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Xtalks, Online
2025-11-13
As the cell and gene therapy (CGT) pipeline continues to expand, the industry faces a critical bottleneck: limited, CGT-experienced site capacity. Traditional sites are oversubscribed, while qualified but underutilized or naïve sites remain untapped. Sponsors require more CGT-capable centers to support safe, high-quality trials, and bridging this gap is essential to advancing CGT programs efficiently and effectively.
This webinar will bring together perspectives from a sponsor, CRO, clinical site and institutional biosafety committee (IBC) expert to explore strategies for expanding and optimizing CGT trial sites. Attendees will gain insight into:
Identifying and evaluating emerging sites, including how sponsors can build trust in those that are naïve or underutilized
CRO strategies to de-risk site selection, accelerate start-up activities and provide ongoing training and operational support
Site-level best practices for creating CGT centers of excellence, fostering cross-departmental coordination and developing sustainable institutional processes
Regulatory readiness, with practical guidance on IBC definitions, requirements and pathways to accelerate study start-up through central IBC models and concierge services
By examining the site capacity issue from multiple perspectives, this session will highlight actionable approaches for sponsors to expand their site networks with confidence. Attendees will leave with a clearer understanding of how to leverage untapped sites, foster collaboration and streamline study initiation, helping ensure their CGT programs have the necessary infrastructure to succeed.
Register for this webinar to learn how to expand site capacity and improve readiness for CGT clinical trials.
Keywords: Cell & Gene Therapies, CGT, Clinical Operations, Clinical Research, Clinical Trial Design, Clinical Trials, CRO, Drug Development, Regulatory, Site Management, Site Selection, Sites
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Organized by:
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Xtalks |
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Invited Speakers:
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Jessica Merryfield, Vice President, Project Delivery, Cell & Gene Therapy, Premier Research
Brittany Groner, Director, Clinical Operations, BridgeBio Gene Therapy
Brian Shayota, MD, MPH, Assistant Professor of Pediatrics and Medical Genetics, University of Utah
Garry Coulson, Senior Director of Regulatory and Quality Assurance, Sabai
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Deadline for Abstracts:
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2025-11-13
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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