Indian and multinational pharma companies are leading the charge by investing in digital transformation and aligning Indian operations with global standards. Essentially, pharmaceutical water systems are

The Subject Expert Committee (SEC), which advises the national drug regulator on approval of new drugs and clinical trials, has recommended grant of market authorisation for Dr Reddy's Laboratories' Siponimod

Oversimplification about integration of traditional and modern treatment systems often creates confusion among the stakeholders, and nobody understands the reality of the integration and what it is meant for, said Dr.

Asahi Kasei Medical has launched the Planova FG1, a next-generation virus removal filter featuring higher flux for the manufacture of biotherapeutics, in October 2024.

Accumold, with over 40 years of experience in micromoulding technology, is set to participate at Compamed, taking place in Düsseldorf, Germany, from 11-14 November. The company will highlight its small and complex parts for medical device OEMs.

In this episode of The MedTalk Podcast, we're bringing you something a little different. One of our sister publications, European Pharmaceutical Manufacturer, secured an interview with Thermo Fisher Scientific's Urmi Prasad Richardson.

When chemist Dora Richardson’s employer decided to terminate the breast cancer research on the drug Tamoxifen in the early 1970s, she and her colleagues continued the work in secret.

A heart attack unleashes immune cells that stimulate neurons in the brain, leading to restorative slumber

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

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

A team at Columbia University School of Engineering and Applied Science has developed a technique to enhance chimeric antigen receptor (CAR) T cell therapy in solid tumors. The technique involves engineering E. coli bacteria, that naturally tend to accumulate in the immune privileged core of solid tumors. The bacteria have been engineered to interact with […]

Charco Neurotech, a medtech company based in the United Kingdom, has developed CUE1, a non-invasive wearable that is intended to assist those with Parkinson’s disease to manage their motor symptoms. The device is typically affixed to the sternum, and provides vibratory action in a focused region of the body. The technology is based on the […]

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

Click here to see the original post from June 2024.

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The 340B contract pharmacy market shows little sign of slowing down. Drug Channels Institute’s exclusive analysis of the 2024 market reveals that:Read more »

Today’s guest post comes from Timothy Nielsen, Vice President of Customer Success at AssistRx.

Timothy discusses the affordability and patient journey challenges of specialty-lite products for patients, manufacturers, and health care providers. He explains how AssistRx's Advanced Access Anywhere (AAA) solution streamlines processes for specialty-lite products and facilitates enrollment via a digital hub.

To learn more, register for AssistRx's free webinar on October 8: Meet Your Patients Where They Are & Gain Visibility: Even at Retail.

Read on for Timothy’s insights.
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 »

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 »

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

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

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

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Disclosure: I sit on the Planning Committee for the FDLI Ad-Promo conference. This is an unpaid, volunteer position. The contents of this post were not discussed with or influenced by any member of the FDLI staff.

This post provides some of the highlights from FDLI's ad-promo conference. An on-demand version of the conference presentations is available on-demand at: https://www.fdli.org/2023/11/advertising-promotion-for-medical-products-conference-on-demand/

The Food and Drug Law Institute's (FDLI) Advertising & Promotion for Medical Products conference wrapped up last week. I attended the conference and also moderated a panel on data privacy and concerns about the use of health data for the targeting of advertising.

The first day kicked off with a fireside chat with Arun Rao from the Department of Justice (DOJ), Lauren Roth from the Food & Drug Administration (FDA), and Serena Viswanathan from the Federal Trade Commission (FTC), led by Christine Simmon of FDLI.

FDA and FTC both noted their recent guidance updates. For FDA, that means the new Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers Guidance for Industry (SIUU) and the newly finalized Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements. 

FTC has also been busy, providing updated guidance on endorsements, reviews and testimonials, and a distinct Health Products Compliance Guidance.

DOJ, FDA, and FTC also mentioned the extent to which they are still very much digging out from the backlog created by the pandemic. More than three years after COVID-19 first came to our shores, its effects are very much still being felt.

Rao also mentioned a new policy from DOJ to create a safe harbor for self-reported disclosures made in connection with a merger or acquisition. Under this new policy, companies that learn of wrongdoing at a company they have acquired can be protected from later liability if they report the wrongdoing to DOJ within six months of closing the merger or acquisition. This is as Rao described it a "very big juicy carrot" to encourage self-reporting of wrongdoing, and it also ramps up the need for effective due diligence during the M&A to ensure that all wrongdoing is uncovered and can be reported.

One final point mentioned by Roth is the importance to FDA of combatting misinformation about medical products. Commissioner Califf has repeatedly warned about the need to combat misinformation, and it is not a stretch to see FDA's SIUU guidance as one small step in that direction. By providing further guidance about exactly how sponsors can share truthful, not misleading information about unapproved uses, FDA is enabling efforts to get good information from the people who should be seen as the most reliable source of that information, the product's sponsors.

The next session of the day included an update from OPDP, APLB, CDRH, and CVM related to advertising and promotion.

Katie Gray from OPDP gave a detailed presentation on the Recorlev enforcement action from earlier this year and an overview of the SIUU guidance. Lisa Stockbridge from APLB provided a reminder on reminder advertising, indicating that this well-established category of communication continues to cause firms difficulties. Debra Wolf of CDRH emphasized that although there has not been a significant amount of publicly available enforcement actions from CDRH, the Agency continues to have many private communications with firms about their marketing efforts.

The next plenary session covered scientific exchange and pre-approval communications. Elisabethann Wright of Cooley provided particular insight into the EU's approach, which of course varies widely by country, and has been especially active on platforms such as LinkedIn. Of note is the extremely active role played by the industry's own associations in not merely promulgating guidance and establishing codes of conduct but in regularly enforcing violations of those codes against member companies.

After lunch, the first set of breakout sessions occurred including the panel I moderated on data privacy. I found the discussion very lively and enjoyed hearing from Elisa Jillson from the FTC, Lyra Correa from HHS's Office of Civil Rights, and Nancy Perkins from Arnold & Porter. I have previously opined that the 2020s will be most known for its focus on privacy, and while the cookie-less future we keep hearing about gets pushed back once again, there's growing awareness and concern about how much deeply personal information has been given up and on how companies are using (or misusing) that data.

Simultaneous sessions looked at the recently finalized guidance from the FDA on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements while another session looked more into the promotion of veterinary products. Because I was leading another session, I couldn't attend either, but I'm looking forward to using that link provided earlier to view the recordings. 

The afternoon plenary sessions resumed with a look at FTC's role in enforcement of healthcare advertising and closed out with a session on that perennial chestnut of social media usage.

Day two of the conference kicked off with an enlightening discussion of so-called CFL (Consistent with FDA-Labeling) claims. Torrey Cope of Sidley Austin provided an insightful look not just at FDA's enforcement post-guidance for claims that failed to meet the CFL standard, but also for taking the time to examine the nature and wording around the acceptance by FDA of so-called Real-World Evidence (RWE) in the context of product approvals. RWE is not the sole source of CFL claims, but Cope was able to provide some valuable lessons.

The afternoon's breakout sessions included one on artificial intelligence (which I attended), promotional challenges in rare disease treatments, and navigating accelerated approval promotion.

The closing session focused on other avenues for enforcement, including of course, the Better Business Bureau National Advertising Division's (NAD), as well as general counsel to general counsel complaint letters, filing complaints with the FDA, and perhaps even bringing a Lanham Act case.

The NAD's finding against Novartis earlier this year was of course a hot topic. But it is worth noting that in a more recent case, Viiv simply declined to participate in the NAD process. NAD referred the matter to FDA and FTC noting that decision, but as of the writing of this post, no further action by the government has been seen.

Alan Minsk of Arnall Golden Gregory noted the importance of determining your goal when looking at the appropriate path. If your goal is get a competitor in trouble then you really need to rely on the government or the courts, but if your goal is primarily to just get the company to stop the use of misleading promotion, then NAD or a direct complaint letter might be a far more cost-effective solution.

Overall, the conference was a huge success, though my opinion should be viewed as biased because I sit on the conference planning committee. FDA is definitely digging itself out from the pandemic backlog. I fully expect we'll see more from the Agency, as a very active 2023 has already demonstrated.

On December 3, a federal appeals court ruled against one of the FDA’s untouchable restrictions on industry—thou shalt not promote the off-label use of pharmaceutical products. An industry that is little interested in constitutional law suddenly finds itself talking about the First Amendment and whether, and on what grounds, the case will be appealed. Meantime, the court’s decision left FDA Matters torn between cheering and booing. Patients are poorly served if their doctor is prescribing drugs without being able to tap into all sources of relevant knowledge. However, permitting off-label promotion undercuts the incentive for companies to thoroughly investigate the safety and efficacy of a drug for a second or third use.

