The UK continues to be recognised as a global leader in cell and gene therapy, supported by a regulatory environment that balances scientific rigour with adaptive flexibility. The Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI-AT) is a central component of this national strategy and aims to strengthen the UK’s regulatory ecosystem and support the translation of advanced therapies from research to clinical deployment.
A key gap identified by CERSI-AT concerns the limited clarity around investor expectations for therapy developers to demonstrate translational readiness across scientific, regulatory, and market access perspectives.
In this whitepaper, CERSI-AT shares findings from in-depth interviews conducted with three leading UK investment firms active in the ATMP sector, exploring how these investors evaluate opportunities and the extent to which regulatory considerations influence their decisions.
