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Orphan Drugs at 30: Will Success Become Too Expensive?

The Orphan Drug Act (ODA) turned 30 this month, demonstrating that good laws really can have an enduring impact. Amidst the celebrations, a reporter asked me a provocative question: can we afford more orphan drugs costing hundreds of thousands of dollars per year? FDA Matters answered “yes.” However, I added a caveat that should worry everyone eager for orphan drugs to succeed. When genomics and personalized medicine become successful, this will multiply the number of rare diseases and the overall cost of orphan drugs, perhaps beyond what the system can bear.




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Minnesota Becomes 18th State to Adopt Consumer Data Privacy Law

On May 24, Governor Tim Walz signed into law Minnesota’s new comprehensive data privacy law, the Minnesota Consumer Data Privacy Act (HF 4757 referenced as the MCDPA). The MCDPA goes into effect on July 31, 2025, with some exceptions for colleges and universities (who have until 2029). The MCDPA is similar to other state privacy laws, […]




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FTC Finalizes “Click-to-Cancel” Rule to Make It Easier for Consumers to End Recurring Subscriptions and Memberships

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EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz

<p>On 19&nbsp;September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion,&nbsp;recommending the granting of marketing authorization&nbsp;for&nbsp;two aflibercept biosimilars:&nbsp;&nbsp;Sandoz’s Afqlir and Samsung Bioepis’s Opuviz.&nbsp;These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p>




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Nearly 200 women were prescribed valproate during pregnancy between April 2018 and September 2020

Some 180 women were prescribed valproate, a medicine used to treat epilepsy and bipolar disorder, during their pregnancy within a 2.5 year interval, NHS data has revealed.




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Semaglutide effective for weight loss in non-diabetic adults, research suggests

The type 2 diabetes mellitus drug semaglutide is effective for weight loss in non-diabetic overweight or obese adults, when taken alongside a reduced-calorie diet and exercise, researchers have found.




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Overseas candidates will be allowed to sit registration assessment remotely, regulator says

The General Pharmaceutical Council has said most candidates living in countries with a two-hour or more time difference from the UK will be able to apply to sit the registration assessment at home.




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Reflections On My Experience As A Board Member

By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC In an industry where boom and bust cycles occur regularly and 90 percent of drug candidates fail to reach the market, an outstanding

The post Reflections On My Experience As A Board Member appeared first on LifeSciVC.



  • Boards and governance
  • From The Trenches
  • Leadership

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Hundreds of clinical trials ruled to be breaking the law

A judge in New York has ruled that hundreds of clinical trials registered on ClinicalTrials.gov are breaking the law by not reporting results. The ruling came in a court case launched against the US Department of Health and Human Services by two plaintiffs, a family doctor and a professor of journalism. The case focused on […]




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Preview of Enrollment Analytics: Moving Beyond the Funnel (Shameless DIA Self-Promotion, Part 2)


Are we looking at our enrollment data in the right way?


I will be chairing a session on Tuesday on this topic, joined by a couple of great presenters (Diana Chung from Gilead and Gretchen Goller from PRA).

Here's a short preview of the session:



Hope to see you there. It should be a great discussion.

Session Details:

June 25, 1:45PM - 3:15PM

  • Session Number: 241
  • Room Number: 205B


1. Enrollment Analytics: Moving Beyond the Funnel
Paul Ivsin
VP, Consulting Director
CAHG Clinical Trials

2. Use of Analytics for Operational Planning
Diana Chung, MSc
Associate Director, Clinical Operations
Gilead

3. Using Enrollment Data to Communicate Effectively with Sites
Gretchen Goller, MA
Senior Director, Patient Access and Retention Services
PRA





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Will Your Family Make You a Better Trial Participant?

It is becoming increasing accepted within the research community that patient engagement leads to a host of positive outcomes – most importantly (at least practically speaking) improved clinical trial recruitment and retention.

But while we can all agree that "patient engagement is good" in a highly general sense, we don't have much consensus on what the implications of that idea might be. There is precious little hard evidence about how to either attract engaged patients, or how we might effectively turn "regular patients" into "engaged patients".

That latter point - that we could improve trial enrollment and completion rates by converting the (very large) pool of less-engaged patient - is a central tenet of the mHealth movement in clinical trials. Since technology can now accompany us almost anywhere, it would seem that we have an unprecedented opportunity to reach out and connect with current and potential trial participants.

However, there are signs that this promised revolution in patient engagement hasn't come about. From the decline of new apps being downloaded to the startlingly high rate of people abandoning their wearable health devices, there's a growing body of evidence suggesting that we aren't in fact making very good progress towards increasing engagement. We appear to have underestimated the inertia of the disengaged patient.

So what can we do? We know people like their technology, but if they're not using it to engage with their healthcare decisions, we're no better off as a result.

Daniel Calvert, in a recent blog post at Parallel 6 offers an intriguing solution: he suggests we go beyond the patient and engage their wider group of loved ones. By engaging what Calvert calls the Support Circle - those people most likely to "encourage the health and well being of that patient as they undergo a difficult period of their life" - trial teams will find themselves with a more supported, and therefore more engaged, participant, with corresponding benefits to enrollment and retention. 

Calvert outlines a number of potential mechanisms to get spouses, children, and other loved ones involved in the trial process:
During the consent process the patient can invite their support team in with them. A mobile application can be put on their phones enabling encouraging messages, emails, and texts to be sent. Loved ones can see if their companion or family member did indeed take today’s medication or make last Monday’s appointment. Gamification offers badges or pop-ups: “Two months of consecutive appointments attended” or “perfect eDiary log!” Loved ones can see those notifications, like/comment, and constantly encourage the patients. 
Supporting materials can also be included in the Support Circle application. There are a host of unknown terms to patients and their team. Glossaries, videos, FAQs, contact now, and so much more can be made available at their fingertips.
I have to admit I'm fascinated by Calvert's idea. I want him to be right: the picture of supportive, encouraging, loving spouses and children standing by to help a patient get through a clinical trial is an attractive one. So is the idea that they're just waiting for us to include them - all we need to do is a bit of digital communication with them to get them fully on board as members of the study team.

