Johns Hopkins Center of Excellence in Regulatory Science and Innovation

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ABSTRACT The U.S. Food and Drug Administration's primary charge is to safeguard the health and well being of the public through the application of scientifically sound regulatory activities. In our rapidly evolving scientific landscape, this complexity of this task continually grows. To help address this, the FDA created the Centers of Excellence in Regulatory Science and Innovation (CERSIs). The CERSIs provide institutions with a valued opportunity to work directly with regulators while simultaneously providing the FDA opportunities for access and exposure to advanced scientific exchange and training focused on the FDA's regulatory science priority areas. As one of the world's leading institutions in higher education, Johns Hopkins University is pleased to extend and expand our collaboration with the FDA as we develop fundamental new knowledge and tools to advance regulatory science. Our proposal leverages the historic relationship between the FDA and Johns Hopkins and it also builds upon the substantial infrastructure that we have developed together during the past two and a half years. Our partnership also has other strengths including the University's internationally renowned scholarship in regulatory science, an immense training platform, close geographic proximity to the FDA and a nimble and organic operational approach. In this new award, we propose to substantially expand our capacity and the return on investment for the FDA. To do so, we will integrate our CERSI further into additional Schools and Divisions at Johns Hopkins, including the Department of Biomedical Engineering and Department of Radiology and Radiological Sciences. We will also introduce several innovations such as a new regulatory toxicology curriculum and a global regulatory science training initiative, as well as nearly twenty compelling scientific proposals carefully selected due to their high relevance and expected impact on regulatory science. These avenues of scientific inquiry, as well as the broader opportunities for partnership with leading centers of higher education, serve as a testament to the ways that the FDA can maximize its effectiveness through state-of-the- art regulation in the 21st Century.