The European Research Infrastructure for Biobanking and Biomolecular Resources  (BBMRI): Towards implementation Kurt Zatlo...
The Preparatory Phase of BBMRI  <ul><li>Assessment of existing resources and technologies </li></ul><ul><li>Concept for in...
The Challenges <ul><li>Harmonized processes  </li></ul><ul><li>Incentives for contributors </li></ul><ul><li>Access rules ...
Starting Points <ul><li>OECD best practice guidelines for Biological Resource Centres </li></ul><ul><li>OECD draft guideli...
Inventory on Existing Biobanks <ul><li>BBMRI questionnaires have been developed jointly by all WPs and P 3 G </li></ul><ul...
BBMRI Prototype <ul><li>Most advanced biobanks will start the construction of a prototype infrastructure already during pr...
BBMRI Policies (in brief) <ul><li>Primacy </li></ul><ul><ul><li>Respect the primacy of national and European legislation a...
The Adaptor Approach of BBMRI <ul><li>Define criteria  </li></ul><ul><ul><li>Which samples and data can be combined? </li>...
Possible Legal Structure  of BBMRI (ERIC)  Distributed hub and spoke structure National members Biobanks Biomolecular res....
Expected Impact of BBMRI <ul><li>BBMRI should provide a pan-European framework to foster excellence in biomedical research...
BBMRI: The Wider Context <ul><li>Global biobanking community </li></ul><ul><li>Life sciences community </li></ul><ul><li>I...
Involvement of the  Biobanking Community <ul><li>ESF workshop, Amsterdam Dec. 06 </li></ul><ul><li>Establishment of FIBO, ...
Involvement of Patients <ul><li>1st Stakeholder meeting: Brussels, March 20th 09 (Chair: M. Griffith) </li></ul><ul><ul><l...
Involvement of Industry <ul><li>Specific issues </li></ul><ul><ul><li>Quality management </li></ul></ul><ul><li>Projects: ...
Expert Centers: A New Model for PPP Hospital Patients Biobank Expert Centers Industry Samples  Med. data Identified Sample...
BBMRI and Publics <ul><li>Socio-economic impact study </li></ul><ul><li>(impact on science, economy, health care) </li></u...
BBMRI and ESFRI Biological and Medical  Sciences  Research Infrastructures EATRIS ELIXIR INFRAFRONTIER ECRIN BBMRI INSTRUC...
White Paper: Key Messages <ul><li>lay the foundation for improved health care for European citizens </li></ul><ul><li>“ ge...
Next Steps <ul><li>Joint web site  www.infrastructures4health.eu </li></ul><ul><li>Media briefing London September 22nd  <...
<ul><li>www.bbmri.eu </li></ul><ul><li>M. Yuille et al.  Briefing in Bioinformatics  9: 14-24 (2008)  </li></ul>Thank You
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Kurt Zatloukal

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Kurt Zatloukal

  1. 1. The European Research Infrastructure for Biobanking and Biomolecular Resources (BBMRI): Towards implementation Kurt Zatloukal, Medical University of Graz, Austria Stakeholder’s Forum Brussels, September 16th 2009 Preparatory Phase Grant Agreement 212111
  2. 2. The Preparatory Phase of BBMRI <ul><li>Assessment of existing resources and technologies </li></ul><ul><li>Concept for integration </li></ul><ul><li>Prototype (voluntary effort) </li></ul><ul><li>Concept for operation </li></ul><ul><li>MoU for infrastructure members and funding </li></ul><ul><ul><li>Legal entity </li></ul></ul><ul><ul><li>Statutory seat </li></ul></ul><ul><ul><li>Governance structure </li></ul></ul>
  3. 3. The Challenges <ul><li>Harmonized processes </li></ul><ul><li>Incentives for contributors </li></ul><ul><li>Access rules </li></ul><ul><li>Heterogenous European ethical and legal landscape </li></ul><ul><li>Data protection in biobanking </li></ul><ul><li>Sustainable funding </li></ul>
  4. 4. Starting Points <ul><li>OECD best practice guidelines for Biological Resource Centres </li></ul><ul><li>OECD draft guidelines on Human Biobanks and Genetic Research Database </li></ul><ul><li>P3G </li></ul><ul><ul><li>International harmonization of biobanking </li></ul></ul><ul><li>FP5-FP7, national programs </li></ul><ul><ul><li>Existing biobanks, resources and networks </li></ul></ul>
