Informa Connect’s PBM Contracting Summit
December 10-11, 2024 | Chicago, IL
Drug Channels readers save 10% with code 24DRCH10*

Experts from across the US come together each year at the PBM Contracting Summit to gain innovative and practical contracting strategies, master PBM innovation and design, improve patient care management and rising costs, understand the current legislative issues impacting contract negotiations and more. Join us in Chicago (or virtually) where you’ll benefit from two days of learning, education and networking, and will return to the office having mastered the complex PBM landscape.

You’ll hear from Matthew Gibbs, Pharm.D., Pharmacy Transformation Leader of Blue Shield of California as he leads a comprehensive discussion on the PBM landscape over the last year, and delves into the evolving trends and emerging challenges shaping the current industry today.

Other expert and thought leaders from within the industry are slated to present deep dive sessions, workshops and panels that will answer your most pressing questions:

• What are the latest legislative updates and proposed federal bills impacting PBM operations?
• What's on the horizon for alternative PBMs? What are the top intricacies of rebate eligibility? What are the market impacts of innovative models such as Mark Cuban's Cost Plus Drugs and Amazon's pharmacy model?
• What can be learned from the J&J lawsuit? Review the expansion of data access and the importance of employer's fiduciary duties.
• What are the challenges of vertical integration?
• How do PBMs manage their contracting processes with plan sponsors to create successful contracts?
• What are the most effective strategies for spread pricing and reimbursement models?
• What is the best solution to navigate the challenges of the 340B drug pricing program and PBM contracting?
• What is the best way to design and optimize benefits for covering GLP-1s?
• How can I ensure compliance with ERISA requirements?
• What are the latest developments in copay maximizer and accumulator programs?
• What market dynamics and barriers are impacting pricing and demand?
• What can be learned from the economic landscape of biosimilars and specialty therapeutics?
• And much more!

View the agenda for the PBM Contracting Summit to see the complete picture – the program, speakers, and more, visit www.informaconnect.com/pbm-contracting for further details and to register. Drug Channels readers will save 10% off when they use code 24DRCH10 and register prior to November 8, 2024.*

*Cannot be combined with other offers or used towards a current registration. Cannot be combined with special category rates or other offers. Other restrictions may apply.

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The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@DrugChannels.net).

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.
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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 »

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

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

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

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

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

• Zoinks! Join the vampire hunters at Drug Channels Institute

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

P.S. Stretch out your arms and join the ever-growing zombie horde who shamble after me on LinkedIn. You’ll find my ghostly rantings along with commentary from the undead hordes in the DCI community.
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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?
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Today’s guest post comes from Chris Dowd, Senior VP of Market Development at ConnectiveRx.

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

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

Read on for Chris’s insights.
Read more »

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

¿Qué son los biosimilares? Los biosimilares son un tipo de medicamento que se usa para tratar una variedad de afecciones, como enfermedades crónicas de la piel y los intestinos, artritis, diabetes, afecciones renales, degeneración macular y algunos tipos de cáncer. Un biosimilar es un tipo de medicamento biológico. La mayoría de los medicamentos biológicos se elaboran usando fuentes vivas, como células animales, bacterias o levaduras. Debido a que en su mayoría provienen de fuentes vivas, todos los tipos de productos biológicos tienen diferencias menores que ocurren naturalmente entre los lotes de producción. Así como los medicamentos de marca tienen versiones genéricas, los biológicos originales pueden tener biosimilares. La cuidadosa revisión de datos, estudios y pruebas por parte de la FDA ayuda a garantizar que los productos biosimilares brinden los mismos beneficios de tratamiento que el producto biológico original aprobado por la FDA. Los biosimilares pueden brindarle más acceso a tratamientos importantes y también pueden ahorrarle dinero, dependiendo de su cobertura de seguro. Se han aprobado muchos biosimilares diferentes y se esperan aún más. Para obtener más información, visite www.fda.gov/biosimilars

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

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Acting Center Director of the Center for Devices and Radiological Health (CDRH). She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture.

