Harmonization

The application of biomarkers to drug discovery and development has the potential of improving the efficacy and speed of bringing more effective and safer new drugs to market. This requires that biomarkers which may be applicable to such uses be qualified for a specific application context. To achieve this, both the process of qualification and the evidentiary criteria and standards for qualification will need to be described and defined. The International Committee on Harmonization's (ICH) E16 [16] is a harmonization effort to define the context, structure, and format of the biomarker qualification submission. It is based on the previous experience by the FDA and EMEA regarding biomarker qualification. This harmonization effort does not address the evidentiary requirements for biomarker qualification.

The structure, format, and content of a submission of biomarker data for qualification depend on the context in which the biomarker is intended to be used. The first step in drafting a submission for qualification of a biomarker is to determine its context of use, preceding specific decisions on applicable structure and format. The context of use for a biomarker is (1) the general area of biomarker application, (2) the specific applications/implementations, and (3) the critical factors that define where a biomarker is to be used and how the information from measurement of this biomarker is to be integrated in drug development and regulatory review. To demonstrate the alignment between proposed context and data, the initial context proposal must be supported by data available at the initial application step or expected to be available throughout the data evaluation process in biomarker qualification. There is a convergent relationship between an initial qualification context and the data supporting it. The initial gap between proposed context and data may need to be filled throughout the qualification process. Initial context proposals, however, should project a significant improvement over currently available biomarkers and/or endpoints.

The context of a biomarker drives data requirements to demonstrate its qualification for the intended application. The structure of a submission document ensures that the context and data can be submitted in a package consistent for consortia submitting qualifications as well as for reviewers in regulatory agencies evaluating a qualification package. The structure of a qualification submission is independent of the context of this submission, but must also be flexible enough to deal with the specific requirements of each context. On the other hand, the format of data required to qualify a biomarker may vary significantly with the context in which it is to be used. It is therefore only possible to harmonize general regulatory guidelines on data format for biomarker qualification submissions.

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Project Management Made Easy

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