The FDA published a new draft guidance on August 10, 2018, entitled, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics. The comment period for the draft guidance closed on October 12, 2018, and approximately 20 comments were submitted to the docket. Several key themes emerged across the comments submitted to the docket. Samantha Eakes of Greenleaf Health explains lists and explains these themes in “Key Takeaways From FDA’s New Guidance On First-In-Human Multiple Expansion Cohort Trials.”
Finally, from all of us at Cell & Gene, we wish you and yours a Happy Thanksgiving.
Cell therapy, gene therapy, and RNA-based therapies. Right now, these are the classes of therapies we’re considering novel. If you look at it historically, ten years ago recombinant proteins and monoclonal antibodies would have been novel therapies, but now they’ve become very much standardized. So now that bar has moved a little bit, and the novel therapies are really cell and gene therapies, and, to a certain extent, the RNA therapies.
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