OpenBiome

Aligned with current fda policy, Openbiome remains committed to ensuring that all patients suffering from c. difficile infection continue to have safe, convenient, and affordable access to fecal microbiota transplantation (fmt) through their physician. In our collaboration with the university of Minnesota (umn), under an active investigational drug application (ind), we continue to distribute fmt to our clinical network and are working with fda to ensure that all regulatory filings are kept current and compliant with the existing policy and guidance. We strive to make the path to treatment as simple as possible for patients and their doctors, while bringing a level of safety and standardization to the process that has set the standard for this emerging field. Openbiome provides fmt that has been manufactured by umn and has been rigorously screened. These ready-to-use fecal microbiota preparations allow physicians to devote their time and energy to treating patients, rather than the complexities of managing a stool donor program.

The global Microbiome conservancy (gmbc) program at Openbiome partners with scientists around the world to conserve, study, and share underrepresented and at-risk human Microbiome diversity. The gmbc has established a network of 80+ researchers in over three dozen countries and built a diverse collection of samples and bacterial isolates to spark scientific discovery and enable new solutions to microbiome-associated disease.the gmbc was established to solve the urgent need for a deeper, more globally representative understanding of the human Microbiome that addresses the Health concerns of all. A deeper understanding of the human Microbiome is critical to solving global Health challenges such as antimicrobial resistance, malnutrition, depression, as well as autoimmune and metabolic disorders that are linked to the communities of bacteria that live within us. However, our current body of knowledge, largely based on u.s. and european populations, is biased and vastly incomplete. As industrialization disrupts human Microbiome diversity on a global scale, the window of opportunity to study and apply the full potential of the human Microbiome is closing.to radically expand scientists' view of the Microbiome, the gmbc program has built a globally representative collection of human Microbiome samples, bacterial isolates, and associated metadata as a resource for the Research community. Working with local scientists around the world, we collect and conserve Microbiome samples (primarily gut, but also mouth, skin and other body sites) from participating communities. These samples are then characterized and, from them, the gmbc generates bacterial isolates. Resulting Research materials and associated data are shared through the gmbc collectionthe most globally representative collection of its kind that provides scientists access to previously unavailable biodiversity.in november 2023, Openbiome began the transfer of the global Microbiome conservancy program to kiel university. Openbiome remains a funder of the program and agreed to distribute a maximum of four (4) grants up to $50,000 each to in-country collaborators in the 2024 collection pipeline.

Clinical Research program: Openbiome seeks to enable translational Research on the human Microbiome. To do so, we provide a suite of services to help investigators uncover the role of the gut Microbiome in human Health, and to discover how engineering it can drive better Health outcomes. Our services include the provision of customized fecal microbiota preparations, study design and regulatory support for clinical trials, and bioinformatics and analytical services. Openbiome also sponsors its own studies investigating critical microbiome-related Health conditions.