EU strategy for innovation
in health research
Ruxandra Draghia-Akli, MD, PhD
Director
Health Directorate
DG Research & Innovation
European Commission
1
What can FP7 Health do?
State of play (Oct. 2011)
2007-2011:
● 13.0% of EU contribution for SMEs
● 13.6% of participants are SMEs
● 462/693 projects (67%) with at least one SME in consortium
● 49 projects (7.0%) coordinated by SMEs
2
Health Theme strategy
to encourage SME participations
● 2007 & 2008: 3 SME topics on the FP6 SME call model
 11% of EU contribution to SMEs
● 2009 & 2010: SME ‘suitable topics’
 ~10% of EU contribution to SMEs
● 2011: SME-targeted topics:
€ 111 million to SMEs (out of €144m)
 1/3 budget
 ‘X% of EU contribution to SMEs’ as an eligibility criteria
 and qualitative approach: ‘Leading role’ for SMEs
● 2012: SME-targeted topics + Pilot initiative for SMEs (INNO-2)
 14 SME / industry targeted topics
 ½ budget; 50% of research topics targeted to SMEs
(with min. funding for SMEs: >15%, >30% or >50%)
 all topics are 2-stages; 6 page proposal in the 1st stage
3
Strong impact:
doubling in EU funding going to SMEs
~20%
of EU funding
going to SMEs
144
150
2011
2012
~11%
of EU funding going to SMEs
70
66
2007
2008
60
2009
70
2010
Conservative estimate; could reach €200m
4
Health Theme strategy
to encourage SME participations
Efforts should be maintained in WP 2013
• to meet the 15% target for SME participation
(not only quantitatively, but also qualitatively
• to mainstream SME participation
(as partners and as project leaders)
To support innovation policy
5
Supporting SME
participation
Fit for Health (complemented by SM BioPower, now finished):
• Increase SME participation in Health proposals
• Support SMEs during negotiation & projects lifetime
• Valorisation of results
Kappa Health (now finished):
• Survey on success factors in FPs participation (see clips)
• Valorisation of results (training + coaching)
Support for Innovation WP 2012 topics (under evaluation):
•
•
Technology/knowledge transfer support-network
IPR/Knowledge transfer trainings for IPR management, business plan,
company launch …
Commission survey on impact assessment & valorisation of results
6
SMEs: Reasons to join
EU health projects
100%
18%
90%
13%
10%
24%
80%
40%
46%
40%
19%
50%
70%
20%
5 - Very Important
4
3
2
1
0 - Not relevant
26%
75%
60%
26%
17%
23%
50%
20%
31%
40%
22%
13%
29%
21%
15%
16%
30%
10%
14%
14%
20%
14%
10%
5%
3%
3%
0%
8%
8%
8%
5%
8%
12%
17%
18%
16%
11%
16%
9%
2%
Integration in a EU
Access to
Large Scale or
netw ork
m ultidisciplinary scope that cannot
academ ic
be achieved at
expertise
National /
institution level
08/04/2015
10%
Funding not
available in your
country
Access to special Links to Industrial
resources and
infrastructures
Access to other
expertise
Source: Impact assessment questionnaire survey (2011)
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Outcomes from participation
(in FP6 & FP7 Health)
60%
50%
*5 choices possible
57%
46%
41%
Academic
SMEs
41%
40%
39%
40%
34%
30%
34%
33%
27%
25%
26%
23%
20%
20%
18%
17%
12%
10%
0%
Networking
and / or
coordination
of science
Publications Significant
in "high
expension
impact"
beyond state
journals
of the art
New or
improved
products
New /
development
of
companies,
new jobs
New
resources
Contribution Clear benefit Free access
to
to patients to important
international
data
research
initiatives
New or
improved
protocols
Patents
Training
programmes
Other
important
outputs
Source: Impact assessment questionnaire survey (2011)
8
Outlook for 2013
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Outlook for SMEs in Europe
Impact of economic crises
● European Biopharmaceutical Enterprise / Alcimed study (2009):
 20% of Europe’s small biopharmaceutical companies at risk of
bankruptcy. Risk of loss of 20,000 high-skill, high-value jobs and a
permanent damage to Europe’s research capacities.
