Commercializing cell and gene therapies: Navigating complex commercial readiness hurdles for a successful product launch
Sponsor
A surge in the number of market approvals for cell and gene therapy products is anticipated, as numerous programs advance into late-phase clinical trials. Nonetheless, the path to commercialization for developers remains exceedingly complex.
To ensure a sufficient return on investment and to provide the maximum benefit to patients in need, sponsors conducting late-phase trials must effectively launch their products. The industry’s understanding of, and expertise in, implementing a successful commercial readiness strategy are still evolving, however.
This webinar will share insights gained from the experience of being the first North American CDMO to gain EMA approval for production of an allogeneic cell therapy drug product. We will also discuss approaches to streamline and accelerate cell-based therapy commercialization.
This webinar will:
- Define the essential factors critical to achieving commercial readiness of cell and gene therapy products
- Examine the main commercial readiness activities on which to focus in order to mitigate risk
- Review appropriate steps to address process and analytical robustness and reproducibility
- Share quality control and regulatory compliance considerations
SPEAKERS
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