CEO Update|Monday 23 March

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.
 

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The COVID-19 situation is rapidly evolving with cases rising here in the UK and around the world. The BIA is linking different parts of the UK life sciences ecosystem with the global effort, understanding the new business environment for companies and working with government on a number of COVID-19 workstreams. 

 

BIA COVID-19 resources for members

 

The BIA has today launched www.biacovid19.org to support businesses and to highlight the important work from across the UK life sciences sector that is being done to help tackle the outbreak. We will update this website regularly and hope this becomes a useful resource.

 

We have also launched a COVID-19 weekly webinar, open to both members and non-members, where the BIA will share the latest industry news and guidance. The first episode of this new series discussed UK efforts to mobilise vaccine manufacturing capability, potential antibody approaches to novel therapeutics and the impact on ongoing clinical trials.
 

Tomorrow we will be joined by the Coalition for Epidemic Preparedness Innovations (CEPI) for a webinar looking at COVID-19 manufacturing capabilities and capacities for which you can sign up here.
 

On Thursday we will be running a webinar titled ‘running a UK life science business in the COVID-19 pandemic’ where we discuss the support that is available for UK biotech companies. Do sign up here.

 

 

What the BIA is doing to support the COVID-19 effort

 

We have been working hard to mobilise manufacturing capability for COVID-19 therapies and vaccines as they develop and support their rapid scale up. We carried out a UK manufacturing capability audit and have already helped form a 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. We are now setting up a Vaccine Manufacturing Taskforce, led by Ian McCubbin, to urgently find a way to manufacture millions of doses of other innovative vaccines as they emerge, be that viral, mRNA or antibody based. We have identified key workstreams and secured leads for these from Cobra, CPI, Alchemab, Innovate UK, GE and UCL, and we have reached out to supporting organisations such as MHRA and VMIC. If you would like more information or feel like you can contribute in any way, please complete the capability audit or contact Netty England at BIA. 

 

An antibody workstream, led by Dr Jane Osbourn of Alchemab Therapeutics and Paul Kellam of Kymab has been set up. There is a huge willingness to provide ideas and capabilities from across our community. The objectives of the workstream are to develop viral neutralising antibodies as prophylactics, to protect at-risk groups and healthcare workers, and to develop antibodies as therapeutics for symptomatic individuals following acute exposure. This workstream already has commitment from many BIA members, the wider life sciences community and academic groups. If you would like more information or feel like you can contribute in any way, please contact Eric Johnsson at BIA.

 

Support for companies during COVID-19

 

Key workers

Last week it was announced that UK schools were to close with only specific groups of children are to continue attending, which includes those with parents whose work is defined as key to the COVID-19 response. I know that many of you were concerned about whether this may include those working in areas such as production and distribution of medicines. On Friday we received further guidance on this, and I can confirm that “those working as part of the health and social care supply chain, including producers and distributers of medicines and medical and personal protective equipment” are defined as key workers. If you’d like more information on this please visit this website.

 

 

Fiscal Support

Many of you have been in touch about the Government’s fiscal support package to keep businesses viable during this difficult period. We have written to the Financial Secretary to the Treasury, Jesse Norman, to ask that the R&D tax credit system be used to provide advance payments to companies. Thank you to everyone who signed the letter – over 50 of you – and for your continuing support. Advance payments, along with HMRC rapidly paying outstanding claims, which we also called for, could make a real difference to companies in our sector facing a period of reduced revenue or no VC investment and milestone payments. In the fiscal support package already announced, the British Business Bank is delivering the Coronavirus Business Interruption Loan Scheme (CBILS) with its high street bank partners but we are sceptical that those providers will help biotech companies. However, we do encourage members to try and let us know how you get on. Please contact Martin ([email protected]) with your experiences and any further suggestions of fiscal support that we should feed into government.

 

 

Clinical trials

Until further notice, the NIHR Clinical Research Network is pausing the site set up of any new or ongoing clinical trials in the NHS that are not nationally prioritised COVID-19 studies. The focus will now be on delivering these nationally prioritised COVID-19 studies or redeployment of the research staff to frontline care where necessary. The MHRA and HRA will continue to operate their approval processes for all trials, thus ensuring trials can restart promptly after the pandemic. You can find a link to the updated statement here.

 

We would like to acknowledge and applaud the MHRA’s flexibility and pragmatism regarding regulatory requirements for managing clinical trials announced in their guidance, noting participant safety is of paramount importance. The MHRA latest information and work prioritised on COVID-19 is available here.

 

 

Who in government to contact regarding COVID-19?

 

Many members have asked us who in government they should contact about various innovative ideas to help in this emergency. Here is our directory for UK businesses – do contact directly the relevant team for speed and copy us in for information. This is an emerging landscape and we will update this list on our microsite regularly.

 

 

COVID-19 Patient Testing Innovation

Public Health England has established a dedicated mailbox for submissions of new proposals for PCR/serology tests, not limited to home testing ([email protected]). This is to shortlist further potential COVID-19 diagnostic tests through performing a 2-stage screening process:

1. The first stage will include a review and a stop/go decision (within 7 days of a company being added to the log), and then move to an assessment phase The stop/go decision will be decided on various factors which are being developed e.g. claimed performance, ease of use, supply, etc.
2. The second stage will involve a laboratory test of the equipment to trial performance

 

COVID-19 antigen testing kits request [email protected]

The BIA is also helping the Government (via the Office for Life Sciences) to raise awareness of an urgent call-out to the life sciences sector to help increase the supply of antigen testing kits for COVID-19.     

Their requirement is for commercial supply of the following:

* Full testing packages (specification below)

* Any of the separate components within the testing package

 * Any alternative tests government should be considering

The specification for testing kit is as follows:

    1. Swabs:

•  Nasopharangeal (Floxsynthetic fiber tipped (polyester) or flocked swabs) with polystyrene shafts that are scored at 80 mm for a breakpoint
•  Nasopharyngeal (minitip) are currently preferred
•  No discoloration on the swab bud (i.e. yellowing or brown discoloration).
•  Sterilised and individually wrapped
•  No calcium alginate swabs
•  No swabs with wooden shafts
•  Nose and throat swabs (Rayon tipped – FDA review in process)

2. Sample Vial

•  Glass (20.25 +- 0.25 x 47.25+- 0.5) & Plastic (TBD)

3. Viral transport medium

•   Covid-19 transport medium

4. Alcohol/Sanitiser wipes

5. Re-packaging (storage/biohazard packaging)

•    Vial wrap – Specification TBD
•    Sealed zip lock bag
•    Second bag (plastic/cushioned)
•    Sealable container – ‘Biobottle’
•    Postal ‘biobox’  

In addition, there is also a requirement for swabs for PCR diagnostic testing.

 

Any organisations that can supply for sale any or all of the above should email [email protected] as soon as possible.

 

Vaccines: [email protected]

Ventilators: Call 0300 456 3565 or email [email protected] or visit the dedicated web portal for ventilators and their components, where companies can register their details.

 

Digital solutions

Send to NHS X via [email protected]

 

All other enquiries or proposals concerning potential solutions should be sent to the Government's COVID Research and Innovation workstream at [email protected]

Best,