In 2018, the FDA’s Centre for Drug Evaluation and Research’s Office of New Drugs- OND went on to develop a new programme so as to centralise as well as enhance the regulatory science research actions. More recently, the OND research programme went on to publish its first two fiscal year annual reports, and there happen to be significant projects that are looking to aid in improving the research outcomes across patient populations.
The associate director of the OND-RP, Laura Jaeger, PhD, mentions in an interaction how most project ideas arise from the scientific review staff of the OND, who analyse and evaluate the safety of the drug and the efficacy of the profile in order to help decide if the treatment has to be approved. She says that the OND reviewers also evaluate if more measures are required for the safe usage of the drug or if certain patient populations shouldn’t take the medication, besides other regulatory decisions.
When it comes to how OND-RP funds regulatory science research against other kinds of research, Jaeger says that the programme is aimed at addressing certain scientific questions that will go on to produce immediate impacts concerning how CDER and FDA would make decisions related to the approval of drugs. These projects happen to be shorter as compared to basic scientific research, with a timeline ranging between three and four years.
There are two ways that OND-RP goes about funding the research: intramurally and extramurally. When it comes to the extramural end, Jaeger goes on to say that there are several mechanisms that fund the research, such as the FDA’s broad agency announcement programme as well as its centre for excellence in regulatory science and innovation. They also make use of agreements such as memorandum of understanding (MoU), research collaborations, and cooperative research and development agreements so as to formalise their research partnerships. On the other hand, when we talk of intramural research, it primarily takes place through the Oak Ridge Institute of Science and Education Fellowship Programme, wherein college students as well as recent graduates can go on to conduct the research under the guidance of an FDA mentor when it comes to a regulatory science project.
An instance of the OND-RP-funded project when it comes to the extramural report is the push to develop blood-based biomarkers or even molecules that give out a signal of a normal or abnormal biologic process in the case of a traumatic brain injury. Drug development in this area happens to be difficult because the symptoms of individuals vary and there are few objective ways to gauge the prognosis. A biomarker will go on to help the investigators sort individuals in clinical trials by way of disease severity, ultimately pushing drug development. The ORISE report focuses primarily on enhancing the bulk drug substance evaluation and how compounders make use of these substances to make customised drugs for specific patients.
In scenario that a patient has an allergy to an ingredient in a drug that is FDA-approved, compounders can go on to use bulk drug substances to compound the drug without the allergen. In this project, the ORISE fellows aided to create internal resources to streamline review of bulk substances.