Mandatory public reporting of vein-to-vein time and failure rate per CAR-T product
Patients and doctors cannot see how long each CAR-T maker takes or how often manufacturing fails. Publishing this would create pressure to get faster and more reliable.
Vein-to-vein times for commercial CAR-T range from roughly three to eight weeks and out-of-specification rates from a few percent to over ten, but these figures appear only in trial publications and investor slides. The proposal is a regulatory condition that each approved cell therapy reports, quarterly and publicly, median and 90th percentile apheresis-to-infusion time, out-of-specification and manufacturing failure rates, and the proportion of enrolled patients never infused, stratified by country.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.
- Weak real-world evidence and registries · We do not reliably know what happens to patients after approval, so we cannot tell which drugs deliver in practice.
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not linked directly; found by shared links- IdeaFull refund for CAR-T if the patient has not responded at three months
Shares Axicabtagene ciloleucel, Ciltacabtagene autoleucel, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaPay-for-cure contracts: instalment payments for curative therapies contingent on durable remission
Shares Axicabtagene ciloleucel, Ciltacabtagene autoleucel, CAR-T cell therapy.
- IdeaHead-to-head bispecific vs CAR-T in second-line LBCL
Shares Axicabtagene ciloleucel, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- TrialCARTITUDE-1
- IdeaA neutral slot exchange so unused CAR-T manufacturing slots go to the next patient
Shares Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaPublic reference standards and potency assays for CAR-T so every lab measures alike
Shares Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaTwo-day CAR-T manufacture paired with rapid release tests that regulators accept
Shares Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaAn open interoperability standard for closed automated cell-processing machines
Shares Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.