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  • Body Clock Protein Found to Protect the Brain by Boosting Vital Energy Molecule | BioFocus

    < Back Body Clock Protein Found to Protect the Brain by Boosting Vital Energy Molecule Circadian regulator REV-ERBα emerges as a brain-specific controller of NAD+ and tau pathology. A new study has uncovered a surprising, brain-specific mechanism through which the circadian protein REV-ERBα regulates levels of the key metabolic cofactor NAD+, revealing a potential new therapeutic target for Alzheimer’s disease (AD) and related neurodegenerative disorders. Researchers report that REV-ERBα suppresses brain NAD+ levels by promoting expression of the NAD+-consuming enzyme CD38, a mechanism distinct from its previously described role in the heart. In the brain, deleting or inhibiting REV-ERBα increased NAD+ concentrations, improved astrocyte function, and reduced tau accumulation and neurodegeneration in mouse models of tauopathy. The findings, published this week in Nature Neuroscience, redefine how NAD+ metabolism is regulated in the central nervous system and highlight the therapeutic potential of REV-ERBα inhibitors and CD38 blockers for neurodegenerative diseases. Nicotinamide adenine dinucleotide (NAD+) is an essential metabolic cofactor involved in redox balance, DNA repair, and sirtuin-dependent protein deacetylation. Declining NAD+ levels are a hallmark of aging and have been linked to neurodegeneration. While boosting NAD+ has been proposed as a neuroprotective strategy, the molecular control of NAD+ in the brain has remained unclear. REV-ERBα, a nuclear receptor that integrates circadian rhythms with metabolic and inflammatory pathways, was already known to regulate NAD+ in the heart by controlling NAMPT, the rate-limiting enzyme in NAD+ synthesis. In this new work, however, the authors demonstrate that brain REV-ERBα does not affect NAMPT. Instead, it operates through a distinct astrocyte-specific mechanism, repressing the transcription factor NFIL3, which in turn suppresses CD38, the enzyme responsible for NAD+ consumption. Deletion of REV-ERBα, either globally or specifically in astrocytes, increased NAD+ levels in the brain and protected against tau pathology in P301S tauopathy mice, a model of Alzheimer’s disease. Pharmacological inhibition of REV-ERBα with the antagonist SR8278 produced similar neuroprotective effects. Mechanistic studies revealed that elevated NAD+ in astrocytes enhanced lysosomal activity and tau uptake, promoting clearance of toxic tau aggregates. This astrocyte-driven protection occurred without detectable neuroinflammation, suggesting that targeted modulation of REV-ERBα can support protein homeostasis in the aging brain. The data also contrast with previous findings that microglia-specific REV-ERBα deletion worsens tau pathology in male mice, highlighting cell-type- and tissue-specific roles for this nuclear receptor. Overall, the balance of effects, particularly in astrocytes, appears protective when REV-ERBα activity is inhibited. The discovery of a REV-ERBα–NFIL3–CD38 axis that governs NAD+ metabolism in the brain opens multiple translational avenues. REV-ERBα antagonists may provide a means to boost brain NAD+ and mitigate tau accumulation. CD38 inhibitors, already under investigation for metabolic and inflammatory disorders, could gain traction as candidates for neurodegenerative disease modification. The work underscores the importance of cell-type-selective targeting in drug development for circadian and metabolic regulators. The researchers note that while total genetic deletion of REV-ERBα can have deleterious effects during development, partial pharmacological inhibition in adulthood appears to enhance neuroprotection without adverse inflammation. This nuance could guide the design of small-molecule modulators optimized for CNS indications. REV-ERBα’s role in linking circadian regulation, metabolism, and proteostasis positions it as a key node in the biology of aging and neurodegeneration. As lead author notes, “Our results reveal that REV-ERBα functions very differently across tissues, suppressing NAD+ production in the heart, but restraining NAD+ consumption in the brain. Understanding these tissue-specific mechanisms is essential for translating circadian biology into safe, effective therapeutics.” Given the ongoing industrial interest in NAD+ augmentation, circadian modulation, and glial biology, this study provides both mechanistic clarity and new targets for drug discovery programs aimed at Alzheimer’s disease, tauopathies, and age-related brain decline. Author BioFocus Newsroom Previous Next

  • Healthcare Policy: Myeloma UK's Call for Equitable NHS Access to CAR-T Cell Treatment | BioFocus

