Dissertations - Pharmaceutical Business & Technology
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Item Optimising dog anthelmintic selection and worming protocols for use in Ireland(2024) Kelly, MartinThis dissertation relates to the use of anthelmintics for dogs in Ireland and the optimisation of the dosage type and protocols. It outlines the most common helminths found in dogs in Ireland as identified by subject matter experts (for the purpose of this research, the subject matter experts were chosen to be veterinarians). It outlines a series of factors which may be influencing pet owner compliance with anthelmintic dosing protocols. It also identifies the most suitable anthelmintic dosing protocol as advised by veterinarians. Recommendations for the most suitable anthelmintic dosage form are provided through surveys with dog owners and interviews with veterinarians. This dissertation was focused on dogs, dog owners and veterinarians working in Ireland. A mixed methodology method was used in this research. 202 surveys were conducted with dog owners and 12 interviews were carried out with veterinarians. The mixed methodology allowed for the combination of qualitative and quantitative data to be gathered for this research topic to get an understanding of the pet owners views in combination with veterinarian’s experience and knowledge. Roundworms were identified as the most common helminth present in dogs in Ireland. A clear lack of public awareness surrounding anthelmintic use, anthelmintic resistance and zoonosis was identified through this research. Based on the findings of this research, there is a need for improved public awareness surrounding the topic mentioned above. This could be done through various avenues such as infographics in public parks or through social media campaigns and various other methods. Secondly, a desire for improved regulation and control over the sale of anthelmintics for dogs in Ireland was identified during the interviews with veterinarians. This research provides valuable insights into Irish dog owners knowledge surrounding anthelmintic use, it identifies pet owners most preferable anthelmintic dosage form which could aid in providing improved pet owner compliance with dosing protocols. The most common helminth present in dogs in Ireland was also successfully identified and the most suitable anthelmintic, dosing method and protocols were also identified.Item Awareness, Benefits and Challenges to Digital Twin Adoption in the Irish Pharmaceutical and Biopharmaceutical Industry(2024) Shevlin, RoryIn this dissertation the awareness of Digital Twin adoption in the Irish Pharmaceutical and Biopharmaceutical industry are investigated. The benefits of Digital Twins, and the technical and regulatory barriers to their adoption are studied. Research was conducted using a mixed-method approach of an online survey (n=109) and an interview that was thematically analysed (n=4). All participants currently work in the Irish Pharmaceutical or Biopharmaceutical industry. The interview process inclusion criteria required participants to have an expert level of knowledge in ‘Digital 4.0’ technology. The survey identified a low awareness level of Digital Twins within the industry generally. There is a notable skew towards lower knowledge levels outside of Automation and IT roles. The interviews supported this with three of the participants describing awareness as minimal and the fourth indicating that knowledge was limited to those directly involved in implementation. The lack of engagement from operations and quality stakeholders would be essential for widespread adoption and highlights a need for broader understanding. Furthermore, there is general confusion across all roles on the definition and purpose of a Digital Twin. The benefits of Digital Twins were considered significant by both survey and interview participants. A greater understanding of manufacturing processes and improved process yields were repeatedly identified as major potential benefits. The interview responses supported and emphasised that financial justifications from both a capital and sustaining perspective are essential. Therefore, investment should be directed strategically to obtain the greatest return. The chief technical barriers identified in the primary research were that of data and system integration. The regulatory barriers were not widely perceived as significant from the survey population. However, respondents that did feel they were significant identified vendor model regulatory compliance and traceability of data as the main barriers. The interview responses indicated the regulatory barriers were significant and that the lack of a regulatory framework or guidance around Digital Twin validation and implementation generally, is a critical barrier to broader adoption of Digital Twins within the industry.Item A study of material differences since the introduction of the High-Tech Hub order website - the acceptance and effectiveness of online technology in the healthcare product reimbursement process(2024) Griffiths Kelly, FionaObjective: In this study it was shown that the introduction of the Health Service Executive High-Tech Hub (HTH) website, had a positive effect on the high-tech product procurement process. The research intention was to determine if users found the website easier to use than the alternate procurement system, and if the High-Tech website supported the end-to-end reimbursement and payment process more effectively. By identifying and understanding the critical success factors that impact user’s satisfaction of online systems. The significance of this study was, no comparative data had been recorded since HT Hub