Tag: United States

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Filing of bipartisan Senate bill boosts momentum for office of men’s health

The Men’s Health Act, a bipartisan bill to establish an office of men’s health within the Department of Health and Human Services, will be introduced in the U.S. Senate on Thursday by Ruben Gallego (D-Ariz.), with co-sponsorship from Roger Marshall (R-Kan.).

Mirroring the bipartisan bill that was introduced in the House this year, the measure would require a study from the Government Accountability Office on the state of men’s health in the U.S. to be presented within a year of the law’s enactment. Following the report, and incorporating its findings, the office would coordinate existing and new research and raise awareness about men’s health, both physical and mental. 

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The power line that could reshape New York’s grid is hitting snags

On July 3, as a heat wave swept the region, New York State’s grid imported 52 gigawatt-hours of electricity from Canada—enough to meet about 9% of its total electricity demand that day.

Some of that power shuttled in on a 339-mile power line stretching from Quebec to Queens called the Champlain Hudson Power Express (CHPE). It opened in May and is officially the longest underground transmission line in North America.

An underground power line might not sound all that exciting, but this could be a big deal for the state’s grid planning, and for emissions. It could provide up to 20% of New York City’s electricity demand, largely with abundant hydropower from Quebec.

One wrinkle: The line has been down for most of this month, and some experts are concerned about how drought will affect the power supply feeding it. Let’s look at how the CHPE transmission line could help shape the future of our grid, and what barriers it needs to overcome to make a difference.

Planning for the CHPE (which is charmingly pronounced “chippy”) started 15 years ago, with the permitting process formally beginning in March 2010. The vision was to build infrastructure to better connect Quebec and southern New York.

Over 99% of Quebec’s electricity comes from renewable sources; most demand is met with hydropower, though the province’s wind capacity is growing quickly. New York has some hydropower of its own, as well as nuclear and wind, but the state still relies on fossil fuels for most of its energy generation.

Transmission Developers, a company owned by the alternative asset management firm Blackstone, and Hydro-Québec, the province’s manager of generation and transmission, partnered to build CHPE. Construction began in late 2022 and wrapped up earlier this year. The total cost for the privately funded project turned out to be  $6 billion.

The construction of this line was a feat. It’s made up of a bundle of two high-voltage direct-current power cables, each measuring roughly five inches across. Developers buried the bundle underground or underwater across the length of New York State. Much of the line was laid at the bottom of the Hudson River, requiring special boats that shot water jets deep into the sediment to create trenches for the cable.

Connecting grids together can help accelerate the transition away from fossil fuels. The ability to move electricity to where it’s needed could also help limit the amount of new capacity we need to build. Research has shown that interconnection can help cut emissions and lower system costs.

But CHPE is off to a slow start and has seen two outages so far. The first, on July 1, was reportedly caused by a trip at a converter on the Canadian side of the border. The second outage began on July 4, and the power line is still down as of the morning of July 22.

Some experts say this isn’t unusual for a new infrastructure project. Other power lines have seen similar startup challenges, and the equipment hasn’t really been fully tested until it’s in operation, Normand Mousseau, a physics professor at Université de Montréal, told the Gazette.

Officials traced the issue to a damaged section of cable on the US side of the border, and the company that manufactured the line sent experts to investigate the cause, according to reporting from RTO Insider, a trade publication. 

The damaged portion of the cable has been removed and replaced, says Lynn St-Laurent, a spokesperson for Hydro-Québec. “It is currently estimated that the remaining work, including necessary post-repair testing, will be completed by the weekend.”

Similar woes have afflicted the New England Clean Energy Connect line, which opened in January, stretching 145 miles from Quebec to Maine. That project has also seen outages, and very little additional energy has flowed into the Northeast.

The good news for New York is that the grid wasn’t relying on CHPE yet. “Our planning studies did not assume CHPE would be available this summer, and that was one reason the grid performed reliably during the heat wave earlier this month,” Kevin Lanahan, a spokesperson for the New York Independent System Operator, the state’s grid management company, said in a statement. “A core principle of reliability planning is not relying on any single project.” 

