Thank you to the many clinical partners who attended our town hall update on September 19^th.  As promised, below is a summary of key points raised during the meeting.

Updates from OpenBiome

• In early August, the FDA conducted inspections of OpenBiome and the University of Minnesota (UMN), which manufactures investigational FMT for OpenBiome. At the conclusion of the inspection, NO safety or quality issues were identified. Still, the University opted to pause manufacturing and suspend distribution to OpenBiome until we had a new IND or written permission from the FDA to resume. We projected that we would run out of investigational FMT to ship toward the end of September and alerted our network of the suspension.
• Knowing that this suspension could have dire consequences for severe, fulminant and pediatric patients, we asked that the FDA allow us to continue distributing UMN-manufactured investigational FMT while we work toward an IND submission.
• On September 19^th, in the interest of patient care, the FDA responded, allowing OpenBiome to continue distributing investigational FMT manufactured by the University of Minnesota through October 31^st while we accelerate the submission of our IND in the same timeframe.
• As a result of this response, UMN agreed to restart manufacturing and distribution to OpenBiome through the end of October.

Clinical Resources

• Dr. Colleen Kelly (Brigham and Women’s Hospital) and Dr. Stacy Kahn (Boston Children’s Hospital) discussed the continuing gap in treatment access for pediatric and severe/fulminant C. difficile infection. Guidelines for FMT treatment use in these populations include the AGA FMT guidelines and the NASPGHAN FMT guidelines.
• Both physicians discussed alternatives to FMT for fulminant/severe disease and pediatric cases from stool banks, including locally screening donor material, Single-Patient IND applications (emergency and non-emergency), and the use of commercially available FMT products.
• Due to the lack of information on these approaches, Dr. Kelly has kindly offered to share her slides from the talk, current protocols, and other resources that may be helpful. She can be reached at: ckelly42@bwh.harvard.edu.