With over 5,000 cell and gene therapies in pre-clinical and clinical development worldwide, regulatory clarity is crucial for developers striving for efficient and seamless approvals in their first regulatory submissions. Leading innovators are pioneering new approaches, like in vivo gene editing, rapidly pushing products from the clinic to commercialization. This rapidly evolving field is now on a mission to learn from case studies and glean insights from the forefront to optimize regulatory processes from pre-IND to approval.

The Cell & Gene Therapy Regulatory Affairs Summit united biopharma experts across non-clinical, clinical, and CMC regulatory domains in the cell and gene therapy sector. This was a uniquely positioned platform for the community to crystallize regulations, learn from the experiences of trailblazers, and engage in conversations to unravel regulatory bottlenecks.

This was an incredible opportunity to gain exclusive insights from industry giants such as Orchard Therapeutics, AstraZeneca, Century Therapeutics, Bristol Myers Squibb, CytoImmune Therapeutics, Prime Medicine, Verve Therapeutics, and more, as they worked collaboratively to tackle the regulatory challenges facing the cell and gene therapy community in 2024.