Sovato’s new CEO explains the plan to scale telesurgery and take it worldwide

Now leading Sovato as the telesurgery software startup’s CEO, former Intuitive EVP and Chief Digital Officer Brian Miller sees a big opportunity to realize the full potential of remote medical procedures. In a Medical Design & Outsourcing interview ahead of the announcement that he’s joined Sovato, Miller — who joined Sovato co-founder Yulun Wang’s Computer…

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FDA warns resin change may have caused tubing danger

A tubing material change appears to be the cause of a potentially serious problem with B. Braun hemodialysis bloodline sets that the manufacturer and FDA are warning about. The FDA said B. Braun sent an urgent medical device correction to customers about its Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines and recommended the…

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Zeus adds catheter components to Chamfr marketplace

NEWS RELEASE: Zeus expands access to catheter components through Chamfr marketplace Over 100 Zeus liner and heat shrink components will now be available to engineers through Chamfr’s online marketplace to accelerate medical device development. ORANGEBURG, S.C. — Zeus, a global leader in advanced polymer solutions and catheter manufacturing, announced a partnership with Chamfr to make…

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Bodycote plans to open a new heat treatment facility in Mexico

Bodycote plans to open a new heat treatment facility near Monterrey in Apodaca, Mexico, this year to increase local processing capacity and improve regional support as manufacturing activity continues to grow. London-based Bodycote provides heat treatment and specialist thermal processing services for the medical device industry and other industrial sectors. The planned facility in Apodaca…

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Evaluation of a Parent Multimedia and Mobile-Based Intervention to Promote Pediatric Oral Health (BeReadyToSmile): Single-Group Pre-Post Feasibility Study

Background: The universal adoption of mobile technologies by households has created an opportunity to provide families with young children with access to high-quality oral health information at convenient times and locations. Using community agencies (eg, Head Start and public health programs) that offer parenting education is an effective approach to reaching families in low-income households. Objective: This study aimed to explore the extent to which a coordinated, in-person oral health prevention intervention, together with an accompanying smartphone app, BeReadyToSmile, is feasible to implement among caregivers of young children. Methods: The BeReadyToSmile program targeted parents of children aged 0 to 6 years attending parenting education classes. This study was designed as a single-group pre-post feasibility study that included quantitative surveys and open-ended feedback. A total of 30 parents attended an in-person session on child oral health and were invited to use the BeReadyToSmile smartphone app. Preintervention and postintervention surveys were administered to assess pediatric oral health knowledge, attitudes toward child toothbrushing, brushing intention, brushing efficacy, program satisfaction, and ease of use. Results: Significant effects were observed on parent-reported pediatric oral health knowledge, attitudes toward brushing, brushing intention, and toothbrushing efficacy. Out of the 30 parents invited to use the BeReadyToSmile app, 1 (3%) completed no sessions and 20 (67%) completed all sessions. Participants rated the app highly on measures of satisfaction and use. We found significant increases in pediatric oral health knowledge (.004), child brushing attitudes and intention (=.01), and parental efficacy regarding child toothbrushing (=.03). Conclusions: Caregivers reported positive experiences with the implementation of BeReadyToSmile, indicating the overall feasibility of delivering oral health prevention to households with young children both in person and through a facilitated smartphone app. Further studies should include a larger and more diverse sample, randomized comparison conditions, and a longer follow-up period to assess outcomes. Trial Registration: ClinicalTrials.gov NCT03637309;
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Assessment of Telemedicine Perceptions, Usability, and Implementation Barriers Among Physicians in Kazakhstan Using the Telehealth Usability Questionnaire-Model for Assessment of Telemedicine-Kazakhstan Version (TUQ-MAST-KZ) Questionnaire: Pilot Cross-Sectional Survey Study

Background: Health care professionals’ perceptions of telemedicine, its usability, and the presence of organizational barriers are important determinants of the successful implementation of digital solutions in health care. In Kazakhstan, the use of international assessment instruments requires contextual adaptation. The Telehealth Usability Questionnaire-Model for Assessment of Telemedicine-Kazakhstan version (TUQ-MAST-KZ) questionnaire was previously developed and psychometrically validated by integrating elements of the TUQ and MAST frameworks to assess perceptions of telemedicine within the national context. Objective: The aim of this study was to conduct the first pilot application of the TUQ-MAST-KZ questionnaire with physicians in Kazakhstan and perform an initial assessment of the organizational, technical, and educational aspects of telemedicine implementation. Methods: This cross-sectional study involved an anonymous online survey using the TUQ-MAST-KZ questionnaire, which covers perceptions of telemedicine, formats of use, platform usability, communication-related aspects, telemonitoring, organizational conditions, and implementation barriers. Responses from 156 physicians were analyzed. Stratified nonparametric comparisons were performed by sex, age group, work experience (years), and workplace, adjusted for multiple comparisons. Results: The most used telemedicine formats were telephone consultations (78/156, 50%), video consultations (69/156, 44.2%), chats and messaging applications (57/156, 36.5%), and mobile apps (48/156, 30.8%). The Kazakhstan National Telemedicine Network was used by 14.7% (23/156). Wearable devices were used by 5.8% (9/156). Telemedicine technologies incorporating artificial intelligence elements were used regularly by 13.5% (21/156) and occasionally by 32.1% (50/156) and not used by 50.6% (79/156). Positive ratings were as follows: 48.7% (76/156) regarding the simplicity and intuitiveness of telemedicine platforms; 56.4% (88/156) regarding the timeliness of patient condition monitoring; 51.9% (81/156) regarding the effectiveness of telemedicine for the management of patients with chronic diseases. The potential usefulness of telemonitoring for earlier detection of deterioration of a patient’s condition was rated as fairly or very high by 48.7% (76/156); 41% (64/156) rated it as moderate. Only 35.9% (56/156) positively rated the connection’s reliability and stability. Regarding the accuracy of wearable device data transmission, 57.1% (89/156) responded neutrally, potentially indicating ambiguity in perception, limited personal experience, or difficulty evaluating this aspect. Readiness to recommend telemonitoring at the national level was more often rated as moderate, high, or very high (78/156, 50%; 42/156, 26.9%; 14/156, 9%, respectively). Conclusions: This pilot application of the TUQ-MAST-KZ questionnaire showed a generally moderately positive perception of telemedicine by physicians, who recognized its potential clinical and organizational value. However, we identified substantial technical and institutional barriers, including connection instability, concerns about the accuracy of data transmission, insufficient process formalization, and a need for additional training. These preliminary findings should be interpreted in light of the pilot study design; however, they may serve to inform future larger-scale research and the development of organizational measures related to physician training, protocol standardization, and infrastructure support for telemedicine implementation.
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A Gamified Pain Management Intervention for Adults With Chronic Pain in Mainland China: Single-Arm Pre-Post Pilot Study With Machine Learning Predictive Modeling

Background: The widespread prevalence of chronic pain (CP) significantly impacts daily functioning worldwide. In mainland China, maintaining engagement in biopsychosocial interventions remains challenging. Gamification, designed based on self-determination theory, can enhance motivation, while machine learning (ML) algorithms can assist clinicians in dynamically optimizing pain management. Objective: This study aimed to (1) evaluate the preliminary effectiveness of a gamified pain management (GPM) program on CP and psychological outcomes and (2) identify key factors of significant pain improvements through the application of ML to guide intervention adjustments. Methods: A single-arm, pre-post study was conducted with 16 participants with CP in mainland China, recruited via social media using convenience sampling. Participants engaged in a 10-week web-based GPM intervention consisting of education, physical activities, and gamified elements, including points, avatars, and feedback. Primary outcomes were pain intensity and interference measured by the Brief Pain Inventory. Secondary outcomes included anxiety, depression, and quality of life. Analysis included paired tests, and ML models were trained to predict clinically meaningful pain reductions. Shapley additive explanations, least absolute shrinkage and selection operator regression, association rule mining, and Kaplan-Meier survival analysis were used to identify key predictors and optimal sessions and intervention durations across subgroups. Results: A total of 16 participants were engaged, with a mean age of 27.63 (SD 9.584) years. Results from paired tests reported significant improvements in pain intensity (decreased by 27.3%, 95% CI 1.061 to 3.064; =.001), pain interference (decreased by 27.3%, 95% CI 8.159-17.216; <.001), and psychological distress, including anxiety (=3.538, 95% CI 0.969 to 3.906; =.003) and depression (=4.559, 95% CI 2.230 to 6.145; <.001). The gradient boosting model demonstrated the highest predictive accuracy (area under the curve=0.89 and accuracy=0.82). Least absolute shrinkage and selection operator regression identified session 3 (β=−0.45, 95% CI −0.68 to −0.22; <.001) and session 5 (β=−0.32, 95% CI −0.59 to −0.05; =.02) as most predictive of clinical success, while association rule mining revealed effective session combinations for different patient subgroups. Time-to-event analyses indicated that individuals with low back pain and higher baseline severity required longer intervention durations for improvement (5 wk; =.03). Conclusions: This pilot study presents an innovative method that combines ML with dynamic engagement data from a GPM program during interventions, rather than relying on static baseline data in prior studies. The results show preliminary efficacy and identify specific optimal session combinations and personalized treatment durations for different pain subgroups. These exploratory findings contribute to the field by providing a data-driven method for adaptive, personalized digital health interventions that move beyond one-size-fits-all strategies, potentially enabling clinicians to modify content and dosage to improve engagement and outcomes if validated in larger sample trials. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400094247; https://www.chictr.org.cn/showprojEN.html?proj=245138

From Reactive to Proactive: Reimagining Hypertension Management in the Precision Medicine Era

According to the World Health Organization, an estimated 1.4 billion adults aged 30–79 worldwide had hypertension in 2024, representing around one-third of the global population of that age. Of these, 44% were unaware that they were living with a leading risk factor for premature death and poor health worldwide due to its association with myocardial infarction, stroke, and kidney disease.

