Latest news with #LawrenceTallon
Telegraph
02-08-2025
- Health
- Telegraph
World first as life-saving cancer drugs to be mixed at patients' bedsides
Cancer patients will get personalised drugs made at their bedside under new laws, The Telegraph can reveal. The UK is the first country in the world to relax the strict manufacturing rules that cause delays to time-sensitive treatments. An increasing number of new medicines, including for cancer and rare genetic disorders, involve creating a bespoke drug for each patient by collecting their cells and modifying them in a laboratory, before they are injected back into the patient. But because the samples have to be taken and edited in specialist facilities – often hundreds of miles away – patients are too often facing delays. They may become too unwell to receive the drug, or the medicine itself may not survive the journey because of its short shelf-life. From now, the last of these steps can be completed closer to the patient, reducing the time it takes to produce a life-saving treatment from months to just days, the medical regulator said. 'Flexible, responsive system' The new laws, introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), will mean the drugs can be manufactured where the patient is – and given to them in hospital or their own homes. Writing in The Telegraph, Lawrence Tallon, the new chief executive of the MHRA, said it was about creating 'a more flexible, responsive system that meets the needs of modern medicine' rather than forcing 'the medicine to fit an outdated system'. 'Some of these advanced therapies are made using a person's own cells. Others are built around their genetic code. A few are so sensitive they can't be frozen or stored – they have to be given to the patient within mere minutes of being made. That's a world away from how medicines are typically mass-made and distributed today,' he said. 'In these cases, delays can be critical. Some patients have become too unwell to receive their treatment in time. In others, the medicine simply didn't survive the journey.' He added: 'Hospitals can now carry out the final steps of manufacturing on-site – under the same strict standards, but far more quickly. 'That means a cancer patient could now have their immune cells collected, modified, and returned at the same hospital. A child with a rare genetic disorder can receive a therapy made at their bedside.' 'Personalised therapies' Mobile units will also be deployed to finish the manufacturing of the drugs for patients who are too sick to leave their homes or need to limit hospital visits because of weakened immune systems. The MHRA said the move mirrored how chemotherapy and antibiotics are prepared locally, but stressed that there would still be strict safeguards and regulatory protocols. There will also be a 'central control site' that will oversee the personalised therapies being completed in hospitals. Wes Streeting, the Health Secretary, said it was a 'game-changer'. 'Cancer treatments tailored in days, not months. Life-saving therapies made at your bedside, not hundreds of miles away,' he said. 'Our Plan for Change promised to build an NHS fit for the future. Today we're delivering on that pledge by bringing cutting-edge care directly to patients when they need it most. 'This type of therapy means patients can be treated and return home more quickly.' One example of a personalised treatment that is set to become more accessible for patients is CAR-T cancer therapy. It involves genetically modifying a blood cancer patients' immune cells so that the immune system recognises and kills the cancer cells that would otherwise go undetected by the body and continue to spread. Previously, hospitals were only able to offer these treatments through complicated, one-off arrangements. The changes have already come into effect after the legislation, known as The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, was passed last month. It covers a range of innovations, including cell and gene therapies, tissue-engineered treatments, 3D printed products, blood products, and medicinal gases. Lord Vallance, the science minister and Government's former chief scientific officer, said the 'world-first framework gives the NHS and innovators a clear, safe way to bring advanced treatments from the lab to the patient's bedside'. 'It's a powerful example of how smart regulation can help more patients benefit from the best of British science.' 'Modern medicine needs a modern delivery system' By Lawrence Tallon For most medicines, the system works well enough. Medicines are made in bulk, boxed up, and shipped off to where they're needed in the world. It's how care has been delivered for decades. But a new generation of personalised therapies is beginning to challenge that model – and unless we adapt, patients could miss out. Some of these advanced therapies are made using a person's own cells. Others are built around their genetic code. A few are so sensitive they can't be frozen or stored – they have to be given to the patient within mere minutes of being made. That's a world away from how medicines are typically mass-made and distributed today. In these cases, delays can be critical. Some patients have become too unwell to receive their treatment in time. In others, the medicine simply didn't survive the journey. We need a more flexible, responsive system that meets the needs of modern medicine, not force the medicine to fit an outdated system. That's why this week, the UK became the first country in the world to introduce a new legal framework that allows these advanced medicines to be made at the point of care. Under new regulations introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), hospitals can now carry out the final steps of manufacturing on-site – under the same strict standards, but far more quickly. That means a cancer patient could now have their immune cells collected, modified and returned at the same hospital. A child with a rare genetic disorder can receive a therapy made at their bedside. No more shipping cells hundreds of miles away and hoping they survive the journey back. It also offers a safer alternative for people too unwell to travel, or whose immune systems make hospital visits risky. 