ServiceNow’s Anna Mazzone discusses obligations of the Cyber Resilience Act and why more Irish software firms may be in scope than most realise.

The EU Cyber Resilience Act’s first deadline on 11 September activated Article 14’s reporting obligations for any Irish company that develops software, or has them developed and markets it under its own name.

This includes downloadable clients, mobile apps, embedded firmware, freemium software and any product connected to a device or network. The Act’s definition of ‘manufacturer’ is legal rather than descriptive, and the products it covers run across hardware and software.

The Act requires products to be secure by design, secure by default and secure throughout their life cycle. Anything short of that cannot be placed on the EU market. The reporting duty arrived first, more than a year ahead of the full technical requirements due in December 2027.

Under EU law, a manufacturer is any person or company that develops products with digital elements, or has them developed, and markets them under its own name or trademark, whether paid, monetised or free.

The qualifier is commercial activity. Software supplied outside a commercial activity, including free and open-source software that its maker does not monetise, falls outside the regulation.

Freemium and open-source components monetised by their original maker are inside it. A product with digital elements is a software or hardware product, together with the remote data processing it needs to function.

Read that against what Irish technology companies actually ship. The National Cyber Security Centre (NCSC) lists operating systems and mobile apps alongside laptops and industrial IoT in its description of in-scope products.

Standalone cloud services sit under separate rules. But when a cloud feature is integral to how the product functions, it becomes part of the product for CRA purposes.

There is no production‑line test. If you write software and put your name on it, you are in scope.

What applies now

Two things start the clock: an actively exploited vulnerability in one of your products, or a severe incident affecting that product’s security.

From the moment you become aware, you have 24 hours to file an early warning and 72 hours to follow it with a severity assessment. Both periods run from awareness, not from each other. Then the two triggers part ways. A vulnerability needs a final report within 14 days of a fix being available, which may be months later or never. An incident needs a final report within a month of the 72-hour filing.

Reports route through ENISA’s Single Reporting Platform to the national Computer Security Incident Response Team (CSIRT), which, for companies that take their product cybersecurity decisions in Ireland, is CSIRT‑IE inside the NCSC. The NCSC published guidelines on Article 14 reporting on 31 August and runs a CRA helpdesk, though it states plainly that it will not advise on whether a given product is in scope.

There is more than reporting to meet. The essential cybersecurity requirements mean protecting the product against unauthorised access, supporting and updating it for its stated lifetime and carrying CE marking.

Each member state designates its own market surveillance authorities, and they can require a product to be corrected, withdrawn or recalled. Fines are tiered. Articles 13 and 14 sit in the highest band alongside those requirements, at the higher of 2.5pc of total worldwide annual turnover from the preceding financial year or €15m. December 2027 is when the fines begin.

The Act also arrives ahead of Ireland’s own cybersecurity legislation.

The National Cyber Security Bill, which will transpose the NIS2 Directive, has not yet been published. The Government expects to notify transposition by the end of 2026. The Cyber Resilience Act is a regulation rather than a directive, so it applies directly and does not wait on national law.

Six practices that put you in a position to comply

Embed compliance in product development

Bring security risk assessments into the design stage and define the controls from there. Retrofitting them after a product ships costs more every time.

Track security markings and vendor commitments

Make sure suppliers give you the same assurances that your customers expect, and store those responses where the incident team can easily find them.

Even if a vulnerability comes from a component you didn’t develop, you’re still responsible. The NCSC named supply chain security as one of three systemic risks in its 2025 National Cyber Risk Assessment and recommended strengthening procurement rules around security from the start.

Incorporate vulnerability management

Continuously check for vulnerabilities, share what you find with your customers and maintain a well‑defined, solid patching process. Article 14 tests this directly, because the 24‑hour clock starts regardless of whether or not a process is in place.

Govern access

Products need protection from unauthorised access through appropriate control mechanisms, including authentication, identity management and secure default configurations.

Test resilience regularly

Ongoing scenario, impact and tolerance testing validates secure life cycle management rather than leaving it on paper.

Maintain a software bill of materials (SBOM)

Document and provide a full inventory of components with each product you sell. The Open Source Security Foundation found in June that only 32pc of manufacturers produce an SBOM for every product they ship.

What you gain

The payoff shows up the first time a report lands. Knowing what is inside what you ship turns ‘is that component in a live product’ from a week of investigation into a few minutes.

