Charting the translational pathway: ISSCR best practices for the development of PSC-derived therapies

초록

The successful translation of a stem cell-derived product from the laboratory into an approved medicine requires specific scientific, technical, and regulatory understanding. Since this knowledge base is fragmented across websites and publications, the ISSCR has developed a new resource, The Best Practices for the Development of Pluripotent Stem Cell-Derived Therapies. This comprehensive, interactive document, designed for academia and industry, addresses critical areas of the translational pipeline and key decision points for the successful translation to a licensed therapy. Uniquely, it provides a global perspective of the regulatory landscape while providing resources for critical processes and links to jurisdictional regulatory information.