______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 《 国立国際医療センター 拠点 》 バックマイ病院 中国科学院 微生物研究所 Devices for Diagnostic of Cancer インド ・ Asia and Africa: 中国農業科学院 ﾊﾙﾋﾞﾝ獣医研究所 《岡山大学 》 国立コレラおよび腸管感染症研究所 Cooperation with 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 感染症研究 推進センター（仮称） 8 Research centers ・拠点間ﾈｯﾄﾜｰｸの強化 拠点間の連携を強化 ・疾病ごとの拠点間共同 研究の推進 等 ・ Cultivation of Human タイ 《大阪大学 》 国立予防衛生研究所 Resources 《動物衛生研究所 拠点 》 国内外関係機関 国立家畜衛生研究所 ザンビア インドネシア フィリピン
《北海道大学 》 《 神戸大学 》 《東北大学 》 ザンビア大学 アイルランガ大学 フィリピン熱帯医学研究所 サモラ・マシェル獣医学部 熱帯病センター 15 3. The New Growth Strategy and the 4th Science and Technology (S&T) Basic Plan
16 June 18, 2010 The New Growth Strategy: Blueprint for Revitalizing Japan Cabinet Decision Targets 2020 2010 ◆ Achieve nominal & real growth in ◇ Sluggish growth (real growth rate at 1% in excess of 3% and 2%. the past decade; potential growth rate at 1%) ◆ Return consumer prices to positive ◇ Trapped in deflation (consumer price increase in FY2011. increase rate at 0% in the past 20 years) ◆ Lower the unemployment rate to ◇ Unemployment rate at 5% 3% - 4% at an early time.
7 Strategic Areas & 21 Creation of New Demand and Jobs National Strategic Projects (Third Approach)
Area Demand Job Life Science Green Innovation Creation Creation Innovation Science-and- Environment ¥ 50 trillion 1.4 million jobs technology Tourism-oriented (Green Innovation) IT oriented nation nation & local revitalization Health ¥ 50 trillion 2.84 million jobs Employment & (Life Science Innovation) human resources Asia Asia ¥ 12 trillion 0.19 million jobs Tourism ¥ 11 trillion 0.56 million jobs Financial sector 17 December 30, 2009 Outline of he New Growth Strategy (Basic Policies) Cabinet Decision BASIC POLICIES FOR SIX STRATEGIC AREAS GrowthGrowth DrivDrivenen byby Japan’sJapan’s StrengthsStrengths AchievAchievinging GrowthGrowth byby PioneeringPioneering NewNew FrontiersFrontiers （１）Strategy for becoming an （３）Asian economic strategy environment and energy power through “Green Innovation” （４）Strategies for promoting a tourism-oriented nation and local （２）Health power strategy through revitalization “Life Science Innovation” PlatformsPlatforms toto SupportSupport GrowthGrowth ・Turning medical, nursing care, and other health-related industries into growth- （５）Science-and-technology- driving industries oriented nation strategy ・Promoting research and development of ・Japan, a nation brimming with know-how innovative pharmaceuticals and medical human resources and nursing care technologies from ・Japan, an IT-oriented nation Japan ・Stronger foundations of medical and （６） nursing care service to eliminate anxiety Employment and human and for an enjoyable life……. etc. resources 18 The New Growth Strategy and the 4th 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 Strategies for promoting Green Life Science Science・ Employment・ Asia a tourism-oriented Human Resources Innovation Innovation nation and local revitalization Technology
Science and Technology play an important roll for prevention of crisis and economic growth
The 4th Science and Technology Basic Plan (2011 - 2015) 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 4. Action Plan
20 Purpose of Action Plan
○ 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
21 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 3 Major Pillars for Life Science Innovation in 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
23 Improvement of the Preventive Method by Integration of Budgetary Request (FY2011) Results of Genome Cohort Study and Medical Record 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》
Co- Co- Promotion of Japan, Eco & Collection, Accumulation, operation Genome operation Integrated Data Child Study and Integration of Medical Cohort Study Base project on （5.14 billion Yen） Record by IT Network Life Sciences 【 Contents of Programs 】 (1.8 billion Yen) ・ 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 】 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
Improvement of Cancer Cure Rate by Development of Budgetary Request (FY2011) Innovative Diagnostic and Treatment Method Total 19.4 billion Yen
Early Diagnosis Medical Treatment Target Oriented Basic Research Biomarker Research Research for New Target
【 MHLW 】 Establishment of early diagnosis method by 【 MHLW 】 Innovative treatment method to attack solid using biomarkers （150 million Yen） cancer stem cells （150 million Yen）
Application Research Detection of Biomarker Medical Treatment
【 MEXT 】 Development of real-time and multi-molecular 【 MEXT 】 Next generation strategic cultivation program imaging system （150 million Yen） for research of cancer seeds （3,800 million Yen）
Development of Diagnostic Device Development of Therapeutic Device 【 MIC 】 3D imaging technology and communication 【 MEXT 】 Advancement of cancer therapy using heavy technology with super realistic sensation （1,040 million particle radiotherapy （2,100 million Yen） Yen） Development of Early Diagnostics Method Development of Therapeutic Method
Translational Construction of the Clinical Research Research Center
Clinical Research 25 Development of the Robotic Technology for Elderly Budgetary Request (FY2011) and Handicapped Persons 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 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 ☆ The 4th S&T Basic Plan (FY2011) （FY2011～FY2015) ・ Green Innovation ・ Green and Life Science Innovation ・ ・ Life Science Innovation Stimulation of Basic Research ・ Renovation of System ・ Prioritization of R&T Budget
CSTP: - The Control Tower of S&T Strategy - ¾ Formulation of S&T Strategy ¾ Execution of Plan-Do-Check-Act (PDCA) Cycle against S&T Programs
Toward a Radiant Japan 27