U.S. Food and Drug Administration (FDA)’s Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) 3 Workshop
Update!Do you want to hear Workshop presentations firsthand? You can! Remote access to the GREAT3 Workshop will be available via telephone or webcast.
About the GREAT3 Workshop
The National Foundation for Celiac Awareness (NFCA) is excited to announce the Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) 3 Workshop organized by the U.S. Food and Drug Administration (FDA), in co-sponsorship with 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), the Pediatric IBD Foundation and the North American Society for the Study of Celiac Disease (NASSCD).
The purpose of this workshop is to provide a scientific and technical forum to consider issues related to the selection of endpoints and clinical outcome measures appropriate for drug development in the following disease areas: inflammatory bowel diseases and celiac disease. NFCA’s President and CEO Alice Bast is honored to serve on the Workshop’s Steering Committee and will represent patients with celiac disease as the Workshop’s FDA Patient Representative. Alice will speak about the patient’s experiences with and expectations of celiac disease treatment.
GREAT 3 is a scientific meeting that will discuss issues related to the selection of endpoints and clinical outcome measures appropriate for drug development in celiac disease and inflammatory bowel diseases (IBD). Stakeholders, including industry sponsors, academia, patients and FDA, will address challenging issues related to selection of endpoints and assessment methodologies in clinical trials intended to support approval of products for treatment of inflammatory bowel diseases and celiac disease.
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. GREAT 3 is an important and essential 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.
Moving forward, NFCA is committed to supporting the development of improved treatments that overcome the challenges and inherent flaws of adhering to the gluten-free diet and our participation in GREAT 3 will be key to future success
When: March 30-31, 2015
Where: FDA White Oak Campus
For more information on this event, visit www.GREAT3.org.
Following the GREAT 3 Workshop, NFCA will be hosting a free webinar, “The Future of Drug Therapy for Celiac Disease: Get the Honest Facts.” Learn more and register here.
Note: Beyond Celiac provides information on gluten-free events as a service to the community. Please note that Beyond Celiac cannot assure the event participant or restaurant patron of the gluten-free practices or knowledge of the restaurants cited if they have not completed the Beyond Celiac GREAT Kitchens program, which provides accredited gluten-free training to restaurants and other foodservice providers. Please call the venue directly to learn more about their preparation processes.