Durrer Cardiogenetic Research Center · 4 Durrer Center Goals: To promote and execute high quality...

Durrer Cardiogenetic Research Center

Labautomation – Evoluon Eindhoven 3 April 2012

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Presentation overview

Durrer Center

Biobank Challenges

Durrer Strategies

Cases

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Durrer Center

Initiative: ICIN NHS & KNAW

Collaboration of all Dutch academic cardiology centersDurrer Center is an autonomous organization and with its own professional accountability

Aim:

Provide infrastructure for biological samples and clinical information from patients and healthy persons. Access to molecular genomic resources and bioinformatics tools to optimally exploit this resource for global medical research.

Physical storage facility

virtual registry of existing collections

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Durrer Center

Goals: To promote and execute high quality cardiovascular research

by combining collected data from participating genetic and cardiac research centers

Transparent and secure storage of samples and data collected from patients with cardiovascular (genetic) diseases

• Existing collections

• Future research projects - ICIN – NHS – CVON – KNAW

Integrate and follow PSI rules and guidelines

Collaborate with European Bio bank initiatives

UMC’sKlin. GeneticaKEBBHF Res Centre

DURRER CENTER ORGANOGRAM

Research Data Management DNA Bank

• AIO • Analist/fieldwork• Analist/fieldwork

Directie ICINRaad van Advies Wetenschappelijke Raad

Durrer Management Team• P.J. Lansberg (managing director - 0,6 FTE)• Leading (young) PI’s larger projects

MT Durrer

AMCA. Moorman K. Zwinderman M. Mannens

AMC Leiden Groningen

Utrecht Maastricht Rotterdam

Nijmegen

VUMC Amsterdam

Durrer Staff• Project manager (0,6 FTE)• Research manager (0,4 FTE)

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The road towards a self supportivebiobank structure

2008-2012: Investments in:• Infrastructure, • Increase collections - size and numbers • Regulatory affairs

2013-2018: Research and international collaboration• Project focused research• Mirror biobanks within EU and Singapore

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Durrer Center Qualities

Bio-banking expertise Genetic Research Access to Phenotype + (long term)

follow-up Collaboration Trust and independence Costs

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Durrer Center

Biobank Challenges

Durrer Strategies

Cases

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Biobanking-ChallengesChanging Disease landscape• Aging population• Chronic and slow progressive complex

diseases vs acute diseases• Non communicable disease vs. infectious

diseasesEurope• Burden of disease: 77% complex diseases• Premature death: 86% complex diseases

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Biobanking-ChallengesParadigm shift

Traditional Biomedical Enterprises• Research• Drug development• Clinical medicine

Translational Medicine “Bench to Bedside”• Molecular/personalized Medicine,

tailored to genetic/molecular profile

3 different, virtually separate activities

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Genomics / bioinformatics revolution Improved prevention Improved effective treatment Decreased side effects of medication Improved success in clinical trial designBibobank is critical resource to accelerate this transformation

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Biobank is Key resource to provide Researchers1. Biomaterials 2. DataProvides understanding on interactions between1. Genes2. Enviroment3. Lifestyle4. Disease

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Biobanking-ChallengesBiobank development – 3 stages1. Context specific research project2. Infrastructural facility3. Integration – Network

To improve critical mass and statistical power

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Biobanking-ChallengesTo guarantee scientific excellence and efficacy of research Expand and secure competitive edge in a global context to attract investments in bio-medical research facilities

• Code of conduct • Standards• Integration

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Biobanking-ChallengesStandardized collection of bio specimens results are representative of patients biology and not artifacts of sampling procedure or sampling handling

SPRECManagement and traceability of biospecimen preanalyticalvariations are necessary to provide effective and efficient interconnectivity and interoperability between BiobanksCancer Epidemiol Biomarkers Prev; 19(4); 1004–11.

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Durrer Center

Biobank Challenges

Durrer Strategies

Cases

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Durrer Center PartnersAcademia CTMM

TRAIT

PSI

Lifelines

BBMRI

CVON

Singapore

Private iDQuest

K-biosystems

Top sector LSH

Dutch Biobank

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Durrer Center - Collaborations

iDQuest sample Registration

• Web based

• Multi user access

• Customizable

• Sample registration

• Sample tracking

• Workflow management

• Logging/tracking/audit trail

• Integration with hardware

• Query and reporting tools

Services & Technologies for Genomics and Drug Discovery.

