How to Ensure a Successful Companion Diagnostic Launch

Jim Adelizzi, Principal

Susan Bobulsky, Manager


Why must pharmaceutical companies improve companion diagnostic launchesand why do they struggle?

Jim Adelizzi: You see hundreds, literally, of research and development programs that are now coupled with a companion diagnostic on the therapeutic side. And so what that represents is billions of dollars being invested in companion diagnostics.

Historically, there’s been a lot of companion diagnostics that have been launched as disruptive technologies after the therapeutic is already out in the market. But what you’ll see in the next five years is actually simultaneous launches of a companion diagnostic that is then coupled with the therapeutic. These organizations fundamentally have very little experience in doing that.

Susan Bobulsky: When we look at the commercialization side, we actually see a lot of companies struggling to optimally launch their companion diagnostics. And the companion diagnostic is really what’s fundamental to unlocking the commercial potential of the biomarker targeted therapy.

If a drug and a diagnostic are launched sub-optimally, there’s a missed opportunity for that drug.

Why it’s a mistake to simplify the complexity in a companion diagnostics launch

Jim Adelizzi: One way to simplify is to silo. And the diagnostic company then becomes responsible for commercializing the diagnostic; the therapeutic company fundamentally then becomes responsible for commercializing the therapeutic. Now, ultimately, this process needs to be integrated.

Susan Bobulsky: They think of the diagnostic as an attribute of the product, and a feature, rather than as a standalone component.

With a diagnostic, what we typically see is a flat to exponential uptake curve and a time to peak of five years or even more. Whereas for a therapeutic, we usually see a logarithmic uptake curve and a faster time to peak—sometimes just two or three years in an example like oncology.

And so if you fail to take into consideration the dynamics of product adoption for the diagnostic, when planning for the therapeutic launch, you could imagine that you end up with a disconnect and potentially a competitive disadvantage for the therapeutic.

What are the key steps to ensure a successful diagnostics-therapeutics product launch?

Jim Adelizzi: One of the common mistakes that I’ve seen is that companies are beginning too late in the process and then get overwhelmed with the complexity.

You need to be starting your launch planning process at early Stage Two, at a minimum, and then assessing the opportunity even before that.

Susan Bobulsky: It’s important to have a team that’s designing the commercial strategy and the associated tactical plans that incorporates people who understand both the therapeutic and the diagnostic components.

And doing this will help to avoid miscommunications between the two siloed organizations that might otherwise be working on the drug and the diagnostic, and it will also ensure that you have a shared set of objectives and a strategic direction that works for both parts of the product.

Jim Adelizzi: Throw out your generic launch playbook, because fundamentally, this will be different than anything you’ve seen in the past.

Every situation that I’ve seen in personalized medicine has been very unique and very different, and by over-relying on these generic launch playbooks, they get into trouble. None of the playbooks tend to show an interrelationship between launching in the diagnostic space and also then launching in the therapeutic space.