The Model-informed Drug Development Imperative in Oncology R&D
Model-informed drug development (MIDD) leverages a range of quantitative methods (modeling and simulation or in silico tools) to inform critical R&D decisions such as dose regimen, evaluation of safety and efficacy, understanding mechanism of action, clinical trial design, including cohort selection and analysis of special populations, as well as the commercial probability of success as compared with existing therapies or those in development. It provides value across the development cycle, for informing internal decisions, including “go/no go” based on probability of regulatory and technical success, and/or regulatory and label decision support. The impact of 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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