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This is the type of innovation we exchange for a sense of absolute security in having highly-vetted decade-long bio R&D and extensive backlogs at the FDA for approvals to sell products on the market. It's go big or go home because the regulatory risk/timeline is so extensive.

Most of these things die quietly or never get started so we never really see the true costs of what it takes to push the pharma world forward. It likely has a big effect on reinforcing existing monopolies as they are the only ones who can play that game (and pharma has been dominated by the same six companies since the 1800s). Usually R&D happens via a single trajectory which is either expensive internal labs at these companies or via anointed universities. There is very little variation on the source.

There's rarely an investment market between small scale seed stage and high growth phase. Which is where these bio R&D projects die.

Maybe there is an opportunity for a YC-style org to disrupt here. But I doubt it given the requirements to get to market.




This is nowhere near the "This is getting tangled up in the FDA" phase. Funding speculative science is hard, and expensive, and this is the type of innovation we exchange for wanting more certain returns on investment, and nothing more than that.


No, this hasn't gotten anywhere near human testing yet. The FDA isn't involved.


FDA rules increase barriers to entry to the market, resulting in fewer companies (especially fewer smaller companies) who would be interested in funding such a project.


If you got DRACO to work in animals, there isn't a pharmaceutical company (or VC) on the planet that wouldn't buy you a small island just to get you to the table. This is probably the worst example you could choose for trying to demonstrate FDA regulations chilling development next to CRISPR.

It's the in vitro -> in vivo part that they're anxious about wasting money on, not the FDA process.


But FDA rules loom large in every decision in medicine. Avenues of research that are going to produce results that will be difficult to bring to market are likely to be abandoned even before the government is involved by law.

That's not necessarily a bad thing.


Obviously it will be in the future, which deters any small scale seed investment...


Are there other nations which have less demanding requirements, but still decent vetting? Why can't these kinds of ideas go there?


My scientist friends tell me China is paying well, making funding available, and has a lower go-to-market burden. Innovation appears to be literally moving to China as talent is being drained away from the US & Europe.


They have a lower go-to-market burden because the regulators don't much mind if you literally fabricate long-term clinical trial results out of whole cloth. The only innovation occurring is in the field of separating fools from their money.



I've seen how clinical trials take place here in India and yes, it's not always pretty. There are plenty of people who mean well and do good work, but the pressure to reduce cost invariably leads to shortcuts.


Just for biotech?


I'd count commodity electronics in there.


One factor is that by far the biggest profits are to be had in the US.

Maybe you can get approved in Australia or Sweden, but that will pay negligible sums compared to getting into the US market.


Could try for market pressure - for example, that male birth control being developed in India we keep hearing about. I bet it'll get approved here faster than normal because of how desired it is.


Related anecdote: to this day, in Japan access to the Pill remains limited because of vague "safety" concerns, despite decades of use. However, when Viagra appeared, it was approved in months...


Well, they do have a shrinking population problem...


> sense of absolute security

Well said -- the keyword is "sense" of security.


There's also the small matter of profiting from desperation with unproven remedies that do unknown, possibly permanent damage. There are good reasons and historical precedent for strong medicine safety regulations; it's not just bureaucracy.


This was covered in Sam Peltzman's "Regulation of Pharmaceutical Innovation" book, where he goes over the statistics before/after the 1962 FDA Amendments. Statistically, the percentage of drugs that later prove to be ineffective or damaging is no different, just the aggregate amount of new drugs, good and bad, is way less.


Preventing fraud is one thing. Holding fraudsters responsible is a thing. However, barring access outright to (properly labeled) experimental medicine is completely different, and that's what the FDA does (as well as enforce a bunch of monopolies).




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