Navigating Clinical Development Pathways to Commercial Approval: Pfizer’s Success with BEQVEZ Gene Therapy for Hemophilia B
Time: 12:30 pm
day: Day 2- Clinical 1
Details:
- Insights into Pfizer’s journey to regulatory approval in the U.S., EU, and Canada, addressing unique challenges and breakthrough solutions for BEQVEZ
- Exploration of risk minimization and safety and efficacy control measures that underpin the commercialization of BEQVEZ
- In-depth examples of product comparability and process characterization that supported BEQVEZ’s development and commercialization as a transformative therapy
