Spotlight session: Expanding horizons for CGT in autoimmune and neurological conditions

The application of cell and gene therapies to autoimmune and neurological indications introduces new considerations for clinical design, biomarker strategy, and long-term safety evaluation. This spotlight session examines how developers are adapting CGT platforms to new disease areas while maintaining translational fidelity and patient safety. 

Key takeaways: 

• Evaluate scientific and clinical drivers for extending CGT to autoimmune and neurological disorders. 

• Discuss biomarker strategies that enable patient stratification in heterogeneous disease settings. 

• Explore dose selection and safety margin considerations unique to chronic conditions. 

• Identify challenges for translational fidelity and predictive validity in new therapeutic areas. 

• Consider regulatory perspectives on CGT for non-oncology indications.