Regulatory science at UCSF gets major boost with FDA CERSI renewal

The FDA Office of Regulatory Science and Innovation (ORSI) has announced the Centers of Excellence in Regulatory Science and Innovation (CERSIs) program funding, granting a $50 million renewal of UCSF’s joint effort with Stanford University (UCSF-Stanford)—led by co-principal investigators Kathy Giacomini, PhD, BSPharm, dean of the UCSF School of Pharmacy, and Russ B. Altman, MD, PhD, Stanford University Schools of Medicine and Engineering.

The five institutions in the CERSI network will receive the funding starting September 1, 2023, and will each receive up to $50 million for five years.

The CERSI network, led by ORSI, was established to foster robust and innovative approaches that advance regulatory science. CERSIs accomplish this goal through collaborative interactions with FDA scientific experts, as well as with funding that targets areas in the FDA Regulatory Science Framework.

“Cooperation between players like UCSF and Stanford, FDA, and private industry is the key for ensuring that the safest and most effective therapies make their way to patients,” said Giacomini. “CERSIs are a focal point that make this possible.”

The CERSIs also provide regulatory science information-sharing opportunities, such as lectures, workshops, courses, scholar awards, fellowships, and competitions, predominantly through cutting-edge scientific research that supports the FDA’s needs.

UCSF’s 2024 CERSI Summit will take place on January 7 at the Mission Bay campus with a stellar lineup of speakers and panels. On January 9 Stanford University will host the 2024 CERSI Scientific Symposium, the first time all the CERSIs in the network will collaborate.

The centers that make up the network were selected and awarded through a competitive process. There were four renewal awards and one new award:

• UCSF-Stanford
• University of Maryland
• Johns Hopkins University
• Yale University (in a joint effort with Mayo Clinic)
• University of North Carolina, Chapel Hill (in a partnership with Duke University). This new CERSI also plans to partner with North Carolina State University and North Carolina Central University, a historically black college and university (HBCU).

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