Fp7 health2012 calls

Orientations for
Work Programme 2012

Dr. Manuel ROMARÍS
Coordination of Joint Programming Initiatives
Health Directorate
DG Research & Innovation
European Commission

Please refer to Work Programme 2012 and call 2011 published 20 July 2011
Health Theme 2012 – July texts
1

The 7th Framework programme (FP7)
•  Introduction & Basic principles
•  2012 Work programme
•  Key features
•  Priorities
•  Conditions
•  Topics

Please refer to Work Programme 2012 and call texts published 20 July 2011
2

EU research policy

Why ?
  to improve quality of life and
  to improve competiveness of Europe
through collaboration
How ?
  by pooling resources (funds for Framework Programme)
  by coordinating national research programmes

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 (2007-2013)

4

Collaborative research
across borders and other barriers
  between countries:
  At least 3 partners from the 27 EU Member States:
Austria, Belgium, Bulgaria, Czech Rep., Cyprus, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, the United Kingdom.
  orthe 13 Associated Countries:
Albania, Bosnia-Herzegovina, Croatia, FYROM, Iceland, Israel,
Liechtenstein, Montenegro, Norway, Serbia, Switzerland, Turkey
and the Faroe Islands.
  Inaddition, researchers from anywhere in the world can participate:
e.g.: Australia, Brazil, Canada, China, Egypt, India, Japan, Korea,
Russia, South-Africa, USA, …
and in many cases, can be funded.
5

Drivers for FP7
from Innovation Union policy
  Innovation-driven approach
  Focus on SMEs through genuine academia-industry collaborations

  Challenge-driven approach, focussed on key challenges
  Support implementation of European Innovation
Partnerships, such as “Active and healthy ageing”
  Stronger socio-economic impact - innovation dimension
  with more attention on exploitation phase
  Balance upstream research and activities closer to market
in order to achieve short and medium-term impact

6

Features of FP7 Health
in 2012 & 2013
  fewer, more prominent priorities
i.e. more focus on fewer areas
  fewer, broader topics, two-stage submission-evaluation
  greater emphasis on innovation
  especially through SME-targeted topics
  and continued support of clinical trials
  emphasis on flexibility for consortium, duration & budget
  international cooperation with more strategic focus

7

Features of FP7 Health
in 2012
Main features:
  Indicative budget for 2012 calls: €650m (tbc)
  2 “Health” calls:
  FP7-HEALTH-2012-INNOVATION-1 (34 topics, €540m)
  FP7-HEALTH-2012-INNOVATION-2 ( 3 topics, €108m)
  FP7-2012-ERA-NET call (1 topic, €2m)

  Two-stage submission for ALL topics (except the ERA-NET)
  Several projects funded for MOST topics (29/38)
- exceptions: 7 CSA, 1.4-3 (Australia) & 2.1.1-1-C (IP)
  14 SME-targeted topics (including special call)
and 3 Industry-targeted topics (including SMEs)

8

Priorities of FP7 Health
in 2012
Main priorities:
  Ageing will be the 1st priority in 2012 – budget ~€220m
(incl. med. tech, biomarkers, clinical trials, co-morbidity, health services)
  Medical technologies – €160m
  Rare diseases – ~€100m
  SME targeted actions:
  3 topics: ≥50% EC contrib. to SMEs: €108m
Total: 14 topics (out of 38 topics) – €336m (~50%)

NB: total budget: €650m (some overlap between priorities & budgets)

9

“SMEs for Innovation”
INNOV-2 call

Aim: to stimulate innovation via enhanced SME participation
3 broad topics with a focus on medical technologies:
1.4-2 Medical technology for transplantation and bio-artificial organs
2.3.0-1 Diagnostics for infectious diseases (in humans)
2.4.5-1 Technological approaches to combating sensory impairment

Note: SME-targeted topics must include SMEs and these must have
leading roles. However, these topics are also open to other entities.

10

“SMEs for Innovation”
INNOV-2 call
Pilot initiative to stimulate innovation via enhanced SME participation
Special conditions:
–  3-5 partners, min. 50% of required EU funding for SME(s)
–  Restricted to entities from EU and Associated Countries
–  Maximum 3 years
–  The SME must have a leading role in the project
–  2-stage submission & evaluation; higher threshold for “Impact”
–  Simplified application process: short project description
–  Accelerated procedures for submission, evaluation & negotiation
i.e.: earlier deadlines for 1st and 2nd stage submission.
–  First deadline: 27 September 2011* (INNOV-1 call: 4 October)*
[ *: to be confirmed in calls published on CORDIS in July 2011. ]