The problem, however, remains: we have absolutely no evidence that this approach will work. There is no data showing that it is superior to other approaches to engage trial patients.

(In fact, we may even have some indirect evidence that it may hinder enrollment: in trials that require active caregiver participation, such as those in Alzheimer's Disease, caregivers are believed to often contribute to the barriers to patient enrollment).

Calvert's idea is a good one, and it's worthy of consideration. More importantly, it's worthy of being rigorously tested against other recruitment and retention approaches. We have a lot of cool new technologies, and even more great ideas - we're not lacking for those. What we're lacking is hard data showing us how these things perform. What we especially need is comparative data showing how new tactics work relative to other approaches.

Over 5 years ago, I wrote a blog post bemoaning the sloppy approaches we take in trial recruitment - a fact made all the more painfully ironic by the massive intellectual rigor of the trials themselves. I'm not at all sure that we've made any real progress in those 5 years.

In my next post, I'll outline what I believe are some of the critical steps we need to take to improve the current situation, and start bringing some solid evidence to the table along with our ideas.

[Photo credit: Flikr user Matthew G, "Love (of technology)"]







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A human bird flu case is thought to be found in Canada for the first time

A person has tested positive in British Columbia, Canadian health officials said, though the results must be sent to another lab for confirmation.




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Cara Melihat Maxwin Saat Bermain Slot

Mesin slot sering kali memiliki istilah maxwin yang mengacu pada jumlah tertinggi yang bisa dimenangkan seorang pemain dalam permainan. Maxwins dalam slot biasanya dikaitkan dengan kombinasi simbol tertentu yang, jika…

The post Cara Melihat Maxwin Saat Bermain Slot appeared first on Biosimilarnews.



  • Tips & Trik

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“Snake-like” Probe Images Arteries from Within



Neurosurgeon Vitor Mendes Pereira has grown accustomed to treating brain aneurysms with only blurry images for guidance.

Equipped with a rough picture of the labyrinthine network of arteries in the brain, he does his best to insert mesh stents or coils of platinum wire—interventions intended to promote clotting and to seal off a bulging blood vessel.

The results are not always perfect. Without a precise window into the arterial architecture at the aneurysm site, Pereira says that he and other neurovascular specialists occasionally misplace these implants, leaving patients at a heightened risk of stroke, clotting, inflammation, and life-threatening ruptures. But a new fiber-optic imaging probe offers hope for improved outcomes.

Pereira et al./Science Translational Medicine

According to Pereira’s early clinical experience, the technology—a tiny snake-like device that winds its way through the intricate maze of brain arteries and, using spirals of light, captures high-resolution images from the inside-out—provides an unprecedented level of structural detail that enhances the ability of clinicians to troubleshoot implant placement and better manage disease complications.

“We can see a lot more information that was not accessible before,” says Pereira, director of endovascular research and innovation at St. Michael’s Hospital in Toronto. “This is, for us, an incredible step forward.”

And not just for brain aneurysms. In a report published today in Science Translational Medicine, Pereira and his colleagues describe their first-in-human experience using the platform to guide treatment for 32 people with strokes, artery hardening, and various other conditions arising from aberrant blood vessels in the brain.

Whereas before, with technologies such as CT scans, MRIs, ultrasounds, and x-rays, clinicians had a satellite-like view of the brain’s vascular network, now they have a Google Street View-like perspective, complete with in-depth views of artery walls, plaques, immune cell aggregates, implanted device positions, and more.

“The amount of detail you could get you would never ever see with any other imaging modality,” says Adnan Siddiqui, a neurosurgeon at the University at Buffalo, who was not involved in the research. “This technology holds promise to be able to really transform the way we evaluate success or failure of our procedures, as well as to diagnose complications before they occur.”

A Decade of Innovation

The new fiber-optic probe is flexible enough to snake through the body’s arteries and provide previously unavailable information to surgeons.Pereira et al./Science Translational Medicine

The new imaging platform is the brainchild of Giovanni Ughi, a biomedical engineer at the University of Massachusetts’ Chan Medical School in Worcester. About a decade ago, he set out to adapt a technique called optical coherence tomography (OCT) for imaging inside the brain’s arteries.

OCT relies on the backscattering of near-infrared light to create cross-sectional images with micrometer-scale spatial resolution. Although OCT had long been used in clinical settings to generate pictures from the back of the eye and from inside the arteries that supply blood to the heart, the technology had proven difficult to adapt for brain applications owing to several technical challenges.

One major challenge is that the fiber-optic probes used in the technology are typically quite stiff, making them too rigid to twist and bend through the convoluted passageways of the brain’s vasculature. Additionally, the torque cables—traditionally used to rotate the OCT lens to image surrounding vessels and devices in three dimensions as the probe retracts—were too large to fit inside the catheters that are telescopically advanced into the brain’s arteries to address blockages or other vascular issues.

“We had to invent a new technology,” Ughi explains. “Our probe had to be very, very flexible, but also very, very small to be compatible with the clinical workflow.”

To achieve these design criteria, Ughi and his colleagues altered the properties of the glass at the heart of their fiber-optic cables, devised a new system of rotational control that does away with torque cables, miniaturized the imaging lens, and made a number of other engineering innovations.

The end result: a slender probe, about the size of a fine wire, that spins 250 times per second, snapping images as it glides back through the blood vessel. Researchers flush out blood cells with a tablespoon of liquid, then manually or automatically retract the probe, revealing a section of the artery about the length of a lip balm tube.

St. Michael’s Foundation

Clinical Confirmation

After initial testing in rabbits, dogs, pigs, and human cadavers, Ughi’s team sent the device to two clinical groups: Pereira’s in Toronto and Pedro Lylyk’s at the Sagrada Familia Clinic in Buenos Aires, Argentina. Across the two groups, neurosurgeons treated the 32 participants in the latest study, snaking the imaging probe through the patients’ groins or wrists and into their brains.

