David Kniaz (Merck) gives an overview of this potential Pistoia Alliance working group during the "Dragons' Den" session at the Pistoia Alliance Conference in Boston, MA, on April 24, 2012.
1. Standards for Exchanging
Screening Data
Dave Kniaz
Merck Research IT, Discovery Pre-Clinical Sciences
Director, Business Architecture
Pistoia Conference, April 24, 2012
http://pistoiaalliance.org
2. 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 Collaboration
To 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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3. Proposal and Value Proposition
Proposal
Devise 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 Proposition
Reduce 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.
4. 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.