Serendipity, luck, and planning opportunity

One of the challenges when talking about 'planned serendipity' with respect to drug development is that to many it sounds like an oxymoron. "How can luck be planned?"

The resolution is easy, and useful.?Serendipity is not the presence of good luck, it is in finding value in 'what just happened' (whether that was good luck or bad...). In other words, it is seeing the opportunity that your new knowledge presents. It is about knowing how to be positive with the situation that just arose.

So, the question is: can you be better at spotting opportunity in what just happened? Yes. The next question is: can you create more situations, by design, where you'll be presented with novel observations? Yes.

As soon as you set out to learn instead of to?prove, you have to embrace the opportunity in seeing things you don't know?now. If you set out simply to prove your current hypothesis, you're left with confirmation or contradiction (or refutation). You may choose to deal with that adversity well, but you will be in a different place than someone who broadened their search for insight. While you may choose to pivot should things go awry, you will have to do it with limited information on your alternatives. They will be in places that you never allowed for - they planned their vantage points strategically.

Pre-planning to recognise opportunity is key to the idea of Asymmetric Learning. If you have spent 3 months exquisitely defining a market opportunity if all the good things come to pass in your phase II, and then they don't, your last 3 months is 'wasted'. Had you instead prepared not just a range of exploratory studies, but a healthy breadth of 'what ifs' (a range of good market characterisations, instead of one deep analysis), you'd be ready to take the next step at speed. Many cite Viagra as a case of good luck, but seeing the opportunity in a market that didn't then exist is not luck, it is a skill. The drug did what the drug did, but seeing what it did as potentially valuable was then down to good commercial opportunity seeking.

The shout of 'Eureka' certainly needs a prepared mind, and a set of questions that make the insight exciting, but it is often said that the most important words in discovery are 'hmm, that's funny...' Recognising a situation as?intriguing?is an approach that can be trained. Seeing it as a pain in the *** is something that is, unfortunately, trained into our language in pharma. Pharma would see water splashing onto the bathroom floor as a 'failure', not as a clue to an open question on buoyant force.?

We do need to see phase I and phase II studies as things that aren't 'successful' or 'failed' - they are an opportunity to present clues to those ready to see opportunity. A typical pushback is ‘that would increase the cost of early phase unacceptably’, but that reveals the wrong view of early phase - that it is a step-wise confirmatory phase, rather than an exploratory phase. Adding a couple more endpoints, or a richer patient population, or one more dose may not actually increase the costs in those studies, even if it increases their complexity (there are some 830 studies on clinicaltrials.gov showing phase IIs with only two doses - two doses cannot give you a dose response curve, but 830 studies seem not to care, or think they have already answered the question to their satisfaction) . Your task is not to see whether the drug works well enough, but to find out what ‘best’ means for a future market. Like investing in a pension plan, the goal should not be to get by, but to give your future self options.

Setting up better decisions in the future has to include the creation of substrate for a decision. If you want to optimise your opportunity to make a good decision in a year’s time (presuming you are open to your future decision not just being a ‘yes’ or a ‘no’), giving yourself more to work with then is a clear good.

The history of drugs that make it by serendipity rather than linear planning is long. You also know that the complexity of clinical trials and then the real world is almost intractable, so the collection of what is by definition the?minimal?amount of information to inform a go/no go is likely to leave you on a path that represents not just a dead end, but a dead end from which you won’t have enough information to turn around and go somewhere else.?

Be lucky by design, and be serendipitous by planning.