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 ...
Andrew Jack’s article “Back to the Lab” in the Financial Times (FT) on the 16th August 2013 (http://www.ft.com/cms/s/0/e5679dae-e565-11e2-ad1a-00144feabdc0.html ) captured some of the step change underway within Pharma R&D as it embraces personalized medicine. However, I was extremely disappointed that Mr Jack left out two critical insights which would have articulated to FT readers the long term business model implications of personalized medicine to the pharmaceutical industry.
The first is that targeted therapies are predominantly dependent upon companion diagnostics for their financial success. For example, the underperformance of Pfizer’s Xalkori is to a large extent due to a poor commercial strategy of the prerequisite ALK test. This has significant implications for long term supply chain management.
Secondly, the triple economic dividend from personalized medicines of smaller clinical trials, accelerated FDA approval and (when planned effectively) a diagnostic-enabled market pull delivering faster peak sales, are changing the fabric of pharma ROI.
Both of these deserve accurate reporting in future FT reviews.