Strand Life Sciences, a pioneer in scientific intelligence, has entered into an agreement with the U.S. Food and Drug Administration (FDA) to deliver the Genomics Reviewer Desktop (GRD), a solution to enable FDA reviewers to manage and analyze pharmacogenomic data submitted through its Voluntary Exploratory Data Submissions (VXDS) program. 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 award-winning workflow-driven data analysis and visualization platform that powers industry leading 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 analyze data submissions submitted as part of the VXDS program,” said Federico Goodsaid, Ph.D., Associate Director for Operations in Genomics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S 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.”
“We are very excited about this relationship with the FDA,” said Dr. Vijay Chandru, Chairman and CEO of Strand Life Sciences. “The GRD built on our award winning AVADIS platform 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”.