CEO Update|Monday 09 November

Steve Bates reflects on important developments regarding the Pfizer BioNTech vaccine, Brexit, the NICE Methods Review and other sector news.

COVID-19 news

Heartening and exciting news today from Pfizer and BioNTech who have announced that their COVID-19 vaccine candidate demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis.

The UK Vaccine Taskforce negotiated a supply agreement to secure this therapy as long ago as July, when much of the excitement was about early leads by other mRNA candidates. Today’s news not only validates the Government’s taskforce of experts' approach to working at speed, but also pays testament to their extraordinary work to date.

One of the key things an early decision to seek supply enabled is the planning time for deployment of what is a novel and complex product, with very low temperature storage requirements, where additional innovation and the expertise of a multifaceted group will be needed. In this, the UK has the advantage of the NHS and Public Health England structures, supply chains and expertise, which should enable the UK to be amongst the first countries in the world to be in a position to vaccinate if this candidate is approved for use and doses are available. The journey of COVID -19 vaccines is the most complex relay team effort I have ever experienced and it's fantastic to see the development leg of this candidate near its successful completion, with regulation and deployment to be the next in turn to grasp the baton.     

Last Thursday, England entered its second national lockdown as the Government looks to contain rising cases and hospitalisations from COVID-19.  There was news last week that the Government has reached its target of 500,000 a tests a week and has now tested 10 million people.  Liverpool has begun its mass city-wide testing pilot, this will last for two weeks and use existing swab tests and new lateral flow tests.  Liverpool will be an interesting test case to see if this testing regime is successful and should be rolled out more widely across the UK. Again, it’s heartening to see innovation rolling at such a scale and the Royal Society’s industrial conference last week was right to highlight the benefits of different traditions working together in the common interest.  

 

Brexit update

Last week we had an important statement from the Government about the Northern Ireland/Ireland Specialised Committee. The statement included information on medicines regulation, stating: “The Committee noted that an agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021, providing the additional time needed for businesses to prepare in relation to batch testing, importation and Falsified Medicines Directive requirements.”

This gives patients and companies the certainty we have been asking for ahead of 31 December 2020, at least into the new year. Thank you to the strong support of members we have had on this important issue. The BIA will continue to work with the joint committee of the Government, Northern Ireland Executive and European Union on a long-term solution to the regulation and supply of medicines to Northern Ireland as part of the UK after 2021, consistent with upholding the Good Friday Agreement and the Northern Ireland Protocol of the Withdrawal Agreement.

This as well as other issues will be discussed at our next Brexit webinar which will take place on November 26, please register here.

 

The NICE Methods Review opens for consultation on the case for change

Last week the NICE Methods Review consultation paper on the case for change was published. The consultation contains welcome elements, with positive movement on modifiers, including the proposal to replace the End of Life modifier with a Severity modifier.

There are also welcome developments within uncertainty, as it is accepted that a greater degree of uncertainty should be recognised for rare diseases, innovative technologies and in managed access agreements.

NICE recognises that there is a case for changing the discounting rate, although this is currently deemed outside the scope of the review. The BIA looks forward to working with NICE to ensure that these proposals develop into tangible changes that can transform the lives of patients.

The formal consultation is now open and can be accessed here.  

 

Peers debate the Innovative Medicines Fund in the passage of the Medicines and Medical Devices Bill

There was an interesting discussion on the Innovative Medicines Fund in the House of Lords last week. We hope the Fund will facilitate access to innovative rare and ultra-rare disease medicines, where the level of unmet need is high, and it was encouraging to see this being raised in the debate. I was especially heartened to hear Lord O’Shaughnessy mention the BIA and agree with us that an ambitious definition of ‘innovation’ is required for the Fund to improve access.

Baroness Penn clarified that NHSE&I and NICE intend to lead an engagement exercise in the first quarter of 2021 to get the Fund established and the BIA looks forward to engaging with this process.

 

Second round of Innovation Scholars Secondment Scheme

UKRI has announced the launch of Innovation Scholars Secondments Scheme which was published on 15 October 2020 and will close on 21 January 2021.  This is UKRI’s second round of the Innovation Scholars Secondment Scheme: Biomedical Sciences, which follows the success of the pilot earlier this year.

The secondee can be at any career stage but must have relevant experience within their field.  Proposals for this round of innovation scholars can come from any discipline but a business within the biomedical sciences must be either the applicant or the partner. More details can be found here.

 

Alderley Park Oncology Development Programme

Last week we saw the launch of Alderley Park’s Oncology Development Programme which is funded by CRUK and Innovate UK. This national programme is designed to develop and progress start-up oncology projects. A collaboration of AstraZeneca, Johnson & Johnson Innovation, GlaxoSmithKline, Roche, the Christie NHS Foundation Trust, Medicines Discovery Catapult and the Manchester Cancer Research Centre will support researchers and start-ups aiming to develop their early-stage innovations. Its goal is to bring forward viable oncology projects much more quickly in order to significantly increase their likelihood of commercial success, and ultimately, patient benefit.

 

London Stock Exchange 1000 companies 

I was delighted to contribute to the London Stock Exchange’s annual 1000 companies report. I emphasised that pension savers are missing out on a key growth sector of the UK and could be an enormous help to encourage the scale-up of innovative biotech companies. 

I’d like to congratulate BIA member Congenica on securing $50m (£39m) in a series C fundraising round led by Legal & General and Tencent. Congenica is a British pioneer in the genomic study of rare diseases and inherited cancer, developing software which enables data analysis 20 times faster than industry averages. The new funding is aimed at accelerating international market development and driving further expansion of Congenica’s product platform into somatic cancer, wellness and through partnerships with pharmaceutical companies.

Best,