The Common Fund’s Regulatory Science program, initiated in fiscal year 2010 as a partnership between NIH and the U.S. Food and Drug Administration (FDA), aims to foster regulatory science, a specialized and inter-disciplinary area of biomedical research that serves to generate new knowledge and tools for assessing experimental therapies, preventives and diagnostics.
The initial phase of the program provided support for four new research awards in high priority areas of regulatory science, including adaptive clinical trial design, a novel strategy to predict eye irritancy, a heart-lung model to test the safety and efficacy of drugs, and nanoparticle characterization. (View the funded research)
In 2012, the NIH Common Fund and the National Institute of Neurological Disorders and Stroke led the trans-NIH effort to establish the NIH Microphysiological Systems (MPS) (Tissue Chip for Drug Screening) program, which now is led by the National Center for Advancing Translational Sciences (NCATS). The NIH Common Fund and NCATS Cures Acceleration Network fund the program. This initiative is the result of collaborations that focus the resources and ingenuity of the NIH, Defense Advanced Research Projects Agency (DARPA), and FDA.
Current methods of assessing drug safety and efficacy in pre-clinical animal models are expensive and time-consuming, and many times do not accurately predict results in humans. The Tissue Chip program aims to develop 3-D human tissues on chips that accurately model the structure and function of human organs, such as the lung, liver and heart. Once developed, 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. Reducing the time and cost associated with the pre-clinical phase of drug testing may go a long way toward streamlining the drug development pipeline.
Common Fund support for the Regulatory Science program ends in 2017, but the Tissue Chip for Drug Screening program led by NCATS will continue to support this important research with the goal of developing tissue chips that can be used to experimentally predict whether newly developed drugs will be safe for testing in humans.