Strand Life Sciences, a pioneer in scientific intelligence has entered into an agreement with the US Food and Drug Administration (FDA) to deliver the Genomics Reviewer Desktop (GRD). The solution will enable FDA reviewers to manage and analyze 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. It will be integrated with FDA’s ArrayTrack and with other third party analysis software tools.
Further, it is built on AVADIS, which is Strand’s award-winning workflow-driven data analysis and visualization platform that supports industry leading software products like 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 analyze data submissions submitted as part of the VXDS programme,” said Dr Federico Goodsaid, 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, he added.
According to Dr Vijay Chandru, chairman and CEO of Strand Life Sciences, the GRD will help the FDA realize the benefits of integrating and standardizing analysis processes and systems in supporting the integration of genomics in drug development and regulatory decision-making.
Strand is a privately held company providing products and services in the areas of omics-based technologies, drug discovery, predictive systems modeling and knowledge management. Seven of the top ten pharmaceutical companies, three of the top six biotechnology companies, and numerous academic institutions across the globe, are part of Strand's customer profile. It is a portfolio company of UTI Venture Funds, Sequoia Capital, and MediBIC group (Japan).