Clinical supplies & logistics
And if broad scientific developments are one way forward here, some insiders are wisely attempting to smooth over the more egregious examples of industry variation. Winters is at the centre of these developments, recently co-authoring a paper for the American Society of Apheresis pushing for increased standardisation. There’s obviously low- hanging fruit here, from those muddled web portals to the fact that some manufacturers actually expect more detailed information than officially accredited medical bodies. In the meantime, both Winters and Quezada advocate putting our collective trust in the doctors – if only to decide who needs a precious manufacturing slot first. As Quezada puts it, physicians appreciate “the condition of the patient” alongside their broader medical history. In the absence of longer-term solutions, deferring to the experts will probably have to do for the moment.
Nurses need a minimum of six months of training before they can use apheresis machines with confidence.
patients continue to rise. To make matters worse, different pharmaceutical firms have developed distinct ways of actually creating their therapies, even as manufacturers oblige nurses to fill out a frustratingly motley set of online forms. “Each of the web portals is a little bit different for what the nurse has to put in there,” is how Winters explains it, adding that even the information nurses are expected to write on cell packets can vary by company.
In one cell swoop
What can be done to widen these chokepoints? In the first place, Winters describes an informal system of industry contacts, whereby doctors will contact manufacturers to argue the case of individual patients. This disorganised lobbying process can sometimes feel farcical. If, for instance, an individual becomes too unwell to use their manufacturing slot (efficacy notwithstanding, CAR T-cell therapies can be brutal on the body), physicians may receive last-minute calls about other deserving patients. Another option involves putting cancer sufferers forward for research protocols, especially if there’s a lack of available commercial slots. No wonder Winters characterises the sector as a “last- minute scramble” for carers and patients alike. It makes sense that insiders are casting about for more sustainable solutions too. For his part, Quezada seems especially optimistic about the scientific work being done to cut manufacturing times for CAR T-cell therapies. In particular cases, waiting periods of three weeks have been sliced to just 48 hours, a development he calls a “game changer” if done at scale. That’s echoed by yet more exciting innovations. At Penn Medicine in Philadelphia, to give one example, researchers last year announced that they’d successfully manufactured CAR T-cell therapies in less than 24 hours – clearly a potential boon for over- stretched factories everywhere.
20 Costs and benefits
Nonetheless, hurdles remain. Perhaps the most important involves manufacturers – and their willingness to standardise. With so much money floating about the CAR T-cell therapy sector, and so many of the technical details remaining closely guarded secrets, Quezada concedes that there’s little incentive for companies to collaborate. A related problem is price. By some estimates, CAR T-cell therapies cost around $500,000 a pop, a figure that potentially rises to as high as $2m if you factor in additional costs, like training and labelling. “It requires a lot of investment,” is how Quezada laconically puts it, a point Winters makes in more strident terms. “Unfortunately – in the US, obviously – many of the pharmaceutical companies are trying to reimburse their shareholders,” he says. “And so there are a number of drugs that one wonders why they’re so expensive.”
And if these financial burdens clearly impact patients in the Western world, the situation is even worse for developing countries. As late as 2021, several years after the first CAR T-cell therapies were approved by the FDA, trials across Africa and Latin America had yet to even start. Yet, if the current sector, characterised by unregulated enthusiasm, is clearly causing issues, there’s some evidence that the same market forces could finally make CAR T-cell therapies more accessible. Already, Winters says that some doctors shop about for available manufacturing slots, a situation made easier given some treatments treat similar ailments. And with masses of new factories coming online soon – European towns from Leiden to Oxford may soon boast their own manufacturing spaces, even as US facilities continue to expand – the Mayo Clinic expert hopes that the “laws of economics” will eventually see prices fall. Given how revolutionary CAR T-cell therapies can be, you certainly have to hope so. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
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