This Week – September 21, 2012

This Week in Washington DC:

  1. ACG Representatives Participate in FDA Public Workshop
  2. Exciting Workshops Scheduled for the 2012 ACG Annual Meeting

FDA Hosts Public Workshop to Discuss Clinical Trial Design and Endpoints in Gastroenterology
This week the Food and Drug Administration (FDA) hosted a public workshop entitled “Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT).” The agency and expert panel reviewed the medical literature and discussed the benefits and risks associated with various clinical trial endpoints in esinophilic esophagitis (EoE) and inflammatory bowel disease IBD (adult and pediatric). The agency will hold a similar session on parenteral associated liver disease next week.

The FDA reached out to ACG for assistance in providing experts for the GREAT Workshop. ACG was pleased to be represented by three clinical experts, including two experts selected to moderate the IBD panels: Marla Dubinsky, MD and Steven Hanauer, MD, FACG. Drs. Dubinsky and Hanauer sat on the pediatric and adult IBD panels respectively and provided the perspective of the GI clinician. ACG Past-President Joel Richter, MD, MACG was also selected to help develop the agenda for the EoE session. ACG would like to thank Drs. Dubinsky, Hanauer, and Richter for taking time out of their schedules and participating in this workshop. We appreciate your efforts to help advance treatment therapies for clinicians and patients.  

Click here to access the agenda and slides from the FDA GREAT Workshop.

ACG hopes to continue this collaborative relationship with the FDA and be the agency’s resource for clinical gastroenterology.

Upcoming Workshops at the 2012 ACG Annual Meeting
ACG is excited to announce two upcoming workshops as part of the 2012 ACG Annual Meeting.

Please join the ACG and the FDA for discussion on EoE treatment and endpoints when designing clinical trials. This workshop is scheduled for October 22nd and is open to all ACG meeting attendees. The ACG and FDA held a similar joint-workshop on IBD and mucosal healing as part of the ACG Annual Meeting in October 2011. 

Click here to view the slides from the ACG-FDA IBD Workshop.

ACG will also host a session on Hepatitis C screening together with the Centers for Disease Control (CDC). This workshop will include a review of CDC’s recently published hepatitis C screening guidelines ( as well as an open-forum discussion to glean the clinician’s perspective. This session is also scheduled for October 22nd and is open to all ACG meeting attendees. 

Please look for more information on these upcoming workshops in the 2012 ACG Annual Meeting marketing material and other announcements.

Please stay tuned for further updates. Please also share and discuss your thoughts with fellow ACG members on the ACG GI Circle. To login and share your comments, go to and sign in as a member. Once you have done so, click here and then click the orange "Visit ACG GI Circle" button to be taken to the GI Circle site. If you have not yet activated your ACG GI Circle account, please email us at

Contact Brad Conway, VP Public Policy, with any questions or for more information.

Brad Conway