Advanced Therapies NHS Readiness Toolkit

Poster outlining the approach to developing an NIHR Clinical Research Facility which is safe for the delivery of Oncology ATMP trials.

SOP to outline the framework and key aspects of training for pharmacists practicing within haematopoietic cellular therapies at The Christie NHS Trust.

Training package to prove nurses with knowledge, skills and expertise to perform specific apheresis procedures for cellular therapy in a safe and professional manner.

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the requirements for labelling human tissues and cells for use as starting materials for advanced therapy medicinal products using the ISBT 128 system.

PowerPoint presentation for an educational seminar on ATMP pharmacy.

Slides from a pharmacy teaching session on ATMPs from Manchester University NHS Foundation Trust

A presentation on ATMP Pharmacy Gene Therapy treatments.

Guidance produced by the Pan UK Pharmacy Working Group for ATMPs regarding the operational implications of the UK exit from the EU for NHS Pharmacy clinical trial sites, including ATiMPs

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the procedural requirements for the procurement of human tissues and cells but does not discuss in depth the consent and ethics requirements

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.

A training needs package and competency guide for healthcare and academic professionals involved in the delivery and direct care of patients receiving advanced therapy treatment; it provides information and signposting to external resources for independent training, learning and further reading on a number of key areas relevant to these medicines.

An example training matrix for staff working in research and development departments in a hospital setting, including suggestions for ATMP specific mandatory training.

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user a refresher of standard clinical trial studies and explains the additional features which impact on the design of trials for investigational advanced therapy medicinal products (ATIMPs) and how they can be addressed. Roles and responsibilities, governance and sources of support for ATIMP clinical trials are also outlined.

A quick reference guide to preparing and infusing frozen stem cells.

This document can be used to help prompt consideration and recording of the competencies that are needed to work safely with dry shippers and/or dry ice.

This document can be used to help prompt consideration and recording of the competencies that are needed to work safely while thawing.

This document sets out what training in advanced therapies is already available and what is required to ensure staff are equipped to understand these medicines

Some ATMPs contain living cells. These cell-based therapies may be cryopreserved to extend their shelf life, requiring carefully controlled thawing prior to administration. Failure to thaw the product correctly may impair the integrity of the cells (viability and/or function) and the product may be rendered unfit for purpose. This document describes and example procedure for thawing cryopreserved ATMPs using a water bath.

The use of immune effector cell therapies can result in significant toxicities that are directly associated with powerful immune-mediated responses. The most frequently observed of these is cytokine release syndrome (CRS). CRS represents a life-​threatening situation that requires early recognition of symptoms and signs and prompt intervention. This short training video can be used to support healthcare professionals and others to gain an introduction to CRS presentation, diagnosis and clinical management.

This webinar to showcases the Pan UK Pharmacy Working Group for ATMP’s pragmatic advice which clarifies the regulatory perspective regarding OOS ATMPs, and provides guidance to NHS organisations which are provider sites for ATMPs, about governance in the event of an OOS ATMP being supplied for one of their patients.

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an introduction to the challenges posed when moving advanced therapies around a hospital and how effective teamwork is required

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an introduction into CAR T cell therapy and how this is currently implemented

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an understanding of cell therapy and how this works

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) focussing on the use of viruses to deliver advanced therapies to patients

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an introduction into the basics of ATMPs including classifications and nomenclature

Gene therapies for the eye often lead the field of advanced therapeutics, introducing exciting new technologies and techniques to the clinic. Topics include the first FDA approved gene therapy (Luxturna), gene editing trials for inherited vision loss, and how a protein that helps algae move is being repurposed into vision saving technology.

Transplantation of insulin-producing cells purified from a donor pancreas is established within the NHS. This is restricted to people with life-threatening complications of type 1 diabetes as liberation from injected insulin cannot yet be guaranteed and life-long immunosuppression is needed. The potential for harnessing regenerative medicine and tissue engineering to deliver truly transformative outcomes is discussed.

A look at some of the recent impacts of ATMP treatments on children at the Royal Manchester Children’s Hospital

A visual guide to the preparation, administration and disposal of non-cellular, genetically modified organisms (GMOs), in a clinical setting

This webinar will focusses on genetically modified immune cells as a treatment choice for solid tumours discussing the use of tumour-infiltrating lymphocyte therapy to treat H&N cancer in the context of a clinical trial

The CAR T cell patient journey from a nursing perspective, some of the challenges faced, and a some of patient case studies.

A presentation of the findings from the CPROR team’s recent publication “Patient and public perspectives on cell and gene therapies: a systematic review” and the CPROR’s ongoing work to develop a an evidence-based toolkit to facilitate the design of patient-focused educational resources.

Focussing on four upcoming ATMPs in 2021, how they work, how patients might benefit, how they are given and other practical issues staff need to aware of.

The training passport is designed for all pharmacists providing pharmaceutical care to HSCT patients including those undergoing autologous and allogeneic transplant, patients admitted to the HSCT unit with post-transplant complications and patients attending post-transplant out-patient clinics

This discusses the new approaches to treating spinal muscular atrophy with advanced therapies. The talk is by Rafeal Yanez, Professor of Advanced Therapy at the Royal Holloway, London

A training webinar exploring the principles of gene editing and what the applications may be in the clinical potential

Full job description for a lead clinical trials nurse focussing on advanced therapies

A training webinar exploring the principles and current progress in treating respiratory diseases with advanced therapies

This review highlights the need for appropriate patient and public education on the various aspects of cell and gene therapies. Patient and public perceptions of these therapies, alongside evidence of clinical and cost-effectiveness, will be central to their uptake and use.

This training webinar gives an overview of the manufacturing of autologous ATMPs

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

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

A webinar to give an introduction into the considerations for dosing patients with ATMPs

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

This training webinar gives an overview of basics of cell therapy and some applications

This is a training webinar that covers the basics and introduction of in vivo gene therapy

A training video demonstrating the visual inspection of a cell therapy product prior to infusion

A training video demonstrating the thawing of a cryopreserved cell therapy product using a waterbath

This module introduces nitrogen vapour phase dry shippers and dry ice shipments, explains the hazards of using these low temperature transport vessels and describes how they can be used and stored safely.

Nitya, a university student from Gloucestershire, was the first patient to undergo CAR T cell therapy at the trust in February 2019. Hear from Nitya what it was like to receive CAR T cell therapy

A training resource on the importance of correctly thawing and inspecting cell therapy medicinal products

A document summarising the challenges and solutions the the collection of starting materials for ATMP manufacture though apheresis

A CAR-T Therapy training slide deck for nurses

A detailed slide deck to support in hospital training for staff covering ATMPs

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

A training video explaining the logistics supply chain for ATMPs and autologous therapies in particular

Horizon Scanning is the systematic process of identifying new medicines or technologies in development. This information is useful to clinical trials sponsors, ATMP developers and manufacturers, organisations aspiring to hold ATMP marketing authorisations, as well as to NHS group members and beyond.

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

An introductory video explaining the basic terminology used when discussing ATMPs

Training video summarising how pharmacy supports the successful delivery of ATMPs

This facilitated workbook has been developed for new and existing staff, caring for patients undergoing IEC therapy, usually within the context of a clinical trial.