FDA Expands CERSI Network

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-06-04-2014, Volume 10, Issue 6

John Hopkins and UCSF-Stanford join FDA?s Centers of Excellence in Regulatory Science and Innovation.

The University of California at San Francisco (UCSF), in a joint effort with Stanford University, and the Johns Hopkins University have become part of FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSIs), a network of academic partnerships aimed at promoting regulatory science. These additions are FDA’s latest expansion of its CERSI network, which awarded $2 million to launch CERSI’s at the University of Maryland and Georgetown University in October 2011. According to FDA, the establishment of CERSIs will help promote cross-disciplinary regulatory science training, scientific exchanges, and research focused on FDA science priority areas.

Launched with an initial $3.3 million FDA grant, the UCSF-Stanford CERSI will bring West Coast representation to the CERSI network and enable FDA to access UCSF’s informatics and data-driven computer models, also known as quantitative pharmacology. These new technologies will help improve drug development and identify new therapies that will be safer, more precise, and have fewer side effects.

 “The pharmaceutical and biotech industries are facing huge challenges, with the majority of drugs failing in clinical trials because they are not effective. These new computer-based models are enabling us to predict how the human body metabolizes a drug, the drug’s toxicity and its effectiveness in preventing and treating various human diseases, as well as how that varies across a population of diverse people,” said Kathy Giacomini, PhD, professor in the UCSF School of Pharmacy and co-chair of the UCSF Center for Quantitative Pharmacology in a statement. “This partnership will enable us to develop new models and methods, and also move these technologies out of academia and into practice.”

In addition, teams of scientists from both institutions and FDA scientists will be working together to develop and offer courses and workshops in drug development and regulatory science through UCSF’s American Course in Drug Development and Regulatory Sciences. This CERSI will also offer scientific exchanges and training that target three of FDA’s regulatory science priority areas: transforming toxicology to improve product safety, improving clinical studies and evaluation, and harnessing diverse data through information sciences to improve health outcomes. 

The Johns Hopkins CERSI will focus on three different FDA priority areas: clinical evaluations, social and behavioral science, and food safety. The university’s geographic proximity to FDA will allow staff to take advantage of workshops, symposia, courses, certificate programs, and a Master’s degree in Regulatory Science. Johns Hopkins will also develop curricular materials, including a new Master's in food science, 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.”


In 2011, the University of Maryland's CERSI received a $1 million grant to focus on modernizing and improving the ways drugs and medical devices are reviewed and evaluated. Through the UM CERSI, researchers will assist the FDA in establishing improvements in medical product development, as well as in advancing laboratory, population, behavioral and manufacturing sciences. The center is a collaborative partnership between the University of Maryland, College Park, and the University of Maryland in Baltimore. The Georgetown University CERSI will use its $1 million grant to concentrate on the development of new methods to guide decision-making and ensure public health in the development of safe and effective medical products. Georgetown will also collaborate with the Georgetown University Medical Center, the Georgetown University Law Center, and the Georgetown-Howard Universities Center for Clinical and Translational Science. This collaboration provides FDA scientists with opportunities in the fields of medicine, nursing, and law.

Stephen Ostroff, MD, the FDA’s acting chief scientist issued a statement on the significance of CERSI. “These partnerships enrich the breadth and depth of FDA expertise, enabling us to base our regulatory decisions on the most current scientific evidence. 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."

All CERSIs are managed by OCS’s Office of Regulatory Science and Innovation, together with teams of scientists from across FDA.

FDA VoiceUniversity of California San Francisco (UCSF)John Hopkins Bloomberg School of Public HealthStandford School of MedicineM-CERSIRegulatory Science at Georgetown University