Navigating Key Complexities In The Development Of Cell And Gene Therapies

Developing and delivering cell and gene therapies pose consistent challenges for biotech organizations. Cell therapy involves transplanting human cells to repair or replace damaged tissue, while gene therapy aims to modify genes for therapeutic purposes. Although cell therapy has been around since 1939, the regulatory landscape has struggled to keep pace with these advancements.

Unlike pharmaceutical companies, biotechs working on these life-changing therapies face more unique complexities in regulation and guidance to approval pathways, manufacturing, and study activation. However, these obstacles can be overcome with the right partner.

Discover how engaging with experts well-aligned with the company’s goals early in the commercialization process can lead to success.