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.

Peytant has announced that the U.S. Food and Drug Administration (FDA) granted marketing authorisation (clearance to market in the United States as a Class II device) for the AMStent Tracheobronchial Covered Stent System, a therapy platform.

President-elect Trump vowed to promote fossil fuels, weaken pollution regulations and reverse Biden administration climate efforts

It is difficult to disentangle Russian and Chinese scientists from international science cooperation. That is a good thing

The 3.2-million-year-old human ancestor known as Lucy rose to fame through an incredible combination of circumstances

Jonny Kim—a former Navy SEAL and ER doctor—is now a NASA astronaut who will soon launch to the International Space Station as flight engineer for the crew of Expedition 72/73

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 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.
Read more »

Here on Drug Channels, we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall.

Novel transparency information reveals that this good news doesn’t always translate into savings. Below, we rely on a unique data set from Turquoise Health to examine how much four national commercial health plans—Aetna, Anthem, Cigna, and UnitedHealthcare—paid hospitals for Avastin and its two most significant biosimilar competitors.

As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars. What’s more, plans can pay hospitals more for a biosimilar than for the higher-cost reference product. The U.S. drug channel system is warping hospitals’ incentives to adopt biosimilars, while simultaneously raising costs for commercial plans.

The namesake of my alma mater once said: “Sunlight is said to be the best of disinfectants.” What would happen if we disinfected the entire channel?
Read more »

Adam J. Fein, Ph.D., president of Drug Channels Institute (DCI) and the author of Drug Channels, invites you to join him for DCI’s new live video webinar:

Friday, December 13, 2024,

from 12:00 p.m. to 1:30 p.m. ET

This post describes the event and explains how to purchase a registration. (Or, just click here to order.) The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia.

This event is part of The Drug Channels 2024 Video Webinar Series. (Please note that our December 2024 webinar is *not* included with next year’s 2025 Video Webinar Series.)

WHAT YOU WILL LEARN

Join Dr. Fein as he helps you and your team get ready for 2025 by outlining key issues and uncertainties that will surely affect your planning. This event can be both a capstone of your annual learning and a touchpoint for the future. DCI’s Outlook webinars have proven to be reliable and informative guides to crucial aspects of the ever-evolving healthcare industry.

During the event, Dr. Fein will share his latest thinking and projections on a wide range of topics, including:

• Latest predictions for the Inflation Reduction Act

• Expectations for the Medicare Part D market in 2025 and beyond

• Update on 340B Drug Pricing Program’s controversies

• Impact of the new Trump administration and Congress on the drug channel

• Vertical integration and consolidation trends—and prospects for dis-integration and de-consolidation

• The state of biosimilar markets

• What’s next for PBMs’ private label products and GPOs

• Retail pharmacy’s future

• Prospects for direct-to-patient channels

• What’s ahead for discount cards and cash-pay pharmacies

• The outlook for state and federal legislation on PBMs and the drug channel

• Gross-to-net bubble developments

• And much more!

PLUS: During the webinar, Dr. Fein will give participants an opportunity to unmute themselves and ask live questions. The webinar will last at least 90 minutes to accommodate audience questions.

As always, Dr. Fein will clearly distinguish his opinions and interpretations from the objective facts and data. He will draw from exclusive information found in DCI's economic reports .

Read on for full details on pricing and registration.
Read more »

At a time when FDA’s responsibilities continue to grow rapidly, the agency has been caught in an across-the-board reduction (sequester) in federal discretionary spending, effective March 2, 2013. Although Congress may yet reverse course and restore money to affected federal agencies, this is not considered a high probability. Altogether, FDA will lose about $209 million between now and September 30, 2013. This will reduce inspections, slow drug and device approvals, and restrict implementation of the Food Safety Modernization Act and other recent legislation. Because of the many questions about the process and outcome, this is FDA Matters’ primer on the sequester of FDA funds.

