CMC Considerations for CAR T Cell Product Development
1:20:20
Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017
36:56
FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy
37:34
Designing First-In-Human Trials for Small Molecules and Biologics
1:19:35
Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018
28:12
Regulatory Considerations for Impurity Qualification: ICH Q3A/Q3C/Q3D, RLD & MDD
34:04
Panel Discussion
1:02:19
Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it.
28:11