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.
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.
For program information, please contact:
Kevin Bugin, MS, RAC
Regulatory Project Manager
Division of Gastroenterology and Inborn Errors Products
For registration information, please contact:
To Register, click here.