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As the director of commercial engagement for the Defense Innovation Unit (DIU), a Department of Defense (DOD) organization that funds startups developing cutting-edge weapons technology for the military, Sarah Pearson is well acquainted with keeping secrets. Whats surprising is that her team often keeps secrets from the very startups it recruits. Its not for any cloak-and-dagger reason, just bureaucracy. With security clearances taking up to 18 months, Pearsons team often supplies startups with fake datamade-up enemy capabilitiesto simulate real defense scenarios, so they have something to work on until they’re cleared to access classified material. In the fast-moving world of AI, if it takes 18 months . . . I no longer need that company, their model is already obsolete, she says. Enter Nooks, a startup that acts as a kind of coworking space for classified communication. The companys cutesy name and squirrel logo belie its purpose: to build and maintain a network of these high-tech, espionage-proof, on-demand facilities where startups can handle classified informationspaces known as SCIFs, or sensitive compartmented information facilities. Traditionally built inside military sites, defense contractor offices, and government buildings, SCIFs are fortified rooms designed to prevent electronic surveillance or intrusion. They require layers of specialized material, electronic shielding, metal reinforcements, and heavy security. Nooks was founded in 2021 by former Navy pilot Sean Blackman and two fellow aviators to solve a paradox plaguing national security: you need a SCIF to win a defense contract, but probably dont have the funds or permission to build one without already having a contract. Instead, they asked, what if startups could rent access to SCIFs without the millions in upfront costs and years it takes to construct? The firm just raised a $25 million Series A round, led by New Yorks Zigg Capital, in conjunction with the Space Development Agency within the Air Force, valuing the firm at $105 million. It now plans to launch its first three locations this year: in Arlington, Virginia; Colorado Springs, Colorado; and El Segundo, California. The idea is to offer classified infrastructure as a service, with 50,000-square-foot-sites subdivided into different classification levels, and eventually, grow to a network of 100 sites nationwide, especially areas with tech talent. Theres only so much you can do unclassified before it becomes, ‘well, this was a nice science project,’ Blackman says. Where traditional SCIFs are like buying a home and companies like Westway offer long-term leases, Nooks is more like Airbnb for classified work. For startups, that means faster entry into military innovationand for the military, a broader talent pool. ‘An outdated process’ SCIFs must be located in buildings without foreign ownership or proximity to adversarial entities, which is why many operators buy entire buildings outright. The design and security standards every SCIF must adhere to, set by the Office of the Director of National Intelligence, evolve sporadically as surveillance threats shift. (Pearson says the reason for the last SCIF update, ICD 705, which contained a laundry list of updates, remains classified.) Meanwhile, many existing SCIFs are aging out of use, and the upkeep costs are adding up. Virginia Representative Rob Wittman, a member of the Houses Defense Modernization Caucus, says older SCIFs are small, isolated, and look like a walk-in cooler slammed into the corner of the building. These older spaces dont make for an attractive workspace for todays budding tech talent, and the cost of replacing offers a huge opportunity to Blackman. Nooks seeks to untangle a bureaucratic bottleneck that defense and tech industry advocates say stifles military innovation. Battlefield technology is rapidly evolving, and startups want to take advantage of federal funding for dual-use tech that has civilian and battlefield applications, and funding is flowing. Already this year, over $3 billion has been invested in defense startups, according to Pitchbook, and the Pentagons $1 trillion budget will focus on high-tech weapon systems like drones, cybersecurity, robotics, and AI. Blackman, who had a stint at Facebook and experience in the defense innovation space, saw an opportunity to get government moving more like a startup; beginning in 2021, he and his colleagues interviewed hundreds of people across the defense innovation space to figure out their pain points and earn the trust needed to open Nooks, and eventually landed a small Air Force contract to start testing out the concept. But to make these startup investments work requires classified info and sharing enemy battlefield capabilities; some DoD requests for proposals cant even be seen outside a SCIF. The large defense contractorscalled primeshave historically taken the overwhelming chunk of defense spending, and maintain a chokehold on SCIF access. But startups often lack such access, and some go to extreme lengths: hiring staff with preexisting clearances, flying employees across the country to SCIFs, or even selling to a prime just to get in the room. Building a new SCIF can cost millionsan immediate barrier to entry that comes at a time when warfare is changing faster than