Dr. Tarver has held various leadership positions while at the FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation, and the Program Director of Patient Science and Engagement. Learn more at www.fda.gov

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required. For more privacy and use information visit: www.flickr.com/people/fdaphotos/

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

Catherine Dasenbrock, director of the U.S. Food and Drug Administration’s National Forensic Chemistry Center, speaks to guests prior to officially reopening the center during a ribbon-cutting ceremony, Sept. 24, 2024, celebrating the completion of the 64,000-square-foot expansion and renovation of the facility in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

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

U.S. Food and Drug Administration officials and General Services Administration leaders officially reopen the National Forensic Chemistry Center during a ribbon-cutting ceremony, Sept. 24, 2024, highlighting the completion of the 64,000-square-foot expansion and renovation of the center in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

(From left)
Marie Maguire, Assistant Special Agent in Charge, Headquarters Operations, Office of Criminal Investigations, FDA
James Sigg, Deputy Commissioner for Operations and Chief Operating Officer, Office of the Commissioner, FDA
Catherine Dasenbrock, Director, National Forensic Chemistry Center, Office of Inspections and Investigations (OII), FDA
Duane Satzger, Associate Director, Office of Medical Products and Specialty Laboratory Operations, OII, FDA
Katy Kale, Deputy Administrator, GSA
Douglas Stearn, Principal Deputy Associate Commissioner, OII, FDA

FDA photo by Matthew MacRoberts

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

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

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

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

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

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

FDA’s mission is “at risk” because of inadequate funding. So says Alliance for a Stronger FDA President Diane Dorman, testifying before the FDA Science Board. Her remarks come 5 years after the Science Board made a similar declaration, concluding that decades of underfunding had left FDA without the resources to fulfill its mandate and make science-based decisions. Congress responded with more monies for the agency, but since then the FDA’s workload has increased even faster. The current threat to FDA comes from two sources: four major new laws to implement since 2009; and changes in the environment in which FDA operates, notably acceleration of globalization and increasing scientific complexity. Ms. Dorman’s remarks are reprinted below. If you care about FDA, FDA Matters urges you to read her testimony, go to the Alliance’s site (www.StrengthenFDA.org) and join.

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 […]

The proposed American Privacy Rights Act (APRA) has taken its first step U.S. House legislative process with several issue disagreements becoming more evident. On May 23, the U.S. House Committee on Energy and Commerce Subcommittee on Data, Innovation and Commerce approved the updated APRA, advancing the bill to full committee consideration. Just prior to the […]

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

The New York legislature passed two bills on June 7, 2024 directed at children’s use of online technologies – the Stop Addictive Feeds Exploitation (SAFE) for Kids Act (S7694) that restricts access to addictive algorithmic feeds and the New York Child Data Protection Act (S7695) that bans sites from collecting, using, sharing or selling personal […]

Early in the pandemic there was a widespread belief that science would be our salvation. With the help of science we would be spared the worst consequences, such as occurred during the 1918 Spanish flu pandemic. A vaccine would arrive, reliably, after a few hard months of research, and in short order the problem would...

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At this moment in time the pre-pandemic cardiology research agenda needs to be completely reprioritized. There are two broad areas that now take precedence over all existing research concerns. On the one hand, researchers need to achieve a better understanding of the staggering incidence of deferred or delayed treatment of cardiovascular events and conditions as...

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I recently posted the following thread on Twitter: I am so disappointed by the large number of pre-pandemic medical skeptics who have now turned into mask/vaccine skeptics. I largely agreed with many of them back in the day. /1 Pre-pandemic they used their skills and intelligence to rightfully question whether, say, a stent should be inserted...

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

<p>The US Food and Drug Administration (FDA) granted approval for two&nbsp;biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing&nbsp;Johnson &amp; Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.</p>

<p> <b>BIOSIMILAR RED TAPE ELIMINATION ACT (S2305):</b><br /> <b><i>Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health</i></b><br /><b>31 October 2024&nbsp;|&nbsp;</b><b><a href="https://youtu.be/X6-dYZ7fjhM" target="_blank">WATCH REPLAY</a></b></p>

<p>In October 2024, China based Bio-Thera Solutions&nbsp;(Bio-Thera)&nbsp;and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to&nbsp;Johnson &amp; Johnson’s Stelara (ustekinumab).</p>

<p>The European Commission (EC) granted marketing authorization for<b>&nbsp;</b>three ustekinumab biosimilars<b>:&nbsp;</b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s&nbsp;Otulfi on 25 September 2024.</p>

<p> <b>Abstract</b><br />CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr&nbsp;Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI<i>&nbsp;</i>(Generics and Biosimilars Initiative) about the company’s strategic focus, which includes expanding its product portfolio, entering highly regulated global markets, and advancing affordable treatments for conditions such as multiple sclerosis and&nbsp;immunological diseases—transforming healthcare in underserved regions.</p><p><b>Keywords</b>: Biosimilars, clinical development, commercialization, MENA</p>

The government implied wholesalers had more personal protective equipment in stock than was the case during the first wave of the COVID-19 pandemic, the Healthcare Distribution Association has said.

