The UCSF School of Pharmacy, through its partnership with Stanford University as the UCSF–Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), convened more than 1,000 leaders from the U.S. Food and Drug Administration (FDA), academia, and industry for the 7th Annual Innovations in Regulatory Science Summit on Jan. 11, 2026.

Held as a hybrid event at Robertson Auditorium at the UCSF Mission Bay Conference Center, the summit focused on how regulatory science must evolve to keep pace with rapid advances in biomedicine and technology. Panels addressed artificial intelligence, early clinical endpoints, biosimilars, FDA leadership, and biopharma strategy, alongside two structured debates designed to surface competing perspectives on some of the field’s most consequential issues.

Hosted annually by the UCSF–Stanford CERSI, the summit aims to stimulate cross-sector dialogue and identify scientific and regulatory priorities essential to advancing the safe and timely development, approval, and monitoring of medical products.

A Full Agenda Reflecting Regulatory Science in Action

Summit sessions included a lightning talk on AI for regulatory efficiency, followed by a panel examining how AI and emerging technologies could help address persistent barriers to drug development and approval.

Additional sessions explored alternatives to animal testing, AI-driven preclinical discovery, and robust early endpoints for chronic disease prevention. An afternoon FDA Leaders Forum brought together senior FDA officials to discuss evolving priorities across drugs, biologics, devices, and food regulation.

Later, former FDA Commissioner Robert Califf, MD, joined a debate on whether biosimilars should be approved based on analytical equivalence and real-world evidence, reinforcing how closely scientific evidence and policy remain intertwined. The day concluded with a forward-looking panel on biopharma innovation at a global crossroads, examining how science, strategy, and global forces are reshaping the industry.

A Defining Moment in a Shifting Regulatory Landscape

The urgency of that mission was underscored during the early endpoints session, when Richard “Rick” Pazdur, MD, former director of the FDA’s Oncology Center of Excellence, received a standing ovation from the audience.

Pazdur’s appearance marked his first public remarks since resigning last month after more than 26 years at the FDA, amid a broader agency shakeup and reports of interference in drug and personnel decisions. His presence lent particular weight to a candid discussion about how regulators and researchers can accelerate access to effective therapies without compromising evidentiary standards.

The panel, co-chaired by Laura Esserman, MD, MBA, UCSF professor of surgery and radiology, and Jane Perlmutter, PhD, MBA, founder and president of Gemini Group, was widely cited by attendees as a highlight of the summit.

Setting the Tone: Leadership and Regulatory Purpose

The summit opened with welcome remarks from UCSF School of Pharmacy Dean Kathy Giacomini, PhD, BSPharm, and Kuldev Singh, MD, MPH, professor of ophthalmology at Stanford University, followed by opening remarks from UCSF Chancellor Sam Hawgood, MBBS, and Stanford School of Medicine Dean Lloyd Minor, MD.

In her keynote presentation, “Innovative Research in Regulatory Science,” Giacomini emphasized that regulatory science is inherently purpose-built — focused on generating the tools, methods, and standards regulators need to make sound decisions that protect patients while enabling innovation.

“CERSI shows what’s possible when regulatory science is embedded in academic excellence,” Giacomini said. “These partnerships generate rigorous, policy-relevant evidence that helps the FDA make better decisions — faster and with greater confidence.”

She pointed to the FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSI) program as a uniquely effective model for embedding academic expertise directly into the regulatory process.

“When universities, regulators, and industry work together through frameworks like CERSI, we can move promising therapies to patients more efficiently, more safely, and with greater public trust,” Giacomini said. “That alignment of science and regulatory purpose is essential to public health.”

UCSF–Stanford CERSI: Impact at Scale

Established in 2014, the UCSF–Stanford CERSI is the only FDA-funded CERSI on the West Coast, strategically positioned at the hub of the nation’s pharmaceutical and technology sectors. Since 2015, the center has received $35 million in FDA funding, supporting 83 collaborative research projects, including 18 currently active studies conducted in close partnership with FDA scientists.

These collaborations have produced more than 100 peer-reviewed manuscripts and informed FDA guidance documents, review tools, and regulatory frameworks. UCSF–Stanford CERSI research has advanced safer gene therapies through improved assessment of CRISPR off-target effects, strengthened drug safety by identifying methods to reduce carcinogenic impurities, and enhanced post-market surveillance using real-world data.

Regulatory Science as a Public Good

Across sessions, speakers returned to a shared conclusion: Sustained investment in the FDA CERSI program is essential to maintaining U.S. leadership in regulatory science. Nationwide, the five FDA-funded CERSIs represent a critical federal investment that has already delivered measurable gains in patient safety, innovation, and public trust.