Roundtable Discussion: Regulatory & Commercial Pathways for ASIT: From Proof-of-Concept to Broad Patient Access
- Navigating relevant endpoints, immune biomarkers, and proof-of-mechanism requirements unique to antigen-specific immune tolerance therapies
- Aligning with regulatory expectations and ensuring data supports both approval and reimbursement
- Planning for scalable adoption, pricing, and payer engagement to bring safe and effective ASIT therapies to patients efficiently