Standards for Exchanging Screening Data Dave Kniaz Merck Research IT, Discovery Pre-Clinical Sciences Director, Business Architecture Pistoia Conference, April 24, 2012http://pistoiaalliance.org
Problem StatementGeneral Introduction (Pistoia Hanover Germany Workshop):Declining R&D productivity, rising costs of commercialization & shorterexclusivity period have driven up the average cost of launching a successfulnew drug to US $ 1.7 billion. To facilitate drug development & to lower thecost & risk of launching new drugs on their own, pharmaceutical companieshave increasingly turned to alliances for outsourcing.Screening Data / Exchange CollaborationTo respond to this challenge, large life science organizations are contributingto virtualization / externalization of R&D via various types of partnershipsbetween organizations including but not limited to outsourcing and co-sourcing assays to CROs. No standards currently exist which supportexchange of screening data within and between organizations impactingcollaboration capabilities and corresponding impacting discovery projectcycle time, cost and efficiency. 2
Proposal and Value PropositionProposalDevise standards including but not limited to definingcommon assay result data formats and data definitions for“routine” primary, secondary in vitro pharmacology assaysgenerally outsourced by large pharmas to CROs.Value PropositionReduce discovery project hit to lead cycle time at reducedcost with improved data quality by reducing the need todevelop 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.