Quantitative Systems Pharmacology in Model-Informed Drug Development

When tailored for specific questions, QSP models enhance our grasp of clinical observations, guiding research with informed decisions, especially when they incorporate mechanistic insights. These models facilitate the integration of theory and data to test our understanding and explore the root causes of events. By offering quantifiable insights into the interactions within physiology, disease, and pharmacology, QSP models steer further research, impacting study design and biomarker selection. The presentation will encompass case studies on monoclonal antibody (mAb) development in bone health (osteoporosis), infectious disease (SARS-CoV-2), and oncology (relapsed/refractory diffuse large B-cell lymphoma).