The procedure was safe and well-tolerated across different anatomies, underlying disease conditions, and the complexity of prior interventions. Moreover, the information provided frequently led to actionable insights—in one case, prompting clinicians to prescribe anti-platelet drugs when hidden clots were discovered; in another, aiding in the proper placement of stents that were not flush against the arterial wall.

“We were successful in every single case,” Ughi says. “So, this was a huge confirmation that the technology is ready to move forward.”

“We can see a lot more information that was not accessible before.” —Vitor Mendes Pereira, St. Michael’s Hospital

A startup called Spryte Medical aims to do just that. According to founder and CEO David Kolstad, the company is in discussions with regulatory authorities in Europe, Japan, and the United States to determine the steps necessary to bring the imaging probe to market.

At the same time, Spryte—with Ughi as senior director of advanced development and software engineering—is working on machine learning software to automate the image analysis process, thus simplifying diagnostics and treatment planning for clinicians.

Bolstered by the latest data, cerebrovascular specialists like Siddiqui now say they are chomping at the bit to get their hands on the imaging probe once it clears regulatory approval.

“I’m really impressed,” Siddiqui says. “This is a tool that many of us who do these procedures wish they had.”




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Bath Engineers Bet on Dirt for Micropower



A thimbleful of soil can contain a universe of microorganisms, up to 10 billion by some estimates. Now a group of researchers in Bath, United Kingdom, are building prototype technologies that harvest electrons exhaled by some micro-species.

The idea is to power up low-yield sensors and switches, and perhaps help farmers digitally optimize crop yields to meet increasing demand and more and more stressful growing conditions. There could be other tasks, too, that might make use of a plant-and-forget, low-yield power source—such as monitoring canals for illegal waste dumping.

The research started small, based out of the University of Bath, with field-testing in a Brazilian primary school classroom and a green pond near it—just before the onset of the pandemic.

“We had no idea what the surroundings would be. We just packed the equipment we needed and went,” says Jakub Dziegielowski, a University of Bath, U.K. chemical engineering Ph.D. student. “And the pond was right by the school—it was definitely polluted, very green, with living creatures in it, and definitely not something I’d feel comfortable drinking from. So it got the job done.”

The experiments they did along with kids from the school and Brazilian researchers that summer of 2019 were aimed at running water purifiers. It did so. However, it also wasn’t very efficient, compared to, say, a solar panel.

So work has moved on in the Bath labs: in the next weeks, Dziegielowski will both turn 29 and graduate with his doctorate. And he, along with two other University of Bath advisors and colleagues recently launched a spinoff company—it’s called Bactery—to perfect a prototype for a network of soil microbial fuel cells for use in agriculture.

A microbial fuel cell is a kind of power plant that converts chemical energy stored in organic molecules into electrical energy, using microbes as a catalyst. It’s more often used to refer to liquid-based systems, Dziegielowski says. Organics from wastewater serve as the energy source, and the liquid stream mixes past the electrodes.

A soil microbial fuel cell, however, has one of its electrodes—the anode, which absorbs electrons—in the dirt. The other electrode, the cathode, is exposed to air. Batteries work because ions move through an electrolyte between electrodes to complete a circuit. In this case, the soil itself acts as the electrolyte—as well as source of the catalytic microbes, and as the source of the fuel.

The Bath, U.K.-based startup Bactery has developed a set up fuel cells powered by microbes in the soil—with, in the prototype pictured here, graphite mats as electrodes. University of Bath

Fields full of Watts

In a primary school in the fishing village of Icapuí on Brazil’s semi-arid northeastern coast, the group made use of basic components: graphite felt mats acting as electrodes, and nylon pegs to maintain spacing and alignment between them. (Bactery is now developing new kinds of casing.)

By setting up the cells in a parallel matrix, the Icapuí setup could generate 38 milliwatts per square meter. In work since, the Bath group’s been able to reach 200 milliwatts per square meter.

Electroactive bacteria—also called exoelectrogens or electricigens—take in soluble iron or acids or sugar and exhale electrons. There are dozens of species of microbes that can do this, including bacteria belonging to genera such as Geobacter and Shewanella. There are many others.

But 200 milliwatts per square meter is not a lot of juice: enough to charge a mobile phone, maybe, or keep an LED nightlight going—or, perhaps, serve as a power source for sensors or irrigation switches. “As in so many things, it comes down to the economics,” says Bruce Logan, an environmental engineer at Penn State who wrote a 2007 book, Microbial Fuel Cells.

A decade ago Palo Alto engineers launched the MudWatt, a self-contained kit that could light a small LED. It’s mostly marketed as a school science project. But even now, some 760 million people do not have reliable access to electricity. “In remote areas, soil microbial fuel cells with higher conversion and power management efficiencies would fare better than batteries,” says Sheela Berchmans, a retired chief scientist of the Central Electrochemical Research Institute in Tamil Nadu, India.

Korneel Rabaey, professor in the department of biotechnology at the University of Ghent, in Belgium, says electrochemical micro-power sources—a category that now includes the Bactery battery—is gaining buzz in resource recovery, for uses such as extracting pollutants from wastewater, with electricity as a byproduct. “You can think of many applications that don’t require a lot of power,” he says, “But where sensors are important.”




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The Best Bionic Leg Yet



For the first time, a small group of patients with amputations below the knee were able to control the movements of their prosthetic legs through neural signals—rather than relying on programmed cycles for all or part of a motion—and resume walking with a natural gait. The achievement required a specialized amputation surgery combined with a non-invasive surface electrode connection to a robotic prosthetic lower leg. A study describing the technologies was published today in the journal Nature Medicine.

“What happens then is quite miraculous. The patients that have this neural interface are able to walk at normal speeds; and up and down steps and slopes; and maneuver obstacles really without thinking about it. It’s natural. It’s involuntary,” said co-author Hugh Herr, who develops bionic prosthetics at the MIT Media Lab. “Even though their limb is made of titanium and silicone—all these various electromechanical components—the limb feels natural and it moves naturally, even without conscious thought.”