  5. 5. Inventory on Existing Biobanks <ul><li>BBMRI questionnaires have been developed jointly by all WPs and P 3 G </li></ul><ul><li>Detailed information on samples, data, access, governance, costs and funding </li></ul><ul><li>Meanwhile questionnaires from <260 biobanks returned </li></ul><ul><li>Stored in a relational database system </li></ul>
  6. 6. BBMRI Prototype <ul><li>Most advanced biobanks will start the construction of a prototype infrastructure already during preparatory phase on a voluntary basis </li></ul><ul><li>Prototype should implement BBMRI policies and structure </li></ul><ul><li>Requires support from national Funders and Ministries </li></ul><ul><li>9 proposals received </li></ul>
  7. 7. BBMRI Policies (in brief) <ul><li>Primacy </li></ul><ul><ul><li>Respect the primacy of national and European legislation and respect the jurisdiction of competent authorities </li></ul></ul><ul><li>Data protection policy: </li></ul><ul><ul><li>No data on individuals will be made publicly accessible </li></ul></ul><ul><li>Access policy: </li></ul><ul><ul><li>Fair access in context of specific research projects and after REC approval; biobanks do not loose control </li></ul></ul><ul><li>Informed consent: </li></ul><ul><ul><li>Implementation of the OECD guidelines for Human Biobanks and Genetic Research Databases </li></ul></ul><ul><li>Infrastructure and management: </li></ul><ul><ul><li>Implementation of the OECD best practice guidelines for Global Biological Resource Centres Networks. </li></ul></ul><ul><li>Sample collection and processing: </li></ul><ul><ul><li>SOPs for processes considering the WHO/IARC guidelines for biological resource centres for cancer research </li></ul></ul>
  8. 8. The Adaptor Approach of BBMRI <ul><li>Define criteria </li></ul><ul><ul><li>Which samples and data can be combined? </li></ul></ul><ul><ul><li>Evidence-based standards </li></ul></ul><ul><li>Develop tools </li></ul><ul><ul><li>Data exchange </li></ul></ul><ul><ul><li>Sample intl. transfer </li></ul></ul>
  9. 9. Possible Legal Structure of BBMRI (ERIC) Distributed hub and spoke structure National members Biobanks Biomolecular res. Technology centers Associated partners Hospitals Universities Service providers … Secretariat (statutory seat)
  10. 10. Expected Impact of BBMRI <ul><li>BBMRI should provide a pan-European framework to foster excellence in biomedical research </li></ul><ul><ul><li>Better projects, faster, cheaper </li></ul></ul><ul><li>Access to high quality resources, technologies, services, education and training </li></ul><ul><li>Partner for academia and industry </li></ul><ul><ul><li>SMEs: Strategic partner, customer </li></ul></ul><ul><ul><li>Pharma: Biomarker and drug development </li></ul></ul><ul><li>Incubator for regional development </li></ul><ul><ul><li>Start-up packages </li></ul></ul>
  11. 11. BBMRI: The Wider Context <ul><li>Global biobanking community </li></ul><ul><li>Life sciences community </li></ul><ul><li>Industry </li></ul><ul><li>Patients/donors </li></ul><ul><li>Publics </li></ul><ul><li>Political decision-makers </li></ul>
  12. 12. Involvement of the Biobanking Community <ul><li>ESF workshop, Amsterdam Dec. 06 </li></ul><ul><li>Establishment of FIBO, Paris, Dec. 06 </li></ul><ul><li>Stakeholder meeting Vienna, Feb. 07 </li></ul><ul><li>Presentation at EU Parliament , May 08 </li></ul><ul><li>Joint workshop DG Research, BBMRI, PHOEBE; Brussels, November 08 </li></ul><ul><li>Joint conference, Brussels, March 09 </li></ul><ul><li>Secretariat for OECD GBRCN pilot, September 09 </li></ul>
  13. 13. Involvement of Patients <ul><li>1st Stakeholder meeting: Brussels, March 20th 09 (Chair: M. Griffith) </li></ul><ul><ul><li>European Cancer Coalition (H. Sundseth) </li></ul></ul><ul><ul><li>Heart EU (M. Livingston) </li></ul></ul><ul><ul><li>Europ. Fed. of Crohn‘s and Ulcerative Colitis Associations (R. Mitchell) </li></ul></ul><ul><ul><li>EURORDIS (V. Bottarelli) </li></ul></ul><ul><ul><li>Internatl. Alliance of Patients‘ Organizations (S. McMahon) </li></ul></ul><ul><ul><li>Europ. Genetic Alliance Network (A. Kent) </li></ul></ul><ul><li>2nd Stakeholder meeting: </li></ul><ul><li>Brussels, September 16th 09 </li></ul>
  14. 14. Involvement of Industry <ul><li>Specific issues </li></ul><ul><ul><li>Quality management </li></ul></ul><ul><li>Projects: Proof-of-concept </li></ul><ul><li>Strategic issues </li></ul><ul><ul><li>Long-term strategy for PPP (EFIPA, EDMA) </li></ul></ul><ul><ul><ul><li>Joint analyses centers </li></ul></ul></ul><ul><ul><ul><li>Biomarker centers </li></ul></ul></ul><ul><ul><ul><li>Biobanking service </li></ul></ul></ul>Expert centers
  15. 15. Expert Centers: A New Model for PPP Hospital Patients Biobank Expert Centers Industry Samples Med. data Identified Samples Med. data Coded Study data Confidential Public Private Provides efficient access to samples, data and expertise Reduces requirements for sample shipment Avoids false impression of sample commercialization
  16. 16. BBMRI and Publics <ul><li>Socio-economic impact study </li></ul><ul><li>(impact on science, economy, health care) </li></ul><ul><li>Public perception (focus groups and Eurobarometer) </li></ul><ul><li>Coordinated communication strategy of all BMS research infrastructures (joint task force) </li></ul><ul><li>White paper for European Parliament </li></ul>
  17. 17. BBMRI and ESFRI Biological and Medical Sciences Research Infrastructures EATRIS ELIXIR INFRAFRONTIER ECRIN BBMRI INSTRUCT Target Id Target Val Hit Lead Lead Optim Preclininc Phase I Phase II Research Discovery Development Phase III e-Infrastructure EMBRC EISBI EU Open Screen Euro Bio- Imaging BSL4 Laboratories B i o b a n k i n g B i o i n f o r m a t i c s PP projects 1st update of roadmap Emerging infrastructures
  18. 18. White Paper: Key Messages <ul><li>lay the foundation for improved health care for European citizens </li></ul><ul><li>“ generate value for society through collaboration” </li></ul><ul><li>Provide unique opportunity to improve competitiveness of European science and industry </li></ul><ul><ul><li>together generate a value generating chain without gaps </li></ul></ul><ul><ul><li>Generate an enormous momentum </li></ul></ul><ul><ul><li>for the first time generate a homogenous European research space (ERIC) </li></ul></ul><ul><ul><li>Health-related economies are the potential next driver of global economy </li></ul></ul><ul><li>Requires co-ordination and collaboration at national, European, and global levels </li></ul><ul><ul><li>Redefine research strategies </li></ul></ul><ul><ul><li>New business models </li></ul></ul><ul><ul><li>Proper legal framework </li></ul></ul><ul><ul><li>Sustainable funding tools </li></ul></ul>ESFRI BMS infrastructures will
  19. 19. Next Steps <ul><li>Joint web site www.infrastructures4health.eu </li></ul><ul><li>Media briefing London September 22nd </li></ul><ul><ul><li>(FT, Bloomberg J Law, Nature, Biotech-Pharma) </li></ul></ul><ul><li>High impact paper </li></ul><ul><ul><li>I. Mattaj/F. Kafatos/ESFRI coordinators </li></ul></ul><ul><li>White paper to be communicated to the </li></ul><ul><li>European Parliament in November 09, formal hearing </li></ul><ul><li>Europe by Satellite (EBS) </li></ul><ul><li>Events during Spanish, Belgium Presidency </li></ul>
  20. 20. <ul><li>www.bbmri.eu </li></ul><ul><li>M. Yuille et al. Briefing in Bioinformatics 9: 14-24 (2008) </li></ul>Thank You

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