Drugs

Model-Informed Drug Development Pilot Program

As displayed in the Federal Register notice on April 16, 2018, the FDA is conducting a Model-Informed Drug Development (MIDD) Pilot Program to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources, referred to as MIDD approaches.  MIDD approaches use a variety of quantitative methods to help balance the risks and benefits of drug products in development. When successfully applied, MIDD approaches can improve clinical trial efficiency, increase the probability of regulatory success, and optimize drug dosing/therapeutic individualization in the absence of dedicated trials.   

Goals of the MIDD Pilot Program

The MIDD Pilot Program fulfills a performance goal agreed to under the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI), included as part of the FDA Reauthorization Act of 2017.

The MIDD Pilot Program is designed to:

  • Provide an opportunity for drug developers and FDA to discuss the application of MIDD approaches to the development and regulatory evaluation of medical products in development, and
  • Provide advice about how particular MIDD approaches can be used in a specific drug development program

Procedures and Submission Information

Under the pilot program, FDA will accept 2-4 paired-meeting requests quarterly each year throughout the PDUFA VI period.  For each meeting request granted as part of the pilot, FDA will conduct an initial and follow up meeting on the same drug development issues to occur within a span of approximately 120 days.

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Eligibility Criteria

  • Drug/Biologics development company with an active IND or PIND number for the relevant development program
  • Interested consortia or software/device developer should come in partnership with a drug development company
  • This excludes statistical designs involving complex adaptations, Bayesian methods, or other features requiring computer simulations to determine the operating characteristics of a confirmatory clinical trial

Selection for Participation

FDA welcomes submissions related to any relevant MIDD topics. However, given that the Agency expects to grant 2-4 meeting requests per quarter as part of the pilot program, the Agency will initially prioritize selecting 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, etc.)
  • Predictive or mechanistic safety evaluation (e.g., use of systems pharmacology/mechanistic models for predicting safety or identifying critical biomarkers of interest)

Submission dates and decisions

FDA will accept requests to participate in the program on a continuous basis beginning on April 13, 2018 through June 15, 2022.  Meeting-granted and -denied decisions will be made the last two weeks of each quarter of the fiscal year based on submissions received to date.  Applicants will receive a meeting-granted or -denied notification the first week of the new quarter.

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Submission Process

Meeting requests should be submitted electronically to the relevant application (i.e., PIND, IND) with “MIDD Pilot Program Meeting Request for CDER” (CDER applications) or “MIDD Pilot Program Meeting Request for CBER” (CBER applications) in the subject line. Information about providing regulatory submissions in electronic format is available at: Electronic Common Technical Document (eCTD)

Content & Format of the Meeting Request

Include the following information in the meeting request (no more than three to four pages):

  • Product name
  • Application number
  • Chemical name and structure
  • Proposed indication(s) or context of product development
  • Brief statement of the purpose and objectives of the meeting. The statement should include a brief background of the MIDD issues underlying the agenda
  • MIDD approach(es) considered for the product under development and how MIDD can assess uncertainties about issues (e.g., dosing, duration, patient selection) in a way that can inform regulatory decision-making
  • List of issues for discussion with the Agency about the specific MIDD proposed approach for the applicable drug development program

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Content & Format of the Meeting Information Package

Sponsors whose meeting requests are granted as part of the pilot program should submit a meeting information package electronically with “MIDD Pilot Program Meeting Package for CDER” (CDER applications) or “MIDD Pilot Program Meeting Package for CBER” (CBER applications) in the subject line no later than 30 days before each (initial and follow-up) meeting. This meeting package should include the following information:

  • Product name
  • Application number
  • Chemical name and structure
  • Proposed indication(s) or context of product development
  • Background section that includes a brief history of the development program and the events leading up to the meeting, and the status of product development
  • Proposed agenda, including estimated times needed for discussion of each agenda item
  • List of questions for discussion with a brief summary for each question to explain the need or context for the question
  • Drug development issue (e.g., dosing, clinical trial design, safety prediction), including the proposed MIDD approach to the solution, information to support discussion (e.g., a description of the data used for developing the models, model development, simulation plan, results), and how the Agency can help guide any next steps relative to the regulatory decision-making process, which should be summarized and clearly articulated with any supporting data imperative to the discussion

Meeting Summaries

  • A meeting summary will be sent to the requester within 60 days of each meeting

Submission Assistance

For more information, contact FDA at MIDD@FDA.HHS.GOV with “MIDD Pilot Program Meeting Package for CDER” (CDER applications) or “MIDD Pilot Program Meeting Package for CBER” (CBER applications) in the subject line.  

Learn More about Model Informed Drug Development at CDER from CDER Researchers – In Their Own Words:

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Page Last Updated: 04/17/2018
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