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. A key goal of the Regulatory Science program is to accelerate the development and use of new tools, standards and approaches to efficiently develop products and to more effectively evaluate product safety, efficacy and quality.
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 2011, 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, 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.
The initiative Discovering New Therapeutic Uses for Existing Molecules (Therapeutics Discovery) program, has transitioned out of the Common Fund to NCATS. Eight companies collaborated with NCATS to make the Therapeutics Discovery program possible: AbbVie (formerly Abbott), AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, L.L.C., Pfizer and Sanofi.
The Regulatory Science program is now focusing solely on the MPS Tissue Chip initiative. Learn more about the initiatives from the Regulatory Science Initiative 1 Projects below.
Accelerating Drug and Device Evaluation through Innovative Clinical Trial Design: This project is examining the use of adaptive clinical trials. These non-traditional clinical trials have the potential to accelerate drug evaluation and improve participant outcomes, all while reducing the cost of clinical trials.
Development of a Replacement Ocular Battery (ROBATT): The objective of this project is to develop a novel strategy for testing ocular irritants that would obviate the need for the commonly used rabbit model. This non-animal testing strategy would result in thousands of animals no longer being needed for ocular irritancy assays and would potentially accelerate and expand capabilities for irritation assays.
Characterization and Bioinformatics-modeling of Nanoparticle-Complement Interactions: The goal of this project is to construct a method for predicting harmful effects of nanoparticles prior to their testing in human subjects. If this could be achieved, safety review of new candidate nanoparticle products and crafting of specific guidelines could be developed to facilitate the regulatory process.
Development of a Heart-Lung Micromachine for Safety and Efficacy Testing: This research is aimed at creating a 'Heart-Lung Micromachine’ as a screening platform that could replace animal assays currently used for development and regulatory review of drugs and nanotherapies.
View all of the funded research here