One of the goals of BioCompute is to improve efficiency of communication and reduce the time spent communicating and interpreting genome analyses and pipelines. Currently, non-standardized methods of communication can result in uncertainties in data communication and interpretation, which can result in several months of added time in communication with the FDA and add millions of dollars to the submission process.
Submissions to the FDA and other regulatory agencies are large investments. Any confusion around a submission that requires troubleshooting increases the time and cost investment without improving the likelihood of an approval, and therefore increases the risk. BioCompute is designed to minimize that risk by eliminating any confusion associated with what has been traditionally one of the most problematic aspects of regulatory submissions: Next Generation Sequencing analysis.
The sheer number of moving parts in a genome analysis experiment increases the probability that the FDA will not be able to repeat an experiment once the data are submitted. Even something as simple as leaving out a version number (a common omission) can cause an experiment to fail. When this happens, the troubleshooting process can draw out the submission time by many months, delaying the time until the therapy is available to the public.
BioCompute addresses this problem by capturing every detail from beginning to end into an “Object.” At present, an Object includes data from the provenance domain, error domain, parameter domain, and others (for more information about the domains, please see the BioCompute User Guide. The Partnership exists to let the FDA and their private sector counterparts define what data should be included in this standard moving forward, as new analyses and pipelines are defined.
The goal of BioCompute with regard to FDA regulation is to improve the efficiency of communication of NGS analysis data, reduce unnecessary inefficiences, and speed time to evaluation. More information about the current BioCompute instance can be found on the Open Science Foundation website. If you or your organization submits high throughput sequencing data to the FDA or if you build scripts, tools, or pipelines for genome analysis and would like to contribute to the BioCompute standard, consider joining the working group or becoming a member of the BioCompute Partnership. To explore the possibility of becoming an institutional member, please contact us.