In our previous installment, we explored how market education lays the commercial foundation for cell and gene therapy (CGT) launches. In this post, we turn to a challenge that’s just as consequential, but often far less visible until it’s too late: Authorized Treatment Center (ATC) activation and site readiness.
ATCs are currently the operational backbone of CGT delivery. Without a well-prepared network of treatment centers, clinical demand cannot translate into real-world patient access. This is not a hypothetical risk. Companies with CGTs have learned, sometimes painfully, that underestimating ATC readiness is one of the most common and costly stumbling blocks in the entire launch process.
From Clinical Trial Site to Commercial ATC: A Transformation, Not a Transition
There is a persistent tendency in the industry to view the shift from clinical trial site to commercial ATC as a procedural step that can be addressed through certification and a readiness checklist. In reality, it’s an organizational transformation that touches nearly every aspect of how a site operates.
A clinical trial environment is structured around sponsor support. Protocols are defined, coordinators are funded, logistics are managed centrally, and the financial risk sits with the sponsor. A commercial ATC must operate independently within that same complexity, or, ideally, with ongoing manufacturer support, though manufacturers are often reluctant to provide it: developing its own SOPs, building billing and reimbursement workflows from scratch, negotiating with payers, training a multidisciplinary care team, and integrating demanding manufacturing and cold-chain logistics into day-to-day clinical operations, all while continuing to serve their existing patient populations.
A further consideration is the transition in personnel between clinical trial and commercial settings. Many academic institutions operate dedicated research units staffed by specialized healthcare professionals and support teams who may have no involvement in routine commercial delivery. As a result, the shift to commercial launch often necessitates transferring operational responsibility to an entirely new cohort of clinicians and support staff, with corresponding investments in training and onboarding.
The scope of this operational lift is often invisible from the outside. Even experienced oncology or specialty centers that have administered CGTs in trials may find the commercial transition unexpectedly demanding. The key insight here is that prior trial participation does not equal commercial readiness.
Time Is Not On Your Side
The practical implication of this complexity is that ATC onboarding requires far more lead time than most organizations expect. Site selection, engagement, contracting, SOP development, staff training, and payer coordination typically require 10–12 months of concerted effort (and that assumes everything goes well). In practice, institutional procurement processes, staff turnover, competing priorities, and payer-specific requirements frequently extend timelines further.
This means that companies planning to launch within two to three years need to begin ATC engagement almost immediately. Waiting until the regulatory approval horizon is in clear view is, in most cases, waiting too long.
Prioritization is also essential. Not every potential site is equally ready or equally important. A rigorous site selection process should weigh:
- Patient access (where are the eligible patients, and can they realistically travel to this center? Is financial or logistical support required and where might it come from?)
- Institutional readiness (does the site have the administrative infrastructure and leadership buy-in to invest in the operational transformation required?)
- Referral potential (is this site well-connected to the community physicians and specialists who will be identifying and referring patients?)
Getting this prioritization right focuses limited resources where they will have the greatest impact on patient flow.
Cross-Functional Diplomacy: The Underrated Ingredient
One of the most underappreciated dimensions of ATC activation is that it is fundamentally a cross-functional challenge. Medical, commercial, market access, and operations teams each have a critical role to activate ATCs, and misalignment between them is one of the most common reasons activation stalls.
Field Medical teams often develop the earliest site relationships during clinical development. Commercial teams bring the contracting and account management expertise needed to formalize ATC agreements. Market Access teams must work alongside sites to resolve payer-specific requirements and build billing workflows. Operations teams coordinate the logistics infrastructure that will support manufacturing scheduling and product delivery.
The sequencing and handoff between these functions matters enormously. A particularly important dynamic is the transition from field medical to commercial engagement: field teams must prepare the care team operationally before commercial teams can effectively facilitate the buying process. When this handoff is poorly choreographed, sites can feel abandoned mid-process, or alternatively, feel that they are being commercially pressured before they’re operationally ready.
When ATCs Aren’t Ready, Patients Pay the Price
The stakes here extend well beyond commercial metrics. When ATCs are inadequately prepared at launch, patients who are eligible and motivated to pursue treatment encounter administrative delays, billing confusion, and care team uncertainty that can derail their path to therapy. In a disease population that is often small, fragile, and emotionally taxed, these friction points can result in patients abandoning treatment or deteriorating while the system catches up. While some of these barriers may originate beyond the manufacturer’s direct control, patients experience their journey as a single process, and any breakdown reflects on the therapy and the organization behind it.
This is ultimately why ATC readiness deserves to be treated as a patient access imperative rather than a basic commercial milestone.
The Bottom Line
ATC activation is a marathon with a fixed finish line. Companies that start early, prioritize strategically, and invest in cross-functional coordination are best positioned to have a treatment network that is genuinely ready on Day 1. Those that treat site readiness as a downstream operational detail risk may discover the hard way that strong clinical demand and an underprepared delivery infrastructure are a frustrating and costly combination.
Next in the series: Success Factor 3 – Referral Process Understanding and Shaping.
