Discoveries over the past decade have revealed the power of microbes to prevent, diagnose and treat disease. As a result, clinical research and development in new therapies and diagnostics is rapidly advancing our understanding of how dysbiosis of the microbiome can result in disease and how prevention or reversal of microbial imbalances can be used in treatment. In this webinar, experts will address the possibilities as well as the challenges in this promising landscape.

Topics will include:

  • Addressing operational, scientific, safety and endpoint challenges in trials evaluating the microbiome
  • How to incorporate microbiome analysis into your study - taxonomy versus function; 16S, metagenomics and qPCR
  • Quality, from manufacturing to clinical trials - GLP and CLIA/CAP
  • Regulatory considerations and requirements

Featured Speakers:

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Brian Murphy, MD, MPH
Vice President, Infectious Diseases and Vaccines
Medpace

Dr. Brian Murphy is board certified in infectious diseases, internal medicine, and pediatrics and has nearly 15 years of experience in clinical research for anti-infectives and vaccines, including studies evaluating the host microbiome.
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Julia Cope, PhD
Director of Scientific Operations
Diversigen

Dr. Julia Cope is a microbiologist and plant pathologist with extensive experience in microbiome study design, handling of various sample types, multiple sequencing platforms and the underlying bioinformatics analysis.
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Steven B. Johnson, PharmD
Vice President, Regulatory Affairs
Medpace

Dr. Steven B. Johnson is globally responsible for all regulatory affairs and medical writing activities at Medpace and is at the forefront in understanding the unique regulatory considerations and guidelines for clinical research involving the human microbiome.
NOW AVAILABLE ON-DEMAND

Register now for this webinar