EU support for Health Research from FP6 to FP7 Stéphane Hogan Head of Biotechnology Unit Directorate for Health Research DG Research - European Commission Valencia - 15 September 2006
EU research programmes managed by the European Commission From the Sixth Framework Programme (FP6) to the Seventh Framework Programme (FP7) The details of the FP7 priorities and modalities are still in negotiation and subject to change. In particular the European Commission s proposal for the Joint Technology Initiative for Innovative Medicines will be subjected to the express approval of the European Council.
Role of the EC in research European Commission programmes bring down barriers between countries: multinational consortia coordination of national funding programmes researchers from almost any country in the world can participate in EU research projects. between different types of organizations: universities, research centres, SMEs, large companies, NGOs, etc. between disciplines: increased focus on translational research and encourages mobility: Marie Curie fellowships available for researchers and for host institutes, including ingoing & outgoing grants.
EC Research Framework Programme 6 (2003-2006) Health research priority ~ 2.4 billion for research 540 projects: 114 Integrated Projects (IPs), 40 Networks of Excellence (NoEs) & 284 Specific Targeted Research Projects (STREPs) Topics are set by the EC following consultation Projects are evaluated by independent experts Average success rate: 24% Consortia receive EC funding for R&D tasks (shared cost) and for project management
the Seventh Framework Programme (2007-2013)
FP7: main elements Annual budget to be increased gradually (+75% by 2013) European Research Council (Ideas) Collaborative research (Cooperation) continuity in themes & instruments, longer duration. funding levels (50%) to be raised in specific cases (+25%) 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 European Union currently invests about 1.9% of GDP in research
FP7: 2007-2013 Cooperation Collaborative research 9 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 in Framework programme 7 for Health Main policy drivers: Improving the health of European citizens Increasing the competitiveness of European health-related industries and businesses Addressing global health issues, including emerging epidemics
FP7 Collaborative research in Framework programme 7 Health Budget: 5984 million 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 in Health 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 (with potential application in many diseases and disorders). Predicting suitability, safety and efficacy of therapies (biological markers, in vivo and in vitro methods and models, including simulation, pharmacogenomics, targeting approaches and alternatives to animal testing)
Collaborative research in Health 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 infectious diseases: to confront major threats to public health (antimicrobial drug resistance, HIV/AIDS, malaria, TB, emerging epidemics) Translational research in other major diseases: (cancer, cardiovascular disease, diabetes/obesity; rare diseases; and other chronic diseases)
Collaborative research in Health 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 in Health FP7 Two other issues will be addressed across activities: Child health The health of the ageing population More information: See Specific programme: http://cordis.europa.eu/fp7/objectives.htm
Collaborative research in Health FP7 Next steps: Approval by Council and European Parliament Preparation of work programmes for years 1 & 2. Currently consulting Advisory Group & Member States (PC) Launch of first calls for proposals: Dec. 06 (tbc)
Collaborative research in Health 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 Networks of Excellence Coordination and support actions Support for frontier research (individual teams) => ERC Support for training and career development of researchers Research for the benefit of specific groups (in particular SMEs)
Health research in FP7 FP7 SUMMARY Continuity in collaborative 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 ]
European Platform Innovative Medicines Initiative
Innovative Medicines Initiative Starting point: drug development: increasing cost, duration and risk competitiveness of pharma industry affected EU concerned by loss of leadership in pharma R&D Response: the Innovative Medicines Initiative collaborative effort between EC and pharma industry (EFPIA) tackle specific issues where research is the key Public Private Partnership for implementation
15 Medicine 10 5 years Idea Creating new medicines is a high risk journey
EU Challenges Biopharmaceutical R&D European, Industry and Scientific challenges Escalating, unsustainable, drug development costs High failure rates - attrition Pharmaceutical R&D moving out of Europe Public spending on health R&D lower & stagnant compared to the US Private investments in sector (VCs, etc.) much lower than the US, and increasing risk adversity among investors Scientific breakthroughs has not given the expected results Fragmentation of research efforts basic, clinical and industry
EU challenges Biopharmaceutical R&D Identifying research needs EC challenged industry to identify the bottlenecks to pharmaceutical innovation and where R&D is the key. Industry via EFPIA s Research Directors Group responded by identifying 4 areas for R&D in agreement with key stakeholders (patients, regulators, clinical and academic researchers, etc.): Predictive safety Predictive efficacy Knowledge management Education and training and the Innovative Medicines Initiaitve (IMI) was created
Innovative Medicines Initiative A collaborative effort IMI shall foster the development a new toolbox for better prediction of safety and efficacy (toxicology tests, biomarkers, clinical trials protocols, etc.) for drug developers to reduce the risk of failure during clinical trials. IMI shall provide the infrastructure for validation of the new tools in view of rapid uptake into regulatory and industry practice. IMI shall set up knowledge platform pooling data from toxicology testing and biomarker validation - will be available to all researchers (industry and academic). IMI shall not develop new medicines or new vaccines it aims at reducing the attrition rate during development of new medicines!
