SC1 Information Day Roma 6 October 2015

Transcription

1 The societal challenge 'Health, demographic change and wellbeing' Work programme SC1 Information Day Roma 6 October 2015 Giorgio CLAROTTI DG Research & Innovation (RTD) Robert BEGIER DG Communication Networks, Content and Technology (CNECT) Image credit: Adam Fagen Rallying for medical research / Creative commons usage license

2 Research and innovation a growing priority for the EU Horizon 2020 must deliver You should perform EXCELLENT research and innovation Your project must have an IMPACT Show ADDED VALUE, be multidisciplinary and well-implemented Reflected in the evaluation criteria

3 Horizon 2020 should support Commission priorities Horizon 2020 Couple research to innovation Jobs and growth Societal challenges European industrial leadership and competitiveness EU international excellence Provide evidence-base for addressing societal challenges, supporting EU policies and better regulation Strengthen research capacities and innovation strategies across all Member States Multidisciplinarity and synergies Address people's concerns

4 There are many ways to measure impact Evidence based policy making Taking the lead in new areas of growth Responding to emergencies Medicines for children Health Technology Assessment ATMP Personalised medicine Knowledge creation and exploitation and many others

5 Where is health research in Horizon 2020? EVERYWHERE

6 Health Research in H2020 Excellent science 24bn* European Research Council Future and Emerging Technologies Industrial leadership 17bn* Marie Skłodowska Curie Research Infrastructures SME instrument Fast Track to Innovation IMI-2 Eureka Eurostars-2 SC1 Health 7.3bn (of 31bn*) Collaborative projects LEIT Biotech AAL-2 Financial instruments EDCTP-2 * Figure to be updated following EFSI investments in

7 SC1 Investment Plan: impact of the EFSI* plan Impact on work programme (15% for RTD, 20% for CNECT) (Mio ) Total Operational budgets (mio ) 100 m 100 m FIRST 8 EFSI projects: * 100m Spanish Medical Research Firm * ~90m AT Hospitals *?? m IE Hospitals * Total Operational budgets Planned-EFSI FP7 Avg *European Fund for Strategic Investment (President Juncker Investment Plan)

8 SC1 Investment: a balanced portfolio, innovative solutions Leveraging investment in various type of instruments (Mio, 2014 to 2017) Coll-EN = WP calls less P2Ps (Public Public Partnership calls) ~350 m in 2016 PPP = Public-Private Partnerships (IMI-2) = ~200 m in m invested P2Ps = JPIs, Art.185, ERA-NETs, EJP, PCP/PPI) = ~150 m in 2016 ~250 m SME Instr = SME Instrument + Financial Instruments (FTI, IFID) = ~100 m in 2016

9 IMI2: - Covers the entire medical research and innovation value chain - Strategic Research Agenda is based on the WHO Priority Medicine Report renewed in July Involves pharmaceutical industries as well as others (diagnostics, imaging, animal health, ICT etc.) - Supports World class research and innovation leading to breakthrough vaccines, medicines and treatments

10 EDCTP2: launched in December 2014 almost 700 million EU co-funding, matching the same Member States contribution broader scope: including HIV, TB, malaria, neglected infectious diseases, all clinical phases, diagnostics and delivery optimisation longer duration: 10 years

11 The SC1 Work Programme in brief Call 'Personalised Medicine' 21 topics (34 in ): 10 in 2016, 10 in 2017, 1 open in 2016 & 2017 including 'coordination activities' 15 topics (17 in ): 12 in 2016, 3 in 2017 SME Instrument : 2 Topics Other Actions: 12 items (incl. InnovFin ID & "Birth Day Prize") Focus Area Digital Security: 1 Topic Focus Area Internet of Things: 1 Topic

12 Main research priorities for Personalised medicine Promoting healthy ageing Human biomonitoring Health ICT Infectious Diseases InnovFin Maternal and child health

13 Developing personalised medicines at EU level Strategic planning & coordination of national initiatives Implementation in SC1 Work Programme A large number of research and innovation topics and coordination topics in the SC1 Work Programme

14 Personalised medicine in SC1 Work Programme (I) Understanding health, well-being and diseases SC1-PM : Multi omics for personalised therapies addressing diseases of the immune system SC1-PM : New concepts in patient stratification SC1-PM : Diagnostic characterisation of rare diseases SC1-PM : Networking and optimising the use of population and patient cohorts at EU level Treating and managing diseases SC1-PM : New therapies for rare diseases SC1-PM : New therapies for chronic diseases SC1-PM : Comparing the effectiveness of existing healthcare interventions in the adult population SC1-PM : Clinical research on regenerative medicine

