Innovation in Regulatory Science

BWF’s Innovation in Regulatory Science Awards provide up to $500,000 over five years to academic investigators developing new methodologies or innovative approaches in regulatory science that will ultimately inform the regulatory decisions the Food and Drug Administration (FDA) and others make.

These awards are open to U.S. and Canadian citizens or permanent residents who have a faculty or adjunct faculty appointment at a North American degree-granting institution.  Awards are made to degree-granting institutions in the U.S. or Canada on behalf of the awardee. 

The application process consists of two phases: a preproposal followed by a full proposal invitation.  Preproposal applicants selected by the Advisory Committee deemed to meet the goals of this initiative will be invited to submit full proposals.

Background

The Burroughs Wellcome Fund identified Innovation in Regulatory Science as an important, underfunded area. This initiative is designed to provide financial support to stimulate research efforts in this area.

The process of translating biomedical discoveries into new therapies has become increasingly complex in light of evolving science and technology, and requires that the science of regulation keep up with the advances in biomedical science and technology. For example, existing animal models of human disease are often poor predictors of efficacy of new therapeutic approaches in humans. As new technologies produce new types of preclinical models, innovation is needed in the evaluation of these models to justify movement into clinical studies. Over the last decade, numerous reports [1] have documented the importance of this area of research to the future of the biomedical enterprise, however it remains inadequately supported.

Regulatory science has been defined as the “development and use of new tools, standards, and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy, and quality”. [2] It is has become the centerpiece of the Food and Drug Administration’s (FDA) strategy for fostering innovation, and the academic and foundation communities have been called to take an active role in building this emerging field.

This initiative of the Burroughs Wellcome Fund is focused on providing support for academic researchers developing new methodologies or innovative approaches in regulatory science that will ultimately inform the regulatory decisions FDA and others make.  This would necessarily draw upon the talents of individuals trained in mathematics, computer science, applied physics, medicine, engineering, toxicology, epidemiology, biostatistics, and systems pharmacology, to name a few.

[1] FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology, FDA Science Board, 2007; Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, Food and Drug Administration 2004; Building a National Framework for the Establishment of Regulatory Science for Drug Development, Institute of Medicine Workshop Report; Advancing Regulatory Science at the FDA, 2011.

[2] FDA, 2010. NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public.