'Supporting early access to promising treatments' This is part of a wider effort to modernise the way we support innovation in the UK. We've shortened the time it takes to approve clinical trials to 40 days. We've introduced new routes for authorising medicines already approved by trusted international regulators. And where the evidence is strong and the need is urgent, we support early access to promising treatments. We're paying particular attention to rare diseases, where patients often face the longest waits for new treatments. While each condition may affect only a few people, the overall impact is large: around 3.5 million people in the UK, and an estimated 300 million globally, live with a rare condition. Yet developing treatments is often more difficult, with fewer clinical trial participants and less commercial return. That's why we're offering targeted support. For companies working on rare disease therapies, we've reduced or waived fees and increased access to expert scientific advice. The aim is to make it simpler and more affordable to bring forward safe treatments where there is high need and few other options. We're also supporting smarter ways to generate evidence. For very rare conditions, large-scale trials aren't always possible. We're working with researchers to use high-quality real-world data, like NHS records and patient registries, so that safe and effective treatments aren't held back for lack of traditional trial data. Medical innovation doesn't end with discovery or what's in the vial. It's also about tackling the barriers that stop new treatments reaching patients. That means creating a safe system built for tomorrow's medicines – especially for people with the fewest options – whether by changing how they're approved, how trials are run, or how evidence is gathered. After all, a life-changing treatment only matters because we can deliver it when and where the person needs it.
Yahoo
16-07-2025
- Business
- Yahoo
UK government targets manufacturing as it eyes £41bn life science sector growth
The UK Government will enhance manufacturing and commercialisation as it looks to harness the value of the life sciences sector for the country's economy. In a new Life Sciences sector plan, the government outlined a six-point action plan to ensure the sector reaches its forecasted value increase of £41bn, representing a growth of 165% by 2035. The government is aiming to make the UK the leading life sciences economy in Europe, and third largest in the world behind only America and China. While excelling at research and development (R&D), the report outlines difficulties with commercialisation and adoption. For example, despite being the first country to approve a CRISPR-based medicine, Vertex and CRISPR Therapeutics' Casgevy for sickle cell anaemia is primarily commercialised overseas. In a bid to scale industry, the government has pledged £520m to improve life science manufacturing. Outlaid via the Life Sciences Innovative Manufacturing Fund (LSMIF), the investment will aim to expand the UK's manufacturing capabilities and supply chain security. The initiative comes at a crucial time, as British pharmaceutical companies are significantly increasing their investments in the United States. GSK invested $800m in drug substance and drug product manufacturing facilities in the US in October 2024. AstraZeneca – which has a market cap of £162bn – is reportedly plotting a move of its public listing to the US stock exchange in what would be a major blow to the UK economy. To facilitate the industry's expansion, the government will look to increase access to scale-up capital. There has been a cautious domestic investor base, leading to a lull in emerging companies with high economic outputs. The government will measure investment by the number of UK life science companies with a valuation of over £10bn, the number of companies on the FTSE 300, and the number of initial public offerings (IPOs) in the sector. From a regulatory standpoint, the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute of Care and Excellence (NICE) will be supported to provide faster approvals and more efficient reimbursement. Optimism and criticism for UK life sciences MHRA's chief executive Lawrence Tallon welcomed the news, saying: 'It's great to see the MHRA is recognised as a pivotal partner in delivering the plan's vision - by supporting innovation, protecting public health, and making the UK a global destination for innovators to research, develop and launch cutting-edge medical products.' David Stockdale, chief executive of the British Healthcare Trades Association (BHTA) highlighted the importance of reducing regulatory and financial barriers to accelerate faster delivery of innovative MedTech solutions to patients. "We welcome today's announcement which rightly aims to make the UK a leading hub for investment and innovation in lifesaving MedTech, an essential step if we are to improve patient care and cut down waiting times. We particularly welcome the renewed commitments to the Life Sciences Innovative Manufacturing Fund and the NHS Innovator Passports. Our members are eager to deliver their innovative products and services to patients more quickly and efficiently, and we look forward to working with the Government to make this a reality. Clinical trials are set to benefit from the plan, with a new 150 day or lower target for trial set up times. Finally, up to £600m will be put towards an artificial intelligence (AI)-ready health data platform, a strategy already launched in April 2025. The BioIndustry Association (BIA) said: 'The life science sector plan is right to focus on getting substantially more public and private investment in early-stage companies, improved access to data, trials and skills to help companies grow, and more streamlined regulation and market access pathways to get innovative medicines to NHS patients.' However, the Association of the British Pharmaceutical Industry (ABPI) commented that the plan falls short of investing in innovative medicines. Richard Torbett, Chief Executive of the ABPI, said: [The UK life sciences sector] has been struggling to remain competitive and attractive to investment. The solutions proposed are necessary and important, but they are not enough to turn around the UK's decline. 'The UK must address the core issue holding back the life sciences sector, the long-term disinvestment in innovative medicines that is increasingly preventing NHS patients from accessing medications that are available in other countries.' The life science sector plan comes hot on the heels of the 10-year health plan unveiled for the NHS earlier this month, which placed emphasis on technology and digitalisation. "UK government targets manufacturing as it eyes £41bn life science sector growth" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