15 Personalised medicine in SC1 Work Programme (II) Preventing diseases SC1-PM : Promoting mental health and well-being in the young Methods and data SC1-PM : Development of new methods and measures for improved economic evaluation and efficiency measures in the health sector Health care provision and integrated care SC1-PM : Implementation research for scaling-up of evidence based innovations and good practice in Europe and lowand middle-income countries

16 Personalised medicine in SC1 Work Programme (III) Coordination activities SC1-HCO : Standardisation of pre-analytical and analytical procedures for in vitro diagnostics in personalised medicine SC1-HCO : Implementing the Strategic Research Agenda on Personalised Medicine SC1-HCO : Coordinating personalised medicine research SC1-HCO : Towards an ERA-NET for building sustainable and resilient health system models

17 European human biomonitoring initiative Implementation in SC1 Work Programme Creating a European joint programme for monitoring and scientific assessment of human exposures to chemicals and potential health impacts Coordinating HBM initiatives in Europe at national and EU level with special focus on a two way dialogue between policy and science in support of evidence based policy making Implementation through a Joint Programme Co-Fund Preventing diseases SC1-PM : The European Human Biomonitoring Initiative

18 Infectious diseases Implementation in SC1 Work Programme Collaborative research HIV/AIDS, Malaria and Tuberculosis; Neglected Infectious Diseases (NID); Emerging Epidemics; Antimicrobial drug resistance (AMR) New financial instruments - InnovFin Infectious Diseases joint initiative between EC-EIB Inducement prizes Horizon 2020 prize for better use of antibiotics Global initiatives - Global Research Collaboration for Infectious Disease Preparedness (GLOPID-R); Global Tuberculosis Vaccine Partnership (GTBVP) Public private partnerships IMI2 Public public partnerships EDCTP2 Joint Programming Initiative on AMR JPIAMR ERA-INFECT

19 Infectious diseases in SC1 WP (I) Understanding health, well-being and diseases SC1-PM : New concepts in patient stratification SC1-PM : Networking and optimising the use of population and patient cohorts at EU level Preventing diseases SC1-PM : Vaccine development for malaria and/or neglected infectious diseases Treating and managing diseases SC1-PM : New therapies for chronic diseases SC1-PM : Comparing the effectiveness of existing healthcare interventions in the adult population Coordination activities SC1-HCO : Towards globalisation of the Joint Programming Initiative on Antimicrobial Resistance

20 Infectious diseases in SC1 WP (II) Other Actions: InnovFin Infectious Diseases (InnovFin Pilot ID) A New Financial Instrument for Infectious Diseases R&D: Jointly developed by the European Commission and European Investment Bank Launched on 15 June 2015 in Riga during 'The First Innovative Enterprise Week' Established under InnovFin - EU Finance for Innovators Provides loans between EUR 7.5m and EUR 75m to innovative players active in developing vaccines, drugs, medical and diagnostic devices, and research infrastructures for combatting infectious diseases

21 Maternal and child health Implementation in SC1 Work Programme Approximately 300,000 women died from preventable causes related to pregnancy and childbirth in 2013 Maternal and perinatal conditions are the seventh contributors to the global burden of disease Other Actions: Horizon Prize on reducing maternal and newborn morbidity and mortality the Birth Day Prize The prize calls for a novel solution to improve the outcome of facility-based deliveries (of a clinical, technological or managerial nature, or a combination of these) Developed by European Commission and Bill & Melinda Gates Foundation More details and prize launch at the high-level conference "Together for the next generation" on 8 December in Brussels

22 Other coordination activities SC1-HCO : Valorisation of FP7 Health and H2020 SC1 research results SC1-HCO : Global Alliance for Chronic Diseases (GACD) SC1-HCO : Actions to bridge the divide in European health research and innovation

23 Promoting healthy ageing Implementation in SC1 Work Programme A large number of research and innovation topics, and coordination topics in the SC1 Work Programme Health ICT

