The Life Innovation Policy of Japan and Activities of MEXT

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The Life Innovation Policy of Japan and Activities of MEXT November 2011 Hiroyuki KAMAI Deputy Director, Life Sciences Division Research Promotion Bureau Ministry of Education, Culture, Sports, Science and Technology (MEXT) Tokyo Japan

Current trends of Policies for Life Sciences in Japan 2 The 2 nd S&T Basic Plan (FY2001-FY2005) The Government decided 4 strategic areas including Life Sciences The 3 rd S&T Basic Plan (FY2006-FY2010) The Government decided 4 priority fields to be promoted including Life Sciences New Growth Strategy (June 2010, Cabinet Decision) The Government decided 7 strategic areas including Life Innovation (innovation in the medical and nursing care sectors) The 4 th S&T Basic Plan (FY2011-FY2015) The Government regards Life Innovation as the priority agenda which should be addressed.

The New Growth Strategy: Blueprint for Revitalizing Japan June 18, 2010 Cabinet Decision Targets 2020 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. 2010 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 Green Innovation Science-andtechnology IT oriented nation Employment & human resources Financial sector Life Science Innovation Tourism-oriented nation & local revitalization Asia Creation of New Demand and Jobs (Third Approach) Area Environment (Green Innovation) Health (Life Science Innovation) Demand Creation 50 trillion 50 trillion Asia 12 trillion Tourism 11 trillion Job Creation 1.4 million jobs 2.84 million jobs 0.19 million jobs 0.56 million jobs 3

The 4 th S&T Basic Plan (FY 2011-2015) 2015) The Forth Science and Technology Basic Plan (FY 2011-2015) (approved by the Cabinet, August 2011) Realization of Sustainable Growth and Societal Development into the Future : Reconstruction and revival from the disaster Promoting Green and Life Innovation System reforms directed at promoting STI The Basic Plan specifies several areas below as Strategic Prioritized issues in life sciences field Development of revolutionary disease prevention methods Development of new early diagnoses methods Realization of safe and highly effective medial treatment Improvement of Quality of life (QOL) for the sick, elderly, and disabled 4

Life Innovation Acceleration Initiative (MEXT) Budget proposal for FY 23: 10 billion yen To keep our society healthy and to sustain our economy continuously growth -- acceleration of R&Ds for unmet medical needs and Regenerative Medicine ACTION:Establish trans-ministerial consistent support system (Regenerative Medicine Highway) 4.7 billion yen - Consistently support the research of stem-cells such as ips cells from basic to clinical research by the cooperation with relevant ministries concerned. -Promote systems biology (unite of life sciences and mathematical principle calculation science) that is the current of research in the world, and generate a technical system that contributes the achievement of regenerative medicine by the network. Cancer Medicine seeds ACTION:Promote world leading innovative cancer researches to the medicine. 3.6 billion yen - Promote world leading innovative cancer researches and accelerate researches aim at the clinical application. Neural and Mental Diseases Medicine ACTION:Overcome neural and mental diseases by brain science research. 1.8 billion yen - Achieve early diagnosis and treatment by clarify the mechanism. Immunological and Allergy Diseases Medicine ACTION:Establish safety and effectiveness of pollenosis vaccine. 0.3 billion yen - Put research progress pollenosis vaccine into practical use by establishing safety and effectiveness. Basic research Innovative seeds ips cells Contribute to growth by overcoming the diseases. The market of over 10 trillion yen scale is expected in the world Create the market of several hundred billion yen scale per one goods by producing a innovative cancer medicine Clinical research Contribute to the social rehabilitation of about 2.7 million depression and dementias patients Contribute to return-towork and improvement of productivity of about 17 million or more pollenosis patients 5

Focusing of S&T Budgets Request (FY2012) 6 Promotion of Life Innovation: 122 billion Yen Focusing on the activities to create life innovation which aims to -overcome incurable diseases and -realizing a society with healthy bodies and minds through effective use of our leading research fields and unique methodologies.