The approach relies on surgery at the amputation site to create what the researchers call an agonist-antagonist myoneural Interface, or AMI. The procedure involves connecting pairs of muscles (in the case of below-the-knee amputation, two pairs), as well as the introduction of proprietary synthetic elements.

The interface creates a two-way connection between body and machine. Muscle-sensing electrodes send signals to a small computer in the prosthetic limb that interprets them as angles and forces for joints at the ankle and ball of the foot. It also sends information back about the position of the artificial leg, restoring a sense of where the limb is in space, also known as proprioception.

Video 1 www.youtube.com

“The particular mode of control is far beyond what anybody else has come up with,” said Daniel Ferris, a neuromechanical engineer at the University of Florida; Ferris was not involved in the study, but has worked on neural interfaces for controlling lower limb prostheses. “It’s a really novel idea that they’ve built on over the last eight years that’s showing really positive outcomes for better bionic lower legs.” The latest publication is notable for a larger participant pool than previous studies, with seven treatment patients and seven control patients with amputations and typical prosthetic legs.

To test the bionic legs, patients were asked to walk on level ground at different speeds; up and down slopes and stairs; and to maneuver around obstacles. The AMI users had a more natural gait, more closely resembling movement by someone using a natural limb. More naturalistic motion can improve freedom of movement, particularly over challenging terrain, but in other studies researchers have also noted reduced energetic costs, reduced stress on the body, and even social benefits for some amputees.

Co-author Hyungeun Song, a postdoctoral researcher at MIT, says the group was surprised by the efficiency of the bionic setup. The prosthetic interface sent just 18 percent of the typical amount of information that’s sent from a limb to the spine, yet it was enough to allow patients to walk with what was considered a normal gait.

Next Steps for the Bionic Leg

AMI amputations have now become the standard at Brigham and Women’s Hospital in Massachusetts, where co-author Matthew Carty works. And because of patient benefits in terms of pain and ease of using even passive (or non-robotic) prosthetics, this technique—or something similar—could spread well beyond the current research setting. To date, roughly 60 people worldwide have received AMI surgery above or below either an elbow or knee.

In principle, Herr said, someone with a previously amputated limb, such as himself, could undergo AMI rehabilitation, and he is strongly considering the procedure. More than 2 million Americans are currently living with a lost limb, according to the Amputee Coalition, and nearly 200,000 lower legs are amputated each year in the United States.

On the robotics side, there are already commercial leg prosthetics that could be made compatible with the neural interface. The area in greatest need of development is the connection between amputation site and prosthesis. Herr says commercialization of that interface might be around five years away.

Herr says his long-term goal is neural integration and embodiment: the sense that a prosthetic is part of the body, rather than a tool. The new study “is a critical step forward—pun intended.”




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Biocompatible Mic Could Lead to Better Cochlear Implants



Cochlear implants—the neural prosthetic cousins of standard hearing aids—can be a tremendous boon for people with profound hearing loss. But many would-be users are turned off by the device’s cumbersome external hardware, which must be worn to process signals passing through the implant. So researchers have been working to make a cochlear implant that sits entirely inside the ear, to restore speech and sound perception without the lifestyle restrictions imposed by current devices.

A new biocompatible microphone offers a bridge to such fully internal cochlear implants. About the size of a grain of rice, the microphone is made from a flexible piezoelectric material that directly measures the sound-induced motion of the eardrum. The tiny microphone’s sensitivity matches that of today’s best external hearing aids.

Cochlear implants create a novel pathway for sounds to reach the brain. An external microphone and processor, worn behind the ear or on the scalp, collect and translate incoming sounds into electrical signals, which get transmitted to an electrode that’s surgically implanted in the cochlea, deep within the inner ear. There, the electrical signals directly stimulate the auditory nerve, sending information to the brain to interpret as sound.

But, says Hideko Heidi Nakajima, an associate professor of otolaryngology at Harvard Medical School and Massachusetts Eye and Ear, “people don’t like the external hardware.” They can’t wear it while sleeping, or while swimming or doing many other forms of exercise, and so many potential candidates forgo the device altogether. What’s more, incoming sound goes directly into the microphone and bypasses the outer ear, which would otherwise perform the key functions of amplifying sound and filtering noise. “Now the big idea is instead to get everything—processor, battery, microphone—inside the ear,” says Nakajima. But even in clinical trials of fully internal designs, the microphone’s sensitivity—or lack thereof—has remained a roadblock.

Nakajima, along with colleagues from MIT, Harvard, and Columbia University, fabricated a cantilever microphone that senses the motion of a bone attached behind the eardrum called the umbo. Sound entering the ear canal causes the umbo to vibrate unidirectionally, with a displacement 10 times as great as other nearby bones. The tip of the “UmboMic” touches the umbo, and the umbo’s movements flex the material and produce an electrical charge through the piezoelectric effect. These electrical signals can then be processed and transmitted to the auditory nerve. “We’re using what nature gave us, which is the outer ear,” says Nakajima.

Why a cochlear implant needs low-noise, low-power electronics

Making a biocompatible microphone that can detect the eardrum’s minuscule movements isn’t easy, however. Jeff Lang, a professor of electrical engineering at MIT who jointly led the work, points out that only certain materials are tolerated by the human body. Another challenge is shielding the device from internal electronics to reduce noise. And then there’s long-term reliability. “We’d like an implant to last for decades,” says Lang.

In tests of the implantable microphone prototype, a laser beam measures the umbo’s motion, which gets transferred to the sensor tip. JEFF LANG & HEIDI NAKAJIMA

The researchers settled on a triangular design for the 3-by-3-millimeter sensor made from two layers of polyvinylidene fluoride (PVDF), a biocompatible piezoelectric polymer, sandwiched between layers of flexible, electrode-patterned polymer. When the cantilever tip bends, one PVDF layer produces a positive charge and the other produces a negative charge—taking the difference between the two cancels much of the noise. The triangular shape provides the most uniform stress distribution within the bending cantilever, maximizing the displacement it can undergo before it breaks. “The sensor can detect sounds below a quiet whisper,” says Lang.

