CEO Update|Monday 28 September

COVID-19 update

Great early news from the BIA Antibody Taskforce project. IONTAS has announced today they’ve identified potent SARS-CoV2 neutralising antibodies that can block COVID-19 infection at doses as low as 20pM in pseudoviral assays and 100pM in live coronavirus assays. The announcement shows just some of the great early work that has developed from the BIA coalition convened by Dr Jane Osbourn OBE, expect more in the coming weeks.

Deputy Chief Medical Officer Jonathan Van Tam will update industry on the UK’s COVID-19 Therapeutics Taskforce during a webinar this Wednesday, kindly hosted by the ABPI. You can register here. The aim is to provide industry with an overview of how the taskforce is organised, its strategic approach, and what your organisation should do if you have a promising therapeutic candidate.

The UK is set to become one of the biggest funders of both the World Health Organisation and its vaccine procurement facility, the Prime Minister announced over the weekend, as the UK looks set to seek a bigger role in the international fight against the coronavirus pandemic.  Speaking to the UN, Boris Johnson committed a total of £571m to the WHO’s Covax programme, designed to facilitate the equitable distribution of a COVID-19 vaccine around the world. The commitment will be split between £71m to secure purchase rights for up to 27m vaccine doses for Britain and £500m in aid funding to help 92 of the world’s poorest countries access doses. Britain has pledged £340m in funding to the WHO over the next four years, a 30 per cent increase on the previous four-year period.

As the UK takes on the presidency of the G7 next year, the Government is seeking to implement a five-point plan to prevent future pandemics and global health crises. Measures include setting up a network of zoonotic research hubs to identify public health threats within animal populations before they spread, increasing manufacturing capacity for the production of treatments and vaccines, and reducing trade barriers that have impeded the coronavirus response.

Another important development is the news that the UK plans to host the world’s first COVID-19 human challenge trials - in which healthy volunteers are deliberately infected with coronavirus to assess the effectiveness of experimental vaccines. If approved, the Government-funded studies could begin in London as soon as January. These trials could speed up the clinical development of several promising vaccine candidates, as well as help us to have a better understanding about how COVID-19 is transmitted.

The Government’s new COVID-19 contact-tracing app is now up and running. You may well have seen the adverts and encouraged your teams to sign up.

Budget and Comprehensive Spending Review

Last week the Chancellor announced and extension of the Future Fund and new job support measures to replace the furlough scheme, as part of the Winter Economy Plan. We also learnt that the Autumn Budget has been postponed in order to focus on the pandemic response. The move has raised to possibility that the Comprehensive Spending Review (CSR) will not go ahead either. Nevertheless, the BIA has submitted its priorities to HM Treasury which you can find here. In summary, the BIA is urging the Government to increase access to finance for start-ups and scale-ups, support world-class R&D, establish the UK as a destination for high-value manufacturing, and make the UK a world-leading drug development and launch market.

Genome UK: The Future of Healthcare 

One part of our CSR submission triumphs the success of Genomics in the UK so it was fantastic and timely to see the launch of ‘Genome UK: The Future of Healthcare’. The Strategy, published over the weekend, sets out the UK’s plan to extend its leadership in this field and deliver world-leading, genomics-driven healthcare to patients. There’s welcome recognition of the role of industry, and particularly start-ups, in the vision it sets out. Genome UK identifies three pillars: diagnosis and personalised medicine; prevention, and research, which the Government will focus on in partnership with the third and private sectors. Our Genomics Advisory Committee is already heavily engaged with Genomics England and other arms of Government active in this space and we look forward to working on the specific programmes as they are rolled out.  

UKRI Accelerating Detection of Disease programme

As part of the genomics strategy, UKRI has launched the Accelerating Detection of Disease (ADD) programme. It is the UK’s largest ever health research initiative and over the next four years it will recruit five million volunteers to support research intended to improve early detection, risk stratification, and early intervention for chronic diseases. You can find out more about this exciting initiative at an upcoming webinar this Thursday, register here. 

