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HORIZON 2020
The societal challenge 'Health, demographic change and
well-being'
Work programme 2016-2017
Beatrice Lucaroni
Project Officer DG Research and Innovation
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The societal challenge 'Health, demographic change and well-being'
Work programme 2016-2017
Information Day
Brussels
18 September 2015
Philippe Cupers Acting Head of Unit
DG Research and Innovation
Image credit: Adam Fagen – Rallying for medical research / Creative commons
usage license https://creativecommons.org/licenses/by-nc-sa/2.0/legalcode
View the full presentation and access all documents: http://ec.europa.eu/research/index.cfm?pg=events&eventcode=7829B368-
BCD2-7BA8-039C396F0C62FA5D
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Horizon 2020 supports Commission priorities
• Jobs and growth
• Societal challenges
• European industrial leadership and competitiveness
• EU international excellence
• Couple research to innovation
• 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
Horizon 2020
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EVERYWHERE
Where is health research in Horizon 2020?
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Collaborative
projects
SME
instrument
Financial
instruments
Eureka Eurostars-2
AAL-2 IMI-2
SC1 Health €7.3bn (of €31bn*)
Industrial leadership €17bn*
Excellent science €24bn*
Health Research in H2020
Future and
Emerging
Technologies
LEIT Biotech
Marie Skłodowska
Curie
Fast Track to
Innovation
EDCTP-2
European Research
Council
Research
Infrastructures
* Figure to be updated following EFSI investments in 2015
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The SC1 Work Programme 2016-17 in brief
including 'coordination activities' 15 topics (17 in 2014-2015): 12 in 2016, 3 in 2017
Call 'Personalised Medicine' 21 topics (34 in 2014-2015): 10 in 2016, 10 in 2017, 1 open in 2016 & 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
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Main research priorities for 2016-2017
Infectious Diseases
InnovFin
Personalised medicine
Human biomonitoring
Maternal and child health
Health ICT
Will be presented this afternoon
Promoting healthy ageing
Included in the presentations of today
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Developing personalised medicines at EU level
Strategic planning & coordination of national
initiatives
Implementation in SC1 Work Programme 2016-2017
A large number of research and innovation topics and
coordination topics in the SC1 Work Programme 16-17
+
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Understanding health, well-being and diseases • SC1-PM-01-2016: Multi omics for personalised therapies addressing
diseases of the immune system • SC1-PM-02-2017: New concepts in patient stratification • SC1-PM-03–2017: Diagnostic characterisation of rare diseases • SC1-PM-04–2016: Networking and optimising the use of population
and patient cohorts at EU level
Treating and managing diseases • SC1-PM-08–2017: New therapies for rare diseases • SC1-PM-09–2016: New therapies for chronic diseases • SC1-PM-10–2017: Comparing the effectiveness of existing
healthcare interventions in the adult population • SC1-PM-11–2016-2017: Clinical research on regenerative medicine
Personalised medicine in SC1 Work Programme 2016-2017 (I)
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Personalised medicine in SC1 Work Programme 2016-2017 (II)
Preventing diseases • SC1-PM-07–2017: Promoting mental health and well-being in the
young
Methods and data • SC1-PM-20-2017: 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-21-2016: Implementation research for scaling-up of
evidence based innovations and good practice in Europe and low- and middle-income countries
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Coordination activities • SC1-HCO-02-2016: Standardisation of pre-analytical and
analytical procedures for in vitro diagnostics in personalised medicine
• SC1-HCO-03–2017: Implementing the Strategic Research Agenda on Personalised Medicine
• SC1-HCO-05–2016: Coordinating personalised medicine research
• SC1-HCO-06–2016: Towards an ERA-NET for building sustainable and resilient health system models
Personalised medicine in SC1 Work Programme 2016-2017 (III)
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European human biomonitoring initiative
Preventing diseases
SC1-PM-05–2016: The European Human Biomonitoring Initiative
• 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
Implementation in SC1 Work Programme 2016-2017
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Infectious diseases
Implementation in
SC1 Work Programme
2016-2017
• 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
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Infectious diseases in SC1 WP 16-17 (I)
Understanding health, well-being and diseases • SC1-PM-02-2017: New concepts in patient stratification • SC1-PM-04–2016: Networking and optimising the use of
population and patient cohorts at EU level
Treating and managing diseases • SC1-PM-09–2016: New therapies for chronic diseases • SC1-PM-10–2017: Comparing the effectiveness of existing
healthcare interventions in the adult population
Preventing diseases • SC1-PM-06–2016: Vaccine development for malaria and/or
neglected infectious diseases
Coordination activities • SC1-HCO-04–2016: Towards globalisation of the Joint
Programming Initiative on Antimicrobial Resistance
