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Biobanking in Finland

Anu Jalanko

28.11.2016

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Major Health reform in Finland

Thegovernmenthaspublisheddra4billsonhealth,socialservicesandregionalgovernmentreform

Oneofthelargesteveradministra9veandopera9veoverhaulsinFinlandThegovernmentwantsacustomer- orientedfreedomofchoicemodelMunipalici9eswillhavekeyresponsibili9es

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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.

National Genome Strategy FinlandwillestablishaGenomeCenterwiththefollowingresponsibili9es:•  Developana9onalreferencedatabaseofgenomesandadatabaseof

genomevariants•  Serveasasinglepointofcontactforresearch,contractualand

commercialisa9onservices•  Evaluateatthena9onallelvelthevalidityandu9lityofgene9ctests•  Promoteethicalprac9cesintheuseofgenomedata•  Promotenetworkingandcollabora9onbetweenvariousactorsofthe

sector•  Ini9ateands9mulatepublicdebateontheu9liza9onofgenomedata•  FacilitateFinland’spar9cipa9onininterna9onalcollabora9veprojects

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Genome Center and Biobanks

TheGenomeCenterhasnotyetbeendefined

GovernmenthasallocatednewfundsfortheestablishmentoftheGenomeCentertobeoperatedinclosecollabora9onwithbiobanks

Legalframeworkforgenomestrategyisplannedtobereadyearliestinfall2017

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The Finnish Biobank Concept TheFinnishbiobanklegistla9onof2013isunique

§  Registra)onofbiobanks,wideconsentandprotec)onofpar)cipants

§  Transferofexis)ngsampleanddatacollec)onstobiobanks§  Possibilitytorecontact§  Collabora)onwithindustry

Possibilitytocollectsamplesanddatafromthehealthcare§  Linkbiobanksampleswithhospitaldata(EMR)§  Linkbiobanksampleswithdatafromna)onalregistries

§  Twona)onwidebiobanks§  Sixclinicalbiobanksbetweenuniversi)es&hospitaldistricts

8 Registered Biobanks in Finland

Transfer of existing collections to registered Biobanks

Exis9ngsample&datacollec9onscanbetransfererredtobiobankbyanopt-outprocedure!Alsodiagnos9csamples!NewsamplescollectedbyawideconsentBiobankmustgivedatatopar9cipantswhenrequired

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Sample Resources in Registered Biobanks

Sampletype/analyses

Sept2016 Dec2016(es)mate)

FFPE 2100000* 3000000Plasma/Serum 148000 148000DNA 95155 111000Biomarkeranalyses 146500 146500GWAS 50000 50000WGS/WES 19950 30000Metabolomics 13200 13200

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*Numberofstudypar9cipants

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)

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Largepopula9oncohorts

Majorfocusingenomics

Currentlysamplesanddatafrom108000studypar9cipants

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Esityksen nimi / Tekijä

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0

20000

40000

60000

2009 2010 2011 2012 2013 2014 2015

Noofaliq

uots

Year

NumberofDNAaliquotssentforanalysisSerum&plasmafrom106000

DNAfrom81000

iPSreadycellsfrom3000

THL Biobank for Health Research

THL Biobank – CRC Samples

Biobankedcohorts:Serum:1130CRCcasesPlasma:330CRCcasesDNA:330CRCcasesCells,Stool,Urine:selectedcases

-Follow-updatafromna9onalregistries --Biochemicaldata,genomedata,metabolomicdata

OtherTHLcohorts:

FinnishMaternityCohort(FMC):Serumfrom800CRCcases

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New collections 2016-2018 – all with DNA

SUPER–Gene9csofpsycho9cillnesses-10000casesSalWeGeneRisk–gene9criskfactors-15000FinHealth2017-THLpopula9oncohort–7000

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THLBiobank•  Transferofexis9ngvaluablecollec9onstobiobank2017-2018•  Upto90000studypar9cipants–allwithDNA

Totalnumberupto200000par)cipantswithDNAby2018

ICD-10I25

ICD-10G20

FiguresfromAuriaBiobank

Hospital biobanks with associated EHRs provide tools for ”Digital Phenotyping”

Hospital Biobanks – Current resources

FFPEsamplesfrom2100000individualsClinicaldataofelectronichospitalrecords

ColonCaasanexample:AuriaBiobank:FFPEsamples&clinicaldatafrom2200HelsinkiBiobank:FFPEsamples&clinicaldatafrom4000-Similarinfrastructureforretrievalofclinicaldata

