Syensqo, previously part of Solvay Group and a global provider of advanced performance materials and chemical solutions, is making its debut at Compamed 2024.

Trelleborg Medical Solutions showcases its comprehensive polymer-based solutions and capabilities for the medical technology and biopharmaceutical industries at Compamed 2024 in Dusseldorf from November 11 to 14, at stand F02 in hall 8A.

Election polls are increasingly vulnerable to huge mistakes

The outcome of the 2024 U.S. presidential election could reshape policies from health care at home to nuclear proliferation abroad

People are really stressed about the U.S. presidential election. A psychiatrist offers several self-help methods to reduce feelings of despair

Analysis of a strain of the virus circulating in Central Africa shows genetic mutations indicative of sustained human-to-human spread

What was once fair under the law may become unfair when science changes. The law must react to uphold due process

In medieval times, astrology was considered a serious science, a branch of astronomy. Curator Larisa Grollemond of the Getty Museum, walks us through the medieval zodiac and how someone’s sign decided their day-to-day life.

The new president-elect can go beyond just pulling out of the Paris Agreement. But it may be more difficult to roll back clean energy policies

Researchers at North Carolina State University have developed a robotic prosthetic ankle that can provide stability for lower limb amputees. The ankle uses electromyographic sensors placed on the sites of muscles in the residual limb that then convey the intentions of the wearer with regard to movement. So far, the system has been shown to […]

On October 8, 2024, Drug Channels Institute will release our 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. This report—our fifteenth edition—remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry.

9 chapters, 350+ pages, 178 exhibits, 750+ endnotes: There is nothing else available that comes close to this valuable resource.

We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2024-25 edition at special discounted prices. This means that you can be among the first to access our new report. Those who preorder will receive a download link before October 8.

• Review pricing/license options and place a preorder

• Download a free pre-publication report overview (including key industry trends, What's New in this edition, the Table of Contents, and a List of Exhibits)

You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal. Click here to contact us if you would like to pay by corporate check or ACH.

Special preorder and launch pricing discounts will be valid through October 23, 2024.

Read on for more details.
Read more »

I am pleased to announce Drug Channels Institute's new 2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, available for purchase and immediate download.

• Download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits)

• Review pricing/license options and download the full 2024-25 report

We’re offering special discounted pricing if you order before October 23, 2024.

2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors—our 15th edition--remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry. This 2024-25 edition includes substantial new material—outlined on page vii of the report overview.

9 chapters, 380+ pages, 178 exhibits, more than 750 endnotes: There is nothing else available that comes close to this valuable resource.

You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal. Click here to contact us if you would like to pay by corporate check or ACH.

Email Paula Fein (paula@drugchannels.net) if you’d like to bundle your report purchase with access to DCI’s video webinars.

If you preordered the report, you should have already received an email with download instructions last week. Please contact us if you did not receive your email.

Read on for some additional details.
Read more »

Today’s guest post comes from Angie Franks, Chief Executive Officer of Kalderos.

Angie discusses how the Maximum Fair Price provision of the Inflation Reduction Act of 2022 will challenge providers, pharmacies, and manufacturers. She explains how Kalderos’ Truzo platform could reduce duplicate claims and address compliance issues.

To learn more, register for Kalderos’ October 25 webinar Cracking the MFP Code: How Flexible Technology Helps You Navigate an Evolving Landscape.

Read on for Angie’s insights.
Read more »

A new survey of plan sponsors sheds light on their satisfaction with transparency at large and small pharmacy benefit managers (PBMs).

As you will see, clients remain slightly more satisfied with the perceived transparency of smaller PBMs compared with the Big Three PBMs—CVS Caremark, Express Scripts, and Optum Rx.

However, plan sponsors are dissatisfied with transparency about how both large and small PBMs make money. Smaller PBMs have an edge, but it’s narrower than you might think.

Perhaps PBMs’ clients are unable or unwilling to negotiate better deals, write more effective contracts, and switch to more satisfying relationships. Or maybe they don’t mind the current system, despite the challenges for patients. Some argue that transparency could swoop down to solve this problem. Riddle me this: Should we watch what plan sponsors say, or what they do?