ever. Drone development alone has created a cat-and-mouse game, says Eric Snelgrove, founder of the consultancy Revere Federal Strategies. Every four to six months, as new GPS, unmanned aerial vehicle (UAV), or electronic warfare tech gets developed, previous drone models become irrelevant. A startup working on this tech needs classified updates of these rapidly changing conditions to make sure their design is relevant, shortening the feedback loop to almost constant iteration. Wittman says the gap between the SCIF space we have and what we need is significant, though he wouldnt get into specific numbers for security reasons. Our defense ecosystem is still hampered by an outdated process that just isnt allowing us to be able to operate at the speed of relevance, he says. ‘A rear-view mirror nation’ Ken Biberaj, an executive managing director at the real estate brokerage Savills, says SCIF access is fast becoming a standard question among advanced manufacturing and dual-use startups he works with. Much of my time now is spent with new defense/dual-use companies looking for a site and the question of a SCIF will always come up, he says. San Diego State University sees the potential of locating a Nooks site within a forthcoming mixed-use campus extension featuring 1.6 million square feet of innovation space, allowing students and startups to do classified work on topics like material science research or cybersecurity. Officials see it as a magnet for engineering and research talent, and funding. The demand for SCIF access grows, which the Pentagon is taking note of, but the challenge remains how fast the government can get more startups in the right, highly-secure rooms. We’ve always had the luxury of being what I call a rear-view mirror nation, says Wittman. Weve just had to look and see how far ahead of our adversaries we are. Today, we have to be a windshield nation, see that there are some folks ahead of us, and not only press the gas pedal, but figure ut how were going to be innovative and creative. The Trump administration has focused on bringing new, innovative companies into the defense-industrial complex and signed an executive order on defense procurement reform. Pearson says the DIU and others are trying to streamline the clearance process; shes optimistically aiming to cut it to three months. The National Defense Authorization Act budget approved last year also has $100 million budgeted for the creation of more shared classified workspaces, some of which will support Nooks. The technology stack that you need to fight a desert war in the Middle East is vastly different from what you need to fight China, right? says Blackman. The companies that the DOD tends to work with dont have that technology; theyre great with planes and tanks and missiles, but they suck at software. Theres just a whole sector thats really good at this stuff that wasnt meaningfully being engaged in the defense business.
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E-Commerce
Inside an airplane hangar in Roswell, New Mexico, a massive blimp-like airship214 feet longis getting ready to float into the stratosphere. Built by a startup called Sceye (pronounced sky), the helium-filled aircraft is designed to gather information that satellites miss. In its next flight, in July, it will hover over New Mexico sending back real-time data about pollution from the states hundreds of oil and gas producers. It can report not only that theres a plume of methane pollution in the air, but that a particular gas tank from a particular company is leaking a specific amount of the potent greenhouse gas each hour. We can see the specific emitter and the rate of emissions in real time, says Mikkel Vestergaard Frandsen, Sceyes CEO. And that’s entirely new. [Photo: Sceye] How a social entrepreneur started working with NASA tech Frandsen, a Danish social entrepreneur, is known for transforming Vestergaard, his familys textile business, into a company focused on humanitarian innovation. (The company makes mosquito nets to help fight malaria, for example, and a spinoff called LifeStraw makes water purification tech.) Because of his work, Frandsen was invited to be part of an effort to discover how tech from NASA could be used to help improve life on Earth. Thats how he learned about HAPS, or high-altitude platform systems, the technology that now underlies Sceyes work. HAPS are designed to go to the edge of space, around 65,000 feet above the surface of the Earth. Youre twice as high as air traffic, youre above the jet stream, youre 95-97% through the atmosphere, Frandsen says. So you can look up with great accuracy at stars, study black holes, look at asteroids. They were promoting this as a platform for science. I was reading this and thinking, sure, but you can also look down. You can have an entirely new way of addressing ocean conservation, or human trafficking, or last-mile connectivity, or methane monitoring, or early wildfire detection. The concept for a HAPS airship wasnt new. It turned out the U.S. government had already spent billions trying to build this stratospheric airship because staying below orbital altitude was considered sort of the holy grail of aviation, he says. He started looking into why past efforts in the 1990s and early 2000s hadnt worked, and realized that some factors had changed. New