Tag: Academic research

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Corning Advances the Organoid Revolution

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The rapid rise of new approach methodologies (NAMs) is reshaping drug development, and organoids are emerging as one of the field’s most promising technologies. With the FDA Modernization Act 2.0 removing the long-standing requirement for animal testing in many drug-development pathways, researchers and industry leaders are increasingly looking toward human-relevant systems that better predict clinical outcomes. Against this backdrop, Corning Life Sciences is positioning itself as a key enabler of the organoid revolution by helping scientists overcome persistent barriers related to complexity, reproducibility, and throughput.

“Corning is helping to overcome challenges to adopting NAMs such as organoid models by providing specialized consumables and reagents that are essential to generating more in vivo-like models,” said Hilary Sherman, senior applications scientist at Corning Life Sciences. Sherman pointed to products including “Corning Matrigel Matrix, Transwell Permeable supports, and a wide variety of specialized plasticware for spheroid and organoid culture” as foundational technologies supporting the transition toward more predictive biological systems.

The push toward NAMs adoption gained further momentum this year when the FDA released draft guidance on alternatives to animal testing in drug development. The agency emphasized that NAMs—including organoids, spheroids, organ-on-chip platforms, and computational models—can improve predictivity while reducing reliance on animal studies.

Those priorities align closely with challenges the organoid field has wrestled with for years. During the GEN virtual event Spotlight on Organoids, Hans Clevers, MD, PhD, an organoid pioneer and distinguished professor at the Hubrecht Institute, stressed that standardization remains one of the field’s biggest hurdles.

“We don’t even have a good definition of what an organoid is,” Clevers said during the GEN virtual event. “When is an organoid an organoid?” He added that “nothing is standardized and nothing is automated,” underscoring the need for scalable workflows that can transition organoid science from exploratory academic research into robust industrial platforms.

Clevers nevertheless remains optimistic about the technology’s transformative potential. “The most important part is we can now grow structures that really represent a small part of the human body,” he said. “Animals are complete organisms, but they’re not humans.” According to Clevers, many diseases—particularly chronic human diseases—are poorly modeled in animals, limiting translational success in drug development.

Corning sees education and workflow optimization as crucial to solving those problems. “Corning feels very strongly about supporting our customers by providing resources to educate scientists on how to create more in vivo-like models that are reproducible,” Sherman explained. “We do this through publishing novel applications, protocols, and webinars.”

The company is also helping researchers streamline increasingly sophisticated organoid workflows. “We have several protocols and optimization guides that educate customers on how to culture organoids to ensure they are set up for success,” Sherman noted. “Additionally, we have many application notes demonstrating different ways of automating organoid assays to give researchers a starting point for their own work.”

Automation and scalability are becoming especially important as organoids move deeper into pharmaceutical pipelines. At the GEN virtual event, Maya Gosztyla, PhD, co-founder and CSO of BrainStorm Therapeutics, described how her company’s platform as “a very high throughput and very scalable and reproducible version of brain organoids.”

Her company is studying CDKL5 deficiency disorder, a rare genetic epilepsy. “The whole reason that we’re doing this work in brain organoids is that the mouse models of CDKL5 don’t recapitulate the symptoms of the disease,” Gosztyla explained.

She believes regulatory changes are accelerating industry confidence in organoid-based drug discovery. “These regulatory shifts have basically allowed drug-discovery companies to show efficacy using an alternative like a brain-organoid model,” Gosztyla said, adding that such systems are “a lot more translational compared to something like a mouse.”

For Corning, helping researchers achieve that translational promise means supporting every stage of organoid adoption—from foundational reagents to reproducible protocols and scalable automation strategies. As NAMs continue gaining regulatory and commercial traction, the ability to standardize organoid workflows might ultimately determine how quickly these human-centric systems become mainstream tools in drug discovery and development.

