The Seventh Framework Programme ( )

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The Seventh Framework Programme (2007-2013) Opportunities for Cardiovascular Research 1 Octavi Quintana Trias, MD, MPH Director Health DG Research - European Commission Octavi.Quintana-Trias@ec.europa.eu

Diseases of the heart and circulatory system (cardiovascular disease) are the main cause of death in Europe Cardiovascular research has an excellent track record of leading to a better understanding of the normal functioning and the pathophysiology of the cardiovascular system, and of translating that knowledge into new treatments Investment in cardiovascular research brings results 2

Cardiovascular Research Support Recognising the importance of stimulating cardiovascular disease (CVD) research activities at the European level, the EU provides direct financial support for research projects through the Framework Programmes (FP) - the main instrument of the European Union for research funding 3

Cardiovascular Research Support in the past FP5 FP6 1998-2002 2002-2006 33 projects devoted to 23 projects - nine largescale and fourteen smaller- CVD research and carried out under various sections scale research projects in of the Quality of Life CVD research Programme more than 50 million almost 124 million from the EU 4

5 Drug development CARDIOWORKBENCH (STREP; biotech) VASOPLUS (SME-STREP) Vascular biology EVGN (NoE) Molecular Physiology EICOSANOX (IP; overarching topic) Stem Cells MYOCARDIAL REPAIR (SSA) HeartRepair (IP) SC & CR (STRP; biotech) STROKEMAP (STREP; biotech) General and Specific Cardiovascular Disease Projects in FP6 Atherosclerosis CVDImmune (SME-STREP) IMMUNATH (SME-STREP) HDLomics (STREP) SOUTH (STREP) CVD genetics BLOODOMICS (IP) Cardiogenics (IP) PROCARDIS (IP) Stroke MOLSTROKE (STREP) EuroClot (STREP) Heart Failure EuGeneHeart (IP) Renal disease GENECURE (STREP) Hypertension InGenious HyperCare (NoE) Pulmonary Hypertension Pulmotension (IP) Arrythmias CONTICA (STREP) NORMACOR (STREP)

FP7 Structure and Budget EC Framework Programme is delineated into four Specific Programmes for indirect actions; total budget of 50.52 billion Cooperation Ideas (European (European Research Research Council) Council) People Euratom JRC (EC) 4,061 1,751 Capacities 4,097 People 4,75 7,51 Ideas Cooperation 32,413* Capacities *of which Health 6,1 billion 6 Total FP7 budget, including EUROATOM: 54,582 billion

Funding Schemes for Research in FP7 Collaborative projects to develop new knowledge, new technology, products, demonstration activities Small- or medium-scale focused research actions (FRP) Large-scale integrating projects (IP) Projects targeted at special groups (SMEs & SICA) Networks of Excellence (NoE) Coordination actions (CA) and support actions (SA) ERA-Nets Support for investigator driven research by individual teams (ERC) Support for training and career development of researchers Research for the benefit of specific groups (in particular SMEs) 7

Cooperation: Collaborative research in FP7 Cooperation Cooperation Ideas Ideas People People Ten Themes 1. Health 2. Food, agriculture, fisheries and biotechnology 3. Information and communication technologies 4. Nanosciences, nanotechnologies, materials and new production technologies 5. Energy 6. Environment (including climate change) 7. Transport (including aeronautics) 8. Socio-economic sciences and the humanities 9. Security 10. Space Capacities Capacities 8

Health Objectives: Improving health of European citizens Addressing global health issues including emerging epidemics Increasing competitiveness of European health-related industries Rationale: Sequencing of human genome and recent advances in post-genomics to integrate vast amounts of data Translational research to bring knowledge into the clinic Clinical research international multi-centre trials Reinforce health policy-driven research from clinical research to clinical practice Strong EU-based biomedical research strengthen competitiveness of industries and SMEs 9

Health Three activities: Biotechnology, generic tools and technologies for human health Translating research for human health Optimising the delivery of health care to European citizens Health Health Biotech, tools, technology Biotech, tools, technology Translational research Translational research Public Health Research Public Health Research Child health and health of the ageing population will be addressed across all activities: - in all topics, where approriate - through specific topics Support will also be provided for coordination and support actions across the theme and to projects responding to EU policy needs 10

Scope of Research in the Health Theme In the Health theme, the Framework Programme supports basic and applied collaborative research This includes discovery activities, translational research and clinical trials Main features of transition from FP6 to FP7: Continuity; broader scope; less focus on genomics; re-introduction of biomedical technology & engineering; emphasis on translational research; health policy driven research reinforced. 11

Areas of Research that will be supported in Activity 1 of the Health Theme: Biotechnology, generic tools and medical technologies for human health High-throughput research Detection, diagnosis and monitoring Biotech Biotech Health Health Translational Translational Public Health Public Health Predicting suitability, safety and efficacy of therapies (incl alternatives to animal testing) Innovative therapeutic approaches and intervention 12

