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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