A myriad of landmark breakthroughs from 2025 demonstrate that the clinical impact of modern therapeutics – including CAR-T therapy – depends as much on disciplined hospital pharmacy implementation as it does on scientific innovation, as Dr João Gonçalves PhD explains as he shares part one of his top five highlights from 2025.
In 2025, hospital pharmacies faced two seemingly conflicting trends. On the one hand, medicine became more complex with the emergence of therapies that function less like standalone ‘products’ and more like platforms – highly engineered interventions in which the clinical outcome depends on how well a hospital manages a sequence of decisions, logistics, monitoring and long-term governance.
Conversely, some therapeutic advances have produced population-level effects by targeting conditions that are so prevalent that even modest improvements in outcomes translate into significant changes in hospital admissions, clinical workload and healthcare budgets.
Hospital pharmacists sit directly at the juncture of these trends and are uniquely positioned to manage the medication-use system, from selection and procurement to safe preparation and administration, as well as pharmacovigilance, real-world monitoring, stewardship and digital decision support.
CAR-T therapy for autoimmune disease
In vivo CD19 CAR-T therapy for refractory systemic lupus erythematosus (SLE) represents a profound conceptual shift for hospital pharmacy because it challenges the traditional boundaries between drug delivery and cell therapy manufacturing.1
Conventional autologous CAR-T delivery involves a carefully coordinated process, including leukapheresis, external manufacturing, quality release and reinfusion, where much of the complexity is logistical and contractual, and a significant part of the risk lies in the chain of identity and chain of custody.
In vivo approaches invert that problem. If the engineering step is triggered within the patient, the hospital’s operational centre of gravity shifts away from manufacturing slots toward clinical governance, patient selection, toxicity monitoring, infection prevention and long-term safety management.
For the pharmacist, this shift is not just administrative; it changes what competence involves. The main distinction becomes the ability to perform an advanced therapy medicinal product (ATMP)-like intervention with drug-like administration features while maintaining ATMP-grade oversight.
Architects of a comprehensive CAR-T pathway
The immediate response from some teams will be to regard early in vivo CAR-T in autoimmune disease as ‘interesting but distant’. This stance underestimates the structural implications.
Autoimmune diseases, even in refractory subsets, represent larger potential groups than many niche oncology indications. Once a platform is proven to be safe and scalable, demand can grow rapidly.
In that scenario, hospital pharmacies will face questions that cannot be answered solely by acquisition costs: What are the eligibility criteria? How is benefit defined? What monitoring and rescue systems must be established?
These questions are relevant to pharmacy because they sit at the intersection of evidence, safety protocols and resource management.
The hospital pharmacist’s role becomes that of an architect of a comprehensive pathway: aligning the governance model, ensuring protocol clarity, and establishing feedback loops that turn patient experience into system learning.
The most important practice implication is therefore not to ‘adopt’ in vivo CAR-T for SLE but to recognise that the operating model needed for this type of intervention is already emerging in other forms, and to use this publication as a catalyst to develop institutional readiness.
That readiness includes governance (who owns decisions and how exceptions are handled), resilience (how rapid escalation pathways are structured) and longitudinal accountability (who tracks outcomes and late effects).
In short, in vivo CAR-T is a scientific milestone that reframes ATMP implementation as a pharmacy-led governance issue rather than a supply-chain issue.1
Next, read part two of this 2025 highlights series, which focuses on radioligand therapy for prostate cancer, as well as part three on tirzepatide in heart failure, part four on oral gepotidacin for gonorrhoea and part five on medication safety and artificial intelligence.
Author
João Gonçalves PharmD PhD
Faculty of Pharmacy, University of Lisbon and Imed Research Institute for Medicines, Lisbon, Portugal
Reference
1 Wang Q et al. In Vivo CD19 CAR T-Cell Therapy for Refractory Systemic Lupus Erythematosus. N Engl J Med 2025;393(15):1542–4.
