FDA Public Workshop on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT3), March 30-31, 2015

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Watch and Hear The FDA GREAT3  Public Workshop Live!

Webcast

Logon to  https://collaboration.fda.gov/greatworkshop/ – both visual and audio will be provided via the webcast *

  • When: March 31, 2015
  • Where: Your computer
  • Time: 8am – 4:30pm EST

Phone

  • Call In number 301-796-7777
  • Meeting ID: 665127
  • Passcode: 12345

*Remote users participating in the webcast do NOT need to call in to the phone line for audio access.

Celiac Disease Foundation is pleased to announce the March 30-31, 2015, U.S. Food and Drug Administration (FDA)  public workshop on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT3). This scientific meeting will address endpoints and outcome measures for clinical trials for products intended to treat adult and/or pediatric celiac disease and inflammatory bowel disease.

Co-sponsors include the North American Society for the Study of Celiac Disease (NASSCD), the American College of Gastroenterology (ACG), the American Gastroenterological Association (AGA), the Crohn’s and Colitis Foundation of America, Inc (CCFA), the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN), and the Pediatric IBD Foundation.

CDF Medical Advisory Board Members Drs. Sheila Crowe, Alessio Fasano, Peter Green, Stefano Guandalini, Ivor Hill, Joseph Murray, and Daniel Leffler will present on the identification of target populations, what is a meaningful clinical benefit and how that benefit can be measured.  CDF’s Chief Executive Officer, Marilyn Geller, serves on the GREAT3 Workshop Steering Committee.

This landmark meeting is a milestone for the celiac disease field. It represents the significant progress that scientists, physicians, the pharmaceutical industry, and the government are making towards improved treatment options beyond the gluten-free diet. GREAT3 is an important and critical step that will support both current and future scientific studies and clinical trials designed to advance celiac disease research and provide celiac disease patients with alternative therapeutic solutions to a strict gluten-free diet.

CDF and its Medical Advisory Board remain committed to supporting the development of treatments for celiac disease beyond the gluten-free diet. To receive alerts about GREAT3 news, including what you can do to support research, sign up now.

Those with a scientific interest in celiac disease treatment development are invited to attend.

By tuning into the GREAT3 Workshop, you are remaining informed, educated, and actively involved with the latest research surrounding celiac disease. It is only through patient engagement and participation that research can advance and pharmaceuticals can be studied. We appreciate your involvement and encourage you to stay up-to-date on celiac disease news by signing up for our email list.

 View the Agenda

FDA Public Workshop on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT3), March 30-31, 2015.

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