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

    1. 1. Custom Laboratory Services<br />for Biomarkers, Esoteric Analysis and Early Stage Studies<br />1<br />
    2. 2. QuickTime™ and a<br /> decompressor<br />are needed to see this picture.<br />LabConnect Overview<br />Global laboratory services organization supporting studies across six continents<br />Central laboratory services<br />Worldwide testing for clinical studies<br />Project and data management<br />Supplies and logistics<br />Specialized laboratory services<br />Leverage network to design solutions to match client needs<br />Focus on specialized analysis and external R&D project management<br />2<br />
    3. 3. LabConnect Overview<br />Global network of laboratories<br />Geographic coverage<br />Analytical capabilities<br />Approximately 340 contracted studies since company’s inception in late 2002.<br />80-90 new projects per year.<br />Diverse client base<br />Customized service solutions<br />Comprehensive Laboratory Project Management <br />Client Service/Follow Up/Flexibility<br />3<br />
    4. 4. Specialized Services Support<br />Combines Scientific project management expertise with LabConnect network and infrastructure<br />R&D and preclinical project management<br />Biomarker discovery <br />Full range of analytical platforms to support hypothesis vetting<br />Assay development<br />Early stage project support<br />Laboratory services project management<br />Custom collection and transport supplies<br />Logistics oversight<br />Site training materials and site support<br />Specimen processing and analysis<br />Specimen tracking<br />4<br />4<br />
    5. 5. Specialized Services Menu<br />5<br />
    6. 6. Client Challenges<br />Biomarker scientific support <br />Current staff stretched thin, hiring freeze<br />Academic collaborations difficult to manage<br />Difficulty coordinating with multiple different commercial labs for preclinical R&D<br />Clinical trial specimen management<br />No central lab, sites were shipping all over<br />Lots of complex sample collections<br />No monitoring of samples<br />Difficulty reconciling conflicting “sample trackers” maintained by individuals<br />Early stage study support<br />Services of current central laboratory provider not a good fit for early stage project requirements<br />Need “go-to” lab services support team<br />6<br />
    7. 7. Scientific Support<br />Project Management<br />Academic institutions<br />Commercial laboratories & vendors<br />Participates in study design and contract outlines<br />Maintaining contact with participating vendors<br />Responsible for daily/weekly project feedback: liaison between vendor and sponsor groups <br />Examples of projects:<br />Serum screening of RBM protein profiles in clinical samples to identify new biomarkers<br />Analysis of SNP profiles in cytokine promoters in clinical cohorts to determine which SNPs can serve as biomarkers (predictive)<br />Analysis of PTM profiles in cytokines of interest<br />7<br />
    8. 8. Technical capabilities<br />Tissue Culture, bioactivity assays, most in vitro applications <br />Immunoassays, neutralization assays, and ELISAs<br />Immunology assays, ELISPOT<br />Flow Cytometry approaches (both high specialized and routine)<br />Cytogenetics: FISH and Karyotyping<br />Genetics: Mutation analysis, Sequencing, Microarray Analysis, SNP, splice variant analysis<br />Mass spectroscopy<br />Western Blot, 2D gel analysis<br />Circulating Tumor Cell Analysis<br />Immunohistochemistry<br />Protein purification and characterization<br />Antibody purification and characterization<br />8<br />
    9. 9. Operational and Logistics Support<br />9<br />
    10. 10. Custom Collection/Transport Supplies<br />10<br />
    11. 11. Custom Collection/Transport Supplies<br />11<br />
    12. 12. Current challenges in sample tracking<br />Increase in esoteric testing requires more detailed sample management<br />Personalized medicine increases the need to look at samples during the study and not at the end of the study.<br />Requires the knowledge of “where are my samples?”<br />Difficult to get comprehensive sample reconciliation during on-going clinical trial<br />Sample tracking is often done manually by clinical operations group, requires extra man hours and results in higher error rate<br />Limited visibility at sites<br />Specimens can sit at sites for extended periods<br />No visibility until samples are shipped/received at a lab<br />Difficult to catch problems at a resolvable stage<br />Hard to monitor sample quality<br />Sample collection/processing more intricate than safety sample preparation.<br />No verification that sample was processed correctly until it is too late<br />Difficult to identify samples in system based on clinical criteria<br />Result data is not associated with Subject/Sample information.<br />Often done manually using different lists from different sources.<br />12<br />
    13. 13. There are gaps in current sample tracking systems<br />Lab 1<br />Client or storage<br />Sites<br />Central lab<br />Lab 2<br />Lab 3<br />Samples are not monitored until they are received at a lab or by the client. <br />Labs (academia or specialized labs) frequently do not have automated sample management capabilities<br />Difficult to reconcile multiple outputs from different locations. Increased error rate.<br />13<br />
    14. 14. LabConnect sample tracking system <br />Lab 1<br />Client or storage<br />Sites<br />LabConnect<br />Lab 2<br />Lab 3<br />Database<br />Digital pen technology and data integration tools allows instant access to sample information and comprehensive real time sample tracking.<br />14<br />
    15. 15. Digital pen technology allows increased visibility without changing behavior<br />1<br />2<br />3<br />4<br />Lab receives sample and enters into LIMS<br />Sample shipped <br />Sample Collection<br />Site documentation<br />Sample stored, batched shipped later<br />Site personnel<br />Digital pen captures site documentation instantly, importing to database<br />15<br />
    16. 16. Case study: Sample tracking solution for large pharma company<br />Lab1<br />Sample types:<br />Tumor<br />Cell pellet<br />Skin<br />CTC<br />Hair<br />Blood<br />Serum<br />Plasma- 16 aliquots<br />Lab2<br />Client lab<br />Sites<br />Lab3<br />Client storage<br />Lab4<br />Lab5<br /><ul><li> Samples being tracked manually, by multiple people
    17. 17. Data was inconsistent, full of errors, not complete
    18. 18. Samples were unaccounted for
    19. 19. Difficult to determine number of missing samples
    20. 20. Difficult to determine what samples are available for analysis</li></ul>16<br />
    21. 21. LabConnect System Benefits<br /><ul><li>Real time tracking, starting at the time of collection
    22. 22. Instant accessioning
    23. 23. Better control on shipping logistics
    24. 24. Fast identification and correction of queries/issues
    25. 25. Multiple user web access (smart phone application available)
    26. 26. Customizable reports
    27. 27. Solid chain of custody
    28. 28. Yields documented quality sample management and saves time
    29. 29. Easy access to sample availability and information for research and analysis determinations</li></ul>17<br />
    30. 30. www.labconnectllc.com<br />

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