Giorgio Clarotti, Health Strategy
Research & Innovation, European
Commission
Rome
Societal Challenge "Health, demographic
change and well-being" – December '17
2SC1 – WP 18-20 - Gio
Research and innovation – a growing priority for the EUHorizon 2020 supports Commission priorities
• Jobs and growth
• Societal challenges
• European industrial leadership and competitiveness
• EU international excellence
Horizon 2020
• 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
• Multidisciplinary and synergies
• Address people's concerns
2
3
Evidence based policy making
There are many ways to measure impact
Medicines for
children
Health
Technology
Assessment
ATMP
and many others…
Taking the lead in new areas of
growth
Personalised
medicine
Responding to emergencies
Knowledge creation and exploitation
SC1 – WP 18-20 - Gio3
Collaborative
projects
SME
instrument
Financial
instruments
Eureka Eurostars-2
AAL-2IMI-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 2016-2017 and FP7 recovery in 2016
SC1 – WP 18-20 - Gio4
5
Public-private partnership
Public-public partnerships
Frontier research
Support to innovation
Research Education Innovation
Health research infrastructures Deployment of
innovative solutions
Health research in Horizon 2020
Modelling & predictive
(neuro)sciences
Human Brain
Project
Loans for de-risking R&I
Collaborative health research (SC1)
SC1 – WP 18-20 - Gio5
6SC1 – WP 18-20 - Gio
6
Collaborative health research
(SC1)
Public-private partnership
Public-public partnerships
Frontier research
Support to innovation
Research Education Innovation
Health research infrastructures
Deployment of innovative solutions
Health research in Horizon 2020
Modelling & predictive
(neuro)sciences
Human Brain
Project
Loans for de-risking R&I
7
Health R&D in Europe and in US
• H2020 SC1 Health: 12,5% of EU total
• EU total: 31,1% of US total
• US - Health R&D = 30% of Civil public R&D
• EU – Health R&D = 8% of Civil public R&D
• H2020 – Health (SC1) = 10% of H2020 total
SC1 – WP 18-20 - Gio 7
8SC1 – WP 18-20 - Gio
Various instruments along the value chain
8SC1 – WP 18-20 - Gio
0
200
400
600
800
1000
1200
1400
FP7 Avg 2014 2015 2016 2017 2018 2019 2020
Total Operational budgets (mio€)
TotalOperationalbudgets
Planned-EFSI
SC1 Investment Plan: back-loaded
Evolution of yearly Impact on 2016-2017 work programme (15% for RTD, 20% for CNECT) (Mio€)
*100 m€ GrifolsBioscience - ES*150m€ UK Hospitals* 70 m€ IE PrimaryCare*??? Life Science RDI
*European Fund for Strategic Investment
(President Juncker Investment Plan)
100 m€ 100
m€
9SC1 – WP 18-20 - Gio
SC1 Investment: a balanced portfolio, innovative solutions
Leveraging investment in various type of instruments (Mio€, 2014 to 2017)
• PPP = Public-Private Partnership (IMI-2) = ~ 24% to date, +100% from industry• P2Ps = (JPIs, Art.185, ERA-NETs, EJP) = ~14% to date, + at least 100 % by partners• SME Instrument and Financial Instruments (FTI, EFSI, InnovFin ID) = ~7% to date• Rest of Work Programme = 49 % to date
1
0SC1 – WP 18-20 - Gio
11SC1 – WP 18-20 - Gio
11
Public-Private
Partnership
12SC1 – WP 18-20 - Gio
- 30 November: Launch of Call 13 (16 topics) – EUcontribution: € 124.5m + In-kind contribution from EFPIA&Associated Partners: € 113.5m
- supports health research and innovation, speeding upthe development of innovative medicines, particularly inareas of unmet medical need
