The Food and Drug Administration Grand Rounds is webcast every other month to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute presentation is followed by questions from the audience.
Dr. Steven Bauer, Chief of Cellular and Tissue Therapy Branch in FDA’s Center for Biologics Evaluation and Research, will be giving a presentation titled Are Stem Cells Ready for Prime Time? A Look at FDA Research Advances in Regenerative Medicine.
The presentation will be about stem cell-based cellular therapies being actively developed and holding tremendous promise for treating a wide variety of medical conditions, from diabetes to heart disease and joint repair. However, the use of stem cell-based products is new and characterizing the product is challenging. Specifically, FDA is conducting research into identifying cell therapy product characteristics that will predict the reliably of the performance of cell-based therapies in humans. In many cases, this is a challenge that is largely unresolved. FDA is concerned with characteristics of identity, purity, and potency, which constitute quality attributes. Ideally, these attributes are related to a given cell preparation’s ability to perform the desired biological function--and result in the intended clinical effect.
More details available at U.S. Food and Drug Administration.