Competitive Environment in the World It will be done Innovative Medicines Initiative (EFPIA-European Commission) FDA Critical Path Initiative (NIH) Safe and Innovative Medicines (PhRMA) Biomarker Initiative (PhRMA) Critical Path Institute (University of Arizona) Center for Biomedical Innovation (MIT) Toxicogenomics Project (JPMA) Proteome Factory Consortium (JPMA) Large-scale Clinical Trial Network
Innovative Medicines Initiative Implementation Public Private Partnership for implementation (I) A new structure is proposed to be set up by the EC and EFPIA to implement the Innovative Medicines Initiative (IMI) in view of optimizing the use of public and private resources. The Innovative IMI is proposed to be set up as a Joint Technology Initiative (JTI) under 7th EU Framework Programme for Research (FP7). IMI s governance structure should reflect - science driven approach - the collaborative spirit between stakeholders - rapid take up of results into practice - convergence and synergies with national and international efforts
Innovative Medicines Initiative Implementation Public Private Partnership for implementation (II) EC and EFPIA will contribute with resources for the structure (cash) and for implementing the SRA i.e. R&D and validation activities. EC will contribute with funds for academics, SMEs, etc. and the EFPIA members with resources in kind). The research will be done by: industry, SMEs, academia, clinics, patient organizations, etc. following open calls. Rules for IPR must be fair and clear to all participants from the onset. Pending favorable decision by the European Council of Ministers, IMI should become operational by 2007
Innovative Medicines Initiative Added value of European level intervention Closing the gap in the innovation system The JTI will fill a gap in the European Innovation system by providing mechanisms and networks for rapid valorisation and translation of research results into methods and technologies for industry and regulatory practice. The research results to be taken up can stem from research done at national/ec/international level and from academia as well as industry. IMI is changing the focus of industry collaboration from competitive research collaborations (to develop products) to pre-competitive collaborative research on scientific challenges.
Innovative Medicines Initiative Added value of European level intervention Stakeholders are looking for leadership and structure The JTI will provide neutral ground for the necessary collaboration between all stakeholders thereby removing the suspicions of biased collaborations that undermines collaborations today. Aiming at structuring the strongly fragmented European research base (both national and sector fragmentation will be addressed)? ERA The necessary R&D cannot be done by any of the stakeholders group alone collaboration is necessary
Innovative Medicines Initiative Added value of European level intervention Industry commitment and collaboration The role of the EC has been, and will be, instrumental for the increased collaboration between companies. The EC and Industry will facilitate the participation of all stakeholder groups in the research following open calls and peer review. Research can be done by anybody as long as it is carried out in Europe. Similar activities has started in the US and Japan. Without a strong European initiative industry will increasingly move its research elsewhere
Innovative Medicines Initiative Indicators of success Improved cooperation between academia, industry, regulators, clinicians, SMEs, patients and policy makers More rapid valorisation of scientific breakthroughs Reduced Risk of Failure in clinical trials Stimulation Biotech-SMEs and investment in sector More resources liberated for more R&D Faster drug development time Move of attrition from late to early development phases Fewer post-marketing withdrawals Fewer patients in pivotal trials Enhance the medicine pipeline Better utilisation of more efficacious medicines
Innovative Medicines Initiative Next steps Next steps: Finalise SRA following open consultation Develop governance structure legal entity, governance rules & financial engineering, IPR rules Obtain approval as part of Framework programme 7 Council decision on its creation Foreseen to become operational by 2007
Innovative Medicines Initiative The research will be done by academia, clinics, industry, SMEs, patient organizations, etc, following open calls and peer evaluation. IMI will develop a new toolbox for better prediction of safety and efficacy (toxicology tests, biomarkers, clinical trials protocols, etc.) for drug developers to reduce the risk of failure during clinical trials. IMI shall provide the infrastructure 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 available to all researchers. IMI shall not develop new medicines or new vaccines it aims at reducing the attrition rate during development of new medicines.
More Information EC funded health research: Framework Programme 6 http://cordis.europa.eu/lifescihealth The Framework Programme 7 http://cordis.europa.eu/fp7 Innovative Medicines Initiative http://ec.europa.eu/research/fp6/index_en.cfm?p=1_innomed