$25 million awarded to center for study of regulatory science

The FDA is funding a collaboration between Stanford and UCSF to improve the regulatory infrastructure that helps to shape modern biomedical research.

Russ Altman

The Food and Drug Administration has awarded the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation a five-year, $25 million grant.

The collaborative venture is one of five FDA Centers of Excellence in Regulatory Science and Innovation intended to advance the science of regulation. New technologies in biomedical research require new approaches to evaluating safety and effectiveness.

The UCSF-Stanford center launched in 2014 with an initial $3.3 million grant from the FDA to develop projects that can help with regulating health care. For example, one project, headed by Russ Altman, MD, PhD, professor of bioengineering, of genetics of medicine and of biomedical data science at Stanford, uses natural language processing and machine learning to analyze the contents of enormous databases of adverse effects from drugs reported by patients and clinicians.

Altman and Kathy Giacomini, PhD, professor of bioengineering and therapeutic sciences in the UCSF School of Pharmacy, lead the center. Altman is also director of Stanford’s biomedical informatics training program.

The new $25 million grant supports research, collaboration and education. Researchers will use the grant to address how to regulate the development and approval of new medical products; provide public lectures, panel discussions and workshops on FDA regulations; and provide training in regulatory science.

About Stanford Medicine

Stanford Medicine is an integrated academic health system comprising the Stanford School of Medicine and adult and pediatric health care delivery systems. Together, they harness the full potential of biomedicine through collaborative research, education and clinical care for patients. For more information, please visit med.stanford.edu.

2023 ISSUE 3

Exploring ways AI is applied to health care