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 ...
Peter Keeling of Diaceutics discusses how recent headlines in the personalized medicine space can be confusing for the reader by inferring that medicine has moved forward dramatically. He highlights that whilst new technology or solutions are now available, they have not been integrated in a way that will fundamentally change the outcome for the patient.
It is no surprise that this headline appears hot on the heels of a few smart technology soundbites such as ‘the $1000 genome’ and the ‘the explosion in ‘immunotherapies’, but honestly these types of hyperbole are misleading and unhelpful. They are misleading simply because for those of us in the thick of personalized medicine we are all too aware of the fact that the integration of personalized medicine into clinical management is highly complex and can only happen incrementally. We agree that the pace is accelerating but instead infer that 2014 will not be any more important than 2013 or 2011. So this type of headline is more about selling news copy than discovery of a hidden tipping point.
It is unhelpful because our research indicates that physicians, patients and laboratories all continue to be confused about how and where to utilize new molecular tests or targeted therapies to achieve the optimum clinical outcome (interestingly, these stakeholders are all at the far end of the supply chain!!). Launches of new ‘solutions’ are often incomplete, technology-centric and highly niched. The disintegrated commercialization approach of industry to date, with each pharma or diagnostic company focusing only on their individual biomarker or patient subset, illustrates that whilst technology is evolving, the traditional approach towards integrating these solutions into highly priced clinical care in a way which fundamentally changes the outcome, has not.
But let us counter this dose of realism with a belief that we wouldn’t want to be anywhere else right now. Why? Let me point towards a series of exciting opportunities for the personalized medicine industry in all its forms. Start with technology, where our eyes were more drawn to the 2014 announcement of Google’s recent new glucose test, a smart contact lens. For diabetics, this real-time monitoring of glucose is a practical and very accessible application of testing to personalize treatment. For us at Diaceutics, it is a beacon directing us away from the excessively narrow definition of personalized medicine as a genetic revolution relevant only to oncology. Elsewhere we have talked about the threat of new entrants like Calico, emanating from [php snippet=34 param=”title=Google&id=987&useTitle=true”].
Moving our 2014 horizons to market-shaping events, we look forward to the first real competitive personalized medicine wars which will arrive with the likely near simultaneous launches of rival oncology therapies targeting the same biomarker in the same disease. Personalized medicine therapies and tests to date have been launched amid near monopolistic market conditions and consequently have prevented adequate performance benchmarks. With two or three pharma companies commercializing alongside each other, we will truly be able to measure their market readiness. We think there will be clear winners and losers here.
Finally, we postulate that 2014 should look out for a personalized medicine market leader appearing. To those of you who say “but isn’t Roche already there as the leader?” we ask you to think about a different definition of leadership other than numbers of targeted therapies on market and combined Rx/Dx capabilities. Instead, look out for the company which steps outside the ‘think therapy first’ mindset and towards a holistic, longitudinal and integrated vision more suited to the promise of personalized medicine. As leaders in other long cycle industries have appeared not from the ranks of the largest but from those who have rethought the customer needs and harnessed the supply chain of converging technologies, so too will it be in personalized medicine. Now that would be a headline event.