Assessment of Safety and Efficacy of Fecal Microbiota for Transplantation Products
December 10, 2020
- December 10, 2020
- Organized By:
About the Speaker
Paul Carlson, PhD
Principal Investigator, Laboratory of Mucosal Pathogens and Cellular Immunology
Office of Vaccines Research and Review, CBER, FDA
Dr. Carlson received his Ph.D. from the University of Pittsburgh and performed postdoctoral research at the University of Michigan in the laboratory of Phil Hanna. Since starting his laboratory at FDA in 2015, Dr. Carlson’s research has focused on infections caused by the enteric pathogens Clostridium difficile and Vancomycin resistant Enterococcus (VRE) species. Laboratory projects include researching mechanisms of C. difficile pathogenesis, development of genetic tools to study C. difficile, host response to C. difficile, the role of the host microbiota in C. difficile colonization resistance, the influence of the host immune system on the microbiome, safety of Fecal Microbiota Transplantation products, and bacteriophage therapy against VRE. Dr. Carlson is the former co-chair of the FDA microbiome working group and the Joint Agency Microbiome (JAM) working group, as well as a former member of the Microbiome Interagency Working Group (MIWG). His regulatory responsibilities include product review for fecal microbiota transplantation (FMT), defined live biotherapeutic products, and bacteriophage therapies.
About the Presentation:
This presentation provides an overview of the FDA’s research on how Fecal Microbiota Transplantation (FMT) is a novel treatment being assessed for use in the treatment of many, highly diverse conditions ranging from infections to inflammatory bowel diseases and even neurological disorders. Additionally, we have been working to understand the impact of the COVID-19 pandemic on this class of products as SARS-CoV-2 viral RNA has been detected in stool. Detail of these efforts, including development and validation of a SARS-CoV-2 stool test, assessment of clinical stool samples and preliminary animal studies will be discussed along with the impact of this work and the pandemic overall on the safety and availability of FMT products.
|December 2020 FDA Grand Rounds Continuing Education Activity Outline||pdf (219.93 KB)|