05-06-2025
- Business
- Yahoo
Medicines watchdog to open 'digital hub' in city
The UK's drug safety watchdog is to open a new "digital hub" in West Yorkshire. The site, to be located in Leeds city centre, would focus on digital delivery, software development and data science, according to the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA regulates new medicines, healthcare products and healthcare technologies for patients to use. Lawrence Tallon, MHRA chief executive, said opening the new site in the city was aimed at "strengthening our ability to collaborate with partners across the north of England". There had been a "huge growth" in healthcare technologies driven by changes in software and AI which were going to revolutionise the way the NHS worked, and the new Leeds hub would help regulate those technologies, Mr Tallon said. Leeds was chosen for the new hub as it was home to over 44,000 tech professionals and about 11,000 students studying tech-related subjects, according to the MHRA. The hub, in Wellington Place, would also serve as a base for the digital operations of NHS England, with increasing investment from major tech companies, an MHRA spokesperson said. About 30 permanent, highly-skilled roles would initially be recruited to work at the new centre in the city, they added. Wes Streeting, secretary of state for health and social care, said: "There is a global tech revolution in healthcare unfolding, and Yorkshire will help our country lead it. "This isn't just about creating new jobs across the region, it's also about bolstering a city that's already leading the way in digital health." Mr Tallon said that by establishing an MHRA digital hub in Leeds, "we're strengthening our ability to collaborate with partners across the north of England – bringing regulatory expertise closer to the people, organisations and innovations we serve". Meanwhile, he said Leeds was "buzzing, thriving, an exciting place". "We are really excited about create new jobs within our organisation right in the heart of Leeds," Mr Tallon added. Fiona Venner, Leeds City Council's executive member for equality, health and wellbeing, said the MHRA's announcement of the plan for a digital hub was "welcome". "Leeds is already a centre for digital health and innovation and this rapidly growing market contributes significantly to the economy," she said. "The hub will support the creation of jobs and provide career opportunities for local graduates and professionals." Listen to highlights from West Yorkshire on BBC Sounds, catch up with the latest episode of Look North. Indian tech firm to create 1,000 jobs in city Sky to create up to 400 jobs in city Medicines and Healthcare products Regulatory Agency NHS England
BBC News
05-06-2025
- Business
- BBC News
Medicines watchdog to open 'digital hub' in Leeds city centre
The UK's drug safety watchdog is to open a new "digital hub" in West Yorkshire. The site, to be located in Leeds city centre, would focus on digital delivery, software development and data science, according to the Medicines and Healthcare products Regulatory Agency (MHRA).The MHRA regulates new medicines, healthcare products and healthcare technologies for patients to Tallon, MHRA chief executive, said opening the new site in the city was aimed at "strengthening our ability to collaborate with partners across the north of England". There had been a "huge growth" in healthcare technologies driven by changes in software and AI which were going to revolutionise the way the NHS worked, and the new Leeds hub would help regulate those technologies, Mr Tallon was chosen for the new hub as it was home to over 44,000 tech professionals and about 11,000 students studying tech-related subjects, according to the hub, in Wellington Place, would also serve as a base for the digital operations of NHS England, with increasing investment from major tech companies, an MHRA spokesperson 30 permanent, highly-skilled roles would initially be recruited to work at the new centre in the city, they added. 'City leading way' Wes Streeting, secretary of state for health and social care, said: "There is a global tech revolution in healthcare unfolding, and Yorkshire will help our country lead it. "This isn't just about creating new jobs across the region, it's also about bolstering a city that's already leading the way in digital health."Mr Tallon said that by establishing an MHRA digital hub in Leeds, "we're strengthening our ability to collaborate with partners across the north of England – bringing regulatory expertise closer to the people, organisations and innovations we serve".Meanwhile, he said Leeds was "buzzing, thriving, an exciting place"."We are really excited about create new jobs within our organisation right in the heart of Leeds," Mr Tallon Venner, Leeds City Council's executive member for equality, health and wellbeing, said the MHRA's announcement of the plan for a digital hub was "welcome"."Leeds is already a centre for digital health and innovation and this rapidly growing market contributes significantly to the economy," she said."The hub will support the creation of jobs and provide career opportunities for local graduates and professionals." Listen to highlights from West Yorkshire on BBC Sounds, catch up with the latest episode of Look North.
