1. Research & Innovation Meet the European Commission’s Directorate-General for Research & Innovation ICE/ENDO 2014 Chicago (USA), 22 June 2014 Horizon 2020: The European Union research and innovation programme Laurent Bochereau European Commission Research and Innovation Directorate General Health Directorate Head of the 'Strategy' Unit

2. Research & Innovation Overview  Our routes to Horizon 2020  Horizon 2020: general features and state of play  Health, Demographic Change and Wellbeing societal challenge

3. Research & Innovation 30 years of EU funded R&I Annual budget (in b€)

4. Research & Innovation Collaborative research: 10 thematic areas Frontier research ERC Capacities : € 4097 People : € 4750 Marie Curie Actions Research Capacity Cooperation : € 32 413 JRC: € 1751 Euratom : € 2751 Nuclear research Ideas : € 7510 FP7 structure (2007-13): EU’s main instrument for funding research

5. Research & Innovation Interacting with Third Countries Associated Countries 14 Associated countries Legal entities participate on the same basis those from MS Countries represented as observers in committees – 'comitology' Science and Technology Agreements 20 S&T agreements to FP Regular (annual) meetings between both sides Areas and mechanisms of cooperation; management; IPR Other Agreements Research and Innovation as a part of broader international policies Regional agreements: ASEAN, AU/Africa, LAC, Med, EaP, WBC

6. Research & Innovation Participation of Third Countries in FP7 Non EU+AC 2.6% budget 5.6% partners 17% of projects

7. Research & Innovation Key figures 5,4 b€ invested to date 1052 projects 12 332 participations 3 613 organisations 124 countries Preliminary outcomes 10 332 publications 3,2 average SJR* publication 203 patent applications 29 spin-offs created 8 international initiatives * SCImago Journal Ranking Health programme in FP7: a few figures

8. Research & Innovation Building on FP 7 experience Scientific excellence Greater SME participation

9. Research & Innovation US organisations in Health, FP7 162 US participations: 70 Universities 40 Research organisations 27 SMEs 9 Foundations 10 Other (International organisations, FDA etc.) 6 Industry Receiving 52 million €

10. Research & Innovation IMmune MOdulating strategies for treatment of MErkel cell Carcinoma A multicentre randomized clinical phase II trial of a immunotherapy for Merkel cell carcinoma based on the targeted delivery of interleukin-2 to the tumour microenvironment Identification and characterization of HLA-restricted immunodominant T cell epitopes specific for MCC to monitor the immune modulating effect and development of specific therapeutics Identification of prognostic and predictive biomarkers, i.e. search for markers foretelling the course of disease or treatment response in MCC Project Consortium: 9 participants coordinated by Medizinische Universitaet Graz (Austria)

11. Research & Innovation Sensory and Biomechanical Markers in Diabetic Neuropathy of the Gut. Basic Investigations and New Approaches for Treatment DIAMARK: Help is on the (Gastro-intestinal) way for diabetes patients Gastrointestinal disorders commonly affect diabetes mellitus sufferers DIAMARK has developed and validated methods, with new probes being developed to deliver electrical stimulations in the oesophagus Project consortium: 6 participants coordinated by Aalborg Sygehus (Denmark) 11

12. Research & Innovation Overview  Our routes to Horizon 2020  Horizon 2020: general features and state of play  Health, Demographic Change and Wellbeing societal challenge

13. Research & Innovation Europe 2020 - 5 EU headline targets 75% employment rate (% of population aged 20-64 years) 3% investment in R&D (% of EU’s GDP) “20/20/20” climate/energy targets School drop-out rates lower than 10% and at least 40% of the population aged 30-34 having completed tertiary education Reducing those at risk of poverty or exclusion by at least 20 million 13

14. Research & Innovation R&D intensity 2000, 2007, 2011 and 2020 target

15. Research & Innovation Evolution of world R&D expenditure in real terms 2004-2014 Source: DG Research and Innovation - Economic Analysis Unit Innovation Union Competitiveness report 2013

16. Research & Innovation A EU budget for growth and jobs The Multiannual Financial Framework 2014-2020: Commission’s proposals of 29 June 2011 Smart & inclusive growth (€491bn) -Education, Youth, Sport -Connecting Europe -Cohesion -Competitive Business SMEs -Horizon 2020 16

