CEO Update|Tuesday 14 April

The UK life sciences sector is engaged on all fronts in tackling the COVID-19 challenge. Major developments in supporting the UK testing effort at scale, scaling vaccine capacity, clinical trials and antibody research, as well as full engagement with national and international communities committed to tackle this global pandemic have happened this week.

The BIA is acting as a facilitator and signpost for the most effective ways for our members to understand the challenge, collaborate and engage. Our primary way of doing this is via our dedicated microsite and weekly BIA webinars through which we are updating on activity and signposting to key events on which we are partnering with others.

Webinars to join this week:

1. BIA webinar Thursday 11am – update on BIA activity - focus on clinical trials and research charities
2. Government and Trade Associations webinar Thursday lunchtime – Steve Bates moderates as John Bell discusses government antibody testing developments, antigen testing developments and next steps
3. Wuxi Apptec Global Forum - Focus on international collaboration, Thursday 3pm-5pm (UK time) – harnessing our collective power with BIO, BA, BIA, and World Economic Forum all featured 

Increasing UK testing capability through better industry/government collaboration

During the past week, I’ve worked closely with government to enable them to access help from businesses to increase the UK’s testing capacity as part of the strategy to protect the NHS and save lives.

I proposed and hosted a joint webinar, coordinated with the ABPI, ABHI, and BIVDA for nearly 500 firms which was joined by Matt Hancock, the Health Secretary who spoke about his new five pillar UK testing strategy and provided specifics about laboratory requirements. The Government’s COVID-19 task force has ramped up in the past week and their website sets out what is needed with far more clarity than a week ago. Please visit it at  www.gov.uk/coronavirus-testing. The presentation from the webinar is available here.

Industry steps up on testing

Responding magnificently, we have seen industry step up to support testing at scale. Three 'Super Labs’ backboned by BIA member, Thermo Fisher Scientific are up and running across the UK, with sample processing and PCR machines at these sites and, as Marc Stevenson, Thermo Fisher’s COO told the BBC Today programme last Thursday (at 0710), with the capacity to reach the target of 100,000 tests a day in the coming weeks. A new testing laboratory is being set up by AstraZeneca and GSK at Cambridge University’s Anne McLaren Laboratory, for high throughput screening for COVID-19 testing and to explore the use of alternative chemical reagents for test kits. Other members have offered kit and consumables, as well as being linked to NHS and PHE labs. The ‘Super Labs’ are going to need people to help staff additional shifts, so keep an eye out for further requests for volunteers.

Crowdsourcing novel antigen testing techniques

Over the Easter weekend, in partnership with BIVDA, the Royal College of Pathology, and government, I’ve been participating in and championing a crowdsourcing platform set up to harvest solutions to four of the biggest science/clinical issues the UK is  facing with viral detection assays/PCR tests. You can view the platform at https://testingmethods.crowdicity.com

The four challenges are:

• New methods for RNA extraction
• Transport media that inactivates the virus
• Use of dry swabs for virus detection
• Using desktop PCR machines for point of care testing

This ‘Easter lab rats challenge’ has seen 13,000 visits to the platform in only 48 hours. 22% of responses have come via Twitter, with the platform having its own hashtag, #TestingMethods2020. This most technical of online Easter pub quizzes has asked and answered some of the most vital practical questions on key bottlenecks in the COVID-19 testing process. Whilst some of the solutions were previously known to the moderators, a significant proportion was not.  I hope this way of working can be used for future challenges in this fast-moving situation.

Parliamentary scrutiny

I was able to report on many of these developments with a timely appearance as a (virtual) witness to Parliament’s Science and Technology Select Committee last Wednesday, where I was joined by Sir Paul Nurse, Director of The Crick. It was a slightly surreal experience to appear via Zoom in order to maintain social distancing and for such a technical session to have created news headlines. The Crick has recently offered assistance in testing using their experienced scientists and resources to support  government efforts to tackle COVID-19.

