Regulatory & Bioethics

Regulatory science is racing to keep pace with cell and gene therapies, AI/ML-enabled devices, and the first generation of in vivo edits. The track will dissect FDA accelerated and platform pathways (Project Orbis, RMAT designation, the new ARC for individualized therapies), EMA PRIME, and the evolving framework for AI-enabled SaMD with predetermined change control plans. Bioethics sessions will tackle germline editing governance post-He Jiankui, equitable access to million-dollar gene therapies, dual-use research of concern in synthetic biology, and informed consent for BCI and neural-data privacy. Real-world evidence, decentralized trials, and N-of-1 trial designs will be examined.