Operational delivery

Operational delivery

The documents in this section will assist in the implementation of new advanced therapy services in a clinical setting, supporting the transition of guidance into practice. 

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pdf
01/06/2020

Apheresis process flow

A document summarising the challenges and solutions the the collection of starting materials for ATMP manufacture though apheresis.
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docx
31/01/2024

Cell Therapy/ATMP Clinical Trial Referral form (Sarcoma)

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Online Article
21/07/2020

Ex Vivo (cell based) gene therapy medicinal products – pharmacy institutional readiness guidance

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).
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Online Article
30/10/2019

Gene Therapy Medicinal Products – Governance and Preparation Requirements

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.
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pdf
30/11/2020

Generic autologous ATMP clinical flow chart

A flow diagram showing the pathway a patient and treatment would follow for an autologous ATMP to be administered.
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pdf
07/02/2022

Harmonised working: How NA-ATTC supports effective collaboration between NHS and Industry

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pdf
17/05/2021

Non-cellular GMO therapies: a visual guide

A visual guide to the preparation administration and disposal of non-cellular genetically modified organisms (GMOs) in a clinical setting.
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pdf
17/11/2021

Patient Pathway for CAR T Cell Therapy

A flow diagram showing the pathway a patient follows when receiving a CAR T.
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pdf
01/01/2020

Pharmacy institutional readiness for marketed CAR-T therapy: checklists for pharmacy services

A Pharmacy Working Group of ATMPs resource. CAR-T treatments require governance and management by Chief Pharmacists. They present risks which Chief Pharmacists should ensure are minimised. Whilst collaboration with expert cellular product handling colleagues will be key operationally it may present challenges for Pharmacy to embed this new working relationship.
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pdf
29/04/2021

Recommendations on the procurement of starting materials by apheresis for ATMP manufacture

This guidance document presents a consensus view on standardised approaches to mononuclear cell procurement to reduce unnecessary complexity and variation.
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  • Governance

    Governance

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    This section is intended to assist NHS organisations to create or modify governance structures to permit the introduction of advanced therapies, encompassing all levels of governance responsibilities and reporting within hospitals.

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  • Business and financial planning

    Business and financial planning

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    The introduction of advanced therapies into hospital treatment pathways requires a significant financial investment in resources and facilities. Information available here will help organisations to develop the appropriate business and financial plans as they prepare to deliver advanced therapies.

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  • Quality assurance and risk management

    Quality assurance and risk management

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    This section provides examples of, and guidance on, the implementation of quality systems and risk assessments for safe delivery of advanced therapies towards preparing for regulatory inspections.

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  • Operational delivery

    Operational delivery

    Read more about this section.

    The documents in this section will assist in the implementation of new advanced therapy services in a clinical setting, supporting the transition of guidance into practice.  Documents include process and patient flow charts to map the treatment pathway and information on the in-hospital logistics requirements.

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  • Clinical practice

    Clinical practice

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    Information is available here to support the clinical practice of the delivery of advanced therapies to patients, including patient assessment, handling advanced therapies, product administration, infusion, treatment and monitoring and recording treatment and side-effects.

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  • Education and training resources

    Education and training resources

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    To safely deliver advanced therapies to patients, staff need to be trained in this new modality of therapeutic intervention. This section includes resources that enable staff to learn more about ATMPs including e-learning, facilitating face to face training and competency assessments, and materials to support patient education.

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  • Long term follow up

    Long term follow up

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    A regulatory feature of advanced therapies is the need for longer-term follow up than for other therapeutic modalities.  The information provided here speaks to the methods of data collection for extended follow up patients after treatment.

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  • Clinical trials

    Clinical trials

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    This section has a range of resources – split into 8 sub-sections – which will assist NHS sites to prepare for the set up and delivery of advanced therapy clinical trials. Its objective is to disseminate learnings from the ATTCs regarding the governance, infrastructure and processes which underpin successful trial set up and delivery.

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