The document summarizes the European Research Infrastructure for Biobanking and Biomolecular Resources (BBMRI) preparatory phase project. It discusses how biobanks across Europe have historically been small and heterogeneous, hindering modern genetic research. The BBMRI aims to integrate existing biobanks and resources to create a large pan-European infrastructure following common standards. The preparatory phase involved over 50 institutions from 28 countries to assess resources and technologies and develop plans for a sustainable infrastructure to support research.

1. The European Research Infrastructure for Biobanking and Biomolecular Resources (BBMRI): Preparatory Phase and European Context Eero Vuorio, University of Turku, Finland September 2009 Preparatory Phase Grant Agreement 212111

2. A concise history of biobanking in Europe Many European countries have a long history of epidemiological research using population cohorts and surveys; large sample collections Health records and health-related registries Collections of human-derived biological samples and data are national and often too small for modern genetic analyses (insufficient statistical power)

3. Biobanks in Medical Research NCI: Biological sampels are #1 roadblock 700,000 Cancer deaths (North America; 2007) Cancer Genome Project struggels with sample shortage (Nature Medicine 2007) ELSI Fragmentation Funding Technical Follow-up BBMRI

4. Biobanks are a unique European strength in biomedical research, but they suffer from… their heterogenous history: lack of common standards, different ownership of samples, different access rules & concent practices heterogenous European ethical and legal landscape, and langauges different data protection practices lack of sustainable funding Challenges

5. ESFRI – European Strategy for Research Infrastructures First Roadmap for Research Infrastructures: BBMRI BBMRI-PP (Preparatory Phase), EU funding Aims : Assessment of existing resources and technologies Concept for integration and operation Prototype Infrastructure with sustainable funding and agreed standard operating procedures and access rules

7. The pan-European Scale of BBMRI 183 Associated organisations 28 Countries 50 Participating institutions Preparatory phase 27 months Funding 5 mio €

8. Key Components of BBMRI Fam. history Lab. param. Treatm. outcome Lifestyle PBMC Serum FFPE tissues Frozen tissues Cells Antibodies Affinity binders Recomb. proteins Gene clone collections* siRNA libraries* Cell lines* Model organisms* Sample storage Human biological samples and data Healthy Population Patients Analysis tools Application Basic research Life sciences Targets for Drug discovery Biomarkers for Drug development New diagnostics Personalized medicine Public health Infrastructure Data storage Biocomputing DNA * : ESFRI BMS report but not funded

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. Organization (prep phase) Governance council (participants, ass. organizations) Executive Management Disease-oriented Biobanks WP3 Biomolecular resources Technologies WP4 Data bases Biocomputing WP5 Advisory board Stakeholder forum Funders Patients Clinicians Industry Partners Users Science Industry ELSI E L S I WP6 Population-based Biobanks WP2 Participants Participants Funding Financing WP7 Participants Coordination board (external projects) Project Management WP1 Steering committee (WP leaders, chairs) Strategic Executive Operative Participants Participants Participants Participants

11. The BBMRI Team: WP Leaders and Chairs Coordination/Executive Mgmnt. K. Zatloukal, AT; E. Vuorio, FI M. Yuille, UK; M Pasterk, FR Population-based Biobanks: L. Peltonen, FI/UK; A. Metspalu,EE Disease-oriented Biobanks: E. Wichmann, GER, T Meitinger, GER Biomolecular Resources: U. Landegren, SE; M. Taussig, UK Databases & Biocomputing: 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: L. Peltonen, FI Advisory Board Chair: G-J van Ommen, NL Coordination Board Chair: K. Zatloukal, AT Stakeholder Forum Chair: M. Griffith, IR 51 Participants (6 Ministries, 18 Funding Organizations) 210 Associated Organizations 30 Countries

12. Synergies of BMS 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

13. The New Dimension in Life Sciences Research networks networks networks resources, technologies services Individual research groups pan-European research infrastructures Access Competition Innovation Collaboration Integration Harmonization Innovation circle

14. Why is BBMRI so important? Modern biomedical research is dependent on high-quality samples and analytical tools, and on data that can be linked to the samples: For basic research For diagnostic purposes For improved (molecular) classification of diseases For development of now drugs and therapeutic concepts („Personalized medicine“) Access to high quality resources, technologies, services, education and training Partner for academia and industry

15. Global interactions of the Biobanking Community European Science Foundation, ESF ( Science Policy Briefing, 2006) European Commission: Funding for BBMRI Interactions with FP5, FP6 and FP7-funded projects (e.g. PHOEBE, BIONET), P3G (Public Population Project in Genomics) and ISBER ( International Society for Biological & Environmental Repositories) OECD: Global Biological Resource Centre Network WHO/IARC: Standards for biological resource centres