A single incident record means the 72-hour notification builds on the 24-hour one rather than starting again. Supplier exposure you can already see is one fewer thing to chase on the day. And a named decision-maker with real authority means you never spend the clock waiting for a call to go up three levels and come back. This last one is what most often causes companies to miss the deadline.

That work pays back beyond the regulator. Customers now ask for an SBOM and a vulnerability disclosure policy during procurement and read the answer as a signal of whether you are a safe supplier.

The Act asks software companies to demonstrate something most already tell customers they do. Since 11 September, the claim is checkable.

By Anna Mazzone

Anna Mazzone is VP of EMEA Operational Resilience, Risk and Security at ServiceNow and non-executive director at the Global Legal Entity Identifier Foundation. In 2013, she founded the first managed KYC shared services for global capital markets at Thomson Reuters. In 2016, Anna was named on Innovate Finance’s ‘Women in Fintech Powerlist’.

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They signal to the world that someone has fully completed a game.

The premium wireless headphone market has become crowded enough that another $400 active noise-cancelling model needs more than a new finish, longer battery life, and an app full of sliders to get anyone’s attention.

Nothing apparently got the memo.

As the new flagship, the $399 Nothing Headphone (1) Pro sits above the $299 Headphone (1) and $199 Headphone (a), but the interesting part is what happened inside the earcups. Each side uses three separate drivers: a 40mm dynamic driver for bass, a 13 x 8mm dynamic driver for the midrange, and a solid-state xMEMS driver for treble. Nothing has also moved away from the original Headphone (1)’s KEF-branded tuning story and is emphasizing a new collaboration with London’s Metropolis Studios, including a physical switch that bypasses the regular EQ profile for a flatter studio-oriented setting.

That is considerably more ambitious than changing the ear pads and adding “Pro” to the box.

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Three Drivers, Three Jobs

Most wireless ANC headphones in this price range use one dynamic driver per earcup and rely heavily on DSP to shape the final presentation.

Nothing has chosen a more complicated route.

The 40mm bass driver uses a PET dome with an electroplated metal-ceramic coating and a dual-magnet motor. Nothing claims 15% greater bass impact and 26% higher sensitivity compared with the original Headphone (1). Those percentages are the company’s own laboratory figures, but they indicate that the low-frequency driver has been substantially reworked rather than simply carried over.

A separate 13 x 8mm midrange driver uses a PEN diaphragm and is tasked with vocals and the middle of the frequency range. The third element is considerably less conventional: a 3.2 x 6.0mm xMEMS solid-state treble driver using a silicon diaphragm. Nothing says the diaphragm is dramatically stiffer than conventional plastics, allowing faster transient response at higher frequencies.

Multi-driver IEMs are hardly exotic in 2026. Multi-driver mainstream wireless over-ear headphones using an xMEMS treble driver? That is a considerably shorter list.

Metropolis Studios Replaces the KEF Story

The original Headphone (1) arrived with considerable fanfare around Sound by KEF, giving Nothing instant credibility with listeners who knew the British loudspeaker company.

The Headphone (1) Pro takes a different approach.

Nothing’s launch materials focus on tuning work performed with Metropolis Studios, the London facility that has hosted generations of recording and mastering engineers. The collaboration produced several EQ profiles inside the Nothing X app along with a dedicated Flat EQ intended for reviewing, producing, and mixing music.

The clever part is that Nothing gave Flat EQ its own physical switch on the headphones.

Flip it one way and you get the normal Nothing EQ setting. Flip it back and the headphone switches to the flatter Metropolis profile without opening the app, digging through menus, or remembering which EQ preset you saved three firmware updates ago. Whether anyone should actually mix a record on Bluetooth ANC headphones is another conversation.

At least Nothing gives you a button.

Hi-Res Wired and Wireless Audio

The Headphone (1) Pro supports SBC, AAC, and LDAC over Bluetooth 6.1, along with multipoint connection and Auracast broadcast reception using LC3. Nothing also provides both USB Type-C and 3.5mm wired connectivity.

USB Type-C supports lossless playback up to 24-bit/192kHz, while the analog AUX connection is rated for Hi-Res playback up to 24-bit/96kHz. The headphones are Hi-Res Audio certified for wired and wireless operation.

