Advanced Therapy Medicinal Products (ATMP)

Advanced Therapy Medicinal Products (ATMP) research is one of Specialty Cluster B’s Emerging Technology and Innovation (ETI) project areas.

An ATMP is a medicinal product which is either i) a gene therapy product, ii) a somatic cell therapy product, or iii) a tissue engineered product. According to a recent Alliance for Regenerative Medicine and UK BioIndustry Association report, there are currently 93 ATMP trials ongoing in the UK, and 1060 worldwide.   This means we are only scratching the surface of delivering ATMP trials in the UK.  Initial scoping for our project identified several challenges that may be contributing to the low number of trials in the UK including a lack of specialised training, restricted access to infrastructure as well as confusion as to what infrastructure is needed, complicated regulatory processes, no single industry offer etc.  However, the biggest challenge was the number of stakeholders sometimes duplicating each other’s work.  Our solution has been to pull together a NIHR ATMP Coordinating Group along with formal Working Groups which have been developed from existing working groups or newly formed.

Chaired by CRN Cluster B, the Coordinating Group enables all UK based stakeholders in the field of ATMPs to come together to discuss the logistics related to the delivery of ATMPs in the NHS for research and eventual clinical translation. Members share knowledge and expertise from various Working Groups to, i) avoid duplication of effort, ii) encourage further collaboration and iii) identify areas for development. Membership, outline in Figure 1, is constantly expanding with stakeholders coming on board as they begin to see the advantages of working together. In addition to those shown in the figure, the Working Groups are pulling in additional stakeholders with specialist expertise, for example Local CRNs (LCRNs) and the UK R&D Forum. 

Figure 1: NIHR ATMP Coordinating Group 

The key outputs for the Coordinating Group include:

1) Communication

• Liaising with the key stakeholder groups to keep them informed of progress

• Producing a publication outlining UK readiness for ATMP trial

• Common webpages linking all stakeholders together and to resources that the Group are developing.

2) Collaboration

• Engaging with new stakeholders as needed

• Establishing new working groups or linking to existing groups as required

The Working Groups and their key outputs are as follows:

Education and workforce led by Uta Griesenbach, Professor of Molecular Medicine at Imperial College and British Society for Gene and Cell Therapy President

• Developing training and educational programmes and activities for the entire workforce impacted by ATMP studies.

Infrastructure and Governance led by Joanna Gray, UK Clinical Research Facility Clinical Manager, Birmingham.

• Ensuring that NHS Trusts have the necessary infrastructure and knowledge required to be involved in ATMP studies

Industry led by Madina Kara, NOCRI Senior Research Collaboration Manager

• Developing a single ATMP offering for the UK, which can be used by all industry entry points.

Patient and Public Involvement and Engagement led by Jayne Spink, CEO, Genetic Alliance UK

• Aiming to enable members of the public and patients to become more aware of and involved in ATMP studies.

To read the Cluster B Assistant Specialty Cluster Lead SMT blog on ATMPs please visit the Buzz.