Guest Column | October 24, 2025
Regulatory Pathways – With Real-Life Examples – For Successful CGT Clinical Trials
By Jessica Cordes, senior consultant, Clinical Excellence GmbH
Cell and gene therapies (CGTs) have been established in the treatment landscape across oncology, rare diseases, and inherited disorders. In this article, I explore the most effective regulatory pathways used to support CGT development and highlight two real-life examples that illustrate how small and midsize biotechs can optimize clinical trial design, site and manufacturing readiness, and regulatory alignment. By integrating regulatory expectations into early development planning, companies can reduce risk, maximize resource efficiency, and position themselves for sustainable success.
Please read the full Clinical Leader Article.