The US Food and Drug Administration will be using Ariana Pharma's data-mining platform to identify genomic markers with the potential to personalize drugs.
Ariana Pharma announced this week that the agency will use its KEM Biomarker technology to "systematically identify potential genomic 'fingerprints' and develop recommendations for the analysis of genomic data prior to submission of biomarker signatures."
KEM refers to Ariana's data-mining solution called the Knowledge Extraction Management platform. The platform employs a rules-based method that has been applied previously in clinical research for drug discovery and safety analysis.
A spokesperson for Ariana told PGx Reporter that KEM Biomarker enables the systematic analysis of combinations of genomic, proteomic, biochemical, and phenotypic data in order to identify combinations or signatures that help identify a specific population. "In practice [the platform] allows users to identify the shortest and most powerful signatures," the spokesperson said. "In particular, it would help the agency to evaluate multiple competing signatures. The software can be applied to the data submitted by sponsors."
The FDA can access the tool through Ariana's analysis service or directly use the software to analyze data submitted to the agency through VXDS.
The agency launched the VXDS program several years ago to encourage sponsors to share genomic data with the agency without any regulatory repercussions (PGx Reporter 11/29/06). According to agency officials, since 2008, submissions to the VXDS program have grown 250 percent.
Several companies are using VXDS to help strategize PGx-guided drug development. For example, Allen Roses, director of Duke's Deane Drug Discovery Institute, turned to the VXDS program to iron out the submission strategy for a new personalized treatment, involving a drug and companion test, for a drug to prevent Alzheimer's disease. Roses is developing this treatment through a company he started called Zinfandel Pharmaceuticals (PGx Reporter 07/14/10).
Drug developers are even starting to use the VXDS program to bring back failed drugs with the help of genomic strategies. For example, last year Novartis submitted data to VXDS for lumiracoxib, a Cox-2 inhibitor that the FDA rejected in 2007 due to serious liver adverse events. After discussions with agency officials, Novartis has settled on a genetic marker with which the company plans to resubmit the drug with a companion diagnostic (PGx Reporter 02/04/10).
Federico Goodsaid, associate director for operations in genomics at the Office of Clinical Pharmacology in FDA's Center for Drug Evaluation and Research, said in a statement that the KEM technology will "help the agency systematically analyze all equivalent signatures combining both genomic and phenotypical data … increasing [the] chances of selecting the best biomarker signature."
Earlier this year, Strand Life Sciences announced that the FDA was using its Genomics Reviewer Desktop software to analyze pharmacogenomic data submitted through the VXDS program. According to Strand, its GRD software enables FDA to "integrate analyses needed to reconstruct a sponsor's interpretation of exploratory biomarker data by using multiple genomics tools and methods."
The spokesperson for Ariana described KEM as "a step beyond existing statistical tools that are available in most standard statistical packages." Specifically, the spokesperson highlighted that the KEM technology "significantly diminishes the risk of selecting the wrong panel in terms of combinations of biomarkers, which can mean savings worth of billions of dollars and years of research" as "this risk is decreased several fold."
Furthermore, Ariana claims that its solution "exhaustively analyzes all combinations of biomarkers," which standard analysis methods do not.
Ariana, which spun out of the Pasteur Institute in 2003, is based in Paris with US offices in Cambridge, Mass.