This interactive seminar will focus on human-relevant New Approach Methodologies(NAMs) and translational biomarkers can be integrated to increase prediction of humanoutcome, support better informed decisions and design smarter first-in-human and early clinical studies.
- Early de-risking with NAMS: How NAMs (3D microtissues, organoids, organ-on-chip and other in vitro systems) can help early safety decisions, identify mechanisms specific risks and derisk molecules while improving the human relevance of preclinical data
- Translational and predictive biomarkers: selecting the right patients, monitoring safety and target engagement, and reading early efficacy signals from first-in-human studies
- Turning early data into clinical decisions: integrating PK-PD modelling, NAM and biomarker data to design smarter early clinical studies