- covers the full spectrum of drug discovery anddevelopment
- facilitates collaboration between universities, researchcentres, the pharmaceutical and other industries; SMEs,patient organisations, and medicines regulators
- Strategic Research Agenda based on the WHO PriorityMedicine Report renewed in July 2013
http://www.imi.europa.eu/get-involvedhttp://www.imi.europa.eu/apply-fundinghttp://www.imi.europa.eu/apply-funding/general-overview/tips-applicants
BUDGET: € 3.276 billion2013-2020: EC: €1.638 bn + EFPIA: €1.425 bn
+ Associated Partners: €0.213 bn
1
2
13SC1 – WP 18-20 - Gio
13
Public-Public
Partnership
14SC1 – WP 18-20 - Gio
- EDCTP2 Annual Work Plan 2018 to be adopted mid-2018:EU-funded activities: € 115m + new ParticipatingStates: € 115m
- covers research accelerating clinical development ofmedical interventions to prevent or treat HIV/AIDS,tuberculosis, malaria and other infectious diseases
- includes the development of drugs, microbicides, vaccines,diagnostics and their delivery
- supports coordination of European national researchprogrammes
- funds collaboration between EU, European countries andsub-Saharan African countries
BUDGET: ~ € 1.37 billionEC: € 683 m + MS: € 683 m
www.edctp.org/see-work/strategywww.edctp.org/funding-opportunities/calls
1
4
15
Public Public Partnerships in H2020, SC1
Overall investment by Member States: More than 2500 M€, 7 actions (Feb'16)
JPIs TOTAL INVESTMENT in JOINT Calls and Actions (MS+EC)
Neurodegenerative
Diseases (+CSA/ERA-NET)27 Countries, 2009-2020, ~130 M€ + 10 M€ EC
Anti-Microbial Resis-tance
(+CSA/ERA-NET)22 Countries, 2011-2020, ~50 M€ + 7.8 M€ EC
More Years, Better Life
(+CSA)19 Countries, 2011-2020, < 10 M€ + 2 M€ EC
Heathy Diet for a Healthy
Life (+CSA/ERA-NET)25 Countries, 2010-2020, > 30 M€ + > 5 M€ EC
Total Investment 4 JPIs: ~200 M€ + > 25 M€ from EC
Art.185 Initiatives TOTAL INVESTMENT in JOINT Calls and Actions (MS+EC)
Ambient Assisted Living
(AAL)22 Countries, 2006-2024, ~0.7 B€ + 0.5 B€ EC + Industry
EU & Dev. Cy Clinical Trials
Partners. (EDCTP)14+14 Countries, 2006-2024, ~1 B€ + 1 B€ EC + BM Gates
EU Metrology Pgm for Inno
& Research (EMPIR)28 Countries, 2006-2024, ~0.6 B€ + 0.6 B€ EC
Total Investment 3 Art.185: ~2.3 B€ + > 2 B€ from EC + Others
16
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 malariaEMA news: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015
9 December 2015 – EDCTP receives Science Diplomacy Award at South African Science Forum
17SC1 – WP 18-20 - Gio
- Expected launch date of Call 2018: 5 February2018 focused on: Smart solutions for ageing well (“opencall”).
- The call is addressing solutions for purchase by olderadults as well as for purchase by those who provide theservices for them such as care organisations ormunicipalities.
- Strong involvement of end users: co-creation processwith end users such as older adults, carers, insurers orhealth care service providers in the whole projectlifecycle Strong business and market orientation sought
- Strong business and market orientation (short time tomarket: 2 years after the completion of the project)
BUDGET (indicative): € 26 M*
http://www.aal-europe.eu/get-involved/calls/
SC1 – WP 18-20 1
7
*total budget project call 2018 (EC + MS). Exact figures MS contribution will be available end 2017.
