of Health, Labour and Welfare (MHLW) Ministry of Economy, Trade and Industry (METI) Other Ministries Coordination 3

6 Members of the Council for Science and Technology Policy Members of the CSTP Chairperson Naoto KAN Prime Minister Tatsuo KAWABATA Yoshito SENGOKU Minister of State for S&T Policy Minister of Education, Culture, Sports, Science and Technology Chief Cabinet Secretary Cabinet Members Kazuhiro HARAGUCHI Minister of Internal Affairs and Communications Executive Members Yoshihiko NODA Masayuki NAOSHIMA Masuo AIZAWA Tasuku HONJO Naoki OKUMURA Minister of Finance Minister of Economy, Trade and Industry Former President, Tokyo Institute of Technology Visiting Professor, Kyoto University (As of August, 2010) Former Representative Director and Executive Vice President, Nippon Steel Corporation, Ltd (academia/industry) Takashi SHIRAISHI Toyoko IMAE Reiko AOKI Ryoji CHUBACHI Former Vice President and Professor, National Graduate Institute For Policy Studies Professor Emeritus, Nagoya University Professor, Institute of Economic Research, Hitotsubashi University Vice Chairman, Sony Corporation Sci. Council Ichiro KANAZAWA President of Science Council of Japan 4

7 5 2. Strategic Support to Clinical Research and Translational Research

8 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

9 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, Takepron/Prevacid ulcer Takeda 3, Crestor cholesterol Shionogi 2, Aricept alzheimer Eisai 2, Cravit/Levaquin antibiotic Daiichi-Sankyo 2, Abilify schizophrenia Otsuka 2, Harnal/Flomax urinary Astellas 1, Blopress/Atacand high blood pressure Takeda 1, NeoRecormon/Epogin anemia Roche/Chugai 1, Prograf Immune suppressor Astellas 1, Olmesartan high blood pressure Daiichi-Sankyo 1, Luprin/Lupron anti-cancer Takeda 1, Aciphex/Pariet ulcer Eisai 1, Pravacol/Mevalotin cholesterol Daiichi-Sankyo 1, Japan Origin Medicines: 14 Medicines / Top 100 Global Sales Y2010 Problem: Patents of 9 Medicines will be expired until 2011 in USA 7

10 Issues of Japanese Medical Device Industry Global Competitiveness Index* of Medical Devices Medical Device for Diagnostic Medical Device ( Total ) Medical Device for Medical Treatment (year) Medical Devices for Diagnostic Medical Devices for Medical Treatment Medical Devices (Total ) Global Competitiveness Good Bad Poor * Global competitiveness index = (Export Import ) / ( Export + Import ) ( Ref.: Statistics on production dynamics of medical industries (MHLW) ) 8

11 Activity of Clinical Research is Weak in Japan Numbers of Published Reports in major 3 journals USA Germany Japan UK France Canada Swiss Italy Holland Australia Sweden Austria China Spain Belgium Israel Scotland Korea Basic Research USA UK Canada Germany France Holland Italy Australia Swiss Belgium Sweden Scotland Spain Denmark China Norway Finland Japan Clinical Research Ref. Thomson Reuters Numbers of Published Reports (in major 3 journals) Clinical Research << Basic Research Improve Clinical Research Activity ( March 7 th, 2010,Yomiuri Shimbun ) 9

12 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) Providing world s best drugs and medical devices to the public The drug/medical devices industries as the driving force for the growth of 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

13 Issues of Clinical Research in Japan Clinical Trial of New Medicines In accordance with Pharmaceutical Affairs Act Clinical Research by Using Candidates of New Medicines in House Approval and National Health Insurance Price Listing for Medicine (MHLW) Application of Advanced Medical Care (MHLW) Evaluation and Approval of Clinical Trial (PMDA ) Private Sector of Medicines (Pharmaceutical Affairs Act) Contract Research (Private Sector) Limited Usage (not all Japan ) Application to MHLW as Special Medical Treatment Clinical Trial by Private Sector or Clinical Trial by MD Development in Universities or Institutes Issues of Clinical Research Quality of Research Protocol Intellectual Properties Research Data and Results Application of Research Results Research Seeds (Drug Candidates) ~ Clinical Trial and Clinical Research in Japan ~ Necessary to Improve : (For example: Revision of Japanese GCP and unification of system) 11

14 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 Sapporo Medical School. Hokkaido University. Asahikawa Medical College Tohoku University Tokyo University Kyoto University Osaka University Foundation for Biomedical Research and Innovation Kyushu University Budget(FY2010) : 6.61 billion Yen MEXT Coordination, Support and Training Program for Translational Research: 2.4 b Yen MHLW Promotion of the Preparation of Clinical Research Platforms : 1.66 b Yen METI Development of Technology to Promote Bridging Basic and Clinical Research : 2.55 b Yen 12

