durrer cardiogenetic research center · 4 durrer center goals: to promote and execute high quality...
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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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Presentation overview
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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Biobanking-ChallengesParadigm shift
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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Biobanking-ChallengesParadigm shift
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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Presentation overview
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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Durrer Center - Collaborations
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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Durrer Center - Collaborations
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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Durrer Center - Collaborations
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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Presentation overview
Durrer Center
Biobank Challenges
Durrer Strategies
Cases
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Biobanking-Legal issues
Gebruik restmateriaal
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Biobanking-Legal issues
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Biobanking-Legal issues
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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Presentation overview
Durrer Center
Biobank Challenges
Durrer Strategies
Cases
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Technological Challenges