Innovación y Calidad en el Sistema Nacional de Salud Miércoles, 25 de Junio de 2014 17:00h http://debateSEC.secardiologia.es Research and Innovation in Cardiovascular Diseases: The EU perspectives Dr. Karim Berkouk Deputy Head of Unit. DG Innovation and Research-European Commission

1. Research and
Innovation
Dr Karim Berkouk
Deputy Head of Unit for Medical Research and Ageing
Health Directorate
Research & Innovation DG
European Commission
Madrid, 25 June2014
Research and Innovation in
Cardiovascular Diseases -
The EU perspectives

2. Research and
Innovation
Content
Challenges in CVD
Research in CVD at EU level
CVD in FP7
Horizon 2020

3. Research and
Innovation
• Ageing population
• Increased disease burden:
chronic diseases
• Health & care sector
unsustainable: under pressure to
reform
• Health industry under pressure
for innovative solution
Health main challenges

4. Research and
Innovation
• First cause of death in Europe
• Costs : 200 Billion per year
• Elderly population
• Co-morbidities (diabetes and obesity)
• Limited innovation in recent years
• Stratification of patients to predict
successful treatment
CVD main
challenges

5. Research and
Innovation
EU
Health
R&I
Collaborative
Research
Bottom-up:
ERC, MC
Public-
Private
Partnerships
IMI
Bio-Eco
Capacity
Building
Infrastructures
(CT, biobank)
Legislation
Directives,
Regulations
International
co-operation
Global consortia
GACD
MS
Coordination
ERA-NET, JPs
EDCTP
EIP AHA
Joint Action
The EU means

6. Research and
Innovation
FP 7 - Health - State of Play
Key figures
5,5 B€ invested
1054 projects
12 505 participations
3 615 organisations
123 countries
First outcomes
(on 349 closed projects)
11 879 publications
3,2 average SJR* publication
227 patent applications
31 spin-offs created
* SCImago Journal Ranking

7. Research and
Innovation
FP 7 - CVD - State of Play
Key figures
810 M€ invested
371 projects
1,788 participations
907 organisations
61 countries
First outcomes
(on 22 closed Health projects)
1,165 publications
2,5 (7,1) average SJR*
publication
27 patent applications
* SCImago Journal Ranking

8. Research and
Innovation
Collabora-
tive
projects -
€620M
77%
Frontier –
€113M
14%
Training –
€74M
9%
EU CVD research –
what’s being funded
• translational research
 atherosclerosis
 arrhythmias
 heart failure
 cardiomyopathies
 hypertension
 congenital disease
 stroke
 biomarkers, drug target
discovery and validation
 tissue regeneration
 imaging
• comparative
effectiveness research
• investigator-driven trials
• public health
Number of projects: 71
Total Costs : € 1,041 million
EU Contribution : € 907million*
*data cover 2007-2013

9. Research and
Innovation
FP 7 – CVD MS Regions
funding
In million € (m€)
0
0 - 0,5
0,5 - 1
1 - 0
0 - 1
1 - 3
3 - 30
30 - 32
32 - 37
37 +
B
N

10. Research and
Innovation
FP 7 – CVD Spanish
Regions funding
ES11
ES12
ES13
ES21
ES22
ES23
ES24
ES30
ES41
ES42ES43
ES51
ES52
ES61
ES62 SPAIN key figures
EC Contribution : 49.878.105
Total Costs : 65.817.228
Number of projects : 79
Number of participations : 141
Number of organisations : 81
Average amount by participations : 353.745

