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Monday, June 25 • 3:00pm - 4:15pm
#146: Development of Microbiome-Derived Therapeutics

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-544-L04-P; CME 1.25; IACET 1.25; RN 1.25

In addition to human cells, our bodies contain an even greater number of microbial cells, collectively referred to as the human microbiome. The majority of these reside in the gastrointestinal tract. Over the past several years, it has become clear that the microbiome within the human body impacts and regulates not only the function of the gut, but also many aspects of clinically relevant biology, including the immune system, liver, and brain, and can also influence carcinogenesis. Approaches to drug development involving modulating the function of the microbiome include both small molecules (e.g. probiotics), as well as the direct transfer of microbial cells. This session will highlight some of the current approaches to targeting the microbiome using cell transfer, as well as a discussion of the regulatory landscape for microbiome targeted drug development.to be developed.

Learning Objectives

Illustrate two approaches to modulating microbiome function; Describe the medical, regulatory, and operational challenges to microbiome targeted therapies.


Philip Brooks, PhD


FDA Perspective
Taruna Khurana

Applying Principles of Rational Drug Development to Living Medicines
Aoife Brennan, MD

The Next Generation of Clinical Trials: Lessons from the Hurdles of the Microbiome
Zain Kassam, MD, MPH

avatar for Aoife Brennan

Aoife Brennan

Interim President and Chief Executive Officer, Synlogic
Aoife is Chief Medical Officer at Synlogic Inc., where she leads clinical development, operations, and regulatory affairs. Previously she was VP and Head of the Rare Disease Innovation Unit at Biogen where her work resulted in the approval of ALPROLIXTM, ELOCTATETM and SPINRAZATM... Read More →
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Program Director, Office of Rare Diseases Research, National Center for Advancing Translational Sciences (NCATS), NIH, United States
Philip John (P.J.) Brooks is a Program Director in the NCATS Office of Rare Diseases Research. He is also the Working Group Coordinator for the NIH Common Fund program on Somatic Cell Genome Editing. He earned his Ph.D. in neurobiology from the University of North Carolina at Chapel... Read More →

Zain Kassam

Executive Vice President, Clinical Development and Translational Medicine, Finch Therapeutics Group
Dr Zain Kassam is a Co-founder and Executive VP, Clinical Development & Translational Medicine at Finch Therapeutics Group, a microbiome therapeutics spin out of OpenBiome, the world’s first stool bank for fecal transplants. He is also a founding team member and former CMO at OpenBiome... Read More →

Taruna Khurana

Regulatory Biologist, Office of Vaccines Research and Review, CBER, USFDA
Dr. Taruna Khurana did her doctoral research in Cell and Molecular Biology at University of Cologne, Germany, followed by postdoctoral fellowships at NIH and FDA. She had joined the Office of Vaccines Research and Review, CBER, FDA as a Research Reviewer in 2009. Currently, she is... Read More →

Monday June 25, 2018 3:00pm - 4:15pm EDT
Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: PreClin Dev-EarlyPhaseCR, Session