Over the past few years the FDA has formalized its links to academia by setting up Centers of Excellence in Regulatory Science and Innovation (CERSI), a process that has mirrored biopharma companies' recognition of the need for collaboration. And, like biopharma, FDA is continuing to strengthen its ties, setting up its first West Coast center to improve its use of informatics and data-driven computer models.
|UCSF Mission Bay--Courtesy of UCSF|
The University of California, San Francisco (UCSF) is housing the CERSI, which it will run in collaboration with scientists at Stanford University. FDA is providing the center with an initial grant of $3.3 million, and its staffers will work with their peers in academia on three priority areas, one of which is the use of diverse data sets to speed drug development. The collaborators will also work to improve preclinical and clinical studies.
UCSF professor Kathy Giacomini picked out computer-based models to "predict how the human body metabolizes a drug, the drug's toxicity and its effectiveness in preventing and treating various human diseases" as ways to improve development. The center will work to develop such models, while also moving existing technologies out of academia and into industry and regulatory practice. Giacomini and her colleagues at UCSF bring pharmacology and therapeutic sciences expertise to the center.
Stanford was brought on board for its bioinformatics skills. "Data on drug action at all levels, from molecular to population, is exploding and requires sophisticated computational integration to fully understand it," Stanford professor Russ Altman said in a statement. With the industry it regulates making use of such data and models, the FDA has to keep pace with technological developments. Setting up the CERSI through a competitive application process is part of the FDA's efforts in this area.