Dr. Lee will expand the scope and impact of the organization’s regulatory consulting for drug developers, from trial design through potential approval.
PHILADELPHIA, PA, UNITED STATES, February 24, 2026 /EINPresswire.com/ — Beyond Celiac, the leading force driving toward a cure for celiac disease in the U.S., announced today that Jessica J. Lee, MD, MMSc, former FDA Division Director of Gastroenterology, will join as Chief Regulatory Officer on March 2, 2026. Dr. Lee’s expertise will further strengthen the organization’s efforts to develop effective treatments toward a cure for celiac disease.
“Dr. Lee’s experience gives Beyond Celiac and the broader celiac community access to unparalleled expertise in drug development,” said Jordan Dubow, MD, Chief Medical Officer of Beyond Celiac. “She understands how clinical trials are designed, how endpoints are evaluated, and how regulatory decisions are made. Her leadership will strengthen our ability to guide companies toward efficient, patient-centered development programs and ultimately bring safe and effective treatments to people living with celiac disease.”
During her 14-year tenure at the FDA’s Center for Drug Evaluation and Research, Dr. Lee oversaw the review of investigational and approved therapies across a wide range of gastrointestinal diseases, including celiac disease. She also supervised the development of the FDA’s 2022 guidance document, Celiac Disease: Developing Adjunctive Treatment to a Gluten-Free Diet, intended to facilitate drug development in the field.
As Division Director, Dr. Lee served as signatory authority on numerous Investigational New Drug applications, New Drug Applications, and Biologics License Applications. She led multidisciplinary teams responsible for evaluating safety and efficacy data. Dr. Lee also helped advance stakeholder engagement initiatives designed to promote drug development in celiac disease and related gastrointestinal disorders.
As Chief Regulatory Officer, Dr. Lee will work closely with Beyond Celiac Chief Scientific Officer, Debra Silberg, MD, PhD, FACG, and Jordan Dubow, MD, Chief Medical Officer. She will be instrumental in expanding the scope and impact of Beyond Celiac’s regulatory consulting for companies developing celiac therapies. Her FDA experience will strategically position Beyond Celiac as a top partner for drug developers from trial design through potential approval.
Additionally, Dr. Lee will be an active member of the Beyond Celiac pre-competitive coalition, participate in due diligence for Beyond Celiac Investments, and serve as a regulatory expert supporting the mission to bring treatments toward a cure.
“I have dedicated my career to advancing therapies for gastrointestinal diseases and to strengthening the bridge between science, regulation, and patient need,” said Dr. Lee. “I am honored to join Beyond Celiac and to help accelerate the development of safe and effective treatments for the celiac disease community.”
Dr. Lee is board-certified in pediatric gastroenterology and nutrition and previously held clinical and academic roles at Boston Children’s Hospital and Harvard Medical School.
Dr. Lee’s appointment is a key step in the organization’s mission to ignite innovation in drug development and be the go-to scientific partner for industry, regulators, researchers, and patients.
About Beyond Celiac
Founded in 2003, Beyond Celiac is the leading science-based catalyst for a celiac disease cure in the United States, serving as a patient advocacy and research-driven organization working to drive diagnosis and accelerate the discovery of new treatments. By engaging with the top scientists in the field, making the right investments in research, supporting the broad community of those with celiac disease and gluten sensitivity, and investing in the most promising treatments, Beyond Celiac envisions a world in which people can live healthy lives and eat without fear – a world Beyond Celiac. BeyondCeliac.org
Angela Crist
Beyond Celiac
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