Mobile menu
Home » Beyond Celiac Coalition and FDA Discuss Major Patient Barriers to Accelerate Clinical Trials for Celiac Disease

Beyond Celiac Coalition and FDA Discuss Major Patient Barriers to Accelerate Clinical Trials for Celiac Disease

July 2, 2024

PHILADELPHIA (July 2, 2024) – The Beyond Celiac Coalition, a precompetitive partnership of multidisciplinary stakeholders involved in the development of potential treatments for celiac disease, met recently with the FDA to discuss a collaborative approach to making therapeutic trials for celiac disease more patient-centric while maintaining scientific rigor.

Participating in clinical trials is necessary to accelerate research for treatment breakthroughs and a cure. Yet clinical trials for celiac disease often struggle because currently most studies require participants to undergo procedures or activities deemed too invasive or debilitating by many patients.

“This was a pivotal meeting because key stakeholders heard directly from people living with celiac disease about how the disease and the gluten-free diet affect their quality of life,” Alice Bast, Founder and CEO of Beyond Celiac, says.

Another key discussion point was about the use of gluten in clinical trials. “It will be difficult to get a drug approved without introducing patients to gluten in clinical trials. However, we recognize that this is a burden for clinical trial participants. There is no one right way to use gluten in clinical trials. It was educational for everyone to hear many perspectives on this topic,” said Debra Silberg, MD, PhD, Chief Scientific Officer at Beyond Celiac.

This was the first time the Beyond Celiac Coalition convened all stakeholders including patients to meet with FDA representatives to discuss the seriousness of celiac disease and the goals for therapies. The purpose of the Beyond Celiac Coalition is to bring together members from the pharmaceutical and biotech industry; academic researchers and clinicians; and gastrointestinal professional societies to identify and address significant barriers to developing treatments for celiac disease.

Beyond Celiac Coalition patient organization and professional society members include the American Gastroenterological Association, Beyond Celiac and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). Academic and clinician members include Robert P. Anderson, MD; Lisa Fahey, MD; Edwin Liu, MD; Joseph A. Murray, MD; Marie Robert, MD; Jocelyn Silvester, MD, PhD; Marisa Stahl, MD, and Adam C. Stein, MD. The industry members are Anokion, Chugai Pharmaceutical Co, Sanofi, Takeda Pharmaceuticals and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.

Although celiac disease is a common disease with a significant unmet need, there is no medical treatment or cure. Following a strict gluten-free diet is the only way the 3.2 million Americans with celiac disease can control it. However, many people get inadvertent exposure to gluten even if they are very careful. “If more Americans understood how dangerous gluten can be for a person with celiac disease, it would be a big step forward for those with celiac disease to be able to eat without fear of unknowingly eating gluten,” Bast adds.

About Beyond Celiac

Founded in 2003, Beyond Celiac is the leading 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 and supporting the broad community of those with celiac disease and gluten sensitivity, Beyond Celiac envisions a world in which people can live healthy lives and eat without fear – a world Beyond Celiac.


Think you may have celiac disease?

Symptoms Checklist