Delivery of adoptive cell therapy in the context of the health-care system in the UK: challenges for clinical sites

Abstract

Advanced Therapy Medicinal Products (ATMPs) comprise novel cell, tissue and gene therapies and offer the potential of durable remissions for diseases where there is a high unmet clinical need. Once considered a niche area of academic research, ATMPs now represent one of the fastest-growing areas of clinical development. The field has seen a rapid expansion of academic and commercial entities successfully translating ATMP research into the clinic. This is reflected in projection that the global gene and cell therapy market will be worth US $11.96 billion by 2025. However, these treatments are complex to deliver and frequently do not fit naturally into established healthcare systems. In the United Kingdom (UK) there has been a long-standing interest in ATMP research and, in order to meet the ambition to act as an international hub of activity for delivery of ATMPs, a collaborative network of Advanced Therapy Treatment Centres (ATTCs) has been established. This review explores the challenges of delivery in the clinical setting, focussing on one form of ATMP, Adoptive Cell Therapy (ACT). We describe the strategy being implemented in the UK to optimise the roll-out of these exciting new therapies.

Keywords: (ATMP); ACT; Advanced Therapy Medicinal Product; Advanced Therapy Treatment Centre (ATTC); CAR-T; CD19; T cell; TCR T cell; TIL.

Figure 1.

Overview of UK treatment pathway for ACT demonstrating six broad stages within which key challenges need to be addressed for safe delivery. ACT, adoptive cell therapy; UK, United Kingdom.

Figure 2.

The ATTC network. The three successful ATTC networks are spread geographically across the UK. LAT has been funded by Research England’s Connecting Capabilities fund. ATTC, advanced therapy treatment centre; LAT, London Advanced Therapies; UK, United Kingdom.