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by arountheworld
2814 days ago
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The linked article is behind the paywall. From you comment I still can't take out _why_ this costs so much. It sounds like development cost X because phase of development cost Y. I find it strange that you can say that something called "phase 2" costs precisely $40-50M+. What does it involve that it cannot cost $1M or $100k? What's so hard about biology that makes it expensive? What I am seeing is just words but no substance or maybe I don't understand something? I would love get more insight. |
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https://www.baybridgebio.com/blog/drug_dev_process.html
It actually costs an average $40M (as of 2010) to do a phase 2 study. That's an average, not a precise cost. The cost entails designing a study, getting regulatory approval, recruiting hundreds of patients, paying for multiple doctor visits for each patient, manufacturing the drug, process engineering, administrative costs, getting hospitals and healthcare facilities onboard to treat patients, lab tests for all the patients, development of custom biological assays to measure the drugs activity, payments to lawyers and consultants, plus paying dozens of employees for a few years
There is an additional $30-40M needed just to get to phase 2 plus the $40m or so for the phase 2 study.
The why is biology hard question is beyond the scope of this post, and I'm not a biologist (though i work with them). But I think a lot of it has to do with the fact that biologists can't directly study human biology -- you can't just delete a gene in people and see what happens, or stick a bunch of random chemicals in somebody. Even if it wasn't ethically, financially and logistically challenging to do that, you couldn't always even see what you want to see. You can't watch changes in live human organs at the level of watching specific molecules, you can't see where all the molecules go and how they impact all other systems in the body in real time. You just have snapshots of specific things, like analysis of blood samples, or imperfect models, like animal or cell models that seek to replicate specific biological phenomena
Contrast that with something like computer science, where you can directly play around with the thing you want to study -- computers. Or chemistry -- you can be in a lab and work directly with the chemical matter you want to study. Not that those are easy, but you at least can poke around directly at the stuff you want to learn about