Current Funding gOpportunities in FP7 Health

d S t A il bland Support Available

Kay Duggan-Walls NCP for Health in FP7Dublin Centre for Clinical Research 26th July 2010Dublin Centre for Clinical Research, 26th July 2010

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FP7 Health• FP7 is the EU’s largest instrument for funding

FP7 Healthg g

collaborative research• The Health theme has the second largest

funding stream in Cooperation: € 6.1 b• Both basic and applied research can be

supported• This includes biotechnology, translational

h i t ifi di d li i lresearch into specific diseases and clinical trials (normally only phase I and II)

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FP7 Health areas topic specific!

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FP7 Health areas – topic specific!

pillar 1:Biotechnology, generic tools

pillar 2:Translating research for

pillar 3:Optimising the delivery g

& technologies for health

human health of health care

cross-cutting issues: child health, the health of ageing populationgender-related health issues

Activity (pillar) 4: Other actions across the theme

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Trends in Health theme

The emphasis of the health theme is:p• Translational research – translation of basic

discoveries in clinical applicationsppClinical research and clinical trials are major tools in funded projectsIncreased participation of SMEs

• Development and validation of new therapiesp p• Methods for health promotion and prevention

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Clinical TrialsC ca a s

• The work programme lists several topics forThe work programme lists several topics for clinical trials – most are for investigator-driven clinical trials

• Several projects to be funded in each topic - 30-40 proposals to be funded- €150-200million

• Aim to strengthen clinical research in Europe in a number of areas with unmet medical needs

• Focus on treatment trials• Most clinical research areas will require only a

short EoI first application – worth applying!5

Clinical Trial TopicsC ca a op cs• Regenerative medicine clinical trials

Investigator-driven Clinical Trials• Clinical trials for childhood-onset neurodegenerative diseases

Clinical trials for therapeutic interventions in elderly populations• Clinical trials for therapeutic interventions in elderly populations• Clinical trials of off-patent antibiotics• Treatment trials for rare cancers• Clinical trials for the management of cardiovascular diseases• Clinical trials to reduce diabetes complications

Cli i l i l ff di i f hild (Si l )• Clinical trials on off-patent medicines for children (Single-stage)

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Pillar 1: Biotechnologya otec o ogy

1 1 Hi h th h t h1.1 High-throughput research1.4 Innovative therapeutic approaches and

interventions

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Pillar 2: Translational Research

2.1 Large-scale data gathering2.2 Brain and brain-related diseases/ Human

development and ageing2.3 Trans. Research in major infectious

diseases: Antimicrobial Drug Resistance, N d i id iNew and re-emerging epidemics

2.4 Trans. Research in other major diseases: Cancer Cardio asc lar Diseases DiabetesCancer, Cardiovascular Diseases, Diabetes and obesity

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Pillar 3: Public Healtha 3 ub c ea t

3.3 Health promotion3.4 International Public Health and Health

Systems

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Pillar 4: Other actions a Ot e act o sacross the theme

4.1 Coordination and Support Actions4.2 Responding to EU policy needs

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What countries can participate?

• EU 27 A i t d C t i (H S/T ti• Associated Countries (Have S/T cooperation agreements) e.g. Switzerland, Israel, Norway, Iceland, Liechtenstein,Turkey, Croatia, the Former Yugoslav Republic of Macedonia Serbia Albania andRepublic of Macedonia, Serbia, Albania and Montenegro, Bosnia-Herzegovina.

• ICPC International Cooperation Partner Countriese g African Asian Western Balkanse.g. African, Asian, Western Balkans

• Third Countries e.g. US, Canada, Australia NB Third Countries participation of organisations or individuals established in countries that are not Member States,established in countries that are not Member States, candidates or associated should also be justified in terms of the enhanced contribution to the objectives of FP7

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Funding schemes in the Health themein the Health theme

Funding schemes upper limits min. partnersg pp p

Large-scale integrating project (CP-IP)* €12m ≥3

Network of Excellence (NoE) €12m ≥3

Small- or medium-scale focussed research project (CP-FP) €3m or €6m ≥3

Coordination action (CA)** €2 0m ≥3Coordination action (CA)** €2.0m ≥3

Support action (SA)** €0.5m ≥1

* for CP-IPs there is a lower limit to the requested EC grant:* for CP IPs there is a lower limit to the requested EC grant: €6m.** for CAs and SAs there are some exceptions to the upper li itlimit.

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Minimum requirementsq

P l tProposals must • Be within scope of topic in published work

programmeprogramme• Have minimum number of eligible,

independent participants/ countries from EUindependent participants/ countries from EU MS/AC or as set out in the Work Programme

• Observe maximum budget for the topic you• Observe maximum budget for the topic you are applying for (including any specific budget for SMEs)g )

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FP7 Health topicsea t top cs• FP7 Health is not bottom-up!• Proposals you submit must fit within a

published topic in annual workpublished topic in annual work programme

• Topics change each year• Topics change each year• General area headings (e.g. 2.4.1

Cancer) do not change each yearCancer) do not change each year

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Call in FP7 HealthCa ea tNow Open

Annual Call for proposals wasAnnual Call for proposals was published on 20th July

http://cordis.europa.eu/fp7/dc/index.cfm?fuseaction=UserSite.FP7CallsPage

DeadlinesSingle Stage 2011 Call10 Nov 2010 at 1700hrs Brussels local time10 Nov 2010 at 1700hrs Brussels local time

Two Stage 2011 Call13 Oct 2010 Stage 1 - at 1700hrs Brussels local time11 F b 2011 St 2 t 1700h B l l l ti (i di ti d t t b11 Feb 2011 Stage 2 - at 1700hrs Brussels local time (indicative date - to be

confirmed)

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1.4 Innovative Therapeutic Approaches and interventions

HEALTH.2011.1.4-4: High impact project for better immunisation. FP7-HEALTH-2011-single-stage.The aim is to apply advanced technologies to study human immune responses

under conditions of health and disease. New knowledge generated by the project should be used to develop informed and rational strategies andproject should be used to develop informed and rational strategies and technologies with wide potential applications for immune stimulation, or modulation of immune responses, depending on the pathological condition. Research should be targeted to prevention or cure of infections but aspects of age-dependent immune senescence or gender specific responses may also be addressed, to understand and inform targeted immune modulation. Major research questions, such as, molecular signatures of immune protection the relationship between systemic andsignatures of immune protection, the relationship between systemic and local immune responses, and the interplay between immune adaptive and innate mechanisms, should be integrated and research capacities be harnessed to develop immunisation strategies and vaccines designed to elicit the specifically desired human immune responses.

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High impact project for better immunisation continued

Dedicated project components should focus on:p j p- adjuvants and immune modulators, platforms and delivery technologies with improved

effectiveness and safety;- routes of immunisation (systemic, local, mucosal, transdermal);- efficacy- and longevity-enhancing immunisation schemes (prime boost approaches age-efficacy and longevity enhancing immunisation schemes (prime boost approaches, agerelated aspects of immune responses, specific target groups);- rational design of therapeutic vaccines.Involvement of research intensive SMEs is required.Funding scheme: Collaborative Project (large scale integrating project)Funding scheme: Collaborative Project (large-scale integrating project)EU contribution per project: Maximum €30.000.000Only up to one proposal can be selected.Expected impact: The project should lead to new interventions modulating the humanp p p j gimmune responses to prevent, alleviate or cure disease. It should structure this area ofresearch in such a way that it favours enhanced exploitation by European industries. Longer term sustainability of the programme could also be achieved. To this end elaboration of appropriate interfaces for co funding by other agencies including Member State andappropriate interfaces for co-funding by other agencies, including Member State and Associated State national programmes could be a major outcome.

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1.4 Innovative Therapeutic Approaches d I t tiand Interventions

HEALTH.2011.1.4-5: New therapeutic approaches in chronic inflammatory and autoimmune diseases. FP7-HEALTH-2011-single-stage.

Projects should aim to develop innovative strategies to therapy based on various approaches, such as small molecules, antibodies, peptides or cells, where understanding of mechanism of action has already been established. Proposals should include validation in relevant pre-clinical models and, if possible, early assessment in humans. The selected project should capitalise on the strong experience available in Brazil and Europe in the fields of immunology and immunopathology. Cooperation with related national and international projects in Brazil should be ensured and a part of the budget should be set aside for this cooperation and for training activities. Industrial participation is required and this will be considered in the evaluation of the proposal.

Complementary call by Brazilian authorities expectedFunding scheme: Collaborative Project (small or medium-scale focused research project).EU contribution per project: max €3 000 000EU contribution per project: max €3 000 000.One or more proposals can be selected.Expected impact: The main impact of this work should be the extent to which new,

innovative therapeutic approaches for these diseases can be tested in relevant preclinical models or in humans. Projects are expected to lead to more links and to closer cooperation between Member States, Associated Countries and Brazil than is the case for traditional FP projects.