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Infectious diseases in SC1 WP 16-17 (II)
Other Actions: InnovFin Infectious Diseases (InnovFin ID) Pilot 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
http://www.eib.org/innovfin
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Maternal and child health Implementation in SC1 Work Programme 2016-2017
• 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 new-born 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
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Implementation in SC1 Work Programme 2016-2017
Health ICT
Promoting healthy ageing
A large number of research and innovation topics, and
coordination topics in the SC1 Work Programme
2016 - 2017
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• SC1-HCO-01-2016: Valorisation of FP7 Health and H2020 SC1 research results
Other coordination activities
• SC1-HCO-07–2017: Global Alliance for Chronic Diseases (GACD)
• SC1-HCO-08–2017: Actions to bridge the divide in European health research and innovation
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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)
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SME instrument in SC1 work programme 2016-2017
Implementation in SC1 Work Programme 2016-2017
• SMEInst-05-2016-2017 – Supporting innovative SMEs in the healthcare biotechnology sector (Health)
• SMEInst-06-2016-2017 – Accelerating market
introduction of ICT solutions for Health, Well-Being and Ageing Well
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• 18 September 2015: SC1 Info Day – Brussels
• 13 October 2015: adoption of WP 2016-2017 by the Commission
• 14 October 2015: publication of WP 2016-2017
• Call 2016 deadlines (depending on topics): 19 January 2016 – 16 February 2016 and 13 April 2016
Calendar for Horizon 2020 Work Programme 2016-2017
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Cross-cutting items Clinical studies
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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).
Applicability and Definition
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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
1e.g.: http://ec.europa.eu/research/participants/portal/doc/call/h2020/h2020-phc-2015-single-stage_rtd/1632634-essential_information_for_clinical_studies_2015callsv3_01122014_en.pdf
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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
Template for clinical studies in SC1 (II)
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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
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about
The template, unit costs, status recruitment sites,
subcontracting, mandatory deliverables
Provided on the Info Day web-site:
Detailed information
http://ec.europa.eu/research/index.cfm?pg=events&eventcode=78
29B368-BCD2-7BA8-039C396F0C62FA5D
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Cross-cutting items Social sciences and humanities (SSH)
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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
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• 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
How to include / assess SSH
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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
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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
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Cross-cutting items International cooperation
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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
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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
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Multi-lateral health research activities
GloPID-R
Global Research
Collaboration for Infectious
Disease Preparedness
www.irdirc.org/
http://intbir.nih.gov/
http://ihec-epigenomes.org/
https://icgc.org/
http://www.iom.edu/Activities/Research/GenomicBasedResearch/Innovation-Collaboratives/Global_Genomic_Medicine_Collaborative.aspx
www.gacd.org/
http://www.glopid-r.org/
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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
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Cross-cutting items
Gender
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Sex and Gender interact
Regitz-Zagrosek, V. (2012). Sex and Gender Differences in Health. EMBO Reports, 13 (7): 596- 603
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Cross-cutting items
Communication
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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 non-specialist, 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)
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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
• Brochure "Communicating EU Research & Innovation
http://ec.europa.eu/research/participants/data/ref/h2020/other/gm/
h2020-guide-comm_en.pdf
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Cross-cutting items Ethics
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• 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
Ethics
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HORIZON 2020
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Find out more: www.ec.europa/research/horizon2020
http://ec.europa.eu/research/participants/portal/desktop/en/home.html