One omission is worth noting: there is no aptX Adaptive or aptX Lossless support. Android users with LDAC-compatible devices are covered, but buyers heavily invested in Qualcomm’s ecosystem will have to look elsewhere.

Nothing has also added Dynamic Spatial Audio with head tracking, along with a Metropolis-tuned spatial mode intended to reproduce the presentation of the studio’s Studio B.

More Serious ANC

Nothing rates the Headphone (1) Pro for up to 46dB of adaptive noise cancellation, up from 42dB on the original model.

The system uses 10 microphones, with three feed-forward and two feedback microphones on each side. A new 8mm silicone baffle wall and dual-layer cushions are also used to improve passive sealing before the electronics start doing their work.

Transparency Mode is included, while Clear Voice processing uses four microphones for calls and voice messages.

Forty-six decibels looks impressive on a product page, but ANC performance is one area where we would wait for a proper review before declaring Sony or Bose ready for retirement.

Those two have been fighting this war for a very long time.

Design & Controls

Nothing has retained the transparent industrial design that made Headphone (1 immediately recognizable, but the Pro receives more premium materials.

The earcups use machined aluminum, titanium-alloy arms, and upgraded 9H Panda Glass. Nothing says the titanium arms are 45% lighter than those used on Headphone (1), while the ear cushions are 50% softer and better suited to eyeglass wearers. The headband is 10% wider with 12% thicker padding.

Weight is 327 grams, almost unchanged from the 329-gram Headphone (1), so this is not Nothing’s attempt at building the lightest flagship ANC headphone on the train.

Physical controls remain one of the company’s better ideas. There is a roller for volume and playback, a paddle for track navigation, a customizable button, the new Flat EQ switch, and a separate Bluetooth pairing control.

The headphones also carry an IP52 rating for dust and water resistance and ship with a hardshell case, 3.5mm cable, and USB Type-C cable. They do not fold inward, so the case still occupies meaningful luggage space.

Battery Life

Nothing rates battery life at up to 68 hours with ANC off using AAC and up to 30 hours with ANC enabled. Switch to LDAC and those figures drop to 53 and 28 hours respectively.

A five-minute charge provides up to four hours of playback with ANC disabled or two hours with ANC engaged. A complete charge takes approximately two hours.

The original Headphone (1) could manage as much as 80 hours without ANC, so the Pro actually moves backward in maximum battery endurance.

Nothing Headphone (1) Pro Specifications

• Type: Wireless closed-back ANC over-ear headphone
• Price: $399
• Bass Driver: 40mm dynamic
• Bass Diaphragm: PET with electroplated metal-ceramic coating
• Midrange Driver: 13 x 8mm dynamic
• Midrange Diaphragm: PEN
• Treble Driver: 3.2 x 6.0 x 1.15mm xMEMS solid-state
• Treble Diaphragm: Silicon
• Frequency Response: 20Hz–40kHz
• Tuning: Metropolis Studios
• EQ: Standard, Flat EQ, Advanced EQ, Personal Sound
• Spatial Audio: Dynamic Spatial Audio with head tracking
• ANC: Real-time adaptive, up to 46dB
• Microphones: 10 total
• Transparency Mode: Yes
• Bluetooth: 6.1
• Codecs: SBC, AAC, LDAC; LC3 for broadcast audio
• Auracast: Yes
• Multipoint: Yes
• USB Type-C Audio: Up to 24-bit/192kHz
• 3.5mm Audio: Up to 24-bit/96kHz
• Battery: 1,060mAh
• AAC Battery Life: Up to 68 hours ANC off / 30 hours ANC on
• LDAC Battery Life: Up to 53 hours ANC off / 28 hours ANC on
• Fast Charge: 5 minutes for up to 4 hours ANC off / 2 hours ANC on
• Full Charge: Approximately 2 hours
• Water/Dust Resistance: IP52
• Weight: 327g
• Dimensions: 190.2 x 174.4 x 78mm
• Included: Hardshell case, 3.5mm cable, USB Type-C cable
• Colors: Black, White

What Makes Headphone (1) Pro Unique?

The obvious answer is the triple-driver architecture.

Sony’s WH-1000XM6, Bose QuietComfort Ultra Gen 2, and most other premium ANC headphones still rely on a single full-range dynamic driver per ear. Nothing has divided bass, midrange, and treble reproduction across three separate transducers, including an xMEMS solid-state driver handling the top end.

