The Future of Clinical Pharmacology: Strategies Driving Global Drug Development and Expectations for Japan

抄録

Quantitative Clinical Pharmacology is redefining drug development, as demonstrated by Pfizer’s integration of Quantitative Medicine (QM) across the clinical research continuum. These strategies employ integrating modeling, real-world data, and novel biomeasures, digital and imaging endpoints to accelerate discovery&development, optimize dose selection, and enhance regulatory engagement. Case studies illustrate the application of mechanistic and more empirical models to inform clinical decisions, support regulatory interactions, and enable robust analyses in complex settings. From early exposure-response modeling to comprehensive frameworks and automated reporting tools, quantitative clinical pharmacology has driven cultural change and productivity gains, fostering objective decision-making and efficient regulatory submissions. Artificial Intelligence is becoming progressively more integrated in the QM toolset and promises transformational increase in productivity. Collectively, these approaches advance a vision for data-driven, efficient, and patient-centered drug development, ensuring that every decision is grounded in quantitative evidence and collaborative innovation. Clinical pharmacology in Japan is consistent with global best practices by embracing quantitative, model-informed strategies, rigorous dose justification, and transparent, evidence-based regulatory submissions. Japan’s early participation in global clinical trials is an opportunity for advancing drug development across all therapeutic areas. The integration of digital measures, real-world data, and advanced modeling will be key to meeting regulatory expectations and ensuring safe, effective medicines for global drug development.