ICH: MIDD concept paper coming by year’s end

Regulatory NewsRegulatory News | 20 May 2021 |  By 

Regulators are increasingly interested in developing model-informed drug development (MIDD) programs, but some barriers still impede their more widespread adoption.
Among these is a lack of common understanding of MIDD between technical and non-technical experts, asserted Scott Marshall, executive director for Pfizer Research and Development in the UK, in a 15 May update on the progress being made by an International Council for Harmonization (ICH) discussion group on the topic of MIDD.
The US Food and Drug Administration (FDA) and Health Canada hosted the regional public meeting to provide an update on current ICH topics.
The ICH Assembly in May 2020 approved the establishment of a discussion group on MIDD; the group aims to recommend appropriate sequencing and format for incorporating MIDD concepts into a proposal on ICH E4. These concepts would either revise E4, be an addendum to the document, or supplement E4 with a question-and-answer document. The group also plans to develop a work plan for MIDD approval and develop a “roadmap” for integrating these approaches to drug development in existing ICH guidelines.
Marshall explained that the purpose of the modeling is to make drug development more efficient and to reduce unnecessary patient exposure by integrating data from mathematical and statistical models in predicting effects of the drug.
MIDD has broad applicability: it can be used to compare drug candidates, make predictions on dose selection, assist in human pharmacokinetic studies, and to make label recommendations. Marshall noted that a recent case study conducted by European Federation of Pharmaceutical Industries and Associations (EFPIA) found over 100 published case studies using MIDD models in drug discovery, development and lifecycle management.
Marshall said that the MIDD discussion group has met 11 times, and plans are to have a guideline outlining general MIDD principles in place by the end of the year.
Growing interest in MIDD
Regulators are also starting to issue guidance in this area.  For example, Marshall said, the European Medicines Agency, Japan’s Pharmaceutical and Medical Devices Agency, and China’s National Medical Products Administration have issued regulatory guidance on certain aspects of MIDD, while FDA issued a 2020 guidance on physiologically based pharmacokinetic analyses. (RELATED: FDA releases draft guidance for physiologically based PK analyses, Regulatory Focus, 1 October 2020).
He added that a 2019 FDA-authored paper also discussed current US regulatory  practice and future considerations for MIDD submission (RELATED: Research examines applications of model-informed drug development, Regulatory Focus, 18 January 2019).
Challenges cited
Marshall said that while there are many benefits of using MIDD in drug development, the working group found a lack of common understanding of MIDD between technical and non-technical experts to be the biggest challenge to its implementation.  Further barriers include the lack of common standards and understanding of MIDD terminology and the variable level of integration of these concepts into regulatory submissions.
ICH regional meeting


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