 

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Evaluating CNS Anti-inflammatory Therapies with Human Brain Organoids

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Inflammatory pathways involving microglia, astrocytes, and cytokine signaling are widely implicated in disorders including Alzheimer’s disease, Parkinson’s disease, ALS, multiple sclerosis, and traumatic brain injury. Yet despite significant investment in anti-inflammatory therapies, clinical success has remained limited.

A primary reason is that conventional preclinical models do not fully capture the complexity of human neuroimmune biology. Many therapies show encouraging results in animal studies but fail to reproduce those effects in human clinical trials.

These limitations have become increasingly problematic as evidence linking neuroinflammation to disease progression continues to grow. Genome-wide association studies have identified immune-related genes associated with Alzheimer’s disease risk, while imaging and postmortem analyses have demonstrated close relationships between inflammatory activation, synaptic loss, and cognitive decline. Drug developers are therefore pursuing therapies directed at neuroimmune biology using models that lack functional human neuroimmune architecture.

CNS-3D Inflammatory Organoids, recently introduced by 28bio, is an assay-ready immunocompetent 3D brain organoid model incorporating neurons, astrocytes, and microglia to evaluate efficacy of anti-inflammatory drugs by quantifying their ability to reduce inflammatory injury, preserve tissue health, and restore neuronal network activity.

The inclusion of microglia is particularly important because it enables researchers to study inflammatory signaling within a more physiologically relevant cellular environment. Rather than measuring isolated cytokine responses in monoculture, researchers can examine how inflammatory activation propagates across interconnected neural and glial populations and how those changes affect tissue integrity and network behavior.

Data presented recently at the Microphysiological Systems World Summit demonstrated distinct cellular responses following exposure to inflammatory stimuli (Fig. 1) including lipopolysaccharide (LPS) and TNF-α. According to the findings, LPS exposure generated a predominantly microglial inflammatory response, while TNF-α produced stronger astrocytic activation patterns. Cytokine profiling also demonstrated measurable increases in inflammatory mediators following stimulation.

Differential microglial and astrocytic responses to inflammatory insults in CNS-3D Inflammatory Organoids.
Figure 1. Differential microglial and astrocytic responses to inflammatory insults in CNS-3D Inflammatory Organoids. CNS-3D Inflammatory Organoids were treated with vehicle, LPS, or TNF-α and assessed by immunofluorescence staining for Iba1-positive microglia and GFAP-positive astrocytes. LPS induced a pronounced microglial response, whereas TNF-α preferentially increased astrocytic activation, highlighting stimulus-specific inflammatory phenotypes within the 3D CNS organoid model.

These findings are highly relevant for therapeutic development because neuroinflammation is not a single biological process. Disease states may involve different combinations of microglial activation, astrocytic dysfunction, oxidative stress, and neuronal injury. Models capable of distinguishing between these responses provide a more predictive framework for evaluating therapeutic candidates.

CNS-3D Inflammatory Organoids also support integration of functional calcium imaging with cytokine analysis, immunostaining, cytotoxicity assays, and molecular profiling. This approach addresses another persistent challenge in CNS drug development: many inflammatory assays quantify molecular markers without determining whether those changes correspond to preservation or disruption of neuronal function.

As neurodegenerative drug discovery continues to confront translational issues, interest is growing in models capable of reproducing human-specific cellular interactions and functional neuroimmune responses. Human brain organoid models help bridge the gap between preclinical findings and clinical outcomes by providing a more physiologically relevant framework for evaluating anti-inflammatory therapeutics in the CNS.

 

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China has approved the world’s first invasive brain-computer chip—here’s what’s next

One day last October, sitting in the courtyard of his house in China’s Henan province, Dong Hui decided to see if he could hold a pen to write. 

Dong, 39, had sustained spinal cord injuries in a car accident six years earlier that left him paralyzed from the neck down. Slowly but determinedly, he wrote his name, “Thank you,” and then the date. This was the result of an 11-month-long rehabilitation enabled by an implant in his brain. Before that process, Dong could move his arms slightly but wasn’t able to use his fingers.

“I couldn’t believe I was able to write again. I was so excited I even missed a stroke in my name,” he told MIT Technology Review on a video call. 

In November 2024, Dong became one of the first people in China to be given an invasive brain-computer interface (BCI) through brain surgery. He had signed up for a clinical trial with the device’s developer one month after seeing on TV how a BCI had apparently enabled another paralyzed Chinese man to hold his granddaughter. 

This March, the implant Dong uses became the first invasive BCI product in the world to be approved for use beyond clinical trials. It’s now available to some patients with paralysis in their limbs due to spinal cord injuries. We spoke to a range of experts to understand why the device was able to reach this global milestone, what makes this moment so significant, and what to expect next. 

A world first

Dong’s brain implant is a coin-size device called NEO. It was developed by Neuracle Technology, a Shanghai-based startup, together with researchers at Tsinghua University in Beijing. 

During a procedure that took just over an hour and a half, the device’s sensors, which collect Dong’s brain signals, were placed on his dura mater, the tough outer layer of tissue that covers and protects the brain. The signals are transmitted to a computer by an implant placed on Dong’s skull. The computer then translates the signals into commands for a soft robotic glove Dong wears during the 2.5-hour training sessions he completes each day to help him learn to grab. 

Dong started his rehabilitation around a week after surgery. “On the ninth day of my training, my right hand successfully grabbed a ball without the glove,” he says. “That was a miraculous moment.” 

Now he continues with his training at home. He wants to be able to control his hands better in order to put on clothes, eat, and do other daily tasks without troubling his aging parents. 

A growing number of people with traumatic injuries in China are now poised to tread a similar path thanks to NEO’s recent approval. According to China’s National Medical Products Administration, the bureau responsible for drug supervision, the product is suitable for patients between 18 and 60 who have paralysis in all limbs due to spinal cord injuries but still have some residual function in their arms. 

NEO beat several other BCIs to approval, including one from Neuralink, a California-based company founded by Elon Musk. Since October 2023, Neuracle has conducted 36 clinical trials using NEO, including the one on Dong. Thirty-two of them took place in the space of a few months in 2025, with the details about one of the four first in-person trials published in a preprint paper last July. Neuracle did not reply to a request for comment from MIT Technology Review.

One reason for NEO’s fast approval could be that it has a “relatively less invasive” design than counterparts such as Neuralink’s N1 brain chip, says Avinash Singh, a BCI researcher at the University of Technology Sydney. NEO’s eight sensors sit on top of the brain’s protective membrane while Neuralink’s N1 chip directly penetrates the cortex, the outermost layer of the brain itself. Neuracle’s device faces fewer regulatory constraints because it presents a lower risk of hemorrhage, glial scarring, and long-term signal degradation, Singh says.

China’s strong support for its BCI industry also means that NEO was put on an expedited regulatory pathway; in comparison, the approval process of the US Food and Drug Administration can take several years, Singh adds.

A big boost for BCIs

NEO’s approval is hugely important for the global BCI industry, says Wang Shouyan, a neuroscientist at Fudan University in Shanghai who was not involved in research or trialing for NEO. Even though research and development on BCIs has taken place for several decades, most of it happened in the lab. The news means that BCIs are now ready for large-scale manufacturing and clinical use in China, Wang says. 

For Dong, however, it means something much more personal. “Now, it will be able to help not only me, but also thousands and thousands of other patients suffering from spinal cord injuries in China who are tortured by despair each day,” he says of NEO. “It will bring them hope and change their lives.” 

Days after NEO was approved, China started incorporating it into the country’s health insurance system by assigning it a unique code. This is one of the first steps toward a future where eligible Chinese patients pay a certain percentage of the BCI’s price if they need it during their treatment.

The growth of China’s BCI industry is expected to accelerate thanks to the government’s policy support and financial backing. The country’s latest five-year plan, published on the same day Neuracle received its approval, lists BCI as one of six key industries important to China’s future tech competitiveness, alongside quantum technology, humanoid robots, and others. Several Chinese startups, including NeuroXess and StairMed, have already worked in the field for many years. 

