June, 2026
Why cell and gene therapy trials demand a different level of execution in clinical trial logistics
Cell and gene therapy (CGT) is changing the rules of clinical development — and execution is where that change is felt most.
Unlike traditional models, where products can be manufactured in advance and distributed at scale, CGT introduces a fundamentally different operating environment. Treatments are often patient-specific, highly time-sensitive, and dependent on complex global coordination.
As a result, clinical trial logistics, CGT supply chain management, clinical trial supply chain coordination, and regulatory alignment are no longer supporting functions. They are central to whether a therapy can be delivered — and whether a clinical trial can proceed.
So what makes execution in CGT so different?
Why traditional clinical trial models don't translate to CGT
Traditional clinical trial supply chain models are built around predictability. Manufacturing, storage, and pharmaceutical distribution can be planned in advance. Timelines are designed to absorb disruption.
In CGT, those assumptions no longer hold.
Many cell and gene therapy companies are working with:
- Individualized therapies rather than batch production
- Time-critical delivery windows
- Complex, multi-country supply chains
- Strict clinical trial compliance and regulatory requirements
This creates a system where execution must operate with far greater precision — and far less tolerance for disruption.
Patient-specific pathways change the clinical trial supply chain
In many CGT trials, each therapy is unique to the individual patient. This means the clinical trial supply chain is triggered by that patient’s treatment pathway — not by forecast demand.
Materials must be:
- Collected from the patient
- Transported for manufacturing
- Processed and analysed
- Returned for administration
This model places significant pressure on clinical supply chain management, particularly in ensuring end-to-end visibility, chain of custody, and real-time coordination across stakeholders.
There is no buffer. No excess stock. No room for delay.
Narrow treatment windows increase execution risk
In traditional trials, delays are often manageable. In CGT, they are not.
From the moment a therapy is ready, there may be only hours to deliver and administer it.
This creates a dependency on highly coordinated clinical trial logistics management and reliable Investigational Medicinal Product (IMP) distribution processes.
Delays go beyond operational impact — they can affect:
-
Product viability
-
Patient safety
-
Clinical trial outcomes
This is where execution becomes critical to success.
Where complexity is underestimated
Many CGT programs originate in academic environments or emerging biopharma organizations. The initial focus is rightly on scientific development and funding. Operational complexity is often considered later.
This can lead to challenges in:
- Regulatory readiness
- Supply chain design
- Infrastructure availability across regions
- Coordination between stakeholders.
Cristina highlights that these challenges often emerge late in the process: “We’ve seen situations where a program was ready to begin — but couldn’t proceed because it hadn’t met required manufacturing compliance standards. Everything else was in place, but without the right regulatory and quality foundations, the trial simply couldn’t start.”
From planning to real-time coordination
The shift in CGT clinical development is not about replacing the model. It’s about operating it differently.
Planning must begin earlier and involve more functions. Clinical, manufacturers, regulatory, supply chain, and operational teams must work together from the outset to design a trial that is both scientifically and operationally viable while compliant with regulatory standards.
Risk assessment becomes crucial rather than optional. Teams must anticipate:
- Delays in transport
- Temperature deviations
- Regulatory timelines
- Variability in manufacturing.
“This requires a higher level of coordination across the entire ecosystem,” says Cristina. “You’re not just running a clinical protocol. You’re coordinating a complex system across multiple stakeholders.”
Why partnerships are critical
No single organization can deliver every element required for CGT clinical development.
Successful trials depend on coordination between:
- Developers
- Manufacturers
- Logistics providers
- Regulatory authorities
- Hospitals and clinical sites
- Patients and patient advocates.
Each plays a distinct role, and each must align in real time. Incorporating the patient voice helps ensure trial design and delivery are shaped around real-world needs, experiences, and outcomes.
“Specialized partners bring expertise in areas such as regulatory management, temperature-controlled logistics, and supply chain design,” says Cristina. “Their role isn’t to replace internal capability, but to extend it. This shift reflects a broader trend across the industry: moving from linear execution to integrated delivery models.”
What this means for clinical development leaders
For leaders across R&D, procurement, clinical operations, and supply chain, the implications are clear.
Scientific innovation alone is no longer enough. Execution must be designed with the same level of rigour as the therapy itself.
This includes:
- Engaging operational and supply chain expertise early
- Designing trials around real-world constraints
- Building partnerships that support end-to-end delivery
- Investing in coordination and communication across teams
As CGT pipelines continue to grow, these considerations will become increasingly important.
Looking ahead
“The clinical development model isn’t being replaced", says Cristina. “It’s evolving. New approaches, including in vivo therapies and more integrated supply models, and digital orchestration platforms powered by AI, may reduce some of today’s constraints over time. But for now, success depends on how effectively organizations can operate within a complex, fast-moving environment. This isn’t a temporary shift. It reflects the direction of travel for clinical development as a whole.”
She adds: “In cell and gene therapy, innovation doesn’t end in the lab. It must be delivered — precisely, reliably, and at speed. Because in these trials, execution isn’t a supporting function. It’s the difference between a therapy existing — and a patient receiving it.”
