Partnership Aims to Improve How the Agency Evaluates New Therapies
The U.S. Food and Drug Administration has awarded the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) a five-year grant with up to $25 million in funding.
UCSF-Stanford CERSI brings together a world-class team of scientists from two outstanding academic institutions, with partners at the FDA, to spur new approaches and technology to enhance the FDA’s ability to evaluate and approve new medical products. The center also develops educational and research programs and fosters collaborations between scientists, faculty, students and postdoctoral researchers at the FDA, UC San Francisco and Stanford University.
The center is led by Kathy Giacomini, PhD, a professor of bioengineering and therapeutic sciences in the UCSF School of Pharmacy, and Russ Altman, MD, PhD, a professor of bioengineering, genetics and medicine at Stanford University. It was launched in 2014.
“This new funding is a strong vote of confidence from the FDA that we are on the right path in developing new models and methods for moving drugs and other medical products such as devices and cell-based therapies from the laboratory to clinical trials – not only more efficiently, but with greater confidence that they will be safe and effective,” Giacomini said.
The grant has four interrelated components – education, collaboration, research and core – that will accelerate training and research in regulatory science and advance the mission of the FDA to ensure public health.
CERSI-Education provides state-of-the-art training and educational programs for students, postdoctoral fellows, faculty and scientists in the industry and at the FDA. Educational programs include online courses in regulatory science, as well as student internships and postdoctoral fellowship programs with rotation in industry, FDA and at UCSF and Stanford.
CERSI-Collaborations sponsors public lectures and workshops with FDA scientists at both UCSF and Stanford. Scientists from the FDA give public lectures and participate in panel discussions while meeting with faculty and students.
CERSI-Research conducts research in regulatory science that is of importance to the FDA and that addresses key scientific issues in the development and approval of a range of medical products. New knowledge generated from the collaborative research helps the FDA in its regulatory decision-making.
CERSI-Core oversees and provides responsive management of the entire UCSF-Stanford CERSI.
“We aim to transform the way therapeutic products are developed and find better ways to assess them for safety,” Altman said. “This grant will enable us to take advantage of the latest in sophisticated computational methods and technologies to reach those goals more quickly and effectively.”
UC San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy; a graduate division with nationally renowned programs in basic, biomedical, translational and population sciences; and a preeminent biomedical research enterprise. It also includes UCSF Health, which comprises three top-ranked hospitals, UCSF Medical Center and UCSF Benioff Children’s Hospitals in San Francisco and Oakland, and other partner and affiliated hospitals and healthcare providers throughout the Bay Area.
Stanford University, located in the heart of California's Silicon Valley, is one of the world's leading teaching and research universities. It is known for its entrepreneurial character, drawn from the legacy of its founders, Jane and Leland Stanford, and its relationship to Silicon Valley. Areas of excellence range from the humanities to social sciences to engineering and the sciences. Stanford Medicine encompasses the Stanford School of Medicine, Stanford Health Care and the Lucile Packard Children's Hospital. This year, Stanford celebrates 125 years of impact in people’s lives and around the world. For more information, please visit www.stanford.edu.