Regulatory Focus™ > News Articles > Documents Shed Light on Role and Potential Impact of FDA's New Office of Computational Science

Documents Shed Light on Role and Potential Impact of FDA's New Office of Computational Science

Posted 18 April 2013 | By

New light is being shed on a brand-new office set up in March 2013 by the US Food and Drug Administration (FDA) to enhance regulators' ability to analyze data about pharmaceutical products.

Background

The Office of Computational Science (OCS), announced 18 March 2013, is the newest addition to FDA's drug regulatory capacity, which is now in the midst of a reorganization spearheaded by Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). While much of that reorganization is focused on generic drugs and quality issues, OCS is intended to address another problem: the overwhelming volume of drug data the agency receives on an ongoing basis.

That point has been made in the past by the office's new director, Lilliam Rosario, formerly associate director of the Office of Critical Path Programs within the Office of the Commissioner. In a presentation made before a regulatory trade group, now hosted on FDA's website, Rosario said that "The challenge [is that] FDA received massive amounts of clinical research data." Compounding that problem, she said, are two factors: the data are now in "extremely disparate formats," and now use "a variety of proprietary standards."

"This makes it extremely difficult, if not impossible, to do cross-study and application reviews," she added.

The good news, from FDA's perspective, is that it's been active on this issue, working toward the creation of standardized approaches meant to, in Rosario's words, "capture, receive and analyze study data." That infrastructure is eventually meant to accommodate standardized scientific data under a single management system, known as Janus, which FDA is now developing along with the National Cancer Institute Center for Biomedical Informatics.

New Light on Responsibilities

The size and scope of that initiative demands leadership and management, however, and that's where OCS is slated to step in.

In a new FDA staff manual guide posted on 18 April 2013, the agency explains that the office will be "responsible for providing oversight of the development of CDER's scientific computing capabilities, including both infrastructure and operations."

Among its specific duties will be the alignment of CDER and FDA initiatives, including Janus, and the coordination of its data initiatives with those of other government agencies, such as those overseen by the National Institutes of Health (NIH).

Another major part of its mission will be planning for the "development and adoption of data and data exchange standards to support CDER's regulatory and research missions in coordination with the FDA Data Standards Council (DSC)," and making sure that these efforts are implemented effectively.

As to when those efforts might bear fruit, the document doesn't say, but if the scope of OCS' current charge of work is any indication, it might be a while yet.


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