1. Home
  2. Insights
  3. Blog
  4. Beyond the vial: Rethinking IRT for cell and gene therapy

Beyond the vial: Rethinking IRT for cell and gene therapy

Cell and gene therapies change the fundamental unit of clinical supply. In a conventional study, supply planning may focus on having the right product at the right site. In cell and gene therapy, the product is inseparable from the patient, treatment schedule, manufacturing and release status, storage conditions, location and chain of identity. The unit of supply becomes an interconnected treatment journey centred on far more than a vial.

That was the central theme of ICON’s presentation, Beyond the vial: IRT’s role in controlling patient-product readiness across the CGT journey, delivered by Alyssa Gilliam, VP, IRT & CSM, at IRT & RTSM 2026. The session explored how interactive response technology (IRT) can help study teams manage the decisions and dependencies surrounding treatment readiness without replacing specialist manufacturing, quality or logistics systems.

For ICON, this discussion also points to how its IRT platform, Flex Advantage, can work within a connected CGT operating model, using trusted information from specialist platforms to support enrolment, treatment scheduling, product allocation and other controlled study actions.

Different therapies require different controls

The operational requirements of autologous and allogeneic therapies may differ significantly. In an autologous therapy, material collected from a patient is used to create a treatment unique to that individual. This creates a closed loop in which identity continuity, coupled scheduling and an individual exception pathway become essential controls.

Allogeneic therapies introduce a different model. Supply may originate from healthy donors or manufacturing batches and be allocated across multiple recipients. This places greater emphasis on donor, batch and lot traceability, attribute-aware inventory management and safeguards that prevent an unsuitable product or variant from reaching a patient.

In both models, the challenge extends beyond knowing where inventory is. The study must maintain the connection between identity, time, condition, place and exception status throughout the treatment journey. Collection, manufacture, release, shipment and treatment dates are interdependent, and product condition, site qualifications, receiving hours and storage capacity can all affect whether the next step may safely proceed.

From inventory visibility to orchestration

As these dependencies multiply, the role of IRT must evolve. Study teams need to define the information IRT must hold, the decisions it must support, the communications it must trigger and the evidence it must retain.

This evolution keeps manufacturing, quality, condition-monitoring and logistics capabilities within the specialist systems designed to manage them. Applications such as ICON’s Advanced Therapy Orchestration Manager (ATOM) can provide visibility and management of participant and product logistics, while the IRT layer uses selected events to trigger controlled study actions. Depending on the event and operating model, IRT can then direct the appropriate user to proceed, hold, notify or escalate.

The distinction matters. Multiple systems can contribute authoritative information while retaining clearly defined responsibilities. In one potential model, ATOM manages authoritative product, manufacturing, release, shipment and detailed custody information, while Flex Advantage supports the study journey through enrolment, scheduling, product assignment, site receipt and study oversight. The precise boundary must be defined for each study, including which system owns each event, who can make a decision and what action should be presented to each role.

Product arrival is one step towards treatment readiness

Receipt of the product at the site is an important milestone within a broader readiness assessment. Before dosing, study teams may need to confirm patient and site readiness, identity continuity, manufacturing and release status, transportation conditions and the resolution of any discrepancies. The final decision may then be to proceed, hold or escalate.

Recording receipt captures one event; controlling readiness requires a decision supported by verified information across the patient-product journey.

A connected approach can bring selected authoritative events from ATOM into Flex Advantage, giving authorised study and site users the information needed for the next controlled action without duplicating the underlying manufacturing or logistics record. The design principle is to exchange the minimum information required to schedule, release, receive, administer and reconcile treatment.

Design around real-world exceptions

Effective orchestration begins early. IRT, clinical supply, quality, manufacturing, logistics and site teams should work together to determine how the journey will be controlled.

The presentation set out five areas for early design:

  • Map the journey by defining persistent identifiers, custody evidence and ownership across systems.
  • Define the controls governing holds, quarantine, readiness gates and role-based actions, with clear boundaries between product authority and IRT-supported study decisions.
  • Design the event logic connecting schedules, trusted events, alerts and reconciliation.
  • Test exceptions involving identity, release, condition, timing and system downtime.
  • Operate and adapt by monitoring system health, governing change and rehearsing exception recovery.

The principle is straightforward: build failed hand-offs and unavailable interfaces into the design from the outset, alongside the ideal pathway.

Making limited supply decision-ready

The presentation also demonstrated IRT’s potential value in an allogeneic cell therapy study involving limited, high-value inventory, a multi-country supply chain and dose-escalation cohorts. Configurable IRT capabilities available through Flex Advantage, including enrolment, cohort-assigned randomisation, product management, reporting and system integrations, provide a foundation for this type of study design. Within a connected CGT operating model, those capabilities could support product allocation, inventory visibility and cohort controls while trusted events from specialist systems inform treatment-readiness decisions.

The example illustrates how IRT can help turn distributed information into controlled and actionable study decisions, provided its role and boundaries are established clearly.

The destination: decision-ready orchestration

For cell and gene therapy studies, visibility is only the starting point. Teams must know whether the patient-product journey can move forward and what must happen when progress is blocked. A decision-ready approach to IRT can help:

  • Prove identity and custody at critical hand-offs.
  • Orchestrate dates, milestones and readiness across systems.
  • Protect patients and studies by preventing progression while product or patient conditions remain unresolved.
  • Recover through predefined exception and downtime pathways. 

By connecting information about the patient, product, place, time, condition and decision status, IRT can support more controlled decisions in complex therapy studies. It brings the right information from specialist systems to the right person when a study decision must be made.

That is how IRT moves beyond the vial.

In this section

Connect with us