Browsing by Subject "FDA required testing"

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    The National Gene Vector Biorepository: Eleven Years of Providing Resources to the Gene Therapy Community
    (Mary Ann Liebert, Inc., 2020-02) Cornetta, Kenneth; Matheson, Lorraine; Long, Ryan; Duffy, Lisa; Medical and Molecular Genetics, School of Medicine
    The National Gene Vector Biorepository (NGVB) program has been highly accessed by gene therapy investigators. The reagent repository has distributed over 1,000 reagents to 397 investigators. The Pharmacology/Toxicology Archive contains over 36,000 specimens from a variety of adeno-associated virus (AAV), adenoviral, and other pharmacology/toxicology studies. NGVB also maintains a searchable database of gene therapy pharmacology/toxicology studies to promote data sharing. NGVB has provided Food and Drug Administration (FDA)-mandated replication-competent virus testing for over 70 clinical trials. From 2008 to 2018, there have been 114 publications acknowledging the NGVB. It is unlikely that any other National Institutes of Health (NIH)-funded program has served as many gene therapy investigators as the NGVB.