FDA Launches Center of Excellence in Drug Development, Regulation at UCSF

The FDA has selected UC San Francisco as the site of its new West Coast regulatory science center. Funded by an initial $3.3 million FDA grant, the joint effort between the UCSF School of Pharmacy and Stanford University will support the FDA’s ability to evaluate and approve new medications through innovative approaches in drug development.

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) will conduct collaborative research and implement education and scientific exchange programs.

The programs will use the universities’ strengths in quantitative sciences to focus on improving preclinical safety and efficacy tests, harnessing diverse data sets through information sciences, and improving clinical trials and evaluations.

Pharmaceutical and biotechnology industries are tapping into informatics and data-driven computer models, known as quantitative pharmacology, to help improve drug development and identify safer therapies with fewer side effects. The FDA hopes to use these technologies to assess which medications are safe and effective for patients.

“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. This partnership will enable us to develop new models and methods, and also move these technologies out of academia and into practice,” said Kathy Giacomini, PhD, a professor in the UCSF School of Pharmacy and co-chair of the UCSF Center for Quantitative Pharmacology. — Kellen Owings

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