24 ICT solutions for Active and Healthy Ageing Draft Pending Commission Decision Exploring new opportunities Catalyse Silver Economy IoT for Smart Living Environments (with ICT-LEIT) Scale up Innovative Care Services Complementing previous calls Groundbreaking R&D in Personalised Coaching (2017) Smart Living Environments Large-scale pilot (2016) EU Japan Cooperation (2016) Stimulate research and growth in SMEs ( ) PPI for deployment and scaling up (2016) CSAs Standards & Silver Economy take-up (2016)

25 Draft H2020 WP 2016/2017 Draft Pending Commission Decision More strategic patient-centred approach and health promotion Creating a body of evidence for IT technologies, support for SME's growth, IT skills for healthcare workforce New approaches in managing health, from well-being to personalisation Data and sharing data challenges Decrease of time to market, better adaptation to innovation and support to policy Contribution to WHO activities and US cooperation The entire chain of innovation is needed, from research to support actions and specific instruments. ICT for Health Principles, areas and strategy Self-management of health and mobile health Digital Health literacy Evidence on IT technologies, Opportunities for SME's, Optimal use of healthcare workforce Well-being Prevention, Personalisation, SSH Data security and privacy Interoperability and standards In-silico clinical trials Big data

26 Draft Pending Commission Decision Draft H2020 WP 2016/2017 SC1- ICT for Health and Well-being - Overview CSAs: EU mhealth Hub; Support for Health ICT SMEs; Digital Health literacy; Healthcare Workforce IT skills; EU/US Interoperability roadmap; EU ehealth Interoperability conformity; PCP: Empowering the patient SME Instrument: Accelerating market introduction of ICT solutions for SC1 RIA: Big Data; Digital Security; Simulation /modelling on wellbeing; In silico trials Horizon Prize: Food scanner *) *) Horizon Prize instrument (not under SC1)

27 PCP to steer the development of solutions towards concrete public sector needs, whilst comparing/validating alternative solution approaches from various vendors PPI to act as launching customer / early adopter / first buyer of innovative commercial end-solutions newly arriving on the market Objectives: Price/quality products that better fit public sector needs Earlier customer feedback for companies developing solutions Better take-up/wider commercialisation of R&D results

28 Horizon 2020: more opportunities for SMEs Integrated approach around 20% of the total budget for societal challenges and LEITs to go to SMEs Simplification of particular benefit to SMEs (e.g. single entry point) A new SME instrument will be used across all societal challenges as well as for the LEITs A dedicated activity for research-intensive SMEs in 'Innovation in SMEs' 'Access to risk finance' with a dedicated SME scheme (debt and equity facility)

29 SME instrument in SC1 work programme Implementation in SC1 Work Programme SMEInst Supporting innovative SMEs in the healthcare biotechnology sector SMEInst Accelerating market introduction of ICT solutions for Health, Well- Being and Ageing Well

30 Calendar for Horizon 2020 Work Programme (indicative) 18 September 2015: SC1 Info Day Brussels 13 October 2015: adoption of WP by the Commission 14 October 2015: publication of WP Call 2016 deadlines (depending on topics): 19 January February 2016 and 13 April 2016

31 Proposal submission and evaluation 2016: single-stage only 2017: mostly single-stage and 4 topics for two-stage Criteria & scoring: in the General Annex to the Work Programme Proposal evaluation process involving at least 3 external experts per proposal in Commission Guidelines

32 Contact and More Info Draft Horizon 2020 Work Programme : horizon2020/files/08.%20sc1-health% _pre-pub.pdf Participant Portal: en/opportunities/h2020/index.html Health and Well-being (H1): Digital Social Platforms (H2):

33 HORIZON 2020 Thank you for your attention Find out more:

34 EU Policy landscape Chronic diseases 3000 B Opportunity EU Policy landscape in Health & Ageing Ageing Empowerment Digital Single Market EIP H2020 AAL Health policy ehealth 2020, mhealth LTC Strategy Ageing policy Health & wellbeing Integrated care Crossborder care Sustainable care Independent living & Active Ageing 34 Legal & market conditions

35 Transforming Health and Care Acute care Long-term-care Single Diseases Multiple chronic conditions Passive Patient Active consumer Institutional care Home care Generic Approach Personalised Care 35

36 How to get there Smarter, innovation friendly Policies Creating scale, partnerships and return of investments Investing in Research and Innovation (H2020) European Innovation Partnership on Active and Healthy Ageing ehealth Action plan mhealth Green paper and follow-up 36

