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The “Analysome”

High Level Implementation Timeline. Business Case. Unmet Need. Value Proposition. The “Analysome”. Shared p roject requirements: p roject a nalyst , platform pilot, socialization, service implementation & Curation Project value for stakeholders:

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The “Analysome”

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  1. High Level Implementation Timeline • Business Case • Unmet Need • Value Proposition The “Analysome” • 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 • 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 • 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 Workstream Start Business Case Funding Available Prioritized list of platforms from U-BIOPRED Biomarker Service Available 1 Business Case Funding Agreed Q2 - 13 Q4 - 13 Q2 - 14 Q4 - 14

  2. 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

  3. Web Portal “Analysome” – Functional Model Ability to select the matrix Direct link to assay provider e.g. Commercial, academic Validation qualifiers Ability to select the matrix Currently > 70.000 assays in test system 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

  4. 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

  5. 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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