Can­cer re­search groups urge FDA to over­haul stan­dards for ear­ly cell ther­a­py tri­als, cut­ting time and cost. But will 'pre-com­pet­i­tive' al­liances fly?

Two in­flu­en­tial non­prof­its fo­cused on can­cer drug R&D are urg­ing the FDA to take a more flex­i­ble ap­proach to clin­i­cal work to help triage an in­flux of new cell and gene can­cer ther­a­pies mak­ing their way to hu­man stud­ies. By chang­ing cur­rent IND and man­u­fac­tur­ing stan­dards, they say, the agency can cut the time and cost of ear­ly-stage work, ac­cel­er­at­ing the ad­vance of the most promis­ing ther­a­pies in the pipeline. 

But can they get the in­dus­try to agree on da­ta shar­ing and pre-com­pet­i­tive al­liances?

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