Webinar Webinar

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

January 31, 2024

11:00 AM - 12:00 PM EST


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

Cris McDavid

Director Global Clinical Operations

Cris leads Parexel’s risk-based quality management operations and drives process and technology implementation. Cris has 20 years’ experience in global clinical trial operations, including data management, and has a successful record of building robust, collaborative customer relationships and leading global teams.

Jamie Pierson

Senior Project Leader and Program Lead, Cell and Gene Therapy Center of Excellence

Jamie is a Senior Project Leader and Program Lead within Parexel’s Cell and Gene Therapy Center of Excellence.  She is responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. Jamie has spent the most of her career in project management, collaborating with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets.