ENHANCING REGULATORY SCIENCE THROUGH A UNIQUE FDA-ACADEMIC PARTNERSHIP

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ABSTRACT The primary charge of the Food and Drug Administration is to safeguard the health and well-being of the public through the application of scientifically sound regulatory activities. The complexity of the FDA's mission is rapidly increasing, with a growing number of food and drug products requiring regulation in the context of rapid evolution of the scientific landscape. These changes pose unprecedented challenges, and opportunities, to ensure that processes and protocols are adopted that reflect innovative and efficient methods of fulfilling the FDA's charge. Partnerships with academic institutions provide these institutions a valued opportunity to work directly with regulators to fulfill the FDA's mission while simultaneously providing the Agency opportunities for access and exposure to advanced scientific exchange and training as well as specific intellectual expertise and human capital focused on the FDA's priority areas. We propose a Johns Hopkins - FDA Collaborating Center of Excellence in Regulatory Science and Innovation (CERSI) that will ensure the FDA remains a standard- bearer in regulatory science. Our CERSI leverages the geographic proximity and extensive relationship between our institutions and uses this as a foundation to develop new training opportunities and to promote a programmatic focus on three priority areas for the agency: (1) improving clinical studies and evaluation; (2) strengthening the social and behavioral science to support informed decisions; and (3) developing a new prevention-focused food safety system. In addition to a strong foundation of collaboration with the Agency, which includes an active Memorandum of Understanding, our partnership will also have many other strengths, including: internationally renowned scholarship in regulatory science; innovative training through online platforms harnessing modern technologies; a nimble and organic operational approach; and the potential for self-sustaining programs that will continue to serve the FDA's strategic mission beyond the time frame of the proposed award.