Despite the size of the hypertension problem, its diagnosis and treatment pathway has remained largely the same for decades.

A 60-year-old pathway

“The current pathway in hypertension diagnosis and treatment has really not changed in over 60 years,” said Sandosh Padmanabhan, MD, PhD, chair of pharmacogenomics and professor of cardiovascular genomics and therapeutics at the University of Glasgow in Scotland.

He explained that it is based on opportunistic detection of hypertension, which has traditionally been defined as a blood pressure (BP) of 140/90 mmHg in the clinic, although thresholds vary by measurement method and guideline. For example, out-of-office measures typically use lower cut-points (e.g., home/daytime ambulatory averages) of 135/85 mmHg.

Sandosh Padmanabhan
Sandosh Padmanabhan, MD, PhD
Professor
University of Glasgow

Diagnosis typically occurs when a patient visits their primary care physician (PCP) or has a pharmacy BP check. Confirmation follows, ideally with out-of-office BP monitoring to avoid misclassification caused by one-off measurements.

Patients are then stratified by predicted 10-year cardiovascular risk, using risk calculators such as Q-risk or the PREVENT score, and treatment is based on a stepwise algorithm. First, patients are generally given lifestyle advice like reducing salt, alcohol, and caffeine intake, improving sleep, managing stress, and increasing exercise. This may give them a chance to reduce their BP without pharmacologic intervention.

If unsuccessful, depending on local guidelines, patients may be offered an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker if under 55 years of age. Those over 55 years or of Black African or Caribbean origin are started on a calcium channel blocker. The next steps combine ACE inhibitors and calcium channel blockers, then add a thiazide-like diuretic, followed by spironolactone or other drugs.

However, this approach uses “a population-level logic,” said Padmanabhan. Although age and ethnicity are considered, “these are broad demographic proxies that don’t include any understanding of the individuals’ underlying pathophysiology or the genetic makeup.”

He stresses that, on a public health basis, the system works. There are multiple effective, low-cost antihypertensive drug classes and many generic options available that effectively lower BP. Despite this, control rates are poor. “Fewer than one in four hypertensive adults globally have their BP adequately controlled,” he said.

The measurement problem

Part of the issue lies in how BP is measured. “To give you an idea about the scale of inertia, we diagnose BP using a device that was introduced in the late 19th century,” Padmanabhan noted, referring to the sphygmomanometer invented by Scipione Riva-Rocci in 1896. Not only that, the technique can also be flawed. Variables such as incorrect cuff size, improper positioning, and patient movement can distort readings. Even talking during measurement can increase BP values by 5–9 mmHg or even higher.

Crucially, a single measurement provides little insight into cumulative lifetime exposure to high BP and can be skewed by issues like white coat hypertension or masked hypertension. “We look at the BP number, but the patients don’t experience that number. What they experience is a lifelong vascular risk,” Padmanabhan explained. “Treatment is not about a short-term reduction in a number. It’s about long-term sustained risk reduction.”

Yet the current system remains reactive and is not working well enough. “We have to move away from reactive diagnosis to proactive identification,” Padmanabhan said. “The earlier we measure accurately and respond systematically, the fewer surprises we’ll see later.”

Continuous monitoring

The pitfalls of opportunistic, or even planned, BP measurement are driving the emergence of new technologies capable of continuous monitoring.

Josep Solà
Josep Solà, PhD
CTO and Co-founder
Aktiia

Josep Solà, PhD, began working on optical sensing technology in 2004 at the Centre for Electronics and Microtechnology in Switzerland. By analyzing subtle changes in reflected light caused by arterial dilation, it became clear that BP could be measured using these light signals. In 2018, this research was spun out into Aktiia, where Solà is CTO and co-founder. The company has developed and commercialized the Hilo™ band: a CE-certified wearable medical device designed for continuous, cuffless, BP monitoring that has been clinically validated against traditional ambulatory BP monitoring.

The band tracks BP and heart rate automatically, about 25 times per day, without requiring any action from users. Paired with an app, the device shows users daily, nightly, and long-term BP trends. It is currently available as a certified medical device across Europe, Australia, and Canada, and, following FDA approval in July 2025, the company is preparing for a U.S. launch.

Solà said he and co-founder Mattia Bertschi, PhD, were convinced they could change how hypertension is being managed today. He believes there is no good reason why most people with hypertension cannot control the condition. The medication is cheap and effective; the problem is that there has been no technology that patients can use to properly manage their condition.

