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 is 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
Senior Director, Global Cell and Gene Therapy Compliance
Andrea Briggs has over 30 years of experience in all aspects of the pharmaceutical industry – development, technical transfers, regulatory support, inspection management/remediation, quality control and quality assurance practices in R&D, clinical, and commercial environments. In her current role, Andrea has overall responsibility for compliance at the Cell and Gene Therapy CDMO sites at Charles River Laboratories. Prior to joining the organization, Andrea served as Director of Quality for Cell and Gene Therapy with Thermo Fisher Scientific where she developed/implemented phase appropriate quality systems in addition to developing the quality department for the business unit. During her career, she has presented on relevant topics such as data integrity and phase appropriate quality oversight. Andrea holds a Bachelor of Science from Central Michigan University in Chemistry and is also an ASQ Certified Six Sigma Black Belt, Certified Quality Auditor, and Certified Quality Engineer.