Volume 3 - Inside the CAR-T Patient Journey: Challenges in New Zealand’s System

In Volume 2, we introduced BioOra and explained why manufacturing quality, local capability, and fit-for-purpose regulation are central to delivering CAR-T therapy safely and reliably. We now automate CAR-T manufacturing domestically, supporting Phase II trials that will treat up to 60 patients in New Zealand. These developments show the country has the scientific and operational capability to produce advanced cell therapies locally. 
 
Yet, the question remains: is the wider system ready to deliver these therapies reliably and equitably at scale?  

Operational challenges in delivering CAR-T in New Zealand 

Access to CAR-T in New Zealand is currently limited to clinical trials, with delivery shaped by a constrained and complex ecosystem, depending on: 

• Specialist manufacturing and testing capability 

• Regulatory approval pathways under the Hazardous Substances and New Organisms (HSNO) Act 1996 

• Hospital coordination for collection, transport, and reinfusion 

• International supply chains for equipment and consumables unavailable in New Zealand  

Spanning two islands with a dispersed population, geography adds coordination pressure. As Associate Professor Joanna Kirman notes, with “fewer flights coming in and out [in Dunedin]… it is actually quite a mission to get to another city” ³. When local manufacturing is limited, patient cells may be processed offshore, adding regulatory steps, handling requirements, and longer turnaround times. Each transfer point increases the risk of delay or administrative bottleneck(s). For therapies governed by strict “vein-to-vein” timelines, even short delays can be consequential -particularly for patients with relapsed or refractory disease ². 

 
Key structural gaps 

1. Limited domestic manufacturing scale 

Each CAR-T treatment is manufactured from a patient’s own cells, meaning capacity must scale with demand. As clinical use expands, throughput becomes a direct determinant of access. Professor Kjesten Wiig warns that without sustained funding, promising programmes may stall, as international pharmaceutical companies tend to prioritise larger markets¹. Limited local capacity can result in waiting lists or reliance on overseas production slots, reinforcing inequities ². 
 
2. Fragmented coordination and knowledge gaps 

CAR-T delivery requires tightly coordinated sequencing - leukapheresis, cell transport, genetic modification, quality testing, release certification, and reinfusion - with little margin for disruption. As Dr Weinkove observes, there is “always a degree of siloing within and between institutions” across the two islands, a challenge compounded by stretched hospital capacity. Fragmented coordination and uneven familiarity with evolving therapy pathways can slow system responsiveness and reduce consistency across a geographically dispersed network ².  
 
3. Regulatory misalignment 

The HSNO Act 1996 was not designed with personalised human health therapies in mind. While oversight is essential, regulatory processes that do not clearly differentiate between agricultural gene technologies and clinical cell therapies can create avoidable complexity. This uncertainty can lengthen development timelines, deter investment, and constrain domestic manufacturing growth. Funding pressures compound the issue, with research support described as “tight” and stagnant Health Research Council (HRC) grants struggling to sustain programmes ³. The Gene Technology Bill seeks to modernise this framework by introducing clearer, proportionate pathways for human health gene therapies and greater certainty for planning and scale. 
 
Implications for the patient journey 

System gaps affect both the broader pathway and the individual experience. Consequences include: 

• Longer vein-to-vein timelines and delayed access 

• Greater logistical complexity across multiple centres 

• Increased reliance on offshore manufacturing 

• Higher costs and administrative burdens 

• Uncertainty in treatment scheduling 

Patients also face practical barriers such as travel to specialist centres, caregiver availability, and financial strain². Beyond these patient-facing challenges, physician-related barriers are equally critical. Knowledge gaps regarding the efficacy, safety, and timing of CAR-T therapies, particularly for patients who have undergone prior treatments affecting T-cell fitness, can delay referrals and limit patient access². 

These physician-related barriers underscore the need to raise awareness of CAR-T and other cell therapies as real treatment options across New Zealand. By equipping clinicians with the knowledge, guidance, and confidence to identify eligible patients promptly, more patients become eligible for life saving treatments.  
 
Why policy and infrastructure matter 

Equitable access depends on aligning regulation, manufacturing capacity, and coordinated clinical pathways. Modernising regulatory settings is a necessary step, but it must be accompanied by sustained investment in facilities, workforce capability, and national coordination. Without alignment across these domains, scientific capability alone cannot ensure reliable delivery. 

Looking ahead 

CAR-T therapy is part of a broader shift toward personalised, cell-based medicine. Countries that align regulatory clarity with scalable infrastructure are better positioned to deliver these therapies safely and equitably. In Volume 4, we examine how comparable jurisdictions have addressed similar constraints and what lessons New Zealand can adopt. 

Science is advancing rapidly. The challenge is ensuring New Zealand’s systems keep up. 

References 

• 1. Malaghan Institute of Medical Research. (2026, February 12). A ground-breaking cancer treatment is within reach – but only if New Zealand acts now [Opinion]. A ground-breaking cancer treatment is within reach – but only if New Zealand acts now  

• 2. Hoffmann, M. S., Hunter, B. D., Cobb, P. W., Varela, J. C., & Munoz, J. (2023). Overcoming barriers to referral for chimeric antigen receptor T cell therapy in patients with relapsed/refractory diffuse large B cell lymphoma. Transplantation and Cellular Therapy, 29(7), 440–448. https://doi.org/10.1016/j.jtct.2023.04.003 

• 3. Kirman, J. R., Weinkove, R., & Borger, J. G. (2024). Immunology across two islands: Understanding the research landscape of Aotearoa (New Zealand). Immunology & Cell Biology, 102(4), 235–239. https://doi.org/10.1111/imcb.12709