Personalized Medicines: Implications for Pharma
The President's Council of Advisors on Science and Technology defines personalized medicine as "tailoring medical treatment to the individual characteristics of each patient by classifying individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment." To this end, FDA is now developing guidelines that address the co-development of a drug and the companion diagnostic test (or diagnostic test and companion therapeutic) that will allow these subpopulations to be identified and treated accordingly.
Pharmaceuticals, in vitro diagnostics, and medical devices have historically used different marketing techniques. For the most part, pharmaceutical marketers have targeted office-based physicians, both primary care and specialty; pharmacists, both retail and hospital-based; and hospital and managed care formulary committees. Diagnostic marketers have targeted hospital-based physicians—particularly pathologists, laboratory managers, laboratory department supervisors, and point-of-care coordinators. Device marketing has an extremely broad range of targets, from physician specialties such as radiologists, cardiologists, orthopedic surgeons, and other surgical disciplines to nursing and materials management representatives.
One of the major differences between marketing in these three segments has been the size of the promotional budget: large for pharmaceuticals, small for diagnostics, and somewhere in between for devices, depending on the type. Personalized medicine blurs those boundaries, and will require interdisciplinary marketing of drugs and diagnostics by marketers that historically have been siloed. Except in those situations where therapeutic drug monitoring is necessary, drugs and diagnostics have been historically separated. Now, however, drugs and diagnostics will not only be co-developed, but also co-marketed, requiring marketers to possess both pharmaceutical and diagnostic expertise.
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