Advanced therapies in the UK

Across the UK, and indeed the world, there is significant growth and clinical progress being made in the field of advanced therapy medicinal products (ATMPs). In this article, Ian Hollingsworth, Associate Director of Product Development at Boyds explores the changing landscape of ATMPs in the UK.

ATMPs comprise of gene therapies, somatic cell therapies and tissue engineered products. This class of treatments offers the potential to address significant unmet medical needs for patients, offering the promise of treating diseases currently underserved by conventional pharmaceuticals. Both Tecartus and Zolgensma have been recommended for use in the NHS in 2021 and the UK and FDA regulatory authorities are expecting significant numbers of ATMPs both in clinical trials and seeking approval in the coming years^1,2. The field of advanced therapies is expecting to develop quickly.

There has been a year-on-year increase in the number of advanced therapies in clinical trials; currently the UK is delivering approximately 12% of global clinical trials in ATMPs³. This is an enviable position that the UK is keen to maintain and build upon. There has been a substantial government backing for the adoption of advanced therapies as evidenced by the Advanced Therapy Treatment Centre Programme that brings together a collaboration between the NHS, industry and academia to really understand the barriers to adoption of ATMPs and make the delivery of these therapies to patients as routinely as possible.

There are many potential issues when taking ATMPs into the clinic, not least the experience of the hospital has in delivering ATMPs to patients. There are numerous activities ongoing across the UK to upskill hospitals, such as education, best practice sharing and standardisation of starting materials⁴. For manufacturers, there are numerous activities to harmonise on best practice being driven through the Industry Advisory Group, coordinated by the Cell and Gene Therapy Catapult⁵.

There are significant potential benefits of ATMPs for patients, but they are also challenging to develop as medicines. Expert guidance in the design, set up and running of the clinical trials is required to maximise the potential benefit to patients and ensure regulatory approval for the medicine.

The global ATMP market is expected to grow at a compound annual growth rate of 13.2% from 2021 to 2028⁶. This trend will rely on specialised expertise and greater collaboration to help translate ideas into medicinal treatments for use in patients.

Boyds has significant expertise in supporting the (often complex) development of a number of ATMPs from early-stage ideas, through the development process, taking them into the clinic and through to regulatory approval. To find out more about how Boyds can help you progress your idea into an ATMP for patient use, contact a member of the team.

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[1] https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics

[2] https://www.england.nhs.uk/aac/wp-content/uploads/sites/50/2020/01/aac005-atmps.pdf

[3] https://ct.catapult.org.uk/clinical-trials-database

[4] https://issuu.com/mark123/docs/2020-ibi_spring-web_compressed_3625ecb9f34a4b/32

[5] https://www.theattcnetwork.co.uk/case_studies/industry-involvement-in-the-attc-programme

[6] https://www.grandviewresearch.com/industry-analysis/advanced-therapy-medicinal-products-market#:~:text=The%20global%20ATMPs%20market%20is,USD%2021.2%20billion%20by%202028.