Workshop Session Two: Industry Perspectives and Challenges for Expedited Programs

Innovative regulatory pathways have accelerated product development and approval for many innovative medicines for patients with an unmet medical need. These pathways have broken down barriers to speed up access for new therapies and have had a direct impact on public health. However, the shortened timelines and pressure to accelerate development creates unique challenges for industry. One of the biggest challenges is to develop, characterize and validate the commercial manufacturing processes and analytical testing methods under compressed clinical development timelines and to provide sufficient data and information to support line of sight from clinical to final intended commercial materials. This session will explore industry perspectives for accelerated programs with focus on process validation, comparability, stability and shelf-life considerations, and post-approval change management plans.