DDMoRe private repository linked with an in-house PK database
Vincent CROIXMARIE (1), Sophie PEIGNE (1), Donato TEUTONICO (1) and Marylore CHENEL (1)
(1) Clinical Pharmacokinetics and Pharmacometrics division, Servier, France
Objectives: The Drug Disease Model Resources (DDMoRe) Repository [1] is a powerful online tool for reference models storage [2]. It has been developed to “enable access to community curated models for the benefit of model-informed drug discovery, development (MID3) and usage”. From frozen databases, time-concentration profiles are analyzed with population modeling approach and individual secondary pharmacokinetics (PK) parameters are derived. As an internal solution at Servier, a dedicated PK database was design to store such secondary PK parameters as well as the associated final models. This parameter database is built for each compound during drug development. Models developed for the determination of such secondary PK parameters are considered as metadata associated with the parameters and are stored as such in the database. The objective of the project was to define a consistent workflow for model storage with both tools and to integrate DDMoRe metadata capabilities to account for internal needs.
Methods: A working group of PBPK and PK/PD modelers was established to define the appropriate database integration and to define the requirements of metadata annotation needed for the DDMoRe private repository.
Results: A private version of the DDMoRe repository was deployed at Servier. A connection between the DDMoRe internal repository and the PK database was established. Due to their different nature, the DDMoRe repository is integrated to host models as a model library, including final and draft versions, while finalized models and derived PK parameters are stored in the PK database. Consistency of final models across the two platforms will be assured thanks to their connection. Metadata capabilities of the original DDMoRe repository have been enhanced internally in order to allow deeper search across model parameters and features.
Conclusions: A workflow for model storage was showed integrating an internal storage solution for final models and model parameters with the DDMoRe model repository, which will be used as general model library. Such integration allows to profit from the advantage of combining a fully customized internal solution with the current and future functionalities of the DDMoRe model repository.
References:
[1] Harnisch L, Matthews I, Chard J, Karlsson MO. Drug and Disease Model Resources: A Consortium to Create Standards and Tools to Enhance Model-Based Drug Development. CPT: Pharmacometrics & Systems Pharmacology. 2013;2(3):e34-. doi:10.1038/psp.2013.10.
[2] http://repository.ddmore.eu/
