Three Tips To Put Your Viral Vector On The Path To Regulatory Success

Navigating the regulatory landscape for viral vector-based gene therapies can feel daunting. While these therapies offer groundbreaking potential for treating complex diseases, their novelty introduces unique challenges. Regulators are still working to understand mechanisms of action, manufacturing processes, and safety profiles, leaving developers with questions about how to move forward. A clear pathway exists, but it isn’t tailored to gene therapies—meaning adaptability is key. Sandra Racordon-Pape, Director of Regulatory Science and Strategy at Cytiva, shares three practical strategies to help developers manage uncertainty, align with evolving expectations, and position their therapies for successful approval.

If you’re looking for guidance on how to approach this complex journey, access the full article to learn more.