The idea is that eventually, states and regions will be able to rely—at least in part—on these projects, so there is pressure to get them working smoothly: Building massive transmission lines is a major long-term investment. In future years, as the equipment gets stress-tested and utilities begin to feel more confident in the projects’ reliability, they could play a bigger role on the grid.

One thing to keep an eye on moving forward is the condition of Quebec’s hydropower fleet: The region has seen intense drought for the past three years, eating into the water reserves used to generate electricity. That could mean there won’t always be abundant hydropower to ship across the border—even if the transmission lines are able to carry it. 

This article is from The Spark, MIT Technology Review’s weekly climate newsletter. To receive it in your inbox every Wednesday, sign up here. 

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Opinion: Good riddance to bundled ‘global’ maternal care billing

A change is coming to the codes OB-GYNs use to bill for maternity care services: Starting Jan. 1, 2027, we will shift from a bundled “global obstetric payment” to a fee-for-service model. This change impacts almost every U.S. family with a pregnancy. Under the current system, families receive a bill that does not distinguish the actual prenatal and postpartum costs from labor and delivery, which makes things incredibly confusing for patients.

In fact, the bundled payment’s impacts have been widespread: It has complicated billing for patients and clinicians, limited access to care, cut back the ability to provide patients with more personalized care, and slowed progress in better understanding U.S. maternal health outcomes.

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STAT+: FDA staff and peptide enthusiasts set to clash at advisory panel

As more Americans experiment with synthetic peptides despite warnings about their unproven benefits and potential risks, an advisory panel to the Food and Drug Administration will meet on Thursday and Friday to discuss changes that could make peptides more accessible. 

At issue is whether to allow compounding pharmacies to manufacture seven peptides that are currently designated as unsafe for them to make. The panel discussion is expected to be unusual in more ways than one. 

First, many of the newly appointed members on the panel hold what critics (including FDA staff) say are conflicts of interest. The panel roster includes several physicians who prescribe peptides to patients as well as pharmacist and Tennessee state Sen. Bobby Harshbarger, whose mother, U.S. Rep. Diana Harshbarger (R-Tenn.) has advocated for looser peptide regulations. Many of these panelists were selected by the Health and Human Services Department, FDA officials previously told STAT. 

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AI Protein Engineering Model Designed for Biomanufacturing

A cell engineering model designed specifically for the biomanufacturing environment could go a long way toward optimizing host cell performance, reducing development timelines, and streamlining biomanufacturing platform design.

“There’s a real challenge in determining how to engineer a host cell’s genome to maximize its performance in a biomanufacturing application.” That’s the difficulty laid out by Shawn Manchester, PhD, CEO, Triplebar Bio, and a view that’s shared by Yun Song, PhD, professor, University of California, Berkeley, and the industry innovation organization BioMADE. The three, with support from the National Science Foundation, are developing such an AI-informed cell engineering model to solve that challenge.

What’s most notable is that this AI-informed predictive and optimization model focuses on the biomanufacturing environment. The large-scale, application-specific training database is being designed to handle bench- to commercial-scale biomanufacturing.

Biomanufacturing-relevant environment

As Manchester says, “There aren’t a lot of organisms that have naturally evolved to make proteins they’ve never seen before, in an environment they’re not well-evolved for. Our ability to generate data in a setting that is relevant to biomanufacturing and to do so at the scale of hundreds of thousands of cells and data points is innovative…and it’s not something that many others are looking at. Most people are working on AI for protein engineering of therapeutics and other molecules as opposed to cell engineering for use in biomanufacturing.”

This project focuses on data capture from Pichia pastoris as the host cell producing five different proteins that are relevant for bioprocessing, food production, and defense. The learnings will be incorporated into Triplebar’s other programs, too, including optimization for its Chinese hamster ovary (CHO) cells, Manchester says.

“Improving the scalability of these proteins directly benefits [not just bioindustrial or biopharmaceutical applications, but a broad range of] biomanufacturing,” Brandon Simmons-Rawls, program manager, BioMADE, emphasizes.