materials like graphene, for example, could help significantly reduce the weight of the airship and the batteries onboard. [Photo: Sceye] A decade of R&D Sceye, which was founded in 2014 and is based in New Mexico, took an iterative approach to its R&D. I learned from studying those previous attempts that government funding often incentives you to go straight to prototype build, he says. You dont have that iterative learning that tells you if you fail, why did you fail? Or if you succeed, why did you succeed? In every case, it didnt succeed, and they didnt really get their arms around the why. So it all stranded there. In 2026, the startup tested a nine-foot version of the device. A year later, that scaled up to 70 feet. The prototypes kept growing and flying higher. By 2021, the team succeeded in reaching the stratosphere. In 2022, they started doing demonstration flights. A year ago, the company successfully showed that the airship could operate through day and night. In the day, it runs on solar power; at night, its powered by batteries. The company also raised a Series C round of funding in 2024, which Pitchbook estimates totalling $130 million. (Sceye declined to confirm fundraising numbers, but said that it was valued at $525 million before the Series C round.) This year, the company plans to use its flights to demonstrate that the tech can hover in place for extended periods of time. Eventually, the team aims to be able to keep the HAPS in position for as long as 365 days. The 2025 flights will also demonstrate some of the uses of the tech. The company plans to deploy its platform in several ways; the next flight will also test the ability to track wildfires, for example. But it’s particularly well suited for tracking methane emissions. [Photo: Sceye] A powerful tool for tracking methane Methane is potent greenhouse gas. Over the short term, its more than 80 times more powerful than CO2 at heating up the planet. Methane emissions are also surging; leaks from fossil fuel production are a major source of the pollution. New Mexico, which is part of the Permian Basin boom in oil and gas, adopted a methane waste rule in 2021 to try to tackle the problem. By the end of next year, producers will have to achieve a 98% capture rate for methane. “We are looking at how we can make sure that gas is kept in the pipe and goes to its intended market instead of being released into the atmosphere, says Michelle Miano, environmental protection division director at the New Mexico Environment Department. The state started working with Sceye in 2021, in a partnership with the EPA. Right now, much of the data about emissions comes directly from companies themselves; that obviously makes it difficult for the state to confirm accuracy. Satellite data can also help track methane emissions but not in the same granular detail. “From space, it takes a lot of time in order to crunch that data and trace it back and figure out who exactly is the emitter in a certain region,” says Miano. “With technology that’s closer to the ground, there is the ability to get closer to some of the facilities to understand more specifically where they might be coming from.” Because the Sceye airship is designed to stay in one position, it can continuously monitor emissions over hundreds of square miles in a region. Infrared sensors monitor methane emissions, while cameras take detailed photographs that can be overlaid with that data. The system means that it’s possible to spot leaks that a satellite can miss because it only passes over an area temporarily. Satellites also don’t have the same resolution. The European Space Agency’s Sentinel-5, for example, sees methane in pixels that each represent seven square kilometers; the HAPS can get as close as one meter. (Sceye says that its approach is also more cost-effective than some other methods, including sensors on the ground that are slow to install, and planes or drones that have high hourly rates and can only take snapshots.) “If we work with an oil company, we can say, ‘Hey, well number 62 has been leaking 68 kilos of methane per hour for the last 12 minutes,” Frandsen says. The company is now negotiating contracts with some fossil fuel companies, and planning to begin demonstration flights for them this year and commercial contracts next year. In a test flight over New Mexico last year, the team identified a “super emitter” in Texas that was pumping an estimated 1,000 kilograms of methane an hour into the airthe equivalent of the hourly emissions from 210,000 cars. When Sceye shared that data with the EPA last year, it’s not clear if the agency sent a warning letter to the polluter. Now, the Trump-era EPA is pulling back on enforcement. Congress also voted to stop the EPA from implementing a tax on excess methane emissions. But the New Mexico state government plans to continue doing as much as it can to fight pollution. Sceye’s data could help it work more efficiently. “We are looking at how to increase funding for our agencies so that we are able to utilize technologies technologies that are coming online up and beyond standard reporting and standard on-the-ground inspections,” Miano says. “Because we have a limited staff, there are new ways that we need to continue looking at facilities with compliance issues to make sure that we can address as much as possible.”
