The societal challenge: health, demographic change and wellbeing, and IMI2. Results from first (2014) calls

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1 The societal challenge: health, demographic change and wellbeing, and IMI2 Results from first (2014) calls Ruxandra Draghia-Akli, MD, PhD Director Health DG Research and Innovation CLORA 20th April 2015

2 Health 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 7.5bn (of 31bn) Collaborative projects LEIT Biotech AAL-2 Financial instruments EDCTP-2

3 SC1 Work Programme Call 'personalising health and care' 34 topics (15 in 2014, 17 in 2015, 2 open in both years) Call for 'co-ordination activities' 16 topics (10 in 2014, 6 in 2015) 1,21 billion

4 SC1 - Analysis of 2014 calls - first coverage overview -

5 Call 'personalising health and care' Topic PHC : Understanding health, ageing and disease: determinants, risk factors and pathways PHC : Health promotion and disease prevention: translating omics into stratified approaches PHC : Evaluating existing screening and prevention programmes PHC : Improving the control of infectious epidemics and foodborne outbreaks through rapid identification of pathogens (see also societal challenge 2) PHC : Vaccine development for poverty-related and neglected infectious diseases: Tuberculosis PHC : Development of new diagnostic tools and technologies: in vitro devices, assays and platforms PHC : New therapies for chronic noncommunicable diseases Funded projects Allocated budget million

6 Call 'personalising health and care' PHC /2015: Clinical research on regenerative medicine PHC : Comparing the effectiveness of existing healthcare interventions in the elderly PHC : Advancing active and healthy ageing with ICT: Service robotics within assisted living environments PHC : Advancing active and healthy ageing with ICT: ICT solutions for independent living with cognitive impairment PHC : Developing and comparing new models for safe and efficient, prevention oriented health and care systems PHC : Self-management of health and disease: citizen engagement and mhealth PHC : Foresight for health policy development and regulation PHC : Advancing bioinformatics to meet biomedical and clinical needs PHC : ehealth interoperability 4 3.8

7 Call 'personalising health and care' (2014) Call PHC-two stage 2014 Number of opened topics 8 Indicative budget available ( ) 303 million Deadline Stage 1 11 March 2014 Stage 1 Number of proposals received 1681 Stage 1 Number of successful proposals 626 Deadline Stage 2 19 August 2014 Stage 2 Number of eligible proposals received 605 Stage 2 Number of funded proposals 62

8 Call 'personalising health and care' (2014) Call PHC-single stage 2014 Number of opened topics 8 Indicative budget available ( ) Deadline 15 April 2014 Number of proposals received 451 Number of funded proposals 41

9 Call 'personalising health and care' (2015) Call PHC-two stage 2015 Number of opened topics 10 Indicative budget available ( ) 306 million Deadline Stage 1 14 October 2014 Stage 1 Number of proposals received 2096 Stage 1 Number of successful proposals 506 Deadline Stage 2 21 April 2015 Stage 2 Number of eligible proposals received evaluation on-going Stage 2 Number of funded proposals evaluation on-going

10 Call 'personalising health and care' (2015) Call PHC-single stage 2015 Number of opened topics 8 Indicative budget available ( ) Deadline 24 February 2015 (RTD) 21 April 2015 (CNECT) Number of proposals received Number of funded proposals 80 (3 topics - RTD) evaluation on-going

11 PHC 1 - Understanding health, ageing and disease: determinants, risk factors and pathways LIFEPATH: Life course biological pathways underlying social differences in healthy ageing Objectives: To understand the mechanisms through which healthy ageing pathways diverge by socio-economic status, including the investigation of lifecourse biological pathways using -omics technologies To examine the consequences of economic recession and of the associated increase in social inequalities on health and biology of ageing To obtain information on healthy ageing at different stages of life, based on the concepts of life-course epidemiology and multi-morbidity To integrate social sciences approaches with biological studies Impact: Understanding the determinants of diverging ageing pathways among individuals belonging to different socio-economic groups Devising innovative Public Health strategies to ensure that healthy ageing is an achievable goal for society as a whole

12 PHC 7 - Improving the control of infectious epidemics and foodborne outbreaks through rapid identification of pathogens COMPARE: COllaborative Management Platform for detection and Analyses of (Re-) emerging and foodborne outbreaks in Europe Objectives: 'One serves all' analytical framework + data exchange platform for real time analysis and interpretation of sequence-based pathogen data in combination with associated data (e.g. clinical, epidemiological data) Integrative approach: animal, human and zoonotic pathogens, public + veterinary health, academics and public/veterinary health officials EU contribution to global efforts: Global Microbial Identifier and GloPID-R Integrated risk assessment and risk communication tools To generate actionable information for support of patient diagnosis, treatment, outbreak detection and investigation Linked to scalable and open-source data- and information platform and to existing and future complementary systems, networks and databases such as those used by ECDC, NCBI and EFSA

