UCSF-Stanford CERSI Hosts Summit to Advance Regulatory Science and Health Care Innovation

Leaders from the academic, industry and regulatory sectors engaged in thoughtful dialogue and addressed critical issues in regulatory science, health care and the development of medical products at the sixth annual UCSF-Stanford Centers of Excellence in Regulatory Science and Innovation (CERSI) Summit on Jan. 12, 2025.

With the largest in-person attendance since its launch in 2019, this year’s CERSI Summit at the UCSF Mission Bay Conference Center featured moderated panels and lively debates on complex issues such as Food and Drug Administration (FDA) transparency in reporting sponsor-level decisions, firewalls between regulatory policy and drug costs, and what the FDA needs to improve what people eat. A particular focus this year was generative AI and women’s health.

UCSF School of Pharmacy Dean Kathy Giacomini, PhD, BSPharm, and Kuldev Singh, MD, MPH, professor at Stanford University, welcomed attendees while UCSF Chancellor Sam Hawgood, MBBS, and Lloyd Minor, MD, dean of the Stanford University School of Medicine, delivered opening remarks. FDA Commissioner Robert Califf, MD, provided a year in review to kick off the event.

Holly Ly

Attendees listen to panel discussions at the CERSI Summit. 

During a special panel session in the morning, experts discussed how they have used generative AI, including how to speed FDA submissions so that drug therapies reach patients sooner. They also discussed risks and opportunities for the use of AI. 

The second panel focused on how to tackle barriers to improving women’s health. The panel agreed that addressing the issue requires: combating misinformation through data and studies led by universities; the FDA and the National Institutes of Health; building broad coalitions comprised of individuals with different perspectives; exploring the use of secondary endpoints in clinical trials; ensuring experts are empowered to speak up rather than be silent; and enlisting the philanthropic sector to help catalyze a conversation about a new women’s health initiative.

During the FDA Chiefs Chat, which is a perennial favorite of the summit, current and former commissioners discussed the future as a new United States presidential administration arrives on Capitol Hill. A collaborative working relationship between the incoming FDA commissioner and the FDA staff will ensure the agency’s continued success, Califf said.

He also stressed the importance of evidence-based decision making.

“Be relentless on the focus on evidence,” Califf said. “Our ability to analyze data independently at the FDA is a huge asset.”

The panel, which included former FDA Principal Deputy Commissioner Janet Woodcock, MD, and past commissioners Scott Gottlieb, MD, and Mark McClellan, MD, PhD, noted the opportunities that lie ahead.

“We have tremendous changes in science and technology: gene editing, AI-enabled molecular design, precision medicine. The debates about nutrition are because the science of nutrition is starting to come together,” Woodcock said. “It’s always salutary when you start something, to look at the big picture. What is changing in the environment and what needs to change in response? What do we want? What are our objectives?”

The summit drew more than 500 in-person attendees, plus about 840 online participants.

The UCSF-Stanford CERSI is part of a network of five centers that are funded by the FDA to foster robust, innovative approaches to advance regulatory science through research, education and scientific exchange. The partnership also engages with foundations and industry interested in the development of FDA-approved medical products.

Summit sponsors included biotechnology and pharmaceutical companies Merck, Intuitive, Takeda, Gilead and Lilly.