Richard Pugh
Mango Solutions
Objectives:
The aims of this work was to develop a software platform that would:
- Provide a regulated environment for modeling work supporting health regulatory drug development activities
- Provide a secure, auditable model management system
- Allow for the storage, management and searching of modeling knowledge
- Provide a sophisticated model development platform
- Apply rigor to the modeling process without adding overhead to the modeler
- Provide a basis for standardisation and best practices across a modeling team
Methods:
The MSWB team collaborated to design an integrated knowledge management and model development platform, meeting the requirements of a health regulated system. The platform has been deployed at Merck, and is required for all PKPD modeling activities at Merck.
The MSWB team developed requirements, architecture and software to create a platform that integrates several elements.
- Security and controlled access, allowing for blinded and due diligence modeling projects
- Searchable and annotated model repository
- Supports model development workflow around NONMEM, including R and Matlab scripting
- Execution of jobs on a high performance computing systems
- “Invisible” rigor (audit trail, versioning, meta data discovery)
Notably, the system supports a range of technical use, encompassing everything from “command line” access to visual “model review” tools.
Results:
Key system features will be demonstrated via screenshots, highlighted by the factors driving the design (such as model review, knowledge integration, remote execution). Conclusions: Navigator Workbench provides a knowledge driven modeling platform that effectively supports the use of modeling for decision-making on drug development programs at Merck
Conclusions:
Mango and Merck formed a cross-functional team that designed and delivered a model development and knowledge platform that meets the needs of a modern pharmacometric team. This close collaboration combined with a phased development approach enabled the creation of a best-in-industry modeling platform that is truly fit for purpose
Reference: PAGE 24 (2015) Abstr 3588 [www.page-meeting.org/?abstract=3588]
Poster: Methodology - Other topics