A Gateway for Health: BBMRI and Africa Prof. Jan-Eric Litton Director General BBMRI-ERIC

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1 A Gateway for Health: BBMRI and Africa Prof. Jan-Eric Litton Director General

2

3 Most of our current knowledge on diseases as well as available diagnostic assays and drugs are based on investigation of biological samples and data 3

4 Estimated Tissue samples in Europe: 1692 Million 4

5 The Process

6 BBMRI-ERIC: A ateway for Health Biological resources living organisms, cells, genes, and related information are the essential for the advancement of biotechnology, human health, and research and development in life sciences. 6

7 BBMRI-ERIC: a gateway for Health We want to build Europe s Largest Health Infrastructure I encourage policy makers to commit to a long-term sustainable policy basis for Biobanking and Biomolecular resources in Europe and beyond 7

8 BBMRI-ERIC 06/04/2017 8

9 BBMRI- ERIC Biobanking and BioMolecular resources Research Infrastructure European Research Infrastructure Consortium 9

10 History 06/04/

11 ESFRI European Strategy Forum of Research Infrastructure 11

12 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

13 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

14 BBMRI towards BBMRI-ERIC ESFRI Roadmap & EU project application: Preparatory Phase: funded EU Project, Interim Phase: ERIC application, Establishment as an ERIC: January July December 2013 Application Awarded ERIC Status 06/04/

15 BBMRI-ERIC - largest infrastructure for health in Europe Members Austria Belgium Czech Republic Estonia Finland France Germany Greece Italy Latvia Malta Netherlands Norway Poland Sweden United Kingdom Observers Cyprus Switzerland Turkey IARC 15

16 Distributed Structure of BBMRI-ERIC Hub and Spoke structure Headquarter (Austria) National nodes Associated partners Hospitals Universities Service providers 06/04/

17 4/6/2017

18 Central Executive Management Office in Graz, Austria 06/04/

19 Greetings from the BBMRI-ERIC HQ

20 Services 20

21 BBMRI- ERIC Biobanking and BioMolecular resources Research Infrastructure European Research Infrastructure Consortium 21

22 IT 06/04/

23 The Process

24

25

26 Cloud European Open Science Cloud

27 Ethical Legal Societal Issue 06/04/

28 Thank you! 06/04/

29 Common Service ELSI Prof. Anne Combon-Thomsen Advise in ethical reviews Provide ethics check for research proposals Monitor ELSI aspects related to biobanking Follow up on relevant legislation/regulations Help-Desk to provide practical guidance on ELSI issues Organise experience sharing Prepare & maintain tools and services Disseminate results of latest ELSI research 06/04/

30 Quality of Samples 06/04/

31 Limited Reproducibility of Scientific Medical Data

32 SAMPLE QUALITY Pre-analytical errors still account for nearly 60%-70% of all problems occurring in laboratory diagnostics, most of them attributable to mishandling procedures during collection, handling, preparing or storing the specimens. Lippi G. et al.. Preanalytical quality improvement: from dream to reality. Clin Chem Lab Med Jul; 49(7): Epub 2011 Apr % 13 % 06/04/

33 06/04/

34 06/04/

35 06/04/

36 06/04/

37 CEN* working documents: Specification for pre-examination processes used in BBMRI-ERIC For blood Circulating cell free DNA For blood Genomic DNA For blood Cellular RNA For metabolomics in urine, serum and plasma For FFPE tissue DNA For FFPE tissue RNA For FFPE-Proteins For frozen tissue RNA For frozen tissue - Proteins *CEN= European Committee for Standardization 37

38 BBMRI-ERIC ISO/TC 276 Biotechnology WG 01 Terminology Identification of currently used national and international standards, guidelines and other relevant documents, as well as terms and definitions, related to ISO/TC 276 Biotechnology. WG 02 Biobanks and Bioresources Elaborate a package of International Standards in the Biobanks field including human, animal, plant and microorganism resources for Research & Development aspects WG 03 Analytical Methods Develop standards for accurate, reproducible and robust measurement and analysis in support of biotechnologies. E.g. Cell Counting WG 04 Bioprocessing Component Material control, Bioreactor processes WG 05 Data processing and Integration 06/04/

39 06/04/

40 Thank you! 06/04/

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