Digital Transformation is one of the hottest ‘buzzwords’ in the pharmaceutical manufacturing landscape at the moment. While new digital technologies offer numerous opportunities for process improvements, regulatory oversight and other barriers have slowed adoption relative to other industries. Good Manufacturing Practices (GMP) such as process validation and data integrity contribute to an environment where compliance can outweigh striving for continuous improvement. Research carried out by McKinsey in 2020 found that 93% of companies surveyed believe that their current business model will not survive and that it will require a digital and analytics transformation. The pharmaceutical sector is struggling with how to address this and reimagine how it does business in this digital era.

This collaborative special issue between the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin, supported by Convene, and the Pharmaceutical Manufacturing Technology Centre (PMTC) at the University of Limerick, builds on continued efforts to increase the adoption of data analytics tools and techniques in pharma manufacturing in Ireland, and in doing so, support the sector through its digital transformation efforts.

With case studies from Accenture, Alkermes Pharma Ireland, Eli Lilly Kinsale Limited, Health Product Regulatory Authority (HPRA), Innopharma Technology, Institute of Technology Management, University of St. Gallen, Switzerland, The Janssen Pharmaceutical Companies of Johnson & Johnson, Jacobs Engineering, MSD, and Odyssey VC. Sincere thanks to colleagues at PRST and PMTC for their contribution.

Event Program:

Welcome and Introductions:

• Professor Declan McCormack, Head of School of Chemical and Pharmaceutical Sciences, TU Dublin
• Sarah Hayes, Centre Manager, PMTC, University of Limerick
• Dr. Deirdre Lillis, Convene Lead, TU Dublin

Case Study Highlights:

• “Deployment of Data Analytics to Support Manufacturing at Janssen,” Patrick O’Sullivan, Global Digital Integration Manager, The Janssen Pharmaceutical Companies of Johnson & Johnson
• “Linking Data, Knowledge and Risk,” Dr. Marty Lipa, Executive Director, Knowledge Management, MSD, PRST member, TU Dublin
• “Introducing an FDA-funded Data Based Research Project,” Matteo Bernasconi, St. Gallen University, Switzerland

Q&A and Closing:

• Professor Anne Greene, Convene Enterprise Partnership Lead at TU Dublin
• Dr. Marcus O’Mahony, PMTC, University of Limerick

Level 3 is an open access, occasional e-journal devised in 2003 as a means of capturing and disseminating the variety and scope of research and innovation practices in TU Dublin. “Steps Towards Digital Transformation in the Pharma Manufacturing Landscape,” will be published via Arrow at TU Dublin on Wednesday, December 15. The December 2020 edition of Level 3 “Pharmaceutical Regulatory Science Matters,” can be accessed here.

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