CEO update - Monday 7 August

MHRA bilateral

The BIA had a positive face-to-face bilateral meeting with the MHRA last week and it was really reassuring to hear their plans for a busy August addressing companies' concerns about delays and lack of predictability on decisions for clinical trial authorisation applications and amendments. This has been a hot topic for members large and small and I’m pleased that the MHRA’s Clinical Trials Task and Finish Group is meeting this week, where we will be represented by our Head of Regulatory Affairs, Christiane Abouzeid.

The MHRA has increased its clinical trials team to 20, with the appointment of 5 new assessors in recent months, as well as looking at taking on additional expertise to get back up to capacity. Understanding more of how the agency have reallocated work across their teams, evaluated queued initial applications and amendments for complexity, and have changed processes to take a joined-up risk-proportionate approach should help companies to see how the agency is tackling the backlog.

The meeting will be a good chance for a broader group to hear more about how the MHRA has changed its operations to meet the challenge. I stressed how easy it can be for silence to be interpreted negatively and that a much more regular drumbeat of communication on the operational improvements by the agency would be welcomed by the sector – a message the MHRA team I think took to heart.

It’s vital for our sector that the log jam is removed as quickly as possible as it is the key enabling step for the recovery of clinical trials and continued investment into the UK ecosystem for many companies. I know we all wish to see improvements in the performance metrics the agency publishes each month – the next data set will be available next week.  I stressed our communities willingness to help the MHRA so there may be some asks of industry from the MHRA next week.

Our Future of UK Regulation Conference is set to be an important point of engagement and discussion on 5 October featuring representatives from MHRA, HRA, NICE, FDA and industry amongst others.   You can book a place to attend here

British Business Bank seeks Chief Investment Officer  

The BBB have started recruiting for a Chief Investment Officer to lead the Bank’s investment teams - British Patient Capital, British Business Investments and Venture Solutions.

This is a key role for our ecosystem and a unique and really exciting opportunity for an investment professional. The Bank is the largest investor in UK venture capital and drives nationally significant purpose - supporting high potential, innovative businesses essential to UK growth. It would be great if the successful candidate had experience in life science investment and I’d encourage applications from our investment community applications close mid-September.

Health Minister drops in on BIA member as part of summer tour

Good to see Health Minister Will Quince making time to visit BIA member Ochre Bio as part of his summer health tour last week when he was in Oxford. He now understands how this biotech start-up is tackling chronic liver disease - the third leading cause of death in the UK and that they're using advanced genomics and data science to develop RNA medicines which are tested on donated livers.

CEO Update.jpg

I’m off on holiday for a couple of weeks so my next CEO update will be after the Autumn Bank Holiday.  Do look at the exciting range of events we’ve got planned for the autumn and book early to avoid disappointment  - I look forward to seeing you at one of them.

 

Steve Bates Headshot.png

 

 

 

 Steve Bates OBE
CEO, BioIndustry Association

 

 

 

More news updates 

 

ImmuONE is celebrating triple triumph at the inspiring herts awards 2024

We’re proud to announce that ImmuONE took home the prestigious award for ‘Business of the Year – North Herts’, which was awarded to us for consistent growth, robust financial performance, and unwavering commitment to staff and innovation. From the pool of winners, there was also a special recognition category which honoured ImmuONE with the ‘Inspiring Business of the Year’ award for making the biggest innovation in Hertfordshire.

Cryoport systems officially launches global supply chain hub in Stevenage

Cryoport, Inc a global leader in innovative supply chain solutions for the cell and gene therapy industry, is thrilled to announce the official launch of the Cryoport Systems state-of-the-art Global Supply Chain Hub in Stevenage, U.K.

Microbiotica to present positive update on manufacturing progress of its live biotherapeutic products

Microbiotica, a biopharma company developing a pipeline of orally-delivered precision microbiome medicines announces that Adam Wilkinson, its Vice President of Pre-Clinical Development, will present an overview of the company’s successful product manufacturing campaigns ahead of its forthcoming melanoma and ulcerative colitis clinical studies at the 9th Microbiome Movement Drug Development Summit, on 11 July, in Boston, USA, together with Claire Derlot, CBO from its GMP manufacturing partner Biose Industrie.

Milner Institute celebrates success of 2024 Pitch Day and therapeutics symposium

The Milner Therapeutics Institute were delighted to host two sell-out events in Cambridge that brought academics, investors, pharma and biotech companies together.

CEO Update - 8 July 2024

It is a fantastic way to start the week with news of Europe’s largest Series A biotech spin-out this year from the UK. Congratulations to Myricx Bio, an Imperial College London and Francis Crick Institute spin-out company focusing on a novel class of payloads for antibody-drug conjugates (ADCs), for announcing their Series A financing of £90 million.

Moa harvests global deal for new herbicide

Moa Technology has signed a major research and commercial agreement with Australian ag giant Nufarm. The deal will see Moa receiving receive upfront payments, milestone development payments and royalties in return for Nufarm gaining exclusive access to a product in one of Moa's breakthrough novel mode of action areas.

Brandon Capital's vision for a transcontinental life science axis

Jonathan Tobin, Partner at Brandon Capital, discusses the firm's recent close of its sixth fund at A$270 million, bringing its total assets under management to over A$1.25 billion. He also explores how Brandon Capital is strategically connecting Australia, New Zealand, the UK, and the US.

Myricx Bio announces £90 million Series A financing to advance its novel NMTi-ADC therapeutics into clinical development

£90 million ($114 million) series A co-led by new leading life science investors Novo Holdings and Abingworth; additional new investors British Patient Capital, Cancer Research Horizons and Lilly participated alongside founding investors Brandon Capital and Sofinnova Partners.

 

 

 

More within