11. Research and
Innovation
Average EC contribution in
CVD projects
682.991
636.870
603.910
532.153
503.037
499.993
484.876
483.157
477.375
425.592
417.189
399.831
369.400
368.340
353.745
349.414
339.891
332.963
265.484
257.132
236.327
234.854
227.135
217.468
215.038
213.240
191.590
190.921
190.907
189.136
167.998
152.486
104.899
100.383
0
0
0
382.185
Netherl…
Finland
Sweden
Israel
Germany
Switzer…
Belgium
France
United…
Turkey
Iceland
Denmark
Greece
Ireland
Spain
Italy
Austria
Norway
Serbia
Portugal
Luxemb…
Bulgaria
Lithuania
Hungary
Czech…
Moldov…
Latvia
Poland
Romania
Slovakia
Cyprus
Estonia
Slovenia
Croatia
Malta

12. Research and
Innovation
FP 7 – CVD connections
with Spain
259
240
198
136
129
108
95
53
53
40
32
32
31
30
28
26
15
15
12
10
10
9
9
8
8
8
7
7
6
6
DE-ES
ES-UK
ES-IT
ES-ES
ES-NL
ES-FR
BE-ES
ES-SE
ES-FI
CH-ES
EL-ES
AT-ES
ES-NO
ES-PT
DK-ES
ES-IE
ES-IL
ES-PL
ES-RS
ES-SI
ES-TR
ES-US
ES-HU
CN-ES
AR-ES
EE-ES
ES-HR
CZ-ES
ES-SK
ES-NZ

13. Research and
Innovation
Horizon 2020
Perspectives

14. Research and
Innovation
The Multiannual Financial Framework
2014-2020: European Council conclusions, 8 February 2013
• Key challenge: stabilise the financial and economic
system while taking measures to create economic
opportunities
1. Smart & inclusive growth (€451 billion)
2. Sustainable growth, natural resources (€373 billion)
3. Security and citizenship (€16 billion)
4. Global Europe (€58 billion)
5. Administration (€61.6 billion)
Education,
Youth, Sport
Connecting
Europe
Cohesion
Competitive
Business
SMEs
HORIZON
2020
TOTAL
€960 billion

15. Research and
Innovation
What Horizon is 2020 about
− Responding to the economic crisis to invest in
future jobs and growth
− Addressing people’s concerns about their
livelihoods, safety and environment
− Strengthening the EU’s global position in
research, innovation and technology
http://ec.europa.eu/research/horizon2020
The EU’s 2014-20 programme
for research & innovation
A core part of Europe 2020,
Innovation Union &
European Research Area

16. Research and
Innovation
Three
priorities
•Excellent
science
•Industrial
leadership
•Societal
challenges
• European Research Council
• Future and Emerging Technologies
• Marie Skłodowska-Curie actions
• Research infrastructures
• Leadership in
enabling and
industrial
technologies
• Access to risk
finance
• Innovation in
SMEs
• Health, demographic
change and wellbeing
• Food security,
sustainable
agriculture and
forestry, marine and
maritime and inland
water research and
the Bioeconomy
• Secure, clean and
efficient energy
• Smart, green and
integrated transport
• Climate action,
environment,
resource efficiency
and raw materials
• Inclusive, innovative
and reflective
societies
• Secure societies
• Science with and for
society
• Spreading excellence
and widening
participation

17. Research and
Innovation
Innovation Investment Package
€22 billion Innovation Investment Package
Joint Technology Initiatives (under Article 187)
• Innovative Medicines Initiative 2
• Clean Sky (Aeronautics) 2
• Fuel Cell and Hydrogen 2
• Bio-based Industries
• Electronic components and systems
Joint programmes (under Article 185)
• European and Developing Countries Clinical Trials
Partnership (EDCTP) 2
• European Metrology Research Programme 2
• Eurostars (for SMEs) 2
• Active and Assisted Living 2

18. Research and
Innovation
General opening
• Horizon 2020 is open to participation from across the
world
• Automatic funding:
• Member States (including overseas departments and
overseas territories)
• Associated Countries
• exhaustive list of countries in annex to work
programme (but: no longer BRIC + Mexico in this list!)
• Participants from other countries only funded in
exceptional cases:
• when provision is made in the call text
• bilateral agreement (e.g. Health challenge – NIH)
• when the Commission deems it essential (case by case
assessment)

