«In the current regulatory environment, after an important discovery is made, a trial alteration is required, which is a costly and lengthy process that limits the ability to bring novel unique therapies quickly to patients with high unmet needs. If those genome engineers at the startup want to make even the slightest improvement to their drug candidate, which may attenuate the previously mentioned serious side effect, they’ll be required to start all over again with a 2.0 version. This kind of versioning is customary in the biotech industry and can often be a race against time.»

Article written by Endpoints Contributor



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