HORIZON The European Union s support for cancer research: towards personalised medicine. The EU Framework Programme for Research and Innovation

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1 The EU Framework Programme for Research and Innovation HORIZON 2020 The European Union s support for cancer research: towards personalised medicine Dominika TRZASKA, PhD Scientific and Policy Officer in charge of cancer Directorate E Health Research DG Research and Innovation European Commission

2 28 Member States + 11 associated countries* pooling resources One unique R&I programme The European Union programme for research and innovation for with a budget of 79 billion Rationale: R&I is increasingly complex, interdisciplinary, costly, requiring critical mass Europe = 28 countries: need for increased collaboration Overarching ambition of Horizon 2020: Respond to the economic crisis to invest in jobs and growth Address people s concerns about their livelihoods, safety and environment Strengthen the EU s global position in research, innovation and technology * Albania, Bosnia and Herzegovina, Faroe Islands, Former Yugoslav Republic of Macedonia, Iceland, Israel, Moldova, Montenegro, Norway, Serbia and Turkey

3 3 Os: Open Innovation Open Science Open to the World "As I see it, European success now lies in sharing as soon as possible, ( ). The days of open science have arrived. Speech at "Presidency Conference Open Science", Amsterdam, April 4, Carlos Moedas, EU Commissioner for Research, Science and Innovation

4 Horizon 2020 budget breakdown The EU R Societal Challenge 1 (SC1) Health, Demographic change and Wellbeing EUR: 7.4 billion Frontier research Future and emerging technologies Training and mobility Research infrastructures

5 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 Blue sky research Loans for small and big R&I companies Knowledge triangle: Higher education, business, R&I

6 Health, demographic change and well-being challenge Our priorities Personalised medicine Call : EUR 1.3 B Call : EUR 1.4 B Healthy ageing ( ) Human biomonitoring ( ) Health ICT ( ) Infectious Diseases ( ) Maternal and child health ( )

7 Health, demographic change and well-being challenge Better health for all A more competitive European health industry and care sector Maximising the digital potential Addressing health as a global challenge Evidence for informed healthcare policies Cancer: a global health priority A changing healthcare landscape Innovative drugs in the pipeline Leading personalised medicine

8 A long term EU priority and investment - Enabling the rise of personalised medicine Large scale data gathering and "-omics" Technology development Diagnostics & biomarkers Clinical trials & methodologies Pre-clinical and clinical research Merging digital and physical; big data Piloting personalised medicine in healthcare

9 Pioneering personalised medicine in cancer Prevention Aetiology Diagnosis / Prognosis Model Systems Therapy Survivorship / QoL Stratification and high-risk groups Molecular understanding of disease Molecular classification of cancer subtypes Risk factors 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 ('xenopatients') Targeted drugs via biology-driven hypothesis Bio-informatics for treatment decision making Novel CT design Solutions for side effects Quality-of-life: Debilitation Infertility Fatigue Early death Second cancers Breast, cervix, colon cancer screening Role HPV virus in Head-and-neck cancer Epigenetic markers Breast and ovarian cancer Modelling prognosis in colorectal cancer Image-guided radiotherapy for lung cancer Identify radiosensitive breast, prostate, lung cancer patients

10 EU cancer research funding (FP7+HORIZON2020) Prevention collaborative research training frontier Screening and diagnosis Infections-related cancers Immunotherapy and vaccines Childhood cancers innovation Survivorship 276 Investigator-driven trials Palliative & end-of-life care EUR 2.1 billion ( ) focus on clinical solutions for patients, innovation, close-to-market

11 Breast cancer: Changing clinical practice FP6, Horizon 2020, million Validation of the 70-gene signature 4 million 2015: MammaPrint final clinical utility 2002: 70-gene signature published 2007: FDA approves Mammaprint MINDACT trial : Microarray In Node negative Disease may Avoid ChemoTherapy Mammaprint reduced chemotherapy prescription postsurgery by 46% Leveraged funds: 43 million Phase III CT 6693 women enrolled

12 CAR T cells a road to cure CAR T cells CANCER THERAPIES Training and education Biology Manufacturing platform Clinical trials Training workforce New targets Increasing the anti-tumour effect and persistence of CAR-T cells Mapping T CAR clinical trials in Europe Automated, safe, and cost efficient manufacture of CAR-modified T-cells Universal CAR T cells produced by ATECT released for compassionate use resulted in molecular remission of B-ALL in two 18-month old infants

13 Childhood cancer a priority Childhood cancer Clinical trials Roadmap Survivorship, quality of life Patients' rights, reducing inequalities Specific paediatric formulations of oncology drugs Clinical trials Acute lymphoblastic leukaemia (IntREALL) Liver cancer (CHILTERN) Sarcomas (EuroSARC, EEC) Survivorship studies Large registries Risk estimates and follow-up guidelines Survivorship PASSPORT cloud-based IT Tool Novel trial methodologies, empowering patients, creating expert networks Over 140 million in 56 projects in FP7 and H2020 European Cancer Plan for Children and Adolescents

14 Difficult to treat cancers: pancreatic cancer Biology New animal models (mouse, zebrafish) Microenvironment Stem cells Pancreatic cancer Better diagnosis Novel biomarkers Nanosystem platform for diagnosis Liquid biopsy Better treatments Novel compounds Image-guided drug delivery Immunotherapy Nanoformulations Clinical trials Over 107 million in 43 projects in FP7 and H2020

15 Rare cancers: EU-wide impact Epidemiology, registries, biobanks Sarcoma research Epidemiology Biomarkers Clinical trials Patient-centred approach Biomarkers Predictive and prognostic markers Prognostic CINSARC sarcoma signature Translational research Response Toxicity Clinical trials Early phases Phase II and III trials (over 10) Patient advocacy groups' involvement Patient-reported outcomes

16 Delivering diagnostics to market Cancer indication Project Beneficiary EU funding What it will deliver Breast cancer MAMMAPRINT Agendia NV 4.1 million Final clinical utility testing of diagnostic test MammaPrint before worldwide uptake Bladder cancer LAUREN CYTOSYSTEMS LTD 3.1 million a commercial non-invasive in vitro diagnostic based on MCM2+ Lung cancer RAIL PT THERAGNOSTIC BV 2.4 million RAIL: Prognostic radiomic biomarker Cervical cancer VALID-SCREEN SELF-SCREEN BV 3.3 million clinical validation of PreCursor-M in well-characterised cohorts before commercialisation Glioma GLIOMARK CONSULTECH 4.7 million Validation of blood-brain-barrier permeability of a 99mTctetrofosmin biomarker using SPECT-CT Pancreatic cancer IMMPACT Immunovia AB 4.2 million Clinical validation serum protein biomarker for early diagnosis *

17 Research in SC1 Work Programmes PHC : Understanding common mechanisms of diseases and their relevance in co-morbidities PHC : Health promotion and disease prevention: translating 'omics' into stratified approaches PHC : Development of new diagnostic tools and technologies: in vitro devices, assays and platforms PHC : Development of new diagnostic tools and technologies: in vivo medical imaging technologies PHC : Clinical research for the validation of biomarkers and/or diagnostic medical devices PHC : New therapies for chronic non-communicable diseases PHC : Comparing the effectiveness of existing healthcare interventions in the elderly PHC : Establishing effectiveness of health care interventions in the paediatric population SC1- PM : New concepts in patient stratification SC1-PM : Networking and optimising the use of population and patient cohorts at EU level SC1-PM : New therapies for chronic diseases SC1-PM : Comparing the effectiveness of existing healthcare interventions in the adult population

18 For individual researchers: European Research Council (ERC) ERC Starting Grants ERC Consolidator Grants ERC Advanced Grants ERC Proof of Concept Marie Skłodowska-Curie Actions Innovative Training Networks (ITN), Research and Innovation Staff Exchange (RISE), Individual Fellowships (IF) Co-funding of regional, national and international programmes (COFUND) Projects funded by ERC under FP from Science Behind the Projects 3 Billion Euro, 1500 projects

