The European Framework Program for Research & Innovation ...grantsaccess.ethz.ch/fileadmin/content/downloads/131125... · The European Framework Program for Research & Innovation:

Sasha Hugentobler National Contact Point Health Euresearch Head Office phone +41 31 380 60 06

The European Framework Program for Research & Innovation: Horizon 2020:

Health, demographic change & wellbeing

© Euresearch S. Hugentobler November 2013 Horizon2020: Health www.euresearch.ch/Horizon2020

Why Participate in “Health” in HORIZON2020? Perhaps you would like to

Finance a project?

Keep researchers in your institute or hire new ones?

Improve your international network?

Strengthen interdisciplinary collaboration? ⇒Whatever your reasons, your project has to fit the expectations

of the European Commission!

Three priorities Smart growth-developing an economy based on knowledge and innovation

Sustainable growth- promoting a sustainable and competitive economy

Inclusive growth- fostering a high employment economy delivering social cohesion

http://www.sxc.hu/browse.phtml?f=download&id=780647&redirect=photo


Structure of Horizon2020 Overview

Industrial Leadership

Societal Challenges

Inclusive Societies

Secure Societies

Life Sciences/Health / ICT-Health


Priority 3: Societal Challenges Principle:

Tackle global and societal challenges & concerns of citizens & society

Address political priorities of the EU

Inter-sectorial and multidisciplinary collaborative research & innovation

Promising solutions need to be tested, demonstrated and scaled up.


Basic Rules

The EU Commission has identified the problems

You provide together with your international consortium of experts the best solution to the identified problem

One can only submit a proposal to a challenge in an open call

5


7.4bn Euro

Societal

Challenges


1. Societal Challenge:

HEALTH, DEMOGRAPHIC

CHANGE AND WELLBEING


Health, demographic change, and wellbeing

Brings together FP7 Health and ICT Health

is also implemented by the Innovative Medicines Initiative (IMI) , the European and developing countries clinical trials partnership (EDCTP), Ambient Assisted Living (AAL) Also builds on FP7 activities: programmatic/thematic

approach, SME


Societal challenge Health, demographic change and wellbeing

Budget for Horizon 2020: 7.4bio Euro

Budget of 1st Call: 1.2bio Euros

Bi-annual Work Programme

Publication 1st Call: 11th December 2013

Focus Area Call 2014-2015: “personalising health & care”

34 topics in 1st Call


Societal challenge Health, demographic change and wellbeing “personalising health & care”

Publication: 11th December 2013

Total indicative budget for 2014 topics of the PHC Call: € 549.30 million

Total indicative budget for 2015 topics of the PHC Call: € 537.00 million

Draft Horizon 2020 Work Programme 2014-2015 “Health, demographic change and wellbeing available here:

http://ec.europa.eu/research/horizon2020/pdf/work-programmes/health_draft_work_programme.pdf#view=fit&pagemode=n

one

http://ec.europa.eu/research/horizon2020/pdf/work-programmes/health_draft_work_programme.pdf





Structure of the topics in the Work Programme

Specific Challenge – this sets the context, the problem to be addressed, and why intervention is necessary

Scope – this delineates the problem, specifies the focus and the boundaries of the potential action but without overly describing specific approaches

Expected Impact – this describes the key elements of what is expected to be achieved in relation to the specific challenge

Type of action- sets out the project type (e.g. collaborative project etc.)

Detailed information can be found in the call fiche


HEALTH Area: Understanding health, ageing & disease Specific Challenges

European research should aim to identify and better understand innovative approaches to enhance society's capacity reduce sedentary behaviour. Research should include the evaluation of innovative implemented initiatives that enhance the level of physical activity combined with dietary or other interventions, for the population at large, including the elderly, children and patients with chronic diseases and people living in deprived areas. ……

Scope of proposals: …… Expected impact of proposals:….

Type of Action: Collaborative Projects (100%) (max. ECcontribution: xx Mio €)

One or more proposals can be selected.

Example of Work programme Challenge

Your project idea must exactly fit the Work Programme text in all aspects!!




