| > I felt good! The next step was in sight: a test of the drug in humans, to see if we actually saw the blood levels of cyclosporine that I expected we would. We had contracted with a CRO in the Netherlands and were raising the $1+ million needed to actually carry out the test when – pop! – the biotech markets imploded. Suddenly, investors literally stopped returning my (and everyone else’s) emails. That sounds like a Phase 1 trial for safety in human volunteers. If the plan was to sell the IP to or partner with a major Pharma, maybe this could work. But the IP situation may not be that clear-cut with a drug repurposing, especially given this: > This is still a tall order for a guy whose background was, again, science blogger. But things went surprisingly ok, all things considered. I linked up with an excellent corporate attorney and patent attorney, both of whom agreed to let me use their services on a pay later basis. ... You really can't do this on the cheap. People in tech (or even science broadly) trying to get into the drug industry frankly have no clue about what it actually takes to get a drug approved for humans in the US. Hundreds of millions are table stakes. The bar is higher than just about any other industry for new product introduction, even for a repurposing. Even if the bear market had stayed in hibernation for another year or two, the fundamental problem is that human drug approval is a massive resource drain that requires very deep pockets and an ironclad IP position. Failure (after massive expenditure) should be considered the base case. |
They weigh up all their current & future pipeline almost daily in terms of risk/reward monetary values. I'm not really sure I feel a great desire to shed a tear for big pharma. They always seem to do alright when their results get posted at the end of each financial year. I've wrestled with the debate as to whether human medicine development/discovery is best done in this environment for a long time. And, I still haven't decided. Competition is good/healthy, but financial drive seems to be trumping the human/healing element more than ever.
In the last decade, it feels like they've spun most of the risks out to the small biotech startups, who they'll all get into a bidding war over once a potential product shows a vague shred of promise/monetary value. I'm not discounting the fact that the hills aren't littered with the hundreds of corpses of failed "promising" new biotechs/drugs they pumped hundreds of millions into for absolutely no return at all. I'm just not convinced the whole ecosystem is the best long-term strategy for human health. I guess that's what I'm really trying to say.