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Session 4 – Beyond the Physical Trial: The Promise of In Silico Modeling and AI-Enabled Methods Applications
Session Chair(s)
Jacob George
Chief Medical & Scientific Officer , MHRA, United Kingdom
Session Chair Invited
, Switzerland
SESSION OVERVIEW: The focus of this session is on the application of in silico modelling (synthetic datasets, digital twins), and AI-enabled evidence methods along the medical product development continuum. Attendees will hear examples and case studies demonstrating successful applications and explore the opportunities these approaches create to accelerate development, improve decision-making, and generate evidence more efficiently. The discussion will also examine the remaining scientific, technical, and regulatory challenges, and consider how regulatory frameworks may continue to evolve to enable broader adoption of in silico approaches and support regulatory decision-making.
SESSION IMPACT: Attendees will gain a clearer understanding of the MHRA’s approach toward current applications of in silico modeling in medical product development, while hearing from UK technology leaders at the forefront of this rapidly evolving field. Participants will learn how these innovative approaches are being applied today, the barriers that remain to broader adoption, and the opportunities to accelerate medical product development and strengthen evidence generation in the future.
Speaker(s)
The challenges and opportunities of utilizing in silico modeling and AI-enabled methods of evidence generation in medical product development – setting the context of where we are and how fast the future is changing
Jacob George
Chief Medical & Scientific Officer , MHRA, United Kingdom
Methodology, technology and regulatory science perspectives
Alejandro F Frangi
Bicentenary Turing Chair-Computational Medicine, Manchester University & E.D., UK Centre of Excellence on InSilico Regulatory Science & Innovation (UK CEiRSI), United Kingdom
Methodology, technology and regulatory science perspectives
Michael Von Forstner, PhD, MPH, MSc
Managing Director, Head of Pharmacoepidemiology Practice, Mesa Laubela Consulting, Switzerland
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