Chicken was once an expensive delicacy. In 1928, America’s quest for a better diet and a better standard of living was summarized by the campaign promise of “a chicken in every pot.” Today, chicken is a ubiquitous, low-cost source of protein, which we largely take for granted. Despite depletion of ocean-based stocks, fish hold similar potential. To begin this transformation, FDA must approve a scientifically-based innovative product—a faster growing genetically-engineered (GE) Atlantic salmon. When FDA Matters wrote about this subject 18 months ago, I believed the agency was near to approval of this first-ever food product from a GE animal. It is still not resolved and there are implications for all innovations that require FDA approval.

FDA Matters appreciates your patience. New columns will be coming in June, with fresh insights into FDA and the FDA-regulated world.  Meantime, I write a weekly column in the Friday Update, published by the Alliance for a Stronger FDA. If you want to receive the Friday Update when it's published each week, you can sign […]

Effective on October 21st of this year, the Federal Trade Commission (FTC) issued a new final rule that is intended to better combat ​“fake” reviews and testimonials by prohibiting the sale or purchase of “fake reviews” as well as granting the agency the opportunity to seek civil penalties against ​willful violators. The FTC made only […]

Starting COVID-19 patients on prophylactic anticoagulation within 24 hours of being admitted to hospital has been linked to a reduced risk of mortality.

Community pharmacies will receive an estimated 12 referrals from the Discharge Medicines Service per year.

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.

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.

Having just turned 50, I’ve been reflecting on my first half-century of late… many fun and impactful moments, a few regrets, and a life I’ve tried to live to the fullest. One thread that has run throughout it has been

The post A Molecular Biologist’s Advice For Life appeared first on LifeSciVC.

By Jonathan Montagu, CEO of HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC HotSpot’s trip to Barcelona for the recent European Society of Medical Oncology (ESMO) Annual Meeting was no ‘European Vacation,’ but it was certainly

The post ESMO Reflections: Glimmers of Hope with the Next Wave of I-O Therapies? appeared first on LifeSciVC.

The UK body that oversees health research is writing a new strategy on clinical trial transparency and it wants to hear opinions on it. The Health Research Authority (HRA) says its strategy aims to “make transparency easy, make compliance clear and make information public.” It has opened a public consultation on the strategy and some […]

[Fair Warning: I have generally tried to keep this blog separate from my corporate existence, but am making an exception for two quick posts about the upcoming DIA 2013 Annual Meeting.]

Improving Enrollment in Pediatric Clinical Trials

Logistically, ethically, and emotionally, involving children in medical research is greatly different from the same research in adults. Some of the toughest clinical trials I've worked on, across a number of therapeutic areas, have been pediatric ones. They challenge you to come up with different approaches to introducing and explaining clinical research – approaches that have to work for doctors, kids, and parents simultaneously.

On Thursday June 27, Don Sickler, one of my team members, will be chairing a session titled “Parents as Partners: Engaging Caregivers for Pediatric Trials”. It should be a good session.

Joining Don are 2 people I've had the pleasure of working with in the past. Both of them combine strong knowledge of clinical research with a massive amount of positive energy and enthusiasm (no doubt a big part of what makes them successful).

However, they also differ in one key aspect: what they work on. One of them – Tristen Moors from Hyperion Therapeutics - works on an ultra-rare condition, Urea Cycle Disorder, a disease affecting only a few hundred children every year. On the other hand, Dr. Ann Edmunds is an ENT working in a thriving private practice. I met her because she was consistently the top enroller in a number of trials relating to tympanostomy tube insertion. Surgery to place “t-tubes” is one of the most common and routine outpatients surgeries there is, with an estimated half million kids getting tubes each year.

Each presents a special challenge: for rare conditions, how do you even find enough patients? For routine procedures, how do you convince parents to complicate their (and their children’s) lives by signing up for a multi-visit, multi-procedure trial?

Ann and Tristen have spent a lot of time tackling these issues, and should have some great advice to give.

For more information on the session, here’s Don’s posting on our news blog.

