University of Bristol 4 th May 2011

EU Framework Programme 7

Victoria Brewer UK National Contact Point – Health Theme (Academia)

International Strategy Manager, Medical Research Council

University of Bristol 4th May 2011

Agenda

• MRC’s role within FP7

• Funding opportunities within FP7

• 2012 Health Work Programme• Key points • Topics by activity area

MRC and FP7

MRC has four roles in FP7:

1. Participant

2. NCP for the Health Theme – Victoria Brewer

3. Programme Management Committee (Health) – Mark Palmer

4. State Representative for Innovative Medicines Initiative – Jill Jones

• MRC leads the PMC delegation at the invitation of the Department of Business Innovation and Skills (BIS)

• Alternative delegates are:

• Department of Health (DH)

• Technology Strategy Board

• Expert group e.g. UKRO• Joint lead between MRC and BIS

What is FP7

• Main mechanism used by the European Commission to fund research across Europe.

• Two main aims:1. To strengthen the scientific and technological base

of European industry. 2. To encourage international competitiveness while

promoting research that supports EU policies.

• How does the EC aim to achieve this?• Pooling resources• Integration of research• Excellence in research• Addressing Specific Needs

• Assembling critical mass

• Enabling “big science”

• Leverage private investment

• Addressing Pan-European challenges

• Coordinating national and regional programmes

• Conducting comparative research at EU level

• Disseminating research result more widely

• Supporting research careers and mobility of research

• Creating world class centres of excellence

• EU level competition to increase quality and creativity

• Orphan research

FP7 Budget

• Seven year funding programme with a budget of around €50.5 Billion

To date the UK has received 14% of the overall funding awarded

Ideas – European Research Council

• € 7.5bn budget

• Managed through the European Research Council (ERC)

• Bottom up/investigator led research

• Research within your own team – no international collaboration

ERC Early grants

• Funding: ~ € 1.5 M for up to 5 year• 2-12 years post PhD at application• UK has received 180* grants to date

• ERC-2010-StG call -79/427 went to UK HEI (19%)

ERC Advanced Grants

• Funding: ~ € 2.5 M for up to 5 year• “exceptional” research leader• UK has received 172* grants to date

• ERC-2010-AdG call - 53/266 went to UK HEI (20%)

People – Marie Curie Actions

• €4.75bn budget

• Managed through Marie Curie Actions

• Research mobility and career development scheme –inc’ coordination of PhD programmes

• Allows for European and International exchange • Schemes for individuals or organisations

•To date €1.3 billion awarded • UK share €300.8 million = 23%

Individual• Marie Curie Intra-European Fellowships for Career

Development (IEF) -move from one EU or FP7 associated country to another for a duration of 1-2 years.

• Marie Curie International Incoming Fellowships (IIF) – bring researchers based outside Europe into an EU Member State or country associated to FP7 for a duration of 1-2 years.

Organisation• Initial Training Networks (ITNs) – aimed at initial training

of researchers, first five years of researchers' careers. Projects will be based around a Joint Training Programme focussing on scientific and technological knowledge, as well as other complementary skills such as IPR, research management, entrepreneurship

• Co-funding of Regional, National and International Programmes (COFUND) - encourage existing or new regional or national programmes to open up and provide for trans-national mobility, as well as to reinforce international programmes.

Cooperation

• € 32.4bn budget

• Top-down research• EC sets the Research Agenda

• Proposals must be topic specific

• Multiple-disciplinary

• Collaborative research • MUST be working with European Partners (or Associated Countries/ target specific countries)

• 3 is a magic number

• SICA – 2x MS/AC & 2x target region(s)

Who is eligible to participate?

• EU-27 – Member States (MS) Austria, Belgium, Bulgaria ,

Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Ireland, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, UK

• Associated Countries (AC) Albania*, Bosnia and

Herzegovina *, Croatia*, Faroe Islands*, FYR, Macedonia*, Iceland*, Israel*, Liechtenstein*, Montenegro*, Norway*, Serbia*, Switzerland, Turkey*

*except Euratom

Third countries: ICPC

What organisation can participate?

