Transcript Slide 1

EU research and innovation activities
for Biomedical Engineering
Arnd Hoeveler
Head of Unit, Advanced Therapies and Systems Medicine
Health Directorate
DG Research & Innovation
European Commission
Brussels, 14 March 2012
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Policy
Research and
Innovation
EU R&I activities for Biomedical Engineering
• - Past and current activities
• - Present and immediate future
• - Perspectives and trends
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Policy
Research and
Innovation
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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Policy
Research and
Innovation
Activities at EU level
-> R&I Funding of sector Biomedical Technologies
Mainly:
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● Health theme:
- FP7 so far: 86 projects funded with a budget of 415M€
9 of the projects are coordinated by SMEs and 43 projects
have 2 or more SMEs as participants
- FP6 - an estimated contribution of ~100M€
Additionally:
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● NMP theme
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● ICT programme
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● CIP
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Policy
Research and
Innovation
Biomedical Technologies:
Project Example 1 - Tissue Engineering
• 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
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and enabling technologies.
Policy
Research and
Innovation
Biomedical Technologies:
Project Example 2 - Diagnostic
• LCAOS : A nanoscale artificial nose to easily detect
volatile biomakers at early stages of lung cancer
• Diagnostic sensor device detecting presence of lung
cancer/risk of a person to develop lung cancer
• approach based on volatile biomarkers emitted from
cell membranes
• Sensor highly sensitive, non-invasive, fast-responsive
• Sample = exhaled breath
• detection of pre-neoplastic volatile biomarkers
• Double track approach:
• Laboratory track
• Clinical track
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Policy
Research and
Innovation
Biomedical Technologies:
Other project examples
● Regenerative Medicine
•
▪
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 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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Policy
Research and
Innovation
Immediate Future
7th Call *
1.3-2 - Innovative approaches to address
adverse immune reactions to biomedical
devices, implants & transplant tissues.
Funding scheme: CP-FP, max. €6m/project.
Industry topic: min. 30% EC contribution to industry, incl. SMEs
Provisional Deadline: early October 2012*
*Pending approval by the Programme Committee of the
Member States and the Commission
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Policy
Research and
Innovation
Horizon 2020: The next framework
programme for research and innovation
• ● Europe needs cutting edge
research and innovation
• ● Essential to ensure
competitiveness, growth and
jobs
• ● Vital to tackle pressing societal
challenges
• ● 3% of GDP invested in R&D:
headline target of Europe 2020
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Policy
Research and
Innovation
Horizon 2020
The Commission proposal for a €80 billion research and
innovation programme (2014-20)
Priorities:
Industrial
leadership
Excellent
science
Societal
challenges
• ● A single programme
• ● More innovation –
“from research to retail”
• ● Focus on societal
challenges
• ● Simplified and
broader access
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Policy
Research and
Innovation
Horizon 2020:
Health, Demographic Change and Wellbeing
Challenge – proposal of priorities ~€8.5bn
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Understanding the determinants of health
(including
environmental
and
climate
related
factors),
improving
health
promotion and disease prevention;
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Transferring knowledge
practice and scalable
actions
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Better use of health data
to clinical
innovation
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Developing effective screening programmes
and improving the assessment of disease
susceptibility
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Improving
scientific
tools
and
methods to support policy making
and regulatory needs
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Improving surveillance and preparedness
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Active ageing, independent and
assisted living
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Understanding disease
-
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Developing better preventive vaccines
Individual empowerment
management of health
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Improving diagnosis
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Promoting integrated care
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Using in-silico medicine for improving
disease management and prediction
-
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Treating disease
Optimising
the
efficiency
and
effectiveness of healthcare systems
and reducing inequalities through
evidence based decision making and
dissemination of best practice, and
innovative
technologies
and
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approaches.
Policy
Research and
Innovation
for
self-
Trends and Perspectives
“Horizon 2020”
The innovation chain - Discovery, translation,
regulation, procurement, market uptake
● Focus on research intensive SMEs playing a leading role
● Different partnerships, IMI, European Innovation
Partnership (EIP), EIT
● New instruments, e.g. Small Business Innovation
Research
● More adapted regulation, e.g. revision of the medical
devices directives (MDD), clinical trial directive
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Policy
Research and
Innovation
Objectives of IMI
Better and faster
medicines for
patients
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Policy
Research and
Innovation
Experience with
the Joint Technology Initiative IMI
● IMI projects perform excellent research
● Very good example of bringing research and
innovation together
● Leads to new forms of collaboration amongst
stakeholders, built on trust: between academia and
industry; also implicating regulators and patient
organisations
● New business models for now and the future
● Rules and procedures need to be fit-for-purpose
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Policy
Research and
Innovation
SBIR-like : “SMEs for Innovation”
INNOV-2 call
Pilot initiative to stimulate innovation via enhanced SME participation
Special conditions:
– 3-5 partners, min. 50% of required EU funding for SME(s)
– Restricted to entities from EU and Associated Countries
– Maximum 3 years
– The SME must have a leading role in the project
– 2-stage submission & evaluation; higher threshold for “Impact”
– Simplified application process: short project description
– Accelerated procedures for submission, evaluation & negotiation
i.e.: earlier deadlines for 1st and 2nd stage submission.
Policy
Research and
Innovation
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SBIR-like: “SMEs for innovation”
– evaluations
FP7-HEALTH-2012-Innovation-2 (special call, 3 topics)
• stage 1 deadline: 27 Sept. 2011 – 112 proposals received
(6 ineligible)
• stage 2 deadline: 13 Dec. 2011 – 45 proposals received
• Overall Evaluation Outcome :
Proposals
Proposals
received
retained for
funding
Total:
112
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Policy
Research and
Innovation
Success
rate
17%
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●
Trends and Perspectives
“Horizon 2020”
Combination of different technologies
Examples:
• Medical tools and devices to assist the establishment of
regenerative therapies in the clinic
• Use of bio-compatible materials
• Use of electronic devices, etc.
●
Health Technology Assessment
• New and improved methods to assess efficacy and
effectiveness of novel therapies
• Specific settings, e.g. hospitals
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To lay the basis for stratified therapies and personalized
medicine
Policy
Research and
Innovation
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Conclusions
•  EU active in supporting biomedical engineering
•  Research is multi-disciplinary so collaboration
needed
•  Moving into the clinic is a real bottleneck
•Experience
•Resources
•  Many business/therapeutic models; not all leading
to new products
•  Science moving rapidly
•  Inducive regulatory framework needed
•  New partnerships
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Policy
Research and
Innovation
EC Research web site
http://ec.europa.eu/research
Further
information
FP7 web site
http://cordis.europa.eu/fp7/health
EMA
http://www.ema.europa.eu/
E-mail contact
[email protected]
Horizon 2020
http://www.ec.europa.eu/research/csfri/
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Policy
Research and
Innovation