This AI project combines two core technologies deployed at Triplebar:

  • Droplet microfluidics, in which a cell is encapsulated in a water and oil emulsion alongside a fluorescent-based sensor to quantify protein production
  • Multimodal transformer-based AI model

The genomes and transcriptomes of cells that make either more or less protein than baseline are sequenced and fed into the AI’s very large, labeled training sets to identify correlations between genotypes and phenotypes. These correlations are important patterns about how the genome works, Manchester explains, and can be used to generate new genomic designs for optimization of the host cell to the biomanufacturing process.

“We first pre-train models on all relevant sequencing data from thousands of genomes, which gives us an underlying structure to the genome. Then we fine-tune those models with the genotype-phenotype data we generate in the biomanufacturing-relevant environment. This allows us to understand which of those patterns in the genome relate to biomanufacturing-specific performance,” Manchester says.

Once this AI-enabled model rolls out, Manchester says he envisions it being used by bioindustrial and biopharma companies that “need to improve the productivity or efficiency of the organism they use in manufacturing. Results should be faster and more efficient than those derived using guess-and-check methods based on our current understanding of how these organisms work.

“The goal is for people to log onto this AI tool, identify what they’re making and what they’ve done, and ask the AI what else they can do to improve performance,” he continues. “The model will serve them specific genetic designs that they can deploy in their organism.”

Manchester predicts that more than 10% of the designs will produce meaningful improvements—significantly more than traditional, early-stage design-build-test cycles. This streamlines the cell engineering cycle by focusing on modifications likely to yield performance improvements that are most meaningful for biomanufacturing.

The post AI Protein Engineering Model Designed for Biomanufacturing appeared first on GEN – Genetic Engineering and Biotechnology News.

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Cell-Therapy Manufacturers Get Creative on Checking Particulates

Manufacturers of cell-containing products are adopting new techniques to work around unclear regulatory guidance on particulates. That’s the experience of Diana Colleluori, PhD, principal chemistry, manufacturing and controls (CMC) consultant at Biologics Consulting.

According to Colleluori, cell-containing products can be harder to visually inspect for particulates, as they’re not clear and are often stored in opaque bags.

“Processing and testing cell-containing products already has challenges because they can’t be terminally sterilized,” she explains. “It’s also harder to make a visual assessment to meet regulatory requirements because they already contain cells and the final product is usually in a cell-freezing bag.”

The particulates are mostly (90%) plastic that enter the product from contact with the inside of single-use equipment used during manufacturing, she says, adding that other particulates can enter from product manipulation and, thus, it’s best to try to minimize this.

Companies that Colleluori has worked with have tackled this problem by running their process with the formulation buffer, but minus cells, she continues. This allows them to assess particulates in a clear solution, outside of a bag, which they can then extrapolate to running the same process with cells.

“By testing visible and sub-visible particles in those samples, you can prove your product contact materials are expected to meet the limits for your cell-containing products,” according to Colleluori.

The company can also run quality control tests on a small sample of the final product. Among the tests carried out are those based on the United States Pharmacopeia (USP) chapters 790 for visible particulates and injections,1790 for visual inspections of injections, and 788 for the sub-visible particles.

In addition, EU guidance on visual inspection of particles can also be relied upon. Which tests are run should depend on the method of administration, adds Colleluori.

“If you’re doing an intramuscular injection, it’s probably a little less rigorous than an intrathecal injection of products that have stricter regulations on the number of particles and sub-particles that can be present,” she says.

The post Cell-Therapy Manufacturers Get Creative on Checking Particulates appeared first on GEN – Genetic Engineering and Biotechnology News.

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Child Mind Institute Launches Research Initiative To Inform Safer AI Systems for Youth

New project will develop tools to study youth mental health during AI chatbot use

New York, NY — Today, the Child Mind Institute announced a new research initiative, launched with support from the OpenAI Foundation, to build the research infrastructure needed to measure and better understand youth mental health while using AI chatbots and over time. The effort aims to identify valid markers that can inform the design and testing of safer AI systems.

