Dx Launch Risks
This case study shows how a risk management strategy for possible recalls could prevent disruption, not only to a biomarker's market progress, but to ...
In Part 1 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses the importance of establishing a robust diagnostic development and commercialization strategy on time.
Christmas always comes as a surprise, right? All of a sudden it’s 22nd December and not only have you not bought a single Christmas present for your wife/husband/kids but what’s worse is you haven’t got the foggiest idea what to get them. Sounds familiar? You may not celebrate Christmas itself but you can all relate to a particularly important event that everyone is well aware of and some even wildly excited about. The people around you—and you, too—know this great event needs careful preparation but year in, year out, you somehow never manage to get everything ready in time.
Now, what could this silly and possibly unseasonable example have in common with the pharmaceutical industry, where whole project management departments watch deadlines with eagle eyes, hang giant progress charts on meeting room walls and where launch dates mean the culmination of not one year, but a decade of hard work and eager expectations? Nothing, you might say. But think again, and think of diagnostic planning. Have you ever heard someone say, “We’ll worry about the diagnostic when we have more robust clinical data, including the biomarker analysis read-out next spring?” Maybe you said it yourself?
Here at Diaceutics, we have delivered many projects to clients who came to us, in near panic mode, six months before an anticipated drug launch that they knew would require a companion diagnostic (CDx). Nevertheless, that CDx would not be anywhere near ready for launch and the clients would have no hint of a plan for bringing a CDx to market successfully. I must admit to hating these ‘firefighting projects’, as we call them within Diaceutics. Not because we can’t cope with the immense yet unneccessary pressure caused by having to fast track every activity—of course we can—but mainly because there is simply no way that a last minute Dx launch could be as well-designed and organized as it could have been if prepared in advance.
When the strategy is well designed and planned a diagnostic can and often does play a crucial role in driving the uptake of a novel drug. If it is not the case, like with the last-minute Christmas shopping panic, you will have to go for a somewhat bland and uncreative solution just to have something to offer. The reaction of the person on the receiving end will often be polite but not particularly enthusiastic, whether that is your husband opening yet another tie, or the oncologist facing another CDx that he does not know how to use or get reimbursed for.
Based on our expertise in the field we have identified the three best practices we consider critical for developing an early and robust diagnostic development and commercialization strategy.
To avoid lagging behind with the Dx strategy, pharma should start developing the commercialization strategy 18 months before launch, invest time and effort to keep track of a TTP and engage in early dialogue with third parties, as you never know how long everything will take. In parallel, drug implementation can be leveraged by aligning the robust Dx strategy to the drug development process, and it’s this topic we will discuss next.
For now, we will let you start planning your diagnostic strategy
Figure 1. The importance of planning the diagnostic strategy early in time: shifting from A to B.