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Published byAmber Marshall Modified over 9 years ago
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The “Analysome” Unmet Need Drug R&D requires validated biomarker assays Information on such assays is available but is neither well coordinated nor vetted Significant time/money is spent researching the availability & quality of biomarkers Drug companies need to reduced the costs of searching for biomarker assays (e.g. $30K to $40K) CROs need a showcase to display their biomarker capabilities for maximum impact to multiple potential users Academics need a simple way to find opportunities to seek new, useful biomarkers Value Proposition The Analysome will accelerate life-science R&D including translational research by: Building an evidence-based database of assays for analytes Standardizing knowledge & vocabulary for analyte use & assay validation Allowing life scientists to find & utilize the best biomarkers for their research. Allowing biomarker & diagnostic developers to understand assay availability, use & cost in the market Fostering a community of scientific users, biomarker developers & assay service organizations Shared project requirements: project analyst, platform pilot, socialization, service implementation & Curation Project value for stakeholders: FTE saving on finding the right biomarker at the right time with the right quality and the right availability FTE saving on in-house curation of biomarker resources providing vendors a marketplace for their assays Risk mitigation – using appropriately validated & qualified biomarkers minimizes experimental and regulatory risks High Level Implementation Timeline Q2 - 13Q4 - 13Q4 - 14Q2 - 14 Workstream Start Business Case Business Case Funding Agreed Business Case Funding Available Biomarker Service Available 1 Prioritized list of platforms from U-BIOPRED
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Vision of the Analysome Service What does the Analysome Service look like when it’s available? On-line, PA-branded service, providing access to information about the availability of assays for human analytes. Search by analyte (gene, protein, metabolite) Expanded search by biological pathway/network Results delivered as list of available assays –Key parameters (sensitivity, multiplexing, cost, validation status…) –Provider 2
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Web Portal “Analysome” – Functional Model Ability to select the matrix Validation qualifiers e.g. Commercial, academic Currently > 70.000 assays in test system Ability to select the matrix Direct link to assay provider 1= Research assay not fully validated for this matrix and/or most 2= Validated research assay and most >LLoQ, supplier’s validation data not in peer-review paper 3= Validated research assay and most >LLoQ, validation in peer-reviewed paper 4= Validated (approved by FDA or other) diagnostic assay and high proportion >LLoQ, validation in peer-reviewed paper Working prototype demonstration of the Analysome is available on YouTube @ https://www.youtube.com/watch?v=o_14ViKsAWE&feature=youtu.be
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Key Stakeholders Provider side –Assay providers (e.g. companies who sell kits / who offer assay services) –CROs (note the relationship between original providers and the ‘appliers’) Consumer side –Translational Research, Biomarker Discovery pharma, biotech, academia, non-profit research organisations –CROs (see above) 4
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Value Proposition For consumers One stop shopping: Rapidly find available assays for analytes of interest (including analytes in related biological networks) For providers Highly effective marketing channel Value proposition for both sides hinges on completeness of the list of available assays 5
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