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EU research and innovation activities for Biomedical Engineering

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. EU R&I activities for Biomedical Engineering.

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EU research and innovation activities for Biomedical Engineering

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  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

  2. EU R&I activities for Biomedical Engineering • - Past and current activities • - Present and immediate future • - Perspectives and trends

  3. 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

  4. Activities at EU level -> R&I Funding of sector Biomedical Technologies Mainly: • ● 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: • ● NMP theme • ● ICT programme • ● CIP

  5. 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 and enabling technologies.

  6. 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

  7. 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 forthe manufacture of engineered tissues, instrumental to facilitate the broad utilization and commercialisation of tissue grafts as therapeutic solutions.

  8. 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

  9. 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

  10. Industrialleadership Excellentscience Societalchallenges Horizon 2020 The Commission proposal for a €80 billion research and innovation programme (2014-20) Priorities: • ● A single programme • ● More innovation – “from research to retail” • ● Focus on societal challenges • ● Simplified and broader access

  11. Horizon 2020: Health, Demographic Change and Wellbeing Challenge – proposal of priorities ~€8.5bn - Transferring knowledge to clinical practice and scalable innovation actions - Better use of health data - Improving scientific tools and methods to support policy making and regulatory needs - Active ageing, independent and assisted living - Individual empowerment for self-management of health - Promoting integrated care - 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 approaches. - Understanding the determinants of health (including environmental and climate related factors), improving health promotion and disease prevention; - Developing effective screening programmes and improving the assessment of disease susceptibility - Improving surveillance and preparedness - Understanding disease - Developing better preventive vaccines - Improving diagnosis - Using in-silico medicine for improving disease management and prediction - Treating disease

  12. 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

  13. Objectives of IMI Better and faster medicines for patients

  14. Experience withthe 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

  15. 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 & negotiationi.e.: earlier deadlines for 1st and 2nd stage submission.

  16. 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 Success • received retained for rate funding • Total: 112 19 17%

  17. 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 ● To lay the basis for stratified therapies and personalized medicine

  18. 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

  19. Furtherinformation EC Research web site http://ec.europa.eu/research FP7 web site http://cordis.europa.eu/fp7/health EMA http://www.ema.europa.eu/ E-mail contact Arnd.Hoeveler@ec.europa.eu Horizon 2020 http://www.ec.europa.eu/research/csfri/

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