Workshop Session One: CMC Strategies to Expedited Program Development: Regulatory Perspectives

In response to increasing demands to expedite the availability of various therapeutic modalities globally, health authorities have developed accelerated regulatory pathways to reduce development timelines towards product licensure with the goal of patient benefit. Due to the complexity and unique nature of each program and product modality, some solutions must be worked out between sponsors and regulatory agencies on a case-by-case basis. This session will provide an overview of currently available regulatory pathways for accelerated product development, as well as tools for effective management of post-approval changes specified in ICH Guideline Q12. Health authorities’ representatives will share their experience with review of requests and submissions under expedited programs and will provide examples and case studies for different therapeutic modalities to illustrate applicability of expedited programs to real cases, success, CMC challenges, and deficiencies with submissions’ packages seen in regulatory reviews. Topics for discussion will include comparability assessment, process validation strategies, specification setting, expectations for regulatory submissions, and some emerging approaches in the context of accelerated programs to facilitate a common understanding of CMC challenges and their resolution.