Key Aspects of Modern, Quantitative Drug Development

One of the main goals of modern drug development is customized care, where doctors match the right patient to the right treatment at the right dose, based on quantitative evidence. In this paper we review three key aspects of drug development that are critical towards achieving this goal. More specifically, we discuss (i) the advantages of modern model-based dose-finding as opposed to traditional pairwise comparisons, (ii) the value of pharmacometrical modeling, understanding the variability in how patients metabolize, tolerate, and respond to drugs, and (iii) the potential impact of enrichment strategies to identify study populations that are most likely to benefit from the investigational drug under development.