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

Session Details:

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

• Session Number: 241
• Room Number: 205B

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

2. Use of Analytics for Operational Planning
Diana Chung, MSc
Associate Director, Clinical Operations
Gilead
3. Using Enrollment Data to Communicate Effectively with Sites
Gretchen Goller, MA
Senior Director, Patient Access and Retention Services
PRA

• Both are university/private collaborations, and both (perhaps unsurprisingly) are rooted in California: Heath eHeart is jointly run by UCSF and the American Heart Association, while Quantified Diet is run by app developer Lift with scientific support from a (unidentified?) team at Berkeley.
• Both are pushing for a million or more participants, dwarfing even very large traditional studies by orders of magnitude.
• Health eHeart is entirely observational, and researchers will have the ability to request its data to test their own hypotheses, whereas Quantified Diet is a controlled, randomized trial.

Maybe those pesky sites are good for something after all. 

It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information and consent was delivered via the web, and medications and diaries were shipped directly to patients' homes.

Despite the initial fanfare, within a month REMOTE's registration on ClinicalTrials.gov was quietly reduced from 600 to 283. The smaller trial ended not with a bang but a whimper, having randomized only 18 patients in over a year of recruiting.

Still, the allure of direct to patient clinical trials remains strong, due to a confluence of two factors. First, a frenzy of interest in running "patient centric clinical trials". Sponsors are scrambling to show they are doing something – anything – to show they have shifted to a patient-centered mindset. We cannot seem to agree what this means (as a great illustration of this, a recent article in Forbes on "How Patients Are Changing Clinical Trials" contained no specific examples of actual trials that had been changed by patients), but running a trial that directly engages patients wherever they are seems like it could work.

The less-openly-discussed other factor leading to interest in these DIY trials is sponsors' continuing willingness to heap almost all of the blame for slow-moving studies onto their research sites. If it’s all the sites’ fault – the reasoning goes – then cutting them out of the process should result in trials that are both faster and cheaper. (There are reasons to be skeptical about this, as I have discussed in the past, but the desire to drop all those pesky sites is palpable.)

However, while a few proof-of-concept studies have been done, there really doesn't seem to have been another trial to attempt a full-blown direct-to-patient clinical trial. Other pilots have been more successful, but had fairly lightweight protocols. For all its problems, REMOTE was a seriously ambitious project that attempted to package a full-blown interventional clinical trial, not an observational study.

In this context, it's great to see published results of the TAPIR Trial in vasculitis, which as far as I can tell is the first real attempt to run a DIY trial of a similar magnitude to REMOTE.

TAPIR was actually two parallel trials, identical in every respect except for their sites: one trial used a traditional group of 8 sites, while the other was virtual and recruited patients from anywhere in the country. So this was a real-time, head-to-head assessment of site performance.

And the results after a full two years of active enrollment?

• Traditional sites: 49 enrolled
• Patient centric: 10 enrolled

Even though we’re six years later, and online/mobile communications are even more ubiquitous, we still see the exact same struggle to enroll patients.

Maybe it’s time to stop blaming the sites? To be fair, they didn’t exactly set the world on fire – and I’m guessing the total cost of activating the 8 sites significantly exceeded the costs of setting up the virtual recruitment and patient logistics. But still, the site-less, “patient centric” approach once again came up astonishingly short.
Krischer J, Cronholm PF, Burroughs C, McAlear CA, Borchin R, Easley E, Davis T, Kullman J, Carette S, Khalidi N, Koening C, Langford CA, Monach P, Moreland L, Pagnoux C, Specks U, Sreih AG, Ytterberg S, Merkel PA, & Vasculitis Clinical Research Consortium. (2017). Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study. Journal of medical Internet research, 19 (2) PMID: 28246067

Hospitals have been forced to innovate with new ways of hydrating patients and giving them medications, after a key factory that produces IV fluid bags flooded during Hurricane Helene. (This story first aired on Morning Edition on Nov. 7, 2024.)

More people are getting cancer in their 20s, 30s, and 40s, and surviving, thanks to rapid advancement in care. Many will have decades of life ahead of them, which means they face greater and more complex challenges in survivorship. Lourdes Monje is navigating these waters at age 29.

This article is part of our exclusive IEEE Journal Watch series in partnership with IEEE Xplore.