“No one wants to use a cuff every day for the next 30 years,” said Solà. “They’re just so inconvenient, and you cannot expect people to proactively measure something they don’t feel.”

The Hilo band gives wearers a feedback loop that has historically been missing from BP measurement. Users can immediately see that reducing their salt or alcohol intake, for example, lowers their BP. “We are empowering people,” said Solà. “We are empowering them to look at the intervention, or combination of interventions, with or without medication, to see what is effective for them, and this reinforces their willingness to continue with the changes they are making.”

Hilo product
Credit: Hilo

Data published by Aktiia has shown that this approach works. A study of 8,950 U.K.-based Hilo users indicated that individuals who monitored their BP continuously showed better control over time. Specifically, users over 50 years of age appeared able to prevent the age-related rise in systolic BP typically seen in the general population, which the researchers say “may reflect greater awareness, stronger treatment adherence, and lifestyle changes prompted by continuous feedback.”

Wearables at scale: Opportunity and caution

Beyond dedicated monitoring devices like the Hilo band, smartwatches and other devices are increasingly capable of detecting physiological signals associated with cardiovascular risk. The Apple Watch can detect potential signs of chronic hypertension by analyzing heart rate sensor data over 30-day periods, the Huawei Watch D provides on-demand and 24-hour ambulatory BP monitoring using an air-filled strap, while the team behind the Oura ring is developing a “Blood Pressure Profile” feature to detect early signs of hypertension.

Although this represents a significant step toward embedding cardiovascular monitoring into everyday life, the increasing use of these devices raises important questions about accuracy, interpretation, and clinical integration, particularly as they often rely on indirect signals rather than direct BP measurement.

Adam Bress
Adam Bress, PharmD
Researcher
University of Utah

As Adam Bress, PharmD, from the Spencer Fox Eccles School of Medicine at the University of Utah, and colleagues have recently shown, translating wearable-derived signals into meaningful clinical information is not straightforward.

They evaluated the hypertension alert feature of the Apple Watch, which has a published sensitivity of 41% and specificity of 92%, meaning that approximately 59% of individuals with undiagnosed hypertension would not receive an alert, while about eight percent of those without hypertension would receive a false alert.

“The problem there, is that this data only tells you how the alert works in a very controlled, limited population,” said Bress. “In order to understand how it’s going to work in the real world, we need to know how the true prevalence of undiagnosed hypertension varies in the population and in subgroups and to what degree.”

Using data from nearly 4,000 adults in the U.S., Bress and colleagues showed that the pretest probability of having hypertension has a significant impact on the reliability of the alert. For example, among adults under 30 years of age, the pretest probability of having hypertension is 14%. A positive alert on the Apple Watch would increase this probability to 47%, whereas no alert reduces the probability to 10%.

However, for adults aged 60 years and older, an alert increases the probability of an individual having hypertension from a pretest level of 45% to 81%, whereas the absence of an alert only lowers it to 34%. This translates to large numbers of false negatives when applied across millions of users.

In Apple’s validation study, the company stresses that the watch is not intended to replace traditional diagnosis methods or to be used as a method of BP surveillance, and that the absence of a notification does not indicate the absence of hypertension.

“The concern is, if you’re not getting an alert, will people interpret that as them not having hypertension,” said Bress. “That’s the worry. … The groups in which the negative alert is the least trustworthy contain the people with the highest risk. We’re most worried about people being falsely reassured.”

At the same time, he is clear that wearables should not be dismissed. “This technology is an important step forward; we need more wearable tech that can screen,” he said.

Unfortunately, access to these devices is not universal. Advanced monitoring technologies are often first adopted by the “worried well”—people who are more affluent and health-conscious—rather than those at highest risk.

“The only thing that can change this is a clear political decision to make awareness of hypertension large scale,” said Solà. Devices like the Hilo band could be used much like the continuous glucose monitors for diabetes. The difference is that if someone with diabetes doesn’t keep their blood glucose levels under control through regular monitoring, they can become ill very quickly. With hypertension, the effects of poor control don’t become apparent for decades.

“We need the policymakers to understand that investing in this technology today will have a return on investment in 10 years from now, not in one year from now,” Solà remarked.

Targeted drug selection

Even when hypertension is detected early and monitored closely, treatment remains largely empirical and can lead to therapeutic inertia, one of the biggest current challenges in hypertension care. “BP is not like diabetes, it doesn’t cause symptoms, and because of that, we don’t escalate treatment often enough,” said Padmanabhan.

At the same time, treatment selection remains largely trial-and-error. Clinicians cycle through medications sequentially, adjusting regimens based on response rather than underlying biology. The issue is that failed attempts risk side effects and can erode trust. That lack of trust can then impact adherence and, therefore, cardiovascular risk.

