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Model-Informed Drug Development: Details on FDA Pilot Project

Posted 16 April 2018 | By Zachary Brennan 

Model-Informed Drug Development: Details on FDA Pilot Project

Details on the US Food and Drug Administration’s (FDA) plans for launching a pilot project on model-informed drug development (MIDD) began trickling out on Monday with a Federal Register notice.

Thanks to the Prescription Drug User Fee Act (PDUFA VI), FDA will begin hosting pilot program meetings later this year and running through 30 September 2022.

“The goal of the early meeting discussions granted under this pilot program is to provide advice on how specific, proposed MIDD approaches can be used in a specific drug development program,” the agency said. “FDA has committed to accepting two to four meeting requests quarterly each fiscal year. The meetings granted will include an initial and followup meeting on the same drug development issues within the span of approximately 120 days.”

FDA said it expects to initially prioritize selecting meeting requests that focus on:
  • “Dose selection or estimation (e.g., for dose/dosing regimen selection or refinement).
  • Clinical trial simulation (e.g., based on drug-trial-disease models to inform the duration of a trial, select appropriate response measures, predict outcomes).
  • Predictive or mechanistic safety evaluation (e.g., use of systems pharmacology/mechanistic models for predicting safety or identifying critical biomarkers of interest).”
FDA will accept requests to participate in the program on a continuous basis beginning 13 April 2018 through 15 June 2022. 

For the pilot, FDA said it defines MIDD as “the application of exposure-based, biological, and/or statistical models derived from preclinical and clinical data sources to address drug development and/or regulatory issues.”

FDA said the pilot will exclude statistical designs involving complex adaptations, Bayesian methods or other features requiring computer simulations to determine the operating characteristics of a confirmatory clinical trial.

In March, the agency held a meeting on complex clinical trial designs.

The Federal Register notice on Monday also included information on the content and format of the meeting request and what sponsors or applicants whose meeting requests are granted should submit electronically.

Model-Informed Drug Development Pilot Program

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