Governance structure organogram for supporting the introduction of ATMPs at the Christie Hospital

Hospital pharmacists are likely to be faced with CAR-T as licensed medicines in the near future but should also be prepared to support commercial and academic clinical trials of novel CAR-T and this briefing document aims to address all scenarios.

Advice produced by the Pan UK Pharmacy Working Group for ATMPs for Pharmacy sites on costings for clinical trials of ATMPs, using the NIHR interactive costing tool.

This document produced by the Pan UK Pharmacy Working Group for ATMPs provides guidance on the management of acute CAR-T cell toxicities to help inform the development of local guidelines and to standardise the management of acute CAR-T cell toxicities across the UK. This is a consensus guideline developed with input from the pharmacists and consultants from the first and second wave CAR-T centres.

Main pages from the EMA website focussed on ATMPs

Ex vivo gene therapy medicinal products are ATMPs, which require pharmacy oversight, even when being handled elsewhere within a healthcare organisation. This document produced by the Pan UK Pharmacy Working Group for ATMPs outlines the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any ex vivo (cell based) Gene Therapy Medicinal Product (GTMP)

Exemplar terms of reference for an ATMP Education and Training Committee at The Christie NHS Foundation Trust

Summary of workshop findings re: barriers to effective ATIMP trial set up, changes required to overcome them and key ATIMP trial metrics.

A Pharmacy Working Group for ATMPs resource. Pharmacy is often the first port of call when an organisation wishes to use a gene therapy and needs to provide pragmatic guidance to facilitate the introduction of these innovative products. This document is designed to give practical advice to centres wishing to undertake gene therapy trials and need to understand the requirements and recommendations for governance and, in particular to have in place a Genetic Modification Safety Committee. The document also gives practical advice for centres to help them understand operational requirements including deciding the optimal location for preparation.

HSE (Health and Safety Executive) guidance to help organisations to choose the most appropriate regulatory procedure, particularly those wishing to undertake studies involving the administration to humans of substances based upon genetically modified microorganisms (GMMs)

A Pan UK Pharmacy Working Group for ATMPs resource. Some medicines, including many ATMPs, achieve greatest stability at ultra-low temperatures. Therefore the use of -80°C and below is commonplace to achieve optimal product shelf-life. As the usage of ATMPs is increasing, Pharmacy departments are becoming required to receive shipments and to store products at ultra-low temperatures

The HTA is the regulator for human tissue and organs, this includes activities using  human tissues or cells used as starting materials in the manufacture of ATMPs

The purpose of document produced by the Pan UK Pharmacy Working Group for ATMPs is to outline the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any in vivo (virus based) Gene Therapy Medicinal Product (GTMP) e.g. IMP for Clinical Trials or Marketed ATMPs.

A webinar giving an overview of governance, operational and clinical challenges which need to be overcome in order to implement these novel medicines