13 PHC 6, 23 and 31 => novelties for health policy development Putting Iodine Deficiency (ID) on the map in Europe. EUTHYROID will evaluate Iodine Deficiency prevention and monitoring programmes in 24 European countries, and initiate capacity building for harmonized European ID prevention and monitoring programmes. Validating financing/payment models for integrated chronic care (ICC) for multi-morbid patients. SELFIE will develop new models of care and generate empirical evidence of the impact of ICC and on financing/payment schemes Building future scenarios for health policy. EUROHEALTHY will focus on the effect on health inequalities FRESHER will address future burden of non-communicable diseases, collaboration with OECD

14 Type of organisations in signed GA resulting from PHC-2014 calls

15 Countries of origin of coordinators in signed GA resulting from PHC-2014 calls

16 Call for 'co-ordination activities' Activitis in 2014 European Innovation Partnership on Active and Healthy Ageing (EIP-AHA) Funded projects 1 2 Allocated budget million Joint Programming Initiative 'More Years, Better Life's (MYBL) 1 2 Joint Programming Initiative on neurodegenerative diseases (JPND) 1 10 Translational cancer research Systems medicine for clinical needs Rare diseases Global Research Collaboration for Infectious Disease Preparedness (GloPID-R) Global Alliance for chronic diseases (GACD) diabetes 3 10

17 Call for 'co-ordination activities' (2014) Call HCO-single stage 2014 Number of opened topics 11 Indicative budget available ( ) 40 Deadline 15 April 2014 Number of proposals received 49 Number of funded proposals 14

18 Call for 'co-ordination activities' (2015) Call HCO-single stage 2015 Number of opened topics 5 Indicative budget available ( ) 29 Deadline 24 February 2015 Number of proposals received 27 Number of funded proposals evaluation on-going

19 HCO 5 - Global Alliance for chronic diseases (GACD) diabetes Feel4Diabetes: Developing and implementing a community-based intervention to create a more supportive social and physical environment for lifestyle changes to prevent diabetes in vulnerable families across Europe Objectives: To develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes Phase I (PRECEDE): identify target population, behaviours and determinants. - review existing type 2 diabetes prevention, policies, legislation - develop a low-cost & applicable in low-resource settings community-based intervention programme Phase II (PROCEED): intervention will be implemented and its process, impact, outcome, cost-effectiveness and scalability will be evaluated Impact: Embedding of the intervention results into new policy and practice

20 Joint Programming Initiative on neurodegenerative diseases (JPND) Establishing synergies between the Joint Programming on Neurodegenerative Diseases Research and Horizon 2020 Following MS represented: FR (coordinator) AT, BE, DE, DK, ES, IL, IT, LU, NL, PL, PT, RO, SE, SK, UK, Associated countries represented: NO, TR Collaboration partners from Canada Three priority topics have emerged through a consultative process: the identification of genetic, epigenetic and environmental risk and protective factors, the development and maintenance of longitudinal cohorts, the creation of advanced experimental models. These are key questions of equal priority to increase understanding of ND mechanisms that will be addressed

21 Global Research Collaboration for Infectious Disease Preparedness (GloPID-R) Support for international infectious disease preparedness research One project, with key institutions involved GloPID-R-Sec: secretarial support to the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R) for 5 years. Staffed by Fondation Mérieux/FR (coordinator) and ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium), hosted by the University of Oxford.

22 Type of organisations in signed GA resulting from HCO-2014 calls

23 Countries of origin of coordinators in signed GA resulting from HCO-2014 calls

24 SME instrument

25 PHC-12: Phase st cut-off - 18 June 208 proposals submitted 24 above thresholds all funded Success rate: 11,5% 4th cut-off 18 March 105 proposals submitted Evaluations on-going 2 nd cut-off - 24 September 152 proposals submitted 21 above thresholds all funded Success rate: 13,8% 3rd cut-off - 17 December 195 proposals submitted 32 above thresholds all funded Success rate: 16,4%

26 Funded SMEs per country phase 1 Country 1 st cut-off 2 nd cut-off 3rd cut-off Total 18 June 24 September 17 December Austria Belgium Germany Denmark Estonia Spain Finland France Hungary Ireland Israel Iceland Italy The Netherlands Norway Serbia Sweden Turkey United Kingdom Total 25* 23* 33* 81*

27 PHC-12: Phase st cut-off 9 October 81 proposals submitted 30 above thresholds 3rd cut-off 18 March 90 proposals submitted Evaluations on-going 10 projects funded Average project size: 3,3 m Success rate: 12,3% 2nd cut-off - 17 December 91 proposals submitted 37 above thresholds 9 projects funded Average project size: 3,3 m Success rate: 10,1%

