Spotlight session: Biomarkers and companion diagnostics in CGT trials: Enabling precision and predictability

Biomarkers and companion diagnostics are increasingly critical for optimizing cell and gene therapy development. This session examines strategies to integrate these tools into clinical trials to enhance patient stratification, monitor therapeutic response, and support regulatory decision-making. 

Key Takeaways:  

• Identify biomarkers that inform patient selection and trial design 

• Develop companion diagnostics to improve predictive validity in CGT trials 

• Integrate biomarker data into adaptive and translational study frameworks 

• Enhance safety monitoring and efficacy assessment using precision diagnostics 

• Align biomarker strategies with regulatory expectations and trial endpoints