Note to readers: After a period of inactivity CardioBrief is coming back, but with some big differences. This website, CardioBrief.Org, will remain my personal website. A new website, CVCTCardiobrief.com, will be the new home for my “professional” blogging activities. To develop this website I have joined forces with the global CVCT Forum. I look forward to...

Click here to continue reading...

The Pharmaceutical Services Negotiating Committee is in talks with the government over potential plans to distribute COVID-19 treatments in primary care.

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

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.

Consultations on the reclassification of two progestogen-only contraceptive pills from prescription-only to pharmacy medicines have been launched.

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.

A new type of drug that targets chemotherapy directly to cancer cells reduces the risk of death from the most common type of bladder cancer by 30%, a phase III trial in the New England Journal of Medicine has suggested.

The Royal Pharmaceutical Society has expressed its sadness at the death of Joy Wingfield, honorary professor of Pharmacy Law and Ethics at the University of Nottingham.

By Arthur O. Tzianabos, PhD, CEO of Lifordi Immunotherapeutics, as part of the From the Trenches feature of LifeSciVC As the biotech industry continues to pick up steam, I have been getting a number of phone calls from folks in

The post Stars and Scars… Some Lessons Learned About Leadership appeared first on LifeSciVC.

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.

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 […]

When university and hospital trusts were called to the UK parliament last year to answer questions on why they were not following the rules on reporting results, we saw how effective the questioning from politicians was. Those of you who watched the parliamentary session saw the pressure the university representatives were put under. Because the politicians asked […]

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.

The decade following passage of FDAAA has been one of easing standards for drug approvals in the US, most notably with the advent of “breakthrough” designation created by FDASIA in 2012 and the 21st Century Cures Act in 2016.

Although, as of this writing, there is no nominee for FDA Commissioner, it appears to be safe to say that the current administration intends to accelerate the pace of deregulation, mostly through further lowering of approval requirements. In fact, some of the leading contenders for the position are on record as supporting a return to pre-Kefauver-Harris days, when drug efficacy was not even considered for approval.

Build a better mouse model, and pharma will beat a path to your door - no laws needed.

In this context, it is at least refreshing to read a proposal to increase efficacy standards. This comes from two bioethicists at McGill University, who make the somewhat-startling case for a higher degree of efficacy evaluation before a drug begins any testing in humans.

We contend that a lack of emphasis on evidence for the efficacy of drug candidates is all too common in decisions about whether an experimental medicine can be tested in humans. We call for infrastructure, resources and better methods to rigorously evaluate the clinical promise of new interventions before testing them on humans for the first time.

The author propose some sort of centralized clearinghouse to evaluate efficacy more rigorously. It is unclear what they envision this new multispecialty review body’s standards for green-lighting a drug to enter human testing. Instead they propose three questions:

• What is the likelihood that the drug will prove clinically useful?
• Assume the drug works in humans. What is the likelihood of observing the preclinical results?
• Assume the drug does not work in humans. What is the likelihood of observing the preclinical results?

These seem like reasonable questions, I suppose – and are likely questions that are already being asked of preclinical data. They certainly do not rise to the level of providing a clear standard for regulatory approval, though perhaps it’s a reasonable place to start.

The most obvious counterargument here is one that the authors curiously don’t pick up on at all: if we had the ability to accurately (or even semiaccurately) predict efficacy preclinically, pharma sponsors would already be doing it. The comment notes: “More-thorough assessments of clinical potential before trials begin could lower failure rates and drug-development costs.” And it’s hard not to agree: every pharmaceutical company would love to have even an incrementally-better sense of whether their early pipeline drugs will be shown to work as hoped.

The authors note

Commercial interests cannot be trusted to ensure that human trials are launched only when the case for clinical potential is robust. We believe that many FIH studies are launched on the basis of flimsy, underscrutinized evidence.

However, they do not produce any evidence that industry is in any way deliberately underperforming their preclinical work, merely that preclinical efficacy is often difficult to reproduce and is poorly correlated with drug performance in humans.

Pharmaceutical companies have many times more candidate compounds than they can possibly afford to put into clinical trials. Figuring out how to lower failure rates – or at least the total cost of failure - is a prominent industry obsession, and efficacy remains the largest source of late-stage trial failure. This quest to “fail faster” has resulted in larger and more expensive phase 2 trials, and even to increased efficacy testing in some phase 1 trials. And we do this not because of regulatory pressure, but because of hopes that these efforts will save overall costs. So it seems beyond probable that companies would immediately invest more in preclinical efficacy testing, if such testing could be shown to have any real predictive power. But generally speaking, it does not.

As a general rule, we don’t need regulations that are firmly aligned with market incentives, we need regulations if and when we think those incentives might run counter to the general good. In this case, there are already incredibly strong market incentives to improve preclinical assessments. Where companies have attempted to do something with limited success, it would seem quixotic to think that regulatory fiat will accomplish more.

(One further point. The authors try to link the need for preclinical efficacy testing to the 2016 Bial tragedy. This seems incredibly tenuous: the authors speculate that perhaps trial participants would not have been harmed and killed if Bial had been required to produce more evidence of BIA102474’s clinical efficacy before embarking on their phase 1 trials. But that would have been entirely coincidental in this case: if the drug had in fact more evidence of therapeutic promise, the tragedy still would have happened, because it had nothing at all to do with the drug’s efficacy.

This is to some extent a minor nitpick, since the argument in favor of earlier efficacy testing does not depend on a link to Bial. However, I bring it up because a) the authors dedicate the first four paragraphs of their comment to the link, and b) there appears to be a minor trend of using the death and injuries of that trial to justify an array of otherwise-unrelated initiatives. This seems like a trend we should discourage.)

[Update 2/23: I posted this last night, not realizing that only a few hours earlier, John LaMattina had published on this same article. His take is similar to mine, in that he is suspicious of the idea that pharmaceutical companies would knowingly push ineffective drugs up their pipeline.]

Kimmelman, J., & Federico, C. (2017). Consider drug efficacy before first-in-human trials Nature, 542 (7639), 25-27 DOI: 10.1038/542025a

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.”

Over the past 20 years, technological advances have enabled inventors to go from strength to strength. And yet, according to the legendary inventor Dean Kamen, innovation has stalled. Kamen made a name for himself with inventions including the first portable insulin pump for diabetics, an advanced wheelchair that can climb steps, and the Segway mobility device. Here, he talks about his plan for enabling innovators.

How has inventing changed since you started in the 1990s?

Dean Kamen: Kids all over the world can now be inventing in the world of synthetic biology the way we played with Tinkertoys and Erector Sets and Lego. I used to put pins and smelly formaldehyde in frogs in high school. Today in high school, kids will do experiments that would have won you the Nobel Prize in Medicine 40 years ago. But none of those kids are likely in any short time to be on the market with a pharmaceutical that will have global impact. Today, while invention is getting easier and easier, I think there are some aspects of innovation that have gotten much more difficult.

Can you explain the difference?

Kamen: Most people think those two words mean the same thing. Invention is coming up with an idea or a thing or a process that has never been done that way before. [Thanks to] more access to technology and 3D printers and simulation programs and virtual ways to make things, the threshold to be able to create something new and different has dramatically lowered.

Historically, inventions were only the starting point to get to innovation. And I’ll define an innovation as something that reached a scale where it impacted a piece of the world, or transformed it: the wheel, steam, electricity, Internet. Getting an invention to the scale it needs to be to become an innovation has gotten easier—if it’s software. But if it’s sophisticated technology that requires mechanical or physical structure in a very competitive world? It’s getting harder and harder to do due to competition, due to global regulatory environments.

[For example,] in proteomics [the study of proteins] and genomics and biomedical engineering, the invention part is, believe it or not, getting a little easier because we know so much, because there are development platforms now to do it. But getting a biotech product cleared by the Food and Drug Administration is getting more expensive and time consuming, and the risks involved are making the investment community much more likely to invest in the next version of Angry Birds than curing cancer.

A lot of ink has been spilled about how AI is changing inventing. Why hasn’t that helped?

Kamen: AI is an incredibly valuable tool. As long as the value you’re looking for is to be able to collect massive amounts of data and being able to process that data effectively. That’s very different than what a lot of people believe, which is that AI is inventing and creating from whole cloth new and different ideas.

How are you using AI to help with innovation?

Kamen: Every medical school has incredibly brilliant professors and grad students with petri dishes. “Look, I can make nephrons. We can grow people a new kidney. They won’t need dialysis.” But they only have petri dishes full of the stuff. And the scale they need is hundreds and hundreds of liters.

I started a not-for-profit called ARMI—the Advanced Regenerative Manufacturing Institute—to help make it practical to manufacture human cells, tissues, and organs. We are using artificial intelligence to speed up our development processes and eliminate going down frustratingly long and expensive [dead-end] paths. We figure out how to bring tissue manufacturing to scale. We build the bioreactors, sensor technologies, robotics, and controls. We’re going to put them together and create an industry that can manufacture hundreds of thousands of replacement kidneys, livers, pancreases, lungs, blood, bone, you name it.

So ARMI’s purpose is to help would-be innovators?

Kamen: We are not going to make a product. We’re not even going to make a whole company. We’re going to create baseline core technologies that will enable all sorts of products and companies to emerge to create an entire new industry. It will be an innovation in health care that will lower costs because cures are much cheaper than chronic treatments. We have to break down the barriers so that these fantastic inventions can become global innovations.

This article appears in the November 2024 print issue as “The Inventor’s Inventor.”

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.

Mental health experts are hopeful about the de-stigmatization of behavioral health, the promise of AI and other areas, they shared at a recent conference.

The post 4 Areas Within Mental Health Care that Give Executives Hope appeared first on MedCity News.

Navigating the regulatory and ethical requirements of different medical data providers across many different countries, as well as safeguarding patient privacy, is a mammoth task that requires extra resources and expertise.  

The post AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges?  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.

Many companies are entering the digital youth mental health space, but it’s important to know which ones are effective, according to a panel of investors at the Behavioral Health Tech conference.

The post Measuring Impact in Digital Youth Mental Health: What Investors Look For appeared first on MedCity News.

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.

The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.

By adopting a contingent workforce model and investing in the right data tools to power better informed decision-making and talent strategy, healthcare organizations can begin to address staffing challenges and turn their talent goals into reality. 

The post Closing Staffing Gaps in Healthcare by Utilizing Diverse Pipelines of Contingent Talent appeared first on MedCity News.

As radiopharmaceuticals enter a new phase, industry leaders must rethink external services and internal capabilities to master the complexities of delivering advanced therapies.

The post Unlocking the Future of Radioligand Therapy: From Discovery to Delivering at Scale 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.

Experts agree that the incoming Trump administration will likely shake things up in the prescription drug world — most notably when it comes to research and development, drug pricing and PBM reform.

The post What Might the Future of Prescription Drugs Look Like Under Trump? appeared first on MedCity News.

In 2018, opioid overdoses in the United States caused one death every 11 minutes, resulting in nearly 47,000 fatalities. The most effective treatments for opioid use disorder (OUD) are three medications approved by the Food and Drug Administration (FDA): methadone, buprenorphine, and naltrexone.

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading

The Centers for Medicare and Medicaid Services (CMS) recently announced a 2.9% cut to Medicare physician payments for […]

The post CMS Cuts Medicare Physician Payments: What It Means appeared first on World of DTC Marketing.

