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Flexible regulatory pathways and key CMC considerations to commercialize cell and gene therapy products
Webinar On Demand
The rapid expansion of the cell and gene therapy pipelines in recent years offers significant potential to cure diseases with great unmet medical need. However, the unique nature of these therapies poses challenges to regulating them within traditional frameworks and regulatory expertise is not uniform across regions.
This webinar will provide key advice for determining and navigating the regulatory pathway for any cell and gene therapy, including the following:
- Early, proactive engagement with the established regulatory authorities that specialize in the evaluation of cell and gene therapies
- The key components of programs to accelerate application review within major regulatory jurisdictions
- Critical considerations for site selection and CMC development of viral vectors for cell and gene therapies
Author:
Clara Ferloni, PhD
and Monica Commerford, PhD