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DIA 2021 Global Annual Meeting
Defining Quality for Cell and Gene Therapy Products
Michael Havert, PhD
- Vice President, Regulatory Affairs
- StrideBio, United States
Cell and Gene Therapy products are rapidly moving from early proof of concept and investigational studies to demonstration of clinical benefit and commercial approval. US and global regions have certainly helped bring important life-changing therapies to patients with remarkable expediency. However, development of robust product quality implementation and characterization often lags behind their rapid clinical programs. To help fill this gap, FDA has encouraged early product characterization, the evaluation of multiple product attributes, and development of a broad set of analytics. This “cast a wide net” approach allows for pruning of different methodologies during the product lifecycle and elevating tests for attributes associated with discernable changes and impacts to product safety, quality and efficacy. FDA has allowed flexibility in method development, specification setting and the identification of CQA in early phases.However, FDA expectation is that fully validated methods will be in place for licensure and that acceptance criteria will be established based on clinical efficacy studies. The transition from the flexible early phase to a more robust late phase expectation, highlights the critical importance for well-planned and step-wise control strategy and control system.
Learning Objective : Explain how to identify critical quality attributes for cell and gene therapy products; Outline when it is appropriate to set quality standards during investigational studies; Identify resources available for standard setting for cells and gene therapies.
Keith Wonnacott, PhD
- Executive Director, Regulatory Affairs
- Pfizer Inc, United States
Data Analytics and Consistency for CAR-T Methods
- Senior Vice President, Quality and Compliance
- Kite Pharma, United States