Instead, Padmanabhan believes that we need to move toward mechanistically informed drug selection.

This approach is common in oncology, where targeted therapies have been matched to specific mutations, but the picture is more complex for BP. Genome-wide association studies (GWAS) have identified more than 30 genes associated with monogenic forms of hypertension or hypotension and more than 2,100 single nucleotide polymorphisms linked to BP regulation, underscoring its highly polygenic nature.

This, combined with the strong influence of environmental factors, means that there is no single pathway or biomarker that can be easily targeted to reduce BP.

Padmanabhan’s work on the uromodulin gene (UMOD), however, shows that GWAS data can translate into therapy. His team identified a signal on chromosome 16 linked to uromodulin, a protein that is only expressed in one part of the kidney and plays a role in salt regulation. In a clinical trial  comparing people with low BP to those with high BP, they found that people with the UMOD allele that increases protein expression experienced a sustained reduction in BP when treated with the loop diuretic torasemide, whereas the effect was only temporary and followed by rebound in those carrying the UMOD allele that lowers protein expression.

Approximately two-thirds of the population carry the UMOD allele that increases protein expression, meaning that loop diuretics like furosemide or torasemide, which are more commonly used to treat heart failure, could potentially be used in hypertension personalized by the patient’s genotype.

So far, “this is the only clinical trial from a GWAS-identified genetic variant in hypertension,” Padmanabhan noted, highlighting both the promise and challenge of pharmacogenomics in hypertension.

Although clinical translation from GWAS of hypertension has been limited, research has shown that genetic variation in drug-metabolizing enzymes can significantly impact hypertension treatment efficacy and toxicity. For example, variants of CYP2D6 affect metoprolol metabolism whereas those in CYP2C9 influence responses to losartan. Research is needed to determine whether testing for these variants or others could reduce trial-and-error prescription, minimize side effects, and thus increase patient confidence and long-term engagement.

Teresa Castielo
Teresa Castielo, MD
Director
MIAL Healthcare

On a more fundamental level, biological sex differences remain a significant consideration in cardiovascular medicine. “Biological factors are an integral part of the clinical picture,” noted Teresa Castiello, MD, consultant cardiologist and director of MIAL Healthcare in London. She points out that clinical trials have historically seen a predominance of male participants; as a result, many standard medication dosages are based on data primarily derived from men.

This can lead to challenges with tolerability and a higher incidence of side effects in women as the therapeutic dose required for efficacy often tends to be lower in female patients.

Castiello suggests that this area of management warrants further refinement in clinical practice. She also emphasizes that key aspects of female cardiovascular risk, including reproductive history, menopause, and conditions like polycystic ovary syndrome, are nuances that may not always receive the necessary focus in routine care.

Toward a precise, preventative system

Ultimately, transforming hypertension care will require more than new technologies or therapies. It will require a fundamental change in how care is delivered.

Padmanabhan argues that hypertension should be managed through a “precision prevention service,” that integrates early detection, continuous monitoring, and personalized treatment, and involves more than just PCPs.

This approach recognizes that the disease is not just a clinical condition but a societal one, influenced by factors such as diet, socioeconomic status, work patterns, and access to care. Equity remains another critical issue. “We treat the ideal average patient under ideal circumstances but that’s not reality,” said Padmanabhan.

There also needs to be a cultural shift, said Castiello. “It’s not just the doctor’s responsibility; we also need to take responsibility for our own health.”

Solà shares a similar vision for the future: he would like to see BP measurement to become as routine as brushing your teeth, supported by technologies that empower individuals and reduce the burden on healthcare systems.

If realized, this shift could transform hypertension from a silent, progressive disease into a manageable, preventable condition, saving millions of lives in the process.

 

Laura Cowen is a freelance medical journalist who has been covering healthcare news for over 10 years. Her main specialties are oncology and diabetes, but she has written about subjects ranging from cardiology to ophthalmology and is particularly interested in infectious diseases and public health.

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Biobanks Set the Stage for Scaling Precision Medicine

Dating back more than a century, biobanks have outgrown their beginnings as small, local collections to become large, global facilities that store and handle millions of samples and serve thousands of researchers at any given time. Over the years, biobanks have transformed from passive repositories into active research infrastructures that are increasingly bridging the gap between medical research and clinical applications.

“Today’s biobanks have evolved far beyond sample storage,” said Yan Zhang, PhD, president of proteomic sciences at Thermo Fisher Scientific. “They are automated, digitally connected systems integrated with hospitals and health networks to ensure appropriate consent, longitudinal clinical context, and the ability to re-engage participants over time.”

