#Canada #Toronto #Clinical Trials #Cell and Gene Therapy #Xtalks

Explore Strategies to Overcome Site Capacity Challenges in CGT Trials

The landscape of cell and gene therapy (CGT) continues to evolve rapidly, presenting remarkable opportunities yet also notable hurdles. One of the most pressing issues facing the industry today is the shortage of experienced sites equipped to conduct CGT trials. As traditional sites reach capacity, it becomes increasingly vital to identify and leverage underutilized facilities. To aid in this endeavor, Xtalks is hosting an insightful webinar designed to provide attendees with valuable knowledge and actionable strategies.

Understanding the Site Capacity Bottleneck

As the CGT pipeline expands, the gap between demand for clinical trial sites and current capacity has led to significant challenges. Traditional CGT sites are often overwhelmed, leading to oversubscription. In contrast, some sites remain underutilized due to their lack of experience or awareness regarding CGT capabilities. This creates a pressing need to bridge the gap by optimizing site selections and operations, thereby enhancing the overall quality of clinical trials.

Webinar Objectives: Key Takeaways

During the free webinar on November 13, 2025, attendees will gather insights on multiple facets associated with site capacity within CGT trials. Several topics will be discussed:

1. Identifying Emerging Sites: Participants will learn how to effectively evaluate and trust sites that may seem naïve or underutilized. Understanding market dynamics and the specific capabilities of these sites is essential.

2. CRO Strategies for Site Selection: The session will introduce various strategies that Clinical Research Organizations (CROs) can adopt to diminish risks associated with site selection. By accelerating start-up activities and ensuring ongoing education and operational support, sponsors can make better-informed decisions.

3. Creating Centers of Excellence: It’s crucial for trial sites to adopt best practices to function effectively as centers of excellence. The webinar will offer insights into fostering collaboration across different departments and establishing sustainable institutional processes that elevate site capabilities.

4. Regulatory Readiness: Attendees will receive practical guidance on Institutional Biosafety Committee (IBC) definitions and requirements. This knowledge will empower sponsors to implement central IBC models—critical pathways that can expedite the initiation of studies.

Meet the Experts

The expertise shared during this webinar will come from a diverse panel of speakers:

• - Jessica Merryfield: Vice President of Project Delivery, specializing in Cell and Gene Therapy at Premier Research.
• - Brittany Groner: Director of Clinical Operations at BridgeBio Gene Therapy.
• - Brian Shayota, MD, MPH: An Assistant Professor of Pediatrics and Medical Genetics from the University of Utah.
• - Garry Coulson: Senior Director of Regulatory and Quality Assurance at Sabai.

Their combined experience will help frame actionable approaches for sponsors to extend their site networks confidently and effectively.

Bridging the Gap

As the CGT sector strives to thrive, overcoming site capacity challenges is paramount. This upcoming webinar aims to equip participants with the necessary tools and knowledge to tackle these issues head-on. By participating, sponsors can learn how to effectively collaborate with underutilized sites, thus ensuring their CGT programs are infrastructure-ready to succeed in delivering high-quality clinical trials.

Registration Information

Interested individuals can register for the webinar through Xtalks’ platform and take a pivotal step toward enhancing their understanding of site capacity challenges relevant to CGT trials. Don't miss this opportunity to learn from industry leaders!

For further details, visit Xtalks.