FDA’s Office of New Drugs Wants in on the Big Data Revolution

,

Two Years of Negotiations Later, Senate Reauthorizes PDUFA

In the age of big data, one might assume that too much information is a good thing. But don’t suggest that to the Center for Drug Evaluation and Research (CDER). This division of the U.S. Food and Drug Administration is currently exploring ways to automate and modernize inefficient review systems as part of an overhaul of review practices in the Office of New Drugs (OND).

Janet Woodcock, director of CDER, acknowledged that establishing a new framework for improved knowledge management is “not that sexy,” but is essential as the agency  tries to process the huge amounts of data that comes its way.

In addition to the traditional clinical trials data, drug development is now informed by a wider collection of information including real-world evidence, patient-reported outcomes, genomic data and reports from registries. Woodcock said that CDER is being “bombarded” by all this data and decision-making is suffering as a result.

Related reading: 2 Real World Examples: Using Real World Data for Commercial Pharmaceutical Product Insights

What’s the answer to the big data dilemma?

Woodcock acknowledges that to overcome its big data dilemma, CDER needs to find an IT platform that can put “all this vast information at the fingertips of reviewers,” which will lead to better informed regulatory decisions.

But, it’s not just the technology that requires an overhaul. Woodcock is overseeing a restructure of the OND, which will involve creating cross-disciplinary teams for each new drug application instead of leaving it to individual reviewers to consult with additional specialists. There are also plans to form a centralized project management operation to ensure that all review divisions follow a consistent review process.

The process could be a lengthy one, however, with any operational changes suggested by OND requiring review and approval by the Department of Health and Human Services, by the Office of Management and Budget, and by Congress.

The proposals include increasing the number of review offices from five to nine, which will contain 30 review divisions, up from 19, and include a division for rare diseases. It’s suggested that this will create more specialized units that have a deeper knowledge of the diseases being treated by the proposed drugs.

As it increases the number of review decisions, Woodcock will need to ensure that the OND still has the capacity for cross-divisional collaboration, which will likely mean a further investment in technology.

In addition to the regulatory hurdles it must overcome, CDER is currently facing an employee deficit of about 1,000 people. This will ultimately force the agency to contract out numerous operations and tasks, until the proposed reorganization is in place.

“These changes are intended to free up resources so that our scientists and physicians have more time to focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly, with appropriate input from external scientists, expert physicians and patient communities,” said Woodcock in a blog posted to the agency’s web site.

 

Related Reading:

Jill Shuman

Author: Jill Shuman

Jill Shuman is a former Director of Product Engagement at Copyright Clearance Center and currently a CCC Consultant. She is also an adjunct faculty member at Tufts University School of Medicine, where she has taught courses in grant writing, searching biomedical literature and expository writing. Prior to her role at CCC, Jill headed up the corporate library and Knowledge Management Centers at Shire, and also served as a healthcare research analyst and an award-winning science journalist. She is active in SLA, HBA, and the American Medical Writers Association (AMWA). In 2016, Jill was the recipient of AMWA’s lifetime achievement award for her success in teaching more than 40 classes, workshops, and seminars. When not at work, she can be found reading (on an e-reader to make the print bigger), looking for her glasses, or writing children’s mysteries that feature sick children as super sleuths.

Don't Miss a Post

Subscribe by Email

For inquiries related to this blog, email blog@copyright.com or join the conversation on social media with @copyrightclear.