CEO Update|Monday 06 April
We ask that you forward this communication to colleagues and relevant stakeholders, so that they can be aware of the important work which the UK life sciences sector is doing to support the national and international efforts in tackling COVID-19. If you would like to receive these CEO updates directly to your inbox please contact us and we will add you to our mailing list.
This week’s challenge for our sector is how to support the national effort to improve COVID-19 testing capacity. The Secretary of State for Health and Social Care, Matt Hancock set out the new 5 pillar UK testing strategy – more detail of how companies can engage with the specifics of the plan will be shared on a webinar which all the life sciences trade associations have come together to support. Details on how to register for this webinar will be sent out to you within the next day.
The UK is becoming the powerhouse for scientific and clinical understanding of COVID-19, scientists from Oxford University are leading the world’s largest randomised clinical trial of potential COVID-19 treatments. The Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial will test a number of treatments, including treatments for HIV, malaria and a steroid to reduce inflammation. Having innovative adaptive trial designs running, linked to a National Health Service able to capture rich genomic data is a strength few other health research ecosystems will be able to match and puts the UK in a great place to significantly contribute to global understanding of effective treatment regimens rapidly and attract global players to put significant clinical trials into the UK.
In the fight against COVID-19 we saw Gilead announce phase III trials of its experimental antiviral drug, Remdesivir, across 15 clinical sites in the UK and Exscientia announced a joint initiative with Diamond Life Source and Scripps Research to identify possible drugs.
It seems to me that a combination of testing, therapeutic and vaccine development alongside innovations in digital health will be key parts of the jigsaw making up an exit strategy from the current lock-down.
I’m heartened in this belief by learnings from Asia and China in particular. Our webinar last week with AstraZeneca and Wuxi I-Campus not only gave us insight into how their ecosystem has lived through the COVID-19 challenge, but also highlighted the explosion in digital health transformation which it has enabled there. It’s a clear lesson for us in Europe and one we discussed with members in our own COVID-19 webinar on Friday. As we think through testing strategies, the UK also needs to weigh up the benefits of a potential NHS app that can acts as an immunity certification but also potentially play a key role in tracking and tracing during any future second peak of infections. NHSX is looking into the idea and with concerns about civil liberties having been expressed, it is vital that a discussion about what is technically possible, which companies can help and what British society is now prepared to embrace is opened up.
Despite the global economic slow-down, our Q1 financing report produced with Informa Pharma Intelligence, highlighted some big investments for our sector in Q1 before the global market downturn. We also saw the formation of a new alliance between Eli Lilly and Sitryx, with Sitryx receiving $50m upfront. The partnership will focus on developing immunometabolism targeted therapeutics. Great to see such positive news in a complex period.
I am pleased to see that global collaboration on COVID-19 is scaling up with strong government and industry support. For more details on global collaboration, industry taskforces and funding calls visit our microsite here.
On our weekly COVID-19 update last Friday, Dr Jane Osbourn updated on antibody developments and Ian McCubbin spoke about vaccine manufacture scale-up – it’s on our YouTube channel here. We will continue to run weekly webinars to update you on the UK life sciences sector response to the pandemic, the next BIA webinar will take place this Thursday, and will focus on supporting staff and managing operations, sign up here.
Key movements in the past week
In the past week the Government has adjusted some of its support schemes for businesses and has added new measures. We are pleased to see the Chancellor has waived duties and VAT on vital medical imports - including ventilators and PPE. Rules on carrying over annual leave are to be relaxed to support key industries, further details were provided on the Coronavirus Job Retention Scheme and there have been changes to the Coronavirus Business Interruption Scheme.
The BIA together with the ABPI, ABHI, BGMA, and BIVDA put out a joint statement on the UK life sciences commitment to fight COVID-19 and support NHS patients. We also put out a joint statement on testing and diagnostics – highlighting the global need for testing kits and facilities. You can read it here.
Vaccine Manufacturing Workstream
The BIA continues to support the critical workstream assessing the UK’s vaccine manufacturing capability. The BIA has supported the projects of Dr Sandy Douglas to develop manufacturing processes to scale-up vaccines and Professor Sarah Gilbert, whose team is developing a new COVID-19 vaccine. The BIA carried out a UK manufacturing capacity audit which assessed capability and has already led to collaboration between the Oxford Clinical Biomanufacturing Facility with Pall, Fujifilm, Cobra, Cell and Gene Therapy Catapult and VMIC, to scale-up the work being done by the Jenner Institute.
The antibody taskforce led by DrJane Osbourn is continuing to move at speed. A steering committee involving Alchemab, Kymab, Abcam and NIBSC has been formed, which will guide and drive work across three main teams: antibody production and early supply of material; manufacturing; and clinical and regulation. These teams involve many other companies and organisations, and it’s great to see a broad coalition from across our sector coming together which is adopting a can-do attitude and open innovation approach.
We continue to advocate for a support package for life sciences and other sectors of the knowledge economy. As part of that we have highlighted to officials that they will need to act to ensure EU State Aid rules don’t prevent biotech companies from accessing current or future COVID-19 support. Following representations, the Chancellor has amended the Coronavirus Business Interruption Loan Scheme (CBILS) so that company directors will not be required to provide personal guarantees for loans under £250,000, which is an issue some of you have raised with us. The scheme has also been extended to companies with a turnover of over £45m. Finally, we are receiving anecdotal reports that HMRC is very amenable to delaying PAYE and social security payments, which members may find very helpful (more information on HMRC support can be found here). Please contact Martin Turner with your experiences and questions.
MHRA regulatory flexibilities
The MHRA has been working with industry, DHSC and other stakeholders to identify areas of regulatory flexibility to support the global healthcare response to the COVID-19 pandemic and the medicines supply chain in the UK.
Further to the guidance detailing flexibilities for clinical trials and clinical trial applications which can be found on the MHRA guidance page for industry on COVID-19, MHRA issued last week additional guidance including on medical devices clinical investigations during the coronavirus (COVID-19) outbreak, guidance on coronavirus (COVID-19) tests and testing kits, guidance on exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID-19) outbreak, and guidance for industry on flexible approaches we are taking on good distribution practices. It is important to note that these regulatory flexibilities are effective immediately and will be kept under review.
People – Critical Worker Status
As discussed last week, there is now a template letter which can be downloaded and used to show an individual’s status as a ‘critical worker’. You can find the letter on our COVID-19 website here. We advise employees who use this letter to carry some form of photographic identification in addition to this letter when travelling.