• Participation is open to a wide range of organisations and individuals:

• research groups at universities or research institutes• small or medium-sized enterprises (SMEs)• SME associations or groupings• public or governmental administration (local, regional or

national)• organisations and researchers from third countries• international organisations• civil society organisations

• Need to register your organisation with the EC

Cooperation

Health €6.1bn

Food, Agriculture, Fisheries, Biotechnology €1.9bn

Information and Communication Technologies

€9.1bn

Nano-sciences, nano-technologies, materials and new production technologies

€3.5bn

Energy €2.4bn

Environment €1.9bn

Transport €4.2bn

Socio-economic sciences and the humanities

€0.6bn

Space €1.4bn

Security €1.4bn

Obesity, allergies, zoonoses and systems biologyMedication information technologies, activities on ageing, patient safety and virtual physiological human beingBiomaterials for health application, nanomedicines and nanotoxicology

Environment and Health

2012 Health Work Programme

Research priorities

1. Active & Healthy Ageing• Europe 2020 - Innovation Union The pilot European Innovation

Partnership on active and healthy ageing• 5 topics each looking to fund more than 1 proposal, 4x €6m and 1x

€12m2. Medical technologies

• Supporting the “innovation" strategy and reduce the time to market• 7 topics each looking to fund more than 1 proposal, 6x €6m and 1x

€3m3. Rare diseases

• Build critical mass for research on rare diseases• Currently 4 topics and 1 HIP but likely to become 7 topics

4. Clinical Trials• Continue on initiative started in 2011 work programme• Improve the quality of clinical trial data in Europe• 1x Active and Healthy ageing, 2x Rare diseases and 1xDiabetes

(type 1)


Key features to look out for..

• Strong SME focus in the majority of call topics: • SME-targeted ≥ 30% budget• SME-focus ≥ 15% budget

• Majority of call are 2 stage (exceptions CSA and ERA Net)Process• Outline submission • Invitation to second stage • Full proposal submission• Results

2011 WP Deadline13th Oct 2010

~ 20th Dec 201010th Feb 2011

~ end April/early May 2011


CLOSED AREAS:

1. BIOTECHNOLOGY, GENERIC TOOLS AND MEDICAL TECHNOLOGIES FOR HUMAN HEALTH

• 1.1 High-throughput research• 1.3 Suitability, safety, efficacy of therapies

2. TRANSLATING RESEARCH FOR HUMAN HEALTH• 2.2.1 Brain and brain-related diseases • 2.3.1 Anti-microbial drug resistance• 2.3.3 Potentially new and re-emerging epidemics • 2.3.4 Neglected infectious diseases • 2.4.1 Cancer• 2.4.2 Cardiovascular diseases

3. OPTIMISING THE DELIVERY OF HEALTHCARE TO EUROPEAN CITIZENS• 3.1 Translating the results of clinical research outcome into clinical practice

including better use of medicines, and appropriate use of behavioural and organisational interventions and new health therapies and technologies

• 3.3 Health promotion and prevention

4. OTHER ACTIONS ACROSS THE HEALTHTHEME• 4.2 Responding to EU policy needs

DRAFT

Refer to the final published version

when released

The Health Theme

1Biotechnology,

generic tools and medical technologies for human

health

2

Translating research for human health

3

Optimising the delivery of

healthcare to European

citizens

4 Emerging policy needs/unforeseen needs

1.2 DETECTION, DIAGNOSIS AND MONITORING

• HEALTH.2012.1.2-1. Development of technologies with a view to patient group stratification for personalised medicine applications.

Key points:• SME-targeted Collaborative Project up to €6m • One or more proposals can be selected.• Two-stage call

Focus:• Research and development of technologies application of

tailored medical intervention in specifically defined patient group

• Proof of principle highlighted• Emphasis of data collection and analysis i.e. statistical tool +

quality control around this• Active inclusion of end users (particular for proof of principle)

≥ 30 %

1.3 SUITABILITY, SAFETY, EFFICACY OF THERAPIES

Innovative Medicines Initiative

• Joint EC and EFPIA funding scheme = €2 billion• Research areas in

• Safety• Efficacy• Education & training• Knowledge management

• 4th call Estimated launched in June 2011• Indicative topics:

– Assessment of drug-induced toxicity in relevant organs – surrogates for early drug failure

– Enhancing translation in neurological diseases– European Medical Information Systems– Stem Cells for drug development and toxicity screening– Beyond high-throughput screening– Disease heterogeneity/taxonomy of disease– Genetic mapping of extreme phenotypes– Combination therapy development

1.4 INNOVATIVE THERAPEUTIC APPROACHES AND INTERVENTIONS

Focus = Transplantation

Rationale:• Clinical demand• Continuity of successful FP6 projects• Recent progress in other areas• Policy developments i.e. DG SANCO


• HEALTH.2012.1.4-1: Innovative approaches to solid organ transplantation.