19. Research and
Innovation
International K.O.
Mouse Consortium
International Human
Microbiome Consortium
International Human
Epigenome Consortium
International Rare
Diseases Research
Consortium
International Initiative
for Traumatic Brain
Injury Research
©rtguest/Fotolia.com
Global Alliance for
Chronic Diseases
New! Global Research
Collaboration for Infectious
Disease Preparedness
International Cancer
Genomics Consortium
Continued and growing
international cooperation

20. Research and
Innovation
Less prescriptive topic texts
Two-year work programme
Stronger focus on end users
Broad topics
Challenge-driven
Health, Demographic change and
wellbeing - aim
Funding: € 7.5 Billion

21. Research and
Innovation
Advancing active and healthy ageing
Integrated, sustainable, citizen-centred care
Improving health information, data exploitation and
providing an evidence base for health policies and regulation
Innovative treatments and technologies
Improving diagnosis
7 Focus Areas
Effective health promotion, disease prevention,
preparedness and screening
Understanding health, ageing & disease

22. Research and
Innovation
• European Innovation Partnership on Active and Healthy
Ageing
• Global Alliance for Chronic Diseases (GACD) – Diabetes
(2014)
• Joint Programming Initiatives on neurodegenerative
diseases (JPND); 'More Years, Better Life's; & Global
Research Collaboration for Infectious Disease
Preparedness (2014)
• ERANETS : Cancer, Systems medicine & rare diseases
(2014); Brain-related disorders, antimicrobial
resistance, cardiovascular diseases (2015)
Support for European and
International Initiatives

23. Research and
Innovation
Strategic Initiatives
Innovative Medicines Initiative 2
www.imi.europa.eu
European & Developing Countries
Clinical Trials Partnership (EDCTP2)
www.edctp.org
Active and Assisted Living 2
www.aal-europe.eu
European Innovation Partnership
on Active and Healthy Ageing
https://webgate.ec.europa.eu/eipaha

24. Research and
Innovation
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
• Emphasis on SMEs and on investigator-driven
clinical trials

25. Research and
Innovation
New EU Clinical Trials
Regulation
• Responds to criticism of current EU Clinical
Trials Directive:
• Single submission portal for multinational trials
• Joint assessment by member states' competent authorities
• Tacit-approval deadlines
• Reduced administrative burden (low-risk trials)
• Applicable two years after publication (+
transition period)

26. Research and
Innovation
Innovation Union Commitment n°7
Ensure stronger involvement of SME in
future EU R&I programmes
*
European Council 4 February 2011
Commission is invited to explore the
feasibility of a Small Business Innovation
Research Scheme
Innovation Initiatives

27. Research and
Innovation
Funding Gap
(range: 1-3 M€)

28. Research and
Innovation
More opportunities
for SMEs
• Integrated approach - around 20% of the
total budget for societal challenges and
LEITs to go to SMEs
• 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' will have a strong
SME focus (debt and equity facility)
• COSME and H2020 are complementary
programmes to generate growth and jobs
Image courtesy of Vlado/ FreeDigitalPhotos.net

29. Research and
Innovation
SME instrument
Concept &
Feasibility
Assessment
Innovation
R&D activities
Commercialisation
Phase 2Phase 1 Phase 3
Idea Market
• Feasibility of concept
• Risk assessment
• IP regime
• Partner search
• Design study
• Development,
prototype, testing
• Miniaturisation/design
• Clinical trials
• Etc.
• Facilitate access to
private finance
• Support via networking,
training, coaching,
knowledge sharing,
dissemination
Lump sum:
~ 50.000 €
~ 6 months
Output-based payments:
1 to 5 M€
12 to 36 months
No direct funding
Deadlines: 2/3 cut off dates in 2014 for phase 1 & 2