Clinical Development Clinical Research Containment In-Vivo 
XTalks
APRIL 24, 2023
Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.
The Pharma Data
JANUARY 10, 2021
The Company is required to develop and submit to the FDA an improved potency assay prior to enrolling the efficacy phase of the RUBY trial. EDIT-301 is an experimental, ex vivo gene editing cell medicine in development for the treatment of sickle cell disease. Clinical trial materials are being manufactured by Editas Medicine.
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