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Roche: How a global pandemic became the ultimate test of partnership working
The whole life sciences industry, from multinational organisations to smaller companies, has mobilised in an unprecedented way to tackle the global COVID-19 healthcare crisis and has played a critical role in supporting the NHS across the UK, including within Wales.
As SARS-CoV-2 – the virus which causes COVID-19 – started to spread, and the scale of the challenge came into focus, it was clear that Invitro Diagnostics (IVD) would be a crucial element in the response to the pandemic, and that tests would need to be developed from a standing start at a previously unsurpassed speed and volume.
In just over a month, Roche (like other industry partners) identified the sequence for COVID-19, created a test which identifies if someone is currently infected by the virus, and secured regulatory approval. Considering it usually takes a minimum of two years to develop a test and get it approved for use, the sheer pace of progress with COVID-19 has been beyond belief.
On 13 March 2020, the US Food and Drug Administration (FDA) authorised the emergency use of the Roche SARS-CoV-2 PCR test which could be run on fullyautomated platforms already installed in hospitals and laboratories around the world – including at the Magden Park Public Health Wales laboratory in Llantrisant. In the weeks that followed, Roche’s emergency response teams worked day and night to enable this equipment for the COVID-19 response and bring this test to patients as quickly as possible. What became apparent in those early weeks, and remains true to this day, is that the even greater challenge would be to produce and distribute the volume of tests needed across the globe.
“The whole IVD industry mobilised at an astonishing pace. Never before have we seen such rapid development and authorisation of assays. In the case of our PCR test that was an almost inconceivable 42 days from development to release.”
Peter Howell Customer Account Manager for Wales Roche Diagnostics
Just over a month later, Roche announced the launch of its elecsys Anti SARS-Cov-2 serology test to detect antibodies in people who have been exposed to the virus. There is still a lot that remains unknown about this virus, particularly if having the antibodies for COVID-19 confirms immunity, and how long that immunity will last. But reliable and accurate antibody
testing is the crucial next step in helping reduce this uncertainty by understanding the spread of the virus.
Again, the Roche platforms needed to run this test were already installed across the UK, and of the 24 in Wales, eight have gone live for COVID-19 antibody testing at:
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Glan Clwyd Hospital
Bronglais Hospital
Glangwili Hospital
Withybush Hospital
Prince Philip Hospital
Prince Charles Hospital
Morriston Hospital
Royal Glamorgan Hospital
These sites were part of the first wave to implement the antibody test within the UK, and in Wales to date more than 70,000 antibody tests have been processed.
It was undoubtedly the strong partnerships and pre-existing relationships between Public Health Wales, NHS Wales and the Roche team, as well as the already established regular Partnership Group Meetings and activity handling, which streamlined the enablement of COVID-19 testing in Wales and helped with, for example, the rapid frontline verification and validation of the new tests. In addition, once the platforms were live and testing was underway, weekly calls and touch points between Roche’s regional representatives and laboratory staff have helped ensure that the process remains as seamless as possible.
“Diagnostics is the cornerstone of every good treatment pathway. But in the case of COVID-19, we had to build the solutions to the crisis while in the eye of the storm. What we have learned is that partnership working is the only way to tackle urgent, demanding health scenarios, alleviate pressures on the NHS and provide quick solutions that work for everyone.”
Cara Livesey Centralised Diagnostics Sales Specialist for Wales
Are the learnings from the COVID-19 pandemic transferable to AMR?
It would not be an understatement to say that the eyes of the world have been firmly planted on infectious diseases over the past six months.
There has been increasing recognition over this time that secondary bacterial and fungal infections can co-occur with initial SARS-CoV-2 infections and that these can be fatal. Treatment options are often limited by resistance of the microbial targets to the drugs used in these secondary infections. This has immediate implications for patients and longer-term implications for managing AMR.
Correctly, much resource has been dedicated to rapidly understanding and effectively controlling the SARS-CoV-2 virus. Collaboration not seen since the last World War has seen significant progress being made over this short period of time. In contrast, development of effective new antimicrobials remains chronically underresourced. Learnings from the Covid-19 pandemic experience could be a valuable resource in re-imagining how diagnostic and treatment tools for bacterial, fungal or parasitic infections are safely developed, timeously commercialised and their impacts monitored in a post-Covid-19 world. Our range of single-use instruments eliminate the risk of COVID-19 cross contamination between procedures. We are focusing on essential product lines to support urgent procedures such as cancer diagnosis. This includes our Cervical Rotating Biopsy Punch that ensures a high-quality sample to be taken, even from a hardened cervix.
The hope is that pandemic-inspired changes to perceptions of the value of infectious disease treatments (and streamlining of regulations, policies and collaboration practices for development of viral diagnostics, therapeutics and interventions) can offer solutions and impetus to the field of antimicrobials in order to avert a future AMR-related pandemic.
This overlapping area of focus is where Biophys Ltd now finds itself. Our established AMR interests have expanded to include an early stage interest in a small molecule with potential activity against RNA viruses. We are cautiously optimistic about the molecule’s potential and looking forward to the journey of discovery that lies ahead to find out.
Increasing production capacity to help hospitals
We are continuing to adapt to better suit the needs of clinicians and the way we support clinics. With the reintroduction of more regular procedures, we are increasing production capacity of our single-use range to ensure customers have all instruments they require.
www.biophys.co.uk
To enable our PPE production to continue we have increased our manufacturing facility and built an additional new Cleanroom. This will allow us to continue to support the NHS and protect our frontline healthcare workers with essential CE marked Innovia Face Visors.
The Innovia Face Visor has been specially designed to provide top, side and front face protection from aerosols and to minimise airborne cross-contamination. UK production is underway at our Swansea site and at our sister company Network Medical’s site in Ripon. The device has been donated to local Welsh hospitals and 1.6 million has so far been supplied to the NHS.
