The Use of AI and ML in Pharmaceutical Manufacturing – The Evolving Regulatory Environment in the GMP and CMC Reg Space in the US and Europe, Illustrated With Some Application Case Studies.

The use of Artificial Intelligence (AI) and Machine Learning (ML) models in the GMP space has been discussed for a couple of years as one important element of an Industry 4.0 approach for Pharma. More recently, both the FDA – via a discussion paper on “Artificial Intelligence in Drug Manufacturing” – and EMA – as a topic for their Quality Innovation Group Listen & Learn Focus Group event -have shown interest in developing a regulatory framework or guidance for the use of these types of models.

This presentation will start with the larger evolving legislative framework on AI in Europe and the US, and then move on to describe the FDA discussion paper topics, as well as the EMA interest and potential next steps. The interplay between existing topics of regulatory interest, such as the use of modeling, and AI/ML-specific new aspects will be discussed. The paper will also show some internal case studies and use cases that span the spectrum of potential applications (from knowledge management to process monitoring to more direct quality control), which many pharma companies are known to work on towards implementation in commercial manufacturing.

Presented by Dr. Gert Thurau, Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Roche

Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering the spectrum from continuous processing, use of process models, robotics and artificial intelligence, to name a few.  Most recently, he participated on behalf of EFPIA in the first EMA Quality Innovation Group “Listen and Learn” session in March 2023, and served on the regulatory panel discussion at the FDA workshop on “Advancing Innovative Manufacturing Approaches” in June 2023 and the FDA/PQRI workshop on the use of AI/ML in manufacturing in September of 2023.

Within the Roche group, Gert leads the policy and advocacy for the use of Artificial Intelligence and Machine Learning in pharmaceutical manufacturing. This includes developing Roche positions on the bigger context of AI/ML in manufacturing within the evolving legal environment (EU AI Act, US congress efforts) as well as engagement of practical aspects of GMP and regulatory dossier relevance of applications.