The European Framework Program for Research & Innovation: Horizon 2020: Health, demographic change & wellbeing

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1 The European Framework Program for Research & Innovation: Horizon 2020: Health, demographic change & wellbeing Sasha Hugentobler National Contact Point Health Euresearch Head Office phone

2 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

3 Structure of Horizon2020 Overview Life Sciences/Health / ICT-Health Industrial Leadership Societal Challenges Inclusive Societies Secure Societies

4 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.

5 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

6 7.4bn Euro Societal Challenges

7 1. Societal Challenge: HEALTH, DEMOGRAPHIC CHANGE AND WELLBEING

8 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

9 Societal challenge Health, demographic change and wellbeing Budget for Horizon 2020: 7.4bio Euro Budget of 1 st Call: 1.2bio Euros Bi-annual Work Programme Publication 1 st Call: 11th December 2013 Focus Area Call : personalising health & care 34 topics in 1 st Call

10 Societal challenge Health, demographic change and wellbeing personalising health & care Publication: 11th December 2013 Total indicative budget for 2014 topics of the PHC Call: million Total indicative budget for 2015 topics of the PHC Call: million Draft Horizon 2020 Work Programme Health, demographic change and wellbeing available here: one

11 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

12 Example of Work programme Challenge 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. Your project idea must exactly fit the Work Programme text in all aspects!!

13 Societal challenge Health, demographic change and wellbeing personalising health & care Call has 7 areas: Publication: 11th December 2013 Understanding health, ageing and disease - risk factors & pathways - systems medicine - mechanisms of diseases & their relevant co-morbidities

14 Health Draft Work Programme Focus area: Understanding health, ageing and disease includes topics PHC1-PHC3 PHC ) 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

15 PHC ) 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

16 Societal challenge Health, demographic change and wellbeing personalising health & care Call has 7 areas: Publication: 11th December 2013 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

17 Focus area: Effective health promotion, disease prevention, preparedness & screening includes topics PHC4-PHC9 PHC : Health promotion and disease prevention: improved intersector 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

18 Societal challenge Health, demographic change and wellbeing personalising health & care Improving diagnosis Publication: 11th December in vitro devices, essays & platforms - in vivo medical imaging technologies - clinical validation of biomarkers (SME instrument)

19 Focus area: Improving diagnosis includes topics PHC10- PHC12 PHC : 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.

20 Societal challenge Health, demographic change and wellbeing personalising health & care Publication: 11th December 2013 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

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

22 PHC : 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

23 Societal challenge Health, demographic change and wellbeing 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

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

25 Societal challenge Health, demographic change and wellbeing 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

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

27 Societal challenge Health, demographic change and wellbeing 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

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

29 Conditions for the Personalising Health Care Call Publication of the Call: 11 December topics Single Stage deadline Two Stage deadlines PHC 7, PHC 8, PHC 15, PHC 19, PHC 20, PHC 26, PHC 31, PHC 34 PHC 1, PHC 5, PHC 6, PHC 10, PHC 13, PHC 17, PHC 23, PHC th April 2014 at 17:00:00 Brussels time 2015 topics Single Stage 2015 topics Two stage PHC 9, PHC 15, PHC 21, PHC 25, PHC 27, PHC 28, PHC 29, PHC 30 Deadline: not yet clear Stage 1: 11 th March 2014 at 17:00:00 Brussels time Stage 2: 19 th August 2014 at 17:00:00 Brussels time PHC 2, PHC 3, PHC 4, PHC 11, PHC 14, PHC 16, PHC 18, PHC 22, PHC 24, PHC 33 Deadline: not yet clear

30 Funding Schemes 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 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

31 General Opening 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)

32 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.

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

34 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 Award criterion Threshold Max Score Excellence 4 5 Impact 4 5 Total 8 10 Note: If a proposal fails to achieve the threshold for a certain criterion at any stage, the evaluation of the proposal will be stopped!

35 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 Award criterion Threshold Max Score Excellence 4 5 Impact 4 5 Quality and efficiency of implementation 3 5 Total Note: If a proposal fails to achieve the threshold for a certain criterion at any stage, the evaluation of the proposal will be stopped!

36 Project example from FP7 Health

37 Protect the public against future flu pandemics The work as a coordinator is an investment into one's future. Dr. Beatrice Pilger FACTS AND FIGURES Project Name: FLUINHIBIT Research Area: Health Coordinator: Dr. Beatrice Pilger Organisation: Pike Pharma GmbH Start - End Date: 2008/04/ /03/31 Duration: 24 months Project Cost: 1.94 million Euros Project Funding: 1.48 million Euros Contract Type: FP7

38 Other Health Programmes under Horizon

39 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

40 Next IMI Call: IMI 11 th 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:

41 Other Health Programmes under Horizon: Ambient Assisted Living - AAL Objectives: Enhance the quality of life of older people Strengthen the industrial base in Europe through the use of Information and Communication Technologies (ICT)

42 Other Health Programmes under Horizon: European & Developing Countries Clinical Trials Partnership EDCTP2 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

43 Euresearch Network Services Sasha Hugentobler National Contact Point Health Euresearch Head Office phone

44 Who is Euresearch? Swiss private non for profit association mandated by State Secretariat for Education, Research & Innovation (SERI) Euresearch provides you with information, advice and support to identify suitable European research and innovation opportunities

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47 Thank you for your time Any questions?