Sea turtles are remarkable creatures for a number of reasons, including the way they hear underwater—not through openings in the form of ears, but by detecting vibrations directly through the skin covering their auditory system. Inspired by this ability to detect sound through skin, researchers in China have created a heart-monitoring system, which initial tests in humans suggest may be a viable for monitoring heartbeats.

A key way in which doctors monitor heart health involves “listening” to the heartbeat, either using a stethoscope or more sophisticated technology, like echocardiograms. However, these approaches require a visit to a specialist, and so researchers have been keen to develop alternative, lower cost solutions that people can use at home, which could also allow for more frequent testing and monitoring.

Junbin Zang, a lecturer at the North University of China, and his colleagues specialize in creating heart-monitoring technologies. Their interest was piqued when they learned about the inner workings of the sea turtle’s auditory system, which is able to detect low-frequency signals, especially in the 300- to 400-hertz range.

“Heart sounds are also low-frequency signals, so the low-frequency characteristics of the sea turtle’s ear have provided us with great inspiration,” explains Zang.

At a glance, it looks like turtles don’t have ears. Their auditory system instead lies under a layer of skin and fat, through which it picks up vibrations. As with humans, a small bone in the ear vibrates as sounds hit it, and as it oscillates, those pulses are converted to electrical signals that are sent to the brain for processing and interpretation.

iStock

But sea turtles have a unique, slender T-shaped conduit that encapsulates their ear bones, restricting the movement of the similarly T-shaped ear bones to only vibrate in a perpendicular manner. This design provides their auditory system with high sensitivity to vibrations.

Zang and his colleagues set out to create a heart monitoring system with similar features. They created a T-shaped heart-sound sensor that imitates the ear bones of sea turtles using a tiny MEMS cantilever beam sensor. As sound hits the sensor, the vibrations cause deformations in its beam, and the fluctuations in the voltage resistance are then translated into electrical signals.

The researchers first tested the sensor’s ability to detect sound in lab tests, and then tested the sensor’s ability to monitor heartbeats in two human volunteers in their early 20s. The results, described in a study published 1 April in IEEE Sensors Journal, show that the sensor can effectively detect the two phases of a heartbeat.

“The sensor exhibits excellent vibration characteristics,” Zang says, noting that it has a higher vibration sensitivity compared to other accelerometers on the market.

However, the sensor currently picks up a significant amount of background noise, which Zang says his team plans to address in future work. Ultimately, they are interested in integrating this novel bioinspired sensor into devices they have previously created—including portable handheld and wearable versions, and a relatively larger version for use in hospitals—for the simultaneous detection of electrocardiogram and phonocardiogram signals.

This article appears in the July 2024 print issue as “Sea Turtles Inspire Heart-Monitor Design.”

For people with diabetes, glucose monitors are a valuable tool to monitor their blood sugar. The current generation of these biosensors detect glucose levels with thin, metallic filaments inserted in subcutaneous tissue, the deepest layer of the skin where most body fat is stored.

Medical technology company Biolinq is developing a new type of glucose sensor that doesn’t go deeper than the dermis, the middle layer of skin that sits above the subcutaneous tissue. The company’s “intradermal” biosensors take advantage of metabolic activity in shallower layers of skin, using an array of electrochemical microsensors to measure glucose—and other chemicals in the body—just beneath the skin’s surface.

Biolinq just concluded a pivotal clinical trial earlier this month, according to CEO Rich Yang, and the company plans to submit the device to the U.S. Food and Drug Administration for approval at the end of the year. In April, Biolinq received US $58 million in funding to support the completion of its clinical trials and subsequent submission to the FDA.

Biolinq’s glucose sensor is “the world’s first intradermal sensor that is completely autonomous,” Yang says. While other glucose monitors require a smartphone or other reader to collect and display the data, Biolinq’s includes an LED display to show when the user’s glucose is within a healthy range (indicated by a blue light) or above that range (yellow light). “We’re providing real-time feedback for people who otherwise could not see or feel their symptoms,” Yang says. (In addition to this real-time feedback, the user can also load long-term data onto a smartphone by placing it next to the sensor, like Abbott’s FreeStyle Libre, another glucose monitor.)

