Evaluation of institutional readiness at sites within the UK NHS using a novel advanced therapy medicinal product assessment tool

Abstract

Aim: This paper reports on a study to assess institutional readiness (IR) of UK National Health Service sites that form part of the Northern Alliance Advanced Therapy Treatment Centre to deliver advanced therapy medicinal products (ATMPs). The paper discusses the development of an assessment tool to support self-assessment of IR in healthcare institutions. Methods: The tool utilized criteria developed by clinicians to self-assess IR to deliver four classes of ATMP over a series of time points. Each assessment was independently analyzed and validated by independent expert groups. Results & conclusion: The collated results indicated an overall trend toward IR for all classes of ATMP. The study highlighted areas where IR is evidenced, areas where work is ongoing and areas where further work is required to achieve IR. The study also facilitated validation of the IR assessment tool.

Keywords: ATMP; NHS; National Health Service; UK; advanced therapy medicinal product; cell-based gene therapy; hospitals; institutional readiness; somatic cell therapy; tissue engineered therapy; viral-based gene therapy.