CEO blog: A four-nations ecosystem supporting SMEs, cancer vaccines, cell therapies and microbiome medicines
Chris Molloy
CEO, BIA
Dear colleagues,
UK life sciences – across all four nations – continues to show the combination of skills, agencies and initiatives it needs to win on the global stage: world-class science, entrepreneurial energy and an enabling environment.
My visit around Scotland demonstrated this across cities, therapeutic areas and disciplines.
Thanks to all BIA members and colleagues from academia, NHS Scotland and UK government who made the trip informative and actionable.
More broadly there was notable progress in personalised cancer vaccines, UK clinical trial momentum in melanoma and progressive regulatory thinking for microbiome-based medicines. MHRA have also published their new charging framework for consultation. This includes a supportive new voucher scheme for UK SMEs which members
In this update:
- mRNA cancer vaccine reaches Phase 3 milestone
- Scancell gains MHRA authorisation
- HDRS Data Driver Projects
- MHRA clarifies route for microbiome-based medicinal products
- MHRA launches voucher scheme for SMEs
- My visit to Scotland
- BIA Charity Partnership of the Year deadline
Personalised mRNA cancer vaccine shows Phase 3 progress in melanoma
One of the biggest global life sciences stories this week was the announcement from BIA members Moderna and Merck that their personalised mRNA cancer therapy, intismeran, provided a clinically meaningful improvement in late-stage melanoma trial when used with Keytruda.
This is a strong signal for mRNA technology beyond infectious disease and an important milestone.
The UK clinical work for this trial was also supported by NIHR, whose Industry Hub we continue to back and to whom SMEs should go to see how UK clinical trials can deliver faster, multi-site programmes.
Scancell’s iSCIB1+ melanoma trial gains UK MHRA authorisation
Also in cancer vaccines, BIA member Scancell has received clinical trial authorisation from the MHRA for a Phase 3 registrational trial of iSCIB1+ in advanced melanoma.
The randomised, double-blind, placebo-controlled study is expected to enrol 550 patients with stage III or IV unresectable melanoma across around 90 global sites.
For the UK ecosystem, this is another reminder that regulatory confidence and globally connected trial infrastructure are essential to turning strong science into patient benefit.
HDRS opens roll call for Data Driver Projects
The Health Data Research Service has opened a rolling call for Data Driver Projects. They will offer funding for work that puts existing health data, infrastructure and access routes to use for research, clinical or public benefit by March 2027.
It is well worth a look for members. Life sciences, pharma, health tech and AI companies – including SMEs and start-ups – are all eligible, alone or in consortia, across discovery research, clinical trials, innovation development and evidence generation. The call is uncapped, up to six projects are expected to be funded, although this is indicative, and reporting is deliberately light touch.
The timeline is tight: applications close at 5pm on 2 October, with an earlier assessment cycle which shuts at 5pm on 9 September – these applicants will get earlier decisions and a longer runway to deliver. Full details, the call brief and FAQs are on the HDRS website, or you can contact [email protected].
MHRA clarifies UK pathway for microbiome-based medicinal products
The MHRA also published a UK position paper on microbiome-based medicinal products, setting out that these products can already move through the existing UK medicines regulatory framework.
That clarity is welcome for developers working in an emerging field with potential to address areas of significant unmet clinical need, including antimicrobial resistance.
The message from the regulator is clear: the UK wants developers to engage early, use the available advice routes and bring well-evidenced products forward.
MHRA charging framework provides boost to SMEs
MHRA also published its consultation document on its charging scheme beginning in April 2027.
Notable for our members is a new £2 million voucher scheme for UK SMEs, which will enable those needing vital scientific advice to access MHRAs skills and counsel.
The outcome of these discussions should be higher impact and investible clinical plans. This is a clear sign that the UK is backing its biotechs.
Scotland visit highlights UK biotech innovation and regional strength
On the road in Scotland last week, I saw first-hand the ‘triple-helix’ of industry, NHS and academia in action.
BIA member Nebu~Flow demonstrated how precision dosing technology is being developed to optimise inhaled delivery of small molecules, biologics and complex medicines.
I was with clinical stage member Resolution Therapeutics, which is tackling fibrosis through cell therapy and RoslinCT, which is manufacturing cell therapies across a transatlantic axis on Edinburgh and Boston. I also met TauRx, an Aberdeen-based biotech targeting the global scourge of Alzheimer’s disease
These members are grown from, and supported by the CRDC UK Network, a trio of Scottish universities and Government.
Even the torrential Scottish ‘mist’ made an appearance along the way. All in a great visit which I look forward to repeating soon.
Charity Partnership of the Year deadline 6 September
The deadline for our 2027 Charity Partnership of the Year is fast approaching.
At its heart, the partnership is about strengthening ties between research charities and the life sciences industry, creating space for long-term collaboration, unlocking fresh fundraising opportunities and connecting charities with new audiences and networks. Please apply by 6 September
As the first chills on autumn meet us in the mornings, enjoy your end to this busy summer and get ready for the ‘return to school’ and the September rush. I’ll be back to you with my next blog on 7 September.
