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The Beyond Celiac Coalition

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Accelerating clinical trials in celiac disease by addressing major patient barriers

Coalition Objectives

  • Identify significant roadblocks to the diagnosis and treatment of celiac disease.
  • Address major patient barriers to accelerate clinical trials for celiac disease.

To that end, the goals of the coalition are as follows:

  • Increase and accelerate patient enrollment
  • Address the value of histology in clinical trial development
  • Standardize the gluten challenge
  • Expand clinical trials network
  • Validate prognostic and diagnostic biomarkers
  • Develop best practices to increase clinical trial diversity
  • Increase pediatric opportunities
  • Better utilize real-world evidence
  • Provide enhanced testing for non-celiac gluten sensitivity

Current Priorities and Progress

The Coalition’s unique composition and pre-competitive nature lends itself well to hosting a monthly meeting among stakeholders committed to accelerating a cure for celiac disease. Primary objectives for 2025-2026 are:

  • Clinical trial coordinator workshop in September 2025 to help better understand the barriers and challenges to clinical trial recruitment from the perspective of clinical trial coordinators.
  • FDA workshop in February 2026 to discuss celiac disease across the lifespan, and considerations for pediatric clinical trials.
  • Continue to work on other drug development priorities for celiac disease such as symptoms, histology, biomarkers and endpoints.

We are proud to report that in May of 2024 the Beyond Celiac Coalition had a collaborative meeting with the FDA to discuss approaches to making therapeutic trials for celiac disease more patient-centric while maintaining scientific rigor. Read more about our meeting with the FDA.



Since 2003, Beyond Celiac has been the leading patient advocacy and research-driven celiac disease organization working to drive diagnosis, advance research and accelerate the discovery of new treatments and a cure.

Beyond Celiac has brought together members of academia, key opinion leaders, government agencies, and pharmaceutical, biotech and diagnostic companies to identify and address significant roadblocks to the diagnosis and treatment of celiac disease.


Membership

There are various membership tiers in our Coalition structure, each offering varying benefits. The Beyond Celiac Coalition is operated and funded by annual membership dues, with projects funded from supplemental funds industry members provide. Participation in individual projects is offered to all members. Individual project costs, principally event venue, external support and/or travel for academic members are agreed upon and shared equally among all industry member organizations participating in those projects.

Member Benefits

  • Play a role in shaping best practices and accelerating celiac disease clinical trials
  • Gain knowledge and insights that will help advance business decisions
  • Leverage resources in a pre-competitive environment
  • Gain access to shared data
  • Contribute to celiac disease science and the expansion of the clinical trials network
  • Have the opportunity to work collaboratively, both in person and remotely, with other members of the Beyond Celiac Coalition
  • Receive frequent communications on the latest science/trends

Learn More and Join

To learn more about membership opportunities, contact our director of corporate partnerships Deanne Field at [email protected]

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