The headline from this discussion is that, despite the challenges of increasing antigen testing at scale there are opportunities to build capacity and improve testing through innovation. The 100,000 tests a day target is a complicated logistical challenge requiring government to bring together equipment, supplies and reagents, trained staff, and coordinating with the NHS front line. Maintaining supply chains is an ongoing issue but government and industry are working together to build resilience into the system.

The challenge of antibody testing – the focus of the next government/trade associations webinar

While antigen testing moved at hyper speed last week, the development of antibody testing took a step back. As John Bell’s blog noted, none of the current antibody tests meets the standards required by the Government,  meaning an antibody test is at least a month (perhaps more like three months) away. Interestingly, over the weekend the US FDA has also raised their own concerns about the accuracy of antibody tests. 

While this is a set-back, developments across our sector on antibody testing are continuing at pace. The UK Rapid Test Consortium (UK-RTC), which comprises the University of Oxford, York based  Abingdon Health, Omega Diagnostics, BBI Solutions and CIGA Healthcare, has been launched to develop and manufacture millions of new COVID-19 antibody tests to determine immunity after contracting the virus. UK-RTC was formed in response to government’s request to develop a home-grown test following validation of existing antibody tests revealed that they were not accurate enough.

Also announcing new work on testing last week were  Avacta, and Cytiva (formerly known as GE Healthcare Life Sciences). Their newly formed collaboration seeks to develop and manufacture a point-of-care diagnostic test for COVID-19. They aim to complete analytical and clinical validation as soon as possible in order to manufacture the test which uses a respiratory sample, with diagnosis within minutes.

Further ideas about developing and scaling Enzyme-Linked Immunosorbent Assay (ELISA) tests and potentially using next-generation DNA/RNA sequencing technology, like Oxford Nanopore’s may also provide novel ways to develop advanced test options in the coming weeks.

All this work helps to support and add to our epidemiologic and scientific understanding of this coronavirus pandemic, as well as being vital to strategies to end lockdown.

Vaccine scale up

Efforts to develop a COVID-19 vaccine continue to make headlines. Just this morning, we have seen two of the world’s largest vaccine companies, GSK and Sanofi join forces to develop an adjuvanted COVID-19 vaccine. The UK taskforce nucleated by the BIA is in advanced discussion with government about scale up as candidates emerge from discovery phase. 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 scaleup the work being done by the Jenner Institute.

Clinical Trials, MHRA guidance and regulatory flexibilities

Really exciting news that the UK Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial is established and ready to go from the University of Oxford. This is the fastest-growing clinical trial in medical history and already has more than 2,700 volunteers enrolled.

The MHRA considered the BIA’s proposals for regulatory simplifications to help our member companies deal with pressures from COVID-19 and provided positive feedback. The MHRA is proposing to update their COVID-19 guidance on managing clinical trials to address some of the points raised and to provide further clarify on confidentiality considerations when accessing health records remotely. The MHRA agreed to develop guidance for medical devices (e.g. inhalation devices) that are being used to deliver drugs in COVID-19 clinical trials outside their current CE mark intended use, so that the clinical trial applications can be submitted and the investigational medical device application be waived. Moreover, the BIA proposals with respect to safety reporting have been included in the MHRA’s proposed pharmacovigilance flexibilities or are currently under consideration.

It is worth noting that the MHRA has updated the guidance on coronavirus (COVID-19) tests and testing kits, giving new opportunities to companies to submit their proposal via the DHSC portal, even when the proposal does not meet the specification criteria for the design and delivery of tests, but looks promising.

Digital and NHS App

We continue to engage on the development of an NHS app with government, as it is a key part of the lockdown solution. However, despite asking for a way for UK innovators in this space to engage successfully, we have not seen a response from NHSX to match that of the NHS COVID-19 testing team. I continue to press government to ensure that the UK is represented at the standards-setting table in the broader European discussion – this may be important for interoperability – or in simple terms to track a future outbreak from a ski resort in the Alps back to the UK. In addition, I am struggling to understand how to reconcile the decentralised approach announced over the weekend by Google and Apple (surprisingly and jointly) with a more centralised process imagined by the NHSX consortium (which includes at least part of Google). I would welcome the advice of members in this area.

