Two teleconferences are planned for the next fortnight aiming to kick off working groups on two topics emanating from the highly fruitful Information Ecosystem Workshop that the Pistoia Alliance held last October in Hannover.
Registration is open for the first teleconference, to be held on Wednesday, 18 January 2012, on Topic #31 from the meeting—Biomarker Exchange Standards. Sandor Szalma, head of external innovation, R&D IT at Janssen R&D, has kindly agreed to head up this discussion. I asked him to elaborate on how this topic has developed, and here are his responses. I’ll publish more information on the other teleconference addressing Canonical Models for Large Molecules (Topic #7 from the meeting) in a future entry, but in the meantime, you can learn more and register for that event too.
What problem is driving this topic?
Pharmaceutical and biotech companies increasingly rely on a network of collaborators—academic labs, specialty service providers, CROs, and other pharma and biotech companies—to bring drug ideas through research and development stages and ultimately to market. As these networks get more complex, so does the management of data and metadata. Currently, data exchange among these networks relies on primitive vehicles such as moving around Word docs, PDFs, and Excel spreadsheets, with no standards to promote effective exchange.
What is this group’s aim?
The initial aim of the Biomarker Exchange Standards workgroup will be to develop requirements and use cases to foster the eventual development and adoption of data and metadata exchange standards for biomarker assays in order to facilitate collaboration.
Who should be involved?
Since many assays in the biomarker domain are similar to (or even the same as) assays in the target validation domain, deliverables from this working group will also have relevance here. Target validation experts should therefore be involved in this project, along with members of screening, target identification and toxicity workstreams. Right now, representatives from AstraZeneca, Bayer, Boehringer-Ingelheim, GSK, Janssen, Merck, Merck-Serono, Roche, and Sanofi have contributed to discussions and are planning to attend the teleconference.
What challenges do you plan to address?
We’ll look into secure, real-time data exchange; IP protection and infringement; process and data harmonization; and the lack of standard data formats and regulatory guidelines around collaboration and networking.