Many pharmaceutical organizations strive to obtain expedited path- way designations for new products as this allows for quicker approval timelines and fast market launches; however, this can also greatly impact the clinical development processes.
While accelerated path- ways offer a variety of potential benefits for manufacturers, there is a great strain placed on CMC and developmental teams as oper- ational and submission timelines are severely condensed. The data compiled, analyzed and reported during CMC operations is vital to showcasing product safety and efficacy; therefore CMC executives are continually exploring avenues to streamline CMC processes that will not diminish the quality of CMC outcomes.
• Effect of expedited pathways on operational deadlines
• Streamlining processes to align with expedited timelines
• Lessons learned from expedited CMC data submissions
1:30 CASE STUDY ONE: Karin Pihel, Director CMC, RA ENZYVANT THERAPEUTICS
2:00 CASE STUDY TWO: Mallika Singh, Senior Director, CMC Project Management
2:30 EXPEDITED PRODUCT APPROVAL APPLICATIONS PANEL DISCUSSION
Jason Birri, HALLORAN CONSULTING GROUP
Karin Pihel, ENZYVANT THERAPEUTICS Mallika Singhm, INCYTE CORPORATION