The US Food and Drug Administration is collaborating with Ariana Pharma, a provider of decision support software for pharmaceutical discovery, development and safety, in the agency’s efforts to improve the analysis of genomic data in support of personalised medicine.
Under the collaboration, Ariana is providing its KEM biomarker technology to help FDA reviewers analyse pharmacogenomic data and patient characteristics for biomarker signatures filed through the agency’s Voluntary Exploratory Data Submission (VXDS) programme.
As things stand, the FDA notes, most pharmacogenomic data are “of an exploratory or research nature”. Accordingly, the agency’s regulations do not require the inclusion of these data in investigational new drug application (INDs), nor do they ask for complete reports on pharmacogenomic data in new drug applications (NDAs) or biologic license applications (BLAs).
Nonetheless, the FDA adds, voluntary submissions “can benefit both the industry and the FDA in a general way by providing a means for sponsors to ensure that regulatory scientists are familiar with and prepared to appropriately evaluate future genomic submissions”.
Launched in 2003 and based in central Paris, France, Ariana Pharma is a spin-off from the Institut Pasteur. Its KEM (Knowledge Management and Extraction) platform is a proprietary decision-support technology for the rapid analysis of parametric/multi-objective data, with applications ranging from drug discovery to optimisation of design and outcomes in clinical trials and early signal detection for drug safety.
According to Ariana, the KEM platform can cut the risk rate in selecting panels for biomarker development from 40% to 10%, potentially saving “billions of dollars”. The technology will help the FDA to identify systematically potential genomic ‘fingerprints’ and to develop recommendations for the analysis of genomic data prior to the submission of biomarker signatures through the VXDS programme, the company said.