Ophthalmic cell and gene therapy (CGT) development presents unique scientific, operational, and regulatory challenges. From delivery method selection to clinical trial design and manufacturing consistency, you won’t succeed unless you build strong processes early and align development decisions with both disease biology and regulatory expectations. This article, featured in Cell & Gene Therapy Review, explains how to do just that.
Grounded in learnings from one of our IRB board members and his work supporting ophthalmic CGTs, it covers:
- Key considerations for ophthalmic CGT development, including product quality, delivery approaches, and manufacturing consistency
- Why disease biology, administration methods, and natural history studies play a critical role in clinical trial planning
- What sponsors, CROs, and IRBs should understand about the operational and regulatory complexities associated with ophthalmic cell and gene therapy trials
Read the full piece for practical insights and development best practices.