Call has 7 areas:

Understanding health, ageing and disease

- risk factors & pathways - systems medicine - mechanisms of diseases & their relevant co-morbidities


Health Draft Work Programme 2014-2015

Focus area: Understanding health, ageing and disease includes topics PHC1-PHC3 PHC 1-2014) Understanding health, ageing and disease: determinants,

risk factors & pathways

Specific challenge:

Exploring the combined role of genetic and non-genetic factors in health and disease development

Better understanding of the mechanisms underlying the process of ageing

Scope: Identification & validation of determinants of health and risk factors for disease through the

generation, integration and validation of data

Involvement of existing longitudinal studies + assessment of the necessity to establish new ones

or

Identification of determinants + pathways characteristic of healthy ageing & health deterioration caused by time, exposure to environmental factors and disease accumulation


PHC 3 -2015) Understanding common mechanisms of diseases and their relevance in co-morbidities

Specific challenge:

Improved understanding of the pathophysiology of diseases

Need to address the current knowledge gaps in disease aetiology in order to support innovation in the development of evidence-based treatments

Better understanding of the mechanisms that are common to several diseases, in particular of those leading to co-morbidities

Scope:

Proposals should focus on the integration of pre-clinical and clinical studies for the identification of mechanisms common to several diseases

Proposals will assess and validate the relevance of these common mechanisms and of their biomarkers (where relevant) on the development of disease-specific pathophysiology, as well as their role in the development of co-morbidities




Call has 7 areas:

Effective health promotion, disease prevention, preparedness & screening - improved inter-sector co-operation for environment & health based interventions - translating omics into stratified approaches - evaluating existing screening & prevention programmes - improving the control of infectious epidemics & foodborne outbreaks - vaccine development for TB & HIV/AIDS


Focus area: Effective health promotion, disease prevention, preparedness & screening includes topics PHC4-PHC9

PHC 4 -2015: Health promotion and disease prevention: improved inter-sector co-operation for environment and health based interventions

Specific challenge: Implementation of better health promotion + disease preventions by integrating

multi-sector teams to work on environment and health based interventions

Scope: Integration of environment & health sectors (including but not limited to climate change, air

quality, water and sanitation, the food chain, workplace) development of inter-sector interventions for health promotion and disease prevention multidisciplinary approach (including stakeholders such as policy makers, the private sector, civil society organisations etc. should be included)

Contextual factors such as the interplay between politics and economics should be addressed

Research activities will be developed to existing international activities and those under development




Improving diagnosis

- in vitro devices, essays & platforms - in vivo medical imaging technologies - clinical validation of biomarkers (SME instrument)


Focus area: Improving diagnosis includes topics PHC10-PHC12

PHC 10 – 2014: Development of new diagnostic tools and technologies: in

vitro devices, assays and platforms Specific challenge: Need for multidisciplinary competencies (translation of existing, new or evolving

scientific & technological knowledge from diverse fields into clinical application) to develop and bring new diagnostics to the patient.

Involvement of many small European companies active in this field is needed Scope: Development of innovative in vitro diagnostic tools & technologies (not novel applications of existing

ones) improvement the performance of diagnosis, prediction, monitoring, intervention or assessment of therapeutic response based on in vitro devices, assays and platforms

Additionally, proposals may include approaches based on high-throughput screening, nanotechnologies or microfluidics, data analysis methodology, or point-of-care diagnostics.




Innovative treatments & technologies

- new therapies for chronic non-communicable diseases - new therapies for rare diseases - clinical research on regenerative medicine - tools & technologies for advanced therapies - comparing the effectiveness of existing healthcare interventions in the elderly - establishing effectiveness of health care interventions in the paediatric population


Focus area: Innovative treatments & technologies includes topics PHC13-PHC18

PHC 13 – 2014: New therapies for chronic non-communicable diseases

Specific challenge:

Development of new therapies for chronic non-communicable diseases is stagnating, in part due to a lack of clinical validation

Scope: Clinical trial(s) supporting proof of concept in humans to assess the potential clinical efficacy of the

novel therapeutic concept(s) / optimisation of available therapies (e.g. drug repurposing).

Application of clinical trial(s) may build on pre-existing pre-clinical research

Provide a concise feasibility assessment justified by available published and preliminary results and supporting data. If relevant, considerations of effectiveness / potential clinical benefit (possibly including real world data) should be integrated


PHC 14 – 2015: New therapies for rare diseases

Specific challenge:

Lack of therapies for rare diseases despite huge knowledge generated by biomedical research due to small and dispersed patient populations, the nature of the therapies proposed, small markets for the therapies developed

Scope: Development of new or improved therapeutic approaches, for existing therapies & for preclinical

research, animal model development & GMP production

Proposed treatments to be developed may range from small molecule to gene or cell therapy

