Managing Complexity in Cell and Gene Trials: Establishing an RBQM Strategy that Drives Better Performance

Cell and gene therapies (CAGT) offer extraordinary hope to patients with advanced cancers and genetic diseases, but pose unprecedented challenges for biopharmaceutical companies. CAGT studies are more complex in nature and require a larger investment from sponsors. At the same time, global regulatory agencies are saying that CAGT studies are too expensive to operate and need to be performed more efficiently.

The more complex protocol designs commonly used in CAGT studies bring increased risks, which when not monitored carefully result in costly delays. A strong risk-based quality management (RBQM) strategy can keep sponsors steps ahead of clinical development data challenges, minimizing delays and keeping studies on track.

In this webinar, clinical development and RBQM experts will discuss where to start when creating an RBQM strategy, how to evaluate a protocol, and leveraging previous study data to determine trends. 

The topics covered will include:

• De-risking the protocol: What are the particular parts of a study design that introduce risk?
• The importance of a Risk Assessment Categorization Tool (RACT)
• Determining quality tolerance limits and key risk indicators
• Creating knowledge management systems that can be leveraged across studies