Document Type

Theses, Ph.D

Disciplines

3.4 HEALTH BIOTECHNOLOGY

Publication Details

Lori Richter, B.S Microbiology College of Science and Health, School of Chemical and Biopharmaceutical Sciences. A thesis submitted to Technological University Dublin in fulfilment of the requirements for the award of Doctor of Philosophy (PhD), February 2024.

Abstract

Drug shortages, quality defects and challenges regarding innovation within the biopharmaceutical industry pose significant risks to patient safety and organisational performance. These problems persist despite the many scientific, technological and economic advances over the past several years in a well-funded, high-revenue industry operated by highly qualified personnel. Evidence suggests that the industry has yet to fully realise the potential for building organisational capabilities to enable learning from mistakes to enhance performance outcomes. This research study explored how biopharmaceutical companies can learn from their mistakes and embrace a culture of learning in order to reduce quality defects and drug shortages by deliberately and continuously innovating to improve operational performance and reduce patient risk. The research unfolded in four phases. Phase I involved a comprehensive literature review and the development of an initial concept for a Patient-focused Learning Excellence Model (PFLEx). Phase II engaged industry experts through a podcast series, Risk Revolution, to gather insights into learning within the biopharmaceutical sector. The research uncovered barriers to adopting organisational learning within the industry. The PFLEx prototype emerged as an output of this phase of research.

DOI

https://doi.org/10.21427/dwa1-y274

Creative Commons License

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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