Cytopathology

Biography

Biography: Gayane Badalian-Very

Abstract

Personalized medicine attempts to identify tailored treatment based on the susceptibility profile of each individual. Although this approach has generated much excitement, few personalized-medicine therapies have achieved high levels of clinical adoption. To personalized medicine, one needs robust diagnostics and a clear understanding of disease pathomechanism. We have observed four main obstacles to the advancement of personalized medicine: scientific challenges (a poor understanding of molecular mechanisms or a lack of molecular markers associated with some diseases, for instance), economic challenges (poorly aligned incentives and high cost of new medications), lack of outcome based data (a comprehensive study of cost effectiveness/health benefit of personalized medicine) and operational issues. Although economic challenges remain, the scientific shortcomings and operational issues now seem to be the biggest hurdle. Diagnostics/companion diagnostics is the key to personalized medicine, yet it is hard to identify which tests truly save costs and select effective responders. On the other hand experimental testing leads to fears that although individual tests may not be very expensive, the overall eventual costs could be unjustifiably high. A third concern is the difficulty of enforcing standard protocols to ensure that physicians follow through with appropriate patient care based on test results. Fourth, test information could be misused—particularly in the early stages of investigation and development—which could harm patients and payers. Finally, there is no longitudinal accounting, which would enable payers to capture long-term cost savings from near-term testing. Even if operational issues get resolved within a particular stakeholder group, overcoming the scientific burden and correcting the incentive structure and modifying the relationships between stakeholders could be more complex.