Personalized Medicine: Challenging Pharmaceutical and Diagnostic Company Business Models

The phrase "Personalized Medicine" has been alternately broadly and narrowly defined. Under its broadest definition, clinicians have been have been providing personalized medicine for as long as there has been medical practice physicians employ diagnostic tools, whether in vitro tests, imaging techniques, or symptomology to determine a particular condition, and then go on to prescribe the appropriate treatment, drug or otherwise. However, it is pharmacogenomics -the ability to test for variations in genes and their expression through molecular diagnostics and then to treat with targeted drugs -that shapes a narrower, and more potent, definition of personalized medicine. For patients and physicians, personalized medicine offers apparently clear clinical advantages -a biomarker points directly to the most appropriate therapeutic intervention. This in turn leads to more predictable outcomes, enhanced efficacy through the identification of drug responders, and a potential reduction in adverse drug reactions. This would be a sea change for at least some of medical practice, where certain drugs may now be prescribed on something of a trial and error basis and the therapy effective for only a portion of the treated patients. While personalized medicine offers the potential to change well-established practices for physicians and patients, the concept presents a direct challenge to the business models of two other health care stakeholders essential to the realization of personalized medicinepharmaceutical and diagnostics companies. At the core of the challenge is a central questionhow will a personalized medicine paradigm change these companies' innovation and commercialization approaches? This question can be aimed at nearly every aspect of these stakeholders' current strategieshow clinical trials are conducted, the depth and breadth of the clinical evidence developed, and, perhaps most importantly, how value is created and captured.