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  The impact of serialisation on operational efficiency and productivity in Irish pharmaceutical sites

  (2020) O'Mahony, Daniel

  Serialisation technology was introduced to protect the pharmaceutical supply chain from infiltration by falsified and substandard medicines. The implementation of serialisation systems required a substantial investment by pharmaceutical manufacturers. This study investigated the impact of serialisation on the operational efficiency and productivity in Irish pharmaceutical sites. Ireland plays an important role in the global pharmaceutical manufacturing network. All of the top ten largest pharmaceutical companies have manufacturing operations in Ireland. A review of the literature showed only limited publications on the topic of serialisation, operational efficiency, and productivity, particularly in the Irish context. A research method was designed to assess the relationship between serialisation, operational efficiency, and productivity. The research consisted of a survey and interview process with 11 manufacturing sites in Ireland. Participating companies operated a total of 114 pack-lines, representing approximately 65% of the automated packing lines in the country. The research focused on measurements such operational equipment effectiveness (OEE), line availability, unit cost and cost per pack. The study revealed that serialisation had a negative impact on pack line OEE and line availability. The research found that serialisation had a negative impact on the unit cost of packaged pharmaceuticals. The study assessed the expected costs of serialisation with the actual costs experienced by manufacturers. The research found that the actual capital costs of serialisation were four times greater than the costs originally outlined by policymakers. The study identified a trend where Irish pharmaceutical sites are moving away smaller batch production and moving toward larger batches so as to gain greater efficiencies, The research also proposed the use of a serialisation depreciation factor ( 𝑆𝐷𝑓) as a method to determine the impact of serialisation on the cost of goods sold.
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  The Impact of Blockchain Technology on Clinical Trial Data Integrity

  (2020) Cullen, Karl

  In this study it was shown how a new and emerging technology known as Blockchain, a data management platform, possesses the potential to address some of the predominant issues pertaining to clinical data integrity within clinical trial research studies. However, many obstacles and challenges persist with its implementation and these must be addressed, understood and solved before the technology can be utilized to manage clinical data. The main research objective of this study was to examine how Blockchain could be suited to address the concerns relating to clinical data integrity and to address the perceptions of participants involved with clinical data management to the technology and its potential application within clinical trials. Through an exploratory quantitative and qualitative mixed methods approach aligned with a pragmatist research philosophy, primary data was collected from participants who were purposively selected from a homogenous sampling pool that consisted of those with backgrounds in clinical data management. Primary data produced from this study highlighted the correlation of data issues that contribute towards the lack of integrity of clinical data with those found in secondary research. It was also found that the perception of Blockchain was generally positive and favorable towards its adoption within clinical trials. However, there was a degree of uncertainty surrounding the security of data within Blockchain. Various challenges were identified, primarily, the complexity of the technology and challenges related to compliancy with data protection laws. The conclusive determination of Blockchain’s suitability to address clinical data concerns, however, remains unanswered and further research is needed to test the application of Blockchain in real-world clinical trial environments. Further research and studies are also necessary to address the many challenges that face Blockchains implementation with clinical data management.
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  An Analysis of The Use of Wearable Technology as A Means of Controlling Drug Delivery Systems and The Challenges Facing Its Usage in Ireland

  (2020) Adewumi, Bolatito Temitayo

  In this study, the possible/existing use (in Ireland) of wearables (such as the smartwatches, patches, and contact lenses) in controlling drug delivery systems (such as pumps and nanoparticles) was analysed. The challenges affecting the use of this technology in Ireland were determined. The public and potential customers' perception of the novel technology was examined along with how the creation will be potentially received in the market. Ireland was the country of choice because the researcher resides there and because of the heavy presence of many pharmaceutical companies in the country. The secondary research was conducted by looking into the concept of controlled drug delivery and how it works. The history, uses and the market for wearable devices was explored globally and in Ireland. The concept of wearable device-controlled drug delivery systems was then introduced. The different commercially available ones were analysed and the challenges facing the use were examined. The data collection involved quantitative research via questionnaire (219 participants) to establish the challenges facing the development and manufacture of this type of drug delivery system. The knowledge and views of Irish consumers concerning the use of this technology were established. Qualitative data was also collected via interviews (of 3 industry experts) to further explain these technologies and determine the level of progress in the research & development and manufacture of the devices in Ireland. The use of wearable devices in controlling drug delivery systems is still at its early stage in Ireland and some people have little or no knowledge of the use of this type of drug delivery system. Majority of the participants were interested in using the technology (83.5%), 65.6% would rather use this wearable device-controlled drug delivery system because more than half of the participants trust that this type of drug delivery system is more effective. Some of the limitations of the use of this type of drug delivery system from the consumers’ point of view are based on the concerns on the high cost, efficiency, and accuracy of this type of drug delivery system. The size, look, comfort, and ease of use of these devices influence the use of this type of drug delivery system. According to the industry experts, challenges like heavy regulations and the massive amount of time, money, and resources involved in the Research & Development affect the manufacture and use of wearable device-controlled drug delivery systems in Ireland.