Authors:

Marina Garassino (UChicago Medicine), 

Kunle Odunsi (UChicago Medicine), 

Marciano Siniscalchi (Northwestern University), 

Pietro Veronesi (University of Chicago, NBER, CEPR)

Abstract

Recent advances in technology and genetic sequencing are opening the road to personalized medicine, highly specialized therapies targeted to small subgroups of patients who display specific molecular mutations (biomarkers). For instance, targeted therapies in cancer research are now available for about 50% of lung cancer patients, 15% of whom never smoked. Such targeted therapies have been one of the main reasons for the increase in life expectancy in lung cancer patients. We provide a model to study the economics and sustainability of this new emerging reality and show that the current infrastructure that requires therapy experimentation and FDA approval of each therapy will fail as the targeted number of patients for each treatment becomes increasingly small. The model also suggests the solution: approving a process for personalized drug development rather than the therapies themselves. The approval of a process for personalized drug development would spur more research in finding new biomarkers and ever more personalized targeted therapies.