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

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

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

By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC In the last decade, our industry has made great strides in combating cancer by harnessing the body’s own immune system. As it was

The post Neuro-Immunology: The Promise Of A Differentiated Approach To Neurodegenerative Disease appeared first on LifeSciVC.

By Peter Tummino, CSO of Nimbus Therapeutics, as part of the From The Trenches feature of LifeSciVC  “Over the next five to 10 years, our goal is to become a company that’s leading the world in personalized medicines, a company

The post Medicinal Chemistry In The Age Of Artificial Intelligence appeared first on LifeSciVC.

By Arthur Tzianabos, CEO of Lifordi Immunotherapeutics, as part of the From The Trenches feature of LifeSciVC Greetings from Lake Winnipesaukee in NH where I am at this time every year. It’s midsummer and vacation time for me and the

The post A Biotech Midsummer’s Madness appeared first on LifeSciVC.

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 […]

• 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.

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

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

Journalist Annie Lowrey has a rare disease that causes a near-constant itch that doesn't respond to most treatments. She likens the itchiness to a car alarm: "You can't stop thinking about it."

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.”

Last month when Google introduced its new AI search tool, called AI Overviews, the company seemed confident that it had tested the tool sufficiently, noting in the announcement that “people have already used AI Overviews billions of times through our experiment in Search Labs.” The tool doesn’t just return links to Web pages, as in a typical Google search, but returns an answer that it has generated based on various sources, which it links to below the answer. But immediately after the launch users began posting examples of extremely wrong answers, including a pizza recipe that included glue and the interesting fact that a dog has played in the NBA.

Renée DiResta has been tracking online misinformation for many years as the technical research manager at Stanford’s Internet Observatory.

While the pizza recipe is unlikely to convince anyone to squeeze on the Elmer’s, not all of AI Overview’s extremely wrong answers are so obvious—and some have the potential to be quite harmful. Renée DiResta has been tracking online misinformation for many years as the technical research manager at Stanford’s Internet Observatory and has a new book out about the online propagandists who “turn lies into reality.” She has studied the spread of medical misinformation via social media, so IEEE Spectrum spoke to her about whether AI search is likely to bring an onslaught of erroneous medical advice to unwary users.

I know you’ve been tracking disinformation on the Web for many years. Do you expect the introduction of AI-augmented search tools like Google’s AI Overviews to make the situation worse or better?

Renée DiResta: It’s a really interesting question. There are a couple of policies that Google has had in place for a long time that appear to be in tension with what’s coming out of AI-generated search. That’s made me feel like part of this is Google trying to keep up with where the market has gone. There’s been an incredible acceleration in the release of generative AI tools, and we are seeing Big Tech incumbents trying to make sure that they stay competitive. I think that’s one of the things that’s happening here.

We have long known that hallucinations are a thing that happens with large language models. That’s not new. It’s the deployment of them in a search capacity that I think has been rushed and ill-considered because people expect search engines to give them authoritative information. That’s the expectation you have on search, whereas you might not have that expectation on social media.

There are plenty of examples of comically poor results from AI search, things like how many rocks we should eat per day [a response that was drawn for an Onion article]. But I’m wondering if we should be worried about more serious medical misinformation. I came across one blog post about Google’s AI Overviews responses about stem-cell treatments. The problem there seemed to be that the AI search tool was sourcing its answers from disreputable clinics that were offering unproven treatments. Have you seen other examples of that kind of thing?

DiResta: I have. It’s returning information synthesized from the data that it’s trained on. The problem is that it does not seem to be adhering to the same standards that have long gone into how Google thinks about returning search results for health information. So what I mean by that is Google has, for upwards of 10 years at this point, had a search policy called Your Money or Your Life. Are you familiar with that?

I don’t think so.