● Europabio survey (2010):
 86% of national associations consider that the main funding gap is at
the later stage of product development
 57% of national associations linked the funding gap to proof of
concept stage
● DG R&I, Health conference (2010): Main conclusions:
 EU should help address the 'valley of death' by financing proof-ofconcept schemes similar to small business innovation research
(SBIR) in the US, eventually with small early funding for proof of
concept, followed by the second phase project funding.
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Evolution of private equity
funds raised in Europe
Source: EVCA/PEREP_Analytics
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Technology offer
SME questionnaire
(July- Sept. 2011)
● All FP6 and FP7 health SMEs (1,236) contacted
● ~1,000 SMEs received the questionnaire
● 106 replied (10%)
● 60-70% have developed / are developing promising technologies
and are seeking:
 Licensing opportunities
 Technical cooperation
 Joint venture agreement
 Manufacturing agreement
 Commercial agreement
12
Feedback from SMEs
•
“This project allowed our company to enter a commercial space which it may
have had difficulty in doing if funding had to be raised through private equity.”
•
“We have the opportunity to benefit from both patients and the scientific
community.”
•
“The EU funding has enabled our company to be in a position where the raising
of significant capital has been made easier through being able to demonstrate
clear capability in this area.”
•
“It allowed the company to expand its service offer, raise awareness about its
activity among the pharmaceutical industry and accelerate the internal product
development.”
•
“Being very young in the market this is a very important opportunity. It gave us
access to knowledge and innovative technologies and processes. And the
possibility to establish important networks for our business.”
13
SME Strategy
in 2013 work programme
Commission proposal:
•
•
~20 SME / industry targeted topics (min. 15%, 30% or 50%)
Special topic on translation of promising FP projects
results into innovative products/services
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Case: European
Biomedical Technologies sector
● Key sector for European competitiveness
●
●
500,000 jobs EU
18,000 Companies
80% of them are SMEs
Very innovative sector
Short Product lifecycle (~ 18 months)
But dispersed due to broad range of technologies
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Activities at EU level
-> R&I Funding of sector Medical Technologies
Mainly:
● Health theme:
- FP7 so far: 54 projects funded with a budget of
252M€
9 of the projects are coordinated by SMEs and 43
projects have more than 2 SME as participants
- FP6 - an estimated contribution of ~100M€
Additionally:
● NMP theme
● ICT programme
● CIP
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Biomedical Technologies: Cutting edge
Project Example
●
LIFEVALVE: Living autologous heart valves for minimally
invasive implantable procedures
 Hi-tech + highly interdisciplinary project
 Combination of tissue engng. approach with strong clinical
component i.e. minimally invasive surgery (and first clinical
trials)
 Coordinator: Simon P. Hoerstrup, UNIV. Zuerich
 8 partners, thereof 3 SMEs
 XELTIS (CH), worldwide leader for tissue engineered
cardiovascular implants.
 PFM AG (DE), specialised in medical technology products in
the fields of pathology/histology, OP/anaesthesia, infusion
therapy and interventional technologies.
 QTIS/E BV (NL), focuses on development of tissue
engineering applications and enabling technologies.
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Last Call FP7
●Regenerative Medicine
Topic 1.4-2: Tools, technologies and devices for application in
regenerative medicine. (>30% for SMEs)
 Topic well covered; 76 proposals submitted, 7 funded,
4 led by SME/IND and in total nearly 50% of budget to SMEs.
 Innovaliv aims to provide the EU healthcare system with a renewable
and reliable GMP source of functional clinical-grade hepatocytes
generated from EU hES lines.
 Biomagscar propose to use a biodegradable magnetised stent to
deliver a novel biological therapy offering regenerative medicine
solutions to the coronary artery vessel wall.
 Bio-comet is a bioreactor with automated, controlled, reproducible
and GMP compliant operation will be developed for the manufacture of
engineered tissues, instrumental to facilitate the broad utilization and
commercialisation of tissue grafts as therapeutic solutions.
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Impact of EU Research&Innovation
funding activities
● EU competitiveness
- Strengthening / creation of SMEs
- Filing / licensing of patents
- Creation of jobs
● Improvement of Public Health
Development of technologies for better diagnosis
and improved treatment
Bringing novel technologies faster to market
Special added value in context of ageing population
19
Potential contribution
to EIP on Active and Healthy Ageing
● Novel medical devices
● HTA (cooperation, new approaches)
● Joint Programming (Neuro)
● Best practices (clinical)
● Gathering of key stakeholders
-> Context: Europe 2020 strategy
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