-
Not
so fast, argue leading pharmaceutical
companies including Lilly, Roche,
GlaxoSmithKline (GSK), and Merck. Their
perspective is considerably more cautious:
-
It will take time to get personalized medicine
right
-
Payers have not adjusted to the new paradigm, yet the same technical assessments done today will take place tomorrow, whether or not a diagnostic is
involved
|
Questions
Remain
The path ahead is simply not clear. Witness ImClone Systems' dilemma with Erbitux. Two years ago, ImClone enriched the trial-subject population for the drug's target, EGFR, probably to increase the proportion of patients who responded to the drug. But because of the EGFR immunohistochemistry test's limitations and the sheer prevalence of EGFR in many cancers, the test became a hindrance. ImClone is now hoping to remove the EGFR test requirement for additional indications and replace it with another biomarker test or no test at all. The company is also pushing the FDA to remove EGFR testing from Erbitux's
label.
This is a matter of managing the science, which is hard enough. It will be even harder to figure out how the pharmaceutical and diagnostics industries can address the following
questions:
- Has the diagnostics industry developed the necessary technologies
yet?
- Who will fund and control the $50-million-plus annual marketing spend needed to create an efficient market in a quicker-than-average time
frame?
- Why have the multiple drug/diagnostic alliances forged over the past decade (Aventis/Pharmanetics, Cygnus/Sankyo, GSK/ Quidel) all failed? What's changed to suggest future alliances will
succeed?
The two industries agree on the potential for personalized medicine but remain far apart on the fundamental question of how to deliver it. So where do we go from here? Perhaps not to a new pharma model, but to a new diagnostics business model that is financially, clinically, and commercially refocused on getting the therapy efficiently to 95 percent (versus 20 percent to 40 percent) of the patients who warrant it: a diagnostic sold like a
therapy.
Such a model will require a profound shift by diagnostics CEOs. They need to adopt a higher level of investment in creating clinical pull into the market and to start applying for pre-market approvals that enable promotional claims, ensure appropriate access, and enable faster physician adoption. Such a shift can only occur if they can also see how much is being invested in the related therapy, and if the pharmaceutical industry dialogues directly with the diagnostic investors. But the rewards could be high, relatively, for both partners: Using a Case-Based Reasoning Investment Model around a disease with a prevalence of 10 million patients, one scenario suggested the five-year net present value (NPV) of additional revenue for a therapeutic enabled by a test might be $157 million. The equivalent NPV for the test is $13
million.
Peter Keeling has founded and run companies in the pharma and diagnostics industries. He is currently CEO of Diaceutics, a consultancy focused on new, ROI-enhancing commercialization frameworks of collaboration between pharma and diagnostic companies. E-mail:
peter.keeling@diaceutics.com.
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