Read on to see what you think of my arguments below. Then, click here to share your thoughts with the Drug Channels community.
Read more »

Eeek! It's time for Drug Channels’ Halloween roundup of terrifying tales to share with your ghoulish fiends. This month’s tricks and treats:

• Spooky! Blue Shield of California frightens away the gross-to-net bubble with its Humira biosimilar strategy

• Vampiric! Prior authorization sinks its fangs into providers’ time

• Wicked! How the IRA will put a stake through specialty physician practices

• Eerie! Google’s monstrous AI podcasts leave me petrified

• Zoinks! Join the vampire hunters at Drug Channels Institute

Plus, Dr. Glaucomflecken tells us a frightening tale of copayments.

P.S. Stretch out your arms and join the ever-growing zombie horde who shamble after me on LinkedIn. You’ll find my ghostly rantings along with commentary from the undead hordes in the DCI community.
Read more »

Today’s guest post comes from Chris Dowd, Senior VP of Market Development at ConnectiveRx.

Chris examines three key trends that will affect patient support programs: the Inflation Reduction Act (IRA), legal/regulatory battles over copay adjustment programs, and uncertainties following a national election. He then outlines three actions that should guide manufacturers' preparation.

To learn more, register for ConnectiveRx’s free webinar on December 11: The Perfect Storm? Patient Support Programming in 2025 and Beyond.

Read on for Chris’s insights.
Read more »

Bonus Episode: Fast Facts on the ACRO D&I Grants Program ACRO’s Good Clinical Podcast is back with bonus episode! Host Sophia McLeod sat down with Tafoya Hubbard (ACRO Site Resource Grants Program Manager) and Kristen Surdam (ACRO D&I Steering Committee Member) to discuss ACRO’s new D&I Site Resource Grants Program. They provide background on the […]

The post Bonus Episode: ACRO’s Good Clinical Podcast first appeared on ACRO.

Today, ACRO is thrilled to announce the Good Clinical Podcast, where we take a look at the current state of clinical research and what direction the industry must head in to continue improving trials for patients. Host Sophia McLeod is joined by industry leaders to discuss the latest industry trends, cutting-edge innovation, and reflect on […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 1 first appeared on ACRO.

On the latest episode of ACRO’s Good Clinical Podcast, Dr. Tala Fakhouri (Associate Director for Data Science and Artificial Intelligence Policy, FDA) and Stephen Pyke (Chief Clinical Data & Digital Officer, Parexel) join the podcast to discuss how the FDA and regulators around the world are thinking about the use of AI in clinical research. […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 2 first appeared on ACRO.

On the latest episode of ACRO’s Good Clinical Podcast, Nicole Stansbury (SVP, Global Clinical Operations, Premier Research) and Madeleine Whitehead (RBQM Product & People Lead, Roche) join the podcast to discuss ACRO’s collaboration with TransCelerate BioPharma, Inc., the impact that ICH E6(R3) will have on Good Clinical Practice, and implications for innovation. They dive deeper […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 3 first appeared on ACRO.

RBQM: Moving Beyond a Belt & Suspenders Approach to Data Quality On the latest episode of ACRO’s Good Clinical Podcast, Danilo Branco (Director, Central Monitoring Operations, Fortrea), Cris McDavid (Director, Global Clinical Operations, RBQM, Parexel), and Valarie McGee (Senior Director, Clinical Systems Optimization, the PPD Clinical Research Business of Thermo Fisher Scientific) join the podcast […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 5 first appeared on ACRO.

The State of Clinical Trials in the UK: 2024 Update On the season 2 finale of ACRO’s Good Clinical Podcast, Steve Cutler (CEO, ICON plc) and Professor Lucy Chappell (CEO, NIHR) join the podcast to discuss the current clinical research landscape in the UK. They dive deeper into the competitive nature of bringing clinical research to a country, process-related challenges that need to […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 6 first appeared on ACRO.

Looking back over the last 40 years at FDA (as I have), there are three characteristics that create a more progressive environment at the agency: continuity of leadership, presidential support, and increased funding. For FDA in 2013 (as the saying goes): 2 out of 3 ain’t bad. In particular, medical innovation seems poised to flourish in an FDA environment where there is continuity of policy and leadership, instead of a new team learning the ropes. I explore this and other themes in the latest issue of Pharmaphorum.com. You can read my thoughts at: http://www.pharmaphorum.com/2013/01/29/fda-post-election-continuity-and-progress-likely-to-mark-2013/.

<p>On 3^&nbsp;June 2024,&nbsp;Resolution&nbsp;RDC No. 876 was published in Brazil in the Official Journal of the Union (DOU)[1],&nbsp;modifying the current regulations regarding the post-registration of biological products (RDC 413/2020).</p>

Community pharmacies should be reimbursed for their additional costs during the COVID-19 pandemic “as soon as possible”, the prime minister has told The Pharmaceutical Journal.

The UK’s first postal inhaler recycling scheme has been launched by pharmaceutical company Chiesi to support a more sustainable way of living for people with respiratory illnesses.

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets. Identifying

The post Looking for Opportunities to Accelerate Clinical Research in Rare Diseases appeared first on LifeSciVC.

An AllTrials report for the House of Commons Science and Technology Select Committee this week has found that 33 NHS trust sponsors and six UK universities are reporting none of their clinical trial results, while others have gone from 0% to 100% following an announcement from the Select Committee in January that universities and NHS […]

New research has shown that the majority of clinical trials which should be following the US law on reporting results aren’t. Less than half (41%) of clinical trial results were reported on time and 1 in 3 trials (36%) remain unreported. The research also found that clinical trials sponsored by companies are the most likely […]

1. Misstated an odds ratio of 4 as “4 times more likely to”
2. Overstated the recruitment success findings as being based on a sample 3 times larger than it actually was
3. Re-interpreted, without reservation, a statistical association as a causal relationship
4. Misstated the difference between the patient involvement categories as being a matter of merely “involving just one or two patients in the study team”

And you did these consistently and repeatedly – in Dr Wykes's blog post, in the KCL press release, and in the NIHR-written Guardian article.

• How to Catalyze a Clinical Trial - My inaugural post introducing the blog and its purpose
• Video: Predicting Referral Conversion in Clinical Trial Advertising - A somewhat technical but very important topic, how to visualize and model the “real time” results of recruitment advertising at the sites.
• The Crystal Ball is on the Fritz - What to do with a broken enrollment feasibility process, and how asking will never be as good as measuring

• The New Breed of Clinical Trial Matchmakers - A (hopefully pretty complete, thanks to knowledgeable commenters) listing of services looking to match interested patients to clinical trials
• Rethinking Patient Enrollment, in One Graphic - The perils of predictability in site-based enrollment
• Seize the Data! Will Big Data Save Us from Ourselves? - My take on what I consider to be the large and serious obstacles in the way of “Big Data” solutions for patient recruitment

Please take a look, and I will see you back here soon.

[Photo credit: detour sign via Flikr user crossley]

Your daily light exposure impacts your health. A new study finds that too much light at night and not enough natural light during the day can be harmful. This story first aired on Morning Edition on Nov. 4, 2024.

The National Institutes of Health, the crown jewel of biomedical research in the U.S., could face big changes under the new Trump administration, some fueled by pandemic-era criticisms of the agency.

Seolah-olah melintasi portal waktu, kita memasuki tahun 2024 dengan deretan provider judi slot online yang tidak hanya menemani, tetapi juga menggoda imajinasi. Setiap klik, setiap putaran gulungan, membuka lembaran baru…

The post Provider Judi Slot Gacor Online Terbaik serta Populer di Tahun 2024 appeared first on Biosimilarnews.

Nearly every day since she was a child, Alex Leow, a psychiatrist and computer scientist at the University of Illinois Chicago, has played the piano. Some days she plays well, and other days her tempo lags and her fingers hit the wrong keys. Over the years, she noticed a pattern: How well she plays depends on her mood. A bad mood or lack of sleep almost always leads to sluggish, mistake-prone music.

In 2015, Leow realized that a similar pattern might be true for typing. She wondered if she could help people with psychiatric conditions track their moods by collecting data about their typing style from their phones. She decided to turn her idea into an app.

After conducting a pilot study, in 2018 Leow launched BiAffect, a research app that aims to understand mood-related symptoms of bipolar disorder through keyboard dynamics and sensor data from users’ smartphones. Now in use by more than 2,700 people who have volunteered their data to the project, the app tracks typing speed and accuracy by swapping the phone’s onscreen keyboard with its own nearly identical one.

The software then generates feedback for users, such as a graph displaying hourly keyboard activity. Researchers get access to the donated data from users’ phones, which they use to develop and test machine learning algorithms that interpret data for clinical use. One of the things Leow’s team has observed: When people are manic—a state of being overly excited that accompanies bipolar disorder—they type “ferociously fast,” says Leow.

Compared to a healthy user [top], a person experiencing symptoms of bipolar disorder [middle] or depression [bottom] may use their phone more than usual and late at night. BiAffect measures phone usage and orientation to help track those symptoms. BiAffect

BiAffect is one of the few mental-health apps that take a passive approach to collecting data from a phone to make inferences about users’ mental states. (Leow suspects that fewer than a dozen are currently available to consumers.) These apps run in the background on smartphones, collecting different sets of data not only on typing but also on the user’s movements, screen time, call and text frequency, and GPS location to monitor social activity and sleep patterns. If an app detects an abrupt change in behavior, indicating a potentially hazardous shift in mental state, it could be set up to alert the user, a caretaker, or a physician.

Such apps can’t legally claim to treat or diagnose disease, at least in the United States. Nevertheless, many researchers and people with mental illness have been using them as tools to track signs of depression, schizophrenia, anxiety, and bipolar disorder. “There’s tremendous, immediate clinical value in helping people feel better today by integrating these signals into mental-health care,” says John Torous, director of digital psychiatry at Beth Israel Deaconess Medical Center, in Boston. Globally, one in 8 people live with a mental illness, including 40 million with bipolar disorder.

These apps differ from most of the more than 10,000 mental-health and mood apps available, which typically ask users to actively log how they’re feeling, help users connect to providers, or encourage mindfulness. The popular apps Daylio and Moodnotes, for example, require journaling or rating symptoms. This approach requires more of the user’s time and may make these apps less appealing for long-term use. A 2019 study found that among 22 mood-tracking apps, the median user-retention rate was just 6.1 percent at 30 days of use.

App developers are trying to avoid the pitfalls of previous smartphone-psychiatry startups, some of which oversold their capabilities before validating their technologies.

But despite years of research on passive mental-health apps, their success is far from guaranteed. App developers are trying to avoid the pitfalls of previous smartphone psychiatry startups, some of which oversold their capabilities before validating their technologies. For example, Mindstrong was an early startup with an app that tracked taps, swipes, and keystrokes to identify digital biomarkers of cognitive function. The company raised US $160 million in funding from investors, including $100 million in 2020 alone, and went bankrupt in February 2023.

Mindstrong may have folded because the company was operating on a different timeline from the research, according to an analysis by the health-care news website Stat. The slow, methodical pace of science did not match the startup’s need to return profits to its investors quickly, the report found. Mindstrong also struggled to figure out the marketplace and find enough customers willing to pay for the service. “We were first out of the blocks trying to figure this out,” says Thomas Insel, a psychiatrist who cofounded Mindstrong.

Now that the field has completed a “hype cycle,” Torous says, app developers are focused on conducting the research needed to prove their apps can actually help people. “We’re beginning to put the burden of proof more on those developers and startups, as well as academic teams,” he says. Passive mental-health apps need to prove they can reliably parse the data they’re collecting, while also addressing serious privacy concerns.

Passive sensing catches mood swings early

A crucial component of managing psychiatric illness is tracking changes in mental states that can lead to more severe episodes of the disease. Bipolar disorder, for example, causes intense swings in mood, from extreme highs during periods of mania to extreme lows during periods of depression. Between 30 and 50 percent of people with bipolar disorder will attempt suicide at least once in their lives. Catching early signs of a mood swing can enable people to take countermeasures or seek help before things get bad.

But detecting those changes early is hard, especially for people with mental illness. Observations by other people, such as family members, can be subjective, and doctor and counselor sessions are too infrequent.

That’s where apps come in. Algorithms can be trained to spot subtle deviations from a person’s normal routine that might indicate a change in mood—an objective measure based on data, like a diabetic tracking blood sugar. “The ability to think objectively about my own thinking is really key,” says retired U.S. major general Gregg Martin, who has bipolar disorder and is an advisor for BiAffect.

The data from passive sensing apps could also be useful to doctors who want to see objective data on their patients in between office visits, or for people transitioning from inpatient to outpatient settings. These apps are “providing a service that doesn’t exist,” says Colin Depp, a clinical psychologist and professor at the University of California, San Diego. Providers can’t observe their patients around the clock, he says, but smartphone data can help close the gap.

Depp and his team have developed an app that uses GPS data and microphone-based sensing to determine the frequency of conversations and make inferences about a person’s social interactions and isolation. The app also tracks “location entropy,” a metric of how much a user moves around outside of routine locations. When someone is depressed and mostly stays home, location entropy decreases.

Depp’s team initially developed the app, called CBT2go, as a way to test the effectiveness of cognitive behavioral therapy in between therapy sessions. The app can now intervene in real time with people experiencing depressive or psychotic symptoms. This feature helps people identify when they feel lonely or agitated so they can apply coping skills they’ve learned in therapy. “When people walk out of the therapist’s office or log off, then they kind of forget all that,” Depp says.

Another passive mental-health-app developer, Ellipsis Health in San Francisco, uses software that takes voice samples collected during telehealth calls to gauge a person’s level of depression, anxiety, and stress symptoms. For each set of symptoms, deep-learning models analyze the person’s words, rhythms, and inflections to generate a score. The scores indicate the severity of the person’s mental distress, and are based on the same scales used in standard clinical evaluations, says Michael Aratow, cofounder and chief medical officer at Ellipsis.

Aratow says the software works for people of all demographics, without needing to first capture baseline measures of an individual’s voice and speech patterns. “We’ve trained the models in the most difficult use cases,” he says. The company offers its platform, including an app for collecting the voice data, through health-care providers, health systems, and employers; it’s not directly available to consumers.

In the case of BiAffect, the app can be downloaded for free by the public. Leow and her team are using the app as a research tool in clinical trials sponsored by the U.S. National Institutes of Health. These studies aim to validate whether the app can reliably monitor mood disorders, and determine whether it could also track suicide risk in menstruating women and cognition in people with multiple sclerosis.

BiAffect’s software tracks behaviors like hitting the backspace key frequently, which suggests more errors, and an increase in typing “@” symbols and hashtags, which suggest more social media use. The app combines this typing data with information from the phone’s accelerometer to determine how the user is oriented and moving—for example, whether the user is likely lying down in bed—which yields more clues about mood.

Ellipsis Health analyzes audio captured during telehealth visits to assign scores for depression, anxiety, and stress.Ellipsis Health

The makers of BiAffect and Ellipsis Health don’t claim their apps can treat or diagnose disease. If app developers want to make those claims and sell their product in the United States, they would first have to get regulatory approval from the U.S. Food and Drug Administration. Getting that approval requires rigorous and large-scale clinical trials that most app makers don’t have the resources to conduct.

Digital-health software depends on quality clinical data

The sensing techniques upon which passive apps rely—measuring typing dynamics, movement, voice acoustics, and the like—are well established. But the algorithms used to analyze the data collected by the sensors are still being honed and validated. That process will require considerably more high-quality research among real patient populations.

Greg Mably

For example, clinical studies that include control or placebo groups are crucial and have been lacking in the past. Without control groups, companies can say their technology is effective “compared to nothing,” says Torous at Beth Israel.

Torous and his team aim to build software that is backed by this kind of quality evidence. With participants’ consent, their app, called mindLAMP, passively collects data from their screen time and their phone’s GPS and accelerometer for research use. It’s also customizable for different diseases, including schizophrenia and bipolar disorder. “It’s a great starting point. But to bring it into the medical context, there’s a lot of important steps that we’re now in the middle of,” says Torous. Those steps include conducting clinical trials with control groups and testing the technology in different patient populations, he says.

How the data is collected can make a big difference in the quality of the research. For example, the rate of sampling—how often a data point is collected—matters and must be calibrated for the behavior being studied. What’s more, data pulled from real-world environments tends to be “dirty,” with inaccuracies collected by faulty sensors or inconsistencies in how phone sensors initially process data. It takes more work to make sense of this data, says Casey Bennett, an assistant professor and chair of health informatics at DePaul University, in Chicago, who uses BiAffect data in his research.

One approach to addressing errors is to integrate multiple sources of data to fill in the gaps—like combining accelerometer and typing data. In another approach, the BiAffect team is working to correlate real-world information with cleaner lab data collected in a controlled environment where researchers can more easily tell when errors are introduced.

Who participates in the studies matters too. If participants are limited to a particular geographic area or demographic, it’s unclear whether the results can be applied to the broader population. For example, a night-shift worker will have different activity patterns from those with nine-to-five jobs, and a city dweller may have a different lifestyle from residents of rural areas.

After the research is done, app developers must figure out a way to integrate their products into real-world medical contexts. One looming question is when and how to intervene when a change in mood is detected. These apps should always be used in concert with a professional and not as a replacement for one, says Torous. Otherwise, the app’s assessments could be dangerous and distressing to users, he says.

When mood tracking feels like surveillance

No matter how well these passive mood-tracking apps work, gaining trust from potential users may be the biggest stumbling block. Mood tracking could easily feel like surveillance. That’s particularly true for people with bipolar or psychotic disorders, where paranoia is part of the illness.

Keris Myrick, a mental-health advocate, says she finds passive mental-health apps “both cool and creepy.” Myrick, who is vice president of partnerships and innovation at the mental-health-advocacy organization Inseparable, has used a range of apps to support her mental health as a person with schizophrenia. But when she tested one passive sensing app, she opted to use a dummy phone. “I didn’t feel safe with an app company having access to all of that information on my personal phone,” Myrick says. While she was curious to see if her subjective experience matched the app’s objective measurements, the creepiness factor prevented her from using the app enough to find out.

Keris Myrick, a mental-health advocate, says she finds passive mental-health apps “both cool and creepy.”

Beyond users’ perception, maintaining true digital privacy is crucial. “Digital footprints are pretty sticky these days,” says Katie Shilton, an associate professor at the University of Maryland focused on social-data science. It’s important to be transparent about who has access to personal information and what they can do with it, she says.

“Once a diagnosis is established, once you are labeled as something, that can affect algorithms in other places in your life,” Shilton says. She cites the misuse of personal data in the Cambridge Analytica scandal, in which the consulting firm collected information from Facebook to target political advertising. Without strong privacy policies, companies producing mental-health apps could similarly sell user data—and they may be particularly motivated to do so if an app is free to use.

Conversations about regulating mental-health apps have been ongoing for over a decade, but a Wild West–style lack of regulation persists in the United States, says Bennett of DePaul University. For example, there aren’t yet protections in place to keep insurance companies or employers from penalizing users based on data collected. “If there aren’t legal protections, somebody is going to take this technology and use it for nefarious purposes,” he says.

Some of these concerns may be mediated by confining all the analysis to a user’s phone, rather than collecting data in a central repository. But decisions about privacy policies and data structures are still up to individual app developers.

Leow and the BiAffect team are currently working on a new internal version of their app that incorporates natural-language processing and generative AI extensions to analyze users’ speech. The team is considering commercializing this new version in the future, but only following extensive work with industry partners to ensure strict privacy safeguards are in place. “I really see this as something that people could eventually use,” Leow says. But she acknowledges that researchers’ goals don’t always align with the desires of the people who might use these tools. “It is so important to think about what the users actually want.”

This article appears in the July 2024 print issue as “The Shrink in Your Pocket.”

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.”

Neuralink’s visual prosthesis Blindsight has been designated a breakthrough device by the U.S. Food and Drug Administration, which potentially sets the technology on a fast track to approval.

In confirming the news, an FDA spokesperson emphasized that the designation does not mean that Blindsight is yet considered safe or effective. Technologies in the program have potential to improve the current standard of care and are novel compared to what’s available on the market, but the devices still have to go through full clinical trials before seeking FDA approval.

Still, the announcement is a sign that Neuralink is moving closer to testing Blindsight in human patients. The company is recruiting people with vision loss for studies in the United States, Canada, and the United Kingdom.

Visual prostheses work by capturing visual information with a video camera, typically attached to glasses or a headset. Then a processor converts the data to an electrical signal that can be relayed to the nervous system. Retinal implants have been a common approach, with electrodes feeding the signal to nerves in the retina, at the back of the eye, from where it travels on to the brain. But Blindsight uses a brain implant to send the signal directly to neurons in the visual cortex.

In recent years, other companies developing artificial vision prosthetics have reached clinical research trials or beyond, only to struggle financially, leaving patients without support. Some of these technologies live on with new backing: Second Sight’s Orion cortical implant project is now in a clinical trial with Cortigent, and Pixium Vision’s Prima system is now owned by Science, with ex-Neuralink founder Max Hodak at the helm. No company has yet commercialized a visual prosthetic that uses a brain implant.

Elon Musk’s Claims About Blindsight

Very little information about Blindsight is publicly available. As of this writing, there is no official Blindsight page on the Neuralink website, and Neuralink did not respond to requests for comment. It’s also unclear how exactly Blindsight relates to a brain-computer interface that Neuralink has already implanted in two people with paralysis, who use their devices to control computer cursors.

Experts who spoke with IEEE Spectrum felt that, if judged against the strong claims made by Neuralink’s billionaire co-founder Elon Musk, Blindsight will almost certainly disappoint. However, some were still open to the possibility that Neuralink could successfully bring a device to market that can help people with vision loss, albeit with less dramatic effects on their sense of sight. While Musk’s personal fortune could help Blindsight weather difficulties that would end other projects, experts did not feel it was a guarantee of success.

After Neuralink announced on X (formerly Twitter) that Blindsight had received the breakthrough device designation, Musk wrote:

The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see.

Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.

To set expectations correctly, the vision will be at first be [sic] low resolution, like Atari graphics, but eventually it has the potential be [sic] better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like Geordi La Forge.

Musk included a picture of La Forge, a character from the science-fiction franchise Star Trek who wears a vision-enhancing visor.

Experts Puncture the Blindsight Hype

“[Musk] will build the best cortical implant we can build with current technology. It will not produce anything like normal vision. [Yet] it might produce vision that can transform the lives of blind people,” said Ione Fine, a computational neuroscientist at the University of Washington, who has written about the potential limitations of cortical implants, given the complexity of the human visual system. Fine previously worked for the company Second Sight.

A successful visual prosthetic might more realistically be thought of as assistive technology than a cure for blindness. “At best, we’re talking about something that’s augmentative to a cane and a guide dog; not something that replaces a cane and a guide dog,” said Philip Troyk, a biomedical engineer at the Illinois Institute of Technology.

Restoring natural vision is beyond the reach of today’s technology. But among Musks recent claims, Troyk says that a form of infrared sensing is plausible and has already been tested with one of his patients, who used it for help locating people within a room. That patient has a 400-electrode device implanted in the visual cortex as part of a collaborative research effort called the Intracortical Visual Prosthesis Project (ICVP). By comparison, Blindsight may have more than 1,000 electrodes, if it’s a similar device to Neuralink’s brain-computer interface.

Experts say they’d like more information about Neuralink’s visual prosthetic. “I’m leery about the fact that they are very superficial in their description of the devices,” said Gislin Dagnelie, a vision scientist at Johns Hopkins University who has been involved in multiple clinical trials for vision prosthetics, including a Second Sight retinal implant, and who is currently collaborating on the ICVP. “There’s no clear evaluation or pre-clinical work that has been published,” says Dagnelie. “It’s all based on: ‘Trust us, we’re Neuralink.’”

In the short term, too much hype could mislead clinical trial participants. It could also degrade interest in small but meaningful advancements in visual prosthetics. “Some of the [Neuralink] technology is exciting, and has potential,” said Troyk. “The way the messaging is being done detracts from that, potentially.”

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.

The vast majority of older adults want to age at home. To support that goal, doctors should encourage them to consider their care options — long before they need assistance.

The post Through Early Discussions About Elder Care, Doctors Can Empower Seniors to Age in Place appeared first on MedCity News.

Two executives at behavioral health care companies discussed why it’s important for provider organizations to partner with the 988 Suicide & Crisis Lifeline during a panel at the Behavioral Health Tech conference.

The post There’s an Opportunity for More Providers to Partner with the 988 Lifeline, Execs Say appeared first on MedCity News.

Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward.

The post Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors appeared first on MedCity News.

Between 1999 and 2014, opioid use disorder (OUD) among pregnant women more than quadrupled, risking the health of the women—before and after giving birth—and their infants. As states grapple with COVID-19’s exacerbation of the opioid crisis, several are taking innovative steps to address the needs of high-risk groups, including low-income, postpartum patients with OUD.

The Pew Charitable Trusts today commended Michigan Governor Gretchen Whitmer (D), state Senate Majority Leader Mike Shirkey (R), and Lee Chatfield (R)—whose term as state House Speaker ended last month—for passing and signing a bipartisan package of bills aimed at protecting public safety while reducing the number of people in county jails.

2020 was a difficult year for dental providers as the COVID-19 pandemic swept across the country. When stay-at-home orders went into effect in the spring, dental offices closed their doors to all but emergency patients.

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.

Technology has revolutionized the way people live their lives. Individuals can use smartphones to access their bank account, shop from almost any store, and connect with friends and family around the globe. In fact, these personal devices have tethered communities together during the coronavirus pandemic, allowing many people to maintain much of their lives remotely.

The Food and Drug Administration published a concept paper in early January that describes a preliminary proposal for how the agency will ensure that companies developing antibiotics for administration to animals establish defined, evidence-based durations of use for all medically important antibiotics.

With Trump’s victory, healthcare and the pharmaceutical industry could shift significantly. Based on Trump’s first-term policies, his administration […]

The post Impact of Trump on Drug Pricing Policies appeared first on World of DTC Marketing.

Singapore's food culture is legendary, with staples such as chicken rice, bak chor mee, laksa, and roti prata feeding generations of locals and visitors alike. But there's one thing they all have in common — carbs! In carb-crazy Singapore, sticking to a keto diet might seem like a gone case and borderline sacrilegious, but trust me, it's doable. I've been through it, and I'm here to share my tips on how you can enjoy our local food scene while staying keto. What is keto? In case you blur about what a ketogenic (keto) diet is, it's all about cutting carbs and eating more fat. Yup, you read that right — more fat. Sounds shiok, right? The goal is to push your body into ketosis, where instead of burning carbs for energy, it burns fat. Hello, weight loss! Beyond that, keto helps you avoid those pesky post-meal sugar crashes — you know, the ones that make want to toh after a heavy meal. My keto experience I first tried keto as a teen, thinking it was just about cutting out rice, bread, and noodles. Wrong! Keto is stricter than that. To stay in ketosis, you've got to limit your carbs to just 20-50g a day.