CMC Workshop

Breakthrough Therapy Designation (BTD), Priority Medicines (PRIME), Sakigake, and other accelerated pathways facilitate earlier patient access to innovative medicines. The timing of the accelerated pathway designation and corresponding marketing application can impact CMC as well as current Good Manufacturing Practice (GMP) development strategies and activities. This session will discuss how implementing a QbD paradigm can facilitate accelerated drug development and approval. Timing of development milestones in early phases, the use of risk to focus development decisions, how novel manufacturing techniques can support speed to market, various approaches for life cycle management that leverage enhanced product and process understanding, and regulatory approaches to meet the rapid development timelines for accelerated approvals will be discussed. During the panel discussion, you will have the opportunity to ask questions and share ideas on using QbD approaches for meeting accelerated timelines.