Yan Zhang
Yan Zhang, PhD
President
Thermo Fisher Scientific

As safeguards of clinical samples, biobanks fulfill a central role in the advancement of precision medicine. Access to the right samples can make or break a research project, with most researchers reporting that they have had to limit their scope of work because of difficulties obtaining the samples they need.

“Robust, population-scale biobanking enables precision medicine to move from isolated findings toward broader clinical relevance,” said Zhang. “Modern biobanks combine genomics, proteomics, and other high-dimensional omics platforms with robust data architecture, high-performance computing, and artificial intelligence (AI)-driven modeling. Dedicated data science teams integrate molecular data, longitudinal health records, and curated public datasets to generate biologically meaningful interpretations.”

Biobanks now provide the infrastructure needed to support population-scale, longitudinal studies that allow scientists to uncover molecular drivers of disease and understand their evolution over time to ultimately identify biomarkers, develop targeted treatments, and inform clinical decisions.

“We’re seeing researchers design studies with scale in mind,” Zhang noted. “They’re combining proteomics, genomics, and clinical data to generate insights that are both statistically powerful and relevant to real-world populations. There’s also a clear shift from searching for a single biomarker to building a more complete, systems-level understanding of disease.”

To navigate today’s rapidly shifting landscape and meet their core purpose of supporting cutting-edge clinical research, biobanks have to keep up with fast-moving targets. Going forward, moving from initial discovery to translation will remain the number one challenge in precision medicine. “Generating discovery insight is no longer the limiting factor,” said Zhang. “Validating, standardizing, and implementing those insights at scale is.”

A matter of scale

Martin K. Rutter
Martin K. Rutter, MD
Deputy Chief Scientist
UK Biobank

One of the most transformative shifts in biobanking over the past decade has been an exponential increase in the scale of data collection and sample storage. At the forefront of this expansion is the UK Biobank, which currently stores around 18 million samples from 500,000 participants, together with imaging and biomarker data, healthcare records, questionnaires, physical measurements, demographics, lifestyle, and environmental data collected over the course of 20 years. This depth of phenotyping is what makes the data so valuable to researchers worldwide, said Martin K. Rutter, MD, professor of cardiometabolic medicine at the University of Manchester and deputy chief scientist at the UK Biobank. “When you link all that together, you can get amazing insights into the biology of disease.”

To keep up with increasing storage needs and researcher requests, the UK Biobank is now getting ready to move more than 10 million samples currently stored in its main laboratory to a new building in central Manchester by the end of the year. The new storage facility is designed to quadruple sample retrieval speed while making the whole infrastructure more energy-efficient and environmentally friendly.

The scale at which facilities like the UK Biobank operate today would have been unthinkable when it was established two decades ago. Such massive growth has been driven by rapid technological advances across genomics, transcriptomics, and proteomics, with costs continuing to fall while coverage, speed, and accuracy keep surging.

Partnerships with the pharmaceutical industry have also been instrumental in nurturing this exponential growth. This can be seen in initiatives like the UK Biobank Pharma Proteomics Project (UKB-PPP), a collaboration between the UK Biobank and 14 biopharmaceutical companies with the goal of analyzing proteomics data from 600,000 samples.

In the long run, scale provides the backbone to enable increasingly ambitious, statistically powerful studies. However, as they grow, biobanks face the challenge of navigating a constantly shifting landscape while making sure the samples and data they collect, store, and maintain are valuable to the entire research community they serve.

“Our job is to make the data available to researchers,” said Rutter. “We are involved now more than ever in connecting with research teams and trying to understand what their needs are.”

Through surveys and consultations, the UK Biobank actively gathers information to design prospective data collection programs that anticipate researcher needs. Next year, the biobank is planning a repeat assessment of its whole cohort, focusing on measurements of aging. The goal is to support researchers looking into causal pathways and mechanisms driving age-related diseases, empowering the development of preventive interventions and new diagnostics and treatments for age-related conditions.

Keeping pace with the evolving demands of researchers, industry, and the broader public is essential for biobanks to secure the funding necessary not only to operate but also to expand such vast enterprises, which remains a major challenge across this resource-intensive field.

Diversity takes the spotlight

Historically, samples collected by biobanks are biased in favor of participants who are white, middle-class, and have a higher education. This creates major disparities in the applicability of clinical research. In fact, studies have shown that patients from non-European ancestry backgrounds have not benefited equally from precision drugs approved by the U.S. Food and Drug Administration (FDA) to treat a range of cancer indications.

Even within biobanks dedicated to sampling the population of a specific region, ethnic minorities, low-income, or elderly people are often underrepresented, skewing results against the real-world populations they strive to serve. As the research community increasingly recognizes the importance of more diverse and representative patient cohorts, demand is rising for resources that address these barriers.

