EU support for Health Research: from FP6 to FP7 Beatrice Lucaroni Unit F4 DG Research - European Commission Ferrara – 25 Ottobre 2006

EU Health Research Perspectives for the 7th Framework Programme The details of the FP7 priorities and modalities are still in negotiation and subject to change. In particular the EC’s proposal for the Joint Technology Initiative for Innovative Medicines will be subjected to the approval of the European Council.

Role of EC in research European Commission programmes bring down barriers between countries: multinational consortia in Europe (EU-25 + associated countries) researchers from almost any country in the world can participate; and promotes coordination of national funding programmes (ERA) between different types of organizations: universities, research centres, SMEs, large companies, etc. between disciplines: focus on translational research and encourages mobility: Marie Curie fellowships for researchers and for host institutes, including ingoing & outgoing grants.

EC Research Framework Programme 6 (2003-2006) €2.4 billion in research grants for 604 projects in 4 years Average success rate for projects: 25.4% Total number of participants: 7,426 Project type number av. EU contribution partners Integrated Projects 119 € 10.0m 21 Networks of Excellence 40 € 9.3m 30 STREPs 322 € 2.2m 8 Coordination Actions 25 € 1.1m 19 Specific Support Actions 98 € 0.4m 6

Special call for SME projects in Health research (2006) 355 proposals received: 86 projects funded € 200 million granted: 43% going to SMEs Average budget requested per SME: € 342,000 ~270 SMEs involved (41% of participants) 40/86 projects (46%) coordinated by SMEs Observations: SMEs taking leading role in projects projects aligned with SME’s strategy SME gaining experience in EC funding schemes

FP7: main elements Budget to be increased: €50.5 billion over 7 years + 40% European Research Council ( Ideas ) Collaborative research ( Cooperation ) continuity in themes & instruments. funding levels to be raised in some cases, eg SMEs: 50%  75% Joint Technology Initiatives Infrastructures, SMEs, regions & potential ( Research Capacities ) Human potential and science careers ( People ) Reminder: The European Commission currently manages about 5% of total public spending in R&D in the European Union. The EU currently invests about 1.9% of GDP in research

FP7 budget (EUR billion, 2004 constant prices)

Cooperation: Collaborative research in FP7 Thematic Priorities Health Food, agriculture and biotechnology Information and communication technologies Nanosciences, nanotechnologies, materials and new production technologies Energy Environment (including climate change) Transport (including aeronautics) Socio-economic sciences and the humanities Security and space + Euratom: fusion energy research, nuclear fission and radiation protection

Collaborative research for Health in FP7 Main policy drivers: Improving health of European citizens Increasing competitiveness of European health-related industries and businesses Addressing global health issues, including emerging epidemics

Collaborative research for Health in FP7 Budget: €6 billion over 7 years (2007-2013) Activities in 3 main areas Biotechnology, generic tools and technologies for human health Translating research for human health Optimising the delivery of healthcare

Collaborative research for Health in FP7 1: Biotechnology, generic tools and technologies High-throughput research enhancing data generation, standardisation, acquisition & analysis Detection, diagnosis and monitoring with emphasis on non-invasive or minimally invasive approaches Innovative therapeutic approaches and interventions gene and cell therapy, regenerative medicine, transplantation, immunotherapy and vaccines, implants & prosthetics Predicting suitability, safety and efficacy of therapies develop and validate parameters, tools, methods and standards (mainly through IMI) and alternatives to animal testing

Collaborative research for Health in FP7 2: Translating research for human health Integrating biological data and processes: large-scale data gathering, systems biology Research on the brain and related diseases, human development and ageing Translational research in major infectious diseases: to confront major threats to public health antimicrobial drug resistance, HIV/AIDS, malaria and TB, emerging epidemics, neglected infectious diseases Translational research in other major diseases: cancer, cardiovascular disease, diabetes and obesity, rare diseases, and other chronic diseases

Collaborative research for Health in FP7 3: Optimising the delivery of health care Enhanced health promotion and disease prevention (providing evidence of best public health measures – life styles, interventions, special focus on mental health, etc.) Translating clinical research into clinical practice (patient safety, better use of medicines, benchmarking, pharmacovigilance, etc.) Quality, solidarity and sustainability of health systems (organisational and financial aspects, health systems, etc.)

Collaborative research for Health in FP7 Two other issues will be addressed across all activities: Child health The health of the ageing population For more information see Specific programme: http://cordis.europa.eu/fp7/spe_programmes.htm

Collaborative research for Health in FP7 Special encouragement and measures for: SMEs Participation of SMEs and larger companies in all areas Special topics for SMEs International Cooperation Participation possible in all areas Special International Cooperation Actions (SICA)

Translational sciences Dialog among basic and clinical scientists Clinical research Forward Translation: Use bioinformatics, functional genomics into clinical practice Develop biomarkers & molecular imaging techniques at early stage of target validation Phase I – II – III studies In vitro studies Animal models Reverse Translation: Validating the biochemistry in target & biomarker discovery Bring measurements from the clinic into earlier stages of basic research Target validation Basic research

Collaborative research for Health in FP7 SUMMARY Continuity in collaborative Health research to: develop new tools and technologies promote translational research enhanced efforts to optimise delivery of health care [ using usual FP funding and coordination mechanisms ] & A novel approach to improve drug development: The Innovative Medicines Initiative [ using the proposed Joint Technology Initiative in FP7 ]

Research funding schemes in FP7 Funding instruments proposed: Collaborative projects to develop new knowledge, new technology, products, demonstration activities Small or medium-sized focused research actions Large-scale integrating projects Projects targeted at special groups (eg SMEs or International) Networks of Excellence Coordination and support actions 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)

Basic principles of evaluation and funding Annual calls for proposals, with topics set by the EC (following consultation and approval by Member States). Proposals evaluated by panels of independent experts (being an expert for the EC is a valuable experience) Criteria and thresholds Proposals short-listed for funding (with recommendations) Consortia receive EC funding for R&D tasks (shared cost) and for project management 12- of 18-month reports and reviews

Collaborative research for Health in FP7 Next steps: Approval by Council and European Parliament Preparation of work programmes for years 1 & 2. Currently consulting Member and Associated States (PC) First calls for proposals: Dec. 2006 (tbc) first deadline end-March ’07 (tbc) second deadline end-June ’07 (tbc) [ not all areas will be open at in each call ]

Information on FP7 EU research: http://europa.eu.int/comm/research Seventh Framework Programme: http://europa.eu.int/comm/research/future/index_en.cfm Information on research programmes and projects: http://www.cordis.lu RTD info magazine: http://europa.eu.int/comm/research/rtdinfo Innovative Medicines Initiative http://europa.eu.int/comm/research/imi.html Information requests: research@cec.eu.int Beatrice.Lucaroni@ec.europa.eu