Drugs

Feedback Sought on Model-Informed Drug Development

CDER and CBER are seeking input to help advance the agency’s model-informed drug development (MIDD) program. FDA has previously described MIDD as an umbrella term covering the “integration and application of statistical, biological, and pharmacological data in support of clinical trial design and quantitative decision making, and includes, but is not limited to, quantitative systems pharmacology, physiologically based pharmacokinetic analyses, dose/exposure-response analyses, and disease progression approaches. MIDD can help to conserve resources for industry, aid regulators in limiting human exposure and enhancing regulatory review, and potentially reduce time for approval and availability of new medicines globally as well as informing their better use.”

CDER/CBER’s new request for feedback aims to determine how to increase application of established MIDD approaches in regulatory decision-making, identify how emerging MIDD approaches are being implements within drug product development, and identify opportunities to enhance interactions with FDA when discussing MIDD approaches, according to a new notice about the program. The agency says it will use the feedback to identify and prioritize potential focus areas for future policy or guidance development.

The agency says feedback is being accepted on the following MIDD priorities:

Methods and Best Practices — FDA says that it is interested in learning about additional areas needing guidance within common quantitative approaches (e.g., population pharmacokinetic modeling, exposure-response modeling, and physiologically based pharmacokinetic modeling). In addition, it seeks input to explore potential guidance needs in all emerging MIDD approaches, including artificial intelligence/machine learning used in both drug design and evaluation and digital-twin technology.
Context-Specific Considerations — Input is being sought on the need to develop guidances to facilitate MIDD methods development, application, uptake, and acceptance in specific therapeutic areas. Related topics include identification of opportunities for incorporation of real-world data, specific therapeutic modality considerations, and preclinical to clinical translations.
Regulatory Engagement — Feedback is sought to advance discussions about MIDD approaches outside the MIDD Paired Meeting Program as part of regulatory meetings and regulatory submissions, including identifying what is currently working well and the barriers (e.g., technical, regulatory) encountered while trying to interact with FDA on MIDD-related activities.
Communication of Policies and Interested Parties’ Engagement — Input is sought to identify and prioritize potential topics and better ways for communication and engagement with interested parties.

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