September 16, 2011
DARPA, NIH, FDA coordinate research efforts to develop chip to screen for safe and effective drugs and vaccines swiftly and efficiently
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. Drug safety and effectiveness in humans are not always accurately predicted through animal testing. And the Department of Defense needs to rapidly develop and field safe and effective medical countermeasures against biological threats to U.S. 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 successfully move through the pipeline and into clinical care.
Success of these programs depends on active program management from each agency and strong collaboration among the research teams from all the organizations. DARPA researchers will concentrate their efforts on engineering platforms and the biology required for scientific proof of concept. The NIH’s National Center for Advancing Translational Sciences will focus on developing complementary microphysiological systems to mimic human physiology and pathology by taking advantage of recent advances in the field. Both agencies will work closely with the U.S. Food and Drug Administration throughout the process. FDA will provide scientific input to help ensure that the regulatory challenges of reviewing drug safety and efficacy are considered before and during development.
“FDA is excited about this program to develop novel new platforms that can be used to screen drugs for safety and efficacy, without the use of animals and in a manner that better predicts what happens in people,” said Margaret A. Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration. “This cheaper, faster and more predictive approach to drug screening could speed the development and improve the evaluation of innovative medicines, bringing needed products to patients safer and faster."