19 IMI2 Europe's partnership for health 2.5 bn Partnership > 5 bn 2.5 bn Focus on unmet needs Non-competitive collaborative research Competitive calls for proposals Open collaboration in public-private consortia Industry contribution is mainly in-kind

20 IMI supports cancer research CancerID Circulating tumour cell based biomarkers MARCAR Cancer risk biomarkers Quic Concept Imaging biomarkers ONCOTRACK Omics, xenopatients From biomarkers to models to big data PREDECT In vitro models HARMONY Big data in haematological malignancies ITCC-P4 Paediatric cancers PoC platform Over EUR 130 million Currently open call: How big data could support better diagnosis and treatment outcomes for prostate cancer Creation of a pan-european Paediatric Clinical Trials Network

21 Coordination DG SANTE: Cancon is a joint action, co-funded by participating institutes, organisations, universities and health care units Will support MS to place cancer firmly on their public health agendas Is producing the European Guide on Quality Improvement in Comprehensive Cancer Control Will improve national healthcare situations by applying and adapting recommendations in the Guide Will contribute to decreasing cancer mortality EUR 6 million,

22 Coordination TRANSCAN-2: long-term translational cancer Public Public Partnership through national programme managers, owners, funders (ERA-NET Cofund) Continuation of TRANSCAN. Started 1 January It links 28 national/regional funding organisations in 19 countries on translational cancer research 1st joint call on 'Tumour heterogeneity' 2 nd joint call on 'Immunology and immunotherapy of cancer: strengthening the translational aspects' 3rd joint call on 'Minimally and non-invasive methods for early detection and/or progression of cancer ' Outcome 1st call Partners funded 16 projects with overall national call budget of 17.2 million EU Cofund contribution 6.7 million Cancer indications: breast, colorectal, leukemia, myeloma, ovaries, gastric, melanoma, head-and-neck

23 ERNs European Reference Networks Innovative, clinical, virtual cross-border networks for the diagnosis and treatment of rare or low prevalence complex diseases. 24 thematic ERNs from 26 countries, following 2 PoC ERNs. Will create clinical coordination hubs across MS in rare-low prevalence disease areas. Set up under the EU Directive on Patients' Rights in Healthcare (2011/24/EU) to facilitate patients' access to information on healthcare and ameliorating treatment options. Cancer ERNs ERN EuroBloodNet - European Reference Network on Rare Haematological Diseases ( ) ERN EURACAN - European Reference Network on Rare Adult Cancers (solid tumours, ) ERN PaedCan - European Reference Network for Paediatric Cancer (haematooncology, ) ExPO-r-Net - European Expert Paediatric Oncology Reference Network for Diagnostics and Treatment ( ). One of two 'proof of concept' ERNs.

24 Teaming up with global partners 15 US partners including 8 NIHs NIH/NINDS NIH NIH Roadmap Epigenomics Program NCI, NHGRI Bill and Melinda Gates Foundation US Dept. of Health and Human Services

25 Health, demographic change and wellbeing challenge Headlines Better health and care, economic growth and sustainable health systems Personalised medicine innovative healthcare industry global health sustainable and evidence based health and care systems Decoding the role of the overall environment for health and well-being Human exposome global changes and health Digital transformation in Health and Care ehealth and mhealth ICT for Active and Healthy Ageing Trusted Big Data solutions and Cybersecurity for Health and Care

26 What EU offers A network of collaborative projects throughout Europe and beyond, addressing the continuum of cancer research-care Established public-private partnership to accelerate the delivery of innovative therapies Established public-public partnerships to boost research coordination between EU countries Close-to-market solutions provided by SMEs A strong experience in international/global cooperation, via a flexible model

27 Conclusions Lot of potential for collaboration, knowledge and data across disciplines and sectors, including public-public and publicprivate partnerships, building on existing projects and schemes Accelerating innovative research for the benefit of patients: prevention, risk reduction, early diagnosis, treatment, care Strong support to international efforts, including the development of research plans and policies Horizon 2020 provides many opportunities to rapidly deliver in the field of cancer research!

28 Keep in touch All about Horizon 2020: visit our website Participant portal: all EU calls and topics