As a rapidly evolving field in healthcare, the new framework establishes a structured route map to enable coordinated knowledge and learning planning, service design, governance planning, workforce development and quality improvement activities across the sector.

Funded by the National Institute for Health and Care Research (NIHR) and Innovate UK, the framework builds on the ATTC network’s programme of activity to improve advanced therapy clinical trial readiness and help ensure that UK maintains its position as a globally attractive destination for advanced therapy clinical research.

Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult, said:

“Advanced therapies treat the root cause of a range of diseases and disorders, including cancer, sickle cell disease and spinal muscular atrophy.

“The creation of an advanced therapy capability framework, as part of a national Advanced Therapy Medicinal Product Training and Education programme, will help address the existing challenge around a lack of therapy‑specific knowledge across trial delivery, research and support service workforces.

“Having this framework in place represents a significant step towards expanding the workforce dedicated to advanced therapy clinical trials and scaling up the delivery of cell and gene therapy treatments across the NHS.”

Fiona Thistlethwaite, Medical Oncology Consultant and iMATCH Director at The Christie, said:

“As a Principal Investigator delivering advanced therapy clinical trials, I see first-hand how essential training and education are as NHS workforce enablers. They underpin our ability to translate innovation safely and effectively into patient benefit.

“This framework provides a much-needed, standardised reference point to support the training and development of the future advanced therapies workforce, ensuring we can meet the needs of patients, trial sponsors and NHS organisations across the UK.”

Vicky Yearsley, Principal Consultant – Education and Standards at Skills for Health, said:

“This framework is intended to be a platform for dialogue that supports the planning and delivery of advanced therapy clinical trials into the future.

“It offers a structured way to consider the role‑relevant capabilities, responsibilities and development needs of individuals and provides a shared language to explore capability dependencies, supporting multidisciplinary coordination and governance.”

The Advanced Therapy Clinical Trials Capability Framework is organised around the typical lifecycle of advanced therapy medicinal product clinical trial activity and comprises five interconnected dimensions: initial sponsor engagement, trial set-up, trial delivery, trial close-out and long-term follow-up. Moreover, it supports understanding of safe and effective practice and is intended to complement existing sponsor and regulatory governance arrangements rather than introduce new obligations.

To find out more visit: Advanced Therapy Clinical Trials Capability Framework

About the Cell and Gene Therapy Catapult

Cell and Gene Therapy Catapult (CGT Catapult) is an independent innovation and technology organisation committed to the advancement of the cell and gene therapy industry. CGT Catapult’s vision for the UK Industry is: globally-leading companies delivering transformative medicine to the world. Its mission is to create a pathway to accelerate breakthrough research in advanced therapies to commercialisation and scale. CGT Catapult works with Innovate UK. For more information, please visit https://ct.catapult.org.uk/ or https://www.ukri.org/councils/innovate-uk/.

Contact: CGT Catapult communications team, comms@ct.catapult.org.uk / Marketbridge, cgtcatapult@marketbridge.com

About the National Institute for Health and Care Research

The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

• Funding high quality, timely research that benefits the NHS, public health and social care;
• Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
• Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
• Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
• Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
• Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK international development funding from the UK government.