That alone does not guarantee better sound. Three mediocre drivers can still lose to one excellent one.

The more compelling idea may be the physical Flat EQ switch. Nothing is acknowledging that some buyers want its normal consumer voicing while others may prefer a less processed presentation, and it lets them move between the two without reaching for a phone.

Combine that with 24-bit/192kHz USB playback, LDAC, extensive EQ, head-tracked spatial audio, Auracast, and tactile controls, and the Pro is clearly trying to bridge the gap between mainstream ANC headphones and more serious listening products.

That is a more interesting proposition than another titanium-colored travel headphone.

What Is Missing?

Nothing has packed a lot into the Headphone (1) Pro, but a few omissions remain.

There is no aptX Adaptive or aptX Lossless, which gives products from Bowers & Wilkins and Sennheiser an advantage for users with compatible Qualcomm devices. Maximum battery life is also lower than Headphone (1), and at 327 grams the Pro is considerably heavier than some mainstream travel-focused ANC rivals.

The headphones also do not fold, which matters if you spend much of your life arguing with airline carry-on limits.

And despite all the studio language, Nothing has not replaced traditional professional monitoring headphones overnight. Flat EQ and Metropolis tuning are intriguing features, but durability, repeatability, long-session comfort, and actual tonal accuracy will need proper listening before anybody starts replacing studio standards with transparent Bluetooth headphones.

Competition?

At $458 Sony’s WH-1000XM6 combines excellent ANC, a lighter travel-friendly design, mature DSP, and Sony’s long experience in wireless headphones.

In our review, the XM6 delivered some of the best noise cancellation we have tested, particularly with difficult mid- and higher-frequency environmental noise. Nothing counters with its unusual driver architecture, wired USB-C lossless audio, and more extensive physical controls.

Sony has the track record.

Nothing has the weirder engineering department.

The $449 Bose QuietComfort Ultra Headphones 2nd Gen remains exceptionally strong on comfort and ANC, and the second-generation Ultra finally added wired USB-C lossless playback and listening while charging. Our recent review found the combination of noise cancellation, comfort, spatial processing, and everyday usability difficult to beat.

Nothing is $50 less and offers LDAC, Auracast, the triple-driver configuration, more adventurous EQ controls, and significantly longer maximum battery life.

Bose will still be the safer recommendation for frequent flyers until we hear how Nothing’s new ANC performs in the real world.

The Headphone (1) Pro is the more interesting piece of engineering on paper.

Price & Availability

The Nothing Headphone (1) Pro is priced at $399 in the United States and is available beginning September 29, 2026 through Nothing, Amazon, and Best Buy in North America.

That places it exactly where Nothing needed another product: above the $299 Headphone (1) and $199 Headphone (a), but still below Sony and Bose’s current $449 flagships.

Where to Buy:

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Seventeen years ago, cell biologist Donald Ingber and his colleagues at Harvard University’s Wyss Institute for Biologically Inspired Engineering submitted a paper to the journal Science describing their model human lung. It was smaller than a USB stick and made of a clear polymer slab containing narrow channels, which were lined with the type of cells that line a lung’s air sacs and blood vessels. When air was pumped through hollow chambers beside the channels, the device rhythmically expanded and contracted—it “breathed.”

This lifelike movement was a dramatic change from previous generations of lung models, which typically used static cultures of lung tissue that were unable to simulate the movements essential to lung function. When exposed to inflammatory proteins and bacteria, Ingber’s artificial lung reacted much as living lungs would. And exposure to silica nanoparticles used to model the effects of ultrafine particulates revealed that movement affected how tissues absorbed them.

Donald Ingber led the team that developed the first human lung-on-a-chip at Harvard University’s Wyss Institute. Sam Ogden

It was a powerful proof-of-principle demonstration of a system that could be used to test drugs and other chemicals, providing a complement and even an alternative to testing in tissue cultures or in animals. Even so, the editors at Science were hesitant. They rejected the paper and suggested that Ingber’s team also run the tests in mice.

It wasn’t an unreasonable request: Harvard’s lung system was new and comparing the results it generated to results from mice would help validate it. Ingber’s team ran the suggested experiments and resubmitted their study a year later, in 2010, at which point it was published. (It has since been cited by nearly 5,400 other papers.) Still, the incident spoke to how animal models have been the default of modern biomedical research.

