One of the things that stands out in Oncology, is the sheer number of Fast Track launches that take place in either orphan drugs or areas of high unmet medical need where there are no therapeutic options available to patients. Thus, the FDA in their great wisdom created a mechanism whereby such conditional status could be conferred and approved or rejected within six months of filing the promising phase II data. The caveat is that the phase III trials must subsequently show a clear survival benefit in order for full approval to be obtained.
It's easy for people on the outside to look at it and think well, that's a great/easy/simple way to get to market early and get sales faster. Except that it isn't that easy and the road is littered with failures, with Iressa being the most spectacular after the failure of their phase III trial to show any significant survival benefit for patients. Of course, others cynically say that others who made it that way were lucky. Hah, little do they know what even goes into such a phenomenally speeded up launch even means for an organisation internally. I should know, I lived through two of them in less than a year and then did a front-line launch 6 months after that. 3 oncology launches in 18 months is enough for anyone. Imagine a close knit cross functional team working flat out and then some. Many worked 18 hour days during that time without complaint; they just rolled up their sleeves and got on with what needed to be done.
Normally, companies have the luxury of 12 months to plan for a launch. That gives you sufficient time to get all the major pieces together with sufficient resources and a decent budget, assuming all the relevant basics were done in phase II development. Suddenly you have 6 months or as we found, 2-3 months after the FDA indicated they weren't going to take all 6 months. Yikes! So the team just works harder and longer hours, rationalises what absolutely needs to be done and just does it. A lean, well oiled and focused team will accomplish far more than a bunch of individuals with more people and money at their disposal. The old adage, "there is no 'i' in team" is a very true altruism here.
Cover of Faldo: In Search of Perfection
Some of you might be wondering why I'm talking about the past, which is rare for me. Well, the memory was triggered reading a post on Paul Kedrosky's 'Infectious Greed' blog where he wrote about a conversation between Malcolm Gladwell and Bill Simmons on ESPN about Tiger Woods, Greg Norman and Nick Faldo (see link in box at end of blog):
And that made me realise that a team going through a Fast Track market launch needs exactly those sort of characteristics. Not all the time, mind, just what a team needs at that period to be successful. For 2.5 years, the Gleevec team 'had' that focus as a unit, from phase I through to launch. The rest is history. You only get one chance to make a first impression and it's one of the toughest things you will ever go through.