Advanced therapy medicinal products
Summary
Researching and delivering Advanced Therapy Medicinal Products (ATMP) crosses a multi-disciplinary field and they are becoming increasingly important in many patient pathways. Recognising the importance of this growing field, the NIHR is working together with partners to improve collaboration and to increase ATMP research in the UK.
ATMPs offer significant promise for the long-term management and even cure of disease, especially in areas of high unmet medical need. The UK plays a leading role globally in growing the ATMP sector and developing transformative future therapies. We are working with patients, health and care professionals, researchers and industry to ensure that the significant innovations in ATMPs bring benefits to patients.
What we do
What do we mean by ATMP research?
An Advanced Therapy Medicinal Product (ATMP) is defined as a medicinal product which is either:
- a gene therapy
- a somatic cell therapy
- a tissue engineered product
Further information about ATMPs can be found via the Human Tissue Authority webpages.
In 2019 there were approximately 127 ATMP trials in the UK (data published by the Cell and Gene Therapy Catapult). Of these, 93 were commercially-sponsored (data published by the Alliance for Regenerative Medicine (ARM) and UK BioIndustry Association (BIA)).
Challenges delivering ATMP research
Advanced therapies have been recognised as a growing area of research within the UK for clinical trials however the challenges have been perceived as follows:
- Lack of specialised training across multiple groups
- Restricted access to infrastructure and lack of clarity as to the infrastructure needed
- Clarifying guidance for pharmacy professionals
- No single industry offering
These factors may be contributing to the low number of ATMP trials in the UK, and therefore many UK-based stakeholders are working to find solutions.
How we support ATMP research
At the NIHR, we are working to avoid duplication of effort and encourage collaboration, through our ATMP Coordinating Group, which brings stakeholders together to address challenges and discuss the logistics related to the delivery of ATMPs in the NHS for research and eventual clinical translation.
ATMP research is supported through all areas of NIHR, from funding crucial research programmes to delivery via the NIHR Infrastructure such as the Biomedical Research Facilities (BRCs), Clinical Research Facilities (CRFs) and the Clinical Research Network (CRN).
This pipeline of support is exemplified through the development and delivery of gene therapy studies for patients with Cystic Fibrosis, delivery of the world’s first gene therapy trial for Choroidaemia and in the successful GOSH Duchenne muscular dystrophy trial. More recently during the COVID-19 pandemic, the REALIST study was designated as Urgent Public Health research and received trial delivery support from the NIHR.
Visit our funding opportunities and Industry funding pages for further details on how your ATMP project could be supported.
Support and resources
Supporting your ATMP research
Supported by the work of the NIHR Coordinating Group, the key partners have jointly produced resources to support ATMP studies. The links below will take you to partner websites where these resources can be found.
Specialist Pharmacy Services - ATMP Guidance
For guidance on handling ATMPs within a pharmacy setting.
Advanced Therapeutic Treatment Centres - Resources
A knowledge hub for advanced therapies.
Advanced Therapeutic Treatment Centres - Webinar Series
Webinar series on advanced therapy medicinal products.
NHS Learn - ATMP e-learning modules
A series of e-learning modules providing a basic understanding of advanced therapies, the steps involved in producing these medicines, how they function in the body. The series also covers products currently being delivered through commissioned treatment and clinical trials.
Experts
NIHR ATMP Coordinating Group
The NIHR ATMP Coordinating Group was established in 2018 after mapping the UK’s capacity and capability to run studies developing ATMPs. The mapping exercise identified barriers including a lack of specialist training and restricted access to infrastructure. With multiple stakeholders wishing to address these challenges the Coordinating Group was established to avoid duplication of effort and resources, and to bring the stakeholders together to share knowledge, ideas and expertise.
Establishing the right infrastructure, training and collaborative working in the field of ATMPs is vital. This group is helping to make significant headway in making the UK a leader in ATMP research.
The group is chaired by Professor Eric Alton.
ATMP Coordinating Group Projects
Specific projects have been undertaken in Working Groups led by the Coordinating Group key partners. The projects and their leads are listed below.
If you would like more information or to become involved in any of the project areas, please contact atmp@nihr.ac.uk.
Education and Workforce Development
These projects aim to:
- join together the workforce, education and training efforts across the UK
- develop training and educational programmes and activities for the entire workforce impacted by ATMP studies in the forming e-learning, short courses and individual modules.
Visit the Advanced Therapy Treatment Centres website to join experts from across the UK for a free webinar series on advanced therapy medicinal products.
Lead: Professor Uta Griesenbach
Guidance development
The Pan UK ATMP Pharmacy Working group has been instrumental in developing guidance in three key areas:
- Clinical and Operational
- Clinical Trials
- Governance and Regulatory
Lead: Anne Black
Developing the trial infrastructure for ATMP clinical studies
Lead: Joanna Gray
Patient and public engagement activities
This work aims to enable members of the public and patients to become more aware of, and involved in, ATMP studies.
Leads: Finn Willingham and Nick Meade.
Our key partners
The NIHR ATMP Group includes clinical leaders from across the NIHR and key UK stakeholder organisations. Find out more about the NIHR ATMP group's key partners.
If you would like more information, please contact atmp@nihr.ac.uk.