15 Examples of Super Special Consortia Super Special Consortia: Deregulation and Financial Support for Clinical Research Center Networks 1. ips Research Prof. Yamanaka s Group: Kyoto Univ. Osaka Univ. Institute of Medical Science, Tokyo Univ. Riken Tokyo Univ. Kyoto Univ. < Prof. Yamanaka > Osaka Univ. Riken Osaka Univ. National Institute of Infectious Diseases. National Institute of Biomedical Innovation < Dr. Yamanishi > Institute of Medical Science, Tokyo Univ. Hokkaido Univ. National Agriculture and Food Research Organization Tokyo Univ. Institute of Medical Science, Tokyo Univ. 18. Next-Generation Vaccine Research Dr. Yamanishi s Group: National Institute of Biomedical Innovation Osaka Univ. Institute of Medical Science, Tokyo Univ. Tokyo Univ. National Agriculture and Food Research Organization National Institute of Infectious Diseases 13

16 Focusing of S&T Budgets (FY2010) S&T Budgets*: billion Yen Basic Research (Universities, etc ) R&D for Policy-Oriented Subjects System Reform billion Yen billion Yen billion Yen Life 19.0% Science ライフサイエンス情報通信環境 3315 億円 19.8% 330 billion Yen ICT 9.2% 7.0% 26.3% Energy Infrastructure 17.4% 億円億円 % 億円 3044 億円 29.4% 18.7% ナノテクノロシ ー 材料ものづくり技術 5.0% 865 billion 489.6billion Yen 億円 2.0% 億円 billion 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. エネルギー社会基盤フロンティア Frontier 14.0% 2446 億円 10.6% 176.4billion Yen 14

17 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 Program for Founding Research Centers for Emerging and Reemerging Infections Diseases (MEXT) 1.9 billion Yen Asia and Africa: Cooperation with 8 Research centers Cultivation of Human Resources ベトナム 長崎大学 国立衛生疫学研究所 国立国際医療センター拠点 バックマイ病院 インド 岡山大学 国立コレラおよび腸管感染症研究所 ガーナ 東京医科歯科大学 ガーナ大学野口記念医学研究所 拠点間の連携を強化 タイ 大阪大学 国立予防衛生研究所 動物衛生研究所拠点 国立家畜衛生研究所 中国科学院 中国科学院 中国農業科学院 中国 東京大学 生物物理研究所 微生物研究所 ハルヒ ン獣医研究所 感染症研究推進センター ( 仮称 ) 拠点間ネットワークの強化 疾病ごとの拠点間共同研究の推進等 国内外関係機関 Health Research Project of Research and Development of Early Diagnostics and Medical Devices for Cancer (METI) 1.2 billion Yen Promotion of R&D on New Medical Devices for Diagnostic of Cancer ザンビア インドネシア フィリピン 北海道大学 ザンビア大学サモラ マシェル獣医学部 神戸大学 アイルランガ大学熱帯病センター 東北大学 フィリピン熱帯医学研究所 15

18 16 3. The New Growth Strategy and the 4 th Science and Technology (S&T) Basic Plan

19 The New Growth Strategy: Blueprint for Revitalizing Japan June 18, 2010 Cabinet Decision Targets Achieve nominal & real growth in excess of 3% and 2%. Return consumer prices to positive increase in FY2011. Lower the unemployment rate to 3% - 4% at an early time. Sluggish growth (real growth rate at 1% in the past decade; potential growth rate at 1%) Trapped in deflation (consumer price increase rate at 0% in the past 20 years) Unemployment rate at 5% 7 Strategic Areas & 21 National Strategic Projects Creation of New Demand and Jobs (Third Approach) Green Innovation Science-andtechnology IT oriented nation Employment & human resources Life Science Innovation Tourism-oriented nation & local revitalization Asia Area Environment (Green Innovation) Health (Life Science Innovation) Demand Creation Job Creation 50 trillion 1.4 million jobs 50 trillion 2.84 million jobs Asia 12 trillion 0.19 million jobs Financial sector Tourism 11 trillion 0.56 million jobs 17

20 Outline of he New Growth Strategy (Basic Policies) BASIC POLICIES FOR SIX STRATEGIC AREAS Growth Driven by Japan s Strengths (1)Strategy for becoming an environment and energy power through Green Innovation (2)Health power strategy through Life Science Innovation Turning medical, nursing care, and other health-related industries into growthdriving industries Promoting research and development of innovative pharmaceuticals and medical and nursing care technologies from Japan Stronger foundations of medical and nursing care service to eliminate anxiety and for an enjoyable life. etc. Achieving Growth by Pioneering New Frontiers (3)Asian economic strategy Platforms to Support Growth (5)Science-and-technologyoriented nation strategy Japan, a nation brimming with know-how human resources Japan, an IT-oriented nation (6)Employment and human resources December 30, 2009 Cabinet Decision (4)Strategies for promoting a tourism-oriented nation and local revitalization 18

21 The New Growth Strategy and the 4 th S&T Basic Plan The New Growth Strategy (Basic Policies) Growth Driven by Japan s Strengths Achieving Growth by Pioneering New Frontiers Platforms to Support Growth Green Innovation Life Science Innovation Asia Strategies for promoting a tourism-oriented nation and local revitalization Science Technology Employment Human Resources Science and Technology play an important roll for prevention of crisis and economic growth The 4 th Science and Technology Basic Plan ( ) Enhancement of Science and Technology as a platform to promote the Green Innovation and Life Science Innovation to lead economic growth Promote Nobel of Science, Technology, and Innovation Policies in an integrated manner Realization of Science and Technology as an Engine of the New Growth Strategy 19

