CEO Update | Monday 23 November

COVID-19 update

The news that we’ve all been waiting for is out today, from the UK-sourced Oxford University and AstraZeneca COVID-19 vaccine. The great news is that the vaccine works in Phase III clinical trials. For an industry audience it is worth digging into the complex dataset.

Today’s data shows that the Phase III interim analysis, which includes 131 COVID-19 cases, indicates that the vaccine is 70.4% effective when combining data from two dosing regimens. Interestingly, a higher efficacy regime used a halved first dose and standard second dose and showed 90% efficacy, whilst the standard dose regimen vaccine efficacy showed 62%.  There were no hospitalisations or severe COVID-19 cases in anyone who received the vaccine and the teams have accrued a large safety database from over 24,000 volunteers through clinical trials in the UK, Brazil and South Africa, with follow up since April. The data also gives an early indication that the vaccine could reduce virus transmission from an observed reduction in asymptomatic infections (for which the other vaccine candidates have not so far presented data). Crucially, this vaccine can be easily administered, stored at ‘fridge temperature’ and distributed using existing logistics.

This data comes shortly after the announcement last week that the vaccine shows a strong immune response in adults in their 60s and 70s, raising hopes that it can protect age groups most at risk from the virus. This adenovirus vaccine will complement the mRNA vaccines from Pfizer/BioNTech and Moderna, and it’s fantastic to have several different vaccine candidates already in production that will help in ending the COVID-19 pandemic.

The BIA and members of its manufacturing community have been proud to support Oxford University and AstraZeneca, by contributing our expertise and resources to help scale up manufacturing efforts and create a UK supply chain for this vaccine. It is testament to the strength of the UK life sciences and biotech sector, that we can bring together world-class academia, researchers, and companies to find solutions to this global health pandemic, in a quick and effective manner.  Our collective early work and collaborative approach underpins the capability now to enable large scale manufacturing to be ongoing in over 10 countries to support equitable global access. Next week we will be celebrating and sharing the UK work so far at our bioProcessUK conference, which is set to be a great event – do register here.

If you want to catch up on two things related to this,  I’d recommend Deputy Chief Medical Office Professor Jonathan Van-Tam’s piece in The Guardian ‘We can't afford to wait for the perfect vaccine’, which makes important public health arguments as we enter a period in which we may see different efficacy results from a range of vaccine candidates. I’d also recommend sharing this video from the University of Oxford which explains how COVID-19 vaccines have been able to be developed so quickly, a key question of concern from members of the public.   

A Rare Chance for Reform

The BIA’s Rare Disease Industry Group (RDIG) has launched an important new report, A Rare Chance for Reform, which calls for action to ensure patients are able to access innovative medicines for rare diseases. The report, created in collaboration with PwC, identifies key areas where reform would remove barriers and ensure access to rare disease medicines.

Innovation in drug development is making treatments available for people living with rare and ultra-rare diseases for the first time. What patients need now is for the medicines appraisal process to be ready and able to properly value and assess treatments for rare diseases and support access. We have been encouraged by the progress made in the NICE methods review in a range of areas, particularly severity, but hope that NICE will look specifically at the impact of rarity in a future review. RDIG's recommendations set out a range of changes that will support faster and more effective patient access to medicines for rare diseases and we look forward to a future NICE review where these changes become a reality.

Freedom of Information request reveals biomedical innovations are at risk

Insufficient government funding is putting the UK’s pipeline of future biomedical innovations at risk, according to data revealed in a Freedom of Information (FOI) request submitted by the BIA to UK Research and Innovation (UKRI).

Fewer than 4% of projects that were ranked as worthy of investment received funding from the Biomedical Catalyst (BMC) in 2019/20, a key funding programme for early stage biotech companies. The average success rate for other grant programmes is around 25%. Over the last three years, research project applications totalling a value of over £530 million have not been funded despite passing the quality threshold. These projects could have leveraged approximately £2.5 billion in private investment, estimates from IPSOS Mori suggest. The BMC is a key source of early-stage funding for UK bioscience companies to help them scale scientific ideas into products and therapies for patients. The BIA is calling on the Government to increase the annual budget for the Biomedical Catalyst to £100 million in the upcoming Spending Review to boost economic recovery, enabling BIA to leverage in even more private investment into our industry of the future.

To read more, please see our press release or this comment piece in Research Fortnight by our Policy and Public Affairs Manager, Eric Johnsson. Find out more about the BIA's decade-long campaign for the BMC here

Brexit update

This Thursday, 26 November at 11am, the BIA is hosting its next Brexit Briefing Webinar. In addition to our usual political update, the webinar will be joined by colleagues from the Office for Life Sciences who will provide an update on guidance ahead of the end of transition on 1 January 2021. There will also be an opportunity for questions.

If you or your company is in the medicines supply chain you should have received a letter from the Department for Health and Social Care last week. This letter was issued following extensive engagement with the Department, it provides an update on plans and preparations ahead of the end of the transition period with the EU. Regardless of any free trade agreement between the UK and EU, these measures are still likely to be necessary.  

KQ Labs

KQ Labs, an accelerator programme focused on data-driven health, run by the Francis Crick Institute and now funded by LifeArc, has selected ten new start-ups for its third cohort

The programme provides customised support and resources for start-ups working on propositions that will have a major positive impact on health. This year’s cohort includes companies tackling diverse problems in domains including Parkinson’s Disease, cancer, and drug discovery.

Sector success

Syncona has funded their sixth gene therapy company, Purespring, in a £45 million deal. The University of Bristol spin out is one of the first AAV gene therapy companies focused on the kidney. By my quick reckoning it’s one of the largest single investments made in a new UK university biotech company. Great news to round off a great week.

Best,

 Steve Bates OBE

Steve Bates OBE

Chief Executive Officer