Championing UK ATMP clinical trials

A new £17.9 million initiative announced on 21 March is set to accelerate advanced therapy development in the UK. The scheme aims to support UK advanced therapy medicinal product (ATMP) clinical trials.

UK Health Minister Andrew Stephenson commented on the news, stating that the investment “reaffirms the UK’s position as a global leader in clinical research”.

Specifically, an additional four years of funding for the Advanced Therapy Treatment Centre (ATTC) Network is available through the programme. The funding will start with three established Centres, and then across an expanded network, according to Chief Clinical Officer for Cell and Gene Therapy Catapult, Jacqueline Barry.

Collaborators include the National Institute for Health and Care Research (NIHR), Innovate UK, the ATTC Network and the Cell and Gene Therapy Catapult (CGT Catapult).

To learn more about the impact of the initiative on the UK ATMP sector, EPR asked Barry to elaborate on how the Advanced Therapy Treatment Centre Network can support UK ATMP clinical trials.

She begun by highlighting that two key areas of improvements in UK clinical trial infrastructure for ATMPs are “extended times for contracting and subsequent start up of trials and the training of specialist staff to carry out the trials”.

Barry noted that to help to overcome the current workforce skill shortage, CGT Catapult is leveraging insights from its in-depth training needs analysis “to develop national training programmes which aim to equip healthcare professionals with essential skills for navigating the complexities of ATMP trials.”

What key solutions will the investment in the Advanced Therapy Treatment Centre Network provide?

The investment in the Advanced Therapy Treatment Centre Network will be deployed to identify and address the challenge in current clinical trial infrastructure, provide solutions, and bolster the NHS readiness for conducting ATMP trials in the UK.

Over the next four years, the funding will be directed towards providing support to the following initiatives aimed to provide solutions to the main barriers we have identified:

• Clinical trials acceleration: Streamlining processes and implementing innovative methodologies to expedite the progression of ATMP clinical trials
• Training and education: Developing specialised training programmes to equip researchers and healthcare professionals with the necessary skills and knowledge to navigate the complexities of ATMP trials
• Data collection and use: Enhancing data infrastructure and analytics capabilities to optimise decision-making and drive evidence-based advancements in ATMP research
• Patient identification and recruitment: Implementing strategies to improve patient access and recruitment for ATMP trials, ensuring diverse and representative participation
• Public and patient involvement and engagement: Engaging with the public and patient communities to foster understanding, awareness, and involvement in ATMP clinical trials
• Logistics: Enhancing logistical capabilities to streamline the supply chain and ensure seamless coordination of ATMP trial activities.

Alongside funding, what can the UK do to enable its readiness for advanced therapy clinical trials?

The UK’s supportive ecosystem for researchers and ATMP manufacturers, which includes substantial investment in skills development, apprenticeship schemes, and the Advanced Therapy Manufacturing task force, has positioned the country as a global frontrunner in this field. With 47 cell and gene therapy developers headquartered in the UK and 84 drugs in clinical development, the UK surpasses other European countries in clinical trial leadership, with these trials offering early access to innovative therapies for patients. In 2023, UK companies secured 55 percent of Europe’s cell and gene therapy venture captial funding, and over 6,000 people are employed in this sector in the UK. The UK had 175 clinical trials ongoing last year, with representation in nine percent of all global trials.¹ Continued holistic support from Government, regulators and healthcare systems can further improve the ecosystem for ATMPs to ensure the UKs leadership in this transformative field.

What is your outlook on future trends for the sector?

The future of the Advanced Therapy sector is incredibly exciting, with ATMPs holding transformative potential, possibly providing cures where unmet medical needs persist. With thousands of ATMPs undergoing clinical trials across various indications, the ATTC Network aims to streamline and standardise these trials across all modalities. This initiative not only aims to enhance patient access to these groundbreaking treatments but also promises significant positive impacts on patient outcomes and the broader healthcare landscape. Moreover, over time, successful adoption of these therapies should alleviate strain on NHS resources, marking a pivotal step towards sustainable healthcare delivery.

About the interviewee

References

1. CGT Catapult UK 2023 ATMP Clinical Trials Database – Highlights. [Internet]. CGT Catapult. 2023. [cited 2024Apr]. Available from: https://cgt.ams3.cdn.digitaloceanspaces.com/Cell-and-Gene-Therapy-Catapult-ATMP-Clinical-Trials-Database-2023-Highlights.pdf