    < Back Healthcare Policy: Myeloma UK's Call for Equitable NHS Access to CAR-T Cell Treatment Myeloma UK is campaigning to ensure life-changing CAR-T cell therapy is accessible to all myeloma patients, regardless of their ability to pay. In recent weeks, several hospitals in the UK have begun treating myeloma patients privately with CAR-T cell treatment. Myeloma UK , the only organisation in the UK exclusively dedicated to myeloma and related conditions, firmly believes that everyone should be able to access treatment, regardless of the ability to pay. They are committed to working with everyone involved to make CAR-T cell treatment available for people with myeloma on the NHS.  Lifted from their recent blog post published in March 2025, Myeloma UK’s Senior Policy Officer, Amy Capper, explains what CAR-T cell treatment is, and what they’re doing to campaign for equal access. What is CAR-T cell treatment? CAR-T cell (chimeric antigen receptor T cell) treatment uses the body’s immune system to kill myeloma cells. The patient’s own T cells are collected and genetically modified in a laboratory so that they can recognise myeloma cells. The modified T cells are then infused back into the patient and can attack myeloma cells.  What is Myeloma UK doing and why? While the treatment is not yet available for people with myeloma in the UK on the NHS – although there are some clinical trials running – Myeloma UK is fighting hard for access to new life-changing treatments like CAR-T cell treatment.  We’ve joined together with our supporter Jason, who was fortunate to receive CAR-T cell treatment through a clinical trial, to call for the treatment to be made available on the NHS. As part of our work, Jason’s story was featured on the BBC last week. Jason was diagnosed with myeloma in 2014. Over the next nine years, Jason’s cancer returned three times and by spring 2023 he was told he had reached the end of the line. Thankfully, he was one of 11 people selected for a clinical trial in the UK to receive the pioneering new treatment known as cilta-cel (ciltacabtagene autoleucel) (Carvykti™), a type of CAR-T cell treatment. 15 months on, Jason is in remission for the very first time: “Until this treatment, I had never been in remission. Now they’re saying it’s undetectable. I never thought when I was diagnosed more than 10 years ago that I would ever get to this point. It feels surreal after all this time. “There were 11 people in the trial in the whole of the UK and I know other people weren’t as fortunate. “I want to give people hope and put pressure on the system to get this treatment where it needs to be. I am doing really well. It is fair to say I am at my best place since I was diagnosed, I have more energy and no side effects. I’m getting married next year. “It’s a bit of a gamble, you don’t know which treatment is going to work for you. That’s why we need more treatments like this available to people.” Shelagh McKinlay, Director of Research and Advocacy said: “Jason’s story shows just how important it is to have access to innovative treatments for people with myeloma. However, access to these treatments should never be on the ability to pay. That’s why we have joined together with Jason to make the call for CAR-T cell treatments to be made available on the NHS. Until we have a cure, Myeloma UK will continue fighting for all patients to have as many options as possible to keep their cancer at bay.” The specific CAR-T cell treatment that Jason was able to access through the clinical trial, cilta-cel, was initially put forward to be assessed by the National Institute of Health and Care Excellence (NICE) in a bid to make it available on the NHS. But the appraisal was terminated in March 2023 after the NICE drug approval process was halted. The case for approving CAR-T cell treatment in myeloma is challenging because the treatments are complex and difficult to manufacture and the trial data, while very promising, has not been as strong as in some other cancers. Since CAR-T cell treatment trials were first introduced, the UK has had other landmark drug approvals, particularly two new bi-specific antibodies, elranatamab (Elrexfio®) and teclistamab (Tecvayli®). This is great news and means that people living with myeloma have more options to treat their cancer. CAR-T cell treatment still can play a vital role in the treatment pathway and access to it should not be based on ability to pay. What’s next? Over the next few weeks Myeloma UK will be getting in touch with politicians as part of our ongoing campaigns and advocacy work. We will be making the case for improving access to CAR-T cell treatment for everyone that needs it. If you are interested in hearing more then please email policy@myeloma.org.uk and we will keep you updated on this work. FAQs Can I access CAR-T cell treatments now? There are some new clinical trials that are taking place for these types of treatment. You can use our Myeloma Trial Finder to see which clinical trials are open to new patients. We would always recommend that you speak to your healthcare team to discuss the best options for your treatment. Are there other similar types of treatment available for people living with myeloma? CAR-T cell treatment is a type of immunotherapy. Immunotherapies are a group of treatments which harness the patient’s immune system to kill myeloma cells. Although CAR-T cell treatments are only available on the NHS through clinical trials for now, we are now seeing more and more emerging immunotherapy treatments for myeloma. Read more about the different immunotherapies here. In recent years, we have seen approval of monoclonal antibodies like daratumumab (Darzalex®) and isatuximab (Sarclisa®), and last year we helped to make the first bispecific antibodies, elranatamab and teclistamab, available on the NHS. Help get more treatments approved on the NHS - for more information, click here . Author Amy Capper , Senior Policy Offer at Myeloma UK Previous Next

