Quantitative Approaches to Informing Clinical Decisions – Where does Systems Pharmacology Fit In?

The need for model-informed drug development to improve clinical trial efficiency, optimize dose and schedule, inform personalized medicine approaches, and generally improve the probability of regulatory success is clear. But MIDD encompasses many methods, including conventional population PK/PKPD modeling approaches, physiologically-based PK modeling, model-based meta-analyses, and mechanism-based quantitative systems pharmacology models.
To successfully accelerate decision-making in drug development, whether that decision is to move forward or terminate a program, the right tools must be applied at the right time and in the right way. Just as we develop parsimonious models, whether mechanistic or not, we must be parsimonious in our application of mechanistic modeling, using it only for those problems that are intractable with other approaches.
This talk will discuss opportunities to inform decision-making in drug development through modeling and simulation, with a particular focus on the appropriate use of QSP models and the challenges associated with their use, and demonstrate the utility of employing the right MIDD approach through presentation of several real-world case studies.