Regulation of In Vivo CAR‑T Therapies
Emerging Regulatory Frameworks for Programmable Immune Engineering Introduction In vivo CAR‑T therapy represents one of the most scientifically disruptive developments in modern biotechnology. Unlike traditional CAR‑T therapies, where T cells are removed from the patient, genetically engineered ex vivo, expanded, and reinfused, in vivo CAR‑T platforms aim to genetically program immune cells directly inside the…
Cell and Gene Therapies Regulation
Navigating the Regulation of Cell and Gene Therapies in Australia and New Zealand Globally, cell and gene therapies are revolutionising modern medicine, offering groundbreaking treatments for life-threatening conditions including cancer, genetic disorders and rare diseases. However, despite the pace of scientific innovation, regulatory frameworks in many countries, including Australia and New Zealand, have struggled to…
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