Tissue Chip for Drug Screening
To help streamline the therapeutic development pipeline, NIH, in collaboration with the Defense Advanced Research Projects Agency (DARPA) and the U.S. Food and Drug Administration, is leading an initiative to improve the process for predicting whether drugs will be safe in humans.
The Tissue Chip for Drug Screening initiative, which marks the first interagency collaboration launched by NCATS, aims to develop 3-D human tissue chips that model the structure and function of human organs, such as the lung, liver and heart, and then combine these chips into an integrated system that can mimic complex functions of the human body. Once developed and integrated, researchers can use these models to predict whether a candidate drug, vaccine or biologic agent is safe or toxic in humans in a faster and more cost-effective way than current methods.
More than 30 percent of promising medications have failed in human clinical trials because they are determined to be toxic despite promising pre-clinical studies in animal models. Tissue chips are a newer human, cell-based approach. These models may enable scientists to predict more accurately how effective a therapeutic candidate would be in clinical studies.
Eliminating toxic and/or ineffective drugs earlier in the development process would save time and money. These human tissue chips also could teach us a great deal about disease progression, enabling researchers to better prevent, diagnose and treat such conditions.
A Unique Partnership
To design and develop the tissue chips, NCATS, DARPA and the FDA are focusing resources and brain power in a novel collaboration.
In 2011, NIH’s Common Fund and National Institute of Neurological Disorders and Stroke led trans-NIH efforts aimed at better understanding how tissue chips work. Seeking the best ideas in engineering, biology and toxicology, NIH issued two requests for applications in the fall of 2011: RFA-RM-11-022 and RFA-RM-12-001.
On July 24, 2012, NIH announced the resulting 17 awards to researchers who will work to develop human tissue chips that could better predict drug safety and efficacy before they are tested in people. Two additional awards funded by other NIH Institutes and Centers were issued in September. View the 2012 tissue chip awardees. On September 16, 2014, NCATS announced the next phase of the program designed to integrate these tissue chips into a full body system to evaluate drugs. NIH awarded approximately $17 million in fiscal year 2014 to 11 institutions. View project descriptions for the 2014 awardees, and learn more about funding for this program.
DARPA is conducting a separate but parallel program in close coordination with the NIH. It has entered into cooperative agreements with two NIH tissue chip award recipients (the Wyss Institute at Harvard University and MIT) to develop engineering platforms capable of integrating 10 or more organ systems.
FDA is exploring how this new technology might be used to assess drug safety prior to approval for first-in-human studies.
For More Information
Tissue Chip News
NIH’s Tissue Chip program focuses on critical challenges in the drug discovery pipeline. Read the thematic issue of Experimental Biology and Medicine published on Sept. 1, 2014, that highlights these innovative projects.