Reducing CMC Risk From IND To Commercial Manufacturing Of Cell And Gene Therapies

By J. Kelly Ganjei, CEO of Cognate BioServices, David Pryce, CEO of Devacel, Shailesh Maingi, Founder and Chairman of Kineticos Life Sciences, Beth Webb, Global GM for Commercial for Cell and Gene Therapy at Cytiva

For those developing potentially curative therapies, it is a critical and exhilarating time. The industry now has some cell and gene therapy approvals, so the question has become: How can we quickly yet safely move new candidates through the clinic?

Experts from the cell and gene therapy field share experiences and discuss growing trends to accelerate treatments. Topics include transitioning from development, what to look for in a CDMO, moving from the bench to the clinic, timeline bottlenecks, approaching manufacturing with new models, how to fill the talent gap, how to advance clinical trials, when to start thinking about a technology transfer, and when in-house manufacturing makes sense.

Industry experts:
J. Kelly Ganjei, CEO of Cognate BioServices
David Pryce, CEO of Devacel
Shailesh Maingi, Founder and Chairman of Kineticos Life Sciences
Beth Webb, Global GM for Commercial for Cell and Gene Therapy at Cytiva