launch, to allow comparative analysis with the alternate procurement system. Methodology: The study adopted a mixed method approach, and was conducted through surveys with Irish community pharmacy, and interviews with pharmaceutical distribution companies. A combined total of 30 participants responded to the interviews and surveys. The data was collected and processed through Google Forms and Microsoft Office suite. Results: The data analysis identified acceptance by users of the High-Tech Hub online implementation, and the effective integration of the HSE HT website with pharmacies and product supplier systems. The challenge identified was the operation of two procurement systems for High Tech products. The data also identified the need to provide additional support for community pharmacies, with the growing need for pharmacy care. Conclusions: Based on this research, there is an opportunity for the HSE to fully integrate all High-Tech products on one online system, to bring greater efficiency and transparency to this €1Billion healthcare process.Item EXPLORING THE ALIGNMENT OF ICH REGIONS IN RELATION TO THE ACCELERATED APPROVAL OF FIRST-IN-CLASS DRUGS(2024) Kennedy, ConorThis study examines the regulatory challenges and organizational strategies in the pharmaceutical industry, focusing on the accelerated approval of first-in-class drugs in International Council for Harmonization (ICH) regions (European Union (EU), United States of America (USA), Japan). The objective is to identify the primary obstacles faced by pharmaceutical organizations in obtaining regulatory approval and to explore effective strategies to navigate these challenges. A quantitative research methodology was employed, utilizing structured surveys distributed to regulatory professionals with direct experience in regulatory submissions for first-in-class drugs. The results indicate that the major challenges include stringent regulatory requirements, complex clinical trial designs, data quality and integrity issues, communication barriers with regulatory agencies, and tight timelines. Significant variability in regulatory requirements was observed across ICH regions, particularly in documentation, approval timelines, and data quality expectations. Effective organizational strategies identified include early engagement with regulatory agencies, leveraging accelerated approval pathways, investing in advanced clinical trial designs, collaborating with external experts, and implementing robust quality management systems. The study finds that while these strategies are generally perceived as effective, their success can vary based on regional regulatory environments and organizational contexts. The study concludes that harmonizing regulatory guidelines across ICH regions, enhancing transparency and communication between regulatory agencies and pharmaceutical companies, expediting review times, and allowing more flexibility in clinical trial requirements are critical for improving the efficiency of the regulatory approval process. These findings offer practical insights for pharmaceutical organizations and policymakers, emphasizing the need for coordinated efforts to streamline regulatory practices and enhance patient access to innovative therapies.Item Advancing Biopharmaceutical Visual Inspection Technologies with Artificial Intelligence(2024) Lawlor, AaronThis research explores the use of Artificial Intelligence (AI) in visual inspection within the biopharmaceutical industry, focusing on the impact of false eject rates, applications of AI, AI as a solution for false ejects, and the challenges of AI adoption. The objectives of the research were to demonstrate the impact of current false eject rates on inspection efficiency, identify AI applications that can reduce these rates, and use industry expertise to evaluate the best solutions. The study has ultimately assessed whether AI implementation can improve the accuracy of visual inspections beyond the current state, offering practical, industry-relevant insights into enhancing inspection processes and reducing waste. Through thematic analysis of interviews with industry professionals, the study identifies key insights and gaps in the existing literature, offering a comprehensive view of current practices and challenges. The findings reveal that false eject rates significantly affect resources, schedules, and costs, with participants highlighting the need for improved processes to minimize these impacts. While existing literature addresses some aspects of false eject rates, this research uncovers additional implications, such as delays in product release and the perceived stability of eject rates, that are not widely discussed in prior studies. The study also explores the potential of AI in enhancing visual inspection processes, particularly through deep learning for recipe development. While participants see promise in AI, they emphasize the continued need for human expertise and raise concerns about the scalability of AI solutions in high-speed production environments. Challenges such as building large defect libraries, regulatory compliance, and the cost of AI adoption are also examined, with the research identifying areas where further guidance and innovation are needed. This research contributes to the body of knowledge by providing industry-specific insights, identifying gaps in the literature, and offering practical recommendations for integrating AI into visual inspection processes. It highlights the importance of collaboration between AI developers and industry experts and calls for future research to explore the long-term impact of AI on visual inspection and the development of supportive regulatory frameworks.