In the first episode of this series, we spoke to Executive Director and Global Head of Regulatory Services Kimberley Buytaert-Hoefen about her experience with cell and gene therapy (CGT) approvals and the barriers to getting these important therapeutics to the patient. Kim advises early regulatory interaction and collaboration to improve the success rate of applications and emphasizes the importance of global harmonization of regulatory standards. We discuss key barriers to CGT approvals including manufacturing and immunogenicity and Kim voices her excitement for the newly approved CRISPR-Cas9 technology to treat sickle cell disease.