CEO Update|Monday 12 October

The BIA's latest investment report shows a record quarter for investment in the UK biotech sector, Nobel prizes and Honours for the sector, plus Tony Blair joins us for a keynote session at our flagship autumn conference, the UK Bioscience Forum.

Great news for UK biotech investment – today the BIA and Clarivate has published data revealing that UK biotech companies have raised more than £1 billion between June and August this year, the highest quarter for investments on record. This means 2020 is on target to be the best year ever recorded for UK biotech.

In a year where COVID-19 has caused major disruptions to the global economy it is fantastic to see the strong investment picture for UK biotech continue to gather pace. UK biotech has shown strategic value during the pandemic and has received interest from UK based investors, many who are investing in our sector for the first time.

Earlier this year we released Opportunity on your doorstep: A guide to investing in the UK biotech sector to help investors from the biggest institutions down to individuals planning for their retirement to understand the sector, including its diverse business models, the R&D process and the risks and benefits.

I am looking forward to presenting the latest biotech financing update at the UK Bioscience Forum alongside Mike Ward of Decision Resources Group (DRG), part of Clarivate. I am also delighted to announce that Former UK Prime Minister Tony Blair will be joining us for a keynote session. Since the start of the pandemic, the Tony Blair Institute for Global Change has played a key thought leadership role in how to tackle the most complex challenge the world has faced in a generation. Mr Blair has a unique perspective from his time in office and will share his perspective on how governments can meet the global COVID-19 challenge.

I will also be delighted to hear from Professor Dame Ottoline Leyser in her new role leading UKRI at this crucial time. Please support the BIA by registering for your place here. The two-day virtual event has a focus on how emerging data technologies are changing our sector and the business models within it. The full agenda is here.

Nobel prizes and Honours

A key week of recognition to celebrate our sector.

British scientist Michael Houghton, was part of the team awarded the Nobel prize for Medicine in his role identifying the hepatitis C virus, work he did whilst at biotech company Chiron in the 1980s. It was therefore particularly heartening to hear him speaking on BBC Radio 4 PM programme (interview starts at 34:37) about the vital role of the biotech industry and how his own journey had taken him from an undergraduate at the University of East Anglia, via a PhD at Kings College and into industry. Although he said “opportunities in biotech were limited” for him in the UK in the “early 1980s” and he’d “decided to pack his bag for California”, he now saw that “the UK has a very strong biotech environment as well as the academics”.

More good news came the next day as the Nobel prize in Chemistry was awarded to Emmanuelle Charpentier of France and Jennifer Doudna of the US for their work in developing CRISPR gene editing. Many BIA members are now working on gene editing tools, including Horizon Discovery, who have a useful explainer video on what CRISPR genome editing is, watch here.

At the weekend even more excellent news for our community as the (delayed) Queen’s Birthday Honour’s list saw Novabiotics CEO and BIA regular Deborah O’Neil made an OBE. A great report in the Aberdeen Press and Journal here and where Deborah was quoted as saying “My flabbers are still completely gasted”. It was also great to see GSK CEO Emma Walmsley made a Dame for services to the pharmaceutical industry and business, after heading the company for three years. She said: “I'm humbled to receive this honour, it is a real testament to the many outstanding people we have.”

COVID-19 update

The MHRA approved the second of two GMP manufacturing suites that will house The Vaccines Manufacturing and Innovation Centre’s (VMIC) specialist vaccines manufacturing equipment last week. This will mean that there are two fully equipped and approved manufacturing suites ready to make a leading COVID-19 vaccine candidate.

The two suites established with VMIC equipment will be operating at 1000L scale and will be dedicated to the manufacture of a leading COVID-19 viral vector vaccine candidate. The suites, operated by Oxford Biomedica, are located in their commercial manufacturing centre, Oxbox, in Oxford and are expected to be fully operational in October.

You can find out more about the UK’s efforts to manufacture a COVID-19 vaccine in this excellent podcast from the UK Vaccine Taskforce. Speakers include Kate Bingham, chair of the UK Vaccine Taskforce, Netty England, secretariat and member of the BIA Manufacturing Advisory Committee, Andy Jones, Industrial Strategy Challenge Fund Medicines Manufacturing Director, and Ian McCubbin, Vaccine Task Force Manufacturing Lead.

NIHR Guidance for a ‘second wave’ of COVID-19 activity

The NIHR has today issued guidance to protect both COVID-19 and non-COVID-19 research during a ‘second wave’ of high COVID-19 activity. We support the key message in this NIHR guidance that research staff funded by NIHR should not be deployed to front line duties except in exceptional circumstances. This contrasts with the ‘first wave’ when many staff from the NIHR’s Local Clinical Research Networks and Clinical Research Facilities were deployed to the clinical front line in anticipation of heightened need. The study prioritisation levels in the Restart Framework (May 2020) to support the restarting of clinical trials paused due to COVID-19 is unchanged, and NIHR restart decisions continue to be locally led. The framework also highlights the importance of non-COVID-19 studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. Today’s guidance applies to England, but has been developed in consultation with representatives of the devolved administrations.

MHRA updated guidance on the UK licensing of biosimilar medicines

On 7 October the MHRA launched a 6-week consultation on the proposed guidance for the UK licensing of similar biological medicinal products (known as biosimilars) at the end of the transition period from 1 January 2021. The MHRA guidance contains some revisions to the EMA’s CHMP guidance documents, taking into account the scientific and regulatory experience gained since the first biosimilar product was authorised in 2006, and complex biosimilars authorised from 2013. These revisions cover details for UK reference products, in vivo studies in animals not being required, and changes in the requirement for a comparative efficacy trial (with justification for the absence of an efficacy trial). Please contact Dr Christiane Abouzeid (cabouzeid@bioindustry.org) if members wish to give feedback on the draft guidance and contribute to the BIA consultation response.

Cell and gene therapy news

It was promising to see that BIA member FUJIFILM is expanding its gene therapy offering with the addition of viral vector process development and GMP manufacturing services in the North East of England. FUJIFILM Diosynth Biotechnologies’ viral vector process development laboratories will be online in the UK from spring 2021. The laboratories will be outfitted with state-of-the-art equipment to support upstream (suspension and adherent) processes, downstream processing and analytical development. The GMP manufacturing capabilities are expected to be available from autumn 2021 and will support bulk drug substance production of investigational drugs used in early-stage clinical trials.

We will keep abreast of new COVID-19 announcements from the UK government this week, alongside any updates ahead of the end of transition ready for our upcoming Brexit webinar next week. I look forward to seeing many of you virtually at the UK Bioscience Forum on Wednesday and Thursday.  

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.