Medicine and Health Sciences Commons^™

Smart Missions That Enable Innovation In High-Risk Environments., Ed Hoffman

Level 3

This article is a lightly edited version of Ed Hoffman’s talk on to the 01-June-2023 seminar hosted by the PRST entitled ICH Q9(R1): The Next Frontier – An audience with international thought leaders exploring how the effective use of knowledge can enhance QRM outcomes to benefit the patient. Ed’s remarks are focused on the future of work, and the needs for relationships, storytelling, and understanding the mission to get the best out of our collective intelligence and navigate the future of work.

Emerging Technologies: Empowering People To Capture, Share And Transfer Tacit Knowledge, Donncadh J. Nagle, Melanie J. Adams

Level 3

ICH Q10 was published in 2008, and presented a model for an effective Pharmaceutical Quality System (PQS). However, the industry still has some way to go in embracing and implementing its principles in order to achieve greater product realisation, to establish and maintain a state of control, and to facilitate continual improvement.

ICH Q10 introduced us to two key enablers: Knowledge Management (KM) and Quality Risk Management (QRM).^[1] While the pharmaceutical industry has made progress in implementing the principles of QRM since 2008, there has been significantly slower progress in implementing knowledge management practices. However, there may be solutions …

Steps Towards Digital Transformation In The Pharmaceutical Manufacturing Landscape Knowledge-Enabled Technology Transfer, Anne Greene Professor, Martin Lipa Dr

Level 3

No abstract provided.

The Implications Of Tacit & Explicit Knowledge For Technology Transfer: When It Goes Well & When It Goes Wrong & What Can Digital Do To Help!, Paige Kane Dr., David Twohig Dr.

Level 3

No abstract provided.

Managing Risk And Knowledge: Frameworks To Guide Knowledge-Enabled Technology Transfer, Martin Lipa Dr, Anne Greene

Level 3

Technology transfer is not only about the transfer of technology, but also about the transfer of knowledge, as evidenced by definitions of KM within the biopharma industry and beyond. However, knowledge transfer is often not well structured and its effectiveness – in particular for tacit knowledge (i.e., know how) – is an opportunity for improvement which can lead to many benefits. This article profiles recent research into the topic of improving knowledge transfer during technology transfer and presents several recently developed frameworks for improving such. The article furthermore explains how the frameworks can be co-deployed in support of robust knowledge …

People Perspectives In The Deployment Of Data Analytics For New Knowledge Generation In Pharmaceutical Manufacturing, Marcus O'Mahony Dr.

Level 3

Digital medicine manufacturing of the future will almost certainly involve greater use of advanced analytics tools for more data-driven decision-making. In this article, the role of people in the deployment of data analytics tools within the pharmaceutical manufacturing setting is explored. Some perspectives are presented for how people can make sense of working cross-functionally on the analytics journey to deliver new knowledge and insights that enable data-driven decisions to be made. Data analytics is defined and is proposed as a critical common ground between the “on-the-ground” data practitioners and the decision-makers who act on new knowledge. Reference is made to …

Enhancing The Capabilities Of Fluid Bed Granulation Through Process Automation And Digitalisation, Marcus O'Mahony, Caroline Mccormack, Chris O'Callaghan, Ian Jones, Gavin Walker, Patrick Cronin

Level 3

This paper describes a PAT-enabled, digitalised, and automated fluid bed granulation system. A multichannel Near-Infrared (NIR) spectrophotometer and a direct imaging particle size and shape analyser in constant dialogue with the SmartX no-code/low-code platform provide a ground-breaking process automation toolset now located at the Bernal Institute in the University of Limerick. Two sets of results are presented for this study, from two iterations of the Advance Dynamic Process Control (ADPC) controller application. The results demonstrate the direct measurement and control of the product’s critical quality attributes through digitality enabled feedback control of processing setpoints and parameters. The platform controlled the …

“Holistic Risk-Based Site Surveillance – A Data-Based Approach To Site Quality Risk Identification And Assessment In The Pharmaceutical Industry”, Matteo Bernasconi, Thomas Friedli, Nuala Calnan (Editor)

Level 3

Effective quality risk management is fundamental in guaranteeing the development and manufacture of high-quality drugs, reducing drug shortages, and avoiding harm to patients’ health. The ability to accurately assess the actual risk environment, predict potential product quality or supply disruption issues and act to eliminate, prevent, reduce or mitigate them is key to improvements in quality management maturity. This paper illustrates a just-launched research project aimed at developing a comprehensive framework for how to assess and predict risks by leveraging a range of diverse factors.

“Gaining Organisational Acceptance Of A Data Analytics Programme In Eli Lilly”, Anthony Maguire, Marcus O'Mahony

Level 3

This paper describes how Eli Lilly overcame barriers to enable new use of data. This was achieved by adopting a deep understanding of end-user needs and the support of site leaders and end-users to standardise process monitoring. A standard approach of ‘Contexting’, ‘Data-Extraction’, ‘Model build’, ‘On-line Config’, ‘Deploy’, was utilised, using a commercial off-the-shelf software. The paper describes proof of concept demonstrations undertaken and discusses the ingredients to make the journey a success.

A Survey Report On The Current State Of Quality Risk Management (Qrm) And Knowledge Management (Km) Integration, Martin Lipa, Kevin O'Donnell, Anne Greene

Level 3

As part of research to better define and improve the integration between quality risk management (QRM) and knowledge management (KM) as dual enablers of an effective pharmaceutical quality system, a survey was conducted in February 2021 to explore this relationship. The survey explored the current state relationship in theory and in practice, solicited feedback on a proposed framework, the Risk-Knowledge Infinity Cycle, to improve the connection between QRM and KM, associated benefits and potential actions to make progress in this regard. The results suggest QRM and KM are highly interdependent in theory but much less so in practice. Further, …

Care For Some Lunch? It’S More Than Just Food! Care, Commensality And Pedagogic Meals In Irish Primary Schools, Caroline Mcgowan

Level 3

This expository article addresses a lacuna in policy and practice literature around using primary school lunches as both a pedagogical opportunity and a space to expose children to social and cultural ‘rituals’ that model both care and food sharing as commensality. The article argues that policy literature in this space broadly tends to be concerned with a medicalised paradigm of nutrition, physical and cognitive development, and disease prevention, with scant regard for the impact that natural ‘everyday’ practices of eating and caring can have on enhancing encultured commensality, care and learning.

Mapping Km Methods And Tools Across The Pharmaceutical Product Lifecycle, Martin Lipa, Paige Kane

Level 3

Knowledge management is positioned as an enabler of ICH Q10, and the visibility and availability of product and process knowledge across the entire pharmaceutical product lifecycle is vital to the sustained success of an organization and to the effectiveness of an organization’s pharmaceutical quality system as defined by ICH Q10. This paper illustrates where knowledge management has a role to play within each product lifecycle phase. This paper goes on to further define phase-appropriate KM methods and tools to help address these needs and create end-to-end product and process knowledge visibility and availability.