Product development teams are facing continued pressure to develop more products in less time and with fewer resources. Platform-based developed is commonly seen as a solution to increase capacity of the product development pipeline. This research identified enablers and barriers to successful platform-based product development. This was achieved through a comprehensive literature review of the current state of the art and an exploratory case study of product development practices within a business-to-business environment from companies with significantly different cultures and experiences with platform-based product development. Key enablers identified in this research include institutionalizing systems engineering, development and communication of product development roadmaps, augmentation of phase gate review process and critical parameter characterization. Operational recommendations from this research are considered to be possible to implement without significant changes to existing processes and organizational structures.
Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report