  • Owlstone Medical Wins $49.1M ARPA-H Award for At-Home Multi-Cancer Detection | BioFocus

    < Back Owlstone Medical Wins $49.1M ARPA-H Award for At-Home Multi-Cancer Detection POSEIDON program aims to make low-cost, over-the-counter screening for 30+ cancers a reality across the U.S. Owlstone Medical, a global leader in Breath Biopsy® and early disease detection, has been awarded up to $49.1 million by the Advanced Research Projects Agency for Health (ARPA-H) to spearhead an ambitious effort to transform how cancer is detected. The initiative, known as POSEIDON (Platform Optimizing SynBio for Early Intervention and Detection in Oncology), will develop the world’s first synthetic-sensor-based multi-cancer early detection (MCED) test capable of identifying more than 30 solid tumor types at Stage I, using only breath and urine samples collected at home. The program brings together a powerful consortium including the Massachusetts Institute of Technology (MIT), Boston University, Georgia Tech Research Corporation, Qurin B.V., and Planned Systems International Inc. Revolutionizing Cancer Screening Nearly 40% of Americans will face cancer in their lifetime, yet early-stage detection, when the disease is most treatable, remains a major challenge. Current screening methods are limited to a few cancer types, and many Americans lack access to clinic-based programs. Owlstone’s POSEIDON project aims to change that. The team will use inhaled synthetic sensors that travel through the body and interact specifically with cancer cells, releasing unique DNA or volatile organic compound (VOC) reporters that can be measured from simple urine and breath samples. These samples will be collected using portable, user-friendly devices, either at home or in clinical settings. The results can then be transmitted directly to electronic health records (EHRs), providing clinicians with real-time data and enabling seamless integration into digital health systems. This at-home approach offers multiple advantages: Stage I detection of 30+ solid tumors with high accuracy Non-invasive collection via breath and urine Low-cost manufacturing and deployment, making nationwide access feasible Rapid digital reporting to healthcare professionals If successful, POSEIDON could dramatically reduce late-stage cancer diagnoses, improving survival rates and potentially saving the U.S. economy up to $2.3 trillion in treatment costs and productivity losses. A Bold Vision for Accessible Cancer Care “The field of cancer screening needs a revolution, and POSEIDON stands ready to deliver,” said Ross Uhrich, DMD, MBA, POSEIDON Program Manager at ARPA-H. “This program will create accurate, at-home tests for over 30 cancers—empowering Americans to detect disease early, long before symptoms appear.” Billy Boyle, co-founder and CEO of Owlstone Medical, emphasized the significance of the award: “Access to an accurate, low-cost MCED test that doesn’t require a doctor’s visit or laboratory testing is key to preventing late-stage diagnoses,” Boyle said. “This award validates both breath as a diagnostic approach and Owlstone’s EVOC® probes as a breakthrough technology to overcome the limitations that have held back early cancer detection.” What this means Owlstone’s Breath Biopsy® platform has already attracted global attention for its ability to detect disease biomarkers in exhaled breath. With ARPA-H’s support, the company is now positioned to expand its reach, building a nationwide, accessible, at-home cancer screening solution designed for scale, equity, and impact. If POSEIDON achieves its goals, Americans could soon have access to an over-the-counter, first-in-class multi-cancer test capable of saving millions of lives through earlier diagnosis and treatment. Author BioFocus Newsroom Previous Next

  • Scottish Brain Sciences Opens New Alzheimer’s Clinical Research Centre at ONE BioHub | BioFocus

