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US FDA finds solution to manage pharmacogenomic data

The US Food and Drug Administration (FDA) is using the Genomics Reviewer Desktop (GRD) from Strand Life Sciences to enable its reviewers to manage and analyse pharmacogenomic data submitted through its Voluntary Exploratory Data Submissions (VXDS) programme. GRD will enable FDA to integrate analyses needed to reconstruct a sponsor's interpretation of exploratory biomarker data by using multiple genomics tools and methods. This effort contributes to the development of recommendations for the submission of genomic data.

GRD will be integrated with FDA's ArrayTrack and with other third-party analysis software tools.  GRD is built on Avadis, Strand's workflow-driven data analysis and visualisation platform that powers software products such as GeneSpring and Sarchitect. As part of this agreement, FDA has also licensed Strand's Avadis software.

'There are a number of analysis tools, methods, and databases available to the FDA, along with our own ArrayTrack, to analyse data submissions submitted as part of the VXDS programme,' said Federico Goodsaid, PhD, associate director for operations in genomics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US FDA. 'GRD will help FDA reviewers to develop integrated data interpretation that is based on using multiple analysis tools and databases, as well as capture the underlying analysis process. A solution such as GRD will be advantageous to both the FDA and the industry to manage pharmacogenomic data submissions.'


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