NFCA to Participate in the FDA-Organized GREAT 3 Workshop | BeyondCeliac.org
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NFCA to Participate in the FDA-Organized GREAT 3 Workshop

The National Foundation for Celiac Awareness (NFCA) joins other experts in the field for the U.S. Food and Drug Administration's (FDA) Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) 3 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. NFCA looks forward to sharing more information and news about GREAT 3 in the coming weeks and months, including what patients can do to join the ongoing conversation about celiac disease drug development and clinical trials

When: March 30-31, 2015

Where: FDA White Oak Campus
              10903 New Hampshire Ave.
              Building 1
              Silver Spring, MD 20993

For more information on this event, visit www.GREAT3.org.

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