Quantitative Systems Pharmacology: Applications and Adoption in Drug Development

Biopharmaceutical companies have increasingly been exploring Quantitative Systems Pharmacology (QSP) as a potential avenue to address current challenges in drug development. The ability to integrate diverse data into a unified framework provides a promising approach for a systematic, quantitative evaluation and prediction of the complex interaction between potential therapeutics and biological pathways of disease, with application across the research and development pipeline. In this chapter, we discuss the potential for QSP to help address pressing needs in drug development, and present numerous examples of past applications to problems ranging from target identification to in vivo experimental design through clinical trial simulation, patient stratification, and regulatory evaluation. These examples also illustrate the diversity of QSP modeling approaches. Moving forward, the adoption and success of QSP will require a clearly articulated record of impact on drug development decisions, alongside the development of approaches to address current challenges in the implementation and technical evaluation of such efforts.