Modeling and simulation (M&S) has the ability to influence every phase of the drug development process, including the commercial decisions around the benefits of even bringing a specific drug to market. One of the most important elements of M&S is that it allows carry-over of knowledge and wisdom from one phase to the next, and from one indication to the next, both in terms of successes and failures. M&S transforms data into information and information into knowledge.
Acknowledging the increasingly high costs and inefficiencies in the drug development process, the US Food and Drug Administration (FDA) launched the Critical Path Initiative (CPI) in 2004 to drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured. Specifically, the CPI called for an aggressive and collaborative effort to create a new generation of predictive tools, such as M&S, for informing crucial drug development decisions. Issues that the FDA wanted to address included first-in-human (FIH) dosing, better understanding of safety and efficacy, linking biomarkers to outcomes, optimizing trial design, and addressing special populations such as pediatrics.