ISSCR Offers Recommendations on Risk Mitigation in Advancing Stem Cell Therapies
On 13 December 2022, ISSCR hosted its annual Liaison Meeting with the U.S. Food and Drug Administration. FDA professionals gathered virtually with ISSCR leaders to discuss advances in the development of stem cell therapies. The attendance of over 50 FDA professionals, including FDA leaders from the Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT), highlights the importance of engaging with regulatory authorities to share scientifically informed recommendations. Members of FDA heard presentations from a group of ISSCR members and affiliates, including Melissa Carpenter, PhD, Chair of ISSCR’s Manufacturing, Clinical Translation, and Industry Committee, regarding recommendations on three topics: screening technology for prion diseases, risk mitigation for genomic heterogeneity, and risk assessments for developing safe hypoimmune therapies.