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  4. Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshop on Eosinophilic Gastrointestinal Disorders Beyond EoE - 07/21/2021 - 07/21/2021
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Workshop | Virtual

Event Title
Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshop on Eosinophilic Gastrointestinal Disorders Beyond EoE
July 21, 2021

Date:
July 21, 2021

Workshop Summary

The goal of the GREAT VI workshop is to discuss disease characteristics, natural history, and endpoints to assess treatment benefit in patients with eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis and provide a forum for open discussion between stakeholders to facilitate drug development in these disorders.

About the Workshop

FDA is announcing a public workshop for eosinophilic gastrointestinal disorders. Discussions will focus on eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis and include the following topic areas:

  • The diagnosis and natural history of eosinophilic gastrointestinal disorders
  • Assessing clinical benefit in eosinophilic gastrointestinal disorders

Event Registration

To participate in the virtual workshop, please register by July 21, 2021 at https://www.eventbrite.com/e/145496486909

Meeting Materials

A full agenda will be available one week before the workshop.

Topic: Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (Great VI): Workshop on Eosinophilic Gastrointestinal Disorders Beyond EoE

Date: Jul 21, 2021 09:00 AM Eastern Time (US and Canada)

Meeting Recording:

Access Passcode: =xj6PaJE

Disclaimer: Please note that the closed-captions for this meeting were auto-generated and may include errors. Please view the full transcript report if you experience closed-caption discrepancies. 

Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI):
Workshop on Eosinophilic Gastrointestinal Disorders Beyond EoE (PDF - 14.17MB)

Topics

Diagnosis and Natural History of EGID

  • EGID pathogenesis and nomenclature
  • Histopathologic characteristics of EGID: a pathologist’s perspective
  • Clinical signs, symptoms, and natural history of EGID
  • Alternative etiologies for gastrointestinal mucosal eosinophilia

Assessing Clinical Benefit in EGID

  • Living with EGID and goals of treatment: a patient perspective
  • Defining treatment benefit in clinical trials for EGID: FDA perspective
  • Clinician perspective on the assessment of meaningful benefit

Contact

For any addition questions or concerns please contact DG Workshops at DGWorkshops@fda.hhs.gov.

 

 

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