FDA, NIH funding nano study to advance regulatory science
In February the agencies outlined a joint effort to shorten time from scientific breakthrough to approved medical therapy. Now the agencies have detailed four projects which will receive a total of $9.4m (€6.9m) from the US National Institutes of Health (NIH) over the next three years.
Some of this money will be allocated to Dennis Hourcade, of Washington University, St Louis, for research into bioinformatics-modelling of nanoparticles. Funding research into nanoparticles, an emerging field of drug delivery, should give a better understanding of a contentious technology.
Nanoparticles’ considerable potential, coupled to fears about side effects, put them within the initiative’s remit of converting scientific breakthroughs into real-world treatments. Information generated by the study will help the US Food and Drug Administration (FDA) regulate.
Grants were also awarded to research into: accelerating drug and device approval thorough innovative clinical trial design; a novel way to predict eye irritation; and a heart-lung micromachine for safety and efficacy testing.
Funding was awarded to the projects because they address high priority areas in advanced biomedical research and regulatory science. Advancing regulatory sciences develops knowledge, tools, standards and approaches needed to access traits such as efficacy, safety and quality.
“This partnership marks the beginning of our work with FDA to use new scientific and technological tools to aid/enhance the review of new drugs and devices”, said Francis Collins, NIH director.
