Biobank Way to Sustainable Research

Transcription

1 Biobank Way to Sustainable Research Johanna Arola, MD. PhD Biobanking for Future Research and Health May 2018 Academy of Finland

2 Johanna Arola Pathologist (Liver and Endocrine) Research group at HU Editor-in-Chief: Finnish Medical Journal Duodecim Head of Pathology: Helsinki Biobank Acting CEO: FinBioBank puh

3 Sustainable Biobank Research Roadmap to P4 Medicine Finnish Biobank Concept Example of biobank research: Pulmonary carcinoids Biobank for researchers Biobank for participants FinBioBank FINBB At the end of the day

4 Bridge to Future P4 Medicine PRESENT Reactive Medicine Disease = symptom based diagnoses Diagnoses = ICD10 codes Treatment = one size fits all Treatment guidelines = evidence based slow changes Methods for earlier detection or prevention of individuals at risk More spesific biomarkers More rapid drug development Better trial design by cohort stratification based on clinical and molecular features FUTURE P4 Medicine Predictive Preventive Personalized Participatory High quality + DATA in Biobank

5

6 Finnish Biobank Concept Grow interest

7 The Finnish Biobank Concept The Finnish biobank legistlation of 2013 has been unique Registration of biobanks Transfer of existing sample and data collections to biobanks Collaboration with industry Wide consent Protection of participants Possibility to recontact Possibility to collect samples and data from the health care Link biobank samples with hospital data (EHR) Link biobank samples with data from national registries

8 Health care based biobank Carpén ja Kosma, Duodecim 2013

9 Diagnostic biobank samples. Carpén ja Kosma, Duodecim 2013

10 but legacy samples do not cover enough potilasta vuodessa, Jokaisella keskimäärin 2.9 diagnoosia Diagnosis Patients Essential hypertension Atrial fibrillation or flutter 7316 Type II diabetes 5565 Sleep apnea 5466 Unspecified stomach pain 4918 Acute upper respiratory inf Pneumonia 3618 Bronchial asthma 3555 Cataract 3052 Atherosclerotic heart disease 3023

11 Prospective samples from all patients B-Bio-0 (EDTA 10 ml)

12 Disease specific collection: Helsinki Urological Biobank (HUB) Systematic collection of 2200 Urological cancer samples Blood (plasma, seerumi) Urin FF tumor tissue FFPE tissue samples from diagnostic moment as well as follow up samples

13 T. Vesterinen May 9, 2018 Biobank study on pulmonary carcinoid tumours Background -1-2% of all lung cancers, biobanked samples needed -Aim to find new diagnostic or prognostic tissue markers Patients -Between 1/1990 and 8/2013 all operated patients with FFPE tissue sample (n=133). FFPE samples were retrieved through the biobank, clinical data was collected as a separate research project. Methods -Tissue Microarray (TMA), immunohistochemistry (IHC), digital pathology Results 100 TC patients, 33 AC patients 5- and 10-year survival: TC 99% ja 99%, AC 87% ja 82% The most remarkable prognostic factors: histological subtype, metastatic disease, tumor size and Ki-67 index

14 T. Vesterinen May 9, 2018 Biobank study on pulmonary carcinoid tumours First paper published Description of the patient cohort (Vesterinen et al, Acta Oncol 2018) Second one, including also patient samples from the Auria Biobank, in the pipeline Future plans To apply for samples and clinical data from all Finnish biobanks to extend the study material Sample and data in the study Application approved, sample and data collection on-going

15 Researchers Biobank access procedure RESEARCH QUESTION or R&D IDEA CONTACT BIOBANK for project preparation, sample availability or budget request. PROJECT PLAN Describe the project, ethical considerations, and sample request. Biobank assists in planning. MTA AND SAMPLE DELIVERY Samples and associated clinical data will be provided in a pseudonymised format. PROJECT COMPLETION When the project ends, results of the sample analysis and/or raw data is returned to the biobank as defined in MTA. PROJECT REVIEW HUS ethics committee provides recommendation for sample release. The decision is made by biobank s director. ADDITIONAL REQUEST Contact biobank, in case additional samples or recontacting of donors is needed.

