Biobanking in Finland
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- Dortha Logan
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1 Biobanking in Finland Anu Jalanko
2 Major Health reform in Finland The government has published dra4 bills on health, social services and regional government reform One of the largest ever administra9ve and opera9ve overhauls in Finland The government wants a customer- oriented freedom of choice model Munipalici9es will have key responsibili9es 2
3 Change of Legal Framework Secondary Use of Health and Welfare Data Reform of the National Health Register Legislation Targeted outcomes: The Act considering national health and welfare registries is modernised The use of Centralised Patient Document Archive for research purposes is permitted Enable the use of data for secondary purposes in a broad sense (incl. service management and industrial purposes) Service Operator - one-stop shop model. 3
4 National Genome Strategy Finland will establish a Genome Center with the following responsibili9es: Develop a na9onal reference database of genomes and a database of genome variants Serve as a single point of contact for research, contractual and commercialisa9on services Evaluate at the na9onal lelvel the validity and u9lity of gene9c tests Promote ethical prac9ces in the use of genome data Promote networking and collabora9on between various actors of the sector Ini9ate and s9mulate public debate on the u9liza9on of genome data Facilitate Finland s par9cipa9on in interna9onal collabora9ve projects 4
5 Genome Center and Biobanks The Genome Center has not yet been defined Government has allocated new funds for the establishment of the Genome Center to be operated in close collabora9on with biobanks Legal framework for genome strategy is planned to be ready earliest in fall
6 The Finnish Biobank Concept The Finnish biobank legistla9on of 2013 is unique Registra)on of biobanks, wide consent and protec)on of par)cipants Transfer of exis)ng sample and data collec)ons to biobanks Possibility to recontact Collabora)on with industry Possibility to collect samples and data from the health care Link biobank samples with hospital data (EMR) Link biobank samples with data from na)onal registries
7 8 Registered Biobanks in Finland Two na)onwide biobanks Six clinical biobanks between universi)es & hospital districts
8 Transfer of existing collections to registered Biobanks Exis9ng sample & data collec9ons can be transfererred to biobank by an opt-out procedure! Also diagnos9c samples! New samples collected by a wide consent Biobank must give data to par9cipants when required 8
9 Sample Resources in Registered Biobanks Sample type / analyses Sept 2016 Dec 2016 (es)mate) FFPE * Plasma / Serum DNA Biomarker analyses GWAS WGS / WES Metabolomics * Number of study par9cipants 9
10 BBMRI.fi = National coordination and collaboration of biobanks Transparent access procedures across all 8 biobanks; sharing all registration documents, nationwide harmonization of broad biobank consent Plans towards operating as a one-stop shop (as requested by the Ministry of Social Affairs and Health) Examples of national collaboration: IT Collaboration databases & harmonization & BBMRI-ERIC (Coordinated by THL) Digital pathology (coordinated by Northern Finland Biobank Borealis) Breast Cancer biobanking (coordinated by Helsinki Biobank) Hospital quality registers (Coordinated by Auria Biobank) National PR collaboration (coordinated by THL Biobank)
11 THL Biobank for Health Research Large popula9on cohorts Major focus in genomics Currently samples and data from study par9cipants Number of DNA aliquots sent for analysis DNA from ips ready cells from 3000 No of aliquots Serum & plasma from Year Esityksen nimi / Tekijä
12 THL Biobank CRC Samples Biobanked cohorts: Serum: 1130 CRC cases Plasma: 330 CRC cases DNA: 330 CRC cases Cells, Stool, Urine: selected cases - Follow-up data from na9onal registries - - Biochemical data, genome data, metabolomic data Other THL cohorts: Finnish Maternity Cohort (FMC): Serum from 800 CRC cases 12
