Specialized Services Biomarker Solutions 2011 05 26
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Specialized Services Biomarker Solutions 2011 05 26

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  • Add in some bullet points in previous slide… sites are manually tracking, no oversight, samples are sitting at site for unknown amounts of time, etc.

Specialized Services Biomarker Solutions 2011 05 26 Specialized Services Biomarker Solutions 2011 05 26 Presentation Transcript

  • Custom Laboratory Services
    for Biomarkers, Esoteric Analysis and Early Stage Studies
    1
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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
    2
  • 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
    4
    4
  • Specialized Services Menu
    5
  • Client Challenges
    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
    6
  • 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
    7
  • 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
    8
  • Operational and Logistics Support
    9
  • Custom Collection/Transport Supplies
    10
  • Custom Collection/Transport Supplies
    11
  • 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
    Lab 1
    Client or storage
    Sites
    Central lab
    Lab 2
    Lab 3
    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.
    13
  • LabConnect sample tracking system
    Lab 1
    Client or storage
    Sites
    LabConnect
    Lab 2
    Lab 3
    Database
    Digital pen technology and data integration tools allows instant access to sample information and comprehensive real time sample tracking.
    14
  • Digital pen technology allows increased visibility without changing behavior
    1
    2
    3
    4
    Lab receives sample and enters into LIMS
    Sample shipped
    Sample Collection
    Site documentation
    Sample stored, batched shipped later
    Site personnel
    Digital pen captures site documentation instantly, importing to database
    15
  • Case study: Sample tracking solution for large pharma company
    Lab1
    Sample types:
    Tumor
    Cell pellet
    Skin
    CTC
    Hair
    Blood
    Serum
    Plasma- 16 aliquots
    Lab2
    Client lab
    Sites
    Lab3
    Client storage
    Lab4
    Lab5
    • 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
    • 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
    17
  • www.labconnectllc.com