NB 15% or more of the EU contribution is to go to industry20

2.2.1 Brain and Brain-related diseases

Health.2011.2.2.1-1Investigator-driven clinical trials for childhood-onset neurodegenerative diseases FP7 HEALTH 2011 two stageneurodegenerative diseases. FP7-HEALTH-2011-two-stage

Support will be provided to clinical trials for primary neurodegenerative diseases that develop during childhood, i.e. up to 18 years of age. Human pharmacokinetics, pharmacodynamics, efficacy and/or safety studies should be included. The outcomes

t b l t f ti t d h li i l ti Pil t t di d t timust be relevant for patients and change clinical practice. Pilot studies and systematic reviews will not be funded. Applicants must demonstrate that clinical trials are appropriately powered to produce statistically significant evidence. Gender aspects and differences related to age subgroups should be appropriately considered. The clinical t i l t b t d t b i t d i bli l ibl li i l t i l i ttrials to be supported must be registered in a publicly accessible clinical trials registry. The applications must consider the relevant governance issues for clinical trials such as good clinical practice and respect of the appropriate international, European and national legislation and guidelines. Patient advocacy groups, which can contribute to the quality, f ibilit d i t f li i l t i l h ld b i l d h i tfeasibility and impact of clinical trials should be involved where appropriate.

SME participation is encouragedFunding scheme: Collaborative Project (small or medium-scale focused research project).EU contribution per project: Maximum €6 000 000EU contribution per project: Maximum €6 000 000One or more proposals can be selected.

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2.2.1 Brain and Brain-related diseases

HEALTH.2011.2.2.1-2: Understanding the role of neuroinflammation in neurodegenerative diseases. FP7-HEALTH-2011-two-stage.neurodegenerative diseases. FP7 HEALTH 2011 two stage.

An accumulating body of evidence indicates an active role of neuroinflammation not only in classical neuroinflammatory diseases like multiple sclerosis, but also in the pathophysiology of progressive neurodegenerative disorders. The successful project(s) should elucidate the link between neuroinflammation and neurodegeneration. The ultimate goal should be the g gidentification of viable targets for the development of neurodegenerative disease therapeutics and/or the validation of protective strategies for neurons and axons that may improve disease outcome in patients. Inclusion of early phase clinical trials to prove the benefit of immunomodulatory therapies will be considered an asset. Transmissible and infectious diseases are excluded

Funding scheme: Collaborative Project (large scale integrating project).EU contribution per project: Maximum €12 000 000.One or more proposals can be selected.Expected impact: The successful project(s) should lead to the identification of susceptibility factors for

addictive and/or compulsive behaviour in children and adolescents, and to a better understanding of the underlying mechanisms of these disorders. Project results will have help in developing new strategies for targeted prevention and health care management, new therapies, and ultimately lead to disease prevention or a significant decrease in the incidence of these diseases A strong participationdisease prevention or a significant decrease in the incidence of these diseases. A strong participation of SMEs and industry in the projects should help ensuring innovation in this area/topic. The degree of active participation of research-intensive SMEs and industry will be considered during the evaluation.

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2.2.1 Brain and Brain-related diseases

HEALTH 2011 2 2 1-3: Addictive and/or compulsive behaviour in children andHEALTH.2011.2.2.1-3: Addictive and/or compulsive behaviour in children and adolescents: translating pre-clinical results into therapies. HEALTH-2011-two-stage.

The projects should focus on one or more paediatric and adolescent neuropsychiatricdisorders characterized by addictive and/or compulsive behaviour such as addiction,obsessive compulsive disorders and tic disorders. In addition to increasing our

knowledge of the pathogenesis and mechanisms of these disorders, the successful project is expected to have well-specified clinical relevance. To this end, pre-clinical studies in relevant animal models and humans should be complemented by cohort studies for evaluating and validating of preventive and/or therapeutic strategies. The cohorts should take into account inequalities by gender, ethnicity and socioeconomic status.

SME participation is encouragedFunding scheme: Collaborative Project (small or medium-scale focused research

project).EU contribution per project: Maximum € 6 000 000EU contribution per project: Maximum € 6 000 000.One or more proposals can be selected.

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The Consortium

• Each project proposal requires a

The Consortium

p j p p q“coordinator” and at least the minimum required number of other partnersq p

• Consortium prepares proposal which addresses the topic and the work isaddresses the topic and the work is described using Work packages

• Coordinator has specific responsibilities• Coordinator has specific responsibilities (e.g. submitting the proposal) and is the point of contact with the Commissionpoint of contact with the Commission

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Tools for Consortium Building

• How can I find partners?

