Custom Laboratory Services for Biomarkers, Esoteric Analysis and Early Stage Studies 1
Jun 19, 2015
Custom Laboratory Servicesfor Biomarkers, Esoteric Analysis and
Early Stage Studies
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LabConnect Overview• Global laboratory services
organization supporting studies across six continents
• Central laboratory services– Worldwide testing for clinical
studies– Project and data
management– Supplies and logistics
• Specialized laboratory services
– Leverage network to design solutions to match client needs
– Focus on specialized analysis and external R&D project management
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LabConnect Overview• Global network of
laboratories– Geographic coverage– Analytical capabilities
• Approximately 340 contracted studies since company’s inception in late 2002.
• 80-90 new projects per year.
• Diverse client base• Customized service
solutions• Comprehensive Laboratory
Project Management • Client Service/Follow
Up/Flexibility 3
Specialized Services Support
• Combines Scientific project management expertise with LabConnect network and infrastructure
• R&D and preclinical project management– Biomarker discovery – Full range of analytical platforms to support hypothesis
vetting– Assay development
• Early stage project support– Laboratory services project management– Custom collection and transport supplies– Logistics oversight– Site training materials and site support– Specimen processing and analysis– Specimen tracking
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Specialized Services MenuAssay
Development and Validation
Scientific Project Management
Sample Storage
Sample TrackingClinical trial
Project Management
Specialized and Exploratory
Analysis
Custom Supplies
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Client Challenges
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• Biomarker scientific support – Current staff stretched thin, hiring freeze– Academic collaborations difficult to manage– Difficulty coordinating with multiple different commercial
labs for preclinical R&D• Clinical trial specimen management
– No central lab, sites were shipping all over– Lots of complex sample collections– No monitoring of samples– Difficulty reconciling conflicting “sample trackers”
maintained by individuals• Early stage study support
– Services of current central laboratory provider not a good fit for early stage project requirements
– Need “go-to” lab services support team
Scientific Support
• Project Management– Academic institutions– Commercial laboratories & vendors
• Participates in study design and contract outlines• Maintaining contact with participating vendors• Responsible for daily/weekly project feedback: liaison between vendor
and sponsor groups
• Examples of projects:– Serum screening of RBM protein profiles in clinical samples to
identify new biomarkers– Analysis of SNP profiles in cytokine promoters in clinical cohorts to
determine which SNPs can serve as biomarkers (predictive)– Analysis of PTM profiles in cytokines of interest
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Technical capabilities
• Tissue Culture, bioactivity assays, most in vitro applications
• Immunoassays, neutralization assays, and ELISAs
• Immunology assays, ELISPOT• Flow Cytometry approaches (both
high specialized and routine)• Cytogenetics: FISH and Karyotyping• Genetics: Mutation analysis,
Sequencing, Microarray Analysis, SNP, splice variant analysis
• Mass spectroscopy• Western Blot, 2D gel analysis• Circulating Tumor Cell Analysis• Immunohistochemistry• Protein purification and
characterization• Antibody purification and
characterization
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Operational and Logistics Support• Developed sample tracker (multiple sites,
samples)• Provide reports regarding samples
(missing, shipped, received)• Developed forecast tool to monitor
samples not collected.• Developed automated sample tracking
tools (digital pen) for use within a study.
Sample tracking
• Developed standardized documentation for biomarker teams
• Assist with Biomarker study set up (protocol, manuals, collection, kits)
• Reconcile and/or update sample tracking information with other documentation (eCRF, result files, manifests, freezer inventories).
Documentation
• Web based training for biomarkers sample collection/processing and digital pen installation and use
• Provided study specific training materials for sample collections (manuals, flow charts, and leaflets).
• Work with scientific groups and vendor labs to verify study logistics and details
Training
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Custom Collection/Transport Supplies
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Custom Collection/Transport Supplies
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Current challenges in sample tracking
• Increase in esoteric testing requires more detailed sample management– Personalized medicine increases the need to look at samples during
the study and not at the end of the study.– Requires the knowledge of “where are my samples?”
• Difficult to get comprehensive sample reconciliation during on-going clinical trial– Sample tracking is often done manually by clinical operations group,
requires extra man hours and results in higher error rate• Limited visibility at sites
– Specimens can sit at sites for extended periods– No visibility until samples are shipped/received at a lab– Difficult to catch problems at a resolvable stage
• Hard to monitor sample quality– Sample collection/processing more intricate than safety sample
preparation.– No verification that sample was processed correctly until it is too
late• Difficult to identify samples in system based on clinical criteria• Result data is not associated with Subject/Sample information.
– Often done manually using different lists from different sources.12
There are gaps in current sample tracking systems
Sites Central lab
Lab 3
Lab 1
Lab 2Client or storage
Samples are not monitored until they are
received at a lab or by the client.
Labs (academia or specialized labs) frequently
do not have automated sample management
capabilities
Difficult to reconcile multiple outputs from
different locations. Increased error rate.
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LabConnect sample tracking system
Sites LabConnect
Lab 3
Lab 1
Lab 2Client or storage
Digital pen technology and data integration tools allows instant access to sample information and comprehensive real time
sample tracking.
Database
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Digital pen technology allows increased visibility without
changing behavior
Site personnel
Sample Collection
Site documentation
Sample stored, batched
shipped later
Sample shipped
1 2 3Lab receives
sample and enters into LIMS
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Digital pen captures site documentation instantly,
importing to database15
Case study: Sample tracking solution for large pharma company
Sites
Lab5
Lab4
Lab3
Lab2
Lab1
Client lab
Client storage
Sample types:Tumor
Cell pelletSkinCTCHair
BloodSerum
Plasma- 16 aliquots
Samples being tracked manually, by multiple people Data was inconsistent, full of errors, not complete
Samples were unaccounted for Difficult to determine number of missing samples
Difficult to determine what samples are available for analysis 16
LabConnect System Benefits
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• Real time tracking, starting at the time of collection• Instant accessioning • Better control on shipping logistics• Fast identification and correction of queries/issues• Multiple user web access (smart phone application
available)• Customizable reports• Solid chain of custody • Yields documented quality sample management and
saves time• Easy access to sample availability and information
for research and analysis determinations
www.labconnectllc.com