An early lung-on-a-chip developed at Harvard’s Wyss Institute used microfluidic channels lined with human cells to reproduce key features of lung function. Wyss Institute at Harvard University

A recent story told by Ilka Maschmeyer, a translational toxicology researcher and executive at the German biotech company TissUse, shows how much things have changed. TissUse specializes in building organ-on-a-chip systems—the conversational name for systems like Ingber’s lung—that are used by pharmaceutical companies for research. A few months ago, says Maschmeyer, a pharmaceutical company approached TissUse after being denied permission by the U.S. Food and Drug Administration to run a clinical trial of a new drug. The problem: It had presented animal data, but the FDA wanted data from organs-on-a-chip or some comparable alternative. The standards had come full circle.

The moment spoke to a trend, perhaps even the early days of a fundamental shift, away from the use of animals in toxicology and drug development. “It’s rare still,” says Maschmeyer, “but I think it’s going to be more and more frequent.”

A host of these kinds of alternatives to experiments on animals have been developed over the years. Collectively they’re known as NAMs, an acronym that stands, depending on whom you’re talking to, for new approach methodologies, novel alternative methods, or nonanimal methods. Most NAMs have yet to be rigorously tested, but early studies suggest their potential.

As NAMs have become more sophisticated, the question of how they will be implemented has become less about their technical qualities and more about the practical next steps needed to realize their potential. Validating NAMs—standardizing the systems, conducting head-to-head comparisons with animal experiments—is an enormous challenge. Moreover, simply outperforming animal models is necessary but not sufficient. The adoption of NAMs will require changes in policy, training, and culture.

“This transition process is much more complicated than you would think,” says Thomas Hartung, a toxicologist and director of the Center for Alternatives to Animal Testing at Johns Hopkins University. “It is more about change management than it is about the technology.”

The Technologies Replacing Animal Testing

For decades, animal advocates and many scientists have criticized both the morality and usefulness of experimenting on animals. An estimated 92 percent of all drugs that enter U.S. clinical trials fail to reach the market, sometimes for business reasons but often because the drugs prove ineffective or unsafe in ways that were not predicted by animal experiments. Failure rates are even higher in drugs for heart disease, cancer, and diseases of the brain.

These statistics don’t automatically mean that a reliance on animals is to blame. Flawed study designs are a problem too, and also the sheer confounding complexity of disease. But there’s little question that animals have made poor surrogates for many conditions. And just as animal experiments may mistakenly suggest efficacy or fail to predict harm in humans, they might also erroneously suggest that drugs are ineffective or harmful when they could actually work in humans. Some researchers argue that if aspirin or acetaminophen had been discovered after the advent of modern testing requirements, they might have been abandoned.

TissUse’s Humimic systems use microfluidic chips to culture human tissues and model interactions between organs. A researcher images tissues in a chip during an experiment [top], Humimic chips sit in a temperature-controlled unit [center], and a researcher prepares chips for use [bottom].TissUse (3)

Researchers developing NAMs have pushed these systems far beyond old-fashioned tissue cultures. The new technologies include organoids that more closely mimic the structure, composition, and function of human organs. More humanlike still are organ-on-a-chip systems; alongside Ingber’s lung-on-a-chip are brains, hearts, kidneys, and even placentas on a chip. As many as 10 such organs have been linked together, yielding multi-organ systems that promise to recapitulate many aspects of human physiology—not perfectly, but better than a mouse or a monkey would. Supporting these systems are computational simulations of organs and organisms, and also artificial intelligence tools that analyze data generated by other systems and inform future experiments in a high-powered iterative loop.

Yet even as studies piled up and some pharmaceutical companies started using NAMs in-house, the U.S. regulatory system governing drug developing and testing remained an obstacle to their wider use. NAM proponents were overjoyed, then, when in late 2022 the FDA Modernization Act 2.0 passed into law. It explicitly authorized the use of NAMs in the preclinical studies required of new drugs before they could enter human trials. Previous regulations had mandated animal testing; now the door was open to alternatives. It was a landmark moment. “That was something I didn’t expect to see in my life,” says Maschmeyer.

