Slim innovation a.s.a.p.

Innovating in that highly-regulated, risk-averse domain of clinical drug development…this is the mission of the biotech/(bio)pharma team with that fantastic new idea about how to tackle a pressing medical need. To make a meaningful difference for a patient by applying completely new insights in an affected pathway in the human body – supplying something that is missing – inhibiting something that should not be active – activating a pathway that should be inhibiting something else – inhibiting an inhibitor.

Doing something complex in a patient that no one has done before. Innovating in an unprecedented way. And… one needs to do this superfast, please, because the patent clock is ticking, because “the patient is waiting”, and yes, the investor is waiting too. From bench to bedside – asap – tick-tock.

We need to be superfast whilst doing something completely new. We need to collect very compelling data that can be scrutinized by all who need to scrutinize. We need to collect impeccable data on that meaningful difference to convince patients, prescribers, key opinion leaders, regulators, payers. Convincingly show that key difference, meaningful to a patient – can I walk further? – can I live longer? – will my cancer stay away longer? – can I keep my pain at bay? – can I have something with less side effects?

We are all patients; some of us a bit; some of us full-time. As patients we appreciate that there is a price to pay for any meaningful difference. How can we keep that price low, without a compromise?

So many things to think of: do the right thing at the right moment in the right direction; understand the goal; make a good plan, and stick to it; execute; learn from results and adjust course if needed; avoid repairs; turn mistakes into something to learn from; do not waste.

Do not waste. It is so easy to overdo it, by doing more - just to make sure. Just to make sure we satisfy everyone, to make sure we do not cut a corner that may only be a curve in the road. No one was ever fired for doing that extra thing, was there?

We published a recent example on how to avoid waste in the first test of a new drug in humans. Often, these tests are done with an ‘abundance of caution’ by testing very low doses in a lot of different people. We provide an approach to collect the very same information with let’s say a 25% smaller test size. So with less money spent. I wish you happy reading in Clin Pharmacol Ther (doi:10.1002/cpt.2101).

And this is just an example. So much more to add.