Chips for tox
How the first data from organs-on-chips could find their way into INDs
After several years’ pushing from FDA, NIH and DARPA for more predictive preclinical tox tests, organ-on-a-chip companies are close to demonstrating their models can detect signals missed in animals. While replacing animals is nowhere in sight, there’s a good chance the chips will become a regular part of IND packages.
In December, FDA issued its latest “Predictive Toxicology Roadmap.” Last month, the National Toxicology Program submitted a similar road map. Both documents reiterated the call for organs-on-chips and other technologies that could catch issues animal models can’t and limit use of animals in safety studies. The NTP is a coalition of 16 agencies, including FDA, run by the U.S. Department of Health and Human Services...