UR CTSI Working to Advance Regulatory Science Training

Dr. Joan Adamo and Dr. Scott Steele recently published an article in the Clinical and Translational Science Journal entitled “Advancing a Vision for Regulatory Science Training.” Regulatory science is a new and burgeoning field and is defined by the FDA as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.” Training programs in regulatory affairs, which is learning what the regulations are and how to apply them to projects is very common. However, training in regulatory science is less developed. In this article, Drs. Adamo and Steele advance regulatory science by identifying 11 thematic areas of training that contribute to regulatory science. These themes were identified by a Regulatory Science workgroup and then vetted by a group of interdisciplinary experts during a workshop in Washington, DC last fall. In support of this workshop, an extensive Regulatory Science survey was conducted of experts from industry, academia, government, not-for-profit organizations, associations and foundations to further prioritize and refine the proposed Regulatory Science competencies. Some examples of the Regulatory Science competencies include regulatory policies and process, research ethics, drug discovery and development, clinical trials, post-marketing and compliance, and communication.

This work was done in collaboration with other CTSAs. Future plans include developing a training network by identifying which academic institutions have expertise in the various thematic training areas, creating opportunities to share training amongst institutions and providing experiential learning opportunities in the training areas. In the future, “investigators will be able to pick and choose training topics related to regulatory science that will bolster the work they do in their field of expertise”, says Adamo.

Many investigators engage in regulatory science and don’t realize they are doing it. “The CTSI is helping faculty realize that their research often impacts this field, even if their work does not directly involve the regulation of a product” says Steele. What scientists work on now may help speed the development of other drugs or devices in the future. Put simply, “Regulatory science is any science that comes up with new ways so that products can be regulated and be brought out safely”, says Adamo. This includes reducing costs and the time it takes to get a safe and effective product approved. Steele notes, “A key element to advancing regulatory science and translational science is enabling research and educational collaborations across FDA, NIH, industry, academia and foundations.”

Stay tuned. In the fall, the UR CTSI will offer a series of seminars on regulatory science. Experts from academia, industry and the FDA will be here to present their latest work in the field of regulatory science.