Recent DARPA research through the Accelerated Manufacture of Pharmaceuticals program has demonstrated the ability to accelerate production of millions of doses of vaccine using novel plant-based methods. Clinical trials, however, for vaccines, drugs or other biologics cannot be initiated without preclinical evidence of their safety in humans. Human safety and drug performance is not always effectively predicted through animal testing. And the Department of Defense needs to rapidly develop and field safe and effective medical countermeasures against biological threats to warfighters.
To create a pathway for the fielding of safe and effective countermeasures, DARPA has launched the Microphysiological Systems program. MPS will develop a platform that uses engineered human tissue to mimic human physiological systems. The interactions that candidate drugs and vaccines have with these mimics will accurately predict the safety and effectiveness that the countermeasures would have if administered to humans. As a result, only safe and effective countermeasures will be fully developed for potential use in clinical trials while ineffective or toxic ones will be rejected early in the development process. The resulting platform should increase the quality and potentially the number of novel therapies that move through the pipeline and into clinical care.
As a force protection measure, DoD has a requirement to protect warfighters from existing or emerging diseases, pandemics and bioterrorism. It has significant interest in developing viable medical countermeasures with an approach that includes aggressive research, removing barriers to innovation and developing capacity to respond quickly to threats.
MPS research expects to concentrate in the following areas: A reconfigurable platform that permits simultaneous study of ten or more in vitro physiological systems, arranged in any sequence. The platform should be a flexible, user-friendly and reliable design that allows biological components to interact in a physiologically relevant manner and able to sustain the resident tissues for up to four weeks. Researchers developing the in vitro mimics should demonstrate that the engineered tissues function together to reproduce each of the human physiological systems. As these system mimics are integrated into a platform of increasing complexity, researchers should demonstrate that the platform reproduces the physiologically-relevant crosstalk between the systems that normally occurs in humans. To validate platform behavior and its potential value for evaluating drugs and vaccines, test compounds with known effects in humans will be applied to the platform. The effects that the test compounds have on the physiological system mimics will then be extrapolated to humans via computer modeling and compared to their health effects previously observed in humans. Research may also demonstrate how an infectious agent might affect the in vitro platform, thus providing an opportunity for scientists to study the infectious agent in a human-relevant manner.
MPS is coordinating efforts with the National Institutes of Health, who is conducting separate but parallel research.
The Food and Drug Administration has been involved from this beginning to help ensure that regulatory challenges of reviewing drug safety and efficacy are considered before and during development.
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