Yahoo
20-05-2025
- Health
- Yahoo
UK clinical trial sector progress ‘remarkable', says former health minister
The progress the UK has made as a global contributor to clinical trials is 'remarkable', says Lord James O'Shaughnessy, former health minister and author of the landmark report into the domestic commercial clinical trials sector. Two years on from the publication of his review, and on Clinical Trials Day (20 May), O'Shaughnessy said that the Medicines and Healthcare products Regulatory Agency (MHRA) is once again taking a global lead. 'The progress the MHRA has made in the two years since I published my review has been remarkable. Despite its global reputation for excellence, by 2023, trial approval set-up times had slipped badly,' O'Shaughnessy said. 'The MHRA is now delivering consistently good approval times while introducing further reforms to add speed and flexibility to the process. With a clear mandate from the prime minister to reduce trial set-up times to 150 days, which would be genuinely world-leading, the MHRA is once again taking a global lead.' Lord O'Shaughnessy became a well-known name in the clinical trial sector after his review was published in May 2023. The review made 27 recommendations where action should be taken by the government and delivery partners, including the MHRA, to address key challenges and transform the UK's commercial clinical trials environment. MHRA chief executive Lawrence Tallon also reflected on the new regulations by the agency, which help to create patient-centric trials and provide a faster and more streamlined approval system. Tallon said: 'The UK is already a research powerhouse driven by innovation, with one in eight trials in the UK testing treatments in humans for the first time. "But we want to go further. Last month, we began implementing the most significant update to UK clinical trials regulation in over two decades. These reforms will address the research sector's need for a more risk-proportionate regulatory framework for clinical trials and will help get cutting-edge new treatments to the NHS as quickly as possible.' Last month, the MHRA placed the UK as a global leader in clinical trials once again following a collaborative report with the University of Liverpool, which was published in the British Journal of Clinical Pharmacology. On top of April's regulation, which was first announced in December 2024, the MHRA is launching a six-week consultation on the use of real-world data (RWD) for external control arms of clinical trials, which has the potential to help accelerate the approval of treatments, especially when randomised controlled trials may not be ethical or feasible. The new guidance is for those planning a clinical trial that may include an RWD external control arm to support a regulatory decision on a medical product. In April 2025, the UK Government announced it would invest £600m ($764m) into a new Health Data Research Service to support researchers. The investment will provide researchers with a secure access point to national datasets to be used in research. The regulation implemented last month should reduce unnecessary administrative burdens on trial sponsors without compromising patient safety. They are also designed to protect trial participants, facilitate the development of new medicines, remove obstacles to innovation, and ensure that legislation enables trial sponsors to work across countries. The legislation is part of a broader overhaul by the MHRA, supported by health system partners including the Health Research Authority (HRA), academia and researchers. The new regulations will be accompanied by guidance from the MHRA and HRA to embed meaningful public involvement in clinical trials and increase participant diversity. The regulatory bodies hope this will demonstrate the UK's potential as a research base that can improve care and minimise health inequalities. The MHRA has also improved its processing of clinical trial applications, with 100% of clinical trials and investigations applications having been handled within statutory timescales since September 2023. "UK clinical trial sector progress 'remarkable', says former health minister" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