To mark Breast Cancer Awareness Month, we speak to inspiring Singaporeans about their journey in battling and overcoming cancer.  Warda Ismail gets anxious about things easily, especially when it comes to her health.  So much so that her doctor once told her that she is a "borderline hypochondriac", she shared with AsiaOne in an interview.  For the uninitiated, hypochondria is a condition where a person is excessively and unduly worried about having a serious illness. To keep her mind at ease, the 44-year-old preschool educator has the habit of going for regular medical checkups.  Though she was vigilant, her worst nightmare came true — she was diagnosed with breast cancer on May 8 this year.  And in the midst of her recovery journey, she got more terrible news — her mother, who had been caring for her, was diagnosed with stage-three gall bladder cancer.  Despite the string of unfortunate events, Warda persevered and tried to have a more positive outlook on life and her health. 

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.

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.

The US Centers for Disease Control and Prevention said on Wednesday that slivered onions served on McDonald's, opens new tab Quarter Pounder hamburgers and other menu items were the likely source of an E. coli outbreak that sickened 90 people. The outbreak linked to Quarter Pounder was first reported on Oct 22, and slivered onions were suspected to be the source of the infections. The US Food and Drug Administration and the company have confirmed that Taylor Farms was the supplier for the affected locations, and it has since recalled several batches of yellow onions produced in a Colorado facility. The FDA on Wednesday said it had initiated inspections at a Taylor Farms processing center in Colorado, a state where 29 people have fallen ill due to the outbreak. An onion grower of interest in Washington state is also being investigated, the FDA added. The CDC said the number of infected people has risen by 15 people from 75 and 27 persons have been hospitalised due to the illness, which has already killed one person.

Life can sometimes feel like a never-ending cycle of stress and decisions. That's usually my weekdays in a nutshell: chasing deadlines, making tough calls, and hopping between meetings. When your brain feels like it's on overdrive, it's time to hit pause. Engaging in some therapeutic activities can give your mind the breather it desperately needs. The good news? They don't have to be complicated or time-consuming. Here are some that can work wonders for your mental clarity and overall well-being. Step outside for a walk Walking is one of the simplest ways to clear your mind. It's amazing what a little fresh air at your nearby PCN can do. Just stepping outside and getting those legs moving can shift your perspective in a matter of minutes — and burn a few calories too! Disconnect from your phone and enjoy the sights and sounds of the great outdoors. I find that a 30-min walk and a change of environment works wonders for me, helping me rationally dissect my worries, such as my crushing feelings of inadequacy at work.

South Korean actor Song Jae-rim died yesterday (Nov 12) at the age of 39. The Seongdong Police Station in Seoul confirmed that he was found deceased in his apartment at around 12.30pm. According to media reports, a friend whom he was supposed to meet for lunch had visited his home and reported the death. A two-page letter was reportedly found at the scene but the cause of death has not been confirmed. A police official, however, stated that there are "no signs of foul play". His wake was held at Yeouido St. Mary’s Hospital Funeral Hall at 5.30pm yesterday. His funeral will be held tomorrow at Seoul City Crematorium. Jae-rim gained popularity after starring in the 2012 drama The Moon Embracing the Sun and the 2014 reality series We Got Married. This year, he starred in two dramas — My Military Valentine and Queen Woo. Following news of his death, comedian Hong Seok-cheon and other celebrities posted tributes to Jae-rim on social media.

SEOUL - South Korea's military said it will hold a three-day joint exercise with the United States and Japan starting on Wednesday (Nov 13), featuring fighter jets and marine patrol aircraft as well as the US nuclear-powered aircraft carrier USS George Washington. The Freedom Edge exercise is a response to what the South Korean military said were threats from North Korea, which recently conducted an intercontinental ballistic missile test, drawing condemnation from Seoul, Tokyo and Washington. It also comes as the US State Department said North Korean troops have started engaging in combat operations in Russia's war with Ukraine. The exercise will include South Korean and Japanese fighter jets and maritime patrol aircraft, as well as the USS George Washington, Seoul's Joint Chiefs of Staff (JCS) said in a statement. The trilateral exercise follows a first round held earlier this year after the leaders of the three countries agreed at a summit in 2023 to hold annual training drills. Pyongyang has long condemned joint drills between South Korea and the United States, calling them a rehearsal for invasion.