$25 million awarded to center for study of regulatory science

Russ Altman
Russ Altman, photo by Rod Searcey

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

The FDA 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, professor of bioengineering, of genetics, of medicine and of biomedical data science, 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, 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.