Key points:• SME-focused Collaborative Project up to €6m • One or more proposals can be selected.• Two-stage call

Focus:• Improve the outcome, increase efficiency &/or widen the scope

of solid transplantation• Clinical focus inc’. Regulatory, safety & immunological

aspects• Improved treatment improved personal targeting &

tolerance

≥ 15 %


• HEALTH.2012.1.4-2: Medical technology for the transplantation sector and bioartificial organs


Focus:• Develop novel tools, techniques & devices for use in

transplantation and in bioartifical organs• Include cells, tissues or organs

• Clinical/in-patient trial = central to the proposal• Cover safety & efficacy assessment + regulatory work

≥ 30 %


• HEALTH.2012.1.4-3: Innovative strategies for translation of stem cell based therapies in regenerative medicine.


• EU and Australia Cooperation• Australian Partners ~ 50% work carried out in Australia• Joint submission to EC and NHMRC• Australian Partners apply to NHMRC ≠ request EU funds €6m

max EC contribution to European Team• Max NHMRC contribution = €6m

≥ 15 %

EU & Australia


• HEALTH.2012.1.4-2 cont’.

Focus:• Characterisation• Mechanisms of action and nature of host response(s)• Quality control of product(s), • Efficacy and safety in relevant preclinical models

• Bridging studies can be included

• 2 phase project 2nd stage dependent on regulatory approval• 5 year – review at Yr 3 Yrs 4&5 dependent on approval of

joint regulatory filing• funds divided equally between the 2 phases

• Outcome = Therapeutic products & clinical protocols developed with industrial partners


• HEALTH.2012.1.4-4: Targeted nucleic acid delivery as an innovative therapeutic or prophylactic approach.


Focus:• Immunotherapy, gene therapy or DNA vaccination, RNA

interference• Clinical testing carried out throughout of the life time of the

project – inc’. regulatory work• Preclinical work around safety, immunogenicity, toxicity and

feasibility studies should have already been completed

≥ 30 %

The Health Theme

1Biotechnology,


health

2


3



citizens


2.1 INTEGRATING BIOLOGICAL DATA AND PROCESSES: LARGE-SCALE DATA GATHERING,SYSTEMS BIOLOGY

2.1.1 Large-scale data gathering

• HEALTH.2012.2.1.1-1: Clinical utility of -omics for better diagnosis and treatment of rare diseases.

Key points:• WAS a High Impact Project – going to broken down into

individual Collaborative Project

Focus:• New topics = Still TBC• Likely to cover

• -omics approaches and technologies for molecular characterisation for a chosen rare disease new diagnostics and treatment in clinical settings

• Utilisation of existing databases/biobanks• Coordination and harmonisation of patient registries

2.1.1 Large-scale data gathering (cont’.)

• HEALTH.2012.2.1.1-2: Validation of -omics-based biomarkers for diseases affecting the elderly.


Focus:• Clinical validation already identified -omics based biomarkers

sensitivity, specificity and predictive power improved diagnosis, prognosis, patient stratification and/or treatment monitoring

• Inc’. statistical models and quality control for data generated

≥ 30 %

2.1.1 Large-scale data gathering (cont’.)

• HEALTH.2012.2.1.1-3: Statistical methods for collection and analysis of -omics data.


Focus:• Improve or develop new statistical models / tools for analysis

of –omic based data• Open to any –omics based data e.g. genomics, proteomics etc

or particular class of analysis• Clinical trials excluded• Must include appropriate training and dissemination activities

≥ 15 %

2.1 INTEGRATING BIOLOGICAL DATA AND PROCESSES: LARGE-SCALE DATA GATHERING,SYSTEMS BIOLOGY

2.1.2 Systems biology

• HEALTH.2012.2.1.2-1: Systems medicine: SME-driven research applying systems biology approaches to address medical and clinical needs.

