UCSF-Stanford CERSI hosts summit of regulatory science leaders

By Levi Gadye / Wed Jan 25, 2023

Giacomini, Hartman, and Gupton sit in front of microphones on a conference stage

Dan Hartman, MD (center), speaks during a panel on global regulation of medical products at the 2023 CERSI Summit, along with Kathy Giacomini, PhD, BSPharm (left) and Frank Gupton, PhD (right).

On January 8, 2023, leaders from academia, the U.S. Food and Drug Administration (FDA), and industry gathered for the fourth annual Centers of Excellence in Regulatory Science and Innovation (CERSI) Summit, hosted by the UCSF-Stanford CERSI, to grapple with ongoing challenges in health care and regulatory science.

“Cooperation between players like UCSF and Stanford, FDA, and private industry is the key for ensuring that the safest and most effective therapies make their way to patients,” said Kathy Giacomini, PhD, BSPharm, co-principal investigator of UCSF-Stanford CERSI and dean of the UCSF School of Pharmacy. “These summits are crucial for the field to stay on top of current issues in regulation and proactively address future ones.”

Sam Hawgood, MBBS, chancellor of UCSF, delivered opening remarks, and FDA Commissioner Robert Califf, MD, provided a year in review to kick off the event. Over the course of several moderated panels and a networking and poster session, innovators and regulators then shared successes, struggles, and new ideas made in pursuit of better regulation of medical product development.

In addition to discussions on misinformation, diversity in clinical trials, and improving the use of evidence in regulatory decision making in the U.S., the summit also addressed the impact of regulation on global health, including how countries like Nigeria look toward the FDA for inspiration in developing their own strategies for effective health care regulation.

“The theme of this meeting was really collaboration,” said Janet Woodcock, MD, principal deputy commissioner of the FDA, in closing. “This really showed the entire circle of folks who need to be involved to bring the advances of science to the health of people around the world.”

CERSI Summit: Wider use of real-world evidence continues to face hurdles (Regulatory Focus)

Califf, past FDA chiefs look for partners to curb misinformation (Regulatory Focus)

Clinical trial diversity, long an issue in drug development, gets legislative mandate (San Francisco Business Times)

Strong regulatory system guarantees access to safe medicines – NAFDAC (The Sun Nigeria)