A major focus of this session is the delivery of microbes as products for human use and on the technical and regulatory hurdles that must be overcome in product development. In this regard, the session aims at providing a clearer understanding of the regulatory pathway and analytical requirements for “Microbes as Therapeutics”. In addition, economic drivers and market size information can be presented in the context of incentives for the production of microbes under Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs).
Another focus of this session is to present novel and innovative approaches to harness and apply the growing knowledge of the interaction of human microbiota with health or disease, such contributions are encouraged at any stage of preclinical or clinical development.
Kristien Mortelmans, Infectious Diseases Group, SRI International, Menlo Park, CA
Johan van Hylckama Vlieg, Microbiome & Human Health Innovation, Chr. Hansen, Hoersholm, Denmark
Maxence Desjonquères, Biose, Cambridge, MA
Thomas Kelleher, University Research Park, Xylome Corporation, Madision, WI