Focus Session

INSIGHTS FROM REGULATORS: LESSONS LEARNED FROM THE ISSCR’S REGULATORY LIAISON MEETINGS

Organized by: ISSCR Industry Committee
Human Pluripotent Stem Cell (hPSC)-derived cell therapies are now being investigated in clinical trials. Despite 26 years of rigorous basic science with hPSCs, navigating the regulatory landscape for the clinical translation of PSC-derived cell therapies remains challenging due to the complexities of cellular drug products and limited experiences reviewing and approving them. As the leading stem cell society, the ISSCR is in a unique position to share its scientific expertise with global regulators and work with agencies to facilitate improved future regulatory processes for stem cell-based therapies. In this ISSCR Industry Focus Session, the society shares important insights and feedback gleaned from its liaison meetings with regulatory agencies with our community of scientists to ameliorate their chances of IND approvals and inform the development of effective and safe new therapies.