FDA launches UCSF-Stanford center for innovation in drug development, regulation

The U.S. Food and Drug Administration (FDA) is tapping the UCSF School of Pharmacy and Stanford University to launch its first West Coast regulatory science center, focused on spurring innovation in the development and evaluation of safer and more effective medications.

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) has been formally launched with an initial FDA grant of $3.3 million.

The new Center will focus on improving the safety and efficacy of drug testing performed prior to human trials, improving clinical trials and evaluation, and using computational and bioinformatics approaches, known as quantitative pharmacology, to harness and dissect vast quantities of diverse data to accelerate and improve the development of new medicines. Such research and technologies will also support the FDA’s ability to assess new drug safety and efficacy.

“The pharmaceutical and biotech industries are facing huge challenges, with the majority of drugs failing in clinical trials because they are not effective,” said Kathy Giacomini, PhD, chair of the Department of Bioengineering and Therapeutic Sciences, a joint department of the UCSF Schools of Pharmacy and Medicine, and co-chair of the UCSF Center for Quantitative Pharmacology.

“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,” she noted. “This partnership will enable us to develop new models and methods, and also move these technologies out of academia and into practice.”

The new Center, co-led by Giacomini and Stanford faculty member Russ Altman, MD, PhD, will conduct collaborative research, offer a range of education and exchange programs for FDA and academic scientists, and also provide FDA internships for students and postdoctoral scholars.

“Our long-term expertise in quantitative science and pharmacology and our Pacific Rim location will both benefit the kinds of novel collaborations among academia, industry, and the FDA the CERSI enables,” said B. Joseph Guglielmo, PharmD, dean of the UCSF School of Pharmacy. “The end result will be better, more effective products for patients.”


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


School of Pharmacy, Department of Bioengineering and Therapeutic Sciences, PharmD Degree Program

About the School: The UCSF School of Pharmacy aims to solve the most pressing health care problems and strives to ensure that each patient receives the safest, most effective treatments. Our discoveries seed the development of novel therapies, and our researchers consistently lead the nation in NIH funding. The School’s doctor of pharmacy (PharmD) degree program, with its unique emphasis on scientific thinking, prepares students to be critical thinkers and leaders in their field.