The Health theme in the Cooperation programme Jürgen Sautter European Commission DG RTD – Biotechnology for Health Bucharest, 14 February 2007

Cooperation Collaborative research in FP7 Thematic Priorities Health 6.1 Food, agriculture, fisheries and biotechnology 1.9 Information and communication technologies 9.1 Nanosciences, nanotechnologies, materials and new production technologies 3.5 Energy 2.3 Environment (including climate change) 1.9 Transport (including aeronautics) 4.2 Socio-economic sciences and the humanities 0.6 Security & 10. Space 2.8 Total for collaborative research €32.4 billion

Collaborative research in the Health theme Main policy drivers: Improving health of European citizens Increasing competitiveness of European health-related industries and businesses Addressing global health issues, including emerging epidemics Budget: €6.1 billion over 7 years (2007-2013)

The Health theme “Improving the health of European citizens and increasing the competitiveness and boosting the innovative capacity of European health-related industries and businesses, while addressing global health issues including emerging epidemics.” (from introduction to Work Programme 2007, p. 4.)

The Health theme “Emphasis will be put on translational research (translation of basic discoveries into clinical applications including scientific validation of experimental results), the development and validation of new therapies, methods for health promotion and prevention including promotion of child health, healthy ageing, diagnostic tools and medical technologies, as well as sustainable and efficient health care systems.” (from introduction to Work Programme 2007, p. 4.)

First calls for the Health theme Work programme published 22 Dec. 2006 for years 1 & 2 one-step proposals first deadline: 19 April 2007 €637 million second deadline: 18 September 2007 €532 million1 (+ JTI: €125 million)2 [ 1: pending approval of 2008 budget ] [ 2: pending approval by Council ] not all areas will be open in each call no Networks of Excellence 1 ERA-NET (cancer registries), with deadline 30 July 2007

Funding levels in the Health theme Warning: these will be an eligibility criteria ! min. max.* Small- or medium-scale focussed research project (FRP) €3m Large-scale integrating project (IP) €6m €12m Projects targeted at (SMEs & SICA) €3m Coordination action (CA) Support action (SA) ERA-Net (for cancer topic) €2m * except where otherwise stated in work programme.

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 early clinical trials (normally only phase I and II)

Collaborative Research Cooperation Collaborative Research THEME 1 HEALTH 3 ACTIVITIES 1st Call budget Biotechnology, generic tools and technologies for human health 138 M € Translating research for human health 472 M € Optimising the delivery of health care to European citizens

Work Programme Work Programmes updated annually One single timetable for all FP7 One single policy approach (cf FP6 SSP & NEST) Provide further detail of topics, expected impact and details of the funding scheme Contain the call ‘fiche’ – the official announcement of the call Contain information on potential future topics, as basis of further consultation One Work Programme/SP, with annexes on ICPC countries, eligibility and evaluation criteria, forms of the grant (and general activities)

Work Programme Theme 1 HEALTH Activity 1 Biotechnology, generic tools and medical technologies for human health Area 1.4 Innovative therapeutic approaches and interventions Sub-Area Immunotherapy Topic HEALTH-2007-1.4-1: Development and production of new generation antibodies

Collaborative Research Cooperation Collaborative Research ACTIVITY 1 Biotechnology, generic tools and medical technologies for human health AREAS High-throughput research Detection, diagnosis and monitoring Innovative therapeutic approaches and interventions Predicting suitability, safety and efficacy of therapies

AREA TOPICS Innovative therapeutic approaches and interventions - Immunotherapy TOPICS HEALTH-2007-1.4-1: Development and production of new generation antibodies HEALTH-2007-1.4-2: Innovative approaches for the development of vaccines for young children HEALTH-2007-1.4-3: Immunotherapy of human food allergies

AREA TOPIC Innovative therapeutic approaches and interventions - Immunotherapy TOPIC HEALTH-2007-1.4-1: Development and production of new generation antibodies. Projects should aim at developing new, efficient and safe preventive strategies and/or therapies by combining high specificity and effector function with stable production, preclinical studies, scale-up and GMP. Projects should combine academic, clinical and industrial expertise and implement a translational approach towards clinical trials. SME participation is strongly encouraged. Funding scheme: Collaborative projects (Small or medium-scale focused research projects with maximum EC contribution of €6,000,000/project).

SMEs in FP7 Aim: 15% of funding to SMEs Special topics: 40% of budget to SMEs EU contribution 50%  75% SMEs in FP7 FP6 collective responsibility  FP7 guarantee fund Research for the benefit of SMEs Competitiveness and Innovation Programme (CIP)

Proposal Submission and Evaluation in FP7 Eligibility Individual evaluation Security Scrutiny (if needed) Consensus Thresholds Applicants informed of results of expert evaluation* Panel review with hearing (optional) Ethical Review (if needed) Commission ranking invitation to submit second-stage proposal, when applicable Negotiation Commission rejection decision Consultation of programme committee (if required) Applicants informed of Commission decision Commission funding and/or rejection decision

Evaluation Criteria Criteria adapted to each funding scheme specified in the work programme (annex 2) Given in Guide for applicants Divided into three main criteria: S&T Quality (relevant to the topic of the call) Concept, objective, work-plan Implementation Individual participants and consortium as a whole Allocation of resources Impact Contribution to expected impacts listed in work programme Plans for dissemination/exploitation

Ethics in the Health theme Key issues for humans: Informed Consent / Data Protection / Privacy for animals: the 3Rs (Reduce, Replace, Refine) for human embryonic stem cells, same conditions as in FP6: “No Community support of research activities destroying human embryos, including for the procurement of stem cells. The exclusion of funding of this step of research will not prevent community funding of subsequent steps involving human embryonic stem cells.” (in addition to: scientific justification / respect of national legislation / national authorisation / Regulatory Committee)

Ethics in the Health theme new for FP7 All the information on ethics must be included in the proposal The EC services dealing with the ethical review will not request additional information from the co-ordinator after the evaluation. recommendations When a researcher is using personal data, animals, human tissue, or human in their research the following points should be addressed necessity no alternative? benefit / burden

Ethics in the Health theme major faults in proposals Researcher do not explain what happens the animals, the data, the samples, at the end of the research period. If the data/samples are retained for further research, they need to insure that the informed consent form shows this. Insurance issues for proposals dealing with humans not clarified. Informed consent forms do not tell the participant how “incidental findings” are handled. For human embryonic stem cells: the source has to be clearly identified (including informed consent/potential financial inducement).

Minimum conditions for participation General 3 independent participants from 3 different Member States (MS) or Associated countries (Ac) Natural persons may participate JRC may participate and is deemed to be from a different MS or Ac (same principles for international European interest organisations and entities established under Community law) Additional conditions can be established by the work programme (WP) or specific programme (SP) (e.g. number or type of participant, place of establishment)

Minimum conditions for participation Specific Frontier research actions (ERC): – at least 1 legal entity established in a MS or Ac Coordination and support actions and actions in favour of training and career development of researchers – minimum of 1 legal entity (except actions to coordinate) Collaborative projects addressing the participation of international cooperation partner countries (ICPC) – minimum is 4 participants of which 2 in MS or Ac and 2 in ICPC countries unless otherwise foreseen in work programme. Participation of international organisations and participants from third countries possible if in addition to minima

Community financial contribution Eligibility for Funding: 1. Legal entities from MS and Ac or created under Community law (and JRC) 2. International European interest organisations 3. Legal entities established in International Cooperation Partner Countries (ICPC) and 4. International organisations, third countries other than ICPC, if provided for in SP or WP; or essential for carrying out action; or provision for funding is provided for in a bilateral agreement between Community and the third country.

Director – Dr. Octavi Quintana-Trias Contacts Director – Dr. Octavi Quintana-Trias Medical and Public Health Research unit – Dr. Manuel Hallen manuel.hallen@ec.europa.eu Cancer – Dr. Maria Vidal maria-jose.vidal-ragout@ec.europa.eu Public Health sector – Dr. Kevin McCarthy kevin.mccarthy@ec.europa.eu Infectious Diseases unit – Dr. Bernard Mulligan bernard.mulligan@ec.europa.eu Emerging Infectious diseases sector – Dr. Anna Lönnroth anna.lonnroth@ec.europa.eu Genomics and Systems Biology unit – Dr. Jacques Remacle jacques.remacle@ec.europa.eu Health Biotechnology unit – Dr. Arnd Hoeveler arnd.hoeveler@ec.europa.eu Coordination unit – Stéphane Hogan stephane.hogan@ec.europa.eu

Contacts Innovative Medicines Initiative (IMI) - Dr. Irene Norstedt Tel. +32 2 296 9527, Email: irene.norstedt@ec.europa.eu SME participation - Dr. Ludovica Serafini Tel. +32 2 295 6759, Email: ludovica.serafini@ec.europa.eu International Cooperation - Dr. Indridi Benediktsson Tel. +32 2 299 3137, Email: indridi.benediktsson@ec.europa.eu

Information 7th Framework Programme http://cordis.europa.eu/fp7 FP7 Fact sheets http://ec.europa.eu/research/fp7/understanding/index.html Inquiries http://ec.europa.eu/research/index.cfm?pg=enquiries&cat=x&lg=en IPR Helpdesk http://www.ipr-helpdesk.org/index.html RTD info magazine http://europa.eu.int/comm/research/rtdinfo/ SMEs go Lifesciences http://www.smesgolifesciences.be/common/home.asp ERC http://ec.europa.eu/erc/index_en.cfm Innovative Medicines Initiative (IMI) http://ec.europa.eu/research/fp6/index_en.cfm?p=1_innomed Experts http://cordis.europa.eu/research_openings/ NCP http://cordis.europa.eu/fp7/get-support_en.html

Thank you for your attention ! juergen.sautter@ec.europa.eu