Session 35: The industrial microbiology behind living therapeutics and microbiome products
Thursday, July 28, 2016: 2:00 PM-5:30 PM
Bayside B/C, 4th Fl (Sheraton New Orleans)
Thomas Kelleher - Xylome Corporation and Andreas Schirmer - REG Life Sciences, LLC
In recent years there has been a growing realization that microbes can be used as therapeutics in a wide range of clinical settings.   The recent approval of viral-based immunotherapies for cancer, the potential for modification of the human microbiome and the renewed interest in more traditional vaccines are all based on the premise that these products can be manufactured as safe and efficacious therapies.  In deed “Microbes as Therapeutics” poses new challenges and opportunities.

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.

2:30 PM
Human Microbiome Therapeutics
John G. Auniņš, Seres Therapeutics, Inc., Cambridge, MA
3:00 PM
Break, Grand Ballroom Foyer 5th Fl
3:30 PM
Developing next generation probiotics from the microbiome
Johan van Hylckama Vlieg, Microbiome & Human Health Innovation, Chr. Hansen, Hoersholm, Denmark
4:30 PM
GMP manufacturing overview for living products
Thomas Kelleher, University Research Park, Xylome Corporation, Madision, WI
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