"Biopharma is not IT where a smart kid can compete from his garage."
Well, I am currently producing one early-stage (xenograft) drug candidate literally in my garage, and have made two new molecules based on the structure, also in my garage, about to be submitted to structural characterization (and eventually, in vitro studies and maybe even xenograft)... But yeah, I do have a PhD in chemistry, and spend 10-20h/wk on the project.
(also with the caveat that all my studies hit a "brick wall" of can't do in the garage when I have to start worrying about GMP).
Don't get me wrong: synthesizing compounds and expressing proteins is not that hard. Those things can be done in a garage. Extensive pharmacological testing in cultured cells and animals is much, much harder. I respect what you're doing, but you obviously know what GMP is and have some idea of what drug research entails, so to claim that a garage hackers could produce a drug candidate is disingenuous. At our company, a drug candidate is something that has shown efficacy in animal pharmacology models and has gone through 13-week tolerability studies in animals appears safe. And that's all before GMP.
I don't think there are specific guidelines as to when you start calling something a candidate or not, although I personally wouldn't call a "hit" from a screen a "candidate". Everything I am working with is a natural product derivate, In fact, engineered to reduce tox of a compound that started off in late-stage preclinicals, so the odds of success are (qualitatively) higher to begin with.
>Extensive pharmacological testing in cultured cells and animals is much, much harder.
And that's why I'm contracting CROs for those parts. I guess technically that's "taking out of the garage", but I never said the whole thing is being done in the garage!
>I don't think there are specific guidelines as to when you start calling something a candidate
True, that's why I said "at our company". It differs everywhere, as you mention. My only point was that we screen thousands of compounds, and it's only after a compound has shown desirable activity, safety, ADME, PKPD, etc, that it becomes a real "candidate". Not everyone realizes this, and thinks you can synthesize a compound and the next step is to file an IND.
Your point about CROs is a good one, and I thought of it after my post. We use lots of CROs, too. And there are obviously lots of successful virtual companies that don't do any wet-work at all. But CROs cost lots of money. Not really cheaper than doing it yourself, just more convenient sometimes. Virtual companies can work because they have millions in VC.
Anyway good luck with your endeavor. I don't mean to sound cynical or negative, but not everyone in IT realizes that the two fields are qualitatively different in many ways and I think the differences are worth pointing out since they're often overlooked around here...
CROs are really expensive, but it's surprising what is and what isn't. An NMR goes for ~$160 (but usually because you have unremovable features like GLP, which you may or may not care about depending on the step). So for some of these things I'm just "calling over a friend who is a professor at X university" and getting a bit of spectrometer time and a grad student.
OTOH, I'm getting xenograft for just about $30k, which I think is about right.
> not everyone in IT realizes that the two fields are qualitatively different in many ways and I think the differences are worth pointing out since they're often overlooked around here...
Well, I am currently producing one early-stage (xenograft) drug candidate literally in my garage, and have made two new molecules based on the structure, also in my garage, about to be submitted to structural characterization (and eventually, in vitro studies and maybe even xenograft)... But yeah, I do have a PhD in chemistry, and spend 10-20h/wk on the project.
(also with the caveat that all my studies hit a "brick wall" of can't do in the garage when I have to start worrying about GMP).