    < Back Scottish Brain Sciences Opens New Alzheimer’s Clinical Research Centre at ONE BioHub Aberdeen expansion widens access to early-stage trials and strengthens Scotland’s position in global brain health innovation. Scottish Brain Sciences (SBS) has opened a major new Alzheimer’s clinical research centre at ONE BioHub in Aberdeen, expanding access to cutting-edge clinical trials for communities across the north-east of Scotland and accelerating national efforts to detect and treat neurodegenerative conditions earlier. The state-of-the-art site, officially opened on 14 November, becomes SBS’s third research facility, joining its St Andrews hub and Edinburgh headquarters. The Aberdeen centre will support advanced clinical studies in early diagnosis, intervention and precision medicine, bringing world-class research closer to patients who have historically faced long waits and long journeys to participate in trials. By locating within ONE BioHub, a flagship launchpad for high-potential life sciences companies, SBS becomes part of a growing cluster of research-driven organisations, including NovaBiotics and Genomes.io. The move links neurological research directly with clinical, commercial, and translational pathways, reinforcing Scotland’s ambition to position itself as a global leader in brain health innovation. For Professor Craig Ritchie, CEO and Founder of Scottish Brain Sciences, the expansion is as much about equity of access as scientific ambition. “The people of the north-east deserve early access to breakthroughs in brain health and dementia research,” he said. “This new site will help ensure that people here can take part in trials, receive advanced assessments, and contribute to discoveries that could change the future of Alzheimer’s disease. Inviting one of our research participants to officially open this centre reflects our belief that progress begins and ends with the people who volunteer to take part. They are the beating heart of discovery.” That participant was Lynne Carroll, an Aberdeen-based volunteer who spoke candidly about the challenges of obtaining a diagnosis and the importance of local opportunities to engage in research. “It took several years to receive my Alzheimer’s diagnosis, and that is the reality for so many people,” Carroll said. “By being part of research that aims to detect and treat Alzheimer’s earlier, I hope I can help make the path a little clearer for others in the future… When [SBS] shared plans to open a research site in Aberdeen, I was thrilled, as it means I will be able to take part in trials that may require regular visits. It is a privilege to be involved in today’s opening, and I would encourage anyone locally affected by Alzheimer’s to connect with the team.” The opening was also attended by Richard Lochhead MSP, Minister for Business and Employment, who highlighted the significance of the investment for Scotland’s innovation economy and public health landscape. As ONE BioHub’s first tenant, Scottish Brain Sciences’ continued expansion underscores the momentum of Aberdeen’s emerging life sciences cluster. Dr Deborah O’Neil OBE FRSE, Chair of ONE Life Sciences and BioAberdeen Ltd, said: “We are delighted that Scottish Brain Science is expanding at ONE BioHub. Their focus on advancing understanding and treatment of neurological conditions adds important strengths to our growing life sciences cluster. The north east has a vibrant community of life science innovators and it is wonderful to see our first tenant growing and scaling within ONE BioHub.” With Alzheimer’s disease affecting millions worldwide and early-intervention strategies gaining urgency, the new centre positions Scotland at the forefront of developing more precise, earlier, and more accessible approaches to treatment. For patients in the north-east, it represents something more immediate: a chance to contribute directly to discoveries that could change the trajectory of dementia care for generations. Author BioFocus Newsroom Previous Next

  • Qureight Appoints Board to Advance AI Imaging for Pulmonary Hypertension Trials | BioFocus

