![]() This is performed through the development of diagnostics called potency assays, which are complex when biologic, cell, and gene therapy drug candidates are involved. Measurement: The FDA wants drug developers to provide evidence that the gene editor made the desired changes inside the patient.First generation gene editors can also result in sloppy repair of edited genomes, or even the shattering of a genome into many small pieces. Tools can accidentally make random and uncontrolled edits, called indel mutations ("insertion deletion mutations"), that permanently impact gene function. Crispr tools can precisely target a section of a patient's gene, but the edits made aren't always so precise. But it's important to be precise when discussing that all-important word. Investors often see the word "precision" thrown around when discussing gene editing tools. Precision: The FDA wants drug developers to think carefully about designing the proper tools for the job.
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