5 ms·
I was surprised when I first got involved with drug development, how rushed the process is. Phase I and Phase II trials are initiated by pharma with strikingly
by Gatsky 8y ago
I was surprised when I first got involved with drug development, how rushed the process is. Phase I and Phase II trials are initiated by pharma with strikingly little understanding of how the drug works. A classic example is iniparib, which made it to a phase 3 trial but turned out not actually hit the target it was supposed to hit (PARP).
The reason for this is I think economics. There is a large advantage to being first to market, especially if the disease has no other treatments. This means that you can set your price, there is zero competition, and you disincentivize all other companies from developing similar drugs. Under these conditions, you can recoup development and trial costs in 1 - 2 years. So it is no wonder that drugs with any sort of signal are pushed quickly through early phase trials.
- lekanwang 8y agoYes, this is a very good point -- you're on the clock as soon as you file your patent, so sponsors have an incredibly strong incentive to take risks with trial design and use surrogate endpoints rather than direct endpoints for the primary to cut down on time. Then it's really an educated guess (albeit a highly educated guess) for your Phase III trial design to balance out your market vs chances of proving efficacy.
- refurb 8y agoPatent life is an important factor, but the other one is that it’s sometimes really hard to validate how a drug works. Either you don’t have the technology, money or time to do it. And in the end all that matters is it works in humans. My favorite story is about gabapentin. Designed to block the GABAase enzyme. It made it all the way to market before they realized it actually works through a different mechanism.