Jürgen Sautter

European Commission

DG RTD – Biotechnology for Health

Bucharest, 14 February 2007

The Health themein the Cooperation programme

Thematic Priorities

1. Health 6.1

2. Food, agriculture, fisheries and biotechnology 1.9

3. Information and communication technologies 9.1

4. Nanosciences, nanotechnologies, materials and new production technologies 3.5

5. Energy 2.3

6. Environment (including climate change) 1.9

7. Transport (including aeronautics) 4.2

8. Socio-economic sciences and the humanities 0.6

9. Security & 10. Space 2.8

Total for collaborative research €32.4 billion

Cooperation Collaborative research in FP7

Cooperation Collaborative research 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

Budget:

€6.1 billion over 7 years (2007-2013)

Collaborative researchin the Health theme

Collaborative researchin 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 themeThe 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.)

The Health themeThe 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

First calls for the Health theme

First calls for 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.

Funding levels in the Health theme

Funding levels 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)

Scope of research in the Health Theme

Scope of research in the Health Theme

Biotechnology, generic tools andtechnologies for human health

Translating research forhuman health

Optimising the delivery of healthcare to European citizens

3 ACTIVITIES

THEME 1

CooperationCollaborative Research

HEALTH

138 M €

472 M €

1st Call budget

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 ProgrammeWork Programme

Work ProgrammeWork Programme

Activity 1Biotechnology, generic tools

and medical technologiesfor human health

Area 1.4Innovative therapeutic approaches

and interventions

TopicHEALTH-2007-1.4-1: Development and production of new generation

antibodies

Sub-AreaImmunotherapy

Theme 1 HEALTH

Biotechnology, generic tools andmedical technologies for human health

• High-throughput research • Detection, diagnosis and monitoring• Innovative therapeutic approaches and interventions • Predicting suitability, safety and efficacy of therapies

AREAS

ACTIVITY 1

CooperationCollaborative Research

• Innovative therapeutic approaches and interventions

- Immunotherapy

AREA

• 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

TOPICS

• Innovative therapeutic approaches and interventions - Immunotherapy

AREA

• 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).

TOPIC

FP6 collective responsibility FP7 guarantee fund

Aim: 15% of funding to SMEs

EU contribution50% 75%

Special topics:40% of budget to SMEs

Research for thebenefit of SMEs

Competitiveness and Innovation Programme (CIP)

SMEs in FP7 SMEs in FP7

Proposal

Individual evaluation

Consensus

Panel review

Consultation of programme committee (if required)

Commission funding and/or rejection decision

with hearing(optional)

Thresholds

Eligibility

Negotiation

Commission ranking

Commission rejection decision

Ethical Review

(if needed)

Security Scrutiny

(if needed)

Applicants informed of results of expert evaluation*

• invitation to submit second-stage

proposal, when applicable

Applicants informed of Commission decision

Proposal Submission and

Evaluation in FP7

Proposal Submission and

Evaluation in FP7

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

Evaluation CriteriaEvaluation Criteria

• 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

Ethics in the Health theme

• new for FP7

All the information on ethics must be included in the proposalThe 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

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).

Ethics in the Health theme

Ethics in the Health theme

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

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

Minimum conditions for participation

Minimum conditions for participation

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.

Community financial contribution

Community financial contribution

ContactsContacts

Director – Dr. Octavi Quintana-Trias

Medical and Public Health Research unit – Dr. Manuel Hallenmanuel.hallen@ec.europa.eu

Cancer – Dr. Maria Vidalmaria-jose.vidal-ragout@ec.europa.eu

Public Health sector – Dr. Kevin McCarthykevin.mccarthy@ec.europa.eu

Infectious Diseases unit – Dr. Bernard Mulliganbernard.mulligan@ec.europa.eu

Emerging Infectious diseases sector – Dr. Anna Lönnrothanna.lonnroth@ec.europa.eu

Genomics and Systems Biology unit – Dr. Jacques Remaclejacques.remacle@ec.europa.eu

Health Biotechnology unit – Dr. Arnd Hoevelerarnd.hoeveler@ec.europa.eu

Coordination unit – Stéphane Hogan stephane.hogan@ec.europa.eu

ContactsContacts

Innovative Medicines Initiative (IMI) - Dr. Irene NorstedtTel. +32 2 296 9527, Email: irene.norstedt@ec.europa.eu

SME participation - Dr. Ludovica SerafiniTel. +32 2 295 6759, Email: ludovica.serafini@ec.europa.eu

International Cooperation - Dr. Indridi BenediktssonTel. +32 2 299 3137, Email: indridi.benediktsson@ec.europa.eu

• 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

InformationInformation

juergen.sautter@ec.europa.eu

Thank you for your attention !Thank you for your attention !