28 Funded SMEs per country phase 2 Country 1 st cut-off 9 October 2 nd cut-off 17 December Total France Germany Greece Ireland 1-1 Italy Spain 1-1 Sweden The Netherlands United Kingdom Total 10 12* 24*

29 SC1 SME instrument Phase 2 projects - domains covered Dental care Respiratory Heart disease - Myocardial Infarction Cancer (2 projects: cervical, collorectal) Diabetes Arthritis Infections - septic shock Infectious diseases (2 projects: TB, ID self testing platform)

30 SC1 SME instrument Phase 2 projects - examples Validation of clinical performance and pre-commercial development of a novel diagnostic for dental caries assessment Development of a digital diagnostics rapid Lung Maturity Test (LMT) for premature infants, to assist neonatologists in the diagnosis of Respiratory Distress Syndrome at birth Validation of a point-of-care H-FABP test for a rapid exclusion of Acute Myocardial Infarction in patients with cardiac complaints. Validation of PreCursor-M for enhanced Cervical (Pre) Cancer detection Moving to Efficient Diabetes care: Multimode Integrated COmorbidity diagnostics platform

31 Ebola

32 The Research Response to the Ebola Outbreak Apr '14 Jul '14 Oct '14 Jan '15

33 Ebola projects funded by : Horizon 2020 emergency procedure FP7 IMI 2 Vaccines: EbolaVac, VSV-EBOVAC, EBOVAC1, EBOVAC2, EBOMAN, EBODAC Therapeutics: REACTION, Ebola_Tx, IF-Ebola Diagnostics: Mofina, FILODIAG, EbolaMoDRAD Basic research: EVIDENT, Antigone, Predemics Prepareness and Communication: Prepare, Tell Me

34

35 IMI Europe s partnership for health > 5 bn 2.5 bn Partnership bn

36 IMI 1: Budget Breakdown IMI funding 759,185,796 Infectious diseases 14,910,397 Relative effectiveness 18,118,249 Drug kinetics Corporate contribution 20,426,255 Drug delivery 214,136,227 Drug discovery 182,980,698 Brain disorders ,601,855 Sustainable chemistry 37,378,289 Education and training 37,966,496 Lung diseases 116,880,300 Metabolic disorders 49,310,000 Geriatrics 116,287,312 Drug safety 55,930,958 Biological 69,739,527 Inflammatory disorders NATURE MEDICINE NEWS

37 The IMI community 63 projects > 8000 researchers 1100 academic & research teams 493 EFPIA teams 178 SMEs 27 patient org. 17 regulators 61% of projects reported some form of PATIENT INVOLVEMENT REGULATORS ON BOARD OF 12 PROJECTS 50% of projects have REGULATORY AUTHORITIES representatives in Scientific Advisory Boards

38 Number of participations to IMI per country

39 Ongoing IMI projects

40 etox Searchable in a database Publically available toxicology data OH HO O N N N OH Predictive in-silico models Reports from companies

41 StemBANCC 500 Patients 1500 ipscs Diabetes CNS Toxicology Identify phenotypes, Develop assays... Grskovic et al. Nature Reviews, Dec

42 IMI s drug discovery platforms European Lead Factory Focus: identification of new hits European Lead Factory Qualified hit ELF Budget: 196 million europeanleadfactor y.eu Target screenin g Hit-tolead Lead-tocandidat e Preclinic al Phase I Phase II Phase III ND4BB Drug Discovery Platform Lead Clinical candidate Phase 1 ready ENABLE Budget: 101 million nd4bb-enable.eu ENABLE focus: to move promising hits into early clinical development

43 Goals of IMI 2 programme Increase the success rate of clinical trials of new medicines & vaccines Speed up the earlier stages of drug development Develop new treatments for areas of unmet need Develop new biological markers to diagnose diseases and assess treatments Improve the drug development process by creating tools to assess the efficacy, safety and quality of medicines

44 How to get involved Organisations bringing own resources to the project Become an EFPIA partner in research Involved in topic incubation Become an IMI2 Associated Partner Join a pre-established topic prior to Call launch Organisations not bringing own resources to the project Submit a topic idea Form / join a consortium and submit a proposal

45 7 priority themes and enablers Neuro-degeneration Immune-Mediated diseases Metabolic Disorders Infection control Translational safety Medicines Adaptive Pathways to Patients Data generation and exploitation

46 IMI2 Calls IMI2 - Call 1 Translational approaches to disease modifying therapy of Type 1 Diabetes Mellitus (T1DM) Discovery and validation of novel endpoints in dry agerelated macular degeneration and diabetic retinopathy IMI2 Call 1 Number of opened topics 2 Number of proposals received 15 Number of funded proposals 2

47 IMI2 Calls IMI2 - Call 2: Ebola and other filoviral haemorrhagic fevers Vaccine development Phase I, II, and III Manufacturing capability Stability of vaccines during transport and storage Deployment and compliance of vaccination regimens Rapid diagnostic tests IMI2 Call 2 Number of opened topics 5 Number of proposals received 19 Number of funded proposals 8

