ISSCR Members Hold First Scientific Advice Meeting with the U.K.’s Medicines and Healthcare products Regulatory Agency
The International Society for Stem Cell Research (ISSCR) held its first Broader Scope Scientific Advice meeting with the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) on May 15, 2023. ISSCR’s regulatory advocacy aims to give its members a voice to help educate policymakers about scientific findings and considerations that will help regulators make scientifically informed policy decisions and facilitate the development of advanced stem cell-based therapies and applications. The 1.5-hour virtual meeting included attendees from the ISSCR’s Manufacturing, Clinical Translation, and Industry (MCTI) Committee, the MHRA’s Biological Products group, the MHRA’s National Institute for Biological Standards and Control, and representatives from the organizer of the meeting, the U.K.’s Cell and Gene Therapy (CGT) Catapult. After a brief introduction of the ISSCR and a review of its regulatory advocacy, the ISSCR delivered recommendations on two topics:
1) The Manufacture and Testing of Induced Pluripotent Stem Cell (iPSC) Banks and Derived Products
2) Genomic Heterogeneity in Pluripotent Stem Cell Therapeutics