The Model-informed Drug Development Imperative in Oncology R&D

The impact of model-informed drug development (MIDD) is especially powerful in oncology, where numerous cases demonstrate its enormous value in streamlining and accelerating the development cycle and supporting breakthrough therapy options for these fragile patients. MIDD is used to elucidate the complexities of oncology development, including those related to combination therapies, drug-drug interactions and other safety issues, and identifying more informative endpoints. However, despite exponential uptake in recent years and increasing bullishness on the part of the regulators, MIDD is still being underutilized—signaling a missed opportunity for many stakeholders.

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