“China’s decision to double down on becoming a global leader in the field owes in part to what these companies have already accomplished,” says Meicen Sun, an information scientist at the University of Illinois Urbana-Champaign who studies information and technology policy. 

But, Sun says, the biggest advantage China may have is that Chinese people, particularly patients like Dong, tend to welcome this technology and are genuinely enthusiastic about it. In comparison, in the US and Western Europe, testing technologies on human bodies elicits an “ick factor,” triggering concerns and even resistance, she says.

Cooperation in a cold climate 

NEO has become the world’s first invasive BCI to go commercial, but scientists interviewed by MIT Technology Review caution against comparing Chinese and US efforts through the lens of a race. 

A race implies an endpoint, but it is hard to say where that is for the development of BCIs, says Nick Ramsey, a neuroscientist at Radboud University Nijmegen in the Netherlands. Also, the US and China have fundamentally different visions, Sun says. The US is primarily concerned with being the first to do something and achieving state-of-the-art performance, while winning to China means capturing more consumers and using technology to deliver solutions on a societal scale. 

“Being exceptional and being accessible are two diametrically opposed definitions of winning,” Sun says. 

In fact, neurotechnology has emerged as a rare tech sector where US-China collaboration is still happening despite geopolitical tensions. The US company Axoft,  based in Cambridge, Massachusetts, says it has teamed up with a Chinese company and a hospital in Shanghai to test its BCI on four patients in China and has plans to expand its trials in the country. 

Looking forward, China’s BCI industry is expected to speed up its growth over the next five years thanks to strong government support. “There is no comparable national-level ambition or coordinated map elsewhere in the world at the moment,” says Singh.

More BCIs are also in the pipeline for domestic approval in the country, including Beinao-1, developed by the Chinese Institute for Brain Research in Beijing and its affiliated startup, NeuCyber NeuroTech. The device, which sits on the dura mater, is designed to help those who have movement and speech difficulties due to spinal cord injuries or amyotrophic lateral sclerosis. These candidates could get the green light as early as 2028, Singh says. 

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STAT+: For prostate cancer patients set on surgery, new hormone regimen may improve outcomes, study finds

CHICAGO — Patients with high risk prostate cancer that hasn’t spread typically have two standard treatment paths before them. Remove the prostate surgically, or do a combination of radiation therapy and hormone therapy. Now, with the results of a new phase 3 clinical trial, some oncologists believe a third option may soon be laid on the table: surgery with hormone therapy both before and after the operation.

The study, called the PROTEUS trial, found that combining two hormone therapies both before and after surgery was superior to just one hormone therapy before and after surgery in high risk, early stage prostate cases. 

There is a range in how prostate cancer experts are interpreting the results, however. Many told STAT that they believed it would lead to a new standard of care, with Emmanual Antonarakis, a genitourinary medical oncologist at the University of Minnesota, calling it a “watershed moment” in prostate cancer in a New England Journal of Medicine editorial.

Continue to STAT+ to read the full story…

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Imaging Technique Can Differentiate Lung Inflammation from Fibrosis

A type of computed tomography (CT) imaging known as SPECT (Single Photon Emission Computed Tomography) in combination with a new imaging agent could allow clinicians and researchers to visualize inflammation in the lungs to better target treatment to patients.

Interstitial lung disease includes over 200 conditions that scar and inflame the lungs. Researchers estimate around 650,000 people in the U.S. have this kind of lung disease and 50,000 new patients are diagnosed in the U.S. each year with interstitial pulmonary fibrosis (IPF) alone. The main problem with interstitial lung disease is that doctors currently cannot reliably tell inflammation from scarring without invasive diagnostic procedures.

In this Phase II study, presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting in Los Angeles, Druin Burch, consultant physician at John Radcliffe Hospital in Oxford, U.K., and colleagues tested whether a radioactive imaging agent, 99mTc-maraciclatide, injected into patients imaged with SPECT-CT could detect inflammation in the lungs.

