IVD Regulatory Implications for Gene Therapies
- Showcasing early readouts of PD activity to support dose selection is critical-Gene therapy is an increasingly expanding therapeutic modality that has the potential to reach patient populations with high unmet medical needs
- Several key characteristics of gene therapies require careful selection of patients both during clinical trials and after regulatory approval
- These patient selection strategies may trigger the requirement for a companion diagnostic, either to identify patients with preexisting immunity to AAV capsids or with specific genetic variants
- Companion diagnostics have regulatory implications throughout development as well as marketing implications after approval