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Organs on a Chip: The Future of Efficacy and Safety Testing

Track:
Nonclinical and Translational Development/Early Phase Clinical Development

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
260

Room Number:
6B

Level:
Intermediate

Type:
Session

Title:
Organs on a Chip: The Future of Efficacy and Safety Testing

Chair(s):
Barry Mangum, MD
Director, Clinical Pharmacology
Duke University Medical Center, United States

Description:
Preclinical studies for proof of concept and drug safety are often performed in animal models. Our desire to reduce animal use in drug development and to make more accurate predictions of safety and efficacy has led to large investments in the development of models of human organs arranged serially on microchips. The goal is to be able to introduce candidate drug substances and monitor pharmacological and toxicological effects in each organ. Significant progress is being made with models of human liver, lung, intestine, and breast. Despite this encouraging progress, significant challenges remain. These include source of human tissues: Normal primary cells usually taken postmortem or induced pluripotent stem cells. Differentiated cells in culture require unique cell culture media in order to maintain their differentiated state; however, multiple organs on a chip will need to be bathed in a common medium. Finally, translating the information collected from the chips to responses in humans will be a challenge. How will this information be used to determine if a candidate pharmaceutical causes pain, nausea, or increases the risk for cancer or birth defects? While progress in the area is encouraging and may be useful in selecting among early drug candidates, it seems clear that utility in the regulatory arena is still years away.

Learning Objective(s):
Discuss progress being made in our ability to grow human organs on microchips; Identify the sources of cells that are used to develop these organs; Discuss which endpoints can be collected from the microchip after introducing a drug sample including how those endpoints translate into pharmacological and toxicological responses in patients; Describe additional progress needed in order to be able to use these tools in regulatory submissions.

Presentation(s) & Speaker(s):
Panelist
Keith Murphy
Chairman and Chief Executive Officer
Organovo, Inc., United States

Panelist
Daniel Kraft, MD
Founder and Executive Director
Exponential Medicine, United States

Body-on-a-Chip: Vascularizing Micro-organs
Christopher C.W. Hughes, PhD
Professor & Chair, Molecular Biology and Biochemistry
University of California-Irvine, United States