FDA’s Peter Marks once again emphasized the crucial need to improve manufacturing of gene therapies at a meeting on the future of regulatory science. He pointed to the need for industry collaboration and the involvement of academia to overcome hurdles and agree on best practices.
Gene Therapy Manufacturing: US FDA Wants Academics Brought ‘Into The Loop’
FDA’s Peter Marks says educating academics about CMC would help them understand why it is necessary to do things in a standardized way. He predicts the field will move away from individual manufacturing platforms in the next five to 10 years.
More from Cell & Gene Therapies
• By
Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
• By
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
• By
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
• By
Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
More from Advanced Technologies
• By
US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.
• By
Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
• By
Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.