More than 2,000 microsensor components are etched onto each 200-millimeter silicon wafer used to manufacture the biosensors.Biolinq

Biolinq’s hope is that its approach could lead to sustainable changes in behavior on the part of the individual using the sensor. The device is intentionally placed on the upper forearm to be in plain sight, so users can receive immediate feedback without manually checking a reader. “If you drink a glass of orange juice or soda, you’ll see this go from blue to yellow,” Yang explains. That could help users better understand how their actions—such as drinking a sugary beverage—change their blood sugar and take steps to reduce that effect.

Biolinq’s device consists of an array of microneedles etched onto a silicon wafer using semiconductor manufacturing. (Other glucose sensors’ filaments are inserted with an introducer needle.) Each chip has a small 2-millimeter by 2-millimeter footprint and contains seven independent microneedles, which are coated with membranes through a process similar to electroplating in jewelry making. One challenge the industry has faced is ensuring that microsensors do not break at this small scale. The key engineering insight Biolinq introduced, Yang says, was using semiconductor manufacturing to build the biosensors. Importantly, he says, silicon “is harder than titanium and steel at this scale.”

Miniaturization allows for sensing closer to the surface of the skin, where there is a high level of metabolic activity. That makes the shallow depth ideal for monitoring glucose, as well as other important biomarkers, Yang says. Due to this versatility, combined with the use of a sensor array, the device in development can also monitor lactate, an important indicator of muscle fatigue. With the addition of a third data point, ketones (which are produced when the body burns fat), Biolinq aims to “essentially have a metabolic panel on one chip,” Yang says.

Using an array of sensors also creates redundancy, improving the reliability of the device if one sensor fails or becomes less accurate. Glucose monitors tend to drift over the course of wear, but with multiple sensors, Yang says that drift can be better managed.

One downside to the autonomous display is the drain on battery life, Yang says. The battery life limits the biosensor’s wear time to 5 days in the first-generation device. Biolinq aims to extend that to 10 days of continuous wear in its second generation, which is currently in development, by using a custom chip optimized for low-power consumption rather than off-the-shelf components.

The company has collected nearly 1 million hours of human performance data, along with comparators including commercial glucose monitors and venous blood samples, Yang says. Biolinq aims to gain FDA approval first for use in people with type 2 diabetes not using insulin and later expand to other medical indications.

This article appears in the August 2024 print issue as “Glucose Monitor Takes Page From Chipmaking.”

Did that rock move, or is it a squirrel crossing the road? Tracking objects that look a lot like their surroundings is a big problem for many autonomous vision systems. AI algorithms can solve this camouflage problem, but they take time and computing power. A new camera designed by researchers in South Korea provides a faster solution. The camera takes inspiration from the eyes of a cat, using two modifications that let it distinguish objects from their background, even at night.

“In the future … a variety of intelligent robots will require the development of vision systems that are best suited for their specific visual tasks,” says Young Min Song, a professor of electrical engineering and computer science at Gwangju Institute of Science and Technology and one of the camera’s designers. Song’s recent research has been focused on using the “perfectly adapted” eyes of animals to enhance camera hardware, allowing for specialized cameras for different jobs. For example, fish eyes have wider fields of view as a consequence of their curved retinas. Cats may be common and easy to overlook, he says, but their eyes actually offer a lot of inspiration.

This particular camera copied two adaptations from cats’ eyes: their vertical pupils and a reflective structure behind their retinas. Combined, these allowed the camera to be 10 percent more accurate at distinguishing camouflaged objects from their backgrounds and 52 percent more efficient at absorbing incoming light.

Using a vertical pupil to narrow focus

While conventional cameras can clearly see the foreground and background of an image, the slitted pupils of a cat focus directly on a target, preventing it from blending in with its surroundings. Kim et al./Science Advances

In conventional camera systems, when there is adequate light, the aperture—the camera’s version of a pupil—is small and circular. This structure allows for a large depth of field (the distance between the closest and farthest objects in focus), clearly seeing both the foreground and the background. By contrast, cat eyes narrow to a vertical pupil during the day. This shifts the focus to a target, distinguishing it more clearly from the background.

The researchers 3D printed a vertical slit to use as an aperture for their camera. They tested the vertical slit using seven computer vision algorithms designed to track moving objects. The vertical slit increased contrast between a target object and its background, even if they were visually similar. It beat the conventional camera on five of the seven tests. For the two tests it performed worse than the conventional camera, the accuracies of the two cameras were within 10 percent of each other.

