Arto Mannermaa. Research Manager, KUH Professor of personalized medicine and Biobanking, UEF

Transcription

1 Doctoral Programme of Clinical Research Introduction to Clinical Research, 2017 Arto Mannermaa Research Manager, KUH Professor of personalized medicine and Biobanking, UEF

2 What is Biobanking about?

3 Motivation for Biobanking

4

5

6 Personalised Medicine SAMPLE & DATA COLLECTION DATA STORAGE & CATEGORISATION Collection Clinical care Transfer PATIENTS Patient interface BIOBANK Personalised care plan PERSONALISED HEALTHCARE Personalised Preventive Care Transfer of information Research Development Data mining RESEARCH Modified from Kaye, Norsk Epidemiologi 2012;21

7

8 Benefits for Finnish biobanks High quality public health care Electronic Health Records of hospitals National registries Individual social security number People support medical research

9

10 Hospital biobanks Samples & data - Routine patients - Research cohorts Biobank - Multi-purpose consent - Quality system - Efficiency - Protection of privacy - Networking Research - Efficiency - Publications - Ideas Society - Awareness of research - Transparency - Data protection Individual - Diagnostics - Personalised medicine

11 P21 (4.68%) PC2 23.8% PC1 36.6% Europe CHB JPT YRI CEU PC1 (8.65%) Austria Bulgaria Czech Republic Estonia Finland (Helsinki) Finland (Kuusamo) France Northern Germany Southern Germany Hungary Northern Italy Southern Italy Latvia Lithuania Poland Russia Spain Sweden Switzerland Metspalu, Estonian Genome Center

12 Biobank of Eastern Finland - population Unique population of Eastern Finland Population is highly homogenous due to geographic barriers and low migration We emphasize the advantage of studying recent genetic isolate populations when performing rare and lowfrequency genetic association analyses, as the multiple testing burden is diminished due to higher genetic homogeneity. Fadista et al, Eur J Hum Genet, 2016

13 Who are we? Population base > One of the key infrastructures of the University of Eastern Finland The biobank's field of research covers the specialty fields in health and clinical care of the owner organizations and stakeholders.

14 Biobank of Eastern Finland - organization Owners: PSSHP, UEF, ESSHP, ISSHP, PKSSK Administrative Board Scientific Board Biobank director Research Manager Research Coordinator Quality Coordinator System Designer (IT) Designer (Development) Laboratory Staff Research Staff

15 Biobank of Eastern Finland Owned by the hospital districts of Noth Savo, South Savo and Eastern Savo, and the North Karelia Central Hospital and Honkalampi Centre and the University of Eastern Finland Part of North Savo Central Hospital and it s budgetary The National Supervisory Authority for Welfare and Health (Valvira) registered Biobank of Eastern Finland to the National Biobank Register in Finnish, English version coming soon

16 Biobank of Eastern Finland supports research addressing metabolic disorders, musculoskeletal disorders, neurological disorders, cancer and mental health in particular one of the key infrastructures of the University of Eastern Finland is on the Academy of Finland's roadmap for research infrastructures, and it constitutes part of the Translational cancer research strategic research area of the University of Eastern Finland

17 Quality management High quality, homogenous samples Current good practices (cgp), International Organization for Standardization (ISO), Best Practices (OECD, IARC/WHO, ) Includes: Written procedures for sample management and data protection Traceability: documented life cycle from sampling to end of research project A strong information technology (IT) structure, a robust tracking system linked to a database, and standard operating procedures (SOPs)

18 Sample storage Liquid nitrogen freezers, samples in vapour Chart MVE Heco 2D barcoded sample storage tubes, readers and capping/decapping system Sample management system SamWise

19 Data transfer into biobank Electronic Health Records Lab data Coding Harmonization Biobank Sample & data registry Medical records Imaging Storage of clinical data Code registry Consent Coding

20 Example of Sample data

21

22 Archived sample set

23 Archived sample set

24

25 How can samples be obtained from the biobank in the future? Samples can be used in medical research according to research field of the biobank Sufficient professional skills and scientific competent Research plan and other documents Preparations together with the biobank A research permit from the local Scientific Board The scientific level and interest of the research and the adequacy of the samples for the applied study Favourable statement from the ethics committee

26 Restrictions to access If the intended use is against the biobank s rules and specific fields of action To safeguard primary research already in action To safeguard immaterial rights (IPR) To preserve limited collections for specific purposes To ensure privacy (small collection, ie rare diseases) Ethical reasons

27

28 Material transfer agreement Assignment is always performed based on a written contract to a research institution or company representing the researcher Samples and data are delivered in a coded format All procedures must protect the privacy of the sample donors Returning the sample analyses data to the biobank!

29 Co-operation part of the national BBMRI.fi and the international BBMRI-ERIC infrastructure networks co-operation with researchers (UEF+ KUH), clinical laboratory ISLAB and local companies

30 Digital pathology The transfer of old samples to Biobank of Eastern Finland begins 2016 Old tissue samples from KUH Pathology are transferred to biobank samples and related data. Tissue Microarray (TMA) sample digitization enables sample analyzing by monitor Data transfer from KUH information systems to Biobank s information systems

31 The Future? Digital TMA

32 Digital pathology

33 Visions Hospital Biobank: Best practises for local action Appreciate local clinical/biomedical expertise Close collaboration with research community Local branding Our Biobank Specialised research areas based on research activities Exosomes, epigenomics, metabolomics Health economics Active collaboration within Biobanks in and outside Finland

34 Digital pathology