    < Back Qureight Appoints Board to Advance AI Imaging for Pulmonary Hypertension Trials Cambridge-based imaging CRO brings together seven global experts to guide development of non-invasive AI endpoints. What Is Qureight and Why Does It Matter in Pulmonary Hypertension Research? Qureight, a Cambridge-based imaging contract research organisation (CRO), has established a Scientific Advisory Board (SAB) dedicated to pulmonary hypertension (PH). The seven-member board will provide strategic and scientific input into the development of Qureight's deep learning imaging models, which are designed to generate precision endpoints for use in PH clinical trials. The company operates as an end-to-end imaging solution provider for lung and heart disease, producing regulatory-grade data outputs intended to support therapeutic approval pathways in a disease area with significant unmet clinical need. The Challenge of Monitoring Pulmonary Hypertension Pulmonary hypertension encompasses several serious conditions characterised by elevated pressure in the pulmonary circulation. Diagnosis and monitoring currently rely heavily on invasive right heart catheterisation, which carries procedural burden and limits the frequency with which disease progression or treatment response can be assessed. Non-invasive imaging-derived endpoints have been identified as a priority by clinical trialists seeking to reduce reliance on catheterisation while improving the sensitivity and reproducibility of outcome measures in interventional studies. For sponsors running trials in rare pulmonary vascular diseases, reproducible imaging endpoints could reduce screen failure rates, improve patient stratification, and provide earlier signals of treatment effect compared with traditional haemodynamic measures. How Qureight's AI Imaging Models Work Qureight's approach applies deep learning models to imaging data to generate quantitative markers that can serve as surrogate or supporting endpoints in trials evaluating novel PH therapeutics. The newly formed SAB will inform model development, validate clinical assumptions, and advise on regulatory strategy as the company expands its presence in the PH trial space. The platform aims to provide a reliable, non-invasive alternative to catheterisation-based monitoring, supporting both patient safety and trial efficiency in a space where imaging-based endpoints are increasingly sought by regulators and sponsors alike. Who Is on Qureight's Pulmonary Hypertension Scientific Advisory Board? The board draws on expertise from leading clinical and research centres across Europe and the United States, spanning pulmonary vascular medicine, rare lung disease, and clinical trial design. Marc Humbert (University Paris-Saclay / AP-HP) is Dean of the Faculty of Medicine at the University Paris-Saclay and Director of the French Pulmonary Hypertension Reference Centre. He has built one of the largest PH patient registries globally and devoted his career to deciphering the mechanisms of pulmonary arterial hypertension. Steven Nathan (Inova Fairfax Hospital / Virginia Commonwealth University) is Director of the Advanced Lung Disease and Lung Transplant Program at Inova Fairfax Hospital and a former Chair of the FDA Anesthesiology and Respiratory Therapy Devices Panel. He brings substantial regulatory experience from advisory roles with the US Food and Drug Administration and steering committee involvement in PH and idiopathic pulmonary fibrosis trials. Oksana Shlobin (Inova Fairfax Hospital / Georgetown University) is Medical Director of the Inova Pulmonary Hypertension Program and Associate Professor at Georgetown University School of Medicine, with a focus on clinical programme development and outreach in advanced lung disease. Vincent Cottin (Louis Pradel Hospital / Claude Bernard University Lyon 1) is Professor of Respiratory Medicine and coordinator of the National Reference Centre for Rare Pulmonary Diseases, a centre recognised within the European Reference Center Network for interstitial lung diseases. He brings expertise in rare lung disease and serves on the steering committees of numerous international clinical trials. Ardeschir Ghofrani (University Hospital Giessen and Marburg / Imperial College London) is Deputy Director and Chair of Pulmonary Vascular Medicine at the University Hospital Giessen and Marburg, a Visiting Professor at Imperial College London, and a founding member of the Pulmonary Vascular Research Institute. Joanna Pepke-Zaba (Royal Papworth Hospital / University of Cambridge) is Consultant Chest Physician at Royal Papworth Hospital in Cambridge and Affiliated Associate Professor at the University of Cambridge. She was instrumental in establishing the National Chronic Thromboembolic PH programme in the UK, with research concentrated on chronic thromboembolic PH and idiopathic PAH. Luke Howard (Imperial College Healthcare NHS Trust / Imperial College London) is Consultant Pulmonologist and Lead Clinician in Cardiopulmonary Medicine at Imperial College Healthcare NHS Trust and Professor of Practice at the National Heart and Lung Institute. He specialises in pulmonary vascular disease, pulmonary embolism, and exercise physiology. What This Means for the Future of Pulmonary Hypertension Clinical Trials The formation of a dedicated PH advisory board reflects growing interest across the clinical trials sector in validated, non-invasive imaging biomarkers as both operational and regulatory tools. As the field moves toward more patient-friendly trial designs, AI-derived imaging endpoints represent a potentially significant advance in how disease severity is measured and treatment response is tracked over time. Qureight has not disclosed details of specific ongoing or planned trials it is supporting in the PH indication. Author BioFocus Newsroom Previous Next

  • Lifestyle and Environment Matter More Than Genes in Determining Longevity | BioFocus

