[fabian2k]

A large part of that failure rate is in phase 3. Your comparison with prototypes would be more like drug development before even phase 1. Phase 3 is enormously expensive, much more than the earlier parts. And what's even worse, you don't get to learn all that much from failures in drug development in many cases. You can't just fix the problem and try again, you essentially have to try a completely new molecule.

[pinkmuffinere]

That's fair, phase 3 testing isn't an early prototype, it's a prototype with many years of effort behind it. But I still think it is _more_ like a prototype than it is like a product coming off an assembly line. Perhaps phase 3 is like the latest prototype from boom (the company trying to bring back super-sonic jets). Those prototypes represent 100s of engineering-years put together, and are not much like the prototypes you'd encounter in consumer product development. I still think 90% failure rate is believable for that. How many significant design iterations has Boom gone through so far? I don't really know, but I could believe it's been 10 significant iterations.

[ethbr1]

Phase I testing is ~$5M. Phase II $6-20M. Phase III is $10-50M. https://pubmed.ncbi.nlm.nih.gov/26908540/ (up to 2012 numbers, non-inflation-adjusted)

Those costs are strictly for the mandatory testing, not the precursor drug design, etc.

The cost and calendar time required to be sunk before 10% pay off is why you generally only have drug development done by (a) some of the largest corporations in the world or (b) fly-by-night companies hoping to sell their preliminary drugs/results to the former to complete testing.

[pinkmuffinere]

tl;dr -- Boom's iterations are very similar to a phase III trial! Please prove me wrong!

Just to clarify, I think our numbers are in agreement here. From your numbers, phase I + II + III would be in the range $21-75M, all told. Let's double that to account for inflation (2012 is quite stale), to get $42-150M. In California, I'm going to estimate a "normal" engineer's compensation is $150-400k, and the company actually pays more than this because of benefits, HR, etc -- call it $250-600k. Let's say it's 350k fully loaded on average. Then the $42-150M number represents 120-430 engineer years. I'd totally believe that Boom has 120-400 engineers working full time, so if they make a major revision every year, then each major revision is like a full phase I-III progression!

I think there's some reverse-dunning-kruger going on in this thread, where because we're all engineers we think engineering is comparably easy. My claim is that it's actually pretty similar to medical testing, in terms of generic human effort (to the extent that can even be measured and quantified).

edit: According to wikipedia, Boom had 150 employees in 2021 [1]! I'm very proud of my estimate lol, it seems like it was right on the nose. Somebody give me a prize!

[1] https://en.wikipedia.org/wiki/Boom_Technology

[ethbr1]

The difference is that phased safety/efficacy trial costs are sunk.

If it fails, you've produced near $0 value, aside from some more information (maybe) about how something doesn't work. Because those costs are strictly for the execution of the trial, not for the development work before/during/after it.

That's in contrast to your hardware prototyping example, where a failed prototype still usually represents >$0 development value.

The appropriate analogy would be if every time a hardware prototype failed testing, it was required by regulation to scrap it, go back to the design stage, and restart from there.

[mft_]

> A large part of that failure rate is in phase 3.

I must ask for some data to support this statement, and also your definition of "a large part".