Panel Discussion: Navigating Preclinical, Translational & Clinical Bottlenecks by Evaluating Key Learnings to Accelerate TCEs Towards Approval
- How to improve preclinical models to better predict activity, clinical safety and de-risk translation into the clinic?
- How are next-generation preclinical platforms (e.g. organoids, humanised models, ex vivo systems) enabling evaluation of conditional activation and masking strategies?
- How can translational biomarker strategies, including antigen density thresholds and T-cell fitness profiling, improve patient stratification and clinical signal prediction?
- What will regulators most want to see before they are comfortable with first-in-human studies in these settings?