Weave Bio Expands Strategic Advisory Board with Two Former FDA Leaders

Appointments add direct U.S. FDA experience in AI policy and regulatory science to the board as Weave scales its AI-native platform across the global regulatory lifecycle

SAN FRANCISCO--(BUSINESS WIRE)--Weave Bio, a leader in AI-native regulatory automation for drug development, today announced the expansion of its Strategic Advisory Board (SAB) with the appointment of two former U.S. Food and Drug Administration leaders, Tala Fakhouri, Ph.D., M.P.H. chief AI and regulatory strategy officer at Parexel, and Sean Khozin, M.D., M.P.H., chief executive officer of the CEO Roundtable on Cancer and Project Data Sphere. Their appointments give the company firsthand insight into how health authorities evaluate AI and modern evidence at a moment when regulatory expectations for the technology are actively being defined.

“Bringing AI into regulatory work responsibly takes people who have written the rules from the inside,” said Brandon Rice, co-founder and CEO of Weave Bio. “Tala and Sean have spent their careers shaping regulatory at the FDA, from AI policy to the modernization of clinical evidence. Their guidance will help ensure Weave is building technology the industry can trust, grounded in how regulators actually work.”

The appointments come as regulators are actively working to define how AI fits into drug development. On Jan. 7, 2025, the FDA published its first draft guidance on the use of AI to support regulatory decision-making for drug and biological products, and on Jan. 14, 2026, the FDA and EMA jointly issued guiding principles on good AI practice in drug development. Dr. Fakhouri and Dr. Khozin bring firsthand experience shaping those guidelines and a perspective that spans both sides of the regulatory relationship, from how health authorities evaluate AI in sponsor submissions to how agencies themselves could deploy the technology to modernize their own review processes.

New Strategic Advisory Board Members

Tala Fakhouri, Ph.D., M.P.H., is chief AI and regulatory strategy officer at Parexel, where she advises life sciences organizations on AI, digital policy, and real-world research. She joined Parexel from the FDA, where she served as associate director for Data Science and Artificial Intelligence in the Office of Medical Policy at CDER and led the agency’s AI policy work in drug development. During her FDA tenure, she led development of the first draft CDER guidance on AI, established the CDER AI Council, and led publication of the agency’s first real-world evidence guidance. Earlier in her career, she served as chief statistician for the CDC’s National Health and Nutrition Examination Survey and was appointed to the Federal Committee for Statistical Methodology in 2023. Dr. Fakhouri holds a Ph.D. in oncological sciences from the University of Utah and an M.P.H. from the Johns Hopkins Bloomberg School of Public Health. She completed a postdoctoral fellowship at Harvard University.

Sean Khozin, M.D., M.P.H., is chief executive officer of the CEO Roundtable on Cancer and Project Data Sphere, where he leads cross-industry initiatives to advance the use of data and technology to improve cancer outcomes. A founding member of the FDA’s Oncology Center of Excellence, he established and led INFORMED, the agency’s first data science and technology incubator, promoting the use of real-world data and AI in oncology drug development. Earlier in his career, he served as chief executive officer of CancerLinQ, ASCO’s precision oncology learning network, and as global head of data strategy at Johnson & Johnson. Dr. Khozin is a board-certified oncologist who completed fellowship training at the National Cancer Institute and holds an M.D. from the University of Maryland School of Medicine and an M.P.H. from George Washington University.

“The promise of AI in drug development rests on getting the regulatory foundation right,” said Dr. Fakhouri. “Weave is approaching that work with the rigor the field requires, combining deep regulatory expertise with AI to make submissions faster and more predictable. I look forward to helping guide where the platform goes next.”

“The pace of modern science calls for a new kind of regulatory record,” said Dr. Khozin. “Weave is helping move the field toward living regulatory records that stay current as programs evolve, and I am glad to help guide that work.”

The new members join Weave’s Strategic Advisory Board, formed in March 2026. Founding members of the board include Andrew Robertson, vice president and head of global regulatory policy and innovation at Takeda; Vada Perkins, vice president and global head of regulatory intelligence and policy at Boehringer Ingelheim; Chris Lee, vice president of regulatory affairs innovation and strategic operations at Gilead Sciences; Russ Altman, Kenneth Fong Professor of Bioengineering, Genetics, Medicine, and Biomedical Data Science and senior fellow at the Stanford Institute for Human-Centered AI; and Stewart Hen, managing partner at Serrado Capital.

About Weave Bio

Weave Bio is an AI-native regulatory automation software company transforming how novel therapies navigate the complex path from lab to market. The Weave platform streamlines regulatory content preparation and lifecycle management for pharmaceutical companies, biotech firms, CROs, and regulatory consultants by infusing AI into every step of the workflow, from data extraction and authoring to review and verification, yielding compliant, submission-ready regulatory dossiers with unprecedented speed.

Founded in 2022 and headquartered in San Francisco, Weave is backed by leading investors including USVP, Innovation Endeavors, Magnetic Ventures, Character, TMV, and Serrado Capital, and trusted by innovative biopharma companies worldwide.

For more information, visit weave.bio and follow us on LinkedIn.