Gene Therapy Manufacturing Hurdle: Sponsors Unwilling To Share ‘Secret Sauce’
US FDA’s Peter Marks says companies are not exchanging information about adenoviral factors, which is probably slowing down the field. He describes NIH's plans for a bespoke gene therapy consortium for vector generation and continued efforts for regulatory harmonization.
You may also be interested in...
CBER’s director says manufacturing and regulatory issues need to be resolved to ensure the gene therapy sector thrives.
Rare disease advocates also argue that the Medicare’s government drug price negotiation orphan drug exemption – which only applies when a drug has one orphan designation – will harm other government efforts aimed at more efficient drug development.
Regenerative Medicines: Development Slowed By Lack of Standardization, Regulatory And Manufacturing Challenges
A Government Accountability Office report identifies 10 policy options aimed at speeding development and boosting the use of regenerative therapies, but breaks little new ground, highlighting the continuing difficulties in the space.