The US Food and Drug Administration (FDA) in May announced it was establishing two new Centers of Excellence in Regulatory Science and Innovation (CERSIs). One of the centers, which is to focus on improving preclinical safety and efficacy tests as well as clinical trials and evaluations, and on using information sciences to capture diverse data sets, will be set up jointly at the University of California, San Francisco (UCSF) and Stanford University. “The pharmaceutical and biotech industries are facing huge challenges, with the majority of drugs failing in clinical trials because they are not effective,” says Kathy Giacomini of the UCSF School of Pharmacy, alluding to the new FDA-sponsored center in California. This partnership aims to develop new computer-based models and methods to predict drug metabolism, toxicity and effectiveness, and help move these technologies out of academia and into practice, Giacomini adds. The second of the new CERSIs, which will be established at Johns Hopkins University in Baltimore, will focus on clinical evaluations, social and behavioral science, and food safety. This brings the number of CERSIs to four, with the two others established in 2011 at the University of Maryland medical campus in Baltimore and at Georgetown University in Washington, DC. “We strongly support regulatory science at FDA and partnerships between government, academia and the private sector to develop new tools and methodologies for evaluating the safety and effectiveness of drugs and biologics,” says Cartier Esham, executive vice president, Emerging Companies Section for the Biotechnology Industry Organization (BIO) in Washington, DC.
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Fox, J. FDA launches two research centers with academia. Nat Biotechnol 32, 601 (2014). https://doi.org/10.1038/nbt0714-601a