22 4. Action Plan 20

23 Purpose of Action Plan 21 Improvement of the S&T budget planning process Discussion early with all ministries about S&T budget Open discussion and application of public comment Indication of output results of programs to consider the goal in 2020 Enhancement of role of CSTP as the control tower of S&T Strategy in the S&T budget planning process Presentation of target priority to responsible ministries Promotion of cooperation and elimination of budget duplication Targets of the Action Plan for Budget Request in 2011 Green Innovation Life Science Innovation Deregulation of Competitive Fund Rules

24 Basic Principle of Life Science Innovation in Action Plan Life Science Innovation Turn medical, nursing care, and other health related industries into growth industries Promote research and development of innovative pharmaceuticals and medical and nursing care technologies from Japan. Promote expansion of medical, nursing care, and other health related industries to Asian and other overseas markets Strengthen the foundations of medical and nursing care services. Life Science Innovation contributed by S&T Solution of problems and realization of innovation by S&T in medical, nursing care, and other health area Improvement of quality of life, medium and long term expansion and growth of industry and economy Formulation of the Action Plan The promotion of the preventive medicine Improvement of cancer cure rate by the development of the innovative diagnostic and treatment method Development of the robotic technology for elderly and handicapped persons 22

25 3 Major Pillars for Life Science Innovation in Action Plan 23 The promotion of the preventive medicine Improvement of cancer cure rate by the development of the innovative diagnostic and treatment method Development of the robotic technology for elderly and handicapped persons

26 Improvement of the Preventive Method by Integration of Results of Genome Cohort Study and Medical Record Budgetary Request (FY2011) Total 500 million Yen Improvement of the Prevention Method by Integration of Results of Genome Cohort Study and Medical Information 500 million Yen New Project using Special Coordination Funds for Promoting Science and Technology Japan, Eco & Child Study (5.14 billion Yen) Genome Cohort Study Collection, Accumulation, and Integration of Medical Record by IT Network Contents of Programs Organization of Cohort Study Analysis method to integrate data of medical record and genetic information Analysis method for biological samples (Metabolome Analysis and Genetic Analysis) Data analysis method using bio-informatics technology Expected Results Cooperation Cooperation Promotion of Integrated Data Base project on Life Sciences (1.8 billion Yen) 1. Scientific Output Data of relationship between phenotype and genetic mutation in human 2. Contribution of Medical Care Selection of target disease and discover of preventive method Biomarker for diagnostic of disease and novel targets for innovative medicine Screening of adverse effect of medicines 3. Application of Resources Reduction of duplication of medical check by integration of medical records using IT Decrease of medical cost 24

27 Improvement of Cancer Cure Rate by Development of Innovative Diagnostic and Treatment Method Budgetary Request (FY2011) Total 19.4 billion Yen Early Diagnosis Target Oriented Basic Research Medical Treatment Biomarker Research MHLW Establishment of early diagnosis method by using biomarkers (150 million Yen) Research for New Target MHLW Innovative treatment method to attack solid cancer stem cells (150 million Yen) Detection of Biomarker MEXT Development of real-time and multi-molecular imaging system (150 million Yen) Application Research Medical Treatment MEXT Next generation strategic cultivation program for research of cancer seeds (3,800 million Yen) Development of Diagnostic Device MIC 3D imaging technology and communication technology with super realistic sensation (1,040 million Yen) Development of Early Diagnostics Method Development of Therapeutic Device MEXT Advancement of cancer therapy using heavy particle radiotherapy (2,100 million Yen) Development of Therapeutic Method Translational Research Construction of the Clinical Research Center Clinical Research 25

28 Development of the Robotic Technology for Elderly and Handicapped Persons Budgetary Request (FY2011) Total 5.8 billion Yen Development and introduction of devices to supporting and supplement dysfunctions for elderly and handicapped persons MIC Innovative Research Program by using Brain Mechanism 2,046 million Yen Improvement of quality and efficiency on nursing care by observation and health information service in house METI Project for development of next-generation robotic brain technology 480 million Yen Development and introduction of devices for supporting caretakers under physical and mental stress METI Project for application of life-supporting robot 1,695 million Yen Policies to expand new device and service, system renovation, and creation of new industries and employment by promoting global business MHLW Development of prevention for nursing care by cutting-edge medical device and cultivation of human resources 50 million Yen 26

29 Summary The New Growth Strategy: Blueprint for Revitalizing Japan (FY2010~FY2020) S&T Policies Life Science Innovation S&T IT oriented Nation Green Innovation Action Plan for S&T Budget Request (FY2011) Green Innovation Life Science Innovation The 4 th S&T Basic Plan (FY2011~FY2015) Green and Life Science Innovation Stimulation of Basic Research Renovation of System Prioritization of R&T Budget CSTP: - The Control Tower of S&T Strategy - Formulation of S&T Strategy Execution of Plan-Do-Check-Act (PDCA) Cycle against S&T Programs Toward a Radiant Japan 27