http://pistoiaalliance.org

Standards for Exchanging Screening Data

Pistoia Conference, April 24, 2012

Dave KniazMerck Research IT, Discovery Pre-Clinical SciencesDirector, Business Architecture

Problem Statement

General Introduction (Pistoia Hanover Germany Workshop):Declining R&D productivity, rising costs of commercialization & shorter exclusivity period have driven up the average cost of launching a successful new drug to US $ 1.7 billion. To facilitate drug development & to lower the cost & risk of launching new drugs on their own, pharmaceutical companies have increasingly turned to alliances for outsourcing.

Screening Data / Exchange CollaborationTo respond to this challenge, large life science organizations are contributing to virtualization / externalization of R&D via various types of partnerships between organizations including but not limited to outsourcing and co-sourcing assays to CROs. No standards currently exist which support exchange of screening data within and between organizations impacting collaboration capabilities and corresponding impacting discovery project cycle time, cost and efficiency.

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Proposal and Value Proposition

ProposalDevise standards including but not limited to defining common assay result data formats and data definitions for “routine” primary, secondary in vitro pharmacology assays generally outsourced by large pharmas to CROs.

Value PropositionReduce discovery project hit to lead cycle time at reduced cost with improved data quality by reducing the need to develop one off methods to exchange screening data.

Discussion Points

• Proposed starting point to select specific low IP risk discovery in vitro pharmacology assays most large pharmas outsource

• Consider partnership with Society for Laboratory Automation and Screening

• Leverage and extend existing standards

• Start with large pharma representatives and add CRO representatives and software vendors as project progresses.

Subject Matter expert resources are needed to required to work with resources Pistoia is committing to define use case scenarios and business case required to prepare a project proposal.