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The Cell and Gene Therapy Products (CGTP) Symposium: Manufacturing, Quality and Regulatory Considerations enables the exchange of scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products…
In recent years, cell and gene therapies have evolved rapidly into approved products for the treatment of both incurable genetic diseases as well as for the treatment of certain cancers. Emerging technologies such as the design of new experimental vectors, use of pluripotent and allogenic cells, improvements in efficacy and specificity of the delivery systems, and the greater understanding of the inflammatory response against these modalities are leading to the expansion of clinical applications in this space. This session will explore examples of emerging molecular and cellular approaches that are tackling the challenges with the current therapeutic options in gene and cell therapy and building the next generation of sophisticated approaches to treating diseases.
The Cell Therapies products space is continuing to build on the potential for innovative treatments for unmet patient needs. Topics include cell products with unique manufacturing process, complex sourcing starting material, and assays with direct relevance to CQAs…