Northern Alliance Advanced Therapies Treatment Centre
The Northern Alliance Advanced Therapy Treatment Centre (NA-ATTC), formally established in March 2018, is a consortium of twenty industry, NHS and academic organisations led by Newcastle Hospitals and the Scottish National Blood Transfusion Service (SNBTS). The purpose of the centre is to develop the systems and infrastructure required to support the delivery of cell and gene therapies with the ultimate aim of increasing patient access to advanced therapy medicinal products (ATMPs) on a national level.
The key objectives of the NA-ATTC are to:
- Identify all areas for improvement through gap analysis
- Design, devise and implement solutions in these areas
- Ensure that solutions are integrated across the clinical delivery pathway
- Roll out and disseminate best practice regionally and nationally.
The Centre will deliver its objectives over 36 months via six Work Packages(WPs);
Work Package One: Manufacturing and Preparation
ATMPs vary in their local requirements for manufacturing and preparation capability from storage and issue, through reconditioning to full manufacturing and supply.
This WP aims to establish a “tool box” to enable best practice for ATMP preparation and manufacturing methods.
Work Package Two: Supply Chain
Advanced Therapies are complex and pose challenges to the supply chain in that they require procurement and transport from raw materials through to manufacturing and distribution.
WP2 aims to identify requirements for Advanced Therapies via an initial supply chain gap analysis. It will then explore optimal solutions for integrated digital traceability, tracking and transportation systems that are scalable, flexible, secure and reliable.
Work Package Three: Patient-Centred Advanced Therapy Delivery
The aim of WP3 is to foster best practice in Advanced Therapy clinical trial design and implementation within the NHS ensuring a patient-centred approach to promote accessible, safe and effective trial delivery. This will be facilitated through establishment of
- The Clinical Advisory Group, to provide clinician, academic, NHS, industry, patient and public stakeholder oversight of the NA-ATTC
- The Trial Coordination Unit, to facilitate and streamline trial delivery, establishing best practice and pathways for sustainable wider adoption/ life-long follow up
Work Package Four: Infrastructure, Reimbursement and Outcomes
ATMPs challenge existing health systems in terms of the infrastructure required by sites to deliver these medications to patients, as well as what commissioners or HTA bodies require to be demonstrated to approve them for use. WP4 will identify the “Institutional Readiness” of NA-ATTC’s clinical sites.
WP4 will provide guidance to ATMP developers on regulatory and commissioning processes and pathways in order to ensure that submissions to HTA bodies are sufficiently robust to ensure the adoption of these products.
Work Package Five: Wider Network Engagement
Communication with all stakeholders is crucial to the acceptability and success of ATMPs. WP5 ensures the NA-ATTC engages with the Advanced Therapies network including industry, charitable bodies and the wider NHS, and that project outputs are captured and disseminated via appropriate mechanisms to ensure they reach their intended audiences.
Work Package Six: Informatics
Informatics and data are crucial both for patient engagement and empowerment, to capture patient outcomes and to inform developers and commissioners. WP6 aims to utilise Informatics to enhance patient engagement via the development of an app to inform and engage patients in their ATMP journey. The WP will also integrate with the supply chain to capture and aggregate data points throughout the ATMP pathway which could be used to identify trends and inform future product or manufacturing developments.
The Centre will develop best practice for safe and effective delivery of advanced therapies to patients. This will include robust and connected supply chains, tracking and tracing systems compliant with regulatory standards, patient follow up and data repositories and ultimately adoption and reimbursement based on clinical service delivery as well as product costs. A key component will be the use of informatics to achieve utility at scale in all elements of the clinical pathway, including product release.
The project will map Institutional Readiness Levels (IRLs; how far an organisation needs to adapt to embrace a new technology given pre-existing practices and infrastructure) for disruptive advanced therapies within the NA-ATTC and across the NHS and enable the therapies to achieve the highest IRLs within the time frame available. Close interaction between NA-ATTC, product and supply chain companies, regulators, health economists and healthcare commissioners will be essential to achieve this.
NA-ATTC’s innovative approach includes development with commercial partners of new and robust supply chains, tracking and capture processes, a harmonised Toolbox for procedures and processes, innovative training networks and novel ways to approach health and safety, including follow-up.