In what may have been one of the last advanced therapy meetings to go ahead for some time, delegates met in London in late February for CAR-TCR.
A central theme was the difficulty of conducting clinical trials in Europe compared with the US and China. Dolores Schendel, Medigene, pulled no punches during the first panel discussion of the event, telling the audience that Medigene needed nine academic centers – not the expected three – for a “small phase I trial” in Germany, as well as a “crackerjack” team of lawyers. Schendel suggested that the German situation was a microcosm for the whole of Europe, as different apheresis sites in Germany are regulated by the different states.
Andre Choulika, CEO of Cellectis, also compared the experience of filing a patent in the US to France. “On the US side you had, like, 10 questions. On the French side, you had 16 pages of questions,” he said. “It took us 18 months to do this and when you're a small biotech company you’re burning cash every month.”
The concerns were reflected in the figures presented by Pippa Gledhil from Beacon Intel (see our infographic below) who reported that there were more than five times as many CAR-TCR developers in China and the US compared with Europe.
In terms of other hot topics at the conference, off-the-shelf cell therapy was certainly one – Choulika claimed that 2020 will be the “year of the allogeneic” – as well as TCRs for solid tumors and 24-hour CAR T. But for some allogeneic therapies, there may only be a handful (perhaps less than 50) donors worldwide. Enter the “super donor,” whose job it will be to supply the cells needed for such therapies...
Elsewhere, Omar Ali spoke about the growth of innovative reimbursement payment models. Here, according to Ali, it is the US that is falling behind because, even if insurers can get their heads around the price, there is ambiguity over who pays when hospitals need more money for administration. “Is it the patient? Is it the government? Is it the insurer? You’re driving an electric car with no charge points,” he said.
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