Johns Hopkins Joins the Food and Drug Administration’s Centers of Excellence in Regulatory Science and Innovation (CERSI)

JHU’s Krieger School of Arts & Sciences, Johns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine Will Lend Support to Three Core FDA Priorities

The Johns Hopkins University is joining the Food and Drug Administration’s Centers of Excellence in Regulatory Science and Innovation (CERSI), the Agency’s academic partnership that promotes regulatory science. Faculty from the Johns Hopkins Krieger School of Arts and Sciences, the Johns Hopkins Bloomberg School of Public Health and the Johns Hopkins School of Medicine will lend their expertise to FDA staff and scientists, as well as participating CERSI faculty, in three FDA priority areas: clinical evaluations, social and behavioral science and food safety.

The FDA launched CERSI in 2011 to address scientific challenges in regulating the country’s food and drug and medical products at a time of rapid technological advancements. Johns Hopkins CERSI, thanks to its proximity to the FDA and to an extensive relationship with the Agency that includes the FDA Commissioner’s Fellows Program, will offer existing training, including certificates and degrees to FDA scientists and staff. Johns Hopkins will also develop curricular materials, including a new Master's in Food Science that will be offered beginning in the fall of 2015 through JHU’s Krieger School, as well as online mini-symposia or courses in regulatory science offered across the University and Schools of Public Health and Medicine.

“In addition to a strong foundation of collaboration with the Agency, our partnership with the FDA will leverage many other institutional strengths,” said G. Caleb Alexander, MD, MS, associate professor of Epidemiology and Medicine and co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. “These include 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 this award.”

To address the first strategic focus, improving clinical studies and evaluation, the Johns Hopkins CERSI will select specific projects for collaborative training and investigation with FDA scientists, drawing from expertise across a range of the University’s centers, including the Center for Clinical Trials, the United States Cochrane Center, the Evidence-Based Practice Center and the Center for Drug Safety and Effectiveness.

The second strategic focus is strengthening social and behavioral science to support informed decisions. Here, Johns Hopkins will leverage several centers whose work touches upon social and behavioral aspects of healthcare delivery and regulation, including the Institute for Tobacco Control and the Center for Communications Programs. “This is important, since the best science in the world does little good if the results of such investigations cannot be communicated to the end user, the general public, who the FDA serves,” said Dr. Alexander.

The final strategic focus is the development of a new prevention-focused food safety system. Johns Hopkins has a wealth of scientists that are working on highly relevant areas of food safety. The Center for a Livable Future, housed at the Johns Hopkins Bloomberg School of Public Health, promotes research to develop and communicate information about the complex interrelationships among diet, food production, environment and human health, to advance an ecological perspective in reducing threats to the health of the public and to promote policies that protect health, the global environment and the ability to sustain life for future generations.

“These partnerships enrich the breadth and depth of FDA expertise, enabling us to base our regulatory decisions on the most current scientific evidence,” said Stephen Ostroff, MD, the FDA’s Acting Chief Scientist. “They also enable FDA to bring its expansive experience to academia, ensuring that the new scientific approaches being developed at these institutions can be applied in a way that increases their usefulness for evaluating FDA-regulated products.  Most importantly, patients and consumers will ultimately benefit from the investment."

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Media contact for Johns Hopkins Bloomberg School of Public Health: Susan Sperry at 410-955-6919 or ssperry1@jhu.edu.