International collaboration

Last week  saw calls continue for a coordinated global effort to develop solutions, from Wellcome, urging firms to donate £6bn for research, to international leaders urging the G20 to coordinate a multi-billion dollar coronavirus fighting fund. The UK is a powerhouse for scientific and clinical understanding and can be part of a global solution. On the search for solutions, Biocentury has a useful tracker looking at the current vaccines and therapies for COVID-19 in development across the globe.

The International Society for Pharmaceutical Engineering (ISPE) has created a database of technical expertise to help projects in the healthcare environment deal with the surprises of the COVID-19 pandemic.  The expertise ranges across all the suppliers of advice and materials into Healthcare and you can find a link to their database here.

This week I am delighted to continue this collaboration by speaking at a Wuxi Apptec global event ‘harnessing our collective power’ with BIO, ourselves and World Economic Forum. The agenda can be found here, do register here.

Free virtual partnering event on COVID-19

Today’s COVID-19 crisis requires a previously unimaginable acceleration of output from the biopharmaceutical and life sciences industry. No company or country will solve this global challenge alone. Partnering is essential, across large pharma companies, biotech and academia, we now need to go the extra mile. The industry’s partnering capacity must be strengthened to handle the massive scale up needed to deliver innovative solutions to patients urgently.

From 20 April to 6 May 2020, a consortium of biotech clusters and trade associations including the BIA, EFPIA, EuropeBIA, EUCOPE and national biotech associations in UK, Sweden, Norway, Finland, Denmark, Belgian and Austria together with Inova and Evaluate Ltd, is hosting a free COVID-19 Virtual Partnering event to bring together the key leaders and decision makers in the global pharma industry to connect and help bring forward solutions. This includes the development, trials and manufacture of patient solutions such as diagnostics, drug treatments and ultimately a COVID-19 vaccine. The one-on-one virtual meetings will take place over the course of three days, on 4-5-6 May. Find out more here.

Supporting life sciences companies affected by the COVID-19 lockdown

Last week’s BIA COVID-19 webinar focussed on how members can support staff and manage operations, our excellent speakers gave some really good advice so I recommend watching it on our YouTube channel here.

Helpful guidance from BEIS was published last week, the Secretary of State, Alok Sharma has written a letter to UK companies, including the pharmaceuticals sector, to clarify that there is no restriction on manufacturing continuing under the current rules. We regularly update our microsite with the latest guidance, so do take a look.

However, despite daily communication with HM Treasury and Ministers we have not yet seen positive action from government to support most businesses in our sector.  We have continued to provide up-to-the-minute information and have regular catch-ups with officials in the Treasury and Office for Life Sciences. Business Minister, Nadhim Zahawi is aware of the sector’s request for advanced R&D tax credit payments, which is a positive sign. This week I wrote to the Chancellor urging him to act and highlight some State Aid rules that we anticipate will need to be addressed to ensure any support package is effective for all companies in our sector.

We remain hopeful that there will be a package of support for the ‘knowledge economy’, we’re therefore also joining up with our counterparts in the tech sector, who are making similar calls for support, including R&D tax reliefs, grants and equity-based instruments.

More welcome news from HMRC is that they have now allocated more resources to processing tax credit claims and aim to clear the backlog of 80 or so claims by 20 April. If you haven’t heard from them by that date, please let Martin Turner know so we can make further representations.

With parliament returning in a virtual format soon, member companies may want to contact your MP and ask them to make representations to HM Treasury on your behalf.  The summary below of sector issues and proposed solutions below, which you may wish to use as a guide to your own personalised email or letter. 

Our next BIA webinar on Thursday this week will look at the impact of COVID-19 on research challenges and the potential implications for future medical research. Register here.

Best,