Clinical trials will only be supported in cases where "orphan designation" has been given, recommendations from protocol assistance given by the European Medicines Agency is taken into account, a clear patient recruitment strategy is presented. A concise feasibility assessment… is to be provided. If relevant, considerations of effectiveness / potential clinical benefit (possibly including real world data) should be integrated

Selected projects should contribute to the objectives of, and follow the guidelines and policies of the International Rare Diseases Research Consortium, IRDiRC



Advancing active & healthy ageing

- service robotics within assisted living environments - ICT solutions for independent living with cognitive impairment - early risk detection & intervention - promoting mental wellbeing: in the ageing population


Focus area: Advancing active and healthy ageing includes topics PHC 19-PHC 22

PHC 19 – 2014: Advancing active and healthy ageing with ICT: Service

robotics within assisted living environments Specific challenge:

Development of new breakthroughs for active and assisted living based on advanced ICT solutions

Scope: Service robotics in assisted living environments to help an ageing population to remain active and

independent for longer

Work will build on advances in this domain, and will combine multi-disciplinary research involving behavioural, sociological, health and other relevant disciplines.

Characteristics of the solutions developed will be their modularity, cost-effectiveness, reliability, flexibility in being able to meet a range of needs and societal expectations, applicability to realistic settings, safety and acceptability to end-users.



Integrated, sustainable, citizen-centred care

- developing & comparing new models for safe & efficient, prevention oriented, health & care systems - piloting personalised medicine in health & care systems - advanced ICT systems & services for integrated care - self-management of health & disease: citizen engagement & mHealth - 3 topics on self-managment of health & disease - 2 topics on eHealth


Focus area: Integrated, sustainable, citizen-centred care includes PHC 23-PHC 30

PHC 23 – 2014: Developing and comparing new models for safe and efficient, prevention oriented, health and care systems

Specific challenge:

Integration of prevention, primary care and treatment into health services by cooperation across sectors and between stakeholders

Scope: Development of new models for health systems to make them more patient-centred, prevention oriented,

efficient, safe and sustainable

Assessment of the models’ applicability and adaptation to different health systems & demonstration of their value, including individual and societal benefits

Application of the models to different levels within the health system (micro – the patient interaction level, meso- the health care organization and community level, and macro - the policy level). Models need to be compared with alternatives (including existing models) ….



improving health information, data exploitation and providing an evidence base for health policies and regulations

- digital representation of health data to improve diseases diagnosis & treatment - foresight for health policy development & regulation - advancing bioinformatics to meet biomedical & clinical needs - new approaches to improve predictive human safety testing


Focus area: Improving health information, data exploitation and providing an evidence base for health policies and regulation includes PHC 31-PHC 36

PHC 31 – 2015: Digital representation of health data to improve disease diagnosis and treatment

Specific challenge:

Need for greater integration of patient information, e.g. of multi-scale and multi-level physiological models with patient specific data & population specific data, to generate new clinical information for patient management

Scope: Development of new decisional support systems based on a complex integration of heterogeneous data

sources and subject-specific models ……


Conditions for the “Personalising Health Care”Call

Publication of the Call: 11 December 2013

2014 topics Single Stage deadline Two Stage deadlines

PHC 7, PHC 8, PHC 15, PHC 19, PHC 20, PHC 26, PHC 31, PHC 34

15th April 2014 at 17:00:00 Brussels time


Stage 1: 11th March 2014 at 17:00:00 Brussels time Stage 2: 19th August 2014 at 17:00:00 Brussels time

2015 topics Single Stage 2015 topics Two stage


PHC 2, PHC 3, PHC 4, PHC 11, PHC 14, PHC 16, PHC 18, PHC 22, PHC 24, PHC 33

Deadline: not yet clear Deadline: not yet clear


Research & Innovation Action (100% reimbursement)

collaborative research projects with clearly defined scientific and technological objectives & expected results carried out by project consortia

Innovation Action (70% reimbursement, for non-profit organization 100 % reimbursement)

are collaborative research projects directly aiming at producing plans and arrangements or designs for new, altered or improved products, processes or services

For this purpose they may include prototyping, testing, demonstrating, piloting, large-scale product validation and market replication

Funding Schemes

Rules for participation for both actions: At least three legal entities independent of each other and each established in a different Member State or an Associated Country Industry, academia, SMEs or others


Horizon 2020 is open to participation from across the world

Automatic funding

Member States (MS, including overseas departments and overseas territories)

Associated Countries (AC)

Countries other than MS and AC third countries (list of these countries will be available in the annex to the work programme)

No longer automatic funding for Brazil, Russia, India, China (BRIC countries) & Mexico!