Emma Wawrzynek, a graduate student at MIT, says that working with PVDF is tricky because it loses its piezoelectric properties at high temperatures, and most fabrication techniques involve heating the sample. “That’s a challenge especially for encapsulation,” which involves encasing the device in a protective layer so it can remain safely in the body, she says. The group had success by gradually depositing titanium and gold onto the PVDF while using a heat sink to cool it. That approach created a shielding layer that protects the charge-sensing electrodes from electromagnetic interference.

The other tool for improving a microphone’s performance is, of course, amplifying the signal. “On the electronics side, a low-noise amp is not necessarily a huge challenge to build if you’re willing to spend extra power,” says Lang. But, according to MIT graduate student John Zhang, cochlear implant manufacturers try to limit power for the entire device to 5 milliwatts, and just 1 mW for the microphone. “The trade-off between noise and power is hard to hit,” Zhang says. He and fellow student Aaron Yeiser developed a custom low-noise, low-power charge amplifier that outperformed commercially available options.

“Our goal was to perform better than or at least equal the performance of high-end capacitative external microphones,” says Nakajima. For leading external hearing-aid microphones, that means sensitivity down to a sound pressure level of 30 decibels—the equivalent of a whisper. In tests of the UmboMic on human cadavers, the researchers implanted the microphone and amplifier near the umbo, input sound through the ear canal, and measured what got sensed. Their device reached 30 decibels over the frequency range from 100 hertz to 6 kilohertz, which is the standard for cochlear implants and hearing aids and covers the frequencies of human speech. “But adding the outer ear’s filtering effects means we’re doing better [than traditional hearing aids], down to 10 dB, especially in speech frequencies,” says Nakajima.

Plenty of testing lies ahead, at the bench and on sheep before an eventual human trial. But if their UmboMic passes muster, the team hopes that it will help more than 1 million people worldwide go about their lives with a new sense of sound.

The work was published on 27 June in the Journal of Micromechanics and Microengineering.




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A Bendy RISC-V Processor



For the first time, scientists have created a flexible programmable chip that is not made of silicon. The new ultralow-power 32-bit microprocessor from U.K.-based Pragmatic Semiconductor and its colleagues can operate while bent, and can run machine learning workloads. The microchip’s open-source RISC-V architecture suggests it might cost less than a dollar, putting it in a position to power wearable healthcare electronics, smart package labels, and other inexpensive items, its inventors add.

For example, “we can develop an ECG patch that has flexible electrodes attached to the chest and a flexible microprocessor connected to flexible electrodes to classify arrhythmia conditions by processing the ECG data from a patient,” says Emre Ozer, senior director of processor development at Pragmatic, a flexible chip manufacturer in Cambridge, England. Detecting normal heart rhythms versus an arrhythmia “is a machine learning task that can run in software in the flexible microprocessor,” he says.

Flexible electronics have the potential for any application requiring interactions with soft materials, such as devices worn on or implanted within the body. Those applications could include on-skin computers, soft robotics, and brain-machine interfaces. But, conventional electronics are made of rigid materials such as silicon.

Open-source, Flexible, and Fast Enough

Pragmatic sought to create a flexible microchip that cost significantly less to make than a silicon processor. The new device, named Flex-RV, is a 32-bit microprocessor based on the metal-oxide semiconductor indium gallium zinc oxide (IGZO).

Attempts to create flexible devices from silicon require special packaging for the brittle microchips to protect them from the mechanical stresses of bending and stretching. In contrast, pliable thin-film transistors made from IGZO can be made directly at low temperatures onto flexible plastics, leading to lower costs.

The new microchip is based on the RISC-V instruction set. (RISC stands for reduced instruction set computer.) First introduced in 2010, RISC-V aims to enable smaller, lower-power, better-performing processors by slimming down the core set of instructions they can execute.

“Our end goal is to democratize computing by developing a license-free microprocessor,” Ozer says.

RISC-V’s is both free and open-source, letting chip designer dodge the costly licensing fees associated with proprietary architectures such as x86 and Arm. In addition, proprietary architectures offer limited opportunities to customize them, as adding new instructions is generally restricted. In contrast, RISC-V encourages such changes.

A bent Flex-RV microprocessor runs a program to print ‘Hello World’. Pragmatic Semiconductor

“We chose the Serv designed by Olof Kindgren... as the open source 32-bit RISC-V CPU when we designed Flex-RV,” Ozer says. “Serv is the smallest RISC-V processor in the open-source community.”

Other processors have been built using flexible semiconductors, such as Pragmatic’s 32-bit PlasticARM and an ultracheap microcontroller designed by engineers in Illinois. Unlike these earlier devices, Flex-RV is programmable and can run compiled programs written in high-level languages such as C. In addition, the open-source nature of RISC-V also let the researchers equip Flex-RV with a programmable machine learning hardware accelerator, enabling artificial intelligence applications.

Each Flex-RV microprocessor has a 17.5 square millimeter core and roughly 12,600 logic gates. The research team found Flex-RV could run as fast as 60 kilohertz while consuming less than 6 milliwatts of power.

All previous flexible non-silicon microprocessors were tested solely on the wafers they were made on. In contrast, Flex-RV was tested on flexible printed circuit boards, which let the researchers see how well it operated when flexed. The Pragmatic team found that Flex-RV could still execute programs correctly when bent to a curve with a radius of 3 millimeters. Performance varied between a 4.3 percent slowdown to a 2.3 percent speedup depending on the way it was bent. “Further research is needed to understand how bending conditions such as direction, orientation and angle impact performance at macro and micro scales,” Ozer says.

Silicon microchips can run at gigahertz speeds, much faster than Flex-RV, but that shouldn’t be a problem, according to Ozer. “Many sensors—for example, temperature, pressure, odor, humidity, pH, and so on—in the flexible electronics world typically operate very slowly at hertz or kilohertz regimes,” he says. “These sensors are used in smart packaging, labels and wearable healthcare electronics, which are the emerging applications for which flexible microprocessors will be useful. Running the microprocessor at 60 kHz would be more than enough to meet the requirements of these applications.”

