KineMed Personalized Medicine

Personalized Medicine (PM) embodies the concept of getting the right medicines to the right patients at the right doses. Over the last several decades, it has become apparent that patients with what would once have been considered the same illness (based on signs, symptoms, and older laboratory tests) may actually have very different underlying patho-physiology, associated with different likelihoods of disease progression and responses to different therapies. For example, about half of patients diagnosed with Rheumatoid Arthritis will respond to anti-TNF therapies such as Enbrel™ and half won’t. What differs between these two groups of RA patients? Of individuals with early signs and symptoms of forgetfulness, some will progress to Alzheimer’s disease and some won’t. What accounts for these sorts of differences? For those who respond to a drug, potential side effects may be worth the risk, given the potential benefits. For those who don’t respond, there is no benefit to counterbalance the risk of side effects. For those with forgetfulness who will progress to AD, treatment, even if costly, would be a godsend. Being able to detect and characterize these differences amongst patients with a particular disease also makes possible greater success during drug development. If it were possible to identify the subsets of patients with accuracy, the ability to detect drug effects in clinical trials would be markedly better; the magnitude of the drug effects would be more apparent, and premium pricing of the drug product would be more supportable given the expected benefit and the expected disease progression in the absence of treatment. Pharmaceutical companies have begun to recognize the value of TM & PM approaches in their efforts to increase the productivity of their R&D efforts. The acceptance of PM has not come easily. Over the last decade, pharmaceutical companies have moved from unwillingness to look at the heterogeneity of major diseases first to grudging acknowledgement of the need for PM, progressing more recently to embracing PM as a win-win opportunity for patients and pharmaceutical companies.