Building Europe Knowledge: Towards the Seventh Framework Programme

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

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Collaborative researchin 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)

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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.)
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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.)
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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

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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.

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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)

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Cooperation Collaborative Research
THEME 1
HEALTH
1st Call budget
3 ACTIVITIES
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
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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)

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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
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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

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AREA

• 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

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AREA

• 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).

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

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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 FP6No 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)

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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

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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).

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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)

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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

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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.

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Contacts
Director Dr. Octavi Quintana-Trias Medical and
Public Health Research unit Dr. Manuel
Hallen manuel.hallen_at_ec.europa.eu Cancer Dr.
Maria Vidal maria-jose.vidal-ragout_at_ec.europa.eu
Public Health sector Dr. Kevin
McCarthy kevin.mccarthy_at_ec.europa.eu Infectious
Diseases unit Dr. Bernard Mulligan bernard.mull
igan_at_ec.europa.eu Emerging Infectious diseases
sector Dr. Anna Lönnroth anna.lonnroth_at_ec.europ
a.eu Genomics and Systems Biology unit Dr.
Jacques Remacle jacques.remacle_at_ec.europa.eu Heal
th Biotechnology unit Dr. Arnd
Hoeveler arnd.hoeveler_at_ec.europa.eu Coordination
unit Stéphane Hogan stephane.hogan_at_ec.europa.
eu
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Contacts
Innovative Medicines Initiative (IMI) - Dr. Irene
NorstedtTel. 32 2 296 9527, Email
irene.norstedt_at_ec.europa.eu SME participation -
Dr. Ludovica SerafiniTel. 32 2 295 6759, Email
ludovica.serafini_at_ec.europa.eu International
Cooperation - Dr. Indridi BenediktssonTel. 32 2
299 3137, Email indridi.benediktsson_at_ec.europa.eu
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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
  ?pgenquiriescatxlgen
• IPR Helpdesk http//www.ipr-helpdesk.org/index.h
  tml
• RTD info magazine http//europa.eu.int/comm/rese
  arch/rtdinfo/
• SMEs go Lifesciences http//www.smesgolifescienc
  es.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?p1_
  innomed
• Experts http//cordis.europa.eu/research_opening
  s/
• NCP http//cordis.europa.eu/fp7/get-support_en.htm
  l

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Thank you for your attention !
juergen.sautter_at_ec.europa.eu