    < Back Lifestyle and Environment Matter More Than Genes in Determining Longevity Recent research has revealed that environmental and lifestyle factors play a far greater role in determining health outcomes and longevity than genetic predisposition, casting light on the age old "nature vs. nurture" debate. Recent research has revealed that environmental and lifestyle factors play a far greater role in determining health outcomes and longevity than genetic predisposition. A large-scale study conducted by Oxford Population Health, published in Nature Medicine , examined data from nearly 500,000 participants in the UK Biobank to analyze the effects of 164 environmental exposures and genetic risk scores for 22 major diseases on biological aging and premature death. The results indicate that the impact of lifestyle and environmental conditions significantly outweighs that of inherited genetic traits. One of the key findings of the study is that environmental factors account for approximately 17% of the variation in mortality risk, whereas genetic influences contribute less than 2%. This suggests that while genes play a role in certain health conditions, the choices individuals make regarding their daily habits and the environments they live in have a much stronger influence on overall health and longevity. The research identified 25 major environmental factors that significantly affect mortality and biological aging. Among the most influential were smoking, socioeconomic status, physical activity, and living conditions. Smoking, in particular, was one of the strongest predictors of early death, demonstrating the profound effect of modifiable lifestyle choices on long-term health outcomes. Socioeconomic factors, including education and income levels, were also closely linked to health risks, as they influence access to healthcare, nutrition, and overall well-being. Interestingly, the study also highlighted the long-term effects of early-life exposures on aging and disease risk. Factors such as body weight at age 10 and maternal smoking during pregnancy were found to contribute to accelerated biological aging and increased susceptibility to premature death decades later. These findings emphasize the importance of early-life interventions in shaping long-term health outcomes. When analyzing the impact of environmental and genetic factors on specific diseases, the study found that lifestyle and environmental exposures had a particularly strong influence on diseases of the lung, heart, and liver. In contrast, genetic predisposition played a more dominant role in conditions such as dementia and breast cancer. This differentiation underscores the complexity of disease development and highlights areas where preventive measures can be most effective. To assess biological aging, researchers developed an innovative "aging clock" based on blood protein levels, allowing them to track the rate at which individuals age biologically, rather than simply by chronological years. This tool helped identify environmental exposures that predict early mortality and linked them to the acceleration of biological aging. Professor Cornelia van Duijn, senior author of the study, emphasized the significance of these findings, noting that while genes do influence certain health conditions, there is substantial potential to reduce the risk of chronic diseases through lifestyle and environmental changes. She highlighted the importance of focusing on modifiable factors such as smoking cessation, improved socioeconomic conditions, and increased physical activity to enhance longevity and overall health. These findings reinforce the idea that public health interventions should prioritize environmental and lifestyle factors to prevent age-related diseases and reduce premature mortality. By addressing the key determinants of health, such as socioeconomic disparities and unhealthy lifestyle choices, society can take significant strides in improving life expectancy and reducing the burden of chronic illness. Author BioFocus Newsroom Previous Next

  • Newsletter sign up | BioFocus

    Coming 2024. The BioFocus InFocus newsletter. Sign up now. The BioFocus InFocus Newsletter is coming SOON What to expect? Stay up to date with the BioFocus InFocus newsletter. A collection of carefully curated discussions touching on topics from across the life science space along with targeted key industry updates spanning bioprocessing, pharma, and biotech. Issue 1 launching in 2024. Sign up now. Sign up Sign up to receive the first word when we go live. First name Last name Email Country I acknowledge and agree to the use of my contact information to receive messages about offerings by BioFocus, its brands, affiliates and/or third-party partners, consistent with the BioFocus Privacy Policy View privacy policy. Submit Thanks for submitting!

  • Pharma and Biotech Quality Summit | BioFocus

    < Back 12th – 13th May, 2026 Munich, Germany Pharma and Biotech Quality Summit Explore how quality functions are evolving into strategic, risk-based and digitally enabled systems in response to increasing regulatory complexity and innovation in pharmaceuticals and biotechnology. The Pharma & Biotech Quality Summit 2026 , hosted by Fleming Pharma and Biotech Events, will take place on 12–13 May in Munich, bringing together senior quality and compliance professionals from across the European pharmaceutical and biotechnology sectors. The event focuses on how quality functions are evolving in response to increasing regulatory expectations, digital transformation, and the growing complexity of modern therapies. Key topics include risk-based quality management, Annex 1 implementation and contamination control strategies, AI-enabled quality systems, and maintaining data integrity in highly regulated environments. Designed for decision-makers and technical leaders, the two-day programme features keynote presentations, case studies, panel discussions, and interactive workshops. Attendees will hear from experts representing leading organisations such as Pfizer, Novo Nordisk, and Takeda Pharmaceutical Company, alongside regulatory perspectives from the Medicines and Healthcare products Regulatory Agency and the International Society for Pharmaceutical Engineering. With a strong emphasis on practical application and peer-to-peer exchange, the summit offers valuable insights for those looking to strengthen quality systems and ensure continuous inspection readiness. Previous Register now Next

