More than 8,000 diseases have no adequate treatment. Bringing one new drug to market costs $2.6 billion and takes over a decade, and still, 9 out of 10 fail before reaching a single patient. The existing tools we use to predict how a drug will work in humans often get it wrong and the ones we rely on come at a growing cost.

Despite Congress clearing the way for NAMs use in 2022, current resources required to clear regulatory acceptance hurdles are inaccessible to vast majority of developers. Innovation has outpaced qualification.

Scientists have built a new generation of testing tools based on human biology, chips lined with living human cells, computer models that simulate how the body responds to a drug. These New Approach Methodologies, or NAMs, give researchers a more direct window into human biology itself.