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Hospital Biobanks now focus on collecting prospective samples

BIOBANK LOCATION CATCHMENTAREA BIOBANKTYPE

AuriaBiobank Turku 869000 Hospital

HelsinkiBiobank Helsinki 1904000 Hospital

TampereClinicalBiobank Tampere 1111000 Hospital

BiobankofEasternFinland Kuopio 816000 Hospital

BiobankofCentralFinland Jyväskylä 275000 Hospital

NorthernFinlandBiobankBorealis

Oulu 742000 Hospital

THLBiobank Helsinki 5400000 Mostlypopula9oncohorts

HematologicalBiobank Helsinki 5400000 Diseasespecific

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The Helsinki Biobank potential

500 000patientsannually

(HUS)

1/3 of theFinns born in

HUSMeilahti campusamong the top 5

in Europe

Pathologysamples of

1,4M patientswith

electronicdata

All the majormedical

specialties(HUS)

CareaEksote

CollaboratorsCCC

FIMMAaltoTHL

Helsinki Biobank

•  Prospec9vecollec9onofsamplesini9atedin2016:10000newconsents&sampleswithin3months

•  BiobankingisoneofthehighestprioritydevelopmentareasofHelsinkiUniversityHospital

•  2017:Aimtocollectbiobanksamplesfrom10%ofallpa9ents(50000)

•  2018:Aimtocollectbiobanksamplesfrom25%ofallpa9ents(125000)

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TARGETEVALUATIONand

FOLLOWUPSTUDIES

POPULATIONISOLATE

HEALTHREGISTERS

BIOBANKS GENOMEDATA

+ + +

WhyFinland?

Na)onalRegisters

Hospitaldischarge

Hospitalprocedure

Outpa9entvisit

Outpa9entprocedure

Primarycare

Primarycareprocedure

Cancerregister

Causeofdeath

Drugpurchase

Drugreimbursement

ICDcode

Drugcode(ATC)

Procedurecode

Procedurecode

ICDcode

ICDcode

ICD,O-3code

ICDcode

Procedurecode

ICDcode

De-id

en9fi

ca9o

n,(P

seud

ocod

ing)

Registerdataforresearch

Genomedata

Otherphenotype

data

FIMM-THLResearchSandbox

Na9onal Cohorts

Extensivehealth,phenotype,

metabolomicdata

Na9onalregistries

Genomewidegenotypedata80000

Sequences>30000WES5400WGS

Imputa9on

Popula9onspecificchip/genotyping

Na9onalreferencedatabase

Popula9oncohorts&diseasespecificcollec9ons

SISU- Sequencing Initiative Suomi

ExampleoftheIPHGproject:•  Interna9onalgene9cresearchcollabora9on•  Partners:Broad,FIMM,THLBiobank,Merck,Pfizer,Eisai,Biogen•  Resultsshared!

Public Private Partnerships have become feasible

FinnGen - Aim for a Nationwide PPP Effort

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0100000200000300000400000500000600000

2016 2017 2018 2019 2020

DNAsamplesfrom500000studypar9cipantsandGWASdata

Allbiobankstopar9cipate

Amajorpossibilityforbiobankresearch

Boosterforlarge-scalebiobankopera9onsna9onwide

Samplesinregisteredbiobanks

Towards one-stop-shop

Finnishbiobanksandtheirbackgroundorganiza9onsallagreethatasinglena9onalorganiza9onoroperatorisanecessity

MinistryofSocialAffairsandHealth&THLnominatedanExpertGrouptoinves9gatethepossibili9estoestablishsuchanoperator.

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Recommendations by Biobank Expert Group: §  Establishajointlegalen9ty”BiobanksFinland”

•  Boardwithmembersfromallbiobankorganiza9ons•  Officialrepresenta9onofallFinnishbiobankingac9vi9es•  ResponsibleofTransparencyandaccountabilityregardtopublic,ELSI,datasafetyandaccesscontrol

§  Establishajointserviceprovider”BiobanksFinlandServices”•  Localbiobankac9vi9esremainbut:•  Localbiobankswillu9lizeopera9onalsevicesprovidedbyajointserviceprovider(Ltd)

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Prerequisites for success

Succesfulcollabora9onofbiobanks&opera9onof”BiobankFinland”asaone-stopshop

Trustofsampledonorsistakencareof

Samplesandrelateddataisu9lizedforhealthcare

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