2. QuickTime™ and a decompressor are needed to see this picture. 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
3. 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
4. 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
6. 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
7. 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
8. 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
12. 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
13. 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
14. 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
15. 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
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17. Data was inconsistent, full of errors, not complete