11

General conditions 2012

  Any research organisation can participate, including larger companies, as
well as service-providers.
  However, the funding levels are different:
  For academia & SMEs: 75% of research costs
  (+ 100% management & training & eligible IP costs)
  For larger companies: 50% of research costs
  (+ 100% management & training & eligible IP costs)

  What is an SME ? (for the EC: 1 + 2 + 3)
1. less than 250 employees
2. annual turnover ≤€50 million OR balance sheet total ≤€43 million
3. must be autonomous*
* check SME status: http://ec.europa.eu/research/sme-techweb

12

Clinical Trial topics
Aim:
•  Translating research into clinical practice
•  Different types of clinical trials,
e.g. investigator-driven, observational, …

Scope:
•  specified in each topic, phases covered are decided by the participants,
and may be depend on the maximum possible allocated budget.
•  expected to be mostly phase I, II, and IV - for details see specific topics
and special instructions for clinical trials on page 9 of orientation paper.

Note:
•  Importance of ethics issues
•  Patient involvement
•  Methodology & Statistics
13

Clinical Trial topics

Guiding principles:
•  EC contribution: max. € 6m/project for all but one topic
•  Number of partners: as appropriate (minimum 3 from 3 diff. MS/AC)
•  Duration of projects: no minimum or maximum duration
- Maximum EU contribution needs to be considered
- Evolution of consortium (e.g. including of additional clinical centres)
possible, but no additional EU contribution
•  Outsourcing/subcontracting possible but…
•  Patient representation in consortium is highly encouraged
•  Ethical and regulatory framework (EU and national)
•  Importance of solid statistical basis

See 2012 Work Programme, introduction (p. 9-10)

14

Successful Proposals
for Clinical Trial Projects
Clinical trial methodology must be properly addressed:
•  Control, number of patients, inclusion/exclusion criteria, etc.
•  Statistical plan
•  Strategy and status of obtaining ethical and regulatory clearance
•  Preliminary data and explanations how the treatment worked needs to
be convincingly described also in the proposal, a YES from the regulators
as explanation in the proposal may not be sufficient for the evaluators
•  If applicable, sourcing of the medicinal product, device, etc.

Clear indication needs to be given already at the first stage;
full proposals must contain all relevant information in detail.

15

Funding schemes
for FP7 Health in 2012
Funding scheme Ceiling for EU Number of % budget
contribution topics
Large-scale integrating €12m 4 ~ 16.5%
project (CP-IP)
Small or medium scale €3m / €6m 24 ~ 78%
focused project (CP-FP)
Coordinating or supporting various 10 ~ 2.5%
action (CSA)
Other actions* various – ~ 2%
Total 38 100%

* including HFSPO, EDCTP, study on emerging areas for research/innovation,
study on impact of ethics review on health research, production of videos.

16

Outcome of 2011 calls

Single-stage call: Two-stage call:
  35/166 proposals short-listed   91/220 proposals short-listed
  Success rate: 21%   Success rate: 41%
  €175m awarded   €495m awarded

Overall
Average grant for research projects: >€5.5m
Clinical trials (8 topics):
  26 projects; €152m awarded (av. €5.85m/project)

SME-targeted topics (10):
  34 projects; €221m awarded (av. €6.5m/project)
  15 projects led by SMEs
17

Basic principles for calls & evaluation
Peer review
Equality of treatment
Transparency

Aim: to fund the best R&D proposals

18

Submission & evaluation
Basic principles:
  Annual calls for proposals (in two stages)
  Evaluation by panels of independent experts
overseen by Independent Observers
  3 criteria:
  Science & Technology excellence
  Implementation & Management
  Potential Impact

  Feedback: Evaluation Summary Reports (ESRs)

19

Calls
FP7-HEALTH-2012-Innovation-1
FP7-HEALTH-2012-Innovation-2
Proposal scoring:
Each criterion is scored 0-5
•  half-scores allowed
•  Scores must pass thresholds if a proposal is to be considered for
funding
•  Thresholds apply to individual criteria…

stage 1 stage2

S&T Impact total S&T Implementation Impact total

Innovation 4/5 3/5 8/10 4/5 3/5 3/5 12/15
-1
Innovation 4/5 4/5 8/10 4/5 3/5 4/5 12/15
-2
20

Key messages
for potentials applicants
Opportunity & Flexibility
Opportunity:
  for ambitious, well-funded R&D projects
  for genuine collaborations (esp. academia – industry), across borders

Flexibility at submission stage:
  Broader topics: more “bottom-up”

