Translational Toxicology Programs for Cellular Therapies

Apr 04 2011

Cell-based therapies are investigational treatments used in trials for serious human diseases ranging from stroke to cancer. After discovering a cell therapy candidate, progress to clinical trials will require safety research. Far from standard toxicology, this translational research program sets out to evaluate the impact of human cells in animals, modeling human use. Each program of study will differ, but raises challenges like transplant compatibility, immunosuppression, evaluation of cell fate, and tumorigenicity. The best programs arise from collaborative relationships between stakeholders (sponsor, safety laboratory, regulatory reviewers), innovative utilization of advanced technologies, and a commitment to simulate clinical risks as closely as possible. This webinar addresses the concerns of underlying program design, as well as translational study designs that have supported clinical success of cell therapies.

Presenter

• Shawna M. Jackman, PhD, Research Scientist, Photobiology and Cellular Therapeutic Safety Division