3 ms·
Short answer: we are. Clinical trials are expensive. NHP (Non-human primate) studies are also expensive, but orders of magnitude less expensive than human stud
by jonlucc 4y ago
Short answer: we are.
Clinical trials are expensive. NHP (Non-human primate) studies are also expensive, but orders of magnitude less expensive than human studies. We pharma researchers don't want to put stuff into humans if there's risk of failure, especially if that failure is a tox finding and not just low efficacy.
So we de-risk as much as possible. We go so far as to prove everything on human cells, then buy mice with humanized portions of their genome to test the target in mice that are more like humans in the way we need them to be. Then we test in NHPs, because it's very unsafe to assume that a drug that works and is safe in cells is safe in primates.
In a current project, I'm dealing with the fallout of this exact problem. We did a ton of testing, modeling, in vitro work, rodent work, then we dosed in monkeys and it caused a massive tox signal. We have to go back to the drawing board and explain what happened to the monkeys, how we're going to address it, maybe kill the whole program, and find a new path forward. It passed all of the rigorous pre-monkey testing. And I'm at a major pharma company, where we have pretty specialized teams doing most of this work.
edited to correct an error
- rocketbop 4y ago> We have to go back to the drawing board and explain what happened to the monkeys They might rather not know.