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The ATTC Network enables NHS Readiness for Advanced Therapies

The challenge

There has been an exceptional growth in Advanced Therapy Medicinal Products (ATMPs) development in recent years which is creating an unprecedented challenge to the NHS. The UK healthcare system is well-equipped to deliver conventional therapeutic products, however these innovative cell and gene therapies require the development of new infrastructure, systems, processes, and skilled staff in order to treat patients safely and at scale as these ATMPs move from clinical trial to marketed products.

The solution

In response to this challenge, three Advanced Therapy Treatment Centres (Midland Wales [MW-ATTC], Northern Alliance [NA-ATTC] and iMATCH) were established in 2018.  These centres act as a network, supported by the Cell and Gene Therapy Catapult. They have developed a range of key, free-to-access, materials aimed to inform, educate and expand NHS expertise and delivery of Advanced Therapies.

MW-ATTC focussed on the creation and delivery of a range of information and resources to provide and support NHS organisations with a variety of tools to enable the successful delivery of ATMPs. These wide-ranging materials include;

  • Educational material, i.e. Introduction to Advanced Therapies, logistic / carrier training and competency assessments etc.
  • Pharmacy governance, template protocols and checklists etc.
  • Organisational guidance generic Advanced Therapy pathways, CRF matrices, workforce identification hierarchy etc.

NA-ATTC produced a number of guidance documents and toolkits which clinical sites can utilise to accelerate the adoption of ATMPs, both through clinical trials and licensed medicines, examples include:

  • An Institutional Readiness toolkit and questionnaire which allows NHS clinical sites to assess their own Institutional Readiness levels for the four classes of AT medicines – tissue engineered, cell-based gene, somatic cell and virus-based gene products.
  • A clinical trials toolkit which includes costing guidelines.
  • A suite of guidance documents and SOPs for clinical delivery and management of CAR T-Cell Therapies.
  • Guidance for developing a hospital business case for ATMP service provision.
  • Pharmacy governance and preparation facilities requirements for gene therapies.

iMATCH’s key Institutional Readiness activities focus across education, governance and safe patient management to increase patient access to ATMPs. Materials generated include:

  • Education programme to up-skill the workforce and aid delivery.
  • Presentations were developed as aids e.g. JACIE readiness for immune-effector cells and ATMP Pharmacy training.
  • Governance structures and terms of reference across various committees e.g. ATMP Board.
  • Oncology adoptive T-cell therapy mapping – concept and complexities of the patient pathway.
  • Checklists for handling ATMPs e.g. Thawing Checklist.

The results

The NHS Readiness Toolkit, launched in April 2021, was developed to provide easy access to the portfolio of resources created by the ATTCs. These resources span 8 categories, including governance, operational delivery and clinical practice, and allow hospitals to evaluate their readiness to deliver ATMP, and demonstrate and embed best practice by preparing UK healthcare organisations to develop local structures, systems, pathways, procedures, processes and workflows.

 

 

 

 

Examples of categories within the NHS Readiness Toolkit

Making further impact

The NHS Readiness Toolkit was visited by over 10,000 users within the first nine months of its launch, demonstrating a clear need for these resources. Feedback from users has highlighted the impact which the Toolkit is already making, and as the ATTC programme matures and further outputs are shared, the Toolkit’s reach is anticipated to extend.

“I find the NHS Readiness Toolkit provides me with a go-to repository of guidance to support the service implementing advanced therapies into the clinical setting. Some of the resources I have found most helpful are the training, education components as well as the clinical practice section which holds useful information such as the thawing SOP and checklist.”

Debbie Worthing, Lead Research Nurse Advanced Therapies Programme

“The Advanced Therapies NHS Readiness Toolkit has been a vital resource for me in coordinating ATiMP cancer trials. In particular, the Clinical Practice guidance and the tools in its Education sections were the best I have found for teaching both research-familiar and research-naïve NHS staff about the differences and complexities of ATiMP trial work, which has benefitted us when planning and managing our early-phase ATiMP cancer trials.”

Sam Moody, Clinical Trial Coordinator in Newcastle

As more hospitals prepare to deliver advanced therapies, the resulting impact will be clear for the greater number of patients who are able to access these life changing medicines faster than ever before.

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