Recently, I was talking to a couple of Pharma marketers and market researchers about their products in development, each in entirely different markets.
They had exactly the same issue though – making decisions about which tumour types to target out of a possible half dozen options. That sort of position often leads to total paralysis by a project team and an unwillingness to put their head on the block.
Too many what if's abound.
The problem is drug development is often a leap of faith into the unknown, a total crapshoot. You have to learn to play the percentages and perhaps consider several smaller phase II trials to minimise the phase III risks and see what data evolves. Trying to pick only one tumour target at the end of phase I is a recipe for disaster and fraught with issues.
My answer is nearly always the same. What data do you have so far?
What I've noticed is that the smart companies in oncology rigourously focus on solid proof of concept studies in phase I and even phase II before making the ultimate Go : No Go decision to pursue a phase III registration strategy. This might mean embarking upon three phase II trials in different cancers before selecting a registration lead rather than just picking one and fretting about the other 5.
Other times, it makes sense to try two indications in a head to head and hoping one emerges as a lead option, thus reducing your development costs. This can be done when you have really solid preclinical data that really jumps out.
In the final analysis, making solid decisions based on actual scientific, clinical and preclinical data is a lot smarter than a total leap into the abyss just because a market looks bigger commercially.
No data, no dice.
Photo Credit: YSK