FDA and NIH Move Forward with Device Industry Grants

The National Institutes of Health (NIH) will award $9.4 million over the course of three years to support four research projects in regulatory science. This research is conducted in partnership with the U.S. Food and Drug Administration (FDA), which will contribute approximately $950,000.

According to the agencies, the program is intended to inform scientists and regulatory reviewers about medical product safety and improve the evaluation and availability of new medical devices.

The projects include research on nanoparticles (extremely small molecules that may be used to deliver drugs in a targeted manner) and their characterization, a heart-lung model to test the safety and efficacy of drugs, innovative clinical trial design, and a novel strategy to predict eye irritation.

“These four projects were chosen among many applications because they were the most meritorious proposals for addressing high priority areas in cutting-edge biomedical research and regulatory science,” said NIH Director Francis S. Collins, M.D., Ph.D. “This partnership marks the beginning of our work with FDA to use new scientific and technological tools to aid and enhance the review of new drugs and devices. It is one facet of our shared commitment to speed the delivery of new medical products to patients.”

The awards follow an announcement in February by the NIH and the FDA to work together on important public health issues. As part of that effort, the agencies established an NIH-FDA Joint Leadership Council to spearhead collaborative activities. In addition, the NIH and the FDA issued a request for applications to stimulate a new research initiative titled: Advancing Regulatory Science through Novel Research and Science-Based Technologies.

Regulatory science involves the development and use of the scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, quality, potency and performance.

“These projects show the potential breadth of opportunity that comes from advancing regulatory science. The results are likely to have broad application to researchers across scientific disciplines and will result in better-informed regulatory decision making and faster drug development and approval processes,” said FDA Commissioner Margaret A. Hamburg, M.D.

The four grantees include:

• University of Michigan, Ann Arbor – Accelerating Drug and Device Evaluation through Innovative Clinical Trial Design;
• MB Research Laboratories, Inc., Spinnerstown, Pa. – Replacement Ocular Battery (ROBatt);
• Washington University, St. Louis, Mo. – Characterization/Bioinformatics-modeling of Nanoparticle: Complement Interactions; and
• Harvard University Medical School, Boston, Mass. – Heart-Lung Micromachine for Safety and Efficacy Testing.