Both Sides Now

At some point, the destination has to inform the direction...

I got a few messages when I put this image out a couple of days ago:

Some see this disconnection as something they confront at launch, some at phase III go/ no go, and some as a conversation they have much earlier. In reality, it doesn't matter - the problem started as soon as the confirmatory phase started without considering where the product should end up.

Let's be clear - the lesson of pharma innovation is not complicated: early phase should be exploratory, with subsequent phases confirmatory. We talk about this as Opportunity Seeking Strategy (OSS). The 'Opportunity' in there is critical. Bridges don't build from just one side, and nor should pharmaceuticals...

To understand opportunity, you need to be exploring your molecule next to where it could go - way beyond just the indication. To choose an indication, you'd also need to understand your potential positioning in that indication, value proposition and more. That 'opportunity' might ask different questions of your molecule - induction or maintenance?, maximum tolerated dose or minimum effective?, companion diagnostic or empirical symptomatic effect? Is your opportunity in one launch, or a series of lifecycle events? Can you read through from one to the next? As soon as you pick and run on one TPP, you narrow your considerations to hoping your bridge meets in the middle, in the future, instead of working together on where else it could go.

Imagine loading a container ship, without knowing what you can sell when it docks in a foreign port? Once it is at sea, it's too late to ask, and therefore to change what's on board. So it is with your phase III...

Anyone who thinks opportunity is simply a scientific endeavour is missing the critical interface between a future market landscape and the molecule. The molecule isn't changing between Discovery and market - all that separates them is what you learn. So, the faster that opportunity description makes its way back into the questions asked of the molecule, the better. Development has many one-way doors. Believing that there's time later to see an opportunity is wrong. A linear path to market automatically creates a lot more unknowns: unknowns that you will need to have managed to make a better decision, later. As Joni Mitchell's Both Sides Now admits, seeing things from both sides may not address uncertainty...

I've looked at clouds from both sides now

From up and down and still somehow

It's cloud illusions I recall

I really don't know clouds at all

...but uncertainty is your friend. Uncertainty is not the same as risk; they're not synonymous. Managing risk can leave uncertainty to flourish - and it is in your management of uncertainty that you find opportunity. Managing risk is typically an inward, minimising behaviour; managing uncertainty is an opportunity-seeking, outward behaviour. Do it faster and better than your competitor. Win by learning asymmetrically.