Horizon 2020: Societal Challenge 1 Health, demographic change and wellbeing

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1 Horizon 2020: Societal Challenge 1 Health, demographic change and wellbeing HHN Brokerage event - 13 January 2016 Philippe Cupers, PhD Deputy Head of Unit, Health Strategy Unit Health Directorate DG Research & Innovation European Commission

2 How do we invest our funding?

3 Better health for all A more competitive European health industry and care sector Maximising the digital potential Addressing health as a global challenge

4 3 Os: Open Innovation Open Science Open to the World Carlos Moedas, EU Commissioner for Research, Science and Innovation

5 : EUR 1.3 B : EUR 1.4 B Personalised medicine ( ) Healthy ageing ( ) Health ICT ( ) Infectious Diseases ( ) Human biomonitoring ( ) Maternal and child health ( )

6 Priority 'Personalised Medicine' 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 European Personalised Medicine Consortium +

7 Personalised Medicine Conference 1-2 June Brussels Policy focus with around 450 participants Official launch of IC PerMed 5 thematic sessions based on PerMed SRIA (see below) Highlighting best practice examples Developing awareness & Empowerment Integrating Big Data & ICT solutions Translating Basic to Clinical Research & Beyond Shaping Sustainable Healthcare Bringing Innovation to the Market

8 European Human Biomonitoring Initiative supporting a better management of chemicals in our daily life Europe has a good regulatory framework for chemicals, but decision making is hampered by lack of evidence of human exposure: human biomonitoring Flame retardants Joining forces and sharing knowledge: 6 Commission DGs, 3 Agencies & 28 countries linking science to policy for better regulations Chemicals matter! In the economy, in the environment and for human health striking the right balance between risks and benefits Bisphenols Polyfluorinated compounds PAHs Phthalates 8 Cd and Cr6+

9 Priority on Infectious Diseases research Collaborative research HIV/AIDS, Malaria and Tuberculosis; Neglected Infectious Diseases (NID); Emerging Epidemics; Antimicrobial drug resistance (AMR) SC1-PM : Vaccine development for malaria and/or neglected infectious diseases 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

10 Priority on ICT solutions for active & healthy ageing 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) EU Japan Cooperation (2016) Smart Living Environments Large-scale pilot (2016) Stimulate research and growth in SMEs ( ) PPI for deployment and scaling up (2016) CSAs Standards & Silver Economy take-up (2016)

11 Priority on ICT for Health 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. 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

12 Health research in Horizon 2020 Support through all funding instruments

13 Health research: different programmes serving different communities & purposes Public-private partnership with big pharma Collaborative projects Public-public partnerships with EU Member States & beyond Grants for small businesses HORIZON 2020 Blue sky research Loans for small and big R&I companies Knowledge triangle: Higher education, business, R&I

14 The world's largest public private partnership in health research IMI 2 billion IMI billion Developing the next generation of vaccines, medicines and treatments EFPIA = European Federation of Pharmaceutical Industry Association

15 Success stories: IMI European Lead Factory 1 st European Compound Library & Screening centre 150 employees combining innovation of academia, agility of SMEs, and experience of Pharma Objective: free access to up to 500,000 novel compounds Drug targets: Already >500 hit compounds handed over to academics and SMEs to start drug development programmes 58 drug targets accepted after screening, 21 Qualified Hit Lists delivered Library designs: 175 validated library proposals, close to 80k compounds delivered Target: 200,000 publicly-sourced compounds adding to the 300,000+ EFPIA compounds

16 The European & Developing Countries Clinical Trials Partnership Capacity for Clinical trials in Africa Synergy Clinical trials in Africa on PRDs

17 Two HIV paediatric formulas safe and highly effective at protecting infants during breastfeeding up to 12 months after birth The Lancet, 18 November 2015 Pyramax approved as antimalarial for treatment of multiple episodes of malaria EMA news: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) November December 2015 EDCTP receives Science Diplomacy Award at South African Science Forum

18 EU health research Achievements

19 Joint Programming Initiative on Antimicrobial Resistance recognised as model in WHO Global Action Plan Cure of leukemia through gene editing First blood test for Alzheimer's diagnostic WHO guidelines: only 2 HPV vaccine doses are needed Nobel Prize: Dr. Moser Success Story SPACEBRAIN Ebola Emergency procedure 2014 Contributions to European Citizen's initiatives on stem cells and on animal experiments EDCTP and GloPID-R recognised by G7 as key instruments of coordination WHO guidelines on the use of illicit drugs in medicine First loan awarded under the InnovFin Financial Facility Adoption of a new innovation-friendly EU clinical trials regulation 2015 Making needs of health research heard in legislative process for Data Protection Regulation

20 Achievements in the areas of Clinical trials Cancer research Vaccines Innovative therapies

21 Clinical Trials FP7 Other Tissue Regeneration HIV/AIDS, malaria and Adverse Drug Reaction Research Brain and brain-related diseases Organ transplantation Cell-based immunotherapy Targeted nucleic acid delivery Cancer Diabetes and obesity Anti-microbial drug resitance Regenerative medicine Cardiovascular diseases Human development and ageing Off-Patent Medicines for Children Rare diseases CT funded in FP7 by FP7 activity area FP7 CT Budget Evolution

22 Clinical Trials Horizon 2020 Key element of health research supported in Horizon 2020: no innovation without clinical trials! Specific Programme (legal basis): "translation of research findings into the clinic, in particular through the conduct of clinical trials [ ] is essential" 2014/15 calls: Over 300 million of funding earmarked for clinical trials projects Emphasis on SMEs and on investigator-driven clinical trials

