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EMA Publishes a Commentary on the MID3 White Paper

EMA Publishes a Commentary on the MID3 White Paper

The value of integrated modeling and simulation (M&S) as a decision-making tool is well established across a range of industries and disciplines, such as engineering, finance, aerospace, and weather forecasting.

Arguably, the pharmaceutical industry has been a relatively late adopter, but in the last 2 decades there has been a steep growth in the application of modeling and simulation across the R&D spectrum, which now ranges from modeling of large biological pathways to guide the identification of new drug targets to the prediction of cost-effectiveness using pharmacoeconomic models. In drug development, modeling and simulation has become an integral and expected part of internal and regulatory decision making, as illustrated by regulatory best practice guidelines. For example, as a response to a request from the European Medicines Agency (EMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA) recently published a good practice document covering all aspects of planning, conduct and documentation of quantitative approaches across R&D, which they labeled model-based drug discovery and development, or MID3. In this White Paper, the value of MID3 and impact on decision making is evidenced by ~100 case studies. It states that Pfizer has reported that model-based drug development approaches enabled a reduction in the annual clinical trial budget of $100 million and resulted in an increase in late-stage clinical trial success, whereas Merck has reported cost savings of $0.5 billion through MID3 impact on decision-making.

The M&S working group (MSWG) of EMA has now published a commentary on the MID3 good practices paper in PSP. It is a critical assessment of the current state of M&S applications EMA receives. For example, it is stated that current applications are often dissociated from clinical decisions on the design and objectives of the clinical trial and that M&S analyses are not well integrated into phase III study protocols since the rationale behind it has not been fully communicated and understood. A “communication gap” between modelers and clinicians is highlighted as a common issue and it emphasizes the importance of improving M&S communications and reporting across disciplines. The EMA MSWG welcomes the MID3 recommendations regarding the routine use of a strategic M&S plan, assumptions table, and use of different sections in an analysis report to serve different audiences and states that implementation of these recommendations will result in a clear improvement compared to the current submissions.

The MSWG invites other groups to develop good practice documents and actively engage in discussions with EMA. PSP is of course, keen to continue to facilitate this and publish best-practice papers to further advance the discipline of pharmacometrics and systems pharmacology.

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