DiResta: Your Money or Your Life acknowledges that for queries related to finance and health, Google has a responsibility to hold search results to a very high standard of care, and it’s paramount to get the information correct. People are coming to Google with sensitive questions and they’re looking for information to make materially impactful decisions about their lives. They’re not there for entertainment when they’re asking a question about how to respond to a new cancer diagnosis, for example, or what sort of retirement plan they should be subscribing to. So you don’t want content farms and random Reddit posts and garbage to be the results that are returned. You want to have reputable search results.

That framework of Your Money or Your Life has informed Google’s work on these high-stakes topics for quite some time. And that’s why I think it’s disturbing for people to see the AI-generated search results regurgitating clearly wrong health information from low-quality sites that perhaps happened to be in the training data.

So it seems like AI overviews is not following that same policy—or that’s what it appears like from the outside?

DiResta: That’s how it appears from the outside. I don’t know how they’re thinking about it internally. But those screenshots you’re seeing—a lot of these instances are being traced back to an isolated social media post or a clinic that’s disreputable but exists—are out there on the Internet. It’s not simply making things up. But it’s also not returning what we would consider to be a high-quality result in formulating its response.

I saw that Google responded to some of the problems with a blog post saying that it is aware of these poor results and it’s trying to make improvements. And I can read you the one bullet point that addressed health. It said, “For topics like news and health, we already have strong guardrails in place. In the case of health, we launched additional triggering refinements to enhance our quality protections.” Do you know what that means?

DiResta: That blog posts is an explanation that [AI Overviews] isn’t simply hallucinating—the fact that it’s pointing to URLs is supposed to be a guardrail because that enables the user to go and follow the result to its source. This is a good thing. They should be including those sources for transparency and so that outsiders can review them. However, it is also a fair bit of onus to put on the audience, given the trust that Google has built up over time by returning high-quality results in its health information search rankings.

I know one topic that you’ve tracked over the years has been disinformation about vaccine safety. Have you seen any evidence of that kind of disinformation making its way into AI search?

DiResta: I haven’t, though I imagine outside research teams are now testing results to see what appears. Vaccines have been so much a focus of the conversation around health misinformation for quite some time, I imagine that Google has had people looking specifically at that topic in internal reviews, whereas some of these other topics might be less in the forefront of the minds of the quality teams that are tasked with checking if there are bad results being returned.

What do you think Google’s next moves should be to prevent medical misinformation in AI search?

DiResta: Google has a perfectly good policy to pursue. Your Money or Your Life is a solid ethical guideline to incorporate into this manifestation of the future of search. So it’s not that I think there’s a new and novel ethical grounding that needs to happen. I think it’s more ensuring that the ethical grounding that exists remains foundational to the new AI search tools.

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

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

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

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

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

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

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

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

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

Fields full of Watts

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

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

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

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

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

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

In the United States alone, more than 100,000 people currently need a lifesaving organ transplant. Instead of waiting for donors, one way to solve this crisis in the future is to assemble replacement organs with bio-printing—3D printing that uses inks containing living cells. Scientists in Israel have found that origami techniques could help fold sensors into bio-printed materials to help determine whether they are behaving safely and properly.

Although bio-printing something as complex as a human organ is still a distant possibility, there are a host of near-term applications for the technique. For example, in drug research, scientists can bio-print living, three-dimensional tissues with which to examine the effects of various compounds.

Ideally, researchers would like to embed sensors within bio-printed items to keep track of how well they are behaving. However, the three-dimensional nature of bio-printed objects makes it difficult to lodge sensors within them in a way that can monitor every part of the structures.

“It will, hopefully in the future, allow us to monitor and assess 3D biostructures before we would like to transplant them.” —Ben Maoz, Tel Aviv University

Now scientists have developed a 3D platform inspired by origami that can help embed sensors in bio-printed objects in precise locations. “It will, hopefully in the future, allow us to monitor and assess 3D biostructures before we would like to transplant them,” says Ben Maoz, a professor of biomedical engineering at Tel Aviv University in Israel.

The new platform is a silicone rubber device that can fold around a bio-printed structure. The prototype holds a commercial array of 3D electrodes to capture electrical signals. It also possesses other electrodes that can measure electrical resistance, which can reveal how permeable cells are to various medications. A custom 3D software model can tailor the design of the origami and all the electrodes so that the sensors can be placed in specific locations in the bio-printed object.

