Program Director, Office of Rare Diseases Research & Div of Clinical Innovation
NIH, National Center for Advancing Translational Sciences (NCATS), United States
In addition to human cells, our bodies contain an even greater number of microbial cells, collectively referred to as the human microbiome. The majority of these reside in the gastrointestinal tract. Over the past several years, it has become clear that the micro biome within the human body impacts and regulates not only the function of the gut, but also many aspects of clinically relevant biology, including the immune system, liver, and brain, and can also influence carcinogenesis. Approaches to drug development involving modulating the function of the micro biome include both small molecules (e.g. probiotics), as well as the direct transfer of microbial cells. This session will highlight some of the current approaches to targeting the microbiome using cell transfer, as well as a discussion of the regulatory landscape for micro biome targeted drug development.to be developed.
Learning Objective : Illustrate two approaches to modulating microbiome function; Describe the medical, regulatory, and operational challeneges to microbiome targeted therapies.
Regulatory Biologist, OVRR, CBER
FDA, United States
Applying Principles of Rational Drug Development to Living Medicines
Chief Medical Officer
Synlogic, United States