CEO Update - 30 June 2025
Upcoming and expected soon are:
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Life Science Sector Plan
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10-Year Health Plan
And no, I’m not just going to put the lot into ChatGPT, serious sunlounger time on all of them will be spent, as they form the backbone of government policy for our sector for the parliament over the next three years. If you have spotted anything that you think we should bring to the sector’s attention, do please drop me a line. What’s important here is that the government has set an ambitious agenda for growth and our sector is at the heart of it – and although the blizzard of plans seems daunting, what it shows is that our sector is taken seriously and valued.
MHRA sets out new priorities and targets in 2025-2026 business plan
Hidden beneath this announcement blitz, last week, the MHRA published its business plan for 2025–26, setting out the agency’s priorities under the leadership of new CEO Lawrence Tallon, including modernising the UK’s regulatory framework for medicines and medical devices, and closer collaboration with NICE to enable concurrent approvals. The plan includes a commitment to work with NHS and HTA bodies to develop a streamlined UK ‘Innovation Gateway’ to provide rapid and continuous support and assessment of the most transformative medicines and devices. I also welcome the MHRA’s plans to design a new framework to improve the regulation of therapies for rare diseases, including platform-based approaches to help streamline approvals. The business plan builds on the strategic direction which Lawrence set out during his recent trip to the US to attend BIO and DIA Global, where he set an ambition for the MHRA to become “a global leader in risk-proportionate regulation”. The BIA’s Regulatory Affairs Advisory Committee (RAAC) is working closely with the MHRA leadership team to support the delivery of these plans, and our Future of Regulation Conference on 6 November will provide an opportunity to hear directly from the MHRA top team about their plans and the progress they are making. You can register for the conference here.
Whole genome sequencing to be rolled out to all newborns
It has been exciting to read reports that the Government’s 10-year health plan will introduce whole genome sequencing for all newborns, building on Genomics England’s 100,000 Genomes Project. This is a revolutionary step and one which will position the UK at the forefront of R&D into rare diseases and precision medicine, improving access to new treatments and transforming patient care. We look forward to working with the government, the NHS, and our members working in rare diseases and genomics to make this plan a reality.
New Rare disease drug from BIA member brings hope on the BBC
It’s always pleasing to see positive stories when patients get access to novel medicines and last week this story on the BBC was a case in point. It was about an NHS patient getting BIA member Pharming’s rare disease drug Joenja, although the coverage didn’t mention the company or focus on the fact that clinical trials had been done here. From a sector perspective, this went through final NICE recommendation in March under NICE’s Highly Specialised Technologies (HST) pathway and received interim funding in England through the Innovative Medicines Fund, ensuring rapid patient access with weeks of approval. Really good to see a policy process deliver at pace on access.
Thanks for great life science leaders summit
Thanks to all who came to the BIA Life Science Leaders Summit in Hertfordshire last week. I found the discussions insightful and was delighted to see the peer-to-peer problem-solving happening throughout the event. Particular thanks to Harpul Kumar and Helen Rowntree for a thought-provoking fireside chat on the future of diagnostics in the coming years.
Get your tickets for the summer party
The BIA’s legendary Summer Party is only a little over a week away, so now is your last chance to get tickets for the UK’s premier summer life science networking event. Catch up with all those excited by the new investment we are seeing from the British Business Bank, and find out at first hand which of the biggest players are looking to access innovation from the UK ecosystem, whilst meeting the new young companies and key stakeholders that make our ecosystem so connected and vibrant. I look forward to welcoming you there.