37 Health and Ageing Well the EU picture EIP on Active and Healthy Ageing New Knowledge Proven Ideas New solutions Evidence and innovation guidelines Deployment support JPIs More Years Better Lives Alzheimer s Health ehealth ICT & Ageing Horizon 2020 Horizon 2020, SC1 AAL JP2 n SME Measures Public Health Programme Structural Funds EIB ESF EIT-KIC Research Innovation 37 Deployment

38 Longer Term Research Areas Service robotics within smart living environments Early risk detection & intervention linked to ageing Advanced ICT for Integrated Care Self-management of health and disease based on predictive computer modelling used by the patient 38

39 Applied Research Open Service Platforms (Open Source IoT middleware for service, device, data integration) Self-management of health and disease: citizen engagement and mhealth ehealth Interoperability 39

40 Market Oriented Action Active and Assisted Living Joint Programme (co-financed with EU Member States) 140+ close to market projects funded until now Transforming proven research ideas into new products and services across Europe Close links with investors Up to 350M EU+MS 40

41 Innovation Agenda Large scale pilot projects Piloting ICT solutions for independent living with cognitive impairments (4 pilots starting) Piloting Integrated Care solutions (3 pilots running) European cooperation in innovative public procurement Pre-commercial Procurement of service robotics solutions (Silver project) Public Procurement of innovative combined health and care services (Stop and go project) Public procurement of innovative ehealth services 41

42 European Innovation Partnership on Active & Healthy Ageing crosscutting, connecting & engaging stakeholders across sectors, from private & public sector specific actions +2 HLY by 2020 Triple win for Europe health & quality of life of European citizens Pillar I Prevention screening early diagnosis Pillar II Care & cure Pillar III Independent living & active ageing Improving prescriptions and adherence to treatment Better management of health: preventing falls Preventing functional decline & frailty sustainable& efficient care systems growth & expansion of EU industry Integrated care for chronic conditions, inc. telecare ICT solutions for independent living & active ageing 42 Age-friendly cities and environments

43 European Innovation Partnership on Active and Healthy Ageing 1,000 regions & municipalities > 500 commitments 3,000 partners 32 Reference Sites 1 billion euro mobilised 30 mio citizens, >2 mio patients Marketplace >100,000 visits 43

44 Reference Sites - coverage 32 RSs =>12 MSs selected for self-assessment and peerreview (innovation, scalability, outcomes) 150+ good practices of care innovationbased impact on the ground Liverpool (1) Scotland Northern Ireland (3) Wales (1) Yorkshire (1) Northern Netherlands (3) Twente (1) Province of Gelderland and Overjssel South Holland Eindhoven (3) Southern Denmark (1) Region Skane City of Oulu (3) 1 July 2013 Star Ceremony announcement of best RSs with stars, ready for replication and coaching 13 Reference Sites 12 Reference Sites 7 Reference Sites Coimbra Collage (3) Ile-de-France (2) Pays de la Loire Lower-Rhine Council Languedoc-Roussillon (3) Basque Country Galicia (2) Madrid (2) Catalonia3) Valencia Andalusia Saxony Liguria Campania Friuli Venezia Giulia Emilia-Romagna Piemonte 44 University Hospital Olomouc

45 A scalable EU Silver Economy 3000 B Wealth by people over Million Consumers over 65 and growing <15% ICT use The Consumer Market Care costs ~1000 B /year in Europe (8 % GDP) 10% for innovation ~100 B /year The Public Market 45

46 EU Silver Economy Strategy See EU silver economy strategy 46

47 Cross-cutting items Clinical studies

48 Applicability and Definition A clinical study is any clinical research involving a substantial amount of work related to the observation of, data collection from, or diagnostic or therapeutic intervention on multiple or individual patients/subjects. It includes but is not limited to clinical trials in the sense of the EU Clinical Trials Directive (2001/20/EC). 48

49 Template for clinical studies in SC1 (I) Purpose Providing structured information to experts for evaluation Giving applicants the chance to provide detailed information about clinical studies without page limitations Reasons: Detailed but important information, e.g. about Scientific Advice Meetings, in-/exclusion-criteria, etc. Potentially high number of studies Providing necessary information to request 'unit costs' Available under 'call documents' 1 and in submission system 1 e.g.: essential_information_for_clinical_studies_2015callsv3_ _en.pdf

50 Template for clinical studies in SC1 (II) Scope Essential information based on a generic Clinical Study Protocol When information is currently not available (e.g. a clinical study is planned for a later stage of the project and will be based on data of previous studies) the source of required data should be provided and / or the selection of the applied methodology should be described Each section must be shortly and concisely described. In case one or more issues do not apply to a particular study, please briefly explain/justify