Central Services & Support

LGC Forensics LGC Standards

LGC Science & Technology

• Reference material distribution

• Cell lines and microbiology products

• Reference material production

• Proficiency testing schemes

• Outsourcing of in‐house reference standards groups

• Analytical quality training courses

LGC Genomics

• DNA sequencing• Next generation

sequencing• DNA shearing• DNA extraction

solutions• Genotyping• Diagnostics• Pharmacogenetics• Bioinformatics

• NMI for chemistry and biology metrology

• Government Chemist• Molecular biology,

mass spectrometry, cell and protein R&D

• POET ‘Operational Excellence’

• Pharmaceutical Services

• MHRA and British Pharmacopoeia Lab

• Consumer protection• Food chain

surveillance• Environmental

testing and Security• Programme

management

• Full-service forensics

• Crime scenes• Pathology• Drugs• Occupational drug

testing• Toxicology• Fluids, marks, stains• Fire investigation• Documents• DNA profiling• Firearms• Computers &

phones• Archaeology

Group structure

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Nine „Top Sectors‟ in the Dutch economy, Life Sciences & Health being one of them.

„Innovation Contract‟• relevant public and private parties agree on and

set out those areas of the sector in which they will be active and how they will contribute

Stakeholders: • companies • universities • university medical centers • charitable funds• healthcare insurers

Top Sectors LSH

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Parel Snoer Initiatief• CONCOR

• Ischemic Heart Disease

• (KINCOR)

Adhere to biobank regulations and guidelines developed by this initiative

Biobank regulations

Sample storage-sample handling

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Center fro Translational Molecular Medicine CTMMTranslational Medicine IT (TraIT)

TraIT WP3 clustered additional usecasesUC1: a universal unique identifier (UUID) is generated for each collected biospecimen UC2: a central participant registry

system (CPR) is linked to a biobanktool

UC3: a participant study calendar (PSC) is linked to a biobank tool

UC4: a Biobank Tool/User manages Tracking SOPs for BiospecimenProcessing.

UC5: a Biobank Tool is able to connect to a TraIT grid and share data across domains.

UC6 Researcher orders specimens through a BiospecimenRequisition Service

UC7 (NEW): quality audit on samples collected at multiple sites.

UC8 (NEW): a list of samples with observed deviations from SOP

UC9 (NEW): Biobanker or researcher generates a list of samples with high risk deviations from SOP

UC10 (NEW):Study coordinator generates inclusion overview with various details

UC11(NEW):Researcher starts a search for samples at a biospecimen catalogue/locator

UC12 + 13 (NEW):Study coordinator/Biobanker checks the ‘Track and Trace’

UC14 (NEW)Biobanker gives researchers access to a biobank tool or catalogue

UC15 (NEW)Data from 2 biobank tools is integrated and merged into one biobank tool.

UC16All references to this particular subjects biomaterial and data should be removed from catalogues/biobank tools

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Singapore collaboration Biomarker research • Basic research ICIN projects since 2006• Proteomics Athero-Express

• Prof. D. Kleijn• Carolyne Lam and Mark Chan

Biobanks Large animal CV models Clinical trials Target identification Cardiovascular imaging Education

Straits Times Singapore June 2nd 2011

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Country Singapore NLArea 710 KM2 41 500 km2

(Utrecht 1400 km2)

Population 5.2 million 16.9 million3.3 million Singaporeans

GDP $ 250 billion (41st) $750 billion (21st) Per capita $ 60 000 (2nd) $ 41 500 (9th)

R&D (% GDP) 3.5% 0.7%

Bio-medical (% GDP) 1.3% (2011 – 2016 16,1 billion SGD)

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Durrer Center

Biobank Challenges

Durrer Strategies

Cases

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Biobanking-Legal issues

Gebruik restmateriaal

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NATURE|VOL 430 | 29 JULY 2004 |www.nature.com/nature

lawsuits claiming $75 million in damages

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Patients - BiobankingResearch participation• Genetic risk information• Database comprising genetic,

phenotypic and lifestyle information

• platform for further research• ‘pledge allegiance’ to a particular

disease (out of a predetermined list of 10 conditions)

• Help to support research, and to provide relevant personal data in connection with these diseases

23andMe

Mission Statement:23andMe's mission is to be the world's trusted source of personal genetic information.

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Patients - Biobanking

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Patients - Biobanking

Platform for peers to interact with one another in a data-driven context.

Opportunity for patients, to monitor and participate in real-world natural experiments.

Study side effects or adverse events. For widely prescribed drugs

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Durrer Center

Biobank Challenges

Durrer Strategies

Cases

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Technological Challenges

Durrer Cardiogenetic Research Center · 4 Durrer Center Goals: To promote and execute high quality...

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