Life Science Project in Japan(1) The research and development of the field of life Science based on social needs A realization project of the regenerative medicine -promote the ips/es cell researches strategically by the All Japan system to survive successfully international competition. Strategic Research program for Brain Science -strategically promote brain science and research that aims at passing and returning the benefits of research results to society as a whole. Research Project for Innovative Cancer Medicine Development -promote the development of advanced cancer medicine by fostering results of basic and clinical researches on cancer into the innovative seeds for translational and clinical cancer researches. Platform for Medical and Pharmaceutical Research -enhance supporting platform for medical and pharmaceutical research for innovative drug development. -construct an interdisciplinary research center (experimental and theoretical approaches) for innovative drug development. Accelerated Networking Program for Translational Research -construct supporting centers for translational research, which lead hopeful outcomes of fundamental researches to bedside. 7

Life Science Project in Japan(2) Reconstruction and revival from the disaster Tohoku Medical-Megabank Plan -conduct genome-cohort studies in afflicted areas to secure medical experts and realize personalized-medicine for local residents, that results in recovery and rehabilitation of damaged local medical system. System maintenance to support the whole life science research National Bio Resources Project -establish the highest quality bio-resources and its supply system at a world-class level to promote life science researches Integrated Life Science Database Project -improve the convenience of Database in Life Science and construct base for supporting world top-level researches 8

The Project for Realization of Regenerative Medicine (1)iPS cell research core institute (1)Kyoto Univ. Prof. Yamanaka Basic research of ips cells Evaluation technology of ips cell RIKEN Sasai group director Operational technology of ips Cell Development of Treatment for visual impairments MEXT Strategic Working Group for Stem cell Research and Regenerative medicine Executive steering committee with Program Director and Officer (3) Development Area of operational technology of Stem Cells Realization of Regenerative Medicine Evaluation committee (2)Stem Cell Bank for Research MEXT ips Cell Research Network (1) Keio Univ. Prof. Okano Focus on central nerve system Development of Treatment for spinal cord injury (4) Development Area of Stem Cells Treatment (1) (1) (attachment) Tokyo Univ. Prof. Nakauch Focus on Blood cells like platelet and red blood cell

Road Map for ips Cell Research by MEXT Goal 1 Basic Research 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Elucidation of the molecular mechanism of initialization of ips cells [Within 5 years] Establishment of new pluripotent stem cells different from ips cells [Within 5 years] (attachment) Goal 2 Standardization Identification of evaluation items for clarifying the characteristics of ips cells Comparison of the characteristics of ips cells established through various protocols [In the next 1 year] Establishment and optimization of the qualified ips cells with low risk Establishment of evaluation method of ips cells Construct of accumulation/analyses framework for systematic evaluation of ips cells [In the next two years] Construct of the system to supply ips cells with high quality and low risk in Japan and abroad [In the next 3 years] Distribution of ips cells with high quality and low risk in Japan and abroad, under low cost and the same conditions [After 3 years] Identification of diseases for efficient establishment of disease-specific ips cells Technological training on ips cells for clinical researchers Industrial applications of toxicity assessment system useful for drug discovery [In progress] Goal 3 ips cells for research of the diseases / drug discovery Establishment and optimization of the preparation protocol of ips cells for disease research Establish the evaluation method of ips cells for disease research Systematic banking of disease-specific ips cells [Within 2 years] Distribution of disease-specific ips cells to researchers in Japan and abroad [After 2 years] Reproduction and elucidation of pathological conditions using ips cells originated from patients with congenital diseases Reproduction and elucidation of pathological conditions using ips cells originated from patients with acquired diseases [Future 5 to 10 years] Goal 4 Regenerative medicine Central nervous system Cornea Retinal pigment epithelial cell Photoreceptor cell Platelet Erythrocyte Hematopoietic stem cell Cardiac muscle Osteogenic cell and cartilage Skeletal muscle Endodermal cell ips cell bank for regenerative medicine Basic research [differentiation induction/purification] Pre-clinical research Basic research [differentiation induction/purification] Pre-clinical research Basic research/pre-clinical research Basic research [differentiation induction/purification] / Pre-clinical research Basic research [differentiation induction/purification] / Pre-clinical research Basic research [differentiation induction/purification] Basic research [differentiation induction/purification] / Pre-clinical research Pre-clinical research Basic research [differentiation induction/purification] Pre-clinical research Basic research [differentiation induction/purification] Pre-clinical research Basic research [differentiation induction/purification] Pre-clinical research Basic research [differentiation induction/purification] / Pre-clinical research Establishment of ips cell bank considering the application of regenerative medicine [Within 5 years] Distribution of ips cells for regenerative medicine for pre-clinical research [After 4 years] * All of descriptions are translated tentatively