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E-Commerce
Hello and welcome to Modern CEO! Im Stephanie Mehta, CEO and chief content officer of Mansueto Ventures. Each week this newsletter explores inclusive approaches to leadership drawn from conversations with executives and entrepreneurs, and from the pages of Inc. and Fast Company. If you’re reading this newsletter on the website, you can sign up to get it yourself every Monday morning. For the first Modern CEO newsletter, published in January 2023, I contacted executive recruiter Jana Rich to talk about the importance of creative leaders in businessa theme Ive explored a few times as generative artificial intelligence (gen AI) and other technologies threaten to commoditize many aspects of work. So, when Rich recently announced that she has stepped away as planned from Rich Talent Group, the firm she founded in 2014 after 12 years at Russell Reynolds Associates, I asked her to reflect on her experiences during the last decade. Edited excerpts follow: Why did you start Rich Talent Group? It was for two primary reasons. One was I really lovedand still loveworking with founders who are to some degree building their first leadership team, their first board. And I didnt feel like that was particularly well aligned with the big firms. I dont think thats really where they spend their time and energy. And then, equally as important to me, was I wanted to do everything I could to find, identify, and promote women, people of color, and LGBTQ+ folks. I also felt, and still do feel, that is not a strong suit of the big firms. What were you seeing in Silicon Valley at the time? When we opened the doors in April of 2014, on day one, we had [as clients]and Im going to use the names that they were called back then versus what theyre called todayFacebook, Uber, Square, Airbnb, Pinterest, Dropbox, and Twitter. All of them. Day one. Why did they take a chance on a boutique? We had relationships, yes. But I truly believe they were all looking for a different approach. They wanted more creativity and a fresher approach to things. I look back and Im like, holy moly, that was a killer group of clients. What kind of searches did you do for them, and how were you different from the incumbents? Just to give you an example, we [recruited] Airbnbs first-ever chief marketing officer (CMO), Jonathan Mildenhall from Coca-Cola, who is Black and gay. We were different because we found someone who had never been in tech or high growth [but] who did have a global perspective and was uniquely passionate about belong anywhere (Airbnbs ethos and branding strategy). Relatively early, we were doing board work, which was unusual in that the presiding wisdom at the time was that board work is done by the biggest firms and the most senior [people in them]. We were a brand-new firm, but we built the first-ever board at Square, the first-ever board at Eventbrite, the first-ever board at Asana. From 2014 to today, how did your business change? Its hard sometimes for people to remember, but in 2014, very few people were talking about DEI. There were no heads of DEI. Those roles didnt exist. If anything, there might have been more junior-level positions that were focused on diversity recruiting. Every single year we would do an offsite, and we would ask one of our clients to come and be unscripted, to sit with us and tell us what we do well and not do well. How can we be better? In 2018, I remember it so clearly. Four years into the journey, this woman who is a Black woman, who was heading recruiting at one of the biggest tech companies, comes to the meeting. Ill never forget, she says, I think you really have to stop talking about DEI because its making you too much of a niche player, and its difficult for me to sell you [as a recruiter] to my big tech company. I cant be mad at her for telling us the truth, but after she left I don’t think Ive ever been in a room of people that I was tasked with leading where the morale was lower. I said to them, I know that each and every one of you have come to this team at Rich Talent Group because you care deeply about this mission. I dont fundamentally believe that its niche. It might be right now, but I didnt jump out of the safety and security [of Russell Reynolds] to build something I thought was going to be inconsequential or tiny. Then you jump forward to the murder of George Floyd and even beforehand. The demand for diversity increased dramatically during this time period. The challenge for us was to do our due diligence to ensure that the [client] was deeply committed to diversity as part of their mission versus merely trying to check a box. What do you make of corporate Americas retreat from diversity? It feels like [DEI] is happening but under the cover of the night or something. Were playing a little bit of a nomenclature game right now. Dont say “diversity” or “equity” or “inclusion,” but its okay to talk about “best teams” or “meritocracy.” Were changing words and, in the best possible scenario, were not changing efforts. Its sucking up a lot of energy that I wish could be just used for the betterment of these teams. Great recruiters should always focus on fully qualified candidates while looking outside the box to broaden the aperture for potential candidates. This is not only about hiring for diversity but also building the best teams. While there has been less emphasis on DEI, this is also a time when great companies are standing out because they are not backing down, such as Costco, for example. How should CEOs think about executive search going forward? Ive been in it for 30 years now, and one of the things I wish most for it is that [executive search] becomes as valued as a CEO relationship might be with McKinsey or Bain. I dont think its there yet, but I do think Ive seen a lot of positive change during a period of time whereby the right founder or CEO looks to a top-notch recruiter as a thought partneras somebody that understands the context of whats going on in the marketplace, the competitive set. The diversity name game How is your company framing diversity efforts today? Have you dismantled diversity, equity, and inclusion programs, and if so, why? Please send your experiences to me at stephaniemehta@mansueto.com. Id be excited to share your stories in a future newsletter. Read and hear more: changes in DEI Does changing the language of DEI protect companies? The wider impact of DEI change What comes after DEI?
