Europe’s pharmaceutical industry wants more clarity on ICH’s modeling guideline
Pharmaceutical industry groups say that more information and examples are necessary to effectively use various modeling techniques for drug development under the International Council for Harmonisation’s (ICH) draft M15 guideline on model-informed drug development (MIDD).The comments were submitted in response to the European Medicines Agency (EMA)’s call for feedback on ICH’s M15 guideline on general principles for MIDD. ICH released the guideline to regulators in November 2024 (RELATED: ICH releases draft GCP annex, MIDD guideline, RAPS Focus 18 November 2024).
EMA received seven comments on the guidance from pharmaceutical groups and companies.
The goal of modeling is to enhance the efficiency of drug development while minimizing unnecessary patient exposure by integrating mathematical and statistical data to predict the drug's effects.
Industry requests more modeling examples
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Teva Pharmaceuticals Industries Ltd. wanted more examples of how different modeling approaches can be used in drug development.
“It would be helpful if this ICH guideline provided detailed elaboration on the use of MIDD in specific therapeutic contexts, such as pediatrics, new indications based on similarities, and others,” according to Teva’s comments.
EFPIA wrote, “The guidance is currently very general - examples would be extremely valuable to include as part of the planned training materials.”
Distinction between model influence and model impact is unclear
Pharmetheus, a consultancy, and Parexel, a clinical research organization, wanted more clarity on the distinction between model influence and model impacts.
The guideline defines model influence as “the intended weight of the model outcomes in decision-making, considering the contribution of other relevant information,” whereas model impact is defined as “the contribution of the model outcomes in relation to current regulatory expectations or standards in answering the Question of Interest.”
Pharmetheus wrote that the “distinction between model influence and model impact is unclear, and the two terms appear to overlap.”
Parexel also requested clarity on the two terms, noting that “the two concepts appear to be strictly related.”
More clarity on validating modeling software
Medicines for Europe and the EFPIA requested more information on how to validate modeling software.
The guideline states that “the quality assurance of computer software used for M&S [modeling and simulation] related data management and analysis should be documented. This includes appropriate software testing procedures, including installation and version tracking.”
Medicines for Europe noted that, “From a QA perspective, the processes involving computerized systems can be validated at different levels (i.e. whole process validation, system validation, software validation, etc.) … What level of validation is expected in the tools and process used for MIDD models? Would it be possible to consider different levels of validation, such as a model development environment and a model application environment?”
EFPIA also requested that ICH “expand” on the acceptability of the software and model evaluation provided by the software developers.
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