Johns Hopkins Center of Excellence in Regulatory Science and Innovation

PROJECT SUMMARY/ABSTRACT
As the world’s leading regulatory authority, and the country’s largest research university, the U.S. Food and Drug
Administration and Johns Hopkins University are ideally suited to broaden and deepen their highly productive
partnership through the Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI).
This program, launched in 2014, has produced fundamental and applied new knowledge impacting a breadth of
regulated products, ranging from COVID-19 therapeutics (Center for Drug Evaluation and Research) to
eCigarettes (Center for Tobacco Products) to upper extremity prostheses (Center for Devices and Radiologic
Health). The program has also undertaken vitally important inquiries relevant to many understudied groups,
including pregnant women, racial and ethnic minorities, children and individuals with opioid use disorder. This
knowledge has been used by the FDA to support rule-making, guidance-development, and the alignment of
strategic priorities, helping to ensure that the FDA remains a global leader in advancing the technical and
scientific foundations of product regulation. Since its inception, JH-CERSI has also leveraged the historically
close relationship between the FDA and Johns Hopkins, and our renewal builds upon the substantial
infrastructure developed together over the past eight years. JH-CERSI’s successes reflect many strengths
including remarkable commitment from the FDA’s Office of the Chief Scientist and Office of Regulatory Science
and Innovation, 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 renewal,
we propose to capitalize on these strengths and on the numerous structural improvements we have made since
inception. We also propose three new programmatic elements to amplify impact. First, we will appoint an
Associate Director of Artificial Intelligence and an Associate Director of Data Science and Informatics to expand
the depth and breadth of our activities across faculty, programs, centers and schools, including the world-
renowned Whiting School of Engineering and the Johns Hopkins Applied Physics Lab. Second, we will develop
new training, including in Preparedness and Public Health Communications, to address the major threat that
misinformation poses to the FDA’s regulatory success. We also propose new interchange with leading overseas
regulators, thereby enhancing global regulatory science. Finally, we will institute an External Partnerships
Initiative to serve as a force-multiplier by leveraging the remarkable scientific networks of Johns Hopkins faculty
in service of the FDA’s mission. Together, through these efforts, Johns Hopkins and the FDA will continue to
achieve remarkable gains that allow the FDA to maximize its effectiveness and impact through state-of-the-art
regulation in the 21st Century.

Grant Number: 5U01FD005942-10
NIH Institute/Center: FDA
Principal Investigator: G. Alexander