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E-Commerce
Moderna CEO and cofounder Stéphane Bancel probably never imagined hed look back on March 2023 as the good old days. Then, he merely had to go before the Senate Health, Education, Labor, and Pensions Committee and take a spitty dressing-down from Senator Bernie Sanders over the price of Modernas COVID vaccine. The company was held up as a poster child for corporate greed. For a U.S. pharma executive, though, that was more or less business as usual. Today, the situation is anything but. With the confirmation of Robert F. Kennedy Jr., a prominent anti-vaxxer, to be the secretary of the Department of Health and Human Services this February, once-fringe medical theories have been escalated to the level of policy, throwing established scientific and regulatory norms into doubt. Among drugmakers, perhaps none is worse situated to absorb the D.C. vibe shift than Moderna, which is now being targeted not for its pricing but for its one and only product: mRNA-based vaccines. Kennedy has shown a particular distaste for mRNA vaccines, such as those that were rapidly developed by Moderna and Pfizer-BioNTech in response to the global outbreak of COVID-19. During the height of the pandemic, Kennedy petitioned the Food and Drug Administration to revoke authorization for COVID-19 vaccines and not approve any future ones, saying that the risks of adverse reactions and death werent adequately studied. These vaccineswhich have been safely administered to billions of people around the world and in 2021 alone saved at least an estimated 14.4 million lives worldwidehave been the subject of conspiracy theories and misinformation since they were first authorized for emergency use in late 2020. Among the debunked claims of critics: the vaccines can alter a persons genome; they contain microchips or tracking devices; They cause something dubbed turbo cancer. Several states, including Florida, Kentucky, South Carolina, Idaho, and Texas are considering laws that would severely limit or ban the use of mRNA vaccines. Louisiana and Texas have already ended mass vaccinations and any promotion of the vaccines. Now, Kennedys HHS is taking action against Modernas signature product. In the past month alone, the CDC has revised its public health recommendations for COVID-19 vaccines, the FDA altered its vaccine approval process, and the government canceled a $766 million contract with Moderna to develop new vaccines against pandemic threats including H5N1 avian influenza. Taken together, these moves have effectively knee-capped Modernas business. Theyve also jeopardized public health, and spread uncertainty across the burgeoning landscape of next-generation RNA-based therapeutics. Moderna can ill afford an unfavorable regulatory environment, much less an administration seemingly bent on its destruction. The company, which declined to make executives available for this story, took in $3.2 billion last yearless than half of the year priorat a net loss of $3.6 billion. For the first quarter this year, it brought in $100 million at a $1 billion loss. Although Moderna launched an RSV vaccine last year and is developing a personalized cancer immunotherapy, almost all of its money still comes from sales of COVID-19 shots, which are steadily declining. And with its entire technology under attack, Modernas future looks anything but certain. Going all in on mRNA While most pharma companies have grown by establishing franchises in particular diseases, Moderna has always been all-in on Bancels conception of a biotech platform company. The entire premise is right there in its ticker symbol: mRNA. The promise of the technology is appealing. Older vaccines typically consist of weakened or killed viruses, or parts of viruses, to mimic an infection and elicit an immune response. These vaccines are grown in eggs or cell cultures, purified, and mixed with adjuvants that help them work in the body. Historically, developing vaccines in this way has taken anywhere from 5 to 10 years. But mRNA vaccines dont require any viruses, or eggs. Instead, they work by delivering into the body genetic instructions, in the form of mRNA molecules, that cells use to manufacture a protein called an antigen, which induces an immune response. The original COVID vaccine contained mRNA instructions to produce a signature spike protein found on the surface of the coronavirus. Because mRNA is digitallike DNA, it encodes a series of nucleotide letters (A, U, G, C)creating new mRNA vaccines is a relatively simple matter of rearranging these letters to create a different antigen. mRNA is made in an egg- and cell-free manufacturing process, and once the sequence for a vaccine has been selected, it can be manufactured in as little as a few weeks. This speed and flexibility are what enabled the development of a working vaccine for COVID within a year of its discovery. And it is why many experts in infectious disease believe mRNA vaccines are an essential tool in responding to future pandemic threats. Bancel has been banking on mRNA not only as a vaccine platform but also as a breakthrough way of treating cancer and other diseases. Until last year, though, Moderna