Advanced Therapies NHS Readiness Toolkit

Terms of Refence for the Research and Innovation ATIMP Board (a sub-committee of the ATMP board) at The Christie Hospital Manchester. Included are aspects such as the boards powers and membership.

This training webinar gives an overview of the preparations required prior to treating patients with 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)

A summary of activities across NA-ATTC hospitals geared towards patient centred, safe and efficient trial set-up, delivery and completion

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.

This guidance summarises the authorisation process for Genetically Modified Organisms (GMO) as Investigational Medicinal Products (IMP) for contained use (CU) within the United Kingdom (UK). These submissions are unique to GMOs, in addition to Clinical Trial Authorisation (CTA) and Ethics

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

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

An example risk assessment used to fully review the risk posed by GTMP/GTiMPs in preparation for submission to local genetic modification safety committee

A proforma outlining considerations for an NHS Trust prior to commencing a cell therapy / immune effector cell trial.

A template produced by The Christie NHS Trust to hold and update frequently asked questions and responses to cell therapy trial feasibility questionnaires.

A proforma for submission to the Manchester Clinical Research Facility (Christie site), which outlines NHS Trust clinical and resource requirements, prior to study set up.

Template for the feasibility and risk assessment of all clinical trials (not just ATIMP)

Risk assessment form that is the basis for assessment of capacity and capability within Manchester University NHS Foundation Trust.

An example risk assessment form to be completed prior to the use of genetically modified organisms (GMO’s) within a hospital

An example risk assessment used to fully review the risk posed by GTMP/GTiMPs in preparation for submission to local genetic modification safety committee