18SC1 – WP 18-20 - Gio
18
Joint Programming initiative on Neurodegenerative Disease Research (JPND)
• 30 countries; EU Member States-led initiative to increase
coordinated investment among participating countries
• Strategic Research Agenda spanning biomedical, healthcare and social science research
• Public database mapping relevant national and European research and infrastructures
• Informing national research agendas/plans
• Currently some EUR 123 million invested in 9 transnational calls (incl. co-fund of 10 million from EC)
Coordinating national research
19
ERA-NET Cofund actions in H2020, SC1Overall investment by Member States: More than 350 M€, 9 actions (Jan '17)Co-Fund: ERA-NET & EJP TOTAL INVESTMENT in JOINT Calls and Actions (MS+EC)
E-RARE 3 Rare Diseases
Runs from ('15-'19)
17 Countries
(19.5 + 5.8 + ~30 Additional Own calls) ~50 M€ (48M€ - 95 % done)
JP cofund, Neurodegene-
rative diseases ('15-'19)
20 Countries
(35 + 10 ? + ? additional) > 40 M€ (46 M€ done, more to do)
TransCan2 Translational
Cancer ('15-'19)
19 Countries
(17 + 6.7 + ~30 Additional Own calls) ~50 M€ (47 M€ - 95% done)
ERACo-Sysmed System
Biology Medicine ('15-'19)
13 Countries
(10 + 4 + Additional Own calls?) > 15 M€ (21 M€ --> More to do)
ERA-NET NEURON Brain
diseases ('16-'20)
17 Countries
(17 + 6.8 + ~40 Additional Own calls) ~60 M€ (40 M€ - 66% done)
ERA-NET JPI Anti-Microbial
resistance ('16-'20)
18 Countries
(21 + 7.8 + Additional Own calls?) > 26.4 (43 M€ done +more todo)
ERA-CVD Cardiovascular
Runs from ('16-'20)
18 Countries
(11.4 + 2.5 + Additional Own calls?) ~20 M€ (14M€ --> More to do)
PM-05-2016 EJP Human
Biomonitoring Initiative 26 Countries, 2017-2022, > 25 M€ + 50 M€ EC (70% fund.)
HCO-03-2017 ERA-NET
Personalised Medicine> 20 Countries, 2018-2023, > 12 M€ + 5-6 M€ EC
Total Investment 8 ERA-NET + 1 EJP: ~250 M€ + 100 M€ from EC
20SC1 – WP 18-20 - Gio
21SC1 – WP 18-20 - Gio
European Innovation Council: pilot 2018-2020 € 2.7 billion to support +5,000 SMEs and innovators
ECOSYSTEM SUPPORT: COACHING, MENTORING for all SME beneficiaries
Test and co-createDemonstrate,
validate
Feasibility / Startup Development
Scale up Investment
Early stagescience & techEmerging tech,Visionary ideas
FTIFast Track to Innovation
FET-OPEN Future
EmergingTechnologies
SME Instrument
Phase 1
SME Instrument
Phase 2Soft blending
HORIZON PRIZES1. Innovative Batteries for eVehicles2. Fuel from the Sun: Artificial Photosynthesis 3. Early Warning for Epidemics4. Blockchains for Social Good5. Low-Cost Space Launch 6. Affordable-HighTech for Humanitarian Aid
MA
RK
ET
CR
EA
TI
NG
21
NEW
21SC1 – WP 18-20 - Gio
22SC1 – WP 18-20 - Gio
22
Full bottom-up and introduction of interviews are the main new features of the evaluation under EIC Pilot
Responsibility
Applicants
H2020 Evaluation team
Experts
Below threshold(s)
Abovethresholds
Invited for interview
Not invited for interview
Proposed for funding
Not proposed for funding
23SC1 – WP 18-20 - Gio
Instrument SME-Instrument
FTI FET-Open EIC Horizon prizesPhase 1 Phase 2
For whom One or more eligible1 SMEs
From 3 to 5
eligible1
entities (mostly
industrial2)
At least 3
entities3
One or more entities
(with restrictions1 for
some of the prizes)
Maximum
funding450,000 € 2.5 M€ 3 M€
3 M€ (RIAs)
0.5 M€ (CSAs)Varies for each prize
Total budget
2018-20164 M€ 1,425 M€ 300 M€
647 M€ (RIAs)
10 M€ (CSAs)40 M€
Focus
Exploring the
feasibility of a
business idea
(~ 6 months)
Breakthrough
innovation &
international
growth
(12-24 months)
Close-to-
market
innovation
Radically
new
technologies
6 different topics
(major societal issues)
(1) Applicants must be established in an EU Member State or in a country associated to Horizon 2020(2) This industry involvement implies: (a) either the allocation of at least 60% of the budget to industry participants in the
consortium, or (b) the presence of a minimum number of two industry participants in a consortium of three or four partners, or of three industry participants in a consortium of five partners
(3) A FET-Open consortium must always include at least 3 participants from 3 different EU Member States or Associated Countries. In addition to these three partners, any legal entity from anywhere in the world can also be included in the consortium.