Note: US researcher are eligible for funding under all topics in Health, demographic change and wellbeing bilateral agreement with the US National Institutes of Health (NIH)

Only funding for other countries in exceptional cases

When provision is made in the call text

Bilateral agreement

When the European Commission deems it essential (case by case assessment)

General Opening


Award criteria

1. Excellence Ground-breaking nature (e.g. beyond the state-of-the-art, novel approach, addresses challenge.. )

Conceptually robust; trans-disciplinarily considered…

2. Impact […] extent to which project outputs contribute to: The expected impacts listed in the work programme under the relevant topic;

Enhancing innovation capacity and integration of new knowledge;

Effectiveness of the proposed measures to communicate the project, disseminate and/or exploit the project results, and appropriate management of IPR.

3. Quality and efficiency of implementation Effectiveness of the work plan, including appropriateness of the allocation of tasks and resources;

Competences, experience and complementarity of the individual participants, as well as of the consortium as a whole;

Appropriateness of the management structures and procedures, including risk management.


Scoring thresholds and maximal scoring: single stage proposal

Scores single stage proposal

Award criterion Threshold Max Score

Excellence 4 5

Impact 4 5

Quality and efficiency of implementation

3 5

Total 12 15

Note: If a proposal fails to achieve the threshold for a certain criterion at any stage, the evaluation of the proposal will be stopped!


Scoring thresholds and maximal scoring: Two stage proposal

Stage 1 of two stage process: Short version of proposal (7 pages) is submitted & evaluated: only Excellence and Impact will be evaluated!

Stage 1 of two stage proposal


Excellence 4 5

Impact 4 5

Total 8 10



Scoring thresholds and maximal scoring: Two stage proposal

Stage 2 of two stage process: If stage 1 proposal evaluated positively: submission of full second stage proposal which will be evaluated against all the 3 criteria Excellence, Impact & Implementation.

Scores single stage proposal


Excellence 4 5

Impact 4 5

Quality and efficiency of implementation

3 5

Total 12 15



Project example from FP7 Health


Protect the public against future flu pandemics

FACTS AND FIGURES

“The work as a coordinator is an investment

into one's future.”

Dr. Beatrice Pilger

Project Name: FLUINHIBIT Research Area: Health Coordinator: Dr. Beatrice Pilger Organisation: Pike Pharma GmbH Start - End Date: 2008/04/01 - 2010/03/31 Duration: 24 months Project Cost: 1.94 million Euros Project Funding: 1.48 million Euros Contract Type: FP7


Other Health

Programmes under Horizon


Other Health Programmes under Horizon:

Innovative Medicines Initiative – IMI2

• Public-Private Partnership between EU and EFPIA (European Federation of Pharmaceutical Industries and Associations)

• Goal: provide faster access to better medicines through identifying promising drug candidates with greater certainty at an earlier stage

ww.imi.europa.eu

http://www.imi.europa.eu/

http://www.eurostars-eureka.eu/


Next IMI Call: IMI 11th Call planned to be launched in December 2013 Indicative topics: Applied public-private research enabling osteoarthritis clinical headway

(APPROACH) European platform for proof of concept for prevention in Alzheimer’s Disease

(EPOC-AD) Blood-based biomarker assays for personalized tumour therapy: value of latest

circulating biomarkers Zoonoses anticipation and preparedness initiative (ZAPI) Generation of research tools to translate genomic discoveries into drug discovery

projects Ecorisk prediction (ERP) Two topics on antimicrobial resistance

Further Information: http://www.imi.europa.eu/content/11th-call-2013-8

http://www.imi.europa.eu/content/11th-call-2013-8

http://www.imi.europa.eu/content/11th-call-2013-8


Objectives: •Enhance the quality of life of older people •Strengthen the industrial base in Europe through the use of Information and Communication Technologies (ICT)

http://www.aal-europe.eu/

Other Health Programmes under Horizon:

Ambient Assisted Living - AAL






•Aim: Accelerate the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis, with a focus on phase II and III clinical trials in sub-Saharan Africa

Other Health Programmes under Horizon: European & Developing Countries Clinical Trials

Partnership – EDCTP2

http://www.edctp.org/



Sasha Hugentobler National Contact Point Health Euresearch Head Office phone +41 31 380 60 06

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The European Framework Program for Research & Innovation ...grantsaccess.ethz.ch/fileadmin/content/downloads/131125... · The European Framework Program for Research & Innovation: