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

Efficient machines, paper ballots and human checks make the U.S. voting system robust

The outcome of the 2024 U.S. presidential election could set the climate agenda, reshape public education and shift the dynamics of global science collaboration.

Famous people who die at age 27, such as Janis Joplin, Jimi Hendrix and Amy Winehouse, get even more famous because of the mythology surrounding that number—an example of how modern folklore emerges

Culture may play a role in how birds build collectively in the Kalahari Desert

“Going viral” appears to be more than just a catchphrase when it comes to the rampant spread of misinformation

Understanding the psychology of ambiguous loss can help people struggling with grief and depression in the wake of the 2024 election results

The unexpected discovery of a geometric phase shows how math and physics are tightly intertwined

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 Greg Skalicky, President, EVERSANA and Faruk Abdullah, President, Professional Services & Chief Business Officer, EVERSANA

Greg and Faruk walk through the marketplace pressures driving Direct-to-Patient commercialization models. They argue that a technology-enabled infrastructure,  combined with clinical and reimbursement support specialists, can improve  patients' access to new therapies, shorten the time to therapy, and enable better overall clinical outcomes.

Click here to learn more about EVERSANA’s Direct-to-Patient care model.

Read on for Greg and Faruk’s insights.
Read more »

Today’s guest post comes from Shabbir Ahmed, Chief Commercial Officer at CareMetx.

Shabbir explains the barriers that providers face when dealing with branded portals for multiple products. He then maintains that patients can access new therapies more quickly when the manufacturer relies on a brand-agnostic hub connected to a large network of providers and integrated with the systems those providers use daily.

To learn more, download CareMetx’s new 2024 Patient Services Report: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage.

Read on for Shabbir’s insights.
Read more »

Today’s guest post comes from Kimberley Chiang, Vice President of Biopharma Commercial Solutions at CoverMyMeds

Kimberley highlghts the crucial roles of field reimbursement managers in removing access and reimbursement barriers. She then identifies the keys to successful implementation of field reimbursement services.

To learn more, register for CoverMyMeds' November 13, 2024, webinar: Specialty Therapies & Field Reimbursement Services: Driving Better Outcomes for Brands and Patients.

Read on for Kimberley’s insights.
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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 »

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.

The U.S. Food and Drug Administration posted a video:

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The FDA doesn’t care about the First Amendment rights of the companies it regulates. It cares even less about the “free speech” rights of those companies’ sales and marketing representatives. And why should the agency care? One of FDA’s primary missions is to protect the public health and safety of the American people from illegal, adulterated and misbranded products. Doing so involves restraining food, drug, device and cosmetics companies from committing fraudulent and deceptive acts that are not protected by companies’ commercial free speech rights. Nonetheless, FDA Matters envisions opportunities for FDA and industry to broaden permissible product communications. The key is understanding history, not constitutional law.

<p> <b>Abstract</b><br />CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr&nbsp;Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI<i>&nbsp;</i>(Generics and Biosimilars Initiative) about the company’s strategic focus, which includes expanding its product portfolio, entering highly regulated global markets, and advancing affordable treatments for conditions such as multiple sclerosis and&nbsp;immunological diseases—transforming healthcare in underserved regions.</p><p><b>Keywords</b>: Biosimilars, clinical development, commercialization, MENA</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 General Pharmaceutical Council has said it is “double, treble, quadruple-checking” for any “flexibility” that would allow all overseas candidates to sit the March 2021 registration assessment exam in their countries of residence.

The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public.

Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19, from investigating the possibility of repurposing existing drugs to searching for novel therapies against the virus.

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.

Community pharmacies able to administer up to 400 COVID-19 vaccines per week can now apply to become designated vaccination sites, NHS England has said.

By Jonathan Montagu, CEO of HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC As Boston’s weather has started its turn from the frigid darkness that is a northeast winter to the longer days and lighter conditions

The post Has Spring Sprouted New Growth in Immuno-Oncology? appeared first on LifeSciVC.

By Ankit Mahadevia, former CEO of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC Drug development is complex. So is running a business. Sometimes, the work of doing both can make your head spin. In my

The post Boiling It Down: Conveying Complexity For Decision-makers appeared first on LifeSciVC.

“Children are not small adults.” We invoke this saying, in a vague and hand-wavy manner, whenever we talk about the need to study drugs in pediatric populations. It’s an interesting idea, but it really cries out for further elaboration. If they’re not small adults, what are they? Are pediatric efficacy and safety totally uncorrelated with adult efficacy and safety? Or are children actually kind of like small adults in certain important ways?

Pediatric post-marketing studies have been completed for over 200 compounds in the years since BPCA (2002, offering a reward of 6 months extra market exclusivity/patent life to any drug conducting requested pediatric studies) and PREA (2007, giving FDA power to require pediatric studies) were enacted. I think it is fair to say that at this point, it would be nice to have some sort of comprehensive idea of how FDA views the risks associated with treating children with medications tested only on adults. Are they in general less efficacious? More? Is PK in children predictable from adult studies a reasonable percentage of the time, or does it need to be recharacterized with every drug?

Essentially, my point is that BPCA/PREA is a pretty crude tool: it is both too broad in setting what is basically a single standard for all new adult medications, and too vague as to what exactly that standard is.

In fact, a 2008 published review from FDA staffers and a 2012 Institute of Medicine report both show one clear trend: in a significant majority of cases, pediatric studies resulted in validating the adult medication in children, mostly with predictable dose and formulation adjustments (77 of 108 compounds (71%) in the FDA review, and 27 of 45 (60%) in the IOM review, had label changes that simply reflected that use of the drug was acceptable in younger patients).

So, it seems, most of the time, children are in fact not terribly unlike small adults.

But it’s also true that the percentages of studies that show lack of efficacy, or bring to light a new safety issue with the drug’s use in children, is well above zero. There is some extremely important information here.

To paraphrase John Wanamaker: we know that half our PREA studies are a waste of time; we just don’t know which half.

This would seem to me to be the highest regulatory priority – to be able to predict which new drugs will work as expected in children, and which may truly require further study. After a couple hundred compounds have gone through this process, we really ought to be better positioned to understand how certain pharmacological properties might increase or decrease the risks of drugs behaving differently than expected in children. Unfortunately, neither the FDA nor the IOM papers venture any hypotheses about this – both end up providing long lists of examples of certain points, but not providing any explanatory mechanisms that might enable us to engage in some predictive risk assessment.

While FDASIA did not advance PREA in terms of more rigorously defining the scope of pediatric requirements (or, better yet, requiring FDA to do so), it did address one lingering concern by requiring that FDA publish non-compliance letters for sponsors that do not meet their commitments. (PREA, like FDAAA, is a bit plagued by lingering suspicions that it’s widely ignored by industry.)

The first batch of letters and responses has been published, and it offers some early insights into the problems engendered by the nebulous nature of PREA and its implementation.

These examples, unfortunately, are still a bit opaque – we will need to wait on the FDA responses to the sponsors to see if some of the counter-claims are deemed credible. In addition, there are a few references to prior deferral requests, but the details of the request (and rationales for the subsequent FDA denials) do not appear to be publicly available. You can read FDA’s take on the new postings on their blog, or in the predictably excellent coverage from Alec Gaffney at RAPS.

Looking through the first 4 drugs publicly identified for noncompliance, the clear trend is that there is no trend. All these PREA requirements have been missed for dramatically different reasons.

Here’s a quick rundown of the drugs at issue – and, more interestingly, the sponsor responses:

1. Renvela - Genzyme (full response)

Genzyme appears to be laying responsibility for the delay firmly at FDA’s feet here, basically claiming that FDA continued to pile on new requirements over time:

Genzyme’s correspondence with the FDA regarding pediatric plans and design of this study began in 2006 and included a face to face meeting with FDA in May 2009. Genzyme submitted 8 revisions of the pediatric study design based on feedback from FDA including that received in 4 General Advice Letters. The Advice Letter dated February 17, 2011  contained further recommendations on the study design, yet still required the final clinical study report  by December 31, 2011.

This highlights one of PREA’s real problems: the requirements as specified in most drug approval letters are not specific enough to fully dictate the study protocol. Instead, there is a lot of back and forth between the sponsor and FDA, and it seems that FDA does not always fully account for their own contribution to delays in getting studies started.

2. Hectorol - Genzyme (full response)

In this one, Genzyme blames the FDA not for too much feedback, but for none at all:

On December 22, 2010, Genzyme submitted a revised pediatric development plan (Serial No. 212) which was intended to address FDA feedback and concerns that had been received to date. This submission included proposed protocol HECT05310. [...] At this time, Genzyme has not received feedback from the FDA on the protocol included in the December 22, 2010 submission.

If this is true, it appears extremely embarrassing for FDA. Have they really not provided feedback in over 2.5 years, and yet still sending noncompliance letters to the sponsor? It will be very interesting to see an FDA response to this.

3. Cleviprex – The Medicines Company (full response)

This is the only case where the pharma company appears to be clearly trying to game the system a bit. According to their response:

Recognizing that, due to circumstances beyond the company’s control, the pediatric assessment could not be completed by the due date, The Medicines Company notified FDA in September 2010, and sought an extension. At that time, it was FDA’s view that no extensions were available. Following the passage of FDASIA, which specifically authorizes deferral extensions, the company again sought a deferral extension in December 2012. 

So, after hearing that they had to move forward in 2010, the company promptly waited 2 years to ask for another extension. During that time, the letter seems to imply that they did not try to move the study forward at all, preferring to roll the dice and wait for changing laws to help them get out from under the obligation.

4. Twinject/Adrenaclick – Amedra (full response)

The details of this one are heavily redacted, but it may also be a bit of gamesmanship from the sponsor. After purchasing the injectors, Amedra asked for a deferral. When the deferral was denied, they simply asked for the requirements to be waived altogether. That seems backwards, but perhaps there's a good reason for that.

---

The Wall Street Journal has an interesting article on the use of “Big Data” to identify and solicit potential clinical trial participants. The premise is that large consumer data aggregators like Experian can target patients with certain diseases through correlations with non-health behavior. Examples given include “a preference for jazz” being associated with arthritis and “shopping online for clothes” being an indicator of obesity.

We've seen this story before.

In this way, allegedly, clinical trial patient recruitment companies can more narrowly target their solicitations* for patients to enroll in clinical trials.

In the spirit of full disclosure, I should mention that I was interviewed by the reporter of this article, although I am not quoted. My comments generally ran along three lines, none of which really fit in with the main storyline of the article:

1. I am highly skeptical that these analyses are actually effective at locating patients
   
2. These methods aren't really new – they’re the same tactics that direct marketers have been using for years
   
3. Most importantly, the clinical trials community can – and should – be moving towards open and collaborative patient engagement. Relying on tactics like consumer data snooping and telemarketing is an enormous step backwards.

The first point is this: certainly some diseases have correlates in the real world, but these correlates tend to be pretty weak, and are therefore unreliable predictors of disease. Maybe it’s true that those struggling with obesity tend to buy more clothes online (I don’t know if it’s true or not – honestly it sounds a bit more like an association built on easy stereotypes than on hard data). But many obese people will not shop online (they will want to be sure the clothes actually fit), and vast numbers of people with low or average BMIs will shop for clothes online.  So the consumer data will tend to have very low predictive value. The claims that liking jazz and owning cats are predictive of having arthritis are even more tenuous. These correlates are going to be several times weaker than basic demographic information like age and gender. And for more complex conditions, these associations fall apart.

Marketers claim to solve this by factoring a complex web of associations through a magical black box – th WSJ article mentions that they “applied a computed algorithm” to flag patients. Having seen behind the curtain on a few of these magic algorithms, I can confidently say that they are underwhelming in their sophistication. Hand-wavy references to Big Data and Algorithms are just the tools used to impress pharma clients. (The down side to that, of course, is that you can’t help but come across as big brotherish – see this coverage from Forbes for a taste of what happens when people accept these claims uncritically.)

But the effectiveness of these data slice-n-dicing activities is perhaps beside the point. They are really just a thin cover for old-fashioned boiler room tactics: direct mail and telemarketing. When I got my first introduction to direct marketing in the 90’s, it was the exact same program – get lead lists from big companies like Experian, then aggressively mail and call until you get a response.

The limited effectiveness and old-school aggressiveness of these programs comes is nicely illustrated in the article by one person’s experience:

Larna Godsey, of Wichita, Kan., says she received a dozen phone calls about a diabetes drug study over the past year from a company that didn't identify itself. Ms. Godsey, 63, doesn't suffer from the disease, but she has researched it on the Internet and donated to diabetes-related causes. "I don't know if it's just a coincidence or if they're somehow getting my information," says Ms. Godsey, who filed a complaint with the FTC this year.

The article notes that one recruitment company, Acurian, has been the subject of over 500 FTC complaints regarding its tactics. It’s clear that Big Data is just the latest buzzword lipstick on the telemarketing pig. And that’s the real shame of it.

We have arrived at an unprecedented opportunity for patients, researchers, and private industry to come together and discuss, as equals, research priorities and goals. Online patient communities like Inspire and PatientsLikeMe have created new mechanisms to share clinical trial opportunities and even create new studies. Dedicated disease advocates have jumped right into the world of clinical research, with groups like the Cystic Fibrosis Foundation and Michael J. Fox Foundation no longer content with raising research funds, but actively leading the design and operations of new studies.

Some – not yet enough – pharmaceutical companies have embraced the opportunity to work more openly and honestly with patient groups. The scandal of stories like this is not the Wizard of Oz histrionics of secret computer algorithms, but that we as an industry continue to take the low road and resort to questionable boiler room tactics.

It’s past time for the entire patient recruitment industry to drop the sleaze and move into the 21st century. I would hope that patient groups and researchers will come together as well to vigorously oppose these kinds of tactics when they encounter them.

Sudan's civil war has displaced 10 million citizens. Here are profiles of two young people from the most vulnerable groups: an unaccompanied minor caring for twin brothers, a woman who was raped.

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.

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.”

If you’ve ever tried to get a bandage to stick to your elbow, you understand the difficulty in creating wearable devices that attach securely to the human body. Add digital electronic circuitry, and the problem becomes more complicated. Now include the need for the device to fix breaks and damage automatically—and let’s make it biodegradable while we’re at it—and many researchers would throw up their hands in surrender.

Fortunately, an international team led by researchers at Korea University Graduate School of Converging Science and Technology (KU-KIST) persevered, and has developed conductor materials that it claims are stretchable, self-healing, and biocompatible. Their project was described this month in the journal Science Advances.

The biodegradable conductor offers a new approach to patient monitoring and delivering treatments directly to the tissues and organs where they are needed. For example, a smart patch made of these materials could measure motion, temperature, and other biological data. The material could also be used to create sensor patches that can be implanted inside the body, and even mounted on the surface of internal organs. The biocompatible materials can be designed to degrade after a period of time, eliminating the need for an invasive procedure to remove the sensor later.

“This new technology is a glimpse at the future of remote healthcare,” says Robert Rose, CEO of Rose Strategic Partners, LLC. “Remote patient monitoring is an industry still in its early stages, but already we are seeing the promise of what is not only possible, but close on the horizon. Imagine a device implanted at a surgical site to monitor and report your internal healing progress. If it is damaged, the device can heal itself, and when the job is done, it simply dissolves. It sounds like science fiction, but it’s now science fact.”

Self-healing elastics

After being cut a ribbonlike film was able to heal itself in about 1 minute.Suk-Won Hwang

The system relies on two different layers of flexible material, both self-healing: one is for conduction and the other is an elastomer layer that serves as a substrate to support the sensors and circuitry needed to collect data. The conductor layer is based on a substance known by the acronym PEDOT:PSS, which is short for Poly(3,4-ethylenedioxythiophene) polystyrene sulfonate. It’s a conductive polymer widely used in making flexible displays and touch panels, as well as wearable devices. To increase the polymer’s conductivity and self-healing properties, the research team used additives including polyethylene glycol and glycol, which helped increase conductivity as well as the material’s ability to automatically repair damage such as cuts or tears.

In order to conform to curved tissues and survive typical body motion, the substrate layer must be extremely flexible. The researchers based it on elastomers that can match the shape of curved tissues, such as skin or individual organs.

These two layers stick to each other, thanks to chemical bonds that can connect the polymer chains of the plastic films in each layer. Combined, these materials create a system that is flexible and stretchable. In testing, the researchers showed that the materials could survive stretching up to 500 percent.

The self-healing function arises from the material’s ability to reconnect to itself when cut or otherwise damaged. This self-healing feature is based on a chemical process called disulfide metathesis. In short, polymer molecules containing pairs of linked sulfur atoms, called disulfides, have the ability to reform themselves after being severed. The phenomenon arises from a chemical process called disulfide-disulfide shuffling reactions, in which disulfide bonds in the molecule break and then reform, not necessarily between the original partners. According to the KU-KIST researchers, after being cut, their material was able to recover conductivity in its circuits within about two minutes without any intervention. The material was also tested for bending, twisting, and its ability to function both in air and under water.