}
  The size of consortium (beyond min. 3)*
  The EU contribution requested** is for applicants to decide
  The duration of the project***

(* with the exception of 3-5 max. for the “SMEs for innovation” call,
**within ceiling, ***some exceptions)

21

Advice for applicants

  Analyse the work programme carefully
  Apply if you see a clear opportunity that fits your strategy
  Chose your partners carefully
  Do not view EC grants only as a source of cash, but as a
means to access know-how & resources from partners.
  Managing the project yourself is a major task – it needs
to be properly planned & resourced – but you have control.
  Use support structures:
National Contact Points (NCPs), Fit-for-Health, …

22

23

Thank you

Contacts & Information:
FP7 Health web site: http://cordis.europa.eu/fp7/health
Participant portal: http://ec.europa.eu/research/participants/portal
To register as an Expert: https://cordis.europa.eu/emmfp7/
FitForHealth: www.fitforhealth.eu
EC projects database: www.healthcompetence.eu

National Contact Points (NCP):
http://cordis.europa.eu/fp7/health/ncp_en.html
24

The Health Theme
Three main activities (“pillars”)

Activity 1: Activity 2: Activity 3:
Biotechnology, Translating Optimising The
generic tools research for the delivery Innovative
& technologies of health care Medicines
human health
Initiative
for health

cross-cutting issues: international cooperation, SMEs,
child health, ageing populations, gender-related health issues

Activity 4: Support actions & response to policy needs

25

Orientations for 2012 WP

Activity 1
Biotechnology, generic tools and medical
technologies for human health
YOU MUST REFER TO THE FINAL PUBLISHED CALL FOR PROPOSALS
for confirmation of deadlines, conditions & final topic descriptions.

26

Activity 1
Biotech, tools & technologies

1.2 - Detection, diagnosis and monitoring

1.2-1 Development of technologies with a view to patient
group stratification for personalised medicine applications.

Funding scheme: CP-FP, SME-topic (min. 30% for SMEs)
max. €6m/project. >10 projects to be funded

27

Activity 1

1.4 - Innovative therapeutic approaches & interventions
1.4-1 Innovative approaches to solid organ transplantation.
max. €6m/project, ~3 projects to be funded

1.4-2 Medical technology for transplantation and
bioartificial organs. [ “SMEs for Innovation” call ]

3-5 partners, max. €6m/project. 5-7 projects to be funded

28

Activity 1
1.4 - Innovative therapeutic approaches & interventions
1.4-3 Innovative strategies for translation of stem cell based
therapies in regenerative medicine (EU-Australia cooperation)
max €6m/project, max 1 project to be funded

1.4-4 Targeted nucleic acid delivery as an innovative
therapeutic or prophylactic approach.
Funding scheme: CP-FP, Industry-topic (min. 30% for industry,
including SMEs); max €6m/project, ~3 projects to be funded

29


Activity 2
Translating research for human health

30

Area 2.1 – Integrating
biological data & processes
2.1.1 – Large-scale data gathering
2.1.1.1-A Support for international rare diseases research.
Funding scheme: SA, max. €2m/project, max. 1 project

2.1.1.1-B Clinical utility of -omics for better diagnosis of
rare diseases.
Funding scheme: CP-IP, SME-topic (min. 30% for SMEs); max.
€12m/project, max. 2 projects

2.1.1.1-C Databases, biobanks rare diseases research.
Funding scheme: CP-IP, max. €12m/project, max. 1 project

31

biological data & processes
2.1.1 – Large-scale data gathering
2.1.1-2 Validation of -omics based biomarkers for diseases
affecting the elderly.
Funding scheme: CP-IP, SME-topic (min. 30% for SMEs)
max. €12m/project, up to ~2-3 projects

2.1.1-3 Statistical methods for collection and analysis of
-omics data.
max. €6m/project, ~1 project to be funded

32

biological data and processes
2.1.2 – Systems Biology
2.1.2-1 Systems medicine: SME-driven research applying sys-
tems biology approaches to address medical & clinical needs
max. €3m/project, up to 6-8 projects

2.1.2-2 Systems medicine: applying systems biology
approaches for understanding multifactorial human diseases
and their co-morbidities.
Funding scheme: IP, max. €12m/project, up to ~3-4 projects

2.1.2-3 Preparing for the future research and innovation
activities in systems medicine.
Funding scheme: CA, max. €3m/project, max. 1 project funded
33

Area 2.2 – Brain, dev. & ageing
2.2.2 – Human development and ageing
2.2.2-1 Integrative systems biology and comparative
genomics for studying human ageing and/or most common
age-related diseases.
max. €6m/project. Up to ~3 projects

2.2.2-2 Investigator-driven clinical trials for optimisation of
management of elderly patients with multiple diseases.