Brexit latest

An important change in guidance on batch testing was slipped out quietly by the Government last Friday afternoon, changing MHRA guidance that had only been issued three weeks ago on 1 September. The new end of transition guidance, now reads “From 1 January 2021, the UK will accept certification by a Qualified Person and Active Substance manufacture from countries specified in these lists. These lists will initially include EEA countries and other countries with whom regulatory equivalence has been confirmed. The lists will be reviewed at least every 3 years. The UK will also accept batch testing done in EEA countries for a period of 2 years after the end of the transition period, until 1 January 2023. This will provide time for industry to adapt supply chains to future UK regulatory requirements.”

In essence, the Government chose to fire the starting gun on the requirement for the duplicative and costly repetition of laboratory testing for companies for each batch of medicines destined for the UK market from January 2023. Since batches that may go to the UK market from then will likely be manufactured well before that date, companies would need to take action to build testing laboratories and capability on both sides of the channel as early as next year. I believe this small but significant change of guidance is unnecessary, ill considered, goes against positions industry agreed with Health Ministers, and likely to be counterproductive, as it risks making the small UK market not cost effective for low margin products and imposes significant bureaucratic red tape on innovative products for no patient benefit.

At a time when certainty and clarity are vital, lab testing capacity is needed for COVID-19, and when the Government is relying on sector goodwill to ensure the uninterrupted and continued supply of medicines through the end of transition, the process of issuing detailed regulation like this twice in a month damages industry confidence in UK government competence and makes the role of the MHRA even harder. Of course, the best outcome from the Brexit negotiation this week is a deal including a Mutual Recognition Agreement (MRA) between the UK and the EU, which would make this point moot. Until there is clarity as to how the Northern Ireland Protocol operates, and as there may be a deal agreed in the next few weeks, my sense is that is one to watch, rather than action, through October 2020.

Concern is growing regarding border delays at the short straits into the new year as a Cabinet Office document made public last week stated that without a free trade deal and in its reasonable worst-case scenario, there may be "maximum queues of 7,000 port-bound trucks in Kent and associated maximum delays of up to two days".

You may remember back in August the letter from the Office for Life Sciences sent to companies in the medicines supply chain asking them to assure stock levels and re-route supply away from the short strait ports, and be ‘trader ready’ for the new customs and border arrangements. It also promised alternative ferry arrangements for category 1 goods including medicines. We have pressed Government to make the routes, plans, and ticketing arrangements for this long-promised capacity to be made available to industry as soon as possible to ensure minimal disruption to supply chains.

With fewer than 100 days until the end of the transition period we still do not have clarity on the Northern Ireland Protocol and the regulatory environment in which businesses will operate from 1 January 2021. Our latest Brexit Briefing webinar last Thursday discussed key topics impacting our sector including the UK Internal Market Bill which you can now watch on our YouTube channel here. If a deal is to be done, my reading is that talks in Brussels this week will be crucial and we will know in the next two weeks if light is emerging from the tunnel.

Upcoming BIA events

The UK Bioscience Forum is taking place virtually in just a few weeks’ time, the theme of this year’s conference is emerging data technologies in life sciences. This will include both how new technologies are addressing longstanding problems faced by life sciences companies in the life science sector, as well as how to deal with challenges of diversity, interoperability and IP. We have an excellent programme and line-up of speakers, which you can find here.

I am also looking forward to our regional event this Thursday, which is focussed on COVID -19 vaccine manufacturing and collaborations at Harwell. This will be a great opportunity to hear about how the UK life sciences sector has come together to find solutions in the pandemic. This is something the BIA has been heavily involved with since the start and you can find out more about our COVID-19 work on our dedicated microsite.

Finally, a quick reminder that this year’s BIO-EUROPE is taking place virtually and BIA members can receive 15% off their ticket if purchased through BioPartner. Find out more here.

BIA Board Election

As a not-for-profit company, limited by guarantee, each member company of the BIA has voting rights at our Annual General Meeting and the opportunity to select Board members to represent them. This year, 16 members have put themselves forward for election for the five positions available on the BIA Board. My thanks to all those individuals who are standing, and I would strongly urge all members to cast their vote. The full details regarding each candidate and the voting process are available here.

Our AGM is going to be held virtually on Wednesday 21 October 2020 from 16.30 to 17.15hrs. The precise details and platform upon which we will be conducting this meeting will be distributed to all main member contacts shortly and will be available on the BIA website. I would encourage you to put this date in your diary.

Best,

Steve Bates OBE

Steve Bates OBE

Chief Executive Officer

 

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