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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Pluripotent Stem Cells in Translation: Preclinical Considerations

Tuesday, July 10, 2012 - Wednesday, July 11, 2012
8:00 AM - 4:40 PM

The National Institutes of Health and the Food and Drug Administration are collaborating on a series of workshops on moving pluripotent stem cell therapies into the clinic. The first two-day workshop, "Pluripotent Cells in Translation: Early Decisions," was held in March, 2011. The second workshop in the series, "Pluripotent Cells in Translation: Preclinical Considerations" will take place at Natcher Auditorium on the NIH campus in Bethesda, Maryland, on July 10–11, 2012.

The first day will cover the product development timeline, the promise and therapeutic challenges, understanding the expectations of the FDA, model/species considerations, and cell delivery and tracking; the second day will cover safety and preclinical study design, combination products, case studies, and emerging areas.

The workshop will also available via webcast.