Key points:• SME-targeted Collaborative Project up to €3m • One or more proposals can be selected.• Two-stage call • Small to minimum consortium sizes• Project duration up to 2 years• No intermediate payments or reports

≥ 30 %

2.1.2 Systems biology (cont’.)

• HEALTH.2012.2.1.2-1 cont’.

Focus:• Development, improvement and application of systems

biology approaches to medical/clinical questions e.g.:

• Re-design of clinical trials by shortening timescale and costs;

• Development of combinatorial therapies and/or chronotherapies for complex diseases

• Development of combinatorial biomarkers• Etc…

• Establish proof-of-concept demonstrate the potential for exploitation

• Exploitation of results in clinical an/ or industrial sectors


• HEALTH.2012.2.1.2-2: Systems medicine: Applying systems biology approaches for understanding complex human diseases and their co-morbidities.

Key points:• Collaborative Project up to €12m • One or more proposals can be selected.• Two-stage call

Focus:• Integrated multidisciplinary research inc’. pre-clinical and

clinical research clinicians, biologists computational scientists, mathematician etc

• Address a clear clinical need new avenues of understanding patho-physiology, diagnosis and treatment of complex diseases


• HEALTH.2012.2.1.2-3: Preparing for the future research and innovation activities in systems medicine.

Key points:• Coordination and Support Action (CAS) up to €3m • Only one proposals can be selected.• Two-stage call

Focus:• Promote, support and coordinate research activities in

systems biology across Europe• Best practice, information and resources of successful

methodological approaches.• Multidisciplinary training requirements for the next

generation• Promote innovation activities technology transfer

exploitation

http://ec.europa.eu/research/health/past-events_en.html

2.2 RESEARCH ON THE BRAIN AND RELATED DISEASES, HUMAN DEVELOPMENT AND AGEING

2.2.2 Human development and ageing = Primary focus

Rationale:• Europe has highest proportion of older people in the world• Grand challenge of understanding the ageing process• More targeted geriatric medicines• Innovation Union partnership – Active and Healthy Ageing

http://ec.europa.eu/research/innovation-union/index_en.cfm?section=active-healthy-ageing

2.2.2 Human development and ageing

• HEALTH.2012.2.2.2-1: Integrative systems biology and comparative genomics for studying human ageing and/or most common age-related diseases.


Focus:• Interactions between genetics, epigenetic and environmental

factors ageing phenotype in normal and disease conditions• Computational approaches, comparative genomic studies of

existing data and appropriate modelling• Can include tools for diagnosis, prognosis and monitoring of

therapies

≥ 30 %

2.2.2 Human development and ageing (cont’.)

• HEALTH.2012.2.2.2.-2: Investigator-driven clinical trials for optimisation of management of elderly patients with multiple diseases.


Focus:• Compare various treatment regimens in elderly population

treated for multiple diseases• Clinical trials looking at efficacy and adverse effects of multi

treatment of common age related diseases

≥ 15 %

2.3 TRANSLATIONAL RESEARCH IN MAJOR INFECTIOUS DISEASES: TO CONFRONT MAJOR THREATS TO PUBLIC HEALTH

2.3.0 Cross-cutting

• HEALTH.2012.2.3.0-1: Diagnostics for infectious diseases.

Key points:• SME-targeted Collaborative Project up to €6m • One or more proposals can be selected.• Two-stage call • No prescribed duration i.e. can be as short as 1-2 years

Focus:• Development and/or validation of diagnostic tests for major

infectious diseases to meet clinical need• Priority to diseases with unmet medical need i.e. no tests

available & improved testing better control and management

≥ 30 %

2.3 TRANSLATIONAL RESEARCH IN MAJOR INFECTIOUS DISEASES: TO CONFRONT MAJOR THREATS TO PUBLIC HEALTH

2.3.2 HIV/AIDS, malaria and tuberculosis

• HEALTH.2012.2.3.2-1: Co-infection of HIV/AIDS, malaria, tuberculosis and/or hepatitis.