“The molecular imaging agent 99mTc-maraciclatide binds to αvβ3 integrin, which is upregulated in vascular endothelial cells during angiogenesis, a cardinal feature of inflammation,” explain Burch and colleagues. “The agent has demonstrated diagnostic promise in other inflammatory conditions such as endometriosis.”

Overall, 15 people were scanned as part of the study: five healthy controls, five with IPF, and five with fibrotic hypersensitivity pneumonitis, which involves more active inflammation. The researchers found that those with fibrotic hypersensitivity pneumonitis had nearly double the inflammatory signal on imaging of healthy controls. Patients with IPF were somewhere between these two groups, which might be expected as IPF is known to be more fibrotic than inflammatory.

“While current imaging techniques can provide a structural view of fibrosis in the lungs, there is no reliable, non-invasive way to identify inflammation,” commented Burch in a press statement. “A tool that could detect inflammation in interstitial lung disease patients could help pinpoint those most likely to respond to anti-inflammatory therapy.”

To reach a wider group of patients a Phase III study is required to test the imaging agent in more people. 99mTc-maraciclatide has FDA Fast Track status for use in patients with interstitial lung disease, so if a larger study is successful it could be available to patients in less than five years.

“Being able to differentiate the fibrotic and inflammation stages of interstitial lung disease is not just beneficial to inform treatment decisions, but also for the development new therapies,” said Burch. “This approach has the potential to unlock a wide range of anti-inflammatory drugs.”

The post Imaging Technique Can Differentiate Lung Inflammation from Fibrosis appeared first on Inside Precision Medicine.

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STAT+: Practice-changing results reported for Revolution Medicines pancreatic cancer drug

CHICAGO — Rachna Shroff, a physician and pancreatic cancer expert, was seeing patients at the University of Arizona Cancer Center in April when she heard the striking clinical results about an experimental pill called daraxonrasib. Patients taking the targeted drug lived nearly twice as long as patients offered standard chemotherapy — an outcome never seen before in the pancreatic cancer field. 

“Having treated pancreatic cancer for 16 years, I actually started crying in the clinic,” Shroff said at a media briefing. “This is such an incredibly impactful study for our patients.”

On Sunday, detailed results from the daraxonrasib clinical trial conducted by the drug’s maker, the biotech company Revolution Medicines, were presented here at the plenary session of the annual meeting of the American Society of Clinical Oncology. The study was published simultaneously in the New England Journal of Medicine. 

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Career Advancement Challenges for Women in Tenure Versus Clinical Tracks in Academic Medicine: Cross-Sectional Survey Study