had brought just one product to the market: the Spikevax vaccine for COVID-19. In 2021, the company sold 807 million doses, pocketing $17.7 billion. The companys stock soaredin 2021, Modernas market cap hovered around $200 billion, surpassing legacy drugmakers including GlaxoSmithKline, Amgen, and Merck. But demand for the vaccines has abated quickly. In 2022, Moderna had $18.4 billion in vaccine sales. In 2023, the year the public health emergency was declared over and the federal government phased out paying for the vaccine doses, Modernas sales were less than $7 billion. Last year, they more than halved yet again. Modernas second commercial product, an mRNA vaccine for Respiratory Syncytial Virus (RSV) was approved by the FDA in May 2024, for people 60 years and older. Marketed as mRESVIA, it had total 2024 sales of $25 million. At the start of this year, Modernas stock was down about 90% from its pandemic peak. Modernas cash reserve, meanwhile, has dwindled from $18.2 billion at the end of 2022 to $8.4 billion today. Last fall, Bancel announced a plan to cut R&D spending by $1.1 billion by 2027 and to shelve five early-stage programs. This January, he said at the JP Morgan Healthcare Conference that the company would cut $1 billion in spending this year alone, and find another $500 million in cuts next year. As Moderna, which was founded in 2010, grew from 800 employees pre-pandemic to 5,600 full-time global employees at the end of 2023, it gained a reputation as a tough workplace that burned through talent. Even so, its recent departures have signaled a company in turmoil. Since late 2023, when chief commercial officer Arpa Garay left the company less than two years after joining from Merck, his former duties have been split between Bancel, covering sales and marketing, and Modernas president Stephen Hoge responsible for commercial pipeline strategy and medical affairs. In November 2024, Hoge took charge of sales, as well. Stephen and Stephane will go down with the ship, says a former employee speaking on background. Theyre a $10 billion company nowhow does that save them? Theyre in a really bad position. Others are jumping. This February, CIO Brad Millerwhod been driving the companys tech-driven insights for just over two yearsretired at age 52, as Moderna downsized its digital departments by about 50 employees, or 10%. Pharma folks took notice in March, when Kate Cronin, whod led marketingsince 2021, left the company and a month later joined Medtronic Diabetes. When Kate Cronin left, I thought, thats the rat leaving the sinking ship, says another industry insider. Multiple employees in communications roles have also recently left the company. Keeping up with the FDA and CDC Modernas pipeline includes vaccines for everything from shingles to HIV, as well as therapeutics for cancer and rare diseases. But near-term, its hopes had been riding on a new, improved COVID vaccine, along with a first-of-its-a-kind combination COVID-flu vaccine. In the last couple of weeks, though, those hopes have been tempered, if not crushed, by changes at the FDA and the Centers for Disease Control and Prevention, which taken together could dramatically limit who will get access to such vaccines moving forwardand determine whether companies like Moderna will continue to make them at all. On May 31, Moderna had a partial win when the FDA approved its next-generation COVID-19 vaccine, called mNEXSPIKE. But unlike its predecessor, which is licensed for use for all individuals 12 years of age and older, regardless of health-risk statusit was authorized for use only for people aged 65 and older, or aged 12 to 64 with a qualifying medical condition. (The FDAs delayed approval in May of a non-mRNA COVID vaccine made by Novavax had the same restrictions.) People aged 65 and older account for the majority of COVID vaccines, and benefit the most from their protection. In previous years, as long as updated COVID shots showed evidence that they generated a comparable immune response to the previous years version, the FDA approved them for use for most people. Now, to get approval for anyone under 65 and without an underlying medical condition, vaccine makers will have to show additional safety and efficacy data from randomized controlled trials. (The FDA and its advisers had previously considered it unfeasible to run such trials quickly enough.) Calling for robust, gold-standard data on persons at low risk,” the new requirements were put forth without the usual input from independent outside advisers. Between 100 million to 200 million Americans (of a total population of 347 million) would be eligible for COVID vaccines under the new approach, according to an estimate cited by FDA commissioner Martin Makary and Vinay Prasad, director of the FDAs Center for Biologics Evaluation and Research. But the changes in the approval processas a new, highly transmissible COVID subvariant has been detected in California, heightening the risk of a summer wavecould leave a lot of people unprotected in the 20252026 season. On June 3, Kennedy announced on X that Moderna had agreed to a true placebo-controlled trial of the new vaccine; its not yet clear how that will impact availability of the 20252026 vaccine. Moderna declined to comment in response to Kennedys statement on X. Further clouding the vaccination landscape is new CDC guidance about who should get an annual COVID booster. On May 28, Kennedy announced he was rescinding the governments recommendation that pregnant women and healthy children get COVID immunizations. Without this recommendation, health insurersincluding Medicaidwill not likely cover the cost of the vaccine. A couple of days later, the CDC partially contradicted Kennedy, advising that kids continue to get the vaccinebut only in consultation with a healthcare provider. It offered no additional guidance for pregnant women, who have higher risk for health complications from COVID. Meanwhile, Moderna has voluntarily withdrawn its application for approval of its new combo flu/COVID vaccine after the FDA requested more efficacy data. Moderna expects to have additional data this summer, but it declined to share a target date for resubmitting its application. Shutting down avian flu research Perhaps the biggest recent blow to Modernas prospects came last week, when the U.S. Department of Health and Human Services terminated a contract with the company to develop vaccines against several strains of flu with pandemic potential, including the highly pathogenic avian flu viruses H1N1 and H7N9. Moderna had won the contractoriginally worth $176 million but expanded in the last days of the Biden administration by another $590 millionon the belief that mRNA vaccines would be a critical part of any future pandemic response. Andrew Nixon, director of communications at HHS, told STAT that the agency had ended the contract because continued investment in Modernas H5N1 mRNA vaccine was not scientifically or ethically justifiable. The same day that news came out, Moderna shared data from its phase 1/2 trial of its avian flu vaccine, showing that three weeks after the second dose, nearly 98% of participants reached antibody levels considered protective. In a statement, Bancel wrote: “While the termination of funding from HHS adds uncertainty [ . . . ] we will explore alternative paths forward for the program. The scientific communitys reaction to HHSs moves has ranged from befuddlement to outrage. This MAHA approach to killing vaccine technologies for ideological reasons and nothing to do with vaccines is both foolish and deadly. It weakens our nations biosecurity, says Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, codirector of Texas Childrens Hospital Center for Vaccine Development, and codeveloper of the low-cost COVID vaccine Corbevax. It also reinforces my view that the MAHA movement is little more than an economic stimulus for the very corrupt wellness and influencer industry. We learned both from Ebola in Democratic Republic of Congo and COVID-19 that the single most important lesson of pandemic preparedness is to keep many vaccine technologies in play, because you cannot predict ahead of time which ones might rise to the top. There are currently three licensed H5N1 vaccines (made by GSK, CSL Seqirus, and Sanofi) that are either made in eggs or grown in cell culture. None are commercially available, though the government has been adding to its stockpile. Even so, getting an up-to-date version of these vaccines ready for broad distribution would take many months. An mRNA-based vaccine, in contrast, could be matched to the most recently circulated variant of the virus and manufactured rapidly. Other drugmakers, including GSK-Curevac and Pfizer, have been working on mRNA vaccines for avian flu. Its unclear what will happen to these programs now. Joe Payne, CEO of San Diego-based Arcturus Therapeutics, says that his company continues to have full support from the Biomedical Advanced Research and Development Authority (BARDA), which has committed up to $63 million to help advance the company’s avian flu vaccine. (Arcturus’s version uses self-amplifying mRNA, a new technology that works at lower doses than first-generation mRNA vaccines like Modernas.) This April, Arcturus received FDA Fast Track designation for the vaccine, which is currently being tested in a phase 1 trial. Arcturus has also developed a self-amplifying mRNA COVID vaccine with CSL Seqirus, which the companies aim to submit for FDA approval later this year. There’s been a desire in the scientific community and regulatory agencies to identify lower-dose alternatives, says Payne. The new FDA guidance, he says, is a positive development for us, because it’s a fair, balanced and professional communication on their COVID policy, where a couple months ago [under Trump], there was a lot of uncertainty. mRNA in the MAHA crosshairs The long-term bet on Moderna rides almost entirely on its individualized cancer therapy, mRNA-4157, which its developing in conjunction with Merck. While sometimes called a personal cancer vaccine, mRNA-4157 doesnt actually protect you from getting cancer, but instead trains the immune system to attack an existing tumor, using custom-made mRNA that encodes antigens specific to each persons cancer. The company has high hopes that the therapy can be used to treat multiple kinds of cancers. In Phase 2 