17. Research & Innovation Concept for Horizon 2020 28 countries pulling resources in one unique R&D programme

18. Research & Innovation What is Horizon 2020? http://ec.europa.eu/research/horizon2020 The European Union’s 2014-20 programme for research & innovation A core part of Europe 2020, Innovation Union & European Research Area Three priorities: 1. Excellent science (24,4 bn €) 2. Industrial leadership (17,0 bn €) 3. Societal challenges (29,7 bn €) + Other activities (5,9 bn €)

19. Research & Innovation Horizon 2020 - basic principles Scientific excellence Support to EU policies Transnational cooperation European added value Public calls, peer review evaluation, competitive selection Cost-sharing Participant ownership of the results Openness to international participation

20. Research & Innovation What is new in Research & Innovation? A budget of 79 billion euro (2014-2020) A single programme bringing together three separate programmes/initiatives Coupling research to innovation – from research to retail, all forms of innovation Focus on societal challenges facing EU society, e.g. health, clean energy and transport Simplified access, for all companies, universities, institutes in EU countries and globally

21. Research & Innovation Excellent scienceExcellent science Industrial leadershipIndustrial leadership Societal challengesSocietal challenges European Research Council Future and Emerging Technologies Marie Skłodowska-Curie actions Research infrastructures Leadership in enabling and industrial technologies Access to risk finance Innovation in SMEs Health, demographic change and wellbeing Food security, sustainable agriculture and forestry, marine and maritime and inland water research and the Bioeconomy Secure, clean and efficient energy Smart, green and integrated transport Climate action, environment, resource efficiency and raw materials Inclusive, innovative and reflective societies Secure societies Horizon 2020 and its three pillars

22. Research & Innovation Overview  Our routes to Horizon 2020  Horizon 2020: general features and state of play  Health, Demographic Change and Wellbeing societal challenge

23. Research & Innovation Health research in Societal Challenge Health, Demographic Change and Wellbeing Central globe image © rtguest/Fotolia.com Global cooperation image courtesy freedigitalfotos.com/ phanlop88 Collaborative RESEARCH image courtesy freedigitalfotos.com/ photostock Collaborative research Public-private partnerships Public-public partnerships Global initiatives GACD, GloPID-R, IRDiRC..

24. Research & Innovation Collaborative research in work programme 2014-2015 Adapting to an ageing population Pursuing the path to more personalized medicine Translational research (clinical trials) Harnessing and encouraging private sector capability Coordinating national efforts Reducing costs (comparative effectiveness research) Expanding global cooperation

25. Research & Innovation and Strategic initiatives:  Understanding health, ageing & disease  Effective health promotion, disease prevention, preparedness and screening  Improving diagnosis  Innovative treatments and technologies  Advancing active and healthy ageing  Integrated, sustainable, citizen-centred care  Improving health information, data exploitation and providing an evidence base for health policies and regulation + co-ordination activities 7 focus areas in (2014) 2015

26. Research & Innovation The Work Programme (2014) 2015 Call for 'co-ordination activities' 16 topics (10 in 2014, 6 in 2015) Call 'personalising health and care' 34 topics (15 in 2014, 17 in 2015, 2 open in both years) € 1,21 billion

27. Research & Innovation Some of the topics for 2015  PHC 3*: Understanding common mechanisms of diseases and their relevance  PHC 11: Development of new diagnostics tools and technologies: in vivo medical imaging technologies  PHC 14: New therapies for rare diseases  PHC 16: Tools and technologies for advanced therapies (e.g. gene or cell therapies)  PHC 16: Promoting mental wellbeing in the ageing population * PHC = Personalising Health and Care

28. Research & Innovation Understanding the call topics: example 'PHC 2 – 2015' 'Specific challenge' 'Scope' 'Expected impact' 'Type of action'

29. Research & Innovation From CALL to GRANT Publication of the calls Submission of proposals Signature grant agreement Information on the outcome of the evaluator Time to prepare the proposal Finalisation of the grant Evaluation

30. Research & Innovation Overview of the Evaluation Process Full Proposal Proposal forms Criteria Eligibility Criteria Final ranking list Panel meeting Submission Consensus meeting Individual reading Proposals in suggested priority order Rejection list Finalisation Individual reports Consensus reports COMMISSION “remote” “on site” Involving evaluators

