Challenges encountered when delivering advanced therapy investigational medicinal products in the National Health Service in the UK: a pharmacy perspective

The UK boasts a rich legacy of innovation in life sciences and is renowned for its contributions to global healthcare advancements. ATMPs hold significant promise for long-term management and potential cure of diseases with high unmet medical need. The UK is a global leader in advancing the ATMP sector and developing innovative future therapies. Despite this, delivery of ATMP clinical trials in the UK National Health Service (NHS) poses challenges. This review aims to highlight the challenges in delivering investigational advanced therapies in the NHS, showcasing the insights gained and emphasizing the efforts made by pharmacy and other stakeholders to move forward within this field. Multiple factors such as the lack of specialized training and advanced infrastructure hinder progress. When considering the pharmacy setup and delivery of ATMP clinical trials within the NHS, it is recommended that pharmaceutical companies engage early with stakeholders to refine product design and establish standardized protocols. The adoption of decentralized delivery models and ready-to-administer ATIMPs can enhance accessibility and streamline integration in the NHS. Furthermore, investment into workforce development can accelerate clinical trial setup in the UK.

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