614876 QbD at Vertex: Back to the Future

Friday, November 20, 2020: 9:40 AM
Pharmaceutical Discovery, Development and Manufacturing Forum (26) (vFairs Auditorium)
Billie Kline1, Mike Filios2, Cristian Harrison2, Adam Looker3, David Moon2, Brian Phenix4, Michael Ryan3 and David Willcox3, (1)Chemical and Materials Engineering, Vertex Pharmaceuticals, Boston, MA, (2)Vertex, Boston, MA, (3)Vertex Pharmaceuticals Inc., Boston, MA, (4)Chemical Development, Vertex Pharmaceuticals, Boston, MA

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.

Extended Abstract: File Not Uploaded
See more of this Session: PD2M Panel Discussion Part 1- QbD based Filing: Realizing the Promise (Invited Talks)
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum