UCSF-Stanford CERSI Hosts 2024 Summit of Regulatory Science Leaders

Nathan Dang

On January 7, 2024, leaders from academia, the U.S. Food and Drug Administration (FDA), and industry gathered for the fifth annual Innovations in Regulatory Science Summit, hosted by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), to address pressing issues and foster meaningful dialogue about the role of regulatory science in medical product development.

Held at UCSF’s Mission Bay Conference Center, the summit was UCSF-Stanford CERSI’s largest in-person meeting yet, showcasing the School’s commitment to advancing innovation and collaboration in the dynamic field of regulatory science with discussion about medical misinformation and its impact on public health, variations in regulatory decision-making among different countries, and the manufacturing and supply chain of medical products.

The FDA Chiefs Chat panel featuring past and present FDA commissioners was once again a crowd favorite among the more than 350 attendees, and the introduction of a new panel brought together three FDA center directors, moderated by FDA Chief Scientist Namandjé Bumpus, PhD. Lively debates covered topics such as direct-to-consumer advertising and the role of FDA advisory committees.

Nathan Dang

FDA Commissioner Robert Califf, MD

A highlight of the daylong event was the FDA Year in Review remarks delivered by FDA Commissioner Robert Califf, MD, in which he offered a comprehensive overview of the agency’s priorities and challenges for the year ahead.

Reflecting on the past year, Califf emphasized the importance of ensuring evidence-based decision-making in regulatory processes. He spoke about leadership changes at the FDA, including the retirement of Principal Deputy Commissioner Janet Woodcock, MD, and about the agency’s subsequent reorganization.

Califf said it was important to leverage synergies across different FDA segments while respecting the unique mandates of each area.

“The work that needs to be done in the leadership at FDA is how to have a more coherent, cohesive FDA,” he said. “But we also have to maintain the differences that are necessary because the laws that govern the different parts of the FDA have significant differences.”

Holly Ly

The FDA Chiefs Chat panel featured past and present FDA commissioners.

Detailing the FDA’s priorities, Califf outlined key areas of focus that included tobacco regulation, food safety, and the development of low-cost medical products. He emphasized the agency’s commitment to addressing emerging challenges, such as misinformation, artificial intelligence (AI), and the need for evidence generation in the post-market arena.

His remarks around the critical role of regulatory agencies in safeguarding public health and promoting innovation in health care also resonated deeply with attendees, underscoring the goal of meetings like the summit––bringing stakeholders together.

“The amazing thing to me about the FDA is, no matter how small an issue is relative to the totality of FDA, there is a constituency for which that issue is everything,” he said. “So when we make our list of priorities, we’re well aware of that.”