Using a reflector to gather additional light

Cats can see more clearly at night than conventional cameras due to reflectors in their eyes that bring extra light to their retinas.Kim et al./Science Advances

Cat eyes have an in-built reflector, called a tapetum lucidum, which sits behind the retina. It reflects light that passes through the retina back at it, so it can process both the incoming light and reflected light, giving felines superior night vision. You can see this biological adaptation yourself by looking at a cat’s eyes at night: they will glow.

The researchers created an artificial version of this biological structure by placing a silver reflector under each photodiode in the camera. Photodiodes without a reflector generated current when more than 1.39 watts per square meter of light fell on them, while photodiodes with a reflector activated with 0.007 W/m² of light. That means the photodiode could generate an image with about 1/200th the light.

Each photodiode was placed above a reflector and joined by metal electrodes to create a curved image sensor.Kim et al./Science Advances

To decrease visual aberrations (imperfections in the way the lens of the camera focuses light), Song and his team opted to create a curved image sensor, like the back of the human eye. In such a setup, a standard image sensor chip won’t work, because it’s rigid and flat. Instead it often relies on many individual photodiodes arranged on a curved substrate. A common problem with such curved sensors is that they require ultrathin silicon photodiodes, which inherently absorb less light than a standard imager’s pixels. But reflectors behind each photodiode in the artificial cat’s eye compensated for this, enabling the researchers to create a curved imager without sacrificing light absorption.

Together, vertical slits and reflectors led to a camera that could see more clearly in the dark and isn’t fooled by camouflage. “Applying these two characteristics to autonomous vehicles or intelligent robots could naturally improve their ability to see objects more clearly at night and to identify specific targets more accurately,” says Song. He foresees this camera being used for self-driving cars or drones in complex urban environments.

Song’s lab is continuing to work on using biological solutions to solve artificial vision problems. Currently, they are developing devices that mimic how brains process images, hoping to one day combine them with their biologically-inspired cameras. The goal, says Song, is to “mimic the neural systems of nature.”

Song and his colleague’s work was published this week in the journal Science Advances.

This article appears in the November 2024 print issue.

Emteq Labs wants eyewear to be the next frontier of wearable health technology.

The Brighton, England-based company introduced today its emotion-sensing eyewear, Sense. The glasses contain nine optical sensors distributed across the rims that detect subtle changes in facial expression with more than 93 percent accuracy when paired with Emteq’s current software. “If your face moves, we can capture it,” says Steen Strand, whose appointment as Emteq’s new CEO was also announced today. With that detailed data, “you can really start to decode all kinds of things.” The continuous data could help people uncover patterns in their behavior and mood, similar to an activity or sleep tracker.

Emteq is now aiming to take its tech out of laboratory settings with real-world applications. The company is currently producing a small number of Sense glasses, and they’ll be available to commercial partners in December.

The announcement comes just weeks after Meta and Snap each unveiled augmented reality glasses that remain in development. These glasses are “far from ready,” says Strand, who led the augmented reality eyewear division while working at Snap from 2018 to 2022. “In the meantime, we can serve up lightweight eyewear that we believe can deliver some really cool health benefits.”

Fly Vision Vectors

While current augmented reality (AR) headsets have large battery packs to power the devices, glasses require a lightweight design. “Every little bit of power, every bit of weight, becomes critically important,” says Strand. The current version of Sense weighs 62 grams, slightly heavier than the Ray-Ban Meta smart glasses, which weigh in at about 50 grams.

Because of the weight constraints, Emteq couldn’t use the power-hungry cameras typically used in headsets. With cameras, motion is detected by looking at how pixels change between consecutive images. The method is effective, but captures a lot of redundant information and uses more power. The eyewear’s engineers instead opted for optical sensors that efficiently capture vectors when points on the face move due to the underlying muscles. These sensors were inspired by the efficiency of fly vision. “Flies are incredibly efficient at measuring motion,” says Emteq founder and CSO Charles Nduka. “That’s why you can’t swat the bloody things. They have a very high sample rate internally.”

Sense glasses can capture data as often as 6,000 times per second. The vector-based approach also adds a third dimension to a typical camera’s 2D view of pixels in a single plane.

