Medicines manufacturing evolved assuming that producers make the medicines. They sell it to the healthcare practitioners and the product waits in a pharmacy cupboard or, if things get really tough, a refrigerator, until a doctor or nurse needs it.
Biotherapeutics raised the bar: more perishable goods were often delivered in a freeze-dried (lyophilized) form or in vials for storage at low temperatures, but the transactional model didn’t change. On rare occasions a medicine for a named patient could be chaperoned through the system by skilled pharmacy and clinical staff.
Advanced therapy medicinal products (ATMPs) changed all that. ATMPs are frequently personalised and require administration in a clinical setting. Control of conditions and timing in the supply chain became a shared responsibility. Everyone became agents in the chain of custody.
In the 1990s I was working with Advanced Tissue Sciences, Inc. of La Jolla, California. There were difficulties simply because few clinics had -70°C freezers for receipt of the foot ulcer treatment, Dermagraft®. This was my first encounter with ‘institutional readiness’, a feature as important to commercialisation of advanced therapies as technical readiness is for the product.
To address that challenge the UK’s Advanced Therapies Manufacturing Taskforce published its Advanced Therapies Manufacturing Action Plan in 2016. Among the series of recommendations needed for the sector to flourish in the UK was a key need to:
Establish a network of cell and gene therapy treatment centres with new government funding (£30 million)…
The result was our investment in the centres through the UK Research and Innovation Medicines Manufacturing Challenge fund. The Cell and Gene Therapy Catapult (CGTC) was central to this activity.
This year the Advanced Therapy Treatment Centre (ATTC) network concluded its planned work and the ATTCs have delivered on institutional readiness culturally, scientifically and commercially.
A nationwide network of centres
The network comprised a nationwide set of centres allowing industry, academia and clinics to develop new ways of working. Ways that make it easier to commercialise advanced therapies and to roll them out across multiple hospitals.
The programme was grounded in the practicalities of existing operations, ensuring that new processes for delivery would integrate with current practice. Alongside this a programme of apprenticeship provided the relevant skills.
The creation of such a seamless chain of custody is essential for ensuring smooth, effective patient access to these advanced medicines. The creation of the ‘Pan-UK Pharmacy Group’, led by Anne Black in Newcastle, introduced a popular and growing library of guidance documents. The work packages were based on products under development by network partners.
Our grants are judged by independent assessors. The 3 successful bids were distributed across the UK as we had hoped. The awards went to:
- Birmingham and South Wales (Midlands-Wales ATTC)
- Manchester (iMATCH)
- Newcastle-Scotland (Northern Alliance ATTC)
The network worked closely with the London Advanced Therapies Network (funded separately via Research England). This was excellent from the point of view of regional access.
In April 2018, when the work began, a really high level of trust and cooperation quickly developed. Was it the shared purpose, the careful choice of partners, the excellent stewardship by the centre managers or the network coordination by the CGTC? I do not know.
This was something to be treasured: social capital is very hard to create. It is one of the most valuable outcomes and will continue to make the UK a great place to manufacture and apply ATMPs. By the time of the Clinical Adoption Forum held by the Catapult in March this year, the network had grown to 114 organisations. This included 25 NHS Trusts and 59 industry partners.
As part of the network, more than 5,000 people overall have received training across different aspects of the industry. The ‘ATTC NHS Readiness Toolkit’ received more than 10,000 views within 9 months of launch and has now had more than 24,000 views across the globe.
Cost-modelling tools were made available as website resources. Equipment introductions included track-and-trace tools and validation of a solid-state cryopreservation unit. An advanced therapy webinar series was released, including ‘institutional readiness: governance and operational considerations for delivering ATMPs in hospitals’.
Alongside the ATTC network, the CGTC works closely with industry to deliver the Advanced Therapy Apprenticeship Community. A unique apprenticeship scheme that gives the trainees the skills they need to ‘develop, manufacture and deliver’ ATMPs at scale, allowing both individuals and industry to thrive. So far more than 250 apprentices have enrolled on the scheme from 51 organisations. The scheme has just been awarded the Princess Royal Training Award standard.
All of this was additional to developing the actual products themselves. Further information can be found on the ATTC website.
Watch this space for opportunities to join forces with the ATTC Network.
Top image: Credit: Maxiphoto, iStock, Getty Images Plus via Getty Images