  • AI, Forecasting, Insights and Analytics for Smarter Decisions in Pharma

    Advance forecasting, AI and analytics to drive strategic commercial decision-making across functions in Pharma. < Back AI, Forecasting, Insights and Analytics for Smarter Decisions in Pharma Advance forecasting, AI and analytics to drive strategic commercial decision-making across functions in Pharma. Forecasting, insights and analytics is a strategic decision-making function within global product strategy and commercial departments in pharmaceutical companies. Unlike operational or sales-focused functions, these teams are responsible for maintaining objectivity in long-term forecasting accuracy and commercial planning for pharma products. This conference will explore how pharma organizations are using advanced analytics, AI and Real-World-Evidence to improve forecasting assumptions, support lifecycle management and drive better strategic decisions. By strengthening forecasting and analytics capabilities, pharma companies can stay ahead of competitors, identify growth opportunities and optimize commercial performance across evolving markets. The Marcus Evans AI, Forecasting, Insights and Analytics for Smarter Decisions in Pharma conference will explore how pharma leaders are embedding Gen AI for long-term forecasting, Agentic AI for Real-World-Evidence generation and advanced analytics into cross-functional workflows to improve forecasting confidence, commercial responsiveness and long-term strategic planning while maintaining strong data and AI governance. Learn from case studies, expert-led panels, roundtable discussions and interactive workshops on Gen AI-powered forecasting, AI-enabled commercial workflows, rare disease forecasting, lifecycle forecasting and strategic decision-making across evolving therapy markets. Whether you are looking to strengthen forecasting assumptions, accelerate AI adoption, improve launch planning or drive more informed commercial decisions, this event will deliver practical insights and actionable strategies from senior forecasting, analytics and AI leaders across pharma. Topics Covered: Drive strategic decision-making through forecasting, scenario planning, and market intelligence Shift from Forecasting to Foresight with Agentic AI and Real-World Evidence to Prepare for Multiple Futures Advance rare disease forecasting through integrated data and patient-centric insights Build forecasting agility in volatile and high-growth therapy markets Maximize forecasting confidence through healthcare data governance and analytical integrity Structure enterprise AI, forecasting and analytics functions through shared governance and operating models Best Practices and Case Studies from: Philippe Barillon , Executive Director, Strategic Intelligence & Business Impact, Global Corporate Affairs, Novartis Alireza Moayyeri, Senior Director, RWE Global, UCB Paul Boutry, Head of Strategic Planning & Analytics, BioMarin Gerardo Martinez, Senior Director, Global Market Access – Pipeline (Immunology & Rare Diseases), CSL Christopher Meyer, Head of Strategy & Operational Excellence, Ferring Pharmaceuticals Peter Elsig Raun, Director, Commercial Leadership Office and Projects, Lundbeck Special discounts available to BioFocus UK members! For more information please contact: Stefanos Ioannou, Digital Media and PR Executive at stefanosi@marcusevanscy.com or visit: https://tinyurl.com/2s42sd5m Author BioFocus Newsroom Previous Next

  • Patient Assistance & Access Programs | BioFocus

    < Back LIVX 2026 8th – 10th December, 2026 Dubai, UAE Hosting the most powerful global ecosystem for longevity, biotech, and investment. ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us. Previous Next