The scientists tested their device on bio-printed clumps of brain cells. The research team also grew a layer of cells onto the origami that mimicked the blood-brain barrier, a cell layer that protects the brain from undesirable substances that the body’s blood might be carrying. By folding this combination of origami and cells onto the bio-printed structures, Maoz and his colleagues were able to monitor neural activity within the brain cells and see how their synthetic blood-brain barrier might interfere with medications intended to treat brain diseases.

Maoz says the new device can incorporate many types of sensors beyond electrodes, such as temperature or acidity sensors. It can also incorporate flowing liquid to supply oxygen and nutrients to cells, the researchers note.

Currently, this device “will mainly be used for research and not for clinical use,” Maoz says. Still, it could “significantly contribute to drug development—assessing drugs that are relevant to the brain.”

The researchers say they can use their origami device with any type of 3D tissue. For example, Maoz says they can use it on bio-printed structures made from patient cells “to help with personalized medicine and drug development.”

The origami platform could also help embed devices that can modify bio-printed objects. For instance, many artificially grown tissues function better if they are placed under the kinds of physical stresses they might normally experience within the body, and the origami platform could integrate gadgets that can exert such mechanical forces on bio-printed structures. “This can assist in accelerating tissue maturation, which might be relevant to clinical applications,” Maoz says.

The scientists detailed their findings in the 26 June issue of Advanced Science.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Any imaging technique that allows scientists to observe the inner workings of a living organism, in real-time, provides a wealth of information compared to experiments in a test tube. While there are many such imaging approaches in existence, they require test subjects—in this case rodents—to be tethered to the monitoring device. This limits the ability of animals under study to roam freely during experiments.

Researchers have recently designed a new microscope with a unique feature: It’s capable of transmitting real-time imaging from inside live mice via Bluetooth to a nearby phone or laptop. Once the device has been further miniaturized, the wireless connection will allow mice and other test subject animals to roam freely, making it easier to observe them in a more natural state.

“To the best of our knowledge, this is the first Bluetooth wireless microscope,” says Arvind Pathak, a professor at the Johns Hopkins University School of Medicine.

Through a series of experiments, Pathak and his colleagues demonstrate how the novel wireless microscope, called BLEscope, offers continuous monitoring of blood vessels and tumors in the brains of mice. The results are described in a study published 24 September in IEEE Transactions on Biomedical Engineering.

Microscopes have helped shed light on many biological mysteries, but the devices typically require that cells be removed from an organism and studied in a test tube. Any opportunity to study the biological process as it naturally occurs in the in the body (“in vivo”) tends to offer more useful and thorough information.

Several different miniature microscopes designed for in vivo experiments in animals exist. However, Pathak notes that these often require high power consumption or a wire to be tethered to the device to transmit the data—or both—which may restrict an animal’s natural movements and behavior.

“To overcome these hurdles, [Johns Hopkins University Ph.D. candidate] Subhrajit Das and our team designed an imaging system that operates with ultra-low power consumption—below 50 milliwatts—while enabling wireless data transmission and continuous, functional imaging at spatial resolutions of 5 to 10 micrometers in [rodents],” says Pathak.

The researchers created BLEscope using an off-the-shelf, low-power image sensor and microcontroller, which are integrated on a printed circuit board. Importantly, it has two LED lights of different colors—green and blue—that help create contrast during imaging.

“The BLE protocol enabled wireless control of the BLEscope, which then captures and transmits images wirelessly to a laptop or phone,” Pathak explains. “Its low power consumption and portability make it ideal for remote, real-time imaging.”

Pathak and his colleagues tested BLEscope in live mice through two experiments. In the first scenario, they added a fluorescent marker into the blood of mice and used BLEscope to characterize blood flow within the animals’ brains in real-time. In the second experiment, the researchers altered the oxygen and carbon dioxide ratios of the air being breathed in by mice with brain tumors, and were able to observe blood vessel changes in the fluorescently marked tumors.

“The BLEscope’s key strength is its ability to wirelessly conduct high-resolution, multi-contrast imaging for up to 1.5 hours, without the need for a tethered power supply,” Pathak says.

However, Pathak points out that the current prototype is limited by its size and weight. BLEscope will need to be further miniaturized, so that it doesn’t interfere with animals’ abilities to roam freely during experiments.

