(264f) QbD at Vertex: Back to the Future
AIChE Annual Meeting
2020
2020 Virtual AIChE Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
PD2M Panel Discussion Part 1- QbD based Filing: Realizing the Promise (Invited Talks)
Friday, November 20, 2020 - 9:40am to 9:50am
This talk focuses on the lessons learned in implementing the QbD approach in DS regulatory filings for the Vertex CF portfolio ranging from Kalydeco (2012) to Trikafta (2019). Case studies are used to address the evolution of approaches taken for risk assessments, experiment design and analysis, nonlinear modeling, design space limits and other areas. These lessons learned are fueling further development as we prepare for future regulatory filings. Further discussion during the panel forum will be welcome.