34

Area 2.3 – Infectious diseases
2.3 – Translational research in major infectious diseases
Covers major HIV/AIDS, malaria, tuberculosis, hepatitis, neglected
infectious diseases, emerging epidemics, fungal pathogens, as well as
anti-microbial drug resistance.

2.3.0-1 Diagnostics for infectious diseases in humans
[ “SMEs for Innovation” call ]
3-5 partners, max. €6m/project. Up to ~6 projects

2.3.0-2 ERA-NET on infectious diseases [ ERA-NET call ]
Funding scheme: CA, max. €2m/project, max. 1 project

35

2.3.2 – HIV/AIDS, malaria and tuberculosis
2.3.2-1 Co-infection of HIV/AIDS, malaria, tuberculosis and/
or hepatitis.
Funding scheme: CP-FP, max. €6m/project, up to 2-3 projects

2.3.2-2 Co-morbidity between infectious diseases and non-
communicable diseases.

36

2.3.2 – HIV/AIDS, malaria and tuberculosis

2.3.2-3 Prevention and treatment for HIV/AIDS, malaria and
tuberculosis.
Small consortia encouraged (3-5 partners), duration 1-3 years.
max. €6m/project, up to 2-3 projects

2.3.2-4 Low-cost interventions for disease control in resource
poor settings.

Action to support preparation of 2nd phase of EDCTP
Funding scheme: CSA, max. €10m. (named beneficiary)

37

Area 2.4 – Major diseases
2.4.3 – Diabetes and obesity

2.4.3-1 Innovative approaches to manage diabetes.
max. €6m/project. Up to 3-4 projects

2.4.3-2 Investigator-driven clinical trials for type 1 diabetes
research.

38

2.4.4 – Rare diseases

2.4.4-1 Preclinical and/or clinical development of substances
with a clear potential as orphan drugs.
Funding scheme: CP-FP, Industry-topic (min. 30% for industry,
including SMEs); max €6m/project, up to ~10 projects

2.4.4-2 Observational trials in rare diseases.
Funding scheme: CP-FP, max. €3m/project, ~3-4 projects

2.4.4-3 Best practice and knowledge sharing in the clinical
management of rare diseases.
Funding scheme: CA, max. €2m/project, max. 1 project

39

2.4.5 – Chronic diseases

2.4.5-1 Technological approaches to combating sensory
impairments. [ “SMEs for Innovation” call ]
3-5 partners, max. €6m/project. Up to ~5-6 projects

2.4.5-2 Biomarkers and diagnostics for chronic inflammatory
diseases of the joints and/or digestive system.
Funding scheme: CP-FP, SME-topic (min. 15% for SME)

40


Activity 3
Optimising the delivery of healthcare

41

Optimising delivery of healthcare
3.2 – Quality, efficiency and solidarity of healthcare systems
3.2-1 Improving the organisation of health service delivery.
Funding scheme: CP-FP, max. €3m/project, up to ~7-8 projects

3.2-2 New methodologies for health technology assessment

3.2-3 Social innovation for active and healthy ageing

42

Optimising delivery of healthcare
3.4 – International public health & health systems
3.4-1 Research on Health systems and services in low/middle
income countries.
•  Projects should generally be 5 years in duration.
•  Min. 6 different ICPC partners & 2 EU/AC partners from different countries.

Funding scheme: CP-FP (SICA), max. €6m/project, ~3 projects

43


Activity 4
Other actions across the theme

44

Activity 4
Actions across the Health theme
4.1 – CSAs across the theme
4.1-1 Network to encourage knowledge transfer activity in
FP-funded health research (especially in academic and
governmental organisations).
Funding scheme: CA, max. €2m/project, up to 1 project.

4.1-2 Training actions linked to intellectual property rights
management and knowledge transfer.
Funding scheme: CA, max. €2m/project, up to 1 project

4.1-3 Support for presidency events. Organisation of
supporting actions and events related to the EU Presidency.
Funding scheme: SA, max. €0.1m/project, up to 2-3 projects

45

Activity 4
Actions across the Health theme
4.1 – CSAs across the theme
4.1-4 Communicating the benefits of European research
to the general public.
Funding scheme: CA, max. €1m/project, up to 1-2 projects

4.1-5 Preparing the future for health research & innovation
Funding scheme: SA, max. €0.5m/project, up to 1-2 projects

4.1-6 Setting health-related development goals beyond 2015
Funding scheme: CA, max. €2m/project, up to 1 project

46

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