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 ...
Mollie Roth discusses how the Diaceutics’ catchphrase can sum up not only a positive commercialization approach for pharmaceutical companies and their relationship with personalized medicine, but also the history of the industry itself. Diaceutics has seen pharma start to like personalized medicine and then begin to learn it but observes that leveraging remains elusive, because to achieve it will require the greatest management change of all.
There are lots of catchphrases out there in the world, some we know and find inspiring, like Nike’s ‘Just Do It’. Some we recall fondly, like Burger King’s ‘Where’s the beef?’ Some that simply make us ask why? Like ‘Gillette, the best a man can get!’
In personalized medicine, the catchphrase has long been ‘the right drug for the right patient’, although various add-ons of additional ‘rights’ have been introduced along the way: ‘at the right time,’ ‘the right dose,’ ‘the right test’, etc.
Here at Diaceutics, we have our own catchphrase for the personalized medicine world, ‘Like It, Learn It, Leverage It.’
We think of this phrase in terms of the level of change management required to achieve. When we first started working in the personalized medicine space back in 2005, most of our clients did not really ‘like’ personalized medicine. Back then, we worked exclusively with pharmaceutical asset development teams, who felt they were almost being forced to do personalized medicine, very likely to the detriment of potentially larger markets and greater returns on investment. Certainly, we did not encounter any initiatives at the higher corporate levels to put their arms around personalized medicine and what it meant for the organization in a broad strategic sense – there were no Centers of Excellence in personalized or precision medicine or pharmacodiagnostics, or any other area.
But over the course of our first five years, up until about 2010, we saw those teams evolve to really begin to ‘like’ personalized medicine – teams seemed to really take to being part of a growing evolution in drug development. Headlines were appearing on a monthly, then weekly and now almost daily basis about the possible benefits to patients, payers and even manufacturers who could possibly reduce development time and costs by using enriched clinical trials.
Around the end of 2010, as companies were regaining their footing after the housing bubble burst and people were beginning to think in terms of long-term strategic initiatives rather than short-term band-aids, we noted another change in the personalized medicine landscape – companies were starting to ‘learn’ it. Perhaps by 2010, there had been enough press about personalized medicine that it was finally decided that it was not a passing fad, perhaps there had been enough approvals of additional targeted therapies—three of which are now blockbusters in terms of sales—that the industry as a whole decided it was time to fully embrace this new paradigm. And in the last 24 months , those various Centers of Excellence have seemed to turn their thinking to how to educate on personalized medicine. And educate not only the teams tasked on specific targeted therapies, but the organizations as a whole. Whether focused on the case studies and specific analogies in the space from which teams could draw a strong foundation of knowledge to contextualize their personalized medicine planning, or finding appropriate specific financial models to run various test scenarios to educate and demonstrate to senior management the likely return on investment, the near-term focus has been on truly taking a deep dive into learning personalized medicine.
Which brings us to the concept of ‘leveraging’ personalized medicine. The first challenge is to define what leveraging looks like and in true ‘look left and right’ fashion at Diaceutics, it is easier to begin by describing what is not leveraging personalized medicine, in our view. For example, we do not believe that the recent approvals of Zelboraf, Xalkori and Tasigna and the revised labels for Tysabri and Rituxan to include biomarker information—great strides forward which they might be—truly represent the concept of leveraging personalized medicine. In our eyes, these are simply the byproducts of smart pharma teams who have come to like (and dare we suggest in some circumstances, love?) and have well learned how to integrate the co-development of biomarkers and therapies and bring them timely to market. We should expect many of these therapies to simultaneously become clinical winners and potential blockbusters. Further, the degree to which ‘other pharma companies’ are following closely the outcomes of parallel FDA approvals for test and treatment and high profile diagnostic partnerships suggests to us that these products are moving the bar for us all.
However, the reason why we believe that leveraging personalized medicine remains elusive is that to achieve it will require the greatest change management of all. Some of the signals we are looking for here include real partnerships between pharma, regulators, physicians, payers, diagnostic companies and laboratories to move past the often adversarial negotiate, launch and educate model of personalized medicine commercialization towards the joint installation of disease-changing paradigms enabled by the ‘right drug, right patient’ promise.
Far-fetched, we hear you whisper.
But consider the plight today of rheumatoid arthritis patients whose access to the best disease-modifying drug for them is inhibited by an unholy alliance of convoluted treatment guidelines, safety warnings within disease-modifying drug labels, inability to identify the patients at highest risk of joint erosion early enough to make a difference and payer reluctance to open the spigot to therapies currently dearly priced to make a return from the small markets to which their default third or fourth line indications limit them.
What is truly exciting for us at Diaceutics is firstly that we believe these inefficient treatment models—which exist across a number of key disease areas—can be utterly transformed by earlier, smarter planning and secondly, that it will only take one or two pharma companies to lead the charge here for the inefficiencies of a segregated clinical model to be integrated across stakeholders. It is a simple but profound thought, but many of the greatest gains in personalized medicine will be made by translating the near-market science into an early clinical impact. In this way, leveraging personalized medicine may require a significant change of mindset but will not be elusive in our view for too much longer.