The ex-GSK supply head Ian McCubbin will join the independent UK organization aimed at advancing cell and gene therapies, but notes issues with scale and manufacturing ahead.
Former UK Vaccines Taskforce member Ian McCubbin, who is joining the UK’s Cell and Gene Therapy Catapult as Chairman, talks about overcoming the challenges around scale and manufacturing hampering the field.
He believes the experience gained in making large amounts of COVID-19 vaccines at speed during the pandemic will pay dividends...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
