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Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.
In 2018, FDA’s Center for Drug Evaluation and Research’s (CDER’s) Office of New Drugs (OND) developed a research program to centralize and enhance its regulatory science research activities. In more recent years, the OND Research Program (OND-RP) published its first two fiscal year annual reports, and there are important projects that are looking to help improve research outcomes for patient populations.
Laura Jaeger, PhD, associate director of the OND-RP, mentions in a Q&A with CDER how most project ideas come from OND’s scientific review staff, who evaluate a drug’s safety and efficacy profile to help decide if the treatment should be approved. “OND reviewers also assess if additional measures are necessary for safe drug use or if some patient populations should not take the medication, among other regulatory decisions,” Jaeger says in the Q&A.
As for how OND-RP funds regulatory science research versus other types of research, Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions. These projects tend to be shorter than basic scientific research, looking at a timeline of three to four years.
There are two main ways that OND-RP funds research: intramurally and extramurally. On the extramural end, Jaeger mentions there are several mechanisms to fund research, like FDA’s Broad Agency Announcement program and FDA’s Centers for Excellence in Regulatory Science and Innovation. “We also use agreements such as memorandums of understanding, research collaboration agreements, and cooperative research and development agreements to formalize our research partnerships,” she says in the Q&A. Intramurally, research is primarily through the Oak Ridge Institute for Science and Education (ORISE) fellowship program, where college students or recent graduates can conduct research with an FDA mentor on a regulatory science project, according to the press release.
An example of an OND-RP funded project from an extramural report is the effort to develop blood-based biomarkers, or molecules that signal a normal or abnormal biologic process, for traumatic brain injury. “Drug development in this area is difficult because people’s symptoms vary and there are few objective ways to determine prognosis,” Jaeger shares in the Q&A. “A biomarker would help investigators sort individuals into clinical trials by disease severity, ultimately fostering drug development.”
In the ORISE report, it focuses on enhancing the evaluation of bulk drug substances, and compounders use these substances to create custom drugs for individual patients. “For example, if a patient has an allergy to an ingredient in an FDA-approved drug, compounders can use bulk drug substances to compound a drug without the allergen,” she says in the Q&A. “In this project, ORISE fellows helped create internal resources to streamline our review of bulk substances.”