Focus:• Basic, translation and/or clinical research

• prevention, therapeutic management and prognosis of co-infected patients

• Immunological mechanisms and response to co-infection• Priority to co-morbidity of relevance to LMIC

2.3.2 HIV/AIDS, malaria and tuberculosis(cont’.)

• HEALTH.2012.2.3.2-2: Co-morbidity between infectious and non-communicable diseases.


Focus:• Basic, translation and/or clinical research

• prevention, therapeutic management and prognosis of patients infectious and non-communicable diseases

• Proposals should address:• Causative links between infectious and non-infectious diseases• Combination of 3 major poverty related diseases (AIDS, malaria

or TB) or any major poverty related diseases with non-infectious diseases


• HEALTH.2012.2.3.2-3: Prevention and treatment for HIV/AIDS, malaria and tuberculosis.

Key points:• SME-targeted collaborative Project up to €6m • One or more proposals can be selected.• Two-stage call • No prescribed duration i.e. can be as short as 1-2 years

Focus:• Basic or translation research addressing current gaps in • Prevention and/or treatment of poverty related diseases

(HIV/AIDS, malaria or TB)• Proposal must inc’:

• Detailed plan for exploitation of end results• Explore synergies with relevant EU funded initiatives e.g.

European and Developing Countries Clinical Trial Partnership (EDCTP)

≥ 15 %


• HEALTH.2012.2.3.2-4: Low-cost interventions for disease control in resource poor settings.


Focus:• Innovative ways to control neglected infectious diseases

and/or malaria low-cost interventions – immediate impact• Novel applications of current tools and knowledge new cost-

effective solutions• Combinational therapy, treatment strategies, epidemiology, access

to diagnostics and drugs, operational and implementation research• Inclusion of partners from disease-endemic countries

2.4 TRANSLATIONAL RESEARCH IN OTHERMAJOR DISEASES

2.4.3 Diabetes and obesity

• HEALTH.2012.2.4.3-1: Innovative approach to manage diabetes.


Focus:• Management of diabetes in pre-and/or clinical settings by

validating therapeutic devices or biological therapies• Attention to safety, bio-compatibility, interoperability and

regulatory aspects fast and safe uptake of approaches/technologies

≥ 30 %

2.4.3 Diabetes and obesity (cont’.)

• HEALTH.2012.2.4.3-2: Investigator-driven clinical trials for type 1 diabetes research.


Focus:• Clinical Trial on type 1 diabetes with focus on paediatric

population improve glycolic control and/or reduce diabetes complications

• Inform clinical management of type 1 diabetes• Excludes pilot studies and systematic reviews


2.4.4 Rare diseases (= < 5/10,000)

• HEALTH.2012.2.4.4-1: Preclinical and/or clinical development of substances with a clear potential as orphan drugs.


Focus:• MUST be EU designated orphan medicinal products

• http://ec.europa.eu/health/documents/community-register/html/orphreg.htm

• Preclinical studies in models and/or clinical studies• Excludes cancer and diseases of the nervous system

≥ 30 %

2.4.4 Rare diseases (cont’.)

• HEALTH.2012.2.4.4-2: Observational trials in rare diseases.


Focus:• Rare diseases with no orphan drug available – treated off-label• Improve clinical management of rare diseases evidence

based clinical guidance • Data collection and comparing outcomes of various treatment

regimens• Evaluation of effectiveness and adverse events

• Excludes cancer, infectious diseases and diseases of the nervous system

2.4.4 Rare diseases (cont’.)

• HEALTH.2012.2.4.4-3: Best practice and knowledge sharing in the clinical management of rare diseases.

Key points:• Coordination and Support Action (CAS) up to €2m • Only one proposals can be selected.• Two-stage call

Focus:• Development of a networking platform supporting the

collection of standardised & validated data and exchange of information providing evidence of best clinical management of rare diseases

• Identify additional research needs • Any group of rare diseases


2.4.5 Other chronic diseases

• HEALTH.2012.2.4.5-1: Technological approaches to combating sensory impairments.


