The Three “Dos”—and “Don’ts” in Launching a Companion Diagnostic

Jim Adelizzi, Principal

Judith Kulich, Principal

Mike Kelly, Principal

Don't "Silo" the companion diagnostic from the therapeutic launch

Do create an "integrated" launch team

Jim Adelizzi: They have deep experience in either launching therapeutics or deep experience in launching separately diagnostics. But the idea of launching two products simultaneously in two different industries is something that is fairly novel.

Fundamentally this is a synergistic model. The two are linked and ultimately the therapeutic potential depends on the diagnostic. And so by decoupling—[and] what happens when that it’s done—is one, launch objectives are thought of in silos. Launch investment in commercial preparedness are made commensurate with the specific product opportunity rather than thinking of it holistically.

By creating an integrated team that can speak both languages, one, you’re in a good position to set up combined launch objectives. Two, you’re able to then define best practice processes for commercial preparedness across both the therapeutic side as well as the diagnostic side. And if you do that, then you’re in a good position to ensure that your diagnostic actually acts as a differentiator rather than limiting the potential of your therapeutic.

Don't treat the companion diagnostic forecast simply as a filter

Do create a robust forecast that can be integrated with the therapeutic forecast

Judith Kulich: Simply adding a filter at the top of the patient funnel in a therapeutic forecast will limit your target patient population according to biomarker status, but that’s really not enough. It doesn’t provide the insights into the companion diagnostic as an opportunity in itself.

A robust forecast will give you insights into key market drivers and challenges that the product might face—[the] risks and uncertainties.

It’s important to make sure that the forecast for the companion diagnostics stands on it’s own, and at the same time is integrated with the therapeutic. So this forecast on it’s own needs to take into account factors as varied as pricing and reimbursement for that diagnostic.—the specific profile of the companion diagnostic as well as the therapeutic that it is supporting.

And really if you have that kind of true understanding of the companion diagnostic—again on it’s own, but also as it relates to and integrates with the therapeutic—then this will provide such deeper insight into the kind of integrated product offering that you are launching.

Don't rely upon old tactics in launching a companion diagnostic

Do customize the launch to help overcome the launch's inherent complexity

Mike Kelly:When it comes down to it, we’re not talking about one launch. We’re talking about two launches happening at the same time.

Now companies tend to get in trouble because this is the first time they’ve been dealing with this type of launch in many cases, and so there’s a natural tendency to rely on what’s always been done in the past. However, that typically results in suboptimal launch uptake.

The good news is companies can actually overcome this challenge, and the way to do it is through a very customized approach to their specific launch and their specific companion diagnostic situation. By taking this customized approach—by taking a very personalized approach to launch strategy and execution for this personalized medicine—companies can overcome this risk.