| FDA shows the path
Since 2022, the Food and Drug Administration has been on a journey to reduce the reliance on animal testing in drug development. It wants to improve drug safety and speed up the drug evaluation process, reduce animal experimentation, lower research and development (R&D) costs, and ultimately, the cost of drugs.
Companies developing these so-called NAMs or New Approach Methodologies also believe that the complexity of drugs being developed is contributing to greater failures of drugs. That's because once drug candidates enter clinical trials, they simply don't behave the way they were expected to in humans. They don't translate very well from mice to humans. A New Kid on the Block?
Revala Bio has been around for a few years, and this Yale University spinout's proposition is whole-organ testing. Donated organs that aren't being transplanted are used in research, and this whole-organ testing allows drugs to be tested in a human liver or kidney, and other organs instead of in those organs in animals. And it's not just to check toxicology profiles. Other tests for more complex delivery targets can also be conducted. Other Human Testing Companies
Vivodyne and Emulate are two other companies also founded on the principle of providing alternatives to animal testing in the early stages of drug development by focusing on data gathered from humans. These companies are developing tests using tissue-based cell models as well as organ-on-a-chip technologies. Do they all have a place in the Drug Testing World?
Yes, says the co-founder and chief operating officer of Revalia Bio. A human organ can be a Rosetta stone where these organs are ultimately going to feed the MPS systems (microphysiological systems) — the organoid, organ-on-a-chip-type systems — but we need to be able to grab data from across the spectrum,” said Jenna DiRito, co-founder and chief operating officer of Revalia, in a recent interview. “And so we partner with organoid, organ-on-a-chip-type companies. We’re in all these NAM consortiums. I think the goal for us is to make sure that the data is 1, complete and 2, integrated with each other.” — By MedCity Influencer Arnav Saxena |
No comments