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Session 5: Phase-Appropriate and Risk-Based Quality Assurance Strategies for Phase 1 GMP of Cell and Gene Therapy Drug Products

4:00 PM – 4:45 PM | East Red Level, Suite 10

Phase-Appropriate and Risk-Based Quality Assurance Strategies for Phase 1 GMP of Cell and Gene Therapy Drug Products

The development of cell and gene therapy (CGT) products brings unique challenges, particularly during Phase 1 GMP manufacturing, where patient safety, product quality, and regulatory compliance must be ensured despite limited clinical data and process variability. These challenges are compounded in scenarios involving a company acquisition, where integration of quality systems, alignment of organizational cultures, and harmonization of operational priorities add layers of complexity. To address these multifaceted issues, implementing phase-appropriate and risk-based quality assurance (QA) strategies becomes essential. This presentation will explore the design and execution of QA strategies tailored to the distinct requirements of an internally manufactured CGT drug product product for Phase 1 clinical trial while navigating challenges arising from both external and internal changes. Key topics include:

1. Establishing foundational quality systems that balance compliance with flexibility to support early-phase innovation.
2. Addressing integration challenges in harmonizing legacy quality systems and practices from the acquiring and acquired entities.
3. Applying risk-based approaches to prioritize critical quality attributes (CQAs) and critical process parameters (CPPs) while ensuring consistent QA oversight across newly combined teams and processes.
4. Overcoming cultural and operational differences that impact the quality-first mindset and cross-functional collaboration during early-phase development.
5. Implementing phase-appropriate documentation and change management processes to maintain agility, traceability, and alignment with regulatory expectations during organizational transitions.
6. Developing strategies to mitigate risks associated with disruption to manufacturing operations, technology transfer, and supply chain complexities during acquisition integration.
7. Enabling continuous improvement and operational excellence throughout the quality organization to anticipate technological innovation.

Using case studies and real-world examples, this session will provide attendees with actionable insights into optimizing quality systems during Phase 1 CGT manufacturing while managing risks and organizational challenges. Attendees will leave equipped with strategies to ensure compliance, product quality, and operational continuity, even in the face of transformational events.

Speaker:

Andrew Cieri, Senior Director Quality QA&QC, Regeneron

Biography:

Andrew Cieri is a seasoned Quality Executive with over 20 years of experience in quality assurance, validation, and manufacturing across GMP, GLP, GDP, and GCP environments. Currently serving as Senior Director of Quality Assurance (QA & QC) at Regeneron, Andrew oversees quality systems, quality operations and strategy, and Quality Control for the recently formed Regeneron Cell Medicines business unit. He has extensive expertise in developing phase-appropriate, risk-based quality assurance frameworks, ensuring regulatory compliance, and fostering operational excellence. Andrew has successfully navigated complex organizational transitions, including the integration of quality systems during company acquisitions and spinouts, while driving process improvements and reducing costs. His leadership has contributed to multiple regulatory approvals, including FDA and EMA submissions for advanced therapies. Andrew holds a Master of Science in Engineering Management from Tufts University and a Bachelor of Science in Chemical Engineering from Worcester Polytechnic Institute.