Over the past decade, advancements in DNA sequencing technology have made it possible for scientists to analyze microbial communities in the human body. By analyzing these single-cell organisms, clinical researchers are finally beginning to get a clear picture of what is going on in the microbiome. Recent discoveries have been made that have revealed the power of microbes to prevent, diagnose, and treat disease. As a result of these discoveries, clinical developers are trying to harness these insights in order to develop new medical therapeutics.
Microbiome-based clinical research is a promising new landscape that can effectively be utilized to discover new treatments. In Medpace’s recent webinar, Medpace experts, who have participated in clinical studies where they have evaluated the host microbiome, invited Julia Cope, PhD, from Diversigen to help them address the opportunities and challenges associated with microbiome based clinical research.
About the Webinar
This webinar touches on a few different topics including:
- 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
- Regulatory considerations and requirements
About the Presenters
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.
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.
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.