CEO Update|Monday 10 August

Congratulations to Theresa Heggie, CEO of Freeline Therapeutics, who became the first CEO of a BIA member company to ring the Opening Bell of the NASDAQ in a virtual bell ringing ceremony, celebrating the company’s successful IPO on the exchange.

Brexit stockpiling

The end of the Brexit transition period is 143 days away and the Government chose last week to send a key letter to medicine suppliers, advising our sector of its multi-layered approach to avoid disruption of supply to patients. I encourage all members involved in supplying the UK market to read it in detail.

The letter follows a warning from the our sector in June highlighting the struggle to rebuild stockpiles due to COVID-19. The Government advice follows a similar (but not identical) approach to the no-deaI Brexit planning of last year, with a focus on asking companies to reroute supply away from the Short Straights ports and encouraging ‘trader readiness’ for the new customs and border arrangements. Companies are also asked “to make stockpiling a key part of contingency plans, and … where possible, to stockpile to a target level of 6 weeks’ total stock on UK soil.”

This time, the Government is not proposing to have additional warehousing. This letter reminds medicines suppliers that they “have a statutory duty to provide early notification of supply disruptions to the department and contact details for the Medicines Supply Team.” Further information on regulatory clarity and the operation of the Northern Ireland protocol, along with explanatory webinars are promised for the weeks ahead.

We at the BIA have worked tirelessly on putting members’ views on Brexit to government. The letter acknowledges the role our sector has played, but leaves us with continued uncertainty on core parts of business. Since the General Election, the Government has chosen a deliberate approach and timetable to negotiation with the EU, fully aware of the integrated European regulatory system and supply chain within which our industry operates. It is also fully aware of the significant timeframes our industry needs to make changes to regulated supply of medicinal products. However, there is still no agreement between the UK and EU and negotiations continue. How the Northern Ireland protocol will operate remains unclear. Untried and untested new border provisions and paperwork are being introduced – and all this in the midst of the COVID-19 pandemic.

It is now clear to me that we will face a very challenging winter, as political brinksmanship risks a real chance of supply disruption, especially if industry is not given the time and clarity it needs to make changes.

COVID-19 vaccine development

It’s great to see the UK ecosystem at the heart of key developments in establishing a COVID -19 vaccine.

On vaccine manufacturing, the UK Government and French vaccine producer Valneva have confirmed a multi-million-pound up-front investment in Valneva’s plant in Scotland. The Livingston site will advance the UK’s vaccine manufacturing capacity and support highly skilled jobs for scientists and technicians. The investment follows Britain’s deal with Valneva announced in July to secure 60 million doses of their experimental vaccine.

UK Vaccine manufacturing capabilities have also been further boosted with the announcement of a 18-month agreement between the Government and Wockhardt to carry out the fill and finish stage of the manufacturing process. The fill and finish line is expected to start this autumn in Wrexham, North Wales.

Deals to secure doses of promising vaccine candidates continue with GSK and Sanofi closing a £500 million deal to supply the UK with 60 million doses of their coronavirus vaccine. This is the UK Vaccine Taskforce’s fourth COVID-19 vaccine deal, with the candidate expected to enter human trials this autumn.

Innovation in testing

As well as securing COVID-19 vaccine manufacturing capability, having the capacity to test for the virus is equally important. That’s why I was pleased to hear that two of the UK’s innovative key players in sequencing will be rolling out two new coronavirus tests ahead of winter. The tests will be able to detect both COVID-19 and other winter viruses in just 90 minutes. The tests created by BIA member Oxford Nanopore and DNANudge will strengthen the coronavirus response as we head into winter with the ability to distinguish between COVID-19 cases and other winter viruses.

To complement the UK’s test and trace programme, a contract-tracing app will soon be rolled out to members of the public. The app will be different to the one initially planned earlier this year, using the Apple-Google Bluetooth method to detect when someone has been within two metres of another person with the app for more than 15 minutes.

NIHR Restart Framework

It has been two months since the National Institute for Health Research (NIHR) published a framework to support the restarting of research paused due to COVID-19. Clear progress has been made; based on data from 4,168 non-commercial studies, we know that 1,451 studies are open to recruitment. Of these, at least 742 have reopened to recruitment following a pause due to the pandemic. Read the update here.

BIA finance news

Over the summer and into the autumn the BIA’s work on finance policy is going to be particularly busy. The Government has launched the Comprehensive Spending Review (CSR), through which it will set its funding priorities for the remainder of this Parliament. We will be submitting a formal response to the CSR as well as meeting directly with Ministers and officials. This week we are also responding to the Government’s R&D Roadmap and I am looking forward to meeting the new CEO of UKRI, Professor Dame Ottoline Leyser, to discuss our views on innovation funding amongst other things. Addressing the lack of scale-up finance remains a key objective and we’re working with a range of partners on that agenda, including the Scaleup Institute, which last week published its Future of Growth Capital Report, drawing on data from the BIA’s most recent finance report. I was particularly pleased to see the recommendations relating to the need for new sources of capital and the need to unlock pension funds to support innovative businesses – with the Canadian pension system cited as a successful model that delivers this far better than the UK system. We will be publishing further data on investment in the sector in October to complement our policy work as well as an exciting new guide to investing in biotech.    

BIA IPAC news

The BIA’s Intellectual Property Advisory Committee (IPAC) has produced a new guide for our members on rewarding inventors within their workforce. It follows a Supreme Court ruling in favour of Professor Shanks in his 13-year compensation claim against Unilever, which reinforced the law under which businesses are expected to reward invention where there has been an outstanding benefit to the company. Thank you to the committee and especially Will James of Osborne Clarke for producing it.

BIA-MHRA Regulatory Innovation Conference

I am pleased to announce that Lord Bethell, Minister for Innovation, will be delivering a keynote address on ‘Future ambition for UK life sciences in 2021 and beyond’ at the BIA-MHRA Regulatory Innovation Conference this September. Find out more and book your place here.

Best,

Steve Bates

Chief Executive Officer

BIA

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.