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Session 2B: QbD Approaches to Accelerated Drug Development
Session Chair(s)
Elaine Morefield, PhD, RPh
Vice President, Regulatory Affairs
VaxForm, LLC., United States
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.
Speaker(s)
Leveraging QbD Paradigm for Accelerated Product Development: A Regulatory Perspective
Sharmista Chatterjee, PhD
Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ/CDER, FDA, United States
Division Director in Division of Pharmaceutical Manufacturing II,
Expedited Drug Development with Quality by Design
James Bush
Syner-G Pharma Consulting, LLC, United States
Associate Director, Regulatory Affairs
CMC QbD Strategies for Accelerated Pathways
Terrance Ocheltree, PhD, RPh
Corium, Inc., United States
VP, Head of Regulatory Affairs and Quality Assurance
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