48 IMI2 Calls IMI2 - Call 3 Remote assessment of disease and relapse (RADAR) - CNS Assessing risk and progression of prediabetes and type 2 diabetes to enable disease modification Linking clinical neuropsychiatry and quantative neurobiology The consistency approach to quality control in vaccine manufacture Pertussis vaccination research Knowledge repository to enable patient focused medicine development IMI2 Call 3 Number of opened topics 6 Number of proposals received Number of funded proposals evaluations on-going evaluations on-going

49 IMI2 Calls IMI2 - Call 4 Enabling platform on medicines adaptive pathway to patients (CSA) IMI2 Call 4 Number of opened topics 1 Number of proposals received Number of funded proposals evaluations on-going evaluations on-going

50 Future IMI Calls - Timelines & info Find out more: Call launch: Summer 2015 Disclaimer - All information regarding future IMI Call topics is indicative and subject to change. Final information about future IMI Calls will be communicated after approval by the IMI Governing Board.

51 Future IMI Calls - Indicative topics 1/2 Patient perspective elicitation on benefits and risks of medicinal products, supplementing benefit risk assessments by regulators and HTAs (health technology assessments) from development through the entire life cycle Development of a quantitative system toxicology (QST) platform Diabetic kidney disease (DKD) biomarker idea

52 Future IMI Calls - Indicative topics 2/2 Inflammation and Alzheimer s disease (AD): modulating microglia function focussing on TREM2 and CD33 Understanding the role of amyloid biomarkers in diagnosis, clinical management and treatment of patients with cognitive impairment Evolving models of patient engagement and access for earlier identification of Alzheimer s disease Bringing apolipoprotein E (APOE) biology to validated Alzheimer s disease targets

53 Integration of social sciences and humanities (SSH)

54 PHC : Understanding health, ageing and disease: determinants, risk factors and pathways PHC : Health promotion and disease prevention: translating omics into stratified approaches PHC : Evaluating existing screening and prevention programmes PHC : Comparing the effectiveness of existing healthcare interventions in the elderly 9 Topics flagged as relevant to integrate SSH elements PHC : Developing and comparing new models for safe and efficient, prevention oriented health and care systems PHC : Foresight for health policy development and regulation HCO 5 - Global Alliance for chronic diseases (GACD) diabetes HCO 14 - Bridging the divide in European health research and innovation HCO 15 - Mobilisation and mutual learning action plan

55 Examples of projects (I) Topic HCO 5 - Global Alliance for chronic diseases (GACD) diabetes Topic scope includes: " Provide evidence of a health economics dimension such as cost effectiveness of the proposed intervention and its scalability " Selected project: "Family-based intervention to improve healthy lifestyle and prevent Type 2 Diabetes amongst South Asians with central obesity and prediabetes" (ihealth-t2d) Includes a WP on health economics (124 PM out of 1317 PM - 9,4%) with expertise on health economics, public health

56 Examples of projects (II) Topic PHC 31 - Foresight for health policy development and regulation Topic scope includes: " Proposals should identify key driving forces- (external and internal to the health systems) likely to influence health and wellbeing in Europe and beyond in the future. Proposals should contribute to the understanding of the inter-relationships between these factors; analyse their economic and social impact and suggest alternative policy options to respond to the challenges they pose " Selected project: "Shaping EUROpean policies to promote HEALTH equity" (EURO-HEALTHY) Includes a WP on Socioeconomic, health behaviours and lifestyle determinants of health and wellbeing (82,5 PM out of 457 PM - 18%) with expertise on public health and statistics

57 Examples of projects (III) Topic HCO 15 - Mobilisation and mutual learning action plan Topic scope includes: " MMLs are Coordination and Support Actions (CSA) with at least 10 countries that allow discussion and cooperation between science and society at different stages of the research and innovation process"; "The consortium may also include media, education establishments, science academies, museums, science centres " Selected project: "A stepping stone approach towards the Genetics Clinic of the Future" (GCOF) Includes a WP on public engagement & mutual learning (19 PM out of 117 PM - 16,2%) with expertise on social science, political science

58 Examples of projects (IV) Topic PHC 17 - Comparing the effectiveness of existing healthcare interventions in the elderly Topic scope includes: " A comprehensive array of clinical and safety parameters, as well as health and socio-economic outcomes should be assessed " Topic PHC 23 - Developing and comparing new models for safe and efficient, prevention oriented health and care systems Topic scope includes: " Public health, biomedical, social and behavioural research have provided evidence for new approaches to prevention, primary care and treatment "

59 Stay in touch horizon2020/en/h2020-section/ health-demographic-change-andwellbeing participants/portal

60 Thank you!