275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2022. Parexel International Corporation.
275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2022. Parexel International Corporation.
5.14.19 -
Manufacturers often ask if there is a checklist for CMC readiness before entering pivotal or Phase III study or if they plan to ask the agency for one of many expediated designations. Since the agency does not have a guidance or points to consider document in this area, a helpful list of questions to considered can be found below. Keep in mind this list includes most but not all the points which should be considered by manufacturers of cell and gene therapy products.
CMC readiness remains to be the major hurdle when conducting cell and gene therapy trials. As a result, insufficient readiness could potentially lead to unnecessary delay and may further complicate and convolute interpretation of very costly clinical trial studies. For this reason, we recommend that our clients conduct a comprehensive and detailed CMC readiness exercise prior to the initiation of their pivotal or licensing trials.
We are always available for a conversation.