This approach offers many advantages over other flexible electronics designs. For example, silver nanowires and carbon nanotubes have been used as the basis for stretchable devices, but they can be brittle and lack the self-healing properties of the KU-KIST materials. Other materials such as liquid metals can self-heal, but they are typically difficult to handle and integrate into wearable circuitry.

As a demonstration, the team created a multifunction sensor that included humidity, temperature, and pressure sensors that was approximately 4.5 square centimeters. In spite of being cut in four separate locations, it was able to heal itself and continue to provide sensor readings.

Implant tested in a rat

To take the demonstration a step further, the researchers created a 1.8-cm² device that was attached to a rat’s bladder. The device was designed to wrap around the bladder and then adhere to itself, so no adhesives or sutures were required to attach the sensor onto the bladder. The team chose the bladder for their experiments because, under normal conditions, its size can change by 300 percent.

The device incorporated both electrodes and pressure sensors, which were able to detect changes in the bladder pressure. The electrodes could detect bladder voiding, through electromyography signals, as well as stimulate the bladder to induce urination. As with the initial demonstration, intentional damage to the device’s circuitry healed on its own, without intervention.

The biocompatible and biodegradable nature of the materials is important because it means that devices fabricated with them can be worn on the skin, as well as implanted within the body. The fact that the materials are biodegradable means that implants would not need a second surgical procedure to remove them. They could be left in place after serving their purpose, and they would be absorbed by the body.

According to Suk-Won Hwang, assistant professor at KU-KIST, a few hurdles remain on the path to commercialization. “We need to test the biocompatibility of some of the materials used in the conductor and substrate layers. While scalable production appears to be feasible, the high cost of disulfide derivatives might make the technology too expensive, aside from some special applications,” he says. “Biocompatibility testing and material synthesis optimization will take one to two years, at least.”

As a leader who has committed much of his career to improving healthcare — an industry that holds millions of people’s lives in its hands — I took from this terrifying incident a new guiding principle. Healthcare needs to pursue a zero-failure rate.

The post What My Daughter’s Harrowing Alaska Airlines Flight Taught Me About Healthcare appeared first on MedCity News.

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.

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.

During a panel discussion at the Behavioral Health Tech conference, experts shared the promise psychedelic medicines hold for mental health and why employers may want to consider offering them as a workplace benefit.

The post 4 Things Employers Should Know About Psychedelic Medicines 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.

While startups in highly regulated industries like healthcare and finance are almost certain to face heightened scrutiny, there are controllable factors that can offset these challenges.

The post The Startup Economy is Turbulent. Here’s How Founders Can Recognize and Avoid Common Pitfalls appeared first on MedCity News.

The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. Use of this ingredient in cold and allergy medicines grew after a federal law required that pseudoephedrine-containing products be kept behind pharmacy counters.

The post FDA Takes Step Toward Removal of Ineffective Decongestants From the Market appeared first on MedCity News.

Building trust while simultaneously building products, selling, recruiting, and fundraising can feel impossible. But it’s required whether you have the time or not, and it doesn’t stop no matter how big you grow.

The post The Trust-Building Playbook: 5 Tips Every Digital Health Marketer Needs to Know appeared first on MedCity News.

Access to care isn’t enough. Healthcare organizations need to build trust in order to reach underserved communities, experts said on a recent panel.

The post How Can Healthcare Organizations Earn Trust with Marginalized Communities? appeared first on MedCity News.

Here’s how four different health systems are partnering with Microsoft to save time for clinicians.

The post How 4 Health Systems Are Partnering with Microsoft appeared first on MedCity News.

During a recent panel, experts discussed the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and how it achieved scale.

The post How One Massachusetts Maternal Mental Health Program Scaled Across the Country 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.

As winter arrives and daylight hours decrease, it gets easier to hit the snooze button and stay in bed. It turns out that there’s a scientific reason behind this phenomenon that helps to explain why people struggle to adjust their internal clocks—also known as circadian rhythm or sleep-wake cycle—when the weather turns colder.