Areas of Research that will be supported in Activity 2 of the Health Theme: Translating research for human health Integrating biological data and processes: large-scale data gathering, systems biology 13 Biotech Biotech Health Health Translational Translational Public Health Public Health Research on the brain and related diseases, human development and ageing Translational research in infectious diseases: drug resistance, HIV/AIDS, malaria, tuberculosis, Hepatitis, new and re-emerging epidemics, etc.) Translational research in major diseases: cancer; cardiovascular disease; diabetes/ obesity; rare diseases; other chronic diseases (e.g. rheumatic, respiratory, musculo-skeletal diseases and arthritis)

Areas of Research that will be supported in Activity 3 of the Health Theme: Optimising the delivery of health care to European citizens Translating clinical outcome into clinical practice Quality,efficiency and solidarity of health systems including transitional health systems (i.e. health systems that are currently under reform) Biotech Biotech Health Health Translational Translational Public Health Public Health Enhanced disease prevention and better use of medicines Appropriate use of new health therapies and technologies 14

Topics from first Calls Translational Research in Major Diseases Cardiovascular disease Topics for first call (19 April 2007): Molecular basis of the inflammatory response and associated vascular remodelling in arteriosclerosis (IP). Vascular remodelling in aneurysmal disease (IP). Combating stroke (IP). Topics for second call, deadline 18 September 2007: Congenital pathologies affecting the heart (FRP). Cell therapies for the treatment of heart ischemia (FRP). Organ imaging in CVD (FRP). Integrating pharmacogenomic approaches into the treatment of CVD (FRP). 15

Results from first Calls Cardiovascular disease First call evaluation is finished 3 proposals selected for funding 1 for each topic. Second call deadline just passed. Big number of proposals received for each topic. Evaluation procedure ongoing. New CVD topics to be defined in the Work Programme for 2008. 16

What is important to know if you are submitting your proposal for one of the topics in the Health theme? 17

Funding rates Cost reporting models eliminated! R&D activities: up to 75% of eligible costs for Public bodies Secondary and higher education establishments Non-profit research organisations SMEs Funding of up to 100% for: Other activities (e.g. management) Coordination and support actions 18

Eligibility and Evaluation Criteria Eligibility deadlines minimum number of participants/countries completeness of proposal relevance to the objectives of the work programme funding ceilings Max. number of pages (others will be ignored) Evaluation criteria 1. Scientific Excellence Quality of objectives and concept, state of the art, methodology 2. Impact Expected impact as set out in work programme, dissemination activities and IPR management 3. Implementation competence of partners, quality of the consortium (complementarity), managerial approach, allocation and justification of resources (budget, staff, equipment) 19

Ethical Framework in FP7 Same as for FP6 with a revision foreseen for 2 nd phase of FP7 (2010-2013) 3 areas are excluded from funding Human reproductive cloning Intentional germ line modification* Creation of human embryos for research or stem cell procurement (including by means of somatic cell nuclear transfer) * Research relating to cancer of the gonads can be financed 20

Other opportunities for CVD research in FP7 New FP7 Cooperation programme - Joint Technology Initiatives Innovative Medicines Initiative New FP7 Ideas Programme - Frontier research European Research Council People Programme Marie Curie Actions 21

Joint Technology Initiatives Innovative Medicines Initiative 22

IMI - Core activities and goals IMI will foster the development a new «toolbox» (toxicology tests, biomarkers, clinical trials protocols, etc.) for drug developers to reduce the risk of failure of new medicines in the drug development process (preclinical and clinical phases). IMI will provide the opportunity for validation of the new tools in view of rapid uptake into regulatory and industry practice. IMI will set up knowledge platform pooling data from toxicology testing and biomarker validation will be set up and will be available to all researchers (industry and academic). IMI will not develop new medicines or new vaccines! 23

European Research Council New FP7 Investigator driven frontier research in all research areas including Life sciences 24 Cooperation Cooperation Ideas Ideas People People Capacities Capacities Europe-wide competitive funding structure Excellence as sole criterion Individual independent teams Grants ~ 1.1 billion per year (100% reimbursement) Two funding schemes: Starting Independent Researcher scheme Advanced Investigator scheme

Marie Curie Actions Initial training of researchers Marie Curie Networks Overall Scope: Human resource development in R&D in Europe 25 Cooperation Cooperation Ideas Ideas People People Capacities Capacities Life-long training and career development Individual Intra-European Fellowships Co-financing of reg./nat./internat. programmes Industry-academia pathways and partnerships Industry-Academia Knowledge sharing Scheme* International dimension Outgoing & Incoming International Fellowships* International Cooperation Scheme Reintegration grants Specific actions Mobility and career enhancement actions Excellence awards * Open to third-country nationals

Team up for new research, discovery and training opportunities available for cardiovascular researchers through the Seventh EU Research Framework Programme 26

EU research http://ec.europa.eu/research/ Seventh Framework Programme http://cordis.europa.eu/fp7/ Health Research in FP7 http://cordis.europa.eu/ Information Innovative Medicines Initiative http://ec.europa.eu/research/fp6/index_en.cfm?p=1_innomed Registering as an expert https://cordis.europa.eu/emmfp7/ European Research Council http://erc.europa.eu/ 27