Ozer and his team suggest each Flex-RV might cost less than a dollar. Although Ozer did not want to say how much less than a dollar it might cost, he says they are confident such low costs are possible “thanks to low-cost flexible chip fabrication technology by Pragmatic and a license-free RISC-V technology.”

The scientists detailed their findings online 25 September in the journal Nature.




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Crop Parasites Can Be Deterred by “Electric Fences”



Imagine you’re a baby cocoa plant, just unfurling your first tentative roots into the fertile, welcoming soil.

Somewhere nearby, a predator stirs. It has no ears to hear you, no eyes to see you. But it knows where you are, thanks in part to the weak electric field emitted by your roots.

It is microscopic, but it’s not alone. By the thousands, the creatures converge, slithering through the waterlogged soil, propelled by their flagella. If they reach you, they will use fungal-like hyphae to penetrate and devour you from the inside. They’re getting closer. You’re a plant. You have no legs. There’s no escape.

But just before they fall upon you, they hesitate. They seem confused. Then, en masse, they swarm off in a different direction, lured by a more attractive electric field. You are safe. And they will soon be dead.

If Eleonora Moratto and Giovanni Sena get their way, this is the future of crop pathogen control.

Many variables are involved in the global food crisis, but among the worst are the pests that devastate food crops, ruining up to 40 percent of their yield before they can be harvested. One of these—the little protist in the example above, an oomycete formally known as Phytophthora palmivorahas a US $1 billion appetite for economic staples like cocoa, palm, and rubber.

There is currently no chemical defense that can vanquish these creatures without poisoning the rest of the (often beneficial) organisms living in the soil. So Moratto, Sena, and their colleagues at Sena’s group at Imperial College London settled on a non-traditional approach: They exploited P. palmivora’s electric sense, which can be spoofed.

All plant roots that have been measured to date generate external ion flux, which translates into a very weak electric field. Decades of evidence suggests that this signal is an important target for predators’ navigation systems. However, it remains a matter of some debate how much their predators rely on plants’ electrical signatures to locate them, as opposed to chemical or mechanical information. Last year, Moratto and Sena’s group found that P. palmivora spores are attracted to the positive electrode of a cell generating current densities of 1 ampere per square meter. “The spores followed the electric field,” says Sena, suggesting that a similar mechanism helps them find natural bioelectric fields emitted by roots in the soil.

That got the researchers wondering: Might such an artificial electric field override the protists’ other sensory inputs, and scramble their compasses as they tried to use plant roots’ much weaker electrical output?

To test the idea, the researchers developed two ways to protect plant roots using a constant vertical electric field. They cultivated two common snacks for P. palmivoraa flowering plant related to cabbage and mustard, and a legume often used as a livestock feed plant—in tubes in a hydroponic solution.

Two electric-field configurations were tested: A “global” vertical field [left] and a field generated by two small nearby electrodes. The global field proved to be slightly more effective.Eleonora Moratto

In the first assay, the researchers sandwiched the plant roots between rows of electrodes above and below, which completely engulfed them in a “global” vertical field. For the second set, the field was generated using two small electrodes a short distance away from the plant, creating current densities on the order of 10 A/m2. Then they unleashed the protists.

With respect to the control group, both methods successfully diverted a significant portion of the predators away from the plant roots. They swarmed the positive electrode, where—since zoospores can’t survive for longer than about 2 to 3 hours without a host—they presumably starved to death. Or worse. Neil Gow, whose research presented some of the first evidence for zoospore electrosensing, has other theories about their fate. “Applied electrical fields generate toxic products and steep pH gradients near and around the electrodes due to the electrolysis of water,” he says. “The tropism towards the electrode might be followed by killing or immobilization due to the induced pH gradients.”

Not only did the technique prevent infestation, but some evidence indicates that it may also mitigate existing infections. The researchers published their results in August in Scientific Reports.

The global electric field was marginally more successful than the local. However, it would be harder to translate from lab conditions into a (literal) field trial in soil. The local electric field setup would be easy to replicate: “All you have to do is stick the little plug into the soil next to the crop you want to protect,” says Sena.

Moratto and Sena say this is a proof of concept that demonstrates a basis for a new, pesticide-free way to protect food crops. (Sena likens the technique to the decoys used by fighter jets to draw away incoming missiles by mimicking the signals of the original target.) They are now looking for funding to expand the project. The first step is testing the local setup in soil; the next is to test the approach on Phytophthora infestans, a meaner, scarier cousin of P. palmivora.

P. infestans attacks a more varied diet of crops—you may be familiar with its work during the Irish potato famine. The close genetic similarities imply another promising candidate for electrical pest control. This investigation, however, may require more funding. P. infestans research can be undertaken only under more stringent laboratory security protocols.

The work at Imperial ties into the broader—and somewhat charged—debate around electrostatic ecology; that is, the extent to which creatures including ticks make use of heretofore poorly understood electrical mechanisms to orient themselves and in other ways enhance their survival. “Most people still aren’t aware that naturally occurring electricity can play an ecological role,” says Sam England, a behavioral ecologist with Berlin’s Natural History Museum. “So I suspect that once these electrical phenomena become more well known and understood, they will inspire a greater number of practical applications like this one.”




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How Did Attendees at a Behavioral Health Conference React to Trump’s Victory?

When it comes to the effects that the upcoming Trump presidency will have on healthcare, attendees’ attitudes ranged from cautiously optimistic to fairly anxious. Some of the issues they highlighted included mental health parity, telehealth prescribing flexibilities, and the role of Robert F. Kennedy Jr.

The post How Did Attendees at a Behavioral Health Conference React to Trump’s Victory? appeared first on MedCity News.




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Pregnant and Empowered: Why Trust is the Latest Form of Member Engagement

Three ways health plans can engage, connect with, and delight their pregnant members to nurture goodwill, earn long-term trust, and foster loyal relationships that last.

The post Pregnant and Empowered: Why Trust is the Latest Form of Member Engagement appeared first on MedCity News.




