Extracellular vesicles are generating excitement as tools for regenerative medicine and drug delivery — but no EV-based therapeutic has received market approval anywhere in the world. In a new Perspective article, we argue the barriers are not solely technical. They are also regulatory.
A genome-edited pig kidney I was pleased to be invited to reflect on the future of xenotransplantation and human genome editing recently in an interview on ABC’s The World with Beverley O’Connor. The interview was broadcast following news of the unfortunate passing of Richard “Rick” Slayman — the first human to have received a genome-edited […]
Exa-cel and the FDA review Just last week, on 31 October, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee met to discuss Vertex Pharma’s Biologics License Application for Exagamglogene autotemcel (or exa-cel, and formerly known as CTX-001) — a cell-based gene therapy designed to treat sickle-cell diseases. I have written about exa-cel many times […]
After a long journey that should have been no surprise whatsoever (not when one looks at the scale and size of this volume), a book chapter I authored with Emeritus Distinguished Prof Dianne Nicol from the University of Tasmania’s Centre for Law and Genetics, way back in 2021, has now been published. The chapter deals […]
Cellular Horizons is a Medical Research Future Fund project investigating how consumers (and health practitioners) can improve decisions about accessing cellular therapies.