<strong>Background:</strong> Despite gender parity in medical school matriculants, women in academic medicine encounter ongoing challenges in career advancement and promotion. <strong>Objective:</strong> This study aimed to assess the experiences and challenges impacting the career trajectory for women-identifying faculty at the Ohio State University College of Medicine (OSUCOM) in tenure track (TT) and clinical track (CT; nontenure track) academic appointments. <strong>Methods:</strong> The OSUCOM Widening Impact in Medicine and Science (WIMS) organization, earlier known as Women in Medicine and Science, conducted a digital online survey in May 2023 distributed to all women-identifying faculty at OSUCOM. We focused on the responses of faculty who reported being on the TT or the CT at the rank of assistant, associate, or full professor. Survey data were compared to ongoing and new career development programming in WIMS that addresses faculty needs across both tracks. <strong>Results:</strong> Approximately half (639/1292, 49.5%) of all women-identifying OSUCOM faculty responded to the survey, with 565 (88.4%) reporting as TT or CT at the rank of assistant, associate, or full professor. Among these respondents, 23.5% (n=133) were on the TT (assistant professors: n=60, 45.1%; associate professors: n=37, 27.8%; professors: n=36, 27.1%), while 76.5% (n=432) were on the CT (assistant professors: n=245, 56.7%; associate professors: n=129, 29.9%; professors: n=58, 13.4%). Across both appointment tracks, of 492 participants, the two most common challenges impacting career advancement were caregiving responsibilities (n=271, 55.1%) and burnout (n=235, 47.8%). Significantly more CT versus TT faculty identified increased patient load (n=187, 47.8%, vs n=10, 9.9%; <i>P</i>&lt;.001) and clinical productivity requirements (n=150, 38.4%, vs n=19, 18.8%; P=.002) as barriers to career advancement. CT faculty were also more likely to report not currently having a mentor compared to TT faculty (n=202, 48.9%, vs n=37, 31.9%; <i>P</i>=.001). In contrast, significantly more TT faculty reported the impact of COVID-19 (n=50, 49.5%, vs n=75, 19.2%; <i>P</i>&lt;.001) and lack of funding (n=28, 27.7%, vs n=66, 16.9%; <i>P</i>=.014) as barriers to advancement. TT faculty were also significantly more likely to report sponsoring an OSU faculty member in their current position (n=55, 54.5%, vs n=147, 38.0%; <i>P</i>=.003). <strong>Conclusions:</strong> Our findings highlight that TT and CT women-identifying faculty experience different career landscapes with distinct track-specific barriers to professional advancement. CT women-identifying faculty are particularly vulnerable in areas such as mentorship and sponsorship, while TT women-identifying faculty experience more challenges related to research productivity. With an increasing number of women hired as CT faculty, it is critical for academic medical centers (AMCs) to maintain and strengthen support for all faculty types by broadening institutional-level strategies and offering targeted career development programming.
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Asynchronous Broadcasting of Audiovisual Content as a Telerehabilitation Strategy for Patients in Rural Areas: Development and Usability Study

Background: Geographical and economic barriers limit access to health care services in rural regions of Colombia. In San Vicente del Caguán, the lack of infrastructure and rehabilitation professionals forces patients to travel long distances. Asynchronous telerehabilitation using video broadcasting is a viable strategy to address these challenges. Objective: This study aims to design and validate a telerehabilitation model using asynchronous audiovisual content broadcasting for rural patients, evaluating functionality, usability, and clinical effectiveness. Methods: A 4-stage case study developed and validated the model in San Vicente del Caguán: (1) analysis of telemedicine experiences and video-based therapy; (2) solution design including telecommunications infrastructure (radio links and Wi-Fi), mobile app (HSRehabiAPP), and web platform (HSRehabiWEB); (3) fieldwork with 7 patients receiving physical, occupational, or speech therapy, evaluating functionality (11 criteria), usability (8 criteria), and content quality (5 criteria); and (4) results analysis. The infrastructure connected San Rafael Hospital with remote centers in Los Pozos and Tres Esquinas. Participants (aged 7-68 years) from urban and rural areas had conditions including stroke, shoulder injuries, knee pathologies, hypertension, and attention-deficit hyperactivity disorder. Results: All 7 patients achieved 100% compliance across functional, usability, and audiovisual content criteria. Functional evaluation covered login, navigation, therapy access, session viewing, exercise execution, pain assessment, therapist communication, and satisfaction surveys. Usability assessment evaluated initial access, content location, navigation comfort, instructional guidance, session organization, video playback, instruction clarity, and interface intuitiveness. Content criteria included exercise clarity, step-by-step instructions, visual quality, audio quality, and correct posture demonstration. Patients reported high satisfaction, noting reduced travel costs and time, family convenience, and effective outcomes. Offline functionality proved essential in areas with limited internet connectivity. Conclusions: The asynchronous audiovisual telerehabilitation model is an effective solution for improving access to rehabilitation services in rural areas. It successfully addressed geographical barriers and infrastructure limitations while maintaining clinical effectiveness across therapies. Implementation requires adequate technological infrastructure, user-friendly platforms with offline capabilities, and quality therapeutic content. Future work demands inclusive health policies, professional training, and research with larger sample sizes to assess long-term sustainability in diverse rural contexts.
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