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Why does it take so long to get new drugs approved?

Our science question of the month.
March 5, 2018
Steps of drug aproval process

The steps required during new drug approvals.

ATHENA research may help speed new drug approval and help ensure safety.

New medicines are constantly under development. However, the Food and Drug Administration (FDA) has strict safety protocols on the steps new drugs must go through before people can use them. Given that approximately 90 percent of pharmaceuticals fail their clinical trials despite passing animal studies, and there are thousands of chemicals whose effects on the human body are unknown, the ability to easily distinguish the harmful from the helpful would be extremely beneficial.

To that end, the Laboratory is working on ATHENA (or the Advanced Tissue-engineered Human External Network Analyzer) to help advance progress in this area. The purpose of the project is to create surrogate organs (currently the liver, heart, lung, and kidney) to provide realistic, cost-effective testing of various chemicals. It uses live human cells in an environment designed to mimic the human body as closely as possible.

As part of the research, a tissue-based artificial lung, called PuLmo (for Pulmonary Lung Model), even breathes so it can be used to test drugs, toxins, particles, and other agents. This latter work won an R&D 100 award. These awards are known as the “Oscars of Innovation.”

Jennifer Harris
Biosecurity and Public Health