ACCELERATION OF CRITICAL PATH MODEL INFORMED DRUG DEVELOPMENT (MIDD) SUBMISSION ACTIVITIES VIA DATA AND TOOL STANDARDIZATION

ACCELERATION OF CRITICAL PATH MODEL INFORMED DRUG DEVELOPMENT (MIDD) SUBMISSION ACTIVITIES VIA DATA AND TOOL STANDARDIZATION Brian W. Corrigan¹, Matthew Riggs¹, Mike Ferguson¹, Joydeep Bhattacharya¹, Marc R. Gastonguay¹ 1 Metrum Research Group, Boston, MA, USA

Regulatory submissions for new drugs (NDAs/BLAs) increasingly rely on
pharmacometric (PK/PD) analyses to support dosing, labeling, and design of
post-approval trial commitments.
More 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.
Accelerating MIDD related CP activities via methods standardization,
process automation, and proactive planning offers a potential mechanism for
increasing speed without compromising quality