51 Mandatory deliverables 1. 'First study subject approvals package', Final version of the study protocol Registration number of clinical study Regulatory and/or ethics approvals 2. 'All approvals package', all further approvals 3. 'Midterm recruitment report', 50% recruitment 4. Report on status of posting results in the study registry(s), result posting

52 Detailed information about The template, unit costs, status recruitment sites, subcontracting, mandatory deliverables Provided on the Info Day web-site (Full presentations about clinical studies in H2020 projects can be requested via NCPs)

53 Cross-cutting items Social sciences and humanities (SSH)

54 Why SSH in SC1 Social Sciences investigate the processes that govern the behaviours of individuals and groups Humanities and Social Sciences are a key part of the research and innovation spectrum and it is important they are integrated in research and innovation programmes Health and wellbeing cannot be achieved by health and medical research alone

55 How to include / assess SSH Some specific SSH areas that might be considered for health research are: ethics, vulnerability, inequality and legal matters SSH needs to be initiated upstream, and not simply considered as an add-on => Help achieving impact through SSH Important to check: a) the level of interaction between STEM and SSH; b) the level of rigour of application of SSH c) and, in the scope, the areas that go beyond health economics Evaluators look for evaluators who have a broader knowledge (economics, statistics, psychology, anthropology and behavioural science) Importance to disseminate more information on good practices in embedding SSH

56 Examples in health research (1) The variability between patients in responses to the same treatment is one of the most challenging health care problems: Need to unravel the mechanisms of how peoples expectations affect immune and endocrine responses and related health outcomes, through the use of multidisciplinary methods in experimental studies (Social Sciences, Biomedical and Life Sciences, Neuroscience and Humanities) adapted from LERU

57 Examples in health research (2) How healthy ageing individuals manage to stabilise their quality of life and health in real life: To examine the determinants of healthy instead of ill ageing and the factors stabilising instead of declining health, through evidence standard for real life instead of laboratory outcomes, with results on the level of individuals instead of populations (gerontology, clinical and experimental psychology, ethnology, psychotherapy, robotics) adapted from LERU

58 Cross-cutting items International cooperation

59 Global challenges call for global responses Engaging in international cooperation is essential to attract talent, access knowledge and markets, thus increasing EU competitiveness Horizon 2020 is a vehicle to work together with the best worldwide International Cooperation Strategy Enhancing and focusing EU international cooperation in research and innovation

60 Horizon 2020 Open to the World General opening Horizon 2020 is fully open to participation of entities from across the globe Targeted opening Many topics are flagged as being specifically relevant for international cooperation, identifying upfront the targeted area and partner country or region

61 Multi-lateral health research activities GloPID-R Global Research Collaboration for Infectious Disease Preparedness Collaboratives/Global_Genomic_Medicine_Collaborative.aspx

62 SC1 and international cooperation Reference to specific multi-lateral initiatives Mutual opening of research programmes with Third Countries (US) Funding of Third Countries entities by their own funding agencies for participating to Horizon 2020 (Switzerland, Australia) Specific actions

63 Cross-cutting items Gender

64 Sex and Gender interact Regitz-Zagrosek, V. (2012). Sex and Gender Differences in Health. EMBO Reports, 13 (7):

65 Cross-cutting items Communication

66 Communicating H2020 projects Increased importance of communication Communication plan and work package in the proposal and the grant agreement (GA article 38.1) Promote your project and its results beyond the projects own community Communicate your research in a way that is understood by nonspecialist, e.g. the media and the public Inform EC/ Agency in advance of communication activities expected to have a major media impact Communication Dissemination Dissemination (GA article 29) is a separate obligation (e.g. through scientific articles and conferences)

67 Guidance Start at the outset, continue through entire lifetime Plan strategically Identify and set clear communication objectives Target audiences beyond own community Choose pertinent messages Use the right medium and means

68 Good communication Horizon 2020 Annotated Grant Agreement Brochure "Communicating EU Research & Innovation - Guidance for project participants" h2020-guide-comm_en.pdf

69 Cross-cutting items Ethics

70 Ethics Ethics issues to be carefully considered in proposals Check on EU guiding principles Ethics evaluation of all proposals included in priority lists Ethics requirements to be implemented in funded projects