CEO Update|Monday 11 May
The Prime Minister’s announcements; last night and this afternoon move the UK into the next phase of the pandemic response. Over the past week we have heard more detail on the test, track and trace initiative which will help in lifting restrictions, we have seen continued global collaboration to tackle the virus and have received details from the NIHR on restarting clinical trials.
Test, track, trace
A week after reaching the 100,000 tests a day target, Boris Johnson has set an ambitious new target of 200,000 tests a day by the end of May. As Lord Bethell noted on the most recent government/industry webinar, there are still challenges and we must continue working to increase diagnostic capacity. The Government has appointed Dido Harding to lead the test, track and trace programme. She has already started work, in a cross-government role reporting directly to the Prime Minister and Cabinet Secretary.
Over the Bank Holiday weekend, the Government updated its requests of industry to increase testing capacity. They want to hear from public or private sector organisations which can offer laboratory capacity. We have published further guidance about the criteria that laboratories need to meet in order to partner with local NHS trusts and groups of organisations that can deliver a high throughput, end-to-end process that integrates home-based blood sampling with lab processing, by using an ELISA or equivalent antibody test at a specificity of >98% and sensitivity of >95%. The solution should be able to deliver at least 10,000 tests a day in the first instance, with the potential to rapidly scale up by mid-July. The group should nominate a lead organisation to act as a single point of contact with government and proposals should be submitted by 5pm on Thursday 14 May 2020. See the serology end-to-end technical specification.
In addition, there are new challenges on the Testing Methods Sourcing Platform, please do submit your ideas through the platform, every suggestion will be considered. The latest bulletin which highlights the progress of the platform so far can be found here.
As the Government considers putting measures in place to ease the lockdown, one of the tools that will help combat the virus in the next phase, the new NHS COVID-19 contact tracing app, has been launched with a test-run on the Isle of Wight. Concerns about technical and data-privacy issues have been reported and a second app is now being developed in parallel, which will use technology provided by Google and Apple.
The UK continues to be involved with international partnership working on the pandemic. Last Monday we saw global leaders get together, pledging financial support to develop and deliver a COVID-19 vaccine to the world. As Chair of the International Council of Biotechnology Associations (ICBA), I will continue to have conversations with our global partners to make sure the UK is at the heart of the global effort. If you want to read more about the UK’s response to COVID-19, I recommend reading the article by Kate Bingham, Managing Partner at SV Health Investors which focusses on collaboration, speed, creativity, and resource commitment.
BIA members explore treatments for COVID-19
One of our members, Scancell, is taking a different approach to developing a vaccine. Working with the University of Nottingham, the team is hoping to produce a vaccine which induces both durable T-cell responses and virus neutralising antibodies, with the possibility of starting human trials this autumn.
A new study, led by BIA member PrecisionLife has identified risk factors for sepsis in the context of COVID-19 and has identified 59 potential drug re-purposing candidates. I am pleased to see a variety of different methods to combat the disease in the works which increases the likelihood of finding a successful treatment.
BIA’s vaccine manufacturing taskforce
The BIA Vaccine Manufacturing Taskforce, led by Ian McCubbin, is continuing to work at pace to ensure that the UK is ready to manufacture the vaccine candidates coming out of Oxford University and Imperial College London. The BIA Taskforce is reporting directly into the Government’s Vaccine Taskforce, which is chaired by Sir Patrick Vallance and discussions are ongoing over how to best drive this work going forward. Vaccines are not our only means to combat COVID-19 though, and the BIA Antibody Taskforce, led by Jane Osbourn, is making good progress in its mission to develop therapeutic antibody therapy. As always, it’s great to see the UK biotech community working at speed to the benefit of patients. Last week two separate studies in Israel and the Netherlands suggested that progress has been made in antibody treatments for COVID-19. The studies hope to treat or prevent the development of respiratory disease caused by coronavirus. It will be interesting to see how this develops.
Restarting clinical trials paused due to COVID-19
On 19 March the NIHR paused the set-up of new or ongoing clinical trials at NHS sites that are not nationally prioritised COVID-19 studies to enable the NIHR research workforce to focus on delivering those studies or redeploying to frontline care where necessary.
The BIA called on government to develop a plan for restarting non-COVID-19 clinical trials, given the impact that paused studies have had for patient participants, BIA member companies and the life sciences sector. In this regard, we welcome the letter of 6 May from the Chief Medical Officers and NHSE Medical Directors to the NHS about recruiting patients into clinical trials for COVID-19 therapeutics, highlighting that a lot of other valuable research is being undertaken across the health and care system “It is important that this other research continues, subject to it not having a negative impact on the system’s ability to recruit participants and provide the resources needed to support priority clinical studies.”
The BIA responded last week to the NIHR consultation on the proposed framework which will form the basis of the DHSC/NIHR ‘Restart Plan’: the restart of paused studies that were underway in the healthcare system, the commencement of new clinical trials and the prioritisation of resources in the NIHR Clinical Research Network and NIHR infrastructure more broadly. We support the draft Restart Plan, which will have a direct benefit of improving patient access to innovative medicines and fits well with member companies’ planning work. The final Restart Plan will be published shortly following the DHSC approval of the framework and the NIHR activities associated with restart.
Other Sector News
We may be experiencing difficult times, but the UK’s life sciences sector carries on. We saw a piece of good news last week from LifeArc and the Medical Research Council (MRC) which have made available £16m to establish Gene Therapy Innovation Hubs. This is great news for the cell and gene therapy sector as the hubs will address challenges that occur when seeking to progress novel gene therapy research into early stage clinical trials. This was a recommendation from the MMIP Advanced Therapies Manufacturing Taskforce which led to a BIA workshop back in 2018 sponsored by Cobra Biologics, British Society for Gene and Cell Therapy (BSGCT), Cell and Gene Therapy Catapult, Knowledge Transfer Network (KTN), and Oxford Biomedica.
Last week’s BIA COVID-19 webinar focussed on the financial issues surrounding the pandemic, and what the financial situation may look like post-lockdown. You can watch it on our YouTube channel here. We continue to press the Government to open the Innovate UK schemes for knowledge-intensive companies, a move announced two weeks ago which is yet to be delivered.
Our BIA COVID-19 webinar this Thursday is titled ‘reinvention for social distancing’, which will focus on adapting operations and exploring new developments in digital health. Sign up here.
Steve Bates has been the CEO of the UK Bioindustry Association since 2012. He currently chairs the International Council of Biotech Associations and has been a Board member of Europabio since 2015. Steve is the visible face of the vibrant UK life sciences industry to government and media. He sits on the UK’s Life Sciences Council and Life Sciences Industrial Strategy Implementation Board. Steve has championed with government effective industrial incentives like the Biomedical Cataylst which have crowded-in private sector investment into UK SMES. He has forged links for the sector across the USA, Europe and in China. In his time at the BIA Steve has developed new member groups focused on cell and gene therapy, genomics and engineered biology. A strong advocate of partnership working, Steve champions sector collaboration with research charities and academia. Proud to lead an organisation with a diverse Board with over 40% female representation, Steve is committed to next generation talent and developing the skills needed for the sector to flourish. Before the BIA, Steve worked for Genzyme and as an advisor to the UK Government of Tony Blair. He was made OBE for services to innovation in 2017.