Lifesavers

There is a certain cancer treatment that is pre-Phase I right now that had better be THE cure for cancer.

OK, so it won't and it isn't. But seriously, if this thing doesn't save millions of lives, I will be one pissed off analytical chemist. I think drug development is a lot like training and racing.

Lots of people put huge amounts of time in early on working for a distant goal. Along the way there are usually some hurdles and setbacks but that's to be expected. After laying down a huge base (a.k.a. pre-FIH), you do an early season training race to test the legs (IND filing). Your performance in the the early season race gives you a good idea of where you stand in your training and may change your plan a bit. Then comes some warm up races (Phases I, IIa and IIb) where you really start to find some form and start logging serious hours. Finally, you build and peak (NDA filing) and, if you've timed it right (got lucky with an efficacious compound), you win (NDA approval and go to market).

But a huge number of people never win in their whole career. So it is with drug development.

More on this later.