  • Sartorius Expands Drug Discovery and Biomanufacturing Deal with NVIDIA

    Sartorius, a leading life sciences and bioprocessing company, has expanded its collaboration with NVIDIA, a pioneer in AI-powered computing. < Back Sartorius Expands Drug Discovery and Biomanufacturing Deal with NVIDIA Sartorius, a leading life sciences and bioprocessing company, has expanded its collaboration with NVIDIA, a pioneer in AI-powered computing. Sartorius, a leading life sciences and bioprocessing company, has expanded its collaboration with NVIDIA, a pioneer in AI-powered computing. This partnership aims to leverage AI technology to enhance drug discovery and biomanufacturing processes. The collaboration Since 2020, Sartorius has integrated NVIDIA’s technology into its instruments, enhancing live-cell imaging and AI assays. The collaboration focuses on developing predictive AI models, particularly for stem cell-derived organoids, to replace animal models in drug discovery and precision medicine. Expansion highlights NVIDIA Clara Suite: Sartorius will increase the use of NVIDIA Clara's AI-powered computing platforms and services. Predictive Models: New predictive AI models, tools, and simulations will be developed for various applications, available through the NVIDIA Clara suite and DGX platform. Advanced Technologies: The partnership will explore 3D-bioprinted spheroids, organoids, and synthetic biological pathways designed with Sartorius cell lines to create novel therapies. Impact on bioprocessing The expanded partnership aims to simplify and accelerate biopharma drug discovery and manufacturing, promising technological innovations that benefit both Sartorius customers and patients. Sartorius and NVIDIA’s enhanced collaboration signifies a step forward in integrating AI with life sciences, potentially revolutionizing drug discovery and biomanufacturing by providing advanced predictive tools and improving efficiency and product quality in the biotech industry. Author BioFocus Newsroom Previous Next

  • World-First Preventative Lung Cancer Vaccine Enters Clinical Trial

    A groundbreaking clinical trial set to begin in summer 2026 will test LungVax, the world’s first vaccine designed to prevent lung cancer in people at high risk, a major milestone in cancer prevention research. < Back World-First Preventative Lung Cancer Vaccine Enters Clinical Trial A groundbreaking clinical trial set to begin in summer 2026 will test LungVax, the world’s first vaccine designed to prevent lung cancer in people at high risk, a major milestone in cancer prevention research. Developed by researchers at the University of Oxford and University College London, and backed by Cancer Research UK and the CRIS Cancer Foundation, LungVax aims to prime the immune system to detect and destroy abnormal lung cells before they turn cancerous. “Lung cancer is lethal and blights far too many lives. Survival has been stubbornly poor for decades. LungVax is our chance to do something to actively prevent this disease,” said Professor Sarah Blagden, co-founder of the LungVax project. How LungVax Works LungVax uses a viral vector technology based on the same platform that powered the Oxford/AstraZeneca COVID-19 vaccine. It delivers genetic instructions to the immune system so it can recognise “red-flag” proteins (neoantigens) on the surface of early abnormal lung cells, marking them for the immune system to destroy. The Phase I trial will focus on individuals at particularly high risk, including patients who have had early-stage non-small cell lung cancer removed, as well as people currently enrolled in NHS England’s targeted lung health checks. Trial Design and Scope The Oncology Clinical Trials Office (OCTO) at Oxford will run the trial. It is designed as a dose-escalation Phase I, followed by a Phase II “precision-prevention” part. The total planned enrollment is 590 patients: 30 in Phase I and 560 in Phase II (280 per arm). The primary goals are to assess safety, determine optimal dosing, and evaluate whether the immune response can be effectively triggered. “Fewer than 10% of people with lung cancer survive their disease for 10 years or more. That must change, and that change will come from targeting lung cancer at the earliest stages,” said Professor Mariam Jamal-Hanjani, trial lead from UCL. Why This Matters Lung cancer remains the UK’s deadliest cancer by survival rate, and early detection continues to be a major challenge. By training the immune system to identify and eliminate abnormal lung cells early, before full-blown cancer develops, LungVax represents a paradigm shift in primary prevention. The vaccine does not replace existing public health measures: smoking cessation remains the most effective way to reduce lung cancer risk. But LungVax could offer a completely new layer of protection for those most vulnerable, especially as part of broader screening programmes. Backing and Future Prospects Cancer Research UK has awarded up to £2.06 million to support the four-year Phase I trial. Michelle Mitchell, Chief Executive of Cancer Research UK, emphasised the long-term vision: “By supporting the LungVax clinical trial, we will put the vaccine through the most rigorous scientific tests and take that important first step towards a world where people live longer, better lives, free from the fear of lung cancer.” The program also builds on a larger GSK-Oxford immuno-prevention partnership, which launched in early 2025, with a £50 million investment in pre-cancer vaccine research. LungVax could redefine how we approach lung cancer prevention, shifting the paradigm from reacting to disease to preventing it altogether. If the trial proves successful, this could become a powerful tool for reducing lung cancer incidence in high-risk populations. Author BioFocus Newsroom Previous Next

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