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For Immediate Release: March 7, 2017

Mary Kuramoto
513-579-9911 x 12523

Webinar: Opportunities and Challenges in Microbiome-based Clinical Research

CINCINNATI, OH — (March 7, 2017) – Medpace (MEDP), a scientifically-driven, global full service clinical research organization (CRO) known for its strong therapeutic and regulatory expertise, announced that it will be conducting a live webinar on April 6th. Medpace experts Brian Murphy, MD, MPH and Steven B. Johnson, PharmD along with Julia Cope, PhD from Diversigen, will engage in an interactive discussion on the possibilities as well as the challenges in clinical research and development involving the human microbiome.

WEBINAR: Opportunities and Challenges in Microbiome-based Clinical Research
DATE: Thursday, April 6, 2017
TIME: 11:30am ET/ 8:30am PT


About the Webinar
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:

  • Understanding how the microbiome is influencing drug discovery across therapeutic areas
  • 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

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.

About Medpace
Medpace is a scientifically-driven, global full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services for drug, biologic, and device programs. Medpace’s physician-led, high-science, and disciplined operating approach leverages regulatory and therapeutic expertise to accelerate the global development of safe and effective medical therapeutics across all major areas including oncology, cardiovascular, metabolic/diabetes, infectious disease, and neuroscience.

About Diversigen
Diversigen provides comprehensive fee-for-service microbiome and metagenomics services focused on solutions to improve human and animal health. Building on research conducted at the Alkek Center for Metagenomics and Microbiome Research at Baylor College of Medicine, Diversigen is at the forefront of setting industry standards for quality with a microbiome CLIA/CAP accredited, GLP compliant laboratory.  From pre-project consulting and study design, to extraction and sequencing to complete bioinformatics analysis, Diversigen is your microbiome partner of choice.  For more information, visit