From Boutique to global: Chimeric antigen receptor T-Cells as a model for clinical development and commercialization
Since the 1990s, there have been clinical trials using genetically modified T cells. This has been possible due to advancements in gene delivery technology, allowing the creation of engineered T cells including chimeric antigen receptor (CAR)-T cell therapies and other novel therapeutic approaches, such as T cells resistant to HIV infection. Modified T-cells targeting CD19 on B-cells, leukemias and lymphomas have increased our artillery in the fight against cancer, enabling induced durable complete treatment responses in cancer patients who are relapsed or refractory to all other available treatments.
The synthetic biology technology used in the creation of CAR-T cells has allowed global, multi-center clinical trials, resulting in T cell immunotherapies with FDA, EMEA, Canada, Switzerland, Japan and Australia approvals. One such treatment, Kymriah™ from Novartis, has recently been approved for use in relapsed/refractory acute lymphoid leukemia in children and young adults, as well as in diffuse large B-cell lymphoma. However, the translation of these technologies from research bench to clinical application requires integrated scientific, engineering, and regulatory expertise.
New designs for genetically engineered T cells include switches and potency enhancements that will be required for targeting solid tumors. The road forward for wide patient access to these uniquely personal cellular therapies depends not only on scientific progress in targeting, gene modification and cellular manipulation, but also on meeting automation, engineering, and health policy changes.
Register now and attend the webinar to understand:
- The mechanism of action of CAR-T cells
- The clinical development from bench to bedside of a unique cell therapy
- The vein-to-vein complexities and healthcare challenges of developing a paradigm shift in therapies
Certificate of Attendance
All webinar participants can request a certificate of attendance, and a learning outcomes summary document for continuing education purposes.