Although immediate in-the-lab impact was limited, the FDA’s decision was a harbinger of things to come. In 2025, the FDA pledged “to make animal studies the exception rather than the norm” for drug safety testing. Then, in September 2026, the agency followed up by issuing a rule that, if it takes effect, will replace references to “animal tests” in its drug-development regulations with the broader term “nonclinical tests.” The change makes explicit that validated alternatives such as human-cell systems, organs-on-chips, and computer models can be used when appropriate.

Also in 2025, the U.S. National Institutes of Health, the world’s largest public biomedical research funder, announced that researchers applying for grants to study animal models would also need to incorporate nonanimal research, such as real-world data or studies of NAMs. Meanwhile, the European Commission and United Kingdom have announced their own plans to phase out animal testing, and the intergovernmental Organisation for Economic Co-operation and Development updated its influential guidelines to allow for expanded use of NAMs.

NAM proponents say these shifts were essential: If regulators won’t accept NAM results, there’s less incentive to adopt them, especially for researchers already working with animals. Maschmeyer says TissUse’s clients increasingly include scientists whose research has been focused on animals. “I see, within the last year, a change,” says Maschmeyer. “It’s more people who are working with animal models who now have to also add in vitro models.” She traces it mainly to the regulatory shift—a trend Ingber calls “game-changing.”

Proving That NAMs Work

It’s not enough for regulators to say that NAMs can or should be used, though. Even more important is the regulatory apparatus dedicated to assessing how they should be used. This begins with their validation: the process by which experimental methodologies and devices are determined to be reliable and trustworthy. A prototype brain-on-a-chip designed to model a rare neurological disease might work fine in the lab that developed it—but to be validated, the system needs to work in the real world.

“You read about all the organ chips that come out of academic labs, which is great—but that’s not going to change their uptake by the FDA, because you have to get the same results anywhere in the world. It has to be a commercial product. It has to be mass-produced and meet very fine performance criteria,” says Ingber. For example, even minute variations in the hydrogels used as tissue scaffolds in organ chips can produce very different growth patterns.

Emulate’s Organ-Chips are connected to the company’s automated culture system, which supplies the chips with nutrients and controls the flow of fluid through them. Emulate

Workflows and procedures need to be uniform, too. One obstacle to wider use of vascularized tumor-on-a-chip platforms in developing cancer therapies, for example, is the different metrics used by different research groups to characterize blood-vessel function and geometry. Experimental guidelines, workflows, checkpoints, metrics, reporting criteria: All need to be standardized in order for researchers to compare their work and collaborate across platforms. Members of Ingber’s lab coach industry researchers on how to use chips developed by Emulate, a company founded by Ingber. But even with instructions, they still need help with the finer points of tending to stem-cell cultures.

When a NAM is ready for commercial use and researchers know how to use it, the most important test—whether it provides clinical benefit—still remains. A rare-disease organ chip might be reliable, but are the biomarkers it measures actually relevant? If so, are the algorithms that extrapolate chip results to the drug’s in-body effects truly predictive?

Microscopic images reveal the human tissues grown inside Emulate’s Organ-Chips. Bacteria, shown in magenta, interact with mucus and airway cells in a LungChip [top]; an IntestineChip develops structures resembling those that absorb nutrients in the small intestine [center]; and tiny hairlike cilia grow on cells in another LungChip, where they help move mucus and trapped particles out of the airway [bottom].Emulate (3)

Such questions have been answered for some NAMs. For example, a liver-on-a-chip system from Emulate correctly flagged about seven out of every eight drugs that had safely passed animal trials but proved toxic to human livers. A similar study was conducted by researchers from Oxford University and Janssen Pharmaceutica (later renamed Johnson & Johnson Innovative Medicine). That team showed that their computational simulations of human heart cells flagged compounds that caused a type of dangerous heart arrhythmia with 89 percent accuracy, compared to animal studies that were 75 percent accurate.

Such studies, however, are complicated and costly. Emulate’s study required 870 chips and the labor equivalent of 16 full-time employees working for 16 weeks—efforts far beyond the reach of the average lab. If the researchers wanted regulatory approval to use their chip to predict large-molecule drugs rather than the small-molecule drugs they tested, they would have needed to run another such study for that particular use. And comparable studies ostensibly need to be conducted for every commercially available NAM and every context in which they would be used—a vast undertaking. “That’s a challenge,” says Kathy Archibald, founder of Safer Medicines Trust, a United Kingdom–based group that considers animals to be poor models of human biology. “It takes too long and costs too much, and small companies can’t afford to do it.”

Ingber thinks that academic scientists need to collaborate more with industry researchers on NAMs, and that governments should fund those projects. He and other NAM proponents also stress the importance of having access to the necessary data: Without information from preclinical animal studies and human clinical trials, comparisons are difficult, but much of that data is now proprietary. Pharmaceutical companies and regulators need to share it, they say, and the FDA has called for an open-access repository of drug toxicity data. Hartung of Johns Hopkins also suggests that new animal experiments be run in parallel with NAMs, producing side-by-side comparisons.

To Christian Maass, a computational biologist at the German biotechnology company ESQlabs, NAMS are overdue for a showdown with animal models. His company makes “digital twin” systems in which data from organ chip systems inform whole-human simulations of drug outcomes and disease progression. “I love what we are doing,” says Maass, speaking not only of his company but of the whole field. But he adds that researchers have not yet provided “the evidence and the proof that we are doing better or as good as the animal models.”

Maass thinks that head-to-head comparisons are essential to good science. After all, if a NAM doesn’t outperform an animal model, or works best as a complement rather than a replacement, that needs to be known. He also believes such studies could convince skeptics. Maass mentions the debut of the iPhone, when people saw for the first time how well a phone could work without buttons. “That was an ‘aha!’ moment,” he says. But for NAMs, “that moment is still lacking.”

Changing Scientific Habits

Even when those head-to-head comparisons are made, though, and regulations are appropriately changed, adoption can be slow. In the mid-1990s, researchers developed and validated the monocyte activation test—an assay that uses human blood cells to predict immune response—to replace the rabbit pyrogen test, which involves injecting a compound into a rabbit’s ear and monitoring the animal’s rectal temperature. But it wasn’t until 2010 that the European Pharmacopeia—the official Europe-wide standards for such testing—accepted the monocyte activation test as a replacement. And rabbits are still widely used for this test worldwide.

Why the slow pace of change? In part because updates to guidance documents referring to animal tests lagged behind, but also because of inertia within the culture and institutions of science. “The formal requirement may disappear, but the informal expectation persists,” says Kathrin Herrmann, a veterinary scientist and colleague of Hartung’s at the Center for Alternatives to Animal Testing. Regulators, grant reviewers, peer reviewers, journal editors—the human infrastructure of science—often still expect to see animal data and are unfamiliar with NAMs.

Herrmann is now overseeing a survey of early-career researchers working with, or trying to make the switch to, NAMs. “We consistently hear concerns that NAM-only proposals are perceived as risky by funders, that there is pressure to ‘add an animal experiment’ for credibility, that access to NAM infrastructure is limited, and that career trajectories become uncertain when departing from established animal models,” says Herrmann.

The vast majority of drugs entering clinical trials in the United States fail to reach FDA approval [failure rates in pink], with particularly high failure rates in some therapeutic areas.

Animal models are embedded in databases, training programs, and the very culture of research. Scientists who use animals may be reluctant to change; their identities as researchers are tied to animals and, more practically, they’ve spent their careers learning the techniques. A toxicologist who has used rats for decades might understandably look askance when asked to take a chance on unfamiliar chunks of polymer and stem cells—especially when human well-being, or millions of dollars, may ride on the choice. Likewise, an academic scientist whose career was built on animal models may not welcome NAMs; a switch may represent the loss of jobs for lab members whose expertise is no longer relevant. “I could see why it’s a hard thing for people to take it up,” says Ingber.

Education and training is vital, say NAM proponents. The NIH and FDA now offer resources for researchers interested in NAMs, as do their counterparts in other countries embracing the technologies. Herrmann helps run webinars where researchers and regulators learn to use and evaluate NAMs; Hartung’s modules on Coursera, the online learning platform, have been taken by about 12,000 students so far. “These trainees will set up their own labs. They will go to industry. They will replace the old guard,” says Joseph Wu, director of Stanford University’s Cardiovascular Institute.

Wu is also a cofounder of Greenstone Biosciences, a company that uses stem-cell-derived human tissues and AI to model disease and predict drug responses. He’s used that position to introduce researchers to NAMs, helping convince the company’s directors to freely share Greenstone’s large library of stem-cell lines with any academic researchers who want to use them. “I really believe that people should understand how this platform works,” says Wu. “At the end of the day, we’re just trying to advance science.”

