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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 has identified two priority projects for 2023-2024.

The Coalition’s unique composition and pre-competitive nature lends itself well to hosting a bi-annual meeting among stakeholders committed to accelerating a cure for celiac disease. Primary objectives would be the following:

  • Focus on priority topics of drug development for celiac disease such as symptoms, histology, biomarkers, endpoints.
  • Highlight differences between approach to celiac vs. other chronic immune-mediated GI disorders (e.g., IBD). Engage with the FDA & NIH.
  • Determine best patient selection for trials.

We are proud to report that in May of 2024 the Beyond Celiac Coalition met with the FDA to discuss a collaborative approach 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.

Now, 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

Our Coalition structure includes an Executive Board to set the vision, strategic priorities and oversee the use of funds, plus a Steering Committee to provide recommendations on project priorities and plans. The Beyond Celiac Coalition is operated and funded by annual membership dues, with projects funded from supplemental funds members provide. Membership benefits include seats on the Executive Board and/or Steering Committee. Participation in project funding is based on the discretion of each potential project participant, with project funding opportunities offered to all members.

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

Contact Director of Corporate Partnerships Deanne Field at [email protected] to learn more about membership opportunities. 

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