Next-gen ther­a­pies are evolv­ing fast. The drug de­vel­op­ment mod­el needs to keep up

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A team of genome en­gi­neers at a start­up biotech has been work­ing for years to cre­ate a cell ther­a­py with the hope that it will cure an ag­gres­sive form of can­cer. Af­ter much gru­el­ing tri­al and er­ror at the edit­ing bench, they are ready to eval­u­ate their drug can­di­date in clin­i­cal tri­als. Things are go­ing well, and they’re ec­sta­t­ic to see that tu­mors are shrink­ing, T cell counts are ris­ing, and the dis­ease is re­treat­ing. But there’s a cloud on this bright hori­zon. A side ef­fect is show­ing up with some of the pa­tients in the tri­al, one which might have long-term con­se­quences for their well-be­ing. The sci­en­tists have an idea: What if they can flip what they call an “off-switch” on one pair of genes they’ve iden­ti­fied that could turn off this side ef­fect of the drug while re­tain­ing the new drug’s cu­ra­tive pow­ers? It sounds like an easy fix but its im­ple­men­ta­tion is go­ing to take a long time.

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