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Translational Research of Live Biotherapeutics
Session Chair(s)
Ryan Ranallo, PhD
Program Officer, Enteric & Hepatic Diseases Branch
NIH, United States
The advances of next generation sequencing have broadened our understanding of microbial ecology and the host-microbe relationship. This combined with the rapid accessibility of bioinformatic and omics based tools is providing a new opportunity to design novel live biotherapeutic (LBP) applications to predict and manipulate microbial community structure and function so as to promote a healthy microbial ecosystem at the level of a single organism, community or the larger host-microbe interface. The improved probability of success with LBP applications requires the integration of genomic standards, translatability of bioinformatic pipelines, and the acceleration of lead optimization processes. This will translate into safer and more effective clinical applications for the prevention and treatment of disease.
Speaker(s)
Products Based on Food, Food Additives, and Dietary Supplements
Robert I. Merker
FDA, United States
Supervisory Consumer Safety Officer, Div. of Biotechnology & GRAS Notice Review
Commensal, Pathogen Definitions & Human Microbiome
Linda Claire Duffy, PhD, MPH
NIH, United States
HSA - Program Director NP-DER
The Role and Utility of Nonclinical Animal Studies in Safety Evaluation of LBPs?
David J Pepperl, PhD
Biologics Consulting, United States
Senior Consultant and Nonclinical Group Leader
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