(4) Per project – with possible exceptions
23
24SC1 – WP 18-20 - Gio
24
EU-funding boosts SMEs deal activity
2010-2015: 4,6 deals per SME (twice more than for non-EU funded SMEs)
Example: NABATIVI project
Source: CORDA/ MedTrack
EU-funding boosts SME's Initial Public Offering
• Example: Immunovia
• Listed at Nasdaq North, market value tripled in 18 months to €300m
Is EU funding worth for SMEs ?
25SC1 – WP 18-20 - Gio
25
Horizon 2020
WorkProgrammes 2018-2020
Political context
26SC1 – WP 18-20 - Gio
26
An attractive, simplified and well-performing programme, highly relevant for stakeholders and societal needs
On track to deliver value for money and to meet its knowledge-creating objectives
Strong EU Added Value through unique opportunities, competition & access to new knowledge
€
Key findings from the H2020 INTERIM EVALUATION
KEY STRENGTHS
27SC1 – WP 18-20 - Gio
27
Key findings from the H2020 INTERIM EVALUATION
KEY AREAS FOR IMPROVEMENT
Underfunding
Has lower success rates than FP7, esp. for high quality proposals
Support for market-creating innovation
Demonstrates potential for breakthrough, market-creating innovation, but it should be strengthened substantially
Greater outreach to civil society
Should better explain the impacts of R&I, and involve even more the users & citizens in agenda-setting & implementation
28SC1 – WP 18-20 - Gio
28
A positioning system in the brain
EU FP5 Life Sciences ('NAPPY') and FP7 Health
('SPACEBRAIN') collaborative research
grants
& ERC grants
EU-supported research: Brain research
29SC1 – WP 18-20 - Gio
29
Treating leukaemia with designer immune cells
EU-supported research: Regenerative medicine
30SC1 – WP 18-20 - Gio
New tissue growth
Project "ESPOIR"
• Heart valve defect (2 in every 100 babies born): valve-replacement surgery very successful BUT limited immune tolerance in young patients, outgrow their valve, re-operations required every 5-10 years
• Implant a decellularised human donor valve: does not activate the immune system, and promotes tissue regeneration
• 121 patients treated: zero valve-related mortality - 83 % of patients free from any re-intervention or re-operation
• Obtained regulatory and reimbursement approval for decellularised human heart valves in DE, CH, NL, IT, UK, BE
EU-supported research: Regenerative medicine
31SC1 – WP 18-20 - Gio
1. Personalised medicine
5. Decoding the role of the environment for health and
well-being
3. Infectious diseases and improving global health
7. Trusted Big Data solutions and Cybersecurity for Health and Care
6. Digital transformation in Health and Care
4. Innovative health, and care systems –Integration of care
2. Innovative health and care industry
Health collaborative research –7 priorities for 2018–2020
© bahtiarmaulana , #110775030, 2017. Source: fotolia.com © robu_s, #101871020, 2017. Source: Fotolia.com, © maxsattana, #174546837, 2017. Source: Fotolia.com; © glopphy, #41555605, 2017. Source: Fotolia.com; © iconimage, #115660282, 2017. Source: Fotolia.com; © Maren Winter, #137474084, 2017. Source: Fotolia.com
32SC1 – WP 18-20 - Gio
7 priorities implemented via SC1 Work Programme 2018–2020 through 3 Calls for proposals
Call 'Better Health and care, economic growth and sustainable health systems'5 main priorities & 32 topics
Call 'Digital transformation in Health and Care'13 topics
Call 'Trusted digital solutions and Cybersecurity in Health and Care'3 topics
Other Actions 2018–2019 7 items
3232SC1 – WP 18-20 - Gio
33SC1 – WP 18-20 - Gio
Priority 1 – Personalised medicine
AIM: Delivering personalised health and care to benefit patients andcitizens
FOCUS: complex disorders, human microbiome, rare diseases and datasharing for enabling personalised medicine, economic models, reinforcinginternational and regional collaboration
POLICY DRIVERS:
Council conclusions on Personalised Medicine
International Consortium on Personalised Medicine
European Reference Networks
33
34SC1 – WP 18-20 - Gio
Personalised Medicine in Work Programme 2018–2020 (I)
• BHC-03-2018: Exploiting research outcomes and applicationpotential of the human microbiome for personalised prediction,prevention and treatment of disease
