As the Cell and Gene Therapy (CGT) sector rapidly expands, the challenges associated with maintaining QA standards while scaling ATMPs are becoming more pronounced. This panel discussion will explore cutting-edge trends and strategic approaches in CGT quality management. Our panelists will discuss the evolution of regulatory expectations and the importance of robust QA oversight from clinical development through to commercial-scale production. The conversation will also address the scalability challenges unique to CGT, including supply chain complexities and the need for agile, adaptive QA processes that ensure compliance without compromising the pace of innovation. Join us as we explore lessons learned for navigating these challenges and driving the future of QA in the CGT landscape.
Time: 5:00 PM - 7:30 PM
- Introductions and Panel Session: 5:00PM - 6:00PM
- Networking: 6:00PM to 7:30PM
Cost: $15.00
Appetizers and drinks provided!
Location:
GLY Construction Facility (Free parking)
14432 SE Eastgate Way, Suite 300
Bellevue, WA 98007
Panelists:
- Lisa Khuu, Associate Director Quality systems, Pfizer
- Maria Amaya, Lead External Advocacy North America (Quality Policy), Genentech
- Chintan Vin, Director of Product Quality Lead, BMS