1:30 PM
Apr 16, 2018
 |  BC Extra  |  Politics & Policy

FDA launches model-informed drug development pilot

FDA began 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.

The agency committed to a series of workshops to enhance the use of MIDD under PDUFA VI, which was included as part of the FDA Reauthorization Act of 2017 (see BioCentury Extra, Aug. 18, 2017).

The pilot aims to provide an opportunity for drug developers and FDA to discuss MIDD approaches to drug development and regulatory evaluation, as well as advice about how particular MIDD approaches can be used in a specific development program.

FDA will accept two to four paired meeting requests quarterly each year through June 15, 2022, with an initial focus on dose selection, clinical trial simulation and predictive or mechanistic safety evaluation.

The agency held a joint workshop in February with the International Society of Pharmacometrics to discuss MIDD for oncology products, as models can support dosing decisions and help companies make faster, better decisions about which products and combinations to take forward. FDA officials championed MIDD as a means to determine the optimal use of new products when scant clinical data leave unanswered questions (see BioCentury, Feb. 16).

One way companies and FDA are using MIDD is to model the phenomena that explain how tumor sizes and rates of growth change over time. This modeling of tumor kinetics gives more information about how tumors respond to treatments than RECIST (Response Evaluation Criteria In Solid Tumors). As a result, these models can allow companies and regulators to draw more conclusions from their data.

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