It is our experience that commercialization of personalized medicine therapies is optimally managed and most successful when undertaken in a joined-up and highly integrated process, much like the routine, standardized and embedded process as currently exists for stand-alone drugs.

Successful personalized planning is about much more than the simple marriage of a test and a drug. In myriad ways, starting as far back as the preclinical phase, the need to align the development of targeted therapy and companion diagnostic requires new ways of thinking and a process within which to focus that thinking to ensure that all of the necessary pieces of the puzzle are properly considered.

Diaceutics extensive hands-on experience in personalized medicine demonstrates that properly considering and shaping the commercial phase of any test to be launched with a drug – whether that is a true companion or simply a diagnostic that will better guide patients to therapy – is crucially important to a successful launch, and no less crucial than the choice of test platform or biomarkers.

It is therefore imperative for the successful commercialization of personalized medicines that teams not compartmentalize their strategy and decisions relating to the different functional frameworks in a personalized medicine commercial plan (i.e. strategy, technology, regulatory, partnering, marketing, clinical etc.) Rather, teams must generate a comprehensive commercial plan within which each functional framework is considered and conceived as part and parcel of an integrated and joined-up process.