31. Research & Innovation Innovation actions higher weighting for "IMPACT" STANDARD AWARD CRITERIA QUALITY & EFFICIENCY OF THE ACTION QUALITY & EFFICIENCY OF THE ACTION IMPACT EXCELLENCE Evaluation of proposals ERC frontier Research actions only EXCELLENCE

32. Research & Innovation Time to grant: speeding up the process A maximum TTG of 8 months 5 months for informing all applicants on scientific evaluation 3 months for signature of Grant Agreement Some exceptions apply

33. Research & Innovation A few points to remember 1b€/year devoted to health research in Horizon 2020 One rule: Minimum 3 partners from 3 EU countries + anyone else from anywhere in the world Funding: 3-12 m€ per project 100%+25% reimbursement rate Project duration: 3-5 years Call publication: 11 December 2013

34. Research & Innovation Endocrine disrupters 1 st call for proposals under Horizon2020 published: Some proposals received address issues related to endocrine disruption (Topic PHC1) A new European Strategy on Endocrine Disrupters under development Discussions are ongoing on the development of a European Platform on human biomonitoring (it would include endocrine active substances)

35. Research & Innovation 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 dedicated activity for research- intensive SMEs in 'Innovation in SMEs' 'Access to risk finance' will have a strong SME focus (debt and equity facility)

36. Research & Innovation SME instrument Concept & Feasibility Assessment Innovation R&D activities Commercialisation Phase 2 Phase 1 Phase 3 Idea Market Feasibility of concept Risk assessment IP regime Partner search Design study Development, prototype, testing Miniaturisation/desi gn Clinical trials Etc. Facilitate access to private finance Support via networking, training, coaching, knowledge sharing, dissemination Lump sum: ~ 50.000 € ~ 6 months EU funding: 1 to 5 M€ 12 to 36 months No direct funding Budget: ~€3 billion

37. Research & Innovation Financing instruments (EC support trough the European Investment Fund) Equity instrument for innovative SMEs Seed, start-up, early stage, expansion & growth phase Target: indirect support to 1,000 SMEs Debt instrument for innovative SMEs Loan guarantees for small and mid caps Target: indirect support to 3,000 SMEs For large organisations RSFF success: 1:9 leverage effect! Renewed loans & guarantees services Budget: ~€2.8 billion NEW!

38. Research & Innovation Funding Third country identified in the Work Programme or International Cooperation participation deemed by the Commission essential in the action or when provided under a bilateral scientific and technological agreement

39. Research & Innovation Multi-lateral health research activities: an experience that will continue International K.O. Mouse Consortium International Cancer Genomics Consortium International Human Microbiome Consortium International Human Epigenome Consortium International Rare Disease Research Consortium International Initiative for Traumatic Brain Injury Research Global Alliance for Chronic Diseases New! Global Research Collaboration for Infectious Disease Preparedness

40. Research & Innovation 200 New Therapies Means to Diagnose Most Rare Diseases © Yuri Arcurs/Fotolia.com © nyul/Fotolia.com IRDiRC vision and 2020 goals

41. Research & Innovation Global Alliance for Chronic Diseases: Global health challenges Why international cooperation ? Health research is a priority for all of us Addressing global challenges needs critical mass of resources, expertise, infrastructures, patients Need for data sharing, exchange of good practices Sharing work and costs Strategic objectives Tackle chronic non-communicable diseases Contribute towards the MDGs GACD is a unique model of pairing HIC with LMIC researchers More @ http://www.gacd.org/

