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Advancing Digital Transformation at the 2024 ISPE Annual Meeting & Expo

Charlie C. Wakeham
Michael L. Rutherford
Robert E. Perks, MSc, CEng
Christian Wölbeling
Mark O'Connor
Digital Transformation at the 2024 ISPE Annual Meeting & Expo

Rise of the Machines

It becomes clear that a topic has become mainstream when it crosses multiple Communities of Practice and areas of interest. In preparation for the 2024 ISPE Annual Meeting & Expo, the Digital Transformation track committee worked closely with multiple teams from other tracks on the topic of artificial intelligence/machine learning (AI/ML) to identify the best and most appropriate tracks and sessions to present. To ensure the best program possible, the track teams took extra care and attention to make sure it would be possible to attend all of the AI/ML sessions irrespective of track across the conference’s five tracks of concurrent education sessions.

It really is testament to the rapid growth of AI/ML that it is now been trialled and adopted along the pharmaceutical product lifecycle, supply chains, drug development, clinical trials, scale up and tech transfer, commercial manufacturing and quality assurance/quality control (QA/QC). Attendees can learn about the challenges of implementing and managing AI/ML, how AI/ML can bring robustness to quality decisions and improve activities such as deviation analysis, how AI/ML can strengthen manufacturing process controls, and how AI/ML can be used in conjunction with digital twins for maximum benefit in sessions across multiple tracks. The speakers from these education sessions will collectively form an interactive panel in the final Digital Transformation education session on Tuesday, 15 October, to address questions and ideas related to AI/ML.

While AI/ML is top of mind for many, a variety of other topics will be covered in this year’s Digital Transformation track at the 2024 ISPE Annual Meeting & Expo.

Digital Tools

Digital tools are becoming increasingly widespread in our industry. They can be utilized for requirements management, automated testing, validation document management, virtual reality (VR) tools for training, and more.

It can be difficult to separate the hard facts from the hype at times. ISPE will host a session dedicated to doing just that, with an “Introduction to Digital Tools” session, Monday, 14 October. This session will introduce attendees to the different types of tools from end users exploring digital validation tools, automated testing and monitoring tools, and innovative virtual reality (VR) training tools shaping the future of the industry. A panel discussion will directly follow the  “Introduction to Digital Tools”  session, with a focus on various use cases and applications for digital tools. Both will feature speakers from Ken Shitamoto with Gilead Sciences, Jeff Gensler with Kindeva Drug Delivery, and Pierre Winnepenninckx with No Deviation Ptd Ltd, with the addition of Patrick Mullin with Sanofi and Stephen Ferrell with Strikegraph, for the panel discussion.

The final session on Monday, 14 October, “GxP Activities with Digital Tools,” will expand to include tools used with GxP data in support of quality decisions. Presenters will discuss how tools within the product lifecycle require additional controls compared to tools only supporting non-product lifecycles, e.g., computerized system lifecycles or training programs. This session will feature all of the speakers noted in the panel discussion, with the addition of Miguelina Matthews, PhD, with Sanofi Aventis.

Transformation with Pharma 4.0 TM

The Pharma 4.0 TM Operating Model concept continues to drive digital business transformation along the pharmaceutical product lifecycle and the supply chains. Hear from big-name leading edge manufacturing companies how they have gained efficiencies and successfully transformed their operations by leveraging innovation and connectivity with the adoption of the holistic Pharma 4.0 principle in the presentation, “Transformational Efficiency in Next-Gen Facilities” by James Weidner, Amgen, and Yvonne Duckworth, CRB. Or hear from Gilead about their innovation framework and a brand-new Pharma 4.0 lab in their presentation, “Innovation Roadmap; Engineering as a Scientific Catalyst.”

Computerized Systems Quality with GAMP

The common theme through the whole Digital Transformation track is the use of computerized systems to create efficiencies, to drive and support innovations, and to build robustness into our processes to support better patient outcomes. But none of these can succeed without a solid foundation to the computerized systems.

After more than 30 years of providing industry with pragmatic guidance, ISPE’s GAMP® Community of Practice continues to lead the way in evolving control frameworks for the adoption of new and innovative technologies. In a dedicated session scheduled for Tuesday, 15 October, titled “When It Happened: Considerations in Disaster Recovery,” Frank Henrichmann, Co-Chair of the GAMP Global Steering Committee, with QFINITY, will address the evolving expectations for computerized systems validation and take a look at the realities of disaster recovery via a hypothetical case of a successful ransomware attack. Henrichmann will outline the recovery activities required and the issues that arise from inadequate disaster recovery planning.

Additional sessions on the Digital Transformation track scheduled for Tuesday, 15 October, include “GxP System Periodic Process Automation,” presented by Abhishek Bachchan with Gilead Sciences and “Is the EMA GCP CSV Guideline a blueprint for other GxPs?” presented by Oliver Hermann of QFINITY and Co-Chair of GAMP Europe.

The track also includes “Responsible Use of AI in a Regulated Environment,” presented by Michael Schmeisner with Sanofi and Nader Shafiei with Sanofi-Aventis. These leading quality experts will outline how modern tools and analytics are relieving the burden of large-scale infrastructure monitoring as part of maintaining multiple regulated systems in a manufacturing company. This presentation is following by "AI Discussion Panel - Reflections on Past Missed Opportunities (QbD, PAT) and How to Navigate AI for Success," with speakers such as Nikolai Makaranka from BMS, Nader Shafiei from Sanofi, Jordan Reynolds from Rockwell, and Brandi Stockton from The Triality Group, LLC share their insight on the topic.

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