• BHC-04-2018: Rare Disease European Joint Programme Cofund
• BHC-05-2018: International flagship collaboration with Canada forhuman data storage, integration and sharing to enable personalisedmedicine approaches
• BHC-01-2019: Understanding causative mechanisms in co- andmultimorbidities
• BHC-02-2019: Systems approaches for the discovery ofcombinatorial therapies for complex disorders
3434SC1 – WP 18-20 - Gio
35SC1 – WP 18-20 - Gio
Personalised Medicine in Work Programme 2018–2020 (II)
Coordination and support actions
• HCO-02-2018: Data integration and data-driven in-silico models forenabling personalised medicine - a European standardizationframework
• HCO-04-2018: ERA-NET to support the Joint Programming inNeurodegenerative Diseases strategic plan (JPND)
• HCO-01-2018-2019-2020: Actions in support of the InternationalConsortium for Personalised Medicine
35
36SC1 – WP 18-20 - Gio
Priority 2 – Innovative health and care industry
AIM: Turn innovative knowledge and technologies into practicalapplications benefiting citizens, healthcare systems and businesses
FOCUS: Regenerative medicine, advanced therapeutics and regulatoryscience
POLICY DRIVERS:
Upgrading the single market
36
37SC1 – WP 18-20 - Gio
• BHC-09-2018: Innovation platforms for advanced therapies of thefuture
• BHC-07-2019: Regenerative medicine: from new insights to newapplications
• BHC-10-2019: Innovation Procurement: Next generation sequencing(NGS) for routine diagnosis
Coordination and support actions
• HCO-05-2018: Strengthening regulatory sciences and supportingregulatory scientific advice
Innovative health and care industry in Work Programme 2018–2020
37
38SC1 – WP 18-20 - Gio
Priority 3 – Infectious diseases and improving global health
European One Health Action Plan against Antimicrobial Resistance
Global Action Plan on antimicrobial resistance
38
AIM: Fighting infectious diseases and the growing threat of antimicrobialresistance. Addressing the needs of the most vulnerable and the globalincrease in chronic diseases
FOCUS: Emerging infectious diseases, poverty and neglected diseases,stratified host-directed approaches to communicable diseases, maternaland child health, global collaboration on non-communicable diseases(cohorts, brain research, hypertension, diabetes, cancer
POLICY DRIVERS:
39SC1 – WP 18-20 - Gio
• BHC-15-2018: New anti-infective agents for prevention and/ortreatment of neglected infectious diseases (NID)
• BHC-16-2018: Global Alliance for Chronic Diseases (GACD) - Scaling-up of evidence-based health interventions at population level for theprevention and management of hypertension and/or diabetes
• BHC-18-2018: Translational collaborative cancer research betweenEurope and the Community of Latin American and Caribbean States(CELAC)
• BHC-21-2018: Research on HIV, tuberculosis (TB) and/or hepatitis C(HCV) in patients with mono-, co-infections and/or comorbidities inthe context of fostering collaboration with the Russian Federation
Infectious diseases and improving global healthin Work Programme 2018–2020 (I)
39
40SC1 – WP 18-20 - Gio
• BHC-13-2019: Mining big data for early detection of infectious diseasethreats driven by climate change and other factors
• BHC-14-2019: Stratified host-directed approaches to improveprevention, treatment and/or cure of infectious diseases
• BHC-19-2019: Implementation research for maternal and child health
Infectious diseases and improving global healthin Work Programme 2018–2020 (II)
40
41SC1 – WP 18-20 - Gio
Coordination and support actions
• HCO-06-2018: Establishment of an International Network of SocialSciences Research Centres to help address governance and otherchallenges in the preparedness for and the response to infectiousthreats
• HCO-08-2018: Creation of a European wide sustainable clinicalresearch network for infectious diseases
• HCO-09-2018: Building international efforts on population and patientcohorts
• HCO-10-2018: Coordinating European brain research and developingglobal initiatives
