The Food and Drug Administration's (FDA) Division of Gastroenterology and Inborn Errors Products is pleased to announce the following Workshop:

Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) Workshop

The purpose of the GREAT workshop is to provide a forum to consider issues related to endpoints that can support drug development in the following disease areas:  Eosinophilic esophagitis, pediatric and adult inflammatory bowel disease, and parenteral nutrition-associated liver disease.

September 19, 20, 21, and 24, 2012
8:00 am to 5:00 pm (each day)
Holiday Inn
10000 Baltimore Ave.
College Park, MD 20740
Room Block:
For sleeping room reservations, please contact the hotel directly to secure their best available rate. We do not have a block of rooms set aside at the hotel for this workshop.
Telephone Access:
You may also participate in the GREAT Workshop by teleconference if you are unable to attend in person. The toll-free number will be 800-857-4143 and the passcode will be 2173985 each day.  Please note that the line will be listen-only and so callers will be unable to ask questions or make comments.

Who Should Attend?
Stakeholders, including industry sponsors, academia, and FDA, will be engaged to address challenging issues related to selection of endpoints and assessment methodologies in registration trials.  Facilitation of efficient drug development, in the context of these issues, will be discussed.

About the Workshop
Each day of the workshop will be devoted to a discussion of a single relevant disease area.  The goal of the September 19 workshop day dedicated to eosinophilic esophagitis (EoE) is to discuss its natural history, development of patient reported outcome (PRO) measures, and biomarkers that might be used to study new treatments for both children and adults. 

The goal of the September 20 workshop day dedicated to pediatric inflammatory bowel disease (IBD) is to discuss issues related to the extrapolation of efficacy data from adult to pediatric patients, the definition and measurement of treatment benefit, and dose-finding strategies in pediatric patients. 

The goal of the September 21 workshop day dedicated to adult IBD is to discuss the definition and measurement of efficacy in adult ulcerative colitis (UC) registration trials, including the timing of endpoint assessment and the roles of specific endpoints and measurement tools. 

The goal of the September 24 workshop day dedicated to parenteral nutrition-induced liver disease is to discuss endpoints and their measurement for clinical trials in which parenteral nutrition-induced liver disease is either an efficacy or safety outcome measure.

For program information, please contact:

Kevin Bugin, MS, RAC
Regulatory Project Manager
Division of Gastroenterology and Inborn Errors Products
For registration information, please contact:

Ann Brameyer

To Register, click here.