2-day In-person Seminar (December 10-11, 2015)
Regulatory and Development Pathway for Cell Therapies
Cell therapies have been considered as the next generation of healthcare for almost two decades. However, the regulatory and development path of cell-based therapies for many professionals is still unclear. While recent analysis has suggested that regenerative medicine is maturing into a multibillion dollar industry, examples of clinical and commercial success are still relatively rare. Geron’s halted clinical trial is just one illustration of FDA’s risk-averse stance toward the clinical use of this high risk medical technology.
This workshops aims to provide the examples of both failed and successful cell therapy products and trials, to highlight the obstacles in developing stem cell-based or patient-derived cell therapy and to focus on the challenges US FDA faces in regulating these therapies.
Who should attend:
For additional information on the workshop agenda and logistics, please call +1 877-566-4981 or +1 410-501-5777 or email: email@example.com