Manufacturers of chimeric antigen receptor T-cell (CAR-T) therapies need to recognize that hospitals play a major role in determining the success of these treatments, and should have a strong site qualification program in place to ensure they can perform the apheresis and maintain product traceability.
Kite Exec Highlights Hospital Role In Cell Therapy Quality Chain
Hospitals will have a large role in success of these treatments, with a high level of teamwork and coordination required between the technical operations team and the commercial teams working in tight time-frames.
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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.
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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.
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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.
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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.
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Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.
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