This week FDA officially introduced its push to open up its data to the public and particularly app developers. The unveiling went over the goals of openFDA, but also detailed some other areas in which the agency is investing. FDA is pushing hard into next-generation sequencing (NGS) and cloud-based genomics.
FDA chief health informatics officer Dr. Taha Kass-Hout outlined the plans, first in a blog post and then with a slide deck he presented at the Healthcare Information and Management Systems Society (HIMSS) Conference. The slides go beyond Kass-Hout's hopes for openFDA to discuss how he sees the agency transitioning into an era in which genome sequencing is commonplace. Faced with the prospect of widespread use of NGS leading to ever larger, more complex drug approval submissions, FDA has hit upon the same solution as industry--use the cloud.
Kass-Hout's presentation describes the cloud-based platform the FDA Office of Informatics and Technology Innovation (OITI) will establish to handle NGS data. The system is designed to equip FDA divisions to generate, analyze and share NGS data, tasks that are difficult using the existing infrastructure. These limitations were exposed in May, when FDA received its first full product review with large NGS data sets. FDA put the NGS data--known as the "Terabyte Submission"--on hard drives and manually moved it to high-performance computing environments for reviewing.
Establishing a cloud-based system should give FDA the storage and computing flexibility to handle such submissions, and the ability to grow its capabilities as submissions become even larger. FDA is also building its open data ambitions into the NGS platform. Kass-Hout said NGS data can potentially deliver tremendous value to the public when combined with openFDA. A schematic presented by Kass-Hout shows the public component of the NGS cloud platform feeding into the FDA App Store.