Document Type

Theses, Ph.D

Rights

Available under a Creative Commons Attribution Non-Commercial Share Alike 4.0 International Licence

Disciplines

1.4 CHEMICAL SCIENCES

Publication Details

Thesis submitted to the Technological University Dublin in fulfilment of the requirements for the award of Doctor of Philosophy (PhD), 2018.

Abstract

This research examined current industry Knowledge Management (KM) methodologies and capabilities in order to gain insights into the level of maturity and understanding of KM within the biopharmaceutical sector. In addition, the researcher has developed models, tools and processes that can assist the sector to gain greater clarity of the value and merits that KM can offer to organizations. The researcher proposes that a systematic KM program can be used to “unlock” the knowledge and organizational capabilities necessary to convey real competitive advantage, but more importantly for the patient, to enable organizations to successfully develop and deliver the next generation of advanced therapeutics. The research questions asked; What are the current levels of adoption of KM within the biopharmaceutical sector? How is ‘critical knowledge’ defined within organizations? What might represent the core elements of a Pharma KM Blueprint to better enable knowledge flow within organizations? The research approach adopted a pragmatic worldview which is most suited to a research topic that is both real world practice orientated and problemcentered and sought to examine the consequences of actions within the biopharmaceutical sector when knowledge is not managed effectively. There were three primary phases of inquiry employed in the thesis and a mixed methods approach was used to explore the problems addressed. The first phase involved quantitative and qualitative data analysis of relevant literature sources, including available international KM benchmarking data. The second phase involved a biopharmaceutical industry consultation phase comprising of focus groups, polls and philosophical dialogues with KM experts, sector KM practitioners and knowledge workers. The third and final phase of inquiry involved the adaptation and development of the Pharma KM Blueprint including practical KM tools, frameworks and models for use within the biopharmaceutical sector. This phase also included a detailed case study executed within one large biopharmaceutical organization of a KM diagnostic tool and process developed as part of this research.

The research findings have established a core principle that knowledge must be valued and managed as a critical asset within an organization, in the same manner as physical assets. In addition, the research identified that in order to realize the ambitions of ICH Q10, stated as, ‘enhance the quality and availability of medicines around the world in the interest of public health’, (ICH Q10, 2008), there is a crucial need to enhance the effective and efficient flow of knowledge across the product lifecycle within organizations. The research finds that in order to extract value from this organizational knowledge there must be practical, integrated and systematic KM approaches implemented for the identification, capture, curation and visibility of the critical knowledge assets before the matter of enhancing the flow of knowledge can be addressed. The research indicates that while these concepts are important to any business within the traditional biopharmaceutical sector planning on remaining competitive, they represent a “game changer” (or “game over”) opportunity for any organization planning to develop, manufacture or market advanced therapeutic products, personalized medicines or next generation products. A key output of the research is the Pharma KM Blueprint that illustrates the holistic integration of core KM principles, models and tools to deliver the real benefits to the patients and the business.

DOI

https://doi.org/10.21427/aex5-5p19

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