Last Updated: December 5, 2025, 3 pm UTC

The cell and gene therapy (CGT) landscape has entered a period of unprecedented growth. Dozens of CGT products have already been approved globally, and more than 4,300 therapies—from AAV gene therapies to RNA-based and gene-modified cell therapies—are moving through development.ⁱ

Yet the infrastructure needed to run these studies is not scaling at the same rate. Most CGT trials still rely on a relatively small number of academic centers that have the institutional experience, biosafety frameworks, and interdepartmental coordination required for these programs.

Those sites remain essential—but they’re also increasingly saturated. Lengthy contracting cycles, heavy operational loads, and limited scheduling flexibility are becoming persistent bottlenecks. As CGT expands into more indications and larger populations, sponsors face an inevitable reality: the industry must broaden its definition of a “CGT-ready” site.

Why Sponsors Need a More Diverse Site Network

The operational demands of CGT trials go far beyond the typical clinical study. Sites must manage:

Complex dosing procedures, sample stability limits, and chain-of-custody workflows
Safety risks that require rapid escalation across specialties
Storage and handling of genetically modified materials
Infrastructure for long-term patient follow-up
Coordination across pharmacy, surgery, imaging, emergency medicine, and diagnostics

These requirements are integral to CGT research—but they are also resource intensive. When layered across multiple studies, even the most seasoned centers face operational strain. Over time, these pressures translate into slow site activation, delayed first-patient-in milestones, and challenges meeting enrollment timelines.

This level of complexity is manageable for established centers, but it is not scalable if the field continues to rely on them exclusively.

Meanwhile, emerging sites—regional hospitals, community-based networks, and new academic departments—bring a different kind of value. They often have:

Strong relationships with target patient populations
Fewer competing trials
Faster startup pathways
Motivated investigators eager to grow in CGT
Institutional interest in expanding capabilities

These sites won’t mirror the experience of major academic hubs on day one, but with structured preparation, they can become critical contributors to the CGT ecosystem.

A More Holistic Way to Evaluate Site Readiness

Rather than labeling a site “CGT-ready” or “CGT-naïve,” sponsors benefit from a more nuanced assessment across four dimensions:

Facilities
- Are preparation and administration areas appropriate for genetically modified materials?
- Are IP storage, environmental controls, and biosafety practices in place?
- Does the site have, or need, Institutional Biosafety Committee (IBC) oversight—a routine biosafety review step for studies involving gene-modified products?
Institution
- How do pharmacy, surgery, PI oversight, and emergency care connect around CGT workflows?
- What is the site’s approach to contracting and startup governance?
- How is long-term follow-up (LTFU) handled within the institution?
Department
- Are there clear SOPs related to gene-modified material handling and GMO patient education?
- Are departmental teams aligned on safety alerts and escalation pathways?
Staff
- Do key personnel have modality-specific training (AAV, CAR-T, RNA)?
- Are coordinators prepared to manage intensive schedules or complex sample management?
- Is there a designated on-call resource to support acute or unexpected events?

This framework reveals where a site is well-positioned—and where targeted enablement can close gaps.

Reducing Risk Through Structured Support

Sponsors consistently raise concerns when considering emerging sites: safety readiness, logistical complexity, regulatory unfamiliarity, or lack of modality experience. Each of these concerns is legitimate—but none are insurmountable.

The following strategies have proven especially effective:

Conduct step-by-step workflow mapping
Walking through the screening, dosing, follow-up, and lab processes—often via dry-run sessions—helps identify potential bottlenecks before they become issues.
Provide tailored, modality-specific training
Training should be ongoing, practical, and timed to key milestones—not a one-and-done exercise at the site initiation visit.
Start IBC processes early
Emerging sites often need time to establish IBC oversight. Starting onboarding alongside protocol development can save weeks.
Simplify long-term follow-up (LTFU)
Flexible visit designs—telehealth check-ins, home health for blood draws, and EMR safety alerts—make LTFU feasible even in smaller settings.

With these supports, emerging sites can safely manage more complex CGT workflows than many sponsors initially assume.

A Broader, Stronger, and More Resilient CGT Network

Building a stronger CGT ecosystem requires looking beyond the long-standing centers of excellence and embracing a wider network of capable partners. Expanding into emerging sites is not a compromise—it is a strategic evolution that ensures the field can keep pace with its own scientific momentum. These centers offer new capacity, greater regional diversity, and the opportunity to bring CGT research closer to the communities it aims to serve.

With thoughtful assessment and tailored support, emerging sites can activate quickly, operate confidently, and ultimately strengthen study continuity from early-phase research through long-term patient follow-up. As demand for CGT trials accelerates, broadening the site landscape will be essential—not only to reduce bottlenecks and timelines, but to build a more connected, more accessible, and more resilient research network.

If you’re exploring ways to broaden your CGT site network, our team can help assess readiness, identify fit-for-purpose sites, and streamline activation. Contact us to learn more.

ABOUT PREMIER RESEARCH:

Premier Research International LLC (Premier) is a global leader in clinical research and consulting services with expertise in driving an efficient and effective path to market for the life sciences industry.

Premier is built with the needs of biotech in mind, turning breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value.

Leveraging deep therapeutic expertise, innovative technology, and product development operational proficiency—from preclinical planning to clinical trial execution and commercialization—our integrated approach offers personalized, end-to-end solutions to identify the pertinent data and insight necessary to make informed decisions earlier and deliver accelerated development timelines for a smarter, faster path to approval. To learn more, visit premier-research.com.

REFERENCES:

[i] American Society of Gene & Cell Therapy, & Citeline (2025, October). Gene, cell, & RNA therapy landscape report: Q3 2025 (Quarterly Industry Landscape Report). https://www.asgct.org/uploads/files/general/Landscape-Report-2025-Q3.pdf