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

2. 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

3. 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 ( )

4. 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.)

5. 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.)

6. First calls for the Health theme
Work programme published 22 Dec for years 1 & 2
one-step proposals
first deadline: 19 April €637 million
second deadline: 18 September €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

7. 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.

8. 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)

9. 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

10. 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)

11. 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 : Development and production of new generation antibodies

12. 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

13. AREA TOPICS Innovative therapeutic approaches and interventions
- Immunotherapy
TOPICS
HEALTH : Development and production of new generation antibodies
HEALTH : Innovative approaches for the development of vaccines for young children
HEALTH : Immunotherapy of human food allergies

14. AREA TOPIC Innovative therapeutic approaches and interventions
- Immunotherapy
TOPIC
HEALTH : 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).

15. 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)

16. 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

17. 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

18. 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)

19. 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

20. 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).

21. 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)

22. 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

23. 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.

24. Director – Dr. Octavi Quintana-Trias
Contacts
Director – Dr. Octavi Quintana-Trias
Medical and Public Health Research unit – Dr. Manuel Hallen
Cancer – Dr. Maria Vidal
Public Health sector – Dr. Kevin McCarthy
Infectious Diseases unit – Dr. Bernard Mulligan
Emerging Infectious diseases sector – Dr. Anna Lönnroth
Genomics and Systems Biology unit – Dr. Jacques Remacle
Health Biotechnology unit – Dr. Arnd Hoeveler
Coordination unit – Stéphane Hogan

25. Contacts
Innovative Medicines Initiative (IMI) - Dr. Irene Norstedt Tel ,
SME participation - Dr. Ludovica Serafini Tel ,
International Cooperation - Dr. Indridi Benediktsson Tel ,

26. Information 7th Framework Programme http://cordis.europa.eu/fp7
FP7 Fact sheets
Inquiries
IPR Helpdesk
RTD info magazine
SMEs go Lifesciences
ERC
Innovative Medicines Initiative (IMI)
Experts
NCP

27. Thank you for your attention !