• HCO-11-2018: Strategic collaboration in health research andinnovation between EU and China
Infectious diseases and improving global healthin Work Programme 2018–2020 (III)
41
42SC1 – WP 18-20 - Gio
Priority 4 – Innovative health and care systems –Integration of care
AIM: Develop effective, accessible and sustainable health interventions and integrated care systems
FOCUS: Mental health in the workplace, novel approaches for palliative care, implementation of personalised medicine, HTA, innovation in health care
POLICY DRIVERS:
Upgrading the single market
Cross-border healthcare Directive
42
43SC1 – WP 18-20 - Gio
• BHC-23-2018: Novel patient-centred approaches for survivorship,palliation and/or end-of-life care
• BHC-26-2018: HTA research to support evidence-based healthcare
• BHC-22-2019: Mental health in the workplace
• BHC-25-2019: Demonstration pilots for implementation ofpersonalised medicine in healthcare
Coordination and support actions
• HCO-12-2018: Innovation in healthcare – a CSA towards usingpre-commercial procurement and public procurement of innovativesolutions in healthcare systems
Innovative health and care systems – Integration of carein Work Programme 2018–2020
43
44SC1 – WP 18-20 - Gio
Priority 5 – Decoding the role of the environment, including climate change, for health and well-being
AIM: Improving the risk assessment of environment on health and well-being, and the related socio-economic impact and developing mitigation measures
FOCUS: New testing/screening methods to identify endocrine disrupting chemicals, the development of the 'human exposome' (to allow the assessment of lifelong environmental influences on individuals) and to set the priorities for a new research agenda
POLICY DRIVERS:
WHO Environment and Health Process (since 1989)
The UNFCCC Paris Agreement
The 7th Environment Action Programme (EAP)
REACH and EU relatedpolicies
45SC1 – WP 18-20 - Gio
• BHC-27-2018: New testing and screening methods to identifyendocrine disrupting chemicals
• BHC-28-2019: The Human Exposome Project: a toolbox for assessingand addressing the impact of environment on health
Coordination and support actions
• HCO-13-2018: Setting the priorities for a European environment,climate and health research agenda
Decoding the role of the environment, including climate change, for health and well-beingin Work Programme 2018–2020
45
46SC1 – WP 18-20 - Gio
Call deadlines
BHC + HCO call topicsCalls open: 7 November 2017
Calls close: 18 April 2018
46
ExceptionBHC-15-2018
Lump Sum Funding: a pilot topicCalls open: 7 November 2017First stage: 6 February 2018
Second stage: 4 September 2018
DTH, HCC, and SU-TDS call topicsCalls open: 7 November 2017
Calls close: 24 April 2018
Better Health and care, economic growth and sustainable health systems
Digital transformation in Health and Care
Trusted digital solutions and Cybersecurity in Health and Care
47SC1 – WP 18-20 - Gio
Participant portal – one–stop shop
• Call topics
• NCPs
• Expert registration
• Documents
• Project officers' list for questions
• FAQs
• Rules for participation
• Upload project reports
http://ec.europa.eu/research/participants/portal
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48SC1 – WP 18-20 - Gio
• until the UK leaves the EU, EU law continues to apply to and withinthe UK, when it comes to rights and obligations; this includes theeligibility of UK legal entities to fully participate and receivefunding in Horizon 2020 actions
• eligibility criteria must be complied with for the entire duration ofthe grant
• if the United Kingdom withdraws from the EU during thegrant period without concluding an agreement with the EUensuring in particular that British applicants continue to beeligible, you will cease to be eligible to receive EU funding (whilecontinuing, where possible, to participate) or be required to leavethe project on the basis of Article 50 of the grant agreement
Participation of UK entities
48
49SC1 – WP 18-20 - Gio
Thank you!
@EUScienceInnov#InvestEUresearch
#EUHealthResearch
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49