Legal Issues in Cellular Therapies
Program Code: 321-A/CEO Monday, October 17, 2005
2:00 PM to 3:30 PM (ET)
MODERATOR Kathleen Sazama, MD, JD, LifeSouth Community Blood Centers, Inc.
SPEAKERS Kathleen Sazama, MD, JD, LifeSouth Community Blood Centers, Inc. Duncan Barr, JD, O'Connor, Cohn, Dillon & Barr Diane Maloney, JD, FDA Center for Biologics Evaluation and Research
DESCRIPTION
The collection and use of cellular therapies, including hematopoietic stem cells, cord blood and tissues provides the promise of life-extending and even life-saving outcomes. Providing these living materials is subject to ethical, regulatory and legal constraints that protect both the donor and recipient from exploitation or poor practices. The speakers will provide a range of expertise and frame the areas in which risks might arise. Where possible, actual case examples will be used to illustrate the topic.
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