Sometimes I find a cartoon sums up so much. This one, one of the earliest I did, remains one of the more telling
In it, we all recognise the challenge: if you don't make it over the first hurdle, even if you see it as a high jump, the rest are irrelevant. However, those hurdles do not go away just because they are subsequent - they need planning as much as the first. What if, anyone could ask, you'd chosen a different lane...?
So, it comes down to decisions, to choices made early. The choice of launch label is a decision, not a given. This is a truth acknowledged by most New Product Planning processes - they choose a lane early that plans for regulatory approval + clinical feasibility + commercial attractiveness, generate a TPP and away the program runs...
However, this is not possible: a decision made early can't have optimised for each of those outcomes (or has prioritised one, possibly to the detriment of the others) - there are too many unknowns. It becomes Aim. Fire... Ready? instead of Ready? Aim. Fire...
Instead, New Product Planning must have a plan to embrace uncertainty, manage it, and seek opportunity, instead of leaving it until later. Later is too late, when the paths not taken combine to define the opportunity lost (taken instead by your competition?).
The new world of New Product Planning focuses on a Plan To Learn, rather than a fixed TPP, an estimated eNPV and a Clinical Development Plan. It looks to emphasise the asymmetry of that learning process, rather than to run with the crowd towards the same set of hurdles. New Product Planning that uses FIVE-X changes the conversation from seeing the same things as everyone else with the same molecule, to seeing the future differently, by design.
This goes beyond 'indication selection': an indication offers up a starting point, not an endpoint - there remains the question of positioning within the indication, or across indications. The value proposition may be entirely dependent on your sequence of launches, your PTRS wholly determined by small adjustments to your plan. So, it makes no sense to work with just one, and allow no variance.
The Plan To Learn is critical to pharma R&D: set out key unknowns (commercial, regulatory, clinical, scientific...) and establish a plan to address those unknowns, before you make a decision. No New Product Planning process exists without evidence. However, it overvalues evidence collected before it turned up, and undervalues evidence that could be collected in a more exploratory, opportunity-seeking process.