| Abstract: |
| Quantitative Systems Pharmacology (QSP) has emerged as a powerful ensemble of approaches aiming to develop integrated mathematical and computational models that elucidate the complex interactions between pharmacology, physiology, and disease. As the field grows and matures, its applications expand beyond the boundaries of research and development and slowly enter the decision-making and regulatory arenas. QSP aims to provide an integrated understanding of pathology in the context of therapeutic interventions. Because of its ambitious nature and the fact that QSP emerged in an uncoordinated manner due to activities distributed across organizations and academic institutions, high entropy characterizes the tools, methods, and computational methodologies and approaches used. The eventual acceptance of QSP model predictions as supporting material for an application to a regulatory agency will require that two key aspects are considered: 1) increase confidence in the QSP framework, which drives standardization and assessment, and 2) careful articulation of the expectations. In this talk, we will summarize how the field emerged and evolved, and through examples, we will highlight some of the challenges and opportunities that are emerging. |
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