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CVS Health Exec: Payers Need to Stop Making Behavioral Health Providers Jump Through Hoops In Order to Participate in Value-Based Care

Value-based care contracting is especially difficult for behavioral health providers, Taft Parsons III, chief psychiatric officer at CVS Health/Aetna, pointed out during a conference this week.

The post CVS Health Exec: Payers Need to Stop Making Behavioral Health Providers Jump Through Hoops In Order to Participate in Value-Based Care appeared first on MedCity News.




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Relaxed Federal Regulations Amid Pandemic Can Help Jails Better Treat Opioid Use Disorder

Few correctional facilities in the United States have treatment programs for individuals with opioid use disorder (OUD), despite clear evidence that certain medications reduce the risk of overdose and death. Even in facilities where treatment is available, the COVID-19 pandemic has complicated efforts to provide such care.




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Pew Urges Federal Government to Prioritize Better Exchange of Health Data

The Pew Charitable Trusts sent comments Jan. 4 to the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) urging them to support the easy exchange of individuals’ health records through a pair of regulations.




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Tools to Boost Beneficial Bacteria Can Help Poultry Farms Fight Salmonella

Chicken products cause an estimated 1 in 7 of the nation’s human Salmonella illnesses each year, partly because the pathogen can easily contaminate the environments where birds are raised. To reduce the risk that contaminated meat will reach consumers, poultry companies need measures that control the bacterium on farms where chickens are bred and raised.




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Do People Believe Misinformation on Vaccines?

Social media has become a significant source of health-related content. But while it connects people to news, updates, […]

The post Do People Believe Misinformation on Vaccines? appeared first on World of DTC Marketing.



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Be a SAS certified data scientist

This new program offers two immersive program levels, industry-recognized credentials, classroom instruction, around-the-clock access to SAS software and course materials, and more.




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China unveils first diagnosis guidelines to battle escalating obesity crisis

HONG KONG — China's National Health Commission (NHC) published its first set of guidelines to standardise the diagnosis and treatment of obesity, with more than half of China's adults already overweight and obese, and the rate expected to keep rising.  The guidelines, made public on October 17, come as China experiences an upward morbidity trend of its overweight and obese population. The rate of overweight or obese people could reach 65.3 per cent by 2030, the NHC said.   "Obesity has become a major public health issue in China, ranking as the sixth leading risk factor for death and disability in the country," the guidelines said. China is facing a twin challenge that feeds its weight problem: In a modernising economy underpinned by technological innovation, more jobs have become static or desk-bound, while a prolonged slowdown in growth is forcing people to adopt cheaper, unhealthy diets.




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McDonald's E. coli crisis reveals why vegetable contamination is harder problem than tainted beef

NEW YORK – Moves by major US fast-food chains to temporarily scrub fresh onions off their menus on Oct 24, after the vegetable was named as the likely source of an E. coli outbreak at McDonald’s, laid bare the recurring nightmare for restaurants: Produce is a bigger problem for restaurants to keep free of contamination than beef. Onions are likely the culprit in the McDonald’s E. coli outbreak across the Midwest and some Western states that has sickened 49 people and killed one, the US Department of Agriculture said late on Oct 23. The company pulled the Quarter Pounder off its menu at one-fifth of its 14,000 US restaurants. In past years, beef patties dominated the dockets of food-borne-illness lawyers, before US federal health regulators cracked down on beef contamination after an E. coli outbreak linked to Jack in the Box burgers hospitalised more than 170 people across states and killed four. As a result, beef-related outbreaks became much rarer, experts say.




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McDonald's rules out beef patties as source of E. coli outbreak

NEW YORK — McDonald's on Sunday (Oct 27) ruled out beef patties as a source of the E. coli outbreak linked to Quarter Pounder hamburgers, which has killed at least one person and sickened nearly 75 others. "We remain very confident that any contaminated product related to this outbreak has been removed from our supply chain and is out of all McDonald's restaurants," the fast-food chain's chief supply chain officer Cesar Pina said in a statement. The Colorado Department of Agriculture said that all subsamples from multiple lots of McDonald's brand fresh and frozen beef patties had tested negative for E. coli, adding that it had completed beef testing and does not anticipate receiving further samples. McDonald's said it would resume distribution of fresh supplies of the Quarter Pounder and that it is expected to be available in all restaurants in the coming week, according to the statement.




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Michelle Yeoh hadn't heard of musical Wicked before being asked to join cast of movie

Michelle Yeoh had never heard of Wicked before she was asked to join the cast of the movie-musical. The Oscar-winning actress plays Madame Morrible in the new film version of the hit stage show, which is based around characters first seen on screen in 1939 movie The Wizard of Oz. She's confessed she knew nothing about the popular musical before she was approached by director Jon M. Chu about joining the cast. According to The Hollywood Reporter, she said: "At that point, I had no clue what he was talking about because I had not seen Wicked the musical before. I knew Wizard of Oz, who doesn't, but not Wicked because I hadn't been going to the theatres and was not doing what I love which is watching musicals for quite a while, I hate to say." The new movie stars Cynthia Erivo as Elphaba and Ariana Grande as Glinda during their time at Shiz University in the Land of Oz with Michelle's character Madame Morrible serving as the school's headmistress. Michelle went on to say: "So I read it [the script] and called Jon back and said, 'This is a musical and she sings'. And he said, 'Oh easy, you'll have fun, you're up for the challenge.'




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Denzel Washington confirms he will star in Black Panther 3 before retirement

Denzel Washington has confirmed he will star in Black Panther 3 before his retirement. The 69-year-old actor is the first to talk about the existence of a third film in the blockbuster Marvel franchise — which will follow the 2018 original and 2022 sequel Black Panther: Wakanda Forever — and has also revealed the film will be among a handful of roles he will take on before he bows out of acting after a career spanning four decades. Confirming director Ryan Coogler has written a role just for the Oscar-winner for the third instalment, Denzel told Australia's Today show: "At this point in my career, I'm only interested in working with the best, I don't know how many more films I will make, probably not that many. I want to do things that I haven't done." Sharing the roles he has lined up before he bids farewell to his Hollywood career, he said: "I played Othello at 22, I'm now going to play it at 70. After that, I'm playing Hannibal. After that, I've been talking with Steve McQueen about a film. After that, Ryan Coogler is writing a part for me in the next Black Panther.