Tools for Consortium Building

• How can I find partners?• Obviously personal contacts• Networking at conferences/brokerage eventsNetworking at conferences/brokerage events• www.smesgohealth.org• www.lifecompetence.eu <- Very Useful!p y

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Current Coordinators

• CORDIS also has a list of FP7 projects fundedfundedhttp://cordis.europa.eu/fp7/projects_en.html

• Not as much information partner names• Not as much information – partner names not given

• Newer projects not listed – only after grant• Newer projects not listed – only after grant signature

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SupportSuppo t

• National Contact Points• Academic Coordinator Support• Travel Supportpp• CSTAR• ICRIN• ICRIN

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• Network of National Delegates and National Contact Points for FP7 inNational Contact Points for FP7 in IrelandM b h h/i d t i l• Members have research/industrial background in the appropriate areaNational Delegates represent the Irish view at EU levelNational Contact Points support applicants at National level pp

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Health NCPs for Irelandea t C s o e a d• Ciaran DuffyEnterprise Ireland, Dublin 3Ciaran.duffy@enterprise-ireland.com(01) 8082760(01) 8082760• Caitriona Creely (National Delegate)Health Research Board, Dublin 2ccreely@hrb.ie(01) 2345204

Kay Duggan Walls• Kay Duggan-WallsHealth Research Board, Dublin 2kdugganwalls@hrb.iegg @(01) 2345187

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How can National Contact Points help you?

• Discuss project ideas• Discuss project ideas• Advise on eligibility, technical issues, ethics….• Do pre-submission proposal checks (feedback onDo pre submission proposal checks (feedback on

draft proposals)• Help with partner searchers for projects• Give assistance at negotiation and implementation

stage (e.g. financial issues, reporting…)R f t th l t EU S i tifi Offi• Refer you to the relevant EU Scientific Officer when necessary

• Give you background material for topicsGive you background material for topics

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How can a National Delegate help you?

• Can submit future topics to the Commission for you:Commission for you:

What is the problem (EU context)??How can this be addressed?

Why is it a priority?Give facts and figures…

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Academic Coordinator Supportpp

• For researchers in higher education/publicly f d d i tit tifunded institutions

• To facilitate preparatory work leading to a proposal for the coordination of any researchproposal for the coordination of any research project under FP7

• Grants up to a maximum of €12,500p ,• The maximum limit for travel is €2,000• The maximum limit for employment of staff is y

€8,000• The maximum limit for professional services is

€4 000€4,00033

Travel Supporta e Suppo t• For researchers in higher education/publicly g y

funded institutions• For visits by Irish researchers abroad to meet

t ti l t tt d EUpotential partners or attend EU information/brokerage events relating to FP7

• Covers least cost travel expenses and• Covers least-cost travel expenses and subsistence rates up to a maximum of €400 (covering out of pocket expenses including hotels, meals, taxis, local fares and incidentals) per day. Visits will be typically up to three days durationduration.

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How to applyo to app y

• Application forms for financial support are available for download fromare available for download from Enterprise Ireland’s FP7 website www fp7ireland comwww.fp7ireland.com

• Forms are short• Requests are processed quickly!

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CSTARCSThe HRB Centre for Support and Training in Analysis

d R hand ResearchAim: To enhance health research quality in Ireland & increase its capacityIreland & increase its capacityExpertise:

Biostatistics Data Management and MethodologicalBiostatistics, Data Management and MethodologicalAspects of Quantitative and Qualitative Health Research

• Study design, sampling methods, sample size calculations• Research protocol development, Grant Application

Statistical Analysis Plan, Data Management Plan• Data analysis

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ICRINIrish Clinical Research Infrastructure Network

Provides integrated support to multinational clinical research proposalsProvides integrated support to multinational clinical research proposals• During the preparation of the clinical research projecte.g. practical information on ethical and regulatory requirements,

insurance consultancy on methodology protocol designinsurance, consultancy on methodology, protocol design, information on clinical trial sites

• During the conduct of the projectI t ti ith thi itt d t tie.g. Interaction with ethics committees, adverse event reporting, training of study personnel

Contact: Siobhan Gaynor Irish European correspondent for ECRIN siobhan.gaynor@molecularmedicineireland.iehttp://www.ecrin.org/index.php?id=26

http://www.molecularmedicineireland.ie/page/g/t/24http://www.molecularmedicineireland.ie/page/g/t/24

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If no suitable topic this year:• Suggest a topic to National Delegate/EU• Become an FP7 evaluator for

experiencehttps://cordis.europa.eu/emmfp7/

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Annual cycle of drafting the work programme

Taken from A rough Guide to the FP7 Work Programmes, by Dan Andrée

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Summary

Call now open

Summary

Call now open Use financial supports from EI where appropriateappropriateGive yourself enough timeRegister as an EvaluatorRegister with your NCP to keep up to date on calls for proposals

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For further information contactFor further information contact

Kay Duggan-Walls (general/clinicians)Kay Duggan-Walls (general/clinicians)kdugganwalls@hrb.ie

Tel (01) 2345 187e (0 ) 3 5 8Caitriona Creely (general/lobbying)

ccreely@hrb.ie Tel (01) 2345 204

Ciarán Duffy (IMI/ industrial liaison)Ciaran.duffy@enterprise-ireland.com

Tel (01) 727 2760

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