In:
Stem Cells Translational Medicine, Oxford University Press (OUP), Vol. 2, No. 7 ( 2013-07-01), p. 483-487
Abstract:
Recently, the U.S. Food and Drug Administration (FDA), the U.S. National Institutes of Health, and the stem cell research community have collaborated on a series of workshops that address moving pluripotent stem cell therapies into the clinic. The first two workshops in the series focused on preclinical science, and a third, future workshop will focus on clinical trials. This summary addresses major points from both of the recent preclinically focused meetings. When entering into a therapeutics developmental program based on pluripotent cells, investigators must make decisions at the very early stages that will have major ramifications during later phases of development. Presentations and discussions from both invited participants and FDA staff described the need to characterize and document the quality, variability, and suitability of the cells and commercial reagents used at every translational stage. This requires consideration of future regulatory requirements, ranging from donor eligibility of the original source material to the late-stage manufacturing protocols. Federal, industrial, and academic participants agreed that planning backward is the best way to anticipate what evidence will be needed to justify human testing of novel therapeutics and to eliminate wasted efforts.
Type of Medium:
Online Resource
ISSN:
2157-6564
,
2157-6580
DOI:
10.5966/sctm.2013-0042
Language:
English
Publisher:
Oxford University Press (OUP)
Publication Date:
2013
detail.hit.zdb_id:
2642270-0
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