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PSLE results to be out on Nov 20

SINGAPORE — Pupils who sat the PSLE will receive their results from 11am on Nov 20. The Education Ministry and Singapore Examinations and Assessment Board, in a joint statement on Nov 13, said arrangements have been made for pupils to collect their results. Pupils will get details on collection arrangements from their schools, it added. Those who are unable to collect their results from school in person can appoint someone to do so on their behalf on Nov 22. Eligible pupils will receive the Secondary 1 (S1) Option Form to select secondary schools with their PSLE results. Pupils are required to use their unique S1 personal identification number found on the top-right hand corner of the form to log in to the S1 Internet System to submit their school choices from 11.30am on Nov 20 to 3pm on Nov 26. Parents who need help with the online submission can contact the primary school before 3pm on Nov 26. Posting results will be released between Dec 18 and Dec 20 through SMS, the statement said. This information can also be accessed through the S1 Internet System or at the pupil's primary school.




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Social media magic: How a former chef became Bobby Saputra, the internet's favourite billionaire playboy

In July 2024, internet personality Bobby Saputra posted a video of himself living it up at what appeared to be the star-studded, ultra-lavish wedding of Radhika Merchant and Anant Ambani, the youngest child of Indian billionaire and Asia's richest man, Mukesh Ambani. The video featured clips of Saputra dancing, feasting and soaking up the "completely crazy" celebrations. He gushes in the voiceover: "It was like watching a Bollywood production." The video quickly went viral, racking up 6.6 million views on Instagram, 5.1 million on TikTok, and another 2.2 million on YouTube. Thousands left comments, including some celebrities who claimed they spotted him there. Except… he never set foot in the party. As it turns out, he had pieced together clips from a wedding he attended a few months prior — complete with him in full Indian attire, dancing with friends — and spliced in shots from the Ambani wedding that he found online. The result? Social media magic.




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Beijing pushes to join security efforts for citizens in Pakistan, sources say

ISLAMABAD — Beijing is pushing Pakistan to allow its own security staff to provide protection to thousands of Chinese citizens working in the South Asian nation, during talks after a car bombing in Karachi that was seen as a major security breach, sources said. Last month's airport bombing in the southern port city that killed two Chinese engineers returning to work on a project after a holiday in Thailand was the latest in a string of attacks on Beijing's interests in Pakistan. The attacks, and Islamabad's failure to deter them, have angered China, which has pushed Pakistan to begin formal negotiations for a joint security management system. Reuters spoke to five Pakistani security and government sources with direct knowledge of the previously unreported negotiations and demands on condition of anonymity, as the talks are sensitive, and reviewed a written proposal sent by Beijing to Islamabad. "They (Chinese) want to bring in their own security," said one official, who sat in on a recent meeting, adding that Pakistan had not so far agreed to such a step.




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Iran's Hiding Behind Deadly Friends Should Have a Price

Assaf Zoran argues that it is crucial to hold Iran accountable and convey the cost associated with arming, training, financing, and promoting violence through proxies.




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Soldiers' Dilemma: Foreign Military Training and Liberal Norm Conflict

When the U.S. military trains other states’ forces, it tries to impart liberal norms such as respect for human rights. But when liberal norms clash, these soldiers prioritize loyalty to their unit, the military, and shared goals.




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Reining in Rebellion: The Decline of Political Violence in South America, 1830–1929

After a century of rebellion, South America experienced a rapid decline in revolts in the early 1900s. Historical narratives and an analysis of a comprehensive new dataset show that the decrease stemmed in large part from the expansion and professionalization of the region’s militaries, which were driven by an export boom and the threat of interstate conflict. 




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After Sobers, Who? The Telegraph

In one of the first books I read, the writer had posed the question: ‘Who was the greatest all-rounder in the history of cricket?’, before providing this answer: ‘He was a left-arm bowler and a right-hand batsman, who was born in the village of Kirkheaton’. I now forget the title of the book, but remember [...]




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A Godson Remembers: Thammu Achaya and Indian Food History, The Telegraph

My first editor, Rukun Advani, once described himself as ‘a composite hybrid of the Indian and the Anglo-European’, who sought to reconcile ‘within himself those varying cultural influences which chauvinistic nationalists could only see as contradictions.’ This self-characterization I might avow as my own. One mark of the Anglo-European in me is that, unlike members [...]



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236332: US saw &quot;additional opportunities&quot; to embed own troops in Pakistan military&rsquo;s FATA operations




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207373: U.S. Special Forces embedded with Pakistan Special Services Group and Frontier Corps for operations in NWFP




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204260: U.S. special forces were embedded with Pakistan troops in 2009 anti-Taliban operations in the North-West Frontier Province




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Benazir asked U.S. for security, was turned away




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Pakistan's Punjab turning into hotbed of extremism, U.S. had warned




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Benazir spoke of terror camps, bid to oust her




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127580: Ambassador's meeting with Benazir Bhutto on security and investigation of Karachi attack

Benazir Bhutto claimed that the Sindh Government had informed her that if she goes to Larkhana (her ancestral home), she would be attacked.




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128579: security status of Benazir Bhutto when she was assasinated

It was made clear to the PPP representatives that certain dangers were inherent in the return of Bhutto to Karachi, mostly directed by elements from the northern areas.




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Maran called Karunanidhi's October 2008 resignation threat a diversionary &lsquo;drama'

Spoke of DMK leader's attempted ‘blackmail' on Sri Lanka, warned that the Congress ‘will carry this grudge and retaliate at the right time'




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&lsquo;Pakistan's actions at the UN may embolden other member states to oppose U.S. positions'

U.S. Mission in New York raised concerns about Pakistan's voting on key issues such as counterterrorism and human rights