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CEO Update|Monday 30 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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We are in a fundamentally different business, social and political environment to where we were a few weeks ago. Many businesses are having to put on pause or fundamentally alter plans they had for the year, as the sector moves to working in the reality of the COVID-19 era. To keep you up to speed with the latest information and guidance we will continue to populate daily, our new COVID-19 microsite. Last week we ran two webinars, one for those running a UK life sciences business, and another looking at how CEPI are thinking about manufacturing capabilities and capacities globally.
BIA member companies are fully engaged in innovative diagnostics, vaccine development, clinical trials and antibodies. It was welcome to see last week, that six UK projects will receive £20 million for coronavirus research. The research groups include the work by Dr Sandy Douglas to develop manufacturing processes to scale up vaccines, and the team working with Professor Sarah Gilbert, who are developing a new COVID-19 vaccine. The BIA has supported both projects by carrying 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.
It was also good that the University of Oxford COVID-19 vaccine programme has opened for clinical trial recruitment and healthy volunteers will test the safety aspects of the vaccine, as well as its ability to generate an immune response.
International collaborations are forming to support COVID -19 between a number of life sciences companies across the globe. This will allow researchers to share resources and expertise to get effective treatments to patients as soon as possible, and we will update on how best to link with them on future webinars.
Key movements in the past week
Critical workers status
Many members have been in contact with the BIA on the status of our sector in relation to critical workers. Government guidance has made clear that everyone who can, should work from home at the current time. After conversations with government ministers, and in collaboration with ABHI, BIVDA, and APBI, there is now a template letter which can be downloaded and used to show your status as a ‘critical worker’. You can find the letter on our COVID-19 website here. We encourage and advise employees who use this letter, to also carry some form of photographic identification, when travelling.
It was good to see Nadhim Zahawi at the weekend standing up for critical workers and those businesses that must stay open when their work cannot be done remotely. We are due to have conversations with the Minister this week and we will report back if there are updates from the Minister on these issues. European guidance has also been issued which is supportive of our work being critical. The European Commission today issued a set of guidelines that allows workers with “critical occupations” to cross EU internal borders amid the coronavirus crisis.
For our sector I am heartened to see that “Workers in pharmaceutical and medical devices industry; “Workers involved in the supply of goods, in particular for the supply chain of medicines, medical supplies, medical devices and personal protective equipment, including in their installation and maintenance” and “Scientists in health-related industries;” are included in the definition of those allowed to cross borders.
Financial support for business
There was welcome support for the self-employed announced towards the end of last week, but we are yet to see a package for equity-backed companies emerge. We’re in constant contact with Treasury officials, Innovate UK and the British Business Bank to feed in the views and needs of the sector. Our suggestion of using the R&D tax credit system to support companies is under consideration and we’re exploring other mechanisms too. Please contact Martin ([email protected]) with your experiences and any further suggestions of fiscal support that we should lobby for. The packages announced so far for businesses and the self-employed can be found here.
Clinical trials
On 26 March the National Institute for Health Research (NIHR) introduced a single, national process to prioritise COVID-19 studies which hold the most potential for tackling the challenges faced, as part of the Government’s response to the pandemic. This process will cover funded studies, irrespective of the source of funding – whether by the public sector, industry or charities and also, in partnership with UKRI, studies that require funding. All NHS Trusts, healthcare providers and universities will need to prioritise support for studies which have been nationally prioritised. A live list of these studies, which includes three commercial studies, will be regularly updated. Details of the process and the new single point of entry can be found here.
As previously announced on our microsite, it is important to highlight that all non COVID-19 NIHR funded studies have been suspended. This will have a knock-on effect for our sector, and we are working with our members to address the challenges as their trials are being de-prioritised.
The BIA, with input from its Regulatory Advisory Committee, provided the MHRA with ideas for regulatory simplifications to help our member companies deal with pressures from COVID-19. These cover the following three key areas: managing clinical trials and clinical trial applications, pharmacovigilance and safety reporting, and recommending MHRA’s coordination with global regulators. On 27 March the MHRA reviewed with the BIA and other Industry Associations the first steps the Agency has taken so far – the consolidated list of regulatory flexibilities already in place can be found on the BIA COVID-19 microsite.
On a final regulatory note, the BIA welcomes the European Commission’s proposal to delay the implementation of the EU Medical Device Regulation by one year, in response to calls from industry to allow them to focus on urgent priorities related to the COVID-19 pandemic.
What to look out for next week
I look forward to joining a webinar this Thursday with AstraZeneca and the Wuxi I-Campus at 10am, UK time. I will be joined by some brilliant panellists who will provide perspectives from China on how to lead businesses through COVID-19 and see where opportunities might be for joint working and learning. If you’d like to listen, the link to join is here.
On Friday the BIA will be hosting a webinar which will cover the latest on the UK effort to battle COVID-19. The webinar will include updates on emergency equipment development, testing capability ramp up, vaccine, antibody, and digital health developments from the UK innovation scene and how we are linking into global collaborations. Register here.
Best,
Steve Bates OBE
What does your role at BIA involve?
Steve Bates is the CEO of the UK Bioindustry Association, the UK’s Trade Association for innovative life science companies with over 550 members. Steve is the visible face of the vibrant UK life sciences industry to government and media. He serves on the UK Government’s Life Sciences Council and the UK Biosecurity Leadership Council. Steve was a founder member of the UK Government’s Vaccine Taskforce in the Covid crisis, sitting on its steering Board alongside Kate Bingham. He is active member and former chair the International Council of Biotech Associations and has been a board member of EuropaBio since 2015.
Previous experience & achievements
Steve has championed, with government, effective industrial incentives like the Biomedical Catalyst, which have crowded in private sector investment into UK SMEs. He is a driving force behind the scale up agenda, spearheading policy agenda to unlock UK pension fund capital into productive UK growth in life sciences. He has forged several 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 joining the BIA in 2012, Steve worked for Genzyme and was advisor to the UK Government of Tony Blair working on NHS reform and the Northern Ireland peace process. He was made OBE for services to innovation in 2017 and became a Fellow of the Academy of Medical Science in 2020.