Biobanking and Biomolecular Resources Research Infrastructure: The need for common standards

Transcription

1 Biobanking and Biomolecular Resources Research Infrastructure: The need for common standards K. Zatloukal Medical University of Graz, Austria Washington, Embassy of Austria June 5th 2012

2 Biobanks and Biomolecular Resources Most of our current knowledge on diseases as well as available diagnostic assays and drugs are based on systematic investigation of human biological samples and medical data From Eigenschaften der Dinge Bartholomäus der Engländer 15.Jh C. Zeiss 1879 HIV Bank Fraunhofer Saarland BGI 2009 Shenzhen, China

3 The European Research Infrastructure for Biobanking and Biomolecular Resources Scientific excellence One type of infrastructure for Europe Access to high quality human biological samples and associated data Ethical and legal compliance Long-term sustainability International integration

4 BBMRI: A pan-european Infrastructure Preparatory Phase Participants 222 Ass. Partners 33 Countries Implementation BBMRI-ERIC mio

5 hub and spoke structure Distributed Structure of BBMRI-ERIC Headquarter (Austria) National nodes Associated partners Hospitals Universities Service providers

6 Future Founding Members of BBMRI-ERIC Full Members: Austria, Bulgaria, Czech Republic, Estonia, Finland, France, Greece, Italy, Latvia, the Netherlands, Malta, Spain, Sweden, Norway, (MoU signed) Germany, (declared intention) Observer: Ireland, Poland, Switzerland, UK 140 million funding allocated

7 The Adaptor Approach of BBMRI to Achieve Interoperability Define criteria Which samples and data can be combined? Evidence-based quality indicators Develop tools exchange Intl. transfer of samples Ethical and legal compliance Interoperability!

8 BBMRI Standardization and Interoperability Fit for purpose Evidence-based quality parameter Quality control Documentation WHO/IARC Standards (recommended) OECD Guidelines (mandatory) SOPs Standards Guidelines

9 BBMRI and Publics Public perception (focus groups and Eurobarometer) Active participation of patient organizations Socio-economic impact study (impact on science, economy, health care) Political engagement process Seminar in European Parliament (May 2009) Hearing in European Parliament (Oct. 2010)

10 Nature September 2009

11 Access for Industry Common good (donations) Industry Medical data Biological samples Knowledge? Diagnostics Drugs Public (not-for-profit) Private (for-profit)

12 Expert s: Win-Win for Public and Private Sectors Common good (donations) Expertise Expertise Funds Industry Medical data Biological samples Knowledge Primary data generation Diagnostics Drugs Public (not-for-profit) Public Private pre-competitive (not-for-profit) Products IPR Standardisation of data generation Basis for data sharing Better usage of finite resources Collaborative research to improve innovation Private (for-profit)

13 (public) Expert s as Highways for Internationational Research Collaborations Biological Resource Samples Medical Country 1 Expert Biological Resource Research Samples Medical Research Research Expert Expert Samples Medical Country 2 Biological Resource Country 3

14 (public) Expert s as Highways for Internationational Research Collaborations Biological Resource Samples Medical Country 1 Expert Biological Resource Research Samples Medical Research Research Expert Expert Samples Medical Country 2 Biological Resource OECD GBRCN Country 3

15 The Translational Research Chain Disease Biospecimens Med. data Molec. data Knowledge Diagnostics Therapies

16 The Translational Research Chain Health care Biotech Pharma industry Disease Biospecimens Med. data Molec. data Knowledge Diagnostics Therapies

17 The Translational Research Chain Health care Biotech Pharma industry Disease Biospecimens Med. data Molec. data Knowledge Diagnostics Therapies

18 International Integration of BBMRI-ERIC BBMRI-ERIC will become the European part of the OECD GBRCN Recent events: EU-Africa collaboration: PEARIP, Cape Town, November 2011; Brussels, May 2012 EU-China collaboration: EU Parliament Seminar, November 21st 2011 EU Arabian Countries collaboration: EU Parliament Hearing, November 22nd 2011 Dubai, October 2012 EU-US collaboration: Washington, June 4th-6th 2012

19 The BBMRI Team: WP Leaders and Chairs Coordination/Executive Mgmnt. Population-based Biobanks: Disease-oriented Biobanks: Biomolecular Resources: bases& Biocomputing: K. Zatloukal, AT; E. Vuorio, FI M. Yuille, UK; M Pasterk, FR L. Peltonen+, FI/UK; M. Perola, FI A. Metspalu,EE E. Wichmann, GER, T Meitinger, GER U. Landegren, SE; M. Taussig, UK J-E Litton, SE Ethical, Legal and Societal Issues: A. Cambon-Thomsen, FR Funding and Financing: G. Dagher, FR; J. Ridder, NL C. Brechot, FR; Governance Council Chair: Advisory Board Chair: Coordination Board Chair: Stakeholder Forum Chair: L. Peltonen+; E. Vuorio, FI G-J van Ommen, NL K. Zatloukal, AT M. Griffith, IR 53 Participants(6 Ministries, 18 Funding Organizations) 222 Associated Organizations 33 Countries

20 Thankyou