Commercializing Cell And Gene Therapies: Navigating Complex Commercial Readiness Hurdles For A Successful Product Launch

The cell and gene therapy market is expected to grow as a number of programs advance into late-phase clinical trials and near regulatory approval. As more and more products enter the market, efficiently navigating the complex path to commercialization is key for developers.

Sponsors conducting late-phase trials must effectively launch their products to achieve cost-effectiveness and deliver the maximum benefit to patients in need. However, the industry’s understanding of, and expertise in, implementing a successful commercial readiness strategy are still evolving.

In this webinar, Charles River's Andrea Briggs, Senior Director, Global Cell and Gene Therapy Compliance, shares insights gained from the experience of being the first North American CDMO to gain EMA approval for commercial production of an allogeneic cell therapy drug product and discuss approaches to streamline and accelerate cell-based therapy commercialization. Review critical factors to achieve commercial readiness, risk mitigation activities, steps to address process/analytical robustness and reproducibility, and quality control and regulatory considerations.