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 - 13 Q4 - 13 Q4 - 14Q2 - 14

Workstream Start

Business Case

Business Case Funding Agreed

Business Case Funding Available

Biomarker Service Available

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Prioritized list of platforms from U-BIOPRED

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…)

– Provider2

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 paper3= Validated research assay and most >LLoQ, validation in peer-reviewed paper4= 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

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

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

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