Marc R. Gastonguay, William Knebel, Timothy Waterhouse, Jeannine Fisher, Brian Corrigan
Presented at the 2026 American Conference on Pharmacometrics (ACoP 2026), an International Conference on Pharmacometrics in the US (ICoP – US), on October 12, 2026.
Regulatory submissions for new drugs (NDAs/BLAs) increasingly rely on MIDD (model-informed drug development) analyses to support dosing, labeling, and design of post-approval trial commitments. Frequently, MIDD related activities (data cleaning/prep, analysis, summary document preparation) are on the filing critical path (CP) following completion of the final registration studies, with delays directly impacting time to file. These delays impact overall medicine value and access for patients. This case study highlights a MIDD acceleration (MIDD-A) strategy that resulted in a meaningful reduction in the NDA submission critical path (CP) for an ongoing Phase 3 drug development program.