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Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

Sep 24, 2013 8:30 AM - Sep 24, 2013 5:00 PM

1750 Rockville Pike, , Rockville, MD 20852 , USA

The Development of Live Biotherapeutics

Translational Research of Live Biotherapeutics

Session Chair(s)

Ryan  Ranallo, PhD

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)

Robert I. Merker

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

Linda Claire Duffy, PhD, MPH

Commensal, Pathogen Definitions & Human Microbiome

Linda Claire Duffy, PhD, MPH

NIH, United States

HSA - Program Director NP-DER

David J Pepperl, PhD

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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