CEO Update | Monday 15 June 2020

After a determined BIA campaign, the Biomedical Catalyst is to be relaunched with £30 million, and Brexit conversations continue.

Fantastic news last week, as Innovate UK’s CEO, Ian Campbell, announced that the Biomedical Catalyst (BMC) is being replenished to the tune of £30 million. The good news was unveiled at our latest BIA webinar which focussed on business finance support, with Ian Campbell being joined by speakers from the British Business Bank. Watch it on our YouTube channel here.

The announcement follows the BIA’s long-running campaign for the funding competition over the last decade, which is covered in a blog here.

We know that the BMC has given entrepreneurs and SMEs access to crucial capital to grow and scale and its light bureaucracy approach means innovators can focus on business development, not red tape. A recent report from Ipsos Mori showed that the programme generates over £4 of private investment for every £1 of public money invested, as well as increasing R&D investment and also employment within companies.

The coronavirus pandemic has brought the importance of a strong UK life sciences sector into sharp focus and the BMC is a key part of government efforts to ensure the UK is resilient in the face of future threats to public health. The competition is set to open on 27 July 2020 and more information will be provided in due course.

We have worked alongside BioCentury to survey our community about financing for biotech companies. We are gathering insights into financing plans, fundraising, government R&D grants, and how COVID-19 has impacted fundraising activities. Do take part in the survey here. The deadline is tomorrow Tuesday 16 June and we plan to share initial results next week.

Next week we will be holding our key summer event, the BIA Life Sciences Leadership Summit, where BIA corporate member leadership teams and investors will discuss a whole range of strategic issues affecting biotech and life sciences companies, including financing during and post COVID-19. We have some fantastic speakers including Kate Bingham, on chairing the Government Vaccines taskforce and Michelle McMurry Heath, the brand-new CEO of BIO, who will have fascinating perspectives from the USA. We expect around 200 C-suite level participants to join us for partnering, panels and networking.  For more information on the event please follow this link or alternatively, email our Director of Business Development and Membership Services, Jane Wall at jwall@bioindustry.org

 

Test and Trace Programme

Innovation in COVID-19 testing continues at a breathtaking pace. The Wellcome Sanger Institute has developed the INSIGHT test (Isothermal NASBA-Sequencing based HIGH-throughput Test) which is a two-stage testing strategy for viral pathogens, including COVID-19 . Last week Illumina announced FDA emergency use authorisation for a COVID-19 diagnostic test that uses next-generation sequencing (NGS).

 

We continue to make sure there is clear communication about these innovations between government and industry. The latest government/industry webinar (with BIVDA, ABPI and ABHI partnering with us on the industry side) was an  ‘Update on the National Test and Trace Programme’,  focused on Pillar 3 and 4 of the National Testing Strategy.  

 

The Testing Methods Sourcing Platform which enables innovators to get to the heart of the Government process has a new challenge this week to reduce the environmental impact of COVID-19 testing processes. You can post a solution here.

After feedback from recent BIA member engagement activity, it was clear that member companies are keen to develop testing processes for their own staff to enable return to working as normally as possible. Thank you to Oxford Immunotec for stepping up and offering a route to a cutting edge COVID-19 testing service for BIA members on a commercial basis, you can find out more here.

 

COVID-19 treatment

Last week the EMA announced that it received an application for conditional marketing authorisation of Gilead’s antiviral medicine remdesivir for the treatment of COVID-19. The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline, which was made possible because some data have already been assessed by EMA scientific committees and working parties, operating synergistically during the first cycle of the rolling review which started late April. These are extraordinary times - an opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) could be issued within weeks, paving the way for the European Commission to support fast-tracking of the decision-making process and granting of a marketing authorisation. It’s worth noting that until remdesivir is authorised for marketing it is available to patients through the Early Access to Medicines Scheme (EAMS) in the UK and compassionate use programmes in the EU, through which patients can get access to unauthorised medicines.

 

COVID-19 regulatory flexibilities

BIA would like to draw attention to the MHRA catalogue of finalised regulatory flexibilities among members – this document, which was shared with Industry Associations, reflects all regulatory flexibilities agreed and published on the MHRA website  over the last couple of months, as well as a comparison of UK against EU regulatory flexibilities. Even if you are not developing a product against COVID-19 this is an important document, as the MHRA and industry will start discussions as to which of these regulatory flexibilities will be COVID-19 specific and which will be kept long-term, and look at the future of regulation post-Brexit transition.  

 

Brexit latest

The Life Sciences Council met last Monday and provided a useful formal contact point for our sector and the Government. The Life Sciences Industrial Strategy was discussed and both sides stressed its continued importance. We look forward to working on this as well as the post COVID -19 pandemic UK market and the trading relationship for the UK following its exit from the EU.

It is clear that the Government has no intention of seeking a further extension to negotiations with the EU and that the transition period will legally finish at the end of the year. However, there is still no deal between the UK and the EU and no clarity on key issues, such as how the Northern Ireland protocol will work for medicines. With the clock ticking again, I know that most companies will have to proceed once more on the basis of no-deal, incurring additional costs and increases in red tape. We continue to be clear with the Government that medicine supply chains are regulated, global in nature, lengthy and relatively inflexible. We continue to stress the need for a deal.

We have also been clear that stockpiling in the way envisaged before the last no-deal deadline is not possible this time around, due to global disruption and capacity challenges caused by COVID -19.  I am confident that Ministers continue to be aware of the industry’s position and I am as frustrated as members are that we still do not have clarity on fundamental parts of our sector’s business environment four years after the referendum.

 

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.