CEO Update|Monday 07 September

Heading into autumn, the BIA has a brilliant selection of upcoming virtual events. From webinars and conferences to networking opportunities, there is something for everyone - take a look at our events calendar here.

Our next big event will be the BIA-MHRA Regulatory Innovation Conference taking place next Thursday, which will explore the future of regulation, patient access, clinical trials and more. I am particularly looking forward to hearing from the Minister for Innovation, Lord Bethell, discussing the future ambition for the UK life sciences sector in 2021 and beyond. Sign up here.

I am also pleased to announce that the Chief Executive of UK Research and Innovation (UKRI), Professor Dame Ottoline Leyser will be delivering a keynote address at the BIA’s Bioscience Forum this October. Take a look at the programme and register for the event here.

Tomorrow I am looking forward to hearing about the exciting work in cell and gene therapies taking place in Stevenage. This virtual networking event will see key names in the field discuss how we can support cell and gene therapy companies in the UK. More details can be found here.

BIA launches guide on investing in UK biotech

Last week the BIA launched ‘Opportunity on your doorstep: A guide to investing in the UK biotech sector’. The guide lifts the lid on our exciting sector and shows the opportunities for investors to reap financial returns from investing in UK biotech. This guide will support our membership by raising investors’ interest in, and understanding of, our sector. Please share the report amongst your networks and add your voice to our social media campaigns on Twitter and LinkedIn using #InvestinBiotech.

COVID-19 news

The drive to develop safe and effective vaccines continues around the globe with BIA members among those at the forefront of these efforts.The promising vaccine candidate developed by GlaxoSmithKline and Sanofi has now begun the clinical trials process, with initial results expected in December.

Manufacturing capacity of the AstraZeneca and Oxford University’s Jenner Institute vaccine (AZD1222) has increased, after AstraZeneca signed a supply agreement with Oxford Biomedica for large-scale commercial manufacture of the vaccine. As part of the agreement, Oxford Biomedica will reserve capacity for AstraZeneca in up to three manufacturing suites in the Group’s new 7,800m2 commercial manufacturing centre, Oxbox, for an initial 18-month period. Alongside this deal, Oxford Biomedica is close to bringing an additional two manufacturing suites online at Oxbox as part of a five-year deal with the U.K.'s Vaccines Manufacturing and Innovation Centre (VMIC).

On COVID-19 testing, the Government has promised a £500 million funding package for next-generation testing technology and increased testing capacity. These new innovative testing technologies include Oxford Nanopore’s rapid LamPORE tests and DnaNudge ‘Nudgebox’ machines. The funding will also be used to further extend capacity for existing polymerase chain reaction (PCR) testing across the country.

Brexit news

The Medicines and Healthcare Products Regulatory Agency (MHRA) has now published guidance for our industry on preparing for the end of the Brexit transition period, which is 115 days away. This post-transition information is useful for our sector; however we still await clarity on the Northern Ireland protocol. The Prime Minister hardened the rhetoric today, saying: “If we can’t agree by then [Oct 15], then I do not see that there will be a free trade agreement between us, and we should both accept that and move on.” We will be watching closely the tabling of the Internal Market Bill on Wednesday, which some media reports have claimed will be used nullify parts of the Withdrawal Agreement in areas including State aid and Northern Ireland customs.

We are aware that the lack of guidance on the Northern Ireland protocol is causing considerable frustration among members and we are continuing to push the Government on this issue at every opportunity. Last week, we hosted a Brexit Briefing Webinar covering the latest Brexit news and guidance, you can find it on our YouTube channel here and I hope to see you at our upcoming Brexit webinars. We also continue to populate the BIA Brexit Portal with the latest information here.

NPL industry recovery programme

The National Physical Laboratory (NPL) is leading a new industry recovery programme called Measurement for Recovery which may be of interest to our members. The programme can help solve analysis or measurement issues that cannot be resolved using standard technologies and techniques and aims to help boost resilience and competitiveness by bringing the UK’s top scientists, engineers and facilities together with companies, to address problems in innovative ways. Find out more here.

EuropaBio news

Congratulations to Novartis’ Andrew Topen who has been appointed as the new Chairman of EuropaBio and takes over at an important time for our European Association. As agricultural and green biotech members leave Europabio, there will be a new focus on research and health issues which will ensure a strong voice for our sector in Brussels. Last week at the EuropaBio General Assembly, I was able to raise with Guido Rasi of the EMA, the challenge of the lack of specific guidance regarding the Northern Ireland protocol, to which Guido charitably admitted that he shares our frustration from a regulator’s perspective.

Trade consultation and new government Life Science Trade Advisory Group

This week will see the first meeting of the Government’s Life Sciences Trade Advisory Group which (although subject to a confidentiality agreement with the Department for International Trade) I have been invited to join.  The BIA will continue to provide a public voice on matters to do with international trade policy, and will be seeking members’ views as we put together our response to the new DIT consultation announced last week on  global regulatory harmonisation.

The consultation seeks to ensure the government’s future strategy aligns with the needs of the wider regulatory and business community, with input from regulators, industry, standards-setting bodies and other interested parties through a public call for evidence.   I hope we can help them understand how the BIA already engages in international regulatory cooperation;   through the work of our  BIA Regulatory Affairs Advisory Committee, engagement with MHRA (with whom we are hosting next week’s joint conference), work with EuropaBio and as part of the International Council of Biotech Associations (ICBA) – especially focusing  on WHO cell and gene therapy policy. The consultation aims to identify priorities for regulatory cooperation and how the Government can best support the international engagement activities of UK bodies.

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.