Focus:• Preclinical and clinical testing of novel tools, devices or

therapies' for overcoming sensory disability• Prevention and treatment strategies, technological

approaches, biological cell based therapies inc’. Stem cells and development of bio-artificial organs

≥ 30 %

2.4.5 Other chronic diseases (cont’.)

• HEALTH.2012.2.4.5-2: Biomarkers and diagnostics for chronic inflammatory diseases of the joints and/or digestive system.


Focus:• Development of improved/novel methodologies early

diagnosis of chronic inflammatory diseases• Indicative markers for inflammatory onset and

development & evaluation of intervention therapies

≥ 15 %

The Health Theme

1Biotechnology,


health

2


3



citizens


3.2 QUALITY, EFFICIENCY AND SOLIDARITYOF HEALTHCARE SYSTEMS INCLUDING TRANSITIONAL HEALTH SYSTEMS

• HEALTH.2012.3.2-1: Improving the organisation of health service delivery.

Key points:• Collaborative Project up to €3m • One or more proposals can be selected.• Two-stage call • ~ 4 year duration

Focus:• Best practice for European health care organisations around,

structure, care processes and performance• Areas to be addressed (either one or many):

1. integration of patient care2. Patient centred care and involvement3. Skill mix and management of resources (only 1 proposal)4. Transfer of knowledge into practice ~ span 5 years

3.2 QUALITY, EFFICIENCY AND SOLIDARITYOF HEALTHCARE SYSTEMS INCLUDING TRANSITIONAL HEALTH SYSTEMS

• HEALTH.2012.3.2-2: New methodologies for health technology assessment.


Focus:• Develop new and/or improved methodologies for Health

Technology Assessment (HTA)• Areas of focus (either or both):

1. Methodologies for addressing the complexity of interventions

2. Methodologies to assess the efficacy and effectiveness of technologies

• Complement previously funded work i.e. EUnetHTA JA

http://www.eunethta.net/

3.4 INTERNATIONAL PUBLIC HEALTH & HEALTH SYSTEMS

• HEALTH.2012.3.4-1: Health systems/services research in low and middle income countries.

Key points:• SICA up to €6m • 6x ICPC and min 2x EU/AC• One or more proposals can be selected.• Two-stage call • ~ 5 years in duration

Focus:• Collection, analysis and translation of data into effective

health service planning and policy• Focus on (either):

1. Methods to investigate country comparisons and scientific capacity

2. Human resources for health3. Knowledge transfer

• Balanced partnership

The Health Theme

1Biotechnology,


health

2


3



citizens


4.1 COORDINATION AND SUPPORT ACTIONS ACROSS THE THEME

• HEALTH.2012.4.1-1: Network to encourage knowledge transfer activity in FP-funded health research (especially in academic and governmental organisations). CSA €2m

• HEALTH.2012.4.1-2: Training actions linked to intellectual property rights management and knowledge transfer. CSA €2m

• HEALTH.2012.4.1-3: Support for Presidency events: Organisation of supporting actions and events related to the Presidency of the European Union. CSA €100,000

• HEALTH.2012.4.1-4: Support for the international rare disease research. CSA €100,000

• HEALTH.2012.4.1-5: Communicating the benefits of European research to the general public. CSA €100,000

Contacts

• NCP Health (Academia): Victoria Brewer [email protected] 020 7395 2205

• NCP Health (Industry): Graham [email protected] 01302 322633

• NCP ERC & Marie Curie: UK Research Office [email protected] 00 32 2 230 1535 /5275

Useful websites

• EC website: http://cordis.europa.eu/fp7/home_en.html

• Connect FP7: https://ktn.innovateuk.org/web/fp7uk

• UKRO website: http://www.ukro.ac.uk/

• MRC website – International funding opportunties:http://www.mrc.ac.uk/Fundingopportunities/Internationalopportunities/index.htm

Useful websites

• Europe 2020 Strategy http://ec.europa.eu/resource-efficient-europe/

• Innovation Union http://ec.europa.eu/research/innovation-union/index_en.cfm?pg=intro

• Active and Healthy Ageing http://ec.europa.eu/research/innovation-union/index_en.cfm?section=active-healthy-ageing

• EDCTPhttp://www.edctp.org/

Any questions?

University of Bristol 4 th May 2011

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