42. Research & Innovation Europe E-RARE 2 Consortium (EU) European Commission EURORDIS (EU) Academy of Finland French Muscular Dystrophy Association French National Research Agency French Foundation for Rare Diseases Children's New Hospitals Management Group (GE) German Federal Ministry of Education and research Italian Higher Institute of Health Research Italian Telethon Foundation Lysogene (FR) Netherlands Organisation for Health Research and Development Prosensa (NL) Spanish Carlos III Health Institute UK National Institute for Health Research Committed members © rtguest/Fotolia.com Australia Western Australian Dept. of Health Asia BGI (CN) Chinese Rare Disease Consortium Korea National Institute of Health North America Canadian Institutes for Health Research Genome Canada FDA Orphan Products Grants Program Genetic Alliance (US) Genzyme (US) Isis Pharmaceuticals (US) Mendelian Disorders Genome Centres (US NIH) National Centre for Translational Sciences (US NIH) National Cancer Institute (US NIH) National Institute of Neurological Disorders and Stroke (US NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (US NIH) National Institute of Child Health and Human Development (US NIH) National Eye Institute (US NIH) NKT Therapeutics (US) NORD (US) Office of Rare Diseases (US NIH) PTC Therapeutics (US) Sanford Research (US) Shire (US)

43. Research & Innovation IRDiRC Policies & Guidelines Common framework with separate sections for researchers and funders addressing various aspects of research, such as Sharing of data and samples Rapid release of research results Common quality standards Interoperability and harmonisation of ontologies and bio-banks Involvement of patients Document available on: www.irdirc.org

44. Research & Innovation Global Research Collaboration for Infectious Disease Preparedness (GloPID-R) A network of funding organisations across the continents

45. Research & Innovation Why a Global Research Collaboration for Infectious Disease Preparedness Future (like past) severe epidemics will not be restricted to single nations or regions, but will have the potential to threaten the population of the entire planet 'Preparedness Research' on (Re-)Emerging Infectious Diseases (development of diagnostics, epidemiology, clinical trials etc.) requires a rapid international research response Unlike the public health response (coordinated by WHO), there is currently no forum for the coordination of an international research response to such outbreaks!

46. Research & Innovation Next steps of GloPID-R Agreement on governance in 2014 "GloPID-R Charter" Establishment of Secretariat end 2014/early 2015 Next meeting: Canada, 30/09-1/10 2014 Contact points: Line Matthiessen, Cornelius Schmaltz, Irene Plank, RTD-Unit E.3

47. Research & Innovation Innovative Medicines Initiative (IMI) 650 Academic & research teams 409 EFPIA teams 17 regulators 25 patient org. 120 SMEs More @ http://www.imi.europa.eu/ 47 P ROJECTS & >6,000 R ESEARCHERS

48. Research & Innovation IMI2, originated from IMI, is the biggest public/private partnership in Life Science  Mission: to create a powerful research and innovation "machine", with broader objectives, activities and partners  Budget: around 3.28 billion euro, equally shared between public and private partners  Key objectives: Pave the way for the breakthrough vaccines, medicines and treatments Enable top quality research and innovations with great public health benefits and commercial possibilities IMI2: main novelties

49. Research & Innovation EDCTP: The European and Developing Countries Clinical Trials Partnership Established in 2003 as Part of the Union's response to the global health crisis caused by HIV/AIDS, malaria and tuberculosis Collaboration between the EC, 16 European countries and 48 sub-Saharan African countries Pioneered joint programming, i.e. the coordination, alignment and integration of European national research programmes. Objectives: Funding clinical trials on HIV/AIDS, TB and Malaria Strengthening related capacities

50. Research & Innovation European and Developing Countries Clinical Trials Partnership 2 (EDCTP2)  EU contribution up to €683 million - to be matched by participating EU/associated countries  Broader scope: including neglected infectious diseases, all clinical phases, diagnostics and delivery optimisation  Longer duration: 10 years

51. Research & Innovation Image courtesy of Ambro/ FreeDigitalPhotos.net Active and Assisted Living 2 Market-oriented ICT research in assisted living technologies and services New instruments e.g. prizes and innovation grants More EU funding of up to €175 million Participating countries pay ~€225 million

52. Research & Innovation Other programmes where health research may be funded  Frontier research (European Research Council)  Marie Skłodowska-Curie actions  Leadership in enabling and industrial technologies  Search by key-word @ https://ec.europa.eu/research/participants/portal/desktop /en/opportunities/h2020/search/search_topics.html

53. Research & Innovation More info @ Health Challenge: http://ec.europa.eu/programmes/horizon20 20/en/h2020-section/health-demographic- change-and-wellbeing Info Day (information for proposers): http://ec.europa.eu/research/health/horizon -2020-health-open-info-days_en.html Examples of projects funded in previous programmes: http://ec.europa.eu/research/health/index_ en.html