Representation is at the heart of All of Us, a program launched by the National Institutes of Health in 2018 to address the gap present at the time in many biobanks and sample repositories. This precision medicine initiative was designed to enroll participants who reflect the full range of populations found within the U.S., including individuals of varied ancestry backgrounds as well as those living in rural commmunities, which are rarely represented in biorepositories due in part to longstanding barriers to research participation, such as the logistical challenges of collecting samples and data from participants in remote locations.

Joshua Denny
Joshua C. Denny, MD
CEO
All of Us

“A lack of diversity impoverishes discovery and applicability of findings for all,” said Joshua C. Denny, MD, CEO of the All of Us Research Program.

For instance, data collected by All of Us has been used to investigate APOL1 gene variants linked to kidney disease, which are more common among people of West African ancestry. This research led to the identification of a novel APOL1 variant that can reduce the risk of kidney disease in individuals carrying high-risk variants.

The program has so far enrolled about 870,000 participants across all U.S. states, with about 80% of them representing communities that have historically been underrepresented in biomedical research. This has been achieved by emphasizing accessibility and flexible participation models; participants can enroll digitally and choose whether to share access to their electronic health records, donate biospecimens, and complete demographics and lifestyle surveys. They may also opt to provide saliva samples, simplifying logistics in rural areas with limited access to blood collection facilities.

“What works in a rural location is different from what works in a big city like New York,” said Denny. Whether it comes to location, age, or language, he emphasized the importance of adapting how the program approaches and engages each population.

Democratizing access to patient data across the research ecosystem is another major biobanking challenge that All of Us is committed to addressing. The program has established a streamlined access model that enables researchers to access the data they need in less than two hours if they belong to one of the 1,300 already approved institutions across the world. Together with central data storage and cloud-based analysis tools, their setup is designed to make the data accessible to researchers lacking the resources and local infrastructure for high-performance computing.

Towards global integration

With precision medicine studies steadily escalating both in size and complexity, researchers increasingly seek to bring together data stored across diverse biobanks to power larger, more ambitious studies with broader scientific and societal impact. However, building the infrastructure needed to enable cross-biobank studies is still a challenge, starting with convening stakeholders to harmonize data collection standards and establish international guidelines.

Anticipating this need, in 2013 the European Union established the Biobanking and Biomolecular Resources Research Infrastructure – European Research Infrastructure Consortium (BBMRI-ERIC), which currently coordinates the activity of about 500 biobanks across 32 countries.

Jens K. Habermann
Jens K. Habermann, MD, PhD
Director General
BBMRI-ERIC

“Precision medicine can only move forward with a strong starting point for research,” said Jens K. Habermann, MD, PhD, professor for translational surgical oncology and biobanking at the University of Lübeck and director general of the BBMRI-ERIC. “It can be very difficult for scientists to get all the information they need in one place, and this is what biobanks can enable.”

Pulling together data from all its members, the BBMRI-ERIC has set up a central catalogue for biobanks, biomolecular resources, and other data and sample collections, which users can employ to identify relevant resources and build virtual cohorts tailored to their research needs. The consortium also works with international committees to set guidelines and support members working towards compliance with international standards.

Despite ongoing progress, there are still obstacles ahead when it comes to harmonizing biobanking practices worldwide, including data collection, annotation, storage, and sharing. Tackling differences in data protection, consent, ethical standards, and regulatory requirements across borders will be another necessary step towards broader standardization. Finally, biobanks will need to invest in cybersecurity to ensure patient data can be shared between institutions safely.

Funding will be key to successfully addressing all these challenges. On this front, biobanks face the difficult task of maintaining their existing infrastructure, staying up to date and relevant to the research community, and investing in cross-biobank initiatives. All this must be balanced with growing financial pressure on research centers, hospitals, and the governments supporting them.

As part of its 10-year roadmap, the BBMRI-ERIC is setting the goal of forming international networks that bring together more diverse biobank types, such as environmental, wildlife, veterinary, and plant biodiversity repositories. The overarching aim is to move towards a One Health approach to biobanking, where samples and data that expand beyond monitoring human populations are brought together to tackle overlapping challenges that simultaneously affect human, animal, and environmental health.

Data-driven horizons

As the field forges ahead, biobanks are undergoing broad transformations in the way they operate. On the technology side, these changes are being propelled by the rise of multi-omics techniques in precision medicine research, as well as by rising demand from the research community for non-invasive patient monitoring data and longitudinal sample collection. All of these will be critical for the development of the next generation of personalized therapies and diagnostics.

“Over the next decade, biobanks are expected to become increasingly integrated into clinical and translational workflows,” said Zhang. “Proteomics, in particular, will play a growing role in helping us understand the dynamic biology of disease, enabling earlier detection, better prediction of recurrence, and more precise therapeutic strategies.”

A key driver of this shift will be AI. No longer just a supporting tool, AI is now becoming an integral part of biobank operations, contributing to real-time sample monitoring, predictive maintenance, risk management, and decision making.

