The ecosystem of how the pharmaceutical industry acquires data, transforms these data into tangible knowledge, and derives valuable insights throughout the process, is highly complex. Data, information, knowledge, and the resulting insights, are necessary to support decision- making, manage risk, problem solve, ensure product realisation, enable continual improvement, and enhance operational effectiveness. Building on the fundamental concepts established in the well-known Data Information Knowledge Wisdom (DIKW) hierarchy, this paper reviews the basic concepts involved in the DIKW pathway and begins to relate these concepts to both established capabilities (e.g., PAT), existing requirements (e.g., data integrity), and emerging trends in the industry (e.g., industry 4.0). This paper introduces additional research studies which the Pharmaceutical Regulatory Science Team (PRST) is considering, regarding how one might apply systems thinking concepts to develop a framework which will enable key stakeholders (Industry, Regulatory and Academia) to better relate the many elements of this ecosystem. The paper concludes by identifying preliminary foundational principles which could form the basis of such a framework, coined by the authors as ‘The pharmaceutical knowledge ecosystem’, and makes the case for further exploration of this concept.

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Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License
This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.



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