Why are ATMPs important?

Advanced Therapy Medicinal Products (ATMPs), which can be cell or gene therapies, show great potential in treating patients with conditions that cannot be cured with current treatments. These therapies provide new opportunities to help patients where treatment has failed. Often they have multiple actions, providing more value than conventional medicines. ATMPs are novel, potentially life-changing medicinal products, yet they are also disruptive and need unprecedented levels of collaboration and communication between product manufacturers and the NHS.

The Midlands and Wales Advanced Therapy Treatment Centre (MW-ATTC), part of the Birmingham BRC portfolio, is a consortium of NHS, Academic and Industry partners which was established in 2018. Our partners work together to facilitate the delivery of ATMPs to patients, by establishing the required infrastructure, logistical and manufacturing processes and creating educational materials so those new to working with ATMPs can learn how to safely handle and administer them. We have already demonstrated impact in a number of areas via several milestones and achievements during our first three years.

Collaboration: Successful partnerships have been built and the consortium expanded to include eight NHS Trusts. The pooling and sharing of resources has supported an inexperienced NHS site in preparing to deliver advanced therapies in a clinical trial. This type of knowledge sharing across our region has also supported adoption of advanced therapies (CART Delivery Centre) as a new standard of care treatment.

Patient and Public Involvement/Engagement: Partners in the MW-ATTC completed and published a systematic review into “Patient and public perspectives on cell and gene therapies” (Nature Communications; Dec 2020) which has been impactful as it identifies gaps in this landscape. Following on from this, we hosted a series of lay patient and public information webinars in June 2021 which remain publically available for any parties to access. Moving forwards, a generic patient toolkit is being built to support industry and researchers when producing patient facing materials in a clinical trial or when providing an ATMP as part of standard of care treatment.

Education: In collaboration with Health Education England, various e-learning modules are being produced which sit alongside a number of other informal guidance documents, flow charts and checklists; developed in particular for Pharmacists. The latter are available on the SPS website and some of the materials have been accessed to support COVID training during the pandemic. One of the most accessed materials is Handling Dry Ice and Vapour Phase Nitrogen Shippers – Advice for Hospital Pharmacies. Additionally, competency frameworks are being produced which enable members of staff to demonstrate their upskill in this area.

Logistics: A commercial partner has used the network to validate their innovative liquid nitrogen free shipper (Cytiva VIA Capsule LN2 shipper) which has now been launched. The first commercial sale occurred in the summer of 2021, supporting the UK bio-tech industry.

Manufacturing: European ATMP manufacturing company, Orbsen Therapeutics, has established a UK footprint and relocated manufacturing for one of their clinical trials to Birmingham’s Advanced Therapy Facility. This demonstrates the attractiveness of the ecosystem within our region.

Informatics: A software solution is being built to provide a single platform to the NHS when ordering and tracking ATMPs. The value of this product is that the clinic will only need to access one system to view all the ATMPs available at that site. Having been designed in the NHS, it will be user friendly as well as cost effective.