[iNOVA4Health] Advanced 3D Cell Models in Preclinical Research: Context, Current State, and the Path Forward

Title: Advanced 3D Cell Models in Preclinical Research: Context, Current State, and the Path Forward

Speaker: Eckhard von Keutz

Abstract: Pharma R&D continues to face high attrition rates, with many candidates failing due to insufficient efficacy or unexpected safety issues in the clinic. Although substantial progress has been made in molecular design, screening technologies, and analytics, translating preclinical findings into meaningful human outcomes remains a central challenge. This presentation examines where key predictivity gaps emerge along the drug development continuum and how industry and regulators view the integration of complementary preclinical approaches, including new approach methodologies (NAMs).

Building on this external context, the talk explores the current state of advanced 3D cell models and their potential role  in  informing earlier,  more  confident  decision-making.  Emphasis is placed on context  of  use,  realistic expectations, and the distinction between sophisticated biological systems and decision-relevant platforms. The session concludes by outlining what needs to improve for these models to deliver greater strategic impact and how developers of 3D cell systems can position their work within evolving scientific and regulatory landscapes.