Bringing advanced cell and gene therapies into routine clinical care will require more than scientific and manufacturing progress. Hospitals themselves must be ready to handle products with very different requirements around storage, preparation, administration and patient management.
In an Oxford Global thought leadership interview, Owen Bain, Director and Qualified Person at the Cell & Vector Innovation Centre, Royal Free London NHS Foundation Trust, highlighted institutional readiness as one of the key barriers to wider adoption.
For cell-based therapies in particular, healthcare professionals are dealing with living products that require specialist handling and tightly controlled logistics. This creates a need for training across pharmacy, nursing, clinical and manufacturing teams.
Bain also stressed that therapy developers should consider the realities of hospital delivery much earlier.
Highly complex preparation requirements or dependence on specialist aseptic facilities can limit the number of centres able to administer a therapy. Autologous therapies add further complexity because patient material must be collected, transported for manufacturing and then returned for treatment.
Point-of-care manufacturing could change this model significantly.
As more personalised therapies emerge, selected NHS centres could play a greater role not only in treatment delivery but also in manufacturing and real-time product release. However, this would require stronger infrastructure, trained workforces and robust quality systems.
Bain also pointed to reimbursement as an important challenge. Many advanced therapies are potentially one-time treatments with high upfront costs, making traditional payment models difficult to apply. Approaches such as staggered or outcomes-linked payments may therefore become increasingly important.
Regulatory models are evolving too, particularly for rare diseases where conventional clinical development pathways can be difficult to apply because patient populations may be extremely small.
The broader message is clear: successfully scaling advanced therapies will require closer integration between manufacturers, hospitals, regulators and payers.
As cell and gene therapies become more personalised, the boundary between manufacturing and clinical delivery may increasingly blur. Preparing the NHS for that shift will be essential if innovative therapies are to move from specialist programmes into broader patient care.