On the data analysis side, Zhang has seen how AI is redirecting the focus from data generation to data interpretation. She said, “Biobanking has already enabled the collection of high-quality biospecimens linked to large-scale molecular and clinical datasets. The challenge now is extracting meaningful biological insight from that complexity.”

Although still in its early days, AI is becoming central to how researchers make use of biobank data, noted Rutter. Drawing from the UK Biobank data, recent studies have developed AI models that can predict a patient’s risk of stroke based on retinal images, calculate the risk of future disease by looking at an individual’s disease history, or spot neurodegenerative diseases like Alzheimer’s and Parkinson’s early using brain scans and physical activity data.

Going forward, Rutter expects to see biobanks moving away from static cohorts and in favor of continuous data collection, enabling more powerful predictions. For example, the UK Biobank is developing a mobile app that can track a participant’s physical activity and monitor their location and sleep patterns, offering an in-depth look at how a variety of factors affect their health with much more accuracy than self-reported surveys.

Over time, all these advances will steer clinical practice from treatment to prevention, allowing healthcare professionals to act early in the patient journey, when interventions are most effective, and eventually, even before disease develops. Ultimately, addressing complex diseases will require coordinated contributions from all stakeholders, including AI innovators, drug developers, clinicians, technology providers, and policymakers.

“The next decade will be incredibly exciting,” said Denny. “It will be all about leveraging the huge scale of resources that are just emerging today.”

 

Clara Rodríguez Fernández is a science journalist specializing in biotechnology, medicine, deeptech, and startup innovation. She previously worked as a reporter at Sifted and editor at Labiotech, and she holds an MRes degree in bioengineering from Imperial College London.

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High-Throughput Platform for Fast-Acting Covalent Protein Therapies

Researchers at Westlake University in China, lead by Bobo Dang, PhD, and Ting Zhou, PhD, report the development of a high-throughput platform for engineering fast-acting covalent protein therapeutics. The team says their study “A high-throughput selection system for fast-acting covalent protein drugs,” published in Science, opens new avenues for next-generation biologics.

Covalent small-molecule drugs have shown great success in cancer therapy by forming irreversible bonds with their targets. This has inspired efforts to extend covalent strategies to protein therapeutics, especially engineered miniproteins. However, their development is limited by a kinetic mismatch. Miniproteins are rapidly cleared in vivo, while covalent bond formation is typically slow. In addition, high-throughput platforms for systematically optimizing covalent protein reactivity have been lacking.

To address this challenge, the researchers proposed that precise spatial positioning of chemical warheads within protein scaffolds could enable molecular preorganization, thereby accelerating covalent bond formation without increasing intrinsic reactivity (see figure).

The principle for developing fast-acting covalent proteins via comprehensive crosslinker and protein sequence engineering. [Bobo Dang's Lab at Westlake University]
The principle for developing fast-acting covalent proteins via comprehensive crosslinker and protein sequence engineering. [Bobo Dang’s Lab at Westlake University]

Based on this concept, the team created a high-throughput platform that combines yeast surface display with chemoselective protein modification to screen diverse crosslinkers and millions of protein variants. The platform enables rapid and irreversible target engagement.

Using this platform, the researchers developed a covalent antagonist targeting PD-L1, termed IB101. Structural analysis revealed that IB101 forms a defined binding pocket that precisely positions the active moiety in a reactive conformation, greatly accelerating covalent bond formation.

Functionally, IB101 effectively blocks the PD-1/PD-L1 immune checkpoint pathway and demonstrates strong antitumor activity in mouse models. Notably, despite its short in vivo half-life, IB101 achieves durable target engagement and tumor suppression, outperforming conventional antibody-based therapies under comparable conditions, according to the scientists.

The platform was further applied to cytokine engineering, leading to the development of a covalent IL-18 variant, IB201. This engineered cytokine rapidly forms a covalent interaction with its receptor, enhancing signaling strength and duration. In vivo studies showed that IB201 induces potent antitumor immune responses without detectable systemic toxicity. These results highlight the potential of covalent engineering to improve the efficacy and safety of cytokine-based therapies.

Beyond immunotherapy targets, the platform was also applied to develop a covalent inhibitor targeting the receptor-binding domain (RBD) of SARS-CoV-2. This molecule showed durable viral neutralization, demonstrating the versatility of the approach across different therapeutic modalities, note the researchers, adding that the study establishes a general strategy for engineering fast-acting covalent protein therapeutics.

By enabling covalent bond formation on timescales compatible with rapid in vivo clearance, the platform overcomes a fundamental limitation in the field, say the scientists. These findings, they continue, provide a new framework for designing biologics with both rapid kinetics and sustained target engagement, with broad implications for cancer immunotherapy, antiviral therapy, and beyond.

 

 

 

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