Millions of children in the United States are struggling with mental health or learning challenges, yet there continues to be a dire shortage of qualified mental health professionals. That, along with stigma and misinformation about mental health, is pushing young people to explore using readily available, often free AI tools for support, including general-purpose chatbots, digital companions, or “therapy bots.”

Novel and emerging digital technologies are shaping mental health faster than the pace of science and the development of evidence-based care can keep up. This new initiative will help advance research studying the impact of these tools and better support youth mental health.

“As the leading nonprofit dedicated to improving youth mental health through science, education, and care, the Child Mind Institute is well positioned to help tackle the key issues affecting the well-being of young people, including technology and the proliferation of AI. It is our belief that with appropriate safeguards and evidence, digital tools may complement care from trained clinicians,” said Harold S. Koplewicz, MD, president and medical director at the Child Mind Institute. “We are excited about filling a gap that currently exists in the research of AI tools and to work toward creating a safer online experience for youth around the globe.”

Using clinical assessments, digital journals, de-identified AI chat histories, real-time behavioral measures, and existing youth mental health datasets, the Child Mind Institute will build an infrastructure to better understand interactions between youth users and AI conversational platforms. With the goal of strengthening our understanding of the mental state in AI chatbot interactions, this initial one-year project will enable the research team to identify and begin scaling the signals needed to meaningfully assess and monitor youth mental health alongside their use of AI tools.

The Child Mind Institute has long been committed to advancing technologies that make mental health research and care more precise, measurable, and connected to real-world settings. Grounded in science and focused on impact, the organization brings together scientific rigor, clinical expertise, and product development experience to build digital tools that accelerate research, improve care, and expand access without compromising safety, quality, or accountability.

“Many of our youth are turning to AI chatbots for important areas of their lives — and mental health is no exception. It is our responsibility to more holistically comprehend the impact of these tools on mental health, both in the long and short term,” said Michael P. Milham, MD, PhD, chief science officer at the Child Mind Institute. “Digital platforms provide an opportunity to rethink the way we conduct mental health research, but they also introduce new challenges and risks. It is critical to better understand the relationship between AI use and youth mental health, and to examine whether, and under what conditions, AI tools can strengthen evidence-based care, support clinician training, and expand access to high-quality mental health services.”

This research initiative is being independently developed and solely executed by the Child Mind Institute. To ensure the safety and security of all study participants, it will be conducted with strong privacy protections, informed consent, ethical oversight, and careful data governance. The project will be co-designed by its principal investigators, Gregory Kiar, PhD, Arno Klein, PhD, and Dr. Milham, who bring expertise in computational methods, digital measurement, clinical science, and youth mental health. Consistent with the Child Mind Institute’s open science philosophy, all data will be shared to help fuel discovery across the field.

About the Child Mind Institute

The Child Mind Institute is an independent nonprofit organization dedicated to transforming the lives of children and families struggling with mental health and learning disorders. Through cutting-edge research, evidence-based clinical care, and public education, the Child Mind Institute builds open science platforms and digital tools to accelerate discovery and improve youth mental health worldwide.

For press questions, contact cmiscience@ssmandl.com or mediaoffice@childmind.org.

The post Child Mind Institute Launches Research Initiative To Inform Safer AI Systems for Youth appeared first on Child Mind Institute.

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Job dissatisfaction and health care access uncertainty grows in the U.S., new study finds

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Good morning. I admit that I didn’t finish rereading “The Odyssey” before I saw the movie last weekend, but it’s never too late. For now, scroll down to read a related First Opinion essay and to sign up for office hours with Bob Herman, STAT’s own Homeric chronicler of the business of health care.

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STAT+: ‘Cochlear implant for blindness’ debuts in Europe, could launch in U.S. in 2027

Europeans can now receive a device that can partially restore their vision loss. Americans may not have to wait long to get it, either.

Science Corporation announced Wednesday that European regulators had approved the commercial sale of the startup’s retinal implant that improves eyesight for patients with age-related macular degeneration in their central vision, enough to read books and road signs more clearly. 

“We have a cochlear implant for vision now,” said Science founder and CEO Max Hodak.

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