Exploring the Future of AI in Pharmaceutical Manufacturing
The LifeFactFuture webinar underscored the transformative potential of AI in pharmaceutical manufacturing. It also highlighted the need for a balanced approach that fosters innovation while ensuring patient safety and regulatory compliance. The discussions emphasized the importance of collaboration between industry and regulators to navigate the complexities of AI implementation effectively.
The LifeFactFuture Webinar held on 5 February, “Computerised Systems and GMP – Regulation of Digital Solutions in Pharmaceutical Manufacturing”, invited experts from the pharmaceutical and technology industries and regulatory agencies to discuss the evolving landscape of artificial intelligence (AI) in pharmaceutical manufacturing. The event featured insightful presentations and a dynamic panel discussion, shedding light on the opportunities and challenges that AI presents in this highly regulated industry. The event attracted almost a hundred participants, highlighting the significant interest in the evolving landscape of AI in pharmaceutical manufacturing.
Setting the Stage
The webinar commenced with a presentation by the Principal Investigator, Research Director Toni Ahlqvist, who introduced the LifeFactFuture (LFF) project. This Business Finland – funded initiative aims to accelerate the digital transformation of Finnish pharmaceutical and life sciences manufacturing by integrating world-class manufacturing with cutting-edge scientific knowledge and strategic foresight. Toni emphasized the project’s objective of positioning Finland as a leader in data-driven capabilities within the life sciences and manufacturing sectors.
Sara Gambier, Product Supply IT Manager at Bayer Pharmaceuticals, followed with a presentation on the challenges and opportunities of integrating AI and digital solutions in pharmaceutical manufacturing. She highlighted the industry’s struggle with adopting Industry 4.0 standards while other sectors are already progressing towards Industry 5.0. Sara underscored the importance of agility and rapid adaptation to these changes, emphasizing the need for regulatory frameworks to support this transformation.
Pekka Mikkola, Director, Industrial Data & Artificial Intelligence at DAIN Studios, provided a thought-provoking presentation on the current state of computerized systems and AI in the pharmaceutical industry. He discussed the rapid advancements in AI and robotics, emphasizing the necessity for companies to adapt to these changes. Pekka highlighted the importance of having a clear vision and strategy for AI implementation, focusing on people and processes rather than just technology. He also raised questions about the new opportunities and potential regulatory challenges that AI brings to the industry. > Presentation slides
Ib Alstrup, IT Medicines Inspector at Danish Medicines Agency and an expert at the scientific committee of the European Medicines Agency, provided an in-depth analysis of the upcoming changes to the EU GMP Annex 11, focusing on AI and computerized systems. He discussed the importance of robust access management, audit trails, and the validation of AI models, particularly in high-risk applications. Ib’s presentation underscored the need for regulatory frameworks to evolve alongside technological advancements to ensure patient safety and product quality.
Elina Asikanius, Biostatistician at Finnish Medicines Agency Fimea, presented a reflection paper on the use of AI in the medicinal product life cycle. She emphasized that the requirements for AI applications are specific to their context of use, with a focus on high patient risk and high regulatory impact. Elina highlighted that the use of AI does not change the responsibilities of clinical trial sponsors, marketing authorization holders, or manufacturers. She also stressed the importance of having access to documentation and proactively communicating with regulators to ensure compliance. > Presentation slides
Panel Discussion: Opportunities and Challenges
The panel discussion featured Hanna Soinio (Computer System Validation Team Lead at Bayer Oy), Mirka Laavola (Senior Inspector at the Finnish Medicines Agency), Mia Sivén (Associate Professor of Sustainable Pharmacy at the University of Helsinki), and Pekka Mikkola from DAIN Studios. Each panelist shared their perspectives on the current and potential applications of AI in pharmaceutical manufacturing.
Hanna highlighted the use of AI for data analysis and documentation, noting that AI could significantly expedite the creation of validation documents and improve data quality. She also emphasized the importance of maintaining data integrity and IT security when implementing AI solutions.
Mirka discussed the regulatory perspective, pointing out that while AI offers numerous benefits, it also poses risks if the data used for training models is incorrect or biased. She stressed the need for cooperation between regulators and the industry to ensure that AI applications are both innovative and compliant with regulatory standards.
Mia focused on the research and development phase, where AI can handle large datasets and identify patterns that might not be apparent through traditional methods. She also highlighted the potential for AI to enhance sustainability in pharmaceutical manufacturing by optimizing processes and reducing waste.
Pekka provided insights into the practical applications of AI, such as using AI to predict issues in manufacturing processes and improve operational efficiency. He also raised concerns about Europe’s position in the global AI landscape, emphasizing the need for robust regulatory frameworks that support innovation while ensuring safety and compliance.
Collaborative Reflections
An interactive session using Miro was conducted during the webinar, where participants were invited to reflect on the presentations and share their views on various topics related to AI and computerized systems in pharmaceutical manufacturing. They were encouraged to provide insights on how AI is currently used in their work, potential applications, and the challenges they face. This session aimed to gather diverse perspectives and foster a collaborative discussion on the future of AI in the industry.
A Collaborative Path Forward
The LifeFactFuture webinar underscored the transformative potential of AI in pharmaceutical manufacturing. However, it also highlighted the need for a balanced approach that fosters innovation while ensuring patient safety and regulatory compliance. The discussions emphasized the importance of collaboration between industry and regulators to navigate the complexities of AI implementation effectively.
This was the first public event of the LifeFactFuture project. A second event focused on the regulation of medical devices is currently in planning.
As the LifeFactFuture project continues to explore the futures of life science manufacturing, events like this webinar play an important role in enabling more opportunities for conversation and collaboration. By bringing together diverse perspectives and expertise, the LifeFactFuture project is well-positioned to speed up the introduction of digital solutions and more efficient utilization of data and to make Finland the most attractive place in the world for investments in data-driven life science manufacturing.
Tero Villman, Mikkel Stein Knudsen & Keijo Koskinen
Finland Futures Research Centre, University of Turku
The basics of the text was formulated using AI.