13 THL Biobank Transfer of exis9ng valuable collec9ons to biobank Up to study par9cipants all with DNA New collections all with DNA SUPER Gene9cs of psycho9c illnesses cases SalWe Gene Risk gene9c risk factors FinHealth THL popula9on cohort Total number up to par)cipants with DNA by
14 Hospital biobanks with associated EHRs provide tools for Digital Phenotyping ICD-10 G20 ICD-10 I25 Figures from Auria Biobank
15 Hospital Biobanks Current resources FFPE samples from individuals Clinical data of electronic hospital records Colon Ca as an example: Auria Biobank: FFPE samples & clinical data from 2200 Helsinki Biobank: FFPE samples & clinical data from Similar infrastructure for retrieval of clinical data 15
16 Hospital Biobanks now focus on collecting prospective samples BIOBANK LOCATION CATCHMENT AREA BIOBANK TYPE Auria Biobank Turku Hospital Helsinki Biobank Helsinki Hospital Tampere Clinical Biobank Tampere Hospital Biobank of Eastern Finland Kuopio Hospital Biobank of Central Finland Jyväskylä Hospital Northern Finland Biobank Borealis Oulu Hospital THL Biobank Helsinki Mostly popula9on cohorts Hematological Biobank Helsinki Disease specific 16
17 The Helsinki Biobank potential patients annually (HUS) 1/3 of the Finns born in HUS All the major medical specialties (HUS) Meilahti campus among the top 5 in Europe Collaborators Pathology samples of 1,4M patients with electronic data Carea Eksote CCC FIMM Aalto THL 17
18 Helsinki Biobank Prospec9ve collec9on of samples ini9ated in 2016: new consents & samples within 3 months Biobanking is one of the highest priority development areas of Helsinki University Hospital 2017: Aim to collect biobank samples from 10 % of all pa9ents (50 000) 2018: Aim to collect biobank samples from 25 % of all pa9ents ( ) 18
19 Why Finland? POPULATION ISOLATE HEALTH REGISTERS BIOBANKS GENOME DATA TARGET EVALUATION and FOLLOWUP STUDIES
20 Na)onal Registers Hospital discharge Hospital procedure Outpa9ent visit Outpa9ent procedure Primary care Primary care procedure Cancer register Cause of death ICD code Procedure code ICD code Procedure code ICD code Procedure code ICD, O-3 code ICD code De-iden9fica9on, (Pseudocoding) Other phenotype data Register data for research Genome data Drug purchase Drug code (ATC) FIMM-THL Research Sandbox Drug reimbursement ICD code
21 SISU- Sequencing Initiative Suomi Genome wide genotype data Sequences > WES 5400 WGS Na9onal Cohorts Imputa9on Popula9on cohorts & disease specific collec9ons Extensive health, phenotype, metabolomic data Na9onal registries Popula9on specific chip/genotyping Na9onal reference database
22
23 Public Private Partnerships have become feasible Example of the IPHG project: Interna9onal gene9c research collabora9on Partners: Broad, FIMM, THL Biobank, Merck, Pfizer, Eisai, Biogen Results shared!
24 FinnGen - Aim for a Nationwide PPP Effort DNA samples from study par9cipants and GWAS data All biobanks to par9cipate A major possibility for biobank research Booster for large-scale biobank opera9ons na9onwide Samples in registered biobanks 24
25 Towards one-stop-shop Finnish biobanks and their background organiza9ons all agree that a single na9onal organiza9on or operator is a necessity Ministry of Social Affairs and Health & THL nominated an Expert Group to inves9gate the possibili9es to establish such an operator. 25
26 Recommendations by Biobank Expert Group: Establish a joint legal en9ty Biobanks Finland Board with members from all biobank organiza9ons Official representa9on of all Finnish biobanking ac9vi9es Responsible of Transparency and accountability regard to public, ELSI, data safety and access control Establish a joint service provider Biobanks Finland Services Local biobank ac9vi9es remain but: Local biobanks will u9lize opera9onal sevices provided by a joint service provider (Ltd)
27 Prerequisites for success Succesful collabora9on of biobanks & opera9on of Biobank Finland as a one-stop shop Trust of sample donors is taken care of Samples and related data is u9lized for health care 27
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