There have been some exciting developments in the half-month since the Pistoia Alliance face-to-face meeting of the board and operational team. Just today, the fledgling working group on Biomarker Exchange Standards held its third meeting. And next Wednesday another working group spawned from the Information Ecosystem Workshop last October in Hannover will have its kickoff meeting. This group is aimed at developing standards for exchanging screening data, and we already have over 90 people signed up for the teleconference.
I asked David Kniaz, director of business architecture at Merck and the one spearheading this topic, to share a bit of information on this topic.
What problem is driving this topic?
To facilitate drug development and lower the cost and risk associated with launching new drugs, pharmaceutical companies are virtualizing and externalizing R&D through various types of partnerships. Screening externalization is a particular area of focus within drug discovery programs. Yet no established standards exist supporting consistency of data formats and naming conventions in this area. As a result, significant one-off effort is required to determine how data and physical samples can be exchanged—effort that slows discovery project cycle time, increases cost, and reduces efficiency and data quality.
What is this group’s aim?
The proposed project, which the Alliance will be devoting resources to accelerate, is targeted to improve discovery project efficiency through the development of standards to simplify and improve internal and external screening data exchange. The initial proposed focused areas include “routine” primary and secondary in vitro pharmacology assays typically outsourced by large pharmaceutical organizations to CROs. CRO data exchange is clearly important, but it’s not the only aspect to consider. As one enthusiastic member of this initial team put it, “I can’t even get my assay data management system to play in the sandbox with my ELN!”
Who should be involved?
I’m thrilled at the response to the teleconference so far. Clearly, this issue is resonating in the community. We’ll require a range of subject-matter expert resources to provide input into the scope of the project and develop the proposal and business case. We’re also looking for opportunities to leverage existing standards where possible and to partner with other organizations such as the Society for Lab Automation and Screening (SLAS).