CEO Update - 11 September 2023

Horizon Europe Deal 

Last week, the UK scientists celebrated the rejoining Horizon Europe research programme. For research and the flow of talented scientists, it is undoubtedly a good thing that has taken too long to agree. The UK government press release was clear that “Horizon will give UK COMPANIES and research institutions unrivalled opportunities to lead global work to develop new technologies and research projects, in areas from HEALTH to AI” (my emphasis), but I was (unusually?) reticent in commenting until I had seen the detail of the bespoke UK/EU deal, especially as I am aware of how complex engaging with these programmes has been for SMEs even when the UK was part of the European Union.

The 2023 UK-EU agreement explainer from the UK government published late on Friday touches on some of this in more detail. For instance, it is explicit thatUK applicants will be excluded from the European Innovation Council (EIC) Fund – which provides equity finance support to EIC Accelerator projects” and there will be “limited exceptional cases where the eligibility for individual funding calls is limited to member states or certain other countries under current Work Programmes.” The document explains that “going forward the EU will assess UK participants’ access to these parts of the Horizon Europe programme on equal terms with other associated countries”. Which I think means the role of Associated countries' participation is assessed at a work programme level with Horizon.

I welcome member insight on this (both contemporary and historical) and I look forward to engaging with DSIT and UKRI on what the granular detail of the deal means for UK SMEs and the process by which they can engage. The agreement still needs to be ratified by member states so isn’t finalized yet.

Labour reshuffle – Peter Kyle MP becomes shadow DSIT Secretary and visits AstraZeneca with the Labour Leader

A big Labour reshuffle of their front bench last week saw Keir Starmer MP move to appoint a shadow DSIT minister to his front bench team for the first time. Hove MP Peter Kyle moved from the Northern Ireland brief to cover DSIT. Within two days both were visiting the AstraZeneca site in Macclesfield.

The Labour Leader Keir Starmer MP posted: “The UK’s life sciences sector could be rocket fuel for our stagnant economy. My Labour government will back British scientists by slashing red tape, removing hurdles and providing certainty. Together we will create the jobs of the future and turbocharge growth.”

Shadow Minister Peter Kyle said the visit was “an amazing chance to glimpse what life sciences contributes to our country. A Labour government will unleash its potential to become the rocket fuel our economy needs”.

Apollo Therapeutics raised $226.5 million 

Many congratulations to everyone at Apollo Therapeutics on closing their $226.5 million Series C financing last week. This portfolio biopharmaceutical company is focused on translating fundamental medical research into medicines through a hub-and-spoke approach. Apollo has a scalable R&D platform for the evergreen discovery and development of new medicines. Partner institutions include the University of Cambridge, Imperial College London, University College London, King’s College London and the Institute of Cancer Research.

Interestingly from a sector perspective, the financing was led by Patient Square Capital, with participation by multiple new investors including UK-based M&G plc and two of the largest US public pension plans, along with existing investor Rock Springs Capital. This shows that the policy agenda of getting new investors into our sector is starting to show practical dividends for member companies.

MHRA progress in clearing the backlog of clinical trial applications – look to the future and BIA Regulatory Conference update

The MHRA Clinical Trials Task and Finish Group was updated last week on speedy progress the MHRA is making in tackling the backlog that has been apparent to the sector for some months. My judgement - from speaking to many across the sector - is that the agency has turned the corner. Since July 2023, they have assessed an impressive total of 1,579 applications. Companies tell me that information flows from the Agency have improved also – and although specific cases may need more questions answered we are in a strong place to look forward rather than backwards as autumn arrives. For information relating to the current status of any enquiry where an MHRA response is overdue, applicants can email [email protected] or phone the helpline on 020 3080 6456.

I know the MHRA is fully committed to meeting their statutory timescales for all newly compliant clinical trial applications received this month and onwards – and we’ll be able to see how that is going in a few weeks' time. Given that the Agency is implementing new legislative measures to make it easier and faster for applicants to gain approvals and to run clinical trials in the UK, and providing guidance on these measures to support the clinical research sector, we are all set for an excellent session on Getting UK clinical trials back on track at our conference The Future of UK Regulation 2023 next month. Do join us for an exciting agenda and hear directly from the MHRA’s top leadership on plans for the future.

International Recognition

The MHRA is in the process of establishing a new international recognition route for medicines utilising pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States. This new framework will sit alongside the MHRA’s current national procedures from 1 January 2024.

The MHRA webinar on International Recognition on 14 September is sold out! This important topic will be covered at our upcoming conference The Future of UK Regulation 2023 on 5 October. To avoid disappointment book your place soon – delegates can ask questions and contribute to the discussions with MHRA, the US FDA and Swissmedic.

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The Future of UK Regulation Conference 2023

No.11 Cavendish Square, London


Medicines Manufacturing Skills Centre of Excellence investment 

I was delighted to welcome the £5.5 million announced to establish a Medicines Manufacturing Skills Centre of Excellence, which was part of the Chancellor’s £650 million ‘Life Sci for Growth’ package announced in May.

A competition to allocate funding, led by Innovate UK, will officially open on 26 September. Growing UK medicines manufacturing will allow us to capture the greatest economic benefit from our world-leading life sciences research and development ecosystem, creating well-paid jobs and export revenues that power the economy. The diverse geographic footprint of specialised medicines manufacturing facilities means the sector delivers high-quality, rewarding jobs across the UK. This significant investment in a centre of excellence to attract, retain and develop talent throughout the UK will enhance Britain’s standing as the best location globally for innovative medicines manufacturing.

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Steve Bates OBE
CEO, BioIndustry Association

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