Ellen Roche, Ph.D

In tandem with AI, the transformative potential of computational modeling and simulation is set to revolutionize clinical trials, providing a compelling vision of how these advanced digital technologies can minimize risks, cut costs, and expedite the product approval process.

Medical device development has already employed modeling and simulation for product development and early-stage product testing. The latest advances now allow for continued operations in virtual environments throughout the clinical trial stage. This includes generating virtual patient cohorts for treatment arms and synthetic patients for control arms, offering an innovative approach to trial design, and streamlining the assessment of novel treatments.

This session will explore the convergence of these technologies and present compelling evidence of progress, including recent collaborative efforts with the FDA in developing a groundbreaking blueprint for utilizing these advanced approaches, representing a significant step towards a more efficient and patient-centric future in device development.

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