These sensors look for activation of facial muscles, and the area around the eyes is an ideal spot. While it’s easy to suppress or force a smile, the upper half of our face tends to have more involuntary responses, explains Nduka, who also works as a plastic surgeon in the United Kingdom. However, the glasses can also collect information about the mouth by monitoring the cheek muscles that control jaw movements, conveniently located near the lower rim of a pair of glasses. The data collected is then transmitted from the glasses to pass through Emteq’s algorithms in order to translate the vector data into usable information.

In addition to interpreting facial expressions, Sense can be used to track food intake, an application discovered by accident when one of Emteq’s developers was wearing the glasses while eating breakfast. By monitoring jaw movement, the glasses detect when a user chews and how quickly they eat. Meanwhile, a downward-facing camera takes a photo to log the food, and uses a large language model to determine what’s in the photo, effectively making food logging a passive activity. Currently, Emteq is using an instance of OpenAI’s GPT-4 large language model to accomplish this, but the company has plans to create their own algorithm in the future. Other applications, including monitoring physical activity and posture, are also in development.

One Platform, Many Uses

Nduka believes Emteq’s glasses represent a “fundamental technology,” similar to how the accelerometer is used for a host of applications in smartphones, including managing screen orientation, tracking activity, and even revealing infrastructure damage.

Similarly, Emteq has chosen to develop the technology as a general facial data platform for a range of uses. “If we went deep on just one, it means that all the other opportunities that can be helped—especially some of those rarer use cases—they’d all be delayed,” says Nduka. For example, Nduka is passionate about developing a tool to help those with facial paralysis. But a specialized device for those patients would have high unit costs and be unaffordable for the target user. Allowing more companies to use Emteq’s intellectual property and algorithms will bring down cost.

In this buckshot approach, the general target for Sense’s potential use cases is health applications. “If you look at the history of wearables, health has been the primary driver,” says Strand. The same may be true for eyewear, and he says there’s potential for diet and emotional data to be “the next pillar of health” after sleep and physical activity.

How the data is delivered is still to be determined. In some applications, it could be used to provide real-time feedback—for instance, vibrating to remind the user to slow down eating. Or, it could be used by health professionals only to collect a week’s worth of at-home data for patients with mental health conditions, which Nduka notes largely lack objective measures. (As a medical device for treatment of diagnosed conditions, Sense would have to go through a more intensive regulatory process.) While some users are hungry for more data, others may require a “much more gentle, qualitative approach,” says Strand. Emteq plans to work with expert providers to appropriately package information for users.

Interpreting the data must be done with care, says Vivian Genaro Motti, an associate professor at George Mason University who leads the Human-Centric Design Lab. What expressions mean may vary based on cultural and demographic factors, and “we need to take into account that people sometimes respond to emotions in different ways,” Motti says. With little regulation of wearable devices, she says it’s also important to ensure privacy and protect user data. But Motti raises these concerns because there is a promising potential for the device. “If this is widespread, it’s important that we think carefully about the implications.”

Privacy is also a concern to Edward Savonov, a professor of electrical and computer engineering at the University of Alabama, who developed a similar device for dietary tracking in his lab. Having a camera mounted on Emteq’s glasses could pose issues, both for the privacy of those around a user and a user’s own personal information. Many people eat in front of their computer or cell phone, so sensitive data may be in view.

For technology like Sense to be adopted, Sazonov says questions about usability and privacy concerns must first be answered. “Eyewear-based technology has potential for a great future—if we get it right.”

CDMO Avid Bioservices is being acquired by the private equity firms GHO Capital Partners and Ampersand Capital Partners. Avid specializes in manufacturing biologic products for companies at all stages of development.

The post Private Equity Is Picking Up Biologics CDMO Avid Bioservices in $1.1B Acquisition 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.

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.

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.

Yesterday’s conference sessions surfaced interesting questions and approaches regarding the post-acute sector, bundled payment, emergency medicine and anesthesia. Post-Acute Focus: With more and more focus on the need to rationalize and re-organize the post-acute sector, we have seen multiple industry leaders start to evolve their strategies.  I blogged yesterday about AccentCare’s interesting strategy in the...… Continue Reading

A large amount of wind, much discussion about the U.S healthcare, and the public getting soaked again – if you were thinking about Washington, DC and the new Congress, you’re 3,000 miles away from the action. This is the week of the annual JP Morgan Healthcare conference in San Francisco, with many thousands of healthcare...… Continue Reading