The Beyond Celiac Coalition recently convened with the FDA to address barriers in pediatric clinical trials for celiac disease.
PHILADELPHIA, PA, UNITED STATES, July 28, 2026 /EINPresswire.com/ — The Beyond Celiac Coalition is a collaboration of multidisciplinary stakeholders working to develop potential treatments for celiac disease. The coalition recently participated in a multi-stakeholder meeting with the FDA, pediatric celiac disease patients and their parents to discuss a collaborative and patient-centric approach to developing pediatric therapeutic trials for celiac disease.
Participating in clinical trials is necessary to accelerate research for treatment breakthroughs and efforts to find a cure. Pediatric clinical trials have not yet been conducted in celiac disease. This multi-stakeholder meeting began the conversation about what pediatric trials might look like, and what pediatric patients with celiac disease and their parents might consider acceptable in a trial. Adult celiac disease studies can struggle to enroll participants because most require procedures or activities that many patients consider invasive or debilitating.
“It is essential for the FDA and all stakeholders involved in celiac disease trials to hear directly from the patient community, especially when considering pediatric clinical trials. Their experiences and perspectives ensure that clinical trial designs align with real-life needs and challenges,” said Kate Avery, MPH, Senior Director of Science with Beyond Celiac.
This meeting marked a significant step forward in bringing together key voices to shape the future of pediatric celiac disease research.
“As we advance clinical research for celiac disease, it’s critical that we begin discussing the unique needs of pediatric trials. Eventually, therapies that aim to serve all patients will need a pediatric trial. Proactively addressing these considerations now will ensure that children are not left behind as new treatments are developed,” said Debra Silberg, MD, PhD, Chief Scientific Officer at Beyond Celiac.
This was the second time the Beyond Celiac Coalition convened all stakeholders, including patients, and FDA representatives to discuss the seriousness of celiac disease and the goals for therapies. The coalition brings together members of the pharmaceutical and biotech industries, academic researchers and clinicians, and gastrointestinal professional societies. Their purpose is to identify and address barriers to developing treatments for celiac disease.
The Coalition is led by Beyond Celiac and includes patient organizations, academic and clinical celiac disease specialists, and professional societies, including the American Gastroenterological Association (AGA), the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN), The American College of Gastroenterology (ACG), and the International Society for the Study of Celiac Disease (ISSCD).
Academic and clinician members include: Imad Absah, MD; Robert Anderson, MBChB BMedSc PhD; Amanda Cartee, MD; Shayna Coburn, PhD; Lisa Fahey, MD; Edwin Liu, MD; Stephanie Moleski, MD; Joseph A. Murray, MD; Marie Robert, MD; Jocelyn Silvester, MD, PhD; Marisa Stahl, MD; and Adam C. Stein, MD. The industry members are First Tracks Bio, Chugai Pharmaceutical Co., Sanofi, Takeda, Alimentiv Inc, Eli Lilly, and Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd.
About Beyond Celiac
Founded in 2003, Beyond Celiac is the leading catalyst for a celiac disease cure in the United States. The organization serves as a patient advocacy and research-driven group committed to driving diagnosis and accelerating the discovery of new treatments. By engaging with top scientists, making the right investments, and supporting people with celiac disease and gluten sensitivity, Beyond Celiac envisions a world where people can live healthy lives and eat without fear—a world Beyond Celiac. Learn more at BeyondCeliac.org.
Ashley Berg
Beyond Celiac
aberg@beyondceliac.org
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