With enough time—and funding, incentives, training, education, collaboration, and generational turnover—the research culture of drug development and safety testing may shift. Whether NAMs will be used in other areas of science, though, is an open question. Early-stage drug development and regulatory testing account for roughly 30 percent of animals used in experiments; the rest are used in basic biological research. Replacing those animals is less straightforward, but it may be possible: Ingber describes organ-on-a-chip-based insights into inflammatory bowel disease, preterm birth, and treating viral infections that couldn’t have been made in animals. Hartung calls the adoption of NAMs in toxicology a “lighthouse function,” helping guide the way for other types of research.

“Suddenly, all the dams have opened,” he says.

Disclaimer: Unless otherwise stated, any opinions expressed below belong solely to the author. All information comes from official government sources.

Two years ago, the Singapore government launched OMIP: Overseas Markets Immersion Programme, a generous support scheme which provides state financing for workers looking to gain skills and experience overseas.

This is an excellent opportunity, designed specifically for those who lack sufficient experience and would benefit from a posting abroad, whether you’re a recent graduate or a middle-aged worker seeking a career boost.

OMIP is very generous, as it covers up to 70% of the candidate’s salary (capped at S$5,000 per month) and allowance covering living expenses (capped at S$3,000), for a total of S$8,000 per month, up to nine months spent abroad—that’s S$72,000 in total.

The programme is currently a pilot, running for two years, 2025 and 2026, with a target of helping 250 local workers, employed by Singapore-registered businesses.

With just a few months left, there are fewer than 70 places remaining, according to figures revealed by Workers’ Party MP, Eileen Chong, in Parliament a few weeks ago, when she cited data showing that over 180 candidates had thus far benefited from the scheme.

It’s quite likely that this number has shrunk further since then.

Once the pilot concludes, the government is going to evaluate the results and decide whether to keep, modify or scrap it.

Which means that, for the time being, the final quarter of 2026 might be your last chance to apply to get invaluable foreign experience at a fraction of the cost to your employer.

And it doesn’t have to be a big one, as SMEs make up 75% of the participating companies.

Who can apply?

You cannot apply on your own, the company you work for has to do it for you. Fortunately, the criteria are not very strict, provided that it has a legitimate interest in a foreign market.

Interestingly, even new hires can benefit from the scheme immediately, and in Jul 2026, the requirement of a minimum of two years of working experience was lifted, opening the doors to fresh graduates as well.

In fact, the eligibility criteria specifically state that the candidate “should have little or no prior experience in identified new role, industry, or market”—thus, lack of experience only strengthens the candidacy.

The programme can be used by both young and older workers, at various stages of their careers, provided that they learn something genuinely new (and it’s not just an attempt to get the government to foot the bill for a foreign placement of an already experienced employee).

Here are the formal requirements for the candidates:

• Singapore Citizen or Permanent Resident
• Minimum 21 years old
• Must not be a shareholder of the company, or its related companies
• Must not be related to the owner(s) of the company
• Completed National Service or graduated from educational institution
• Not currently participating in any other SWDA-funded programmes
• Should have little or no prior experience in identified new role, industry, or market
• Must not have started training before application is approved
• Employees are required to be relocated overseas for work postings to support business growth internationally for a minimum of six consecutive months

There are also some basic criteria a candidate company has to fulfil to qualify:

1. Registered in Singapore
2. Have a clear market expansion/ business transformation plans with defined KPIs
3. Provide a full-time permanent or contract position with a min. fixed monthly salary of at least S$4,000

If your employer ticks these three boxes, then you can suggest entering the programme to them. Its unique feature is that it explicitly supports workers with less, not more, experience. The goal is to help Singaporeans garner foreign exposure, which would otherwise require risky and expensive immigration.

The process takes some time, so you have to keep that in mind.

The Singapore Business Federation, which manages OMIP, requires six weeks to review applications, and the starting date should be no longer than six months from the date of subsequent approval.

Applications submitted on short notice are almost certainly going to be rejected, so plan accordingly.

With the end of the year approaching fast, there’s still no word on when the next steps (e.g. its future continuation) will be announced. Time is ticking away, and the number of available seats with it.

You can find more details about it on the SWDA website.

• Read other articles we’ve written on Singapore’s current affairs here.

Featured Image Credit: SBF /Min. Tan See Leng via Facebook