alt Hacker NewsCan someone explain whether design of protein binders is an important rate-limiting step in drug creation (of which antivenom is a very small market)? Or AI-driven drug discovery in general? It feels like something that will definitely help the drug market but is nowhere near the rate-limiting step, but that's from my own researcher as someone without a background in it.
My understanding is that FDA trials (specifically phase 2 + 3) are the death valley for most drugs and finding a biomarker is something mostly done through a mix of gene bank scraping + looking at old biomarker databanks. The majority of the cost and time is in failed drugs that do not pass FDA trials (which average 6-7 years end-to-end).
Note: I am asking this in earnest. I am not trying to ask a leading question and saying it is not important at all.
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While Clinical Trials are the most expensive step and have a 90% failure rate, it is not the *source* of the failures, it's just where failures are revealed.
Much of whether or not a candidate drug will succeed was determined all the way back in the design/discovery stage. If we can design better drugs, then we would enjoy a higher probability of success in the later clinical trials.
The single biggest improvement to pharma drug development would be from increasing the probability of success in clinical trials.
The impression I have, which admittedly is purely as a layman reading articles, is that by far the rate-limiting factor in all drug creation is the cost of doing clinical trials in humans.
There would be less failures if problematic therapies were filtered out before the clinical stage.
Your impression is correct. Clinical trials are the rate limiting step and the primary source of cost and risk.
My understanding is it is not - this is something we have models for, and there was a flurry of machine learning based drug discovery companies about 8-10 years ago. But they ran into the testing bottleneck real fast because they would spit out thousands of candidates for binders and so on that all needed to be tested in vitro before they could even start the real drug dev circuit. Furthermore the drugs need to be manufacturable and that's not a trivial problem.
It's nice to (as the blog post suggests) give the opportunity to non medical experts, say in this case a snake/venom research center, to pursue a problem and produce some realistic candidates that they could pay to test. I do think it's good to democratize what parts of the process can be, but it's more of a resource prioritization problem than a molecular design one.