16 HOSPITAL EHRs HOSPITAL BIOBANK Infrastructure Supporting Research (FFPE) samples TMA Automated IHC/ISH 2 Genome and other omics TRANSLATIONAL RESEARCH TOOLS (e.g. drug testing, cell cultures) ANALYSIS TOOLS (Deep learning/artificial intelligence) Datalake with comprehensive EHR information HEALTH CARE INNOVATIONS

17 Condensing information: tissue microarrays

18 Benefits of biobank research Professional, centralized sample collection and storage, where a single sample can benefit multiple research projects of different disciplines over time The knowledge accumulated on the healthcare sector can be used for the benefit of research, and the data stemming from research projects can be returned to the health care units Centralized and cost-efficient operation, wide usability of the samples Availability of phenotype Certified practices enable research data to be used for the benefit of clinical practices Centralized infrastructure supporting research projects, e.g. tissue microarray facilities

19 Benefits of biobank research - and worries Professional, centralized sample collection and storage, where a single sample can benefit multiple research projects of different disciplines over time The knowledge accumulated on the healthcare sector can be used for the benefit of research, and the data stemming from research projects an be returned to the health care units Centralized and cost-efficient operation, wide usability of the samples Availability of phenotype Certified practices enable research data to be used for the benefit of clinical practices Centralized infrastructure supporting research projects, e.g. tissue microarray facilities Samples run out Someone will use my samples and data Challenges in implementing new operation and infrastructure

20 Biobank for Doners

21 Biobank for patients - participants Participatory Carpén ja Kosma, Duodecim 2013

22 Biobank for patients - participants Participatory 1. Right to know the use of your own sample 2. Speed up research of your own disease 3. Recontacting is possible 4. May even benefit personally Carpén ja Kosma, Duodecim 2013

23 Finnish Biobanks 2018 Six hospital integrated BB Four nationwide BB First private biobank Terveystalo BBMRI.fi Finland member of BBMRI.eric 2017 FinBioBank FINBB Cooperative for Finnish Hospital Biobanks

24 Address: FinBioBank FINBB, Joukahaisenkatu 6, 7 fl Turku, Finland FinBioBank FINBB

25 FinBioBank - FINBB Vision: Advance Health Care Serve as a key contributor to making population resources available for advancements in public and personal health. Mission: Support Biobank Creators and Users Provide coordinated services to help biobanks set up infrastructure and processes to create high quality, standardized collections with interoperative utility and critical-mass-based market value. Facilitate scalable, sustainable, revenue-generating utilization of biobank resources by academic, public, and commercial biobank users. 25

26 FINBB: Services & products Biobank Customers Operational Support on protocols and processes: harmonization Basic: IC, sample collection, processing, storage, access, utilization Optional: sample processing, analysis, etc. Informatics Infrastructure and Applications; Integrated National BB platform Quality Management Systems Procurement of External Services and Products Ethical, Legal and Structural/Organizational Aspects Biobank Users Single Point of Contact One-Stop Shopping of integrated resource Standardized, efficient project contracting Project management Business Development, Marketing, Sales, Channel, Pricing, Contracts, MTAs Both Communications Financials and Accounting Project Management

27

28 STM3547/2017 Harmonization and Collaboration of Biobanks Government funding M Campaign Implementing Biobank Sample Collection - Focus on New Cancer Patients Goal to catch 20% of new patients Collect Liquid biopsy + fresh frozen tumor tissue (FF) in hospital biobanks Availability data base one stop shop We stand with your rand.

29

30 FF Tissue Processing in Helsinki Biobank A 2-4 putkea 2 putkea LN 2 Tiina Vesterinen

31 Liquid biopsy Isomursu A, Kononen J, Kuopio T Verenkierron Solunulkoinen DNA syövän merkkiaineena Duodecim 2015;131:424 32

32 Availability database

33 One- stop-

34 At the end of the day Patients Rights First Lääkärin tai tutkijan etu ei saa koskaan mennä potilaan edun edelle Heikki Mäkisalo Who Stands for the Sick? Kuka pitää sairaan ihmisen puolia? Perttu Lindsberg Equality of Patients Terveydenhuollon ammattilaiset eivät voi kieltäytyä pyytämästä biopankkisuostumusta potilaalta Anne Pitkäranta

35