“We’re planning to miniaturize the necessary electronic components onto a flexible light-weight printed circuit board, which would reduce weight and footprint of the BLEscope to make it suitable for use on freely moving animals,” says Pathak.

This story was updated on 14 October 2024, to correct a statement about the size of the BLEscope.

In the spirit of the Halloween season, IEEE Spectrum presents a pair of stories that—although grounded in scientific truth rather than the macabre—were no less harrowing for those who lived them. In today’s installment, Robert Langer had to push back against his field’s conventional wisdom to pioneer a drug-delivery mechanism vital to modern medicine.

Nicknamed the Edison of Medicine, Robert Langer is one of the world’s most-cited researchers, with over 1,600 published papers, 1,400 patents, and a top-dog role as one of MIT’s nine prestigious Institute Professors. Langer pioneered the now-ubiquitous drug delivery systems used in modern cancer treatments and vaccines, indirectly saving countless lives throughout his 50-year career.

But, much like Edison and other inventors, Langer’s big ideas were initially met with skepticism from the scientific establishment.

He came up in the 1970s as a chemical engineering postdoc working in the lab of Dr. Judah Folkman, a pediatric surgeon at the Boston Children’s Hospital. Langer was tasked with solving what many believed was an impossible problem—isolating angiogenesis inhibitors to halt cancer growth. Folkman’s vision of stopping tumors from forming their own self-sustaining blood vessels was compelling enough, but few believed it possible.

Langer encountered both practical and social challenges before his first breakthrough. One day, a lab technician accidentally spilled six months’ worth of samples onto the floor, forcing him to repeat the painstaking process of dialyzing extracts. Those months of additional work steered Langer’s development of novel microspheres that could deliver large molecules of medicine directly to tumors.

In the 1970s, Langer developed these tiny microspheres to release large molecules through solid materials, a groundbreaking proof-of-concept for drug delivery.Robert Langer

Langer then submitted the discovery to prestigious journals and was invited to speak at a conference in Michigan in 1976. He practiced the 20-minute presentation for weeks, hoping for positive feedback from respected materials scientists. But when he stepped off the podium, a group approached him and said bluntly, “We don’t believe anything you just said.” They insisted that macromolecules were simply too large to pass through solid materials, and his choice of organic solvents would destroy many inputs. Conventional wisdom said so.

Nature published Langer’s paper three months later, demonstrating for the first time that non-inflammatory polymers could enable the sustained release of proteins and other macromolecules. The same year, Science published his isolation mechanism to restrict tumor growth.

Langer and Folkman’s research paved the way for modern drug delivery.MIT and Boston Children’s Hospital

Even with impressive publications, Langer still struggled to secure funding for his work in controlling macromolecule delivery, isolating the first angiogenesis inhibitors, and testing their behavior. His first two grant proposals were rejected on the same day, a devastating blow for a young academic. The reviewers doubted his experience as “just an engineer” who knew nothing about cancer or biology. One colleague tried to cheer him up, saying, “It’s probably good those grants were rejected early in your career. Since you’re not supporting any graduate students, you don’t have to let anyone go.” Langer thought the colleague was probably right, but the rejections still stung.

His patent applications, filed alongside Folkman at the Boston Children’s Hospital, were rejected five years in a row. After all, it’s difficult to prove you’ve got something good if you’re the only one doing it. Langer remembers feeling disappointed but not crushed entirely. Eventually, other scientists cited his findings and expanded upon them, giving Langer and Folkman the validation needed for intellectual property development. As of this writing, the pair’s two studies from 1976 have been cited nearly 2,000 times.

As the head of MIT’s Langer Lab, he often shares these same stories of rejection with early-career students and researchers. He leads a team of over 100 undergrads, grad students, postdoctoral fellows, and visiting scientists, all finding new ways to deliver genetically engineered proteins, DNA, and RNA, among other research areas. Langer’s reputation is further bolstered by the many successful companies he co-founded or advised, like mRNA leader Moderna, which rose to prominence after developing its widely used COVID-19 vaccine.

Langer sometimes thinks back to those early days—the shattered samples, the cold rejections, and the criticism from senior scientists. He maintains that “Conventional wisdom isn’t always correct, and it’s important to never give up—(almost) regardless of what others say.”

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