23 Cancer research: setting the path for personalised medicine Prevention Aetiology Diagnosis / Prognosis Model Systems Therapy Survivorship / QoL Stratification and high risk groups Molecular understanding of disease Molecular classification of cancer subtypes Molecular taxonomy Biomarker identification for: Diagnosis Prognosis Prediction Monitoring Medical Imaging to optimize treatment options Wide range of animal models In silico models In vitro & exvivo models (xeno patients) Targeted drug development via biology driven hypothesis Bio-informatics for treatment decision making Novel CT design Identification of sub-groups for better quality of life

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25 Inplementation modalities European strategy for vaccines Discovery Preclinical Phase I Phase II/ III Regulatory Capacity building vaccine Small/Large collaborative projects / SME instrument EDCTP clinical trials program IMI non-competitive technology, bottlenecks BioVacSafe Translational research Clinical capacity Advance

26 Financial instruments

27 Idea Phase 1 Phase 2 Phase 3 Concept & Feasibility Assessment Innovation R&D activities Commercialization Market Feasibility of concept Risk assessment IP regime Partner search Design study Lump sum: ~ ~ 6 months Development, prototype, testing Miniaturisation/design Clinical trials Etc. EU funding: 1 to 5 million EUR 12 to 36 months Facilitate access to private finance Support via networking, training, knowledge sharing, dissemination No direct funding

28 SME instrument in SC1 WP 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

29 Success stories: SME instrument Immunovia AB: Spin-off from Lund University & CREATE the Center for Translational Cancer Research in Lund - founded in 2007 IMMray, a technology platform used to diagnose, predict disease progression and monitor the therapeutic responsiveness of cancers Dec. 2014: SME instrument project - EU contribution: 4 million EUR Dec. 2015: Initial Public Offering (IPO) at Nasdaq First North Stockholm Mats Grahn, CEO of Immunovia: "The fact that we received this very large grant in competition with so many companies and after thorough evaluations has given the confidence to our investors in the process of making the IPO"

30 InnovFin products overview

31 Which projects can be supported? Infectious diseases Innovative Vaccines, drugs Medical and diagnostic devices R&D Infrastructures Projects which have passed pre-clinical stage and for which clinical validation is needed for further development Loan amount: min EUR 7.5 million, max EUR 75 million Loan maturity: up to 7 years Currency: EUR and local currency Pricing : commensurate to the risk incurred

32 1 project signed 10 million loan from EIB, backed by H2020 Signed July 2015 Low-cost HIV viral load testing device was proven in FP7 EU project to work in simplified, less sophisticated laboratories Loan will allow Cavidi to develop an automated, high-throughput version of the device, and launch it in 2016

33 Summary of investments (November 2015) Type of support Number of health related projects EU support (EUR million) Total project cost (EUR million) SME instrument Fast-track to Innovation (FTI) InnovFin EFSI * Grant Grant Loan Loan ** *** 290**** ,599.7 at least double * Data in progress ** Including InnovFin Infectious Diseases *** InnovFin loan amount **** EFSI financing, as published

34 Addressing global health challenges Open to the world

35 Global coordination of R&I with funding agencies outside Europe intbir.nih.gov ihec-epigenomes.org G2MC icgc.org

36 Success stories: Global Alliance for Chronic Diseases Feel4Diabetes: Project supporting social and physical lifestyle changes to prevent diabetes in vulnerable families across Europe Strategy: Phase I (PRECEDE): Identification of target populations, behaviors and determinants Review of existing type 2 diabetes prevention, policies, legislation Development of a low-cost & applicable in low-resource settings community-based intervention programme Phase II (PROCEED): Implementation of intervention Assessment of the impact, outcome, cost-effectiveness and scalability

37 SC1 Statistics Calls Tips for applicants

38 SC1 implementation so far (EU28 & AC) EU contribution: EUR 1.3 B 401 projects 1,480 organisations 54 countries EUR 3.4m average project size Academia:40.2% Research org: 25.3% SME: 19.7% Industry: 6.4% Other: 8.4%

39 Horizon 2020 SC1: Specific activities (excl. IMI 2 & EDCTP 2) SC1 Specific activities Understanding health, well-being and disease Topics ( ) Projects funded ( ) EU contribution ( ) (EUR million) ,8 Preventing disease* ,6 Treating and managing disease* 14* 238* 491,3* Active ageing and selfmanagement of health ,5 Methods and data ,1 Health care provision and integrated care Specific implementation aspects (coordination) * Including SME instrument topic (phase 1 & 2) ,

40 H2020 should contribute to Commission priorities Research and innovation is a priority for the EU but Horizon 2020 must deliver EXCELLENT research and innovation Projects must have an IMPACT Show ADDED VALUE, be multidisciplinary and well-implemented Reflected in the evaluation criteria

41 Health research expected outputs More healthy life years Evidence based policy making Medicines for children Taking the lead in new areas Responding to emergencies Health Technology Assessment Personalised medicine Knowledge creation and exploitation and many others ATMP

42 Towards SC1 WP

43 2016 Timetable towards the Work Programme Updates 2017 January Finalisation of Draft WP texts February March Discussion in PC configurations April-May June Inter-Service Consultation (adoption of the proposal for Draft Budget 2017) Opinion of PC configurations July Adoption of WP/Financing Decision 2017

44 Process towards WP Q1-Q3/2016 Q4/ Foresight and stakeholder consultation (Advisory Groups) Consultation Member States Strategic Priorities Elaboration and adoption of work programme

45 HORIZON 2020 Thank you for your attention