trials, the therapy cut the risk of recurrence or death in advanced melanoma (after surgical resection) by 65% when combined with Mercks drug Keytruda, compared with Keytruda alone. Moderna also has trials underway or enrolling for its use in treating high-risk melanoma, non-small cell lung cancer, invasive bladder cancer, and adjuvant renal cell carcinoma. While these personalized treatments could be very lucrative for the company, they wont be easy to scale quickly. And the timeline for FDA approval is uncertain, depending on trial results and regulatory review. The melanoma study isnt expected to be fully complete until 2030, and the FDA has not been supportive of accelerated approval. Whether Moderna can hang on that long is an open question. In the meantime, a host of researchers and well-funded biotechs developing second- and third-generation therapies using mRNA and related technologies are quietly holding their breath, feeling that, for now, Kennedy and his lieutenants are concerned almost exclusively with examining the use of mRNA in protective vaccines for healthy people. Using mRNA for treating cancer and rare diseases seems to be a different story. In the past year or so, researchers at the University of Florida and Memorial Sloan Kettering have published promising results from small studies of personalized mRNA-based therapeutic vaccines for glioblastoma and pancreatic cancer, respectively. The next wave of mRNA is with inhaled mRNA and intravenously dosed mRNA to treat really serious and fatal rare disease conditions, says Payne at Arcturus. And that’s where we’re getting the warmest support from the new administration. There is a general belief that science will prevail, says another CEO of a venture-backed company focusing on therapeutic uses of self-amplifying mRNA. But there is anxiety from the uncertainty. Uncertainty is not good for anything. Perhaps no company knows that better than Moderna.
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This article is republished with permission from Wonder Tools, a newsletter that helps you discover the most useful sites and apps. Subscribe here. Googles AI Studio and Labs let you experiment for free with new AI tools. I love the way these digital sandboxeslike the one from Hugging Facelet you try out creative new uses of AI. You can dabble around then download and share what you make, without having to master a complex new platform. Read on for a few Google AI experiments to try. All are free, fast, and easy to use. 1. Transform an image Upload a photo and use Geminis AI Studio Image Generation to transform it with prompts. Iterate on your original image until you get a version you like. The model understands natural language, so you dont have to master prompt lingo. 2. Generate an AI voice conversation AI-generated voices are increasingly hard to distinguish from human ones. If youre surprised, try Generate Speech in the AI Studio or Googles NotebookLM. How to use Generate Speech in Googles AI Studio Paste in text, either for a narration or a conversation between two people Open the settings tab to pick from 30 AI voices. Each is labeled with a characteristice.g. upbeat, gravelly, or mature. Click run to generate the conversation. Optionally adjust the playback speed. Download the file if you want to keep it, or paste in different text to try again. Example: a silly 90-sec chat between two violinists I scripted with Gemini and rendered quickly with this Generate Speech tool. Use case: Make a narration track for an instructional video. ElevenLabs has a better professional model for this, but AI Studios is free, easy and quick. Alternatives Googles Gemini AI app can also now generate audio overviews from files you upload, if youre on a paid plan. Googles free NotebookLM has a new mobile app, and now lets you generate an audio conversation in any of 50 languages. Unlike Generate Speech in AI Studio, NotebookLM audio overviews summarize your material, they dont perform words as written. Why NotebookLM is so useful. Googles Illuminate lets you generate, listen to, share, and download AI conversations about research papers and famous books. Heres an audio chat about David Copperfield, for example. A bit dry to listen to, but still useful. 3. Make a gif Try Magical Gif Maker, one of 20 showcase apps in the Build section of AI Studio. Try making a moving visual featuring the name of your publication, group, or event. I experimented with kinetic text and word art. Also worth trying in the Build AI Studio: Flashcard maker, Video to Learning App & Maps Planner. Alternative: You can also make a static image with Googles Imagen 3 or the new Imagen 4. Write a short prompt and select your preferred aspect ratio. So far I still prefer Ideogram (why I like it) and ChatGPTs new image engine. 4. Generate a short video Googles Veo 2 and Flow let you generate free short video clips almost instantly with a prompt. Create a clip to add vibrancy or humor to a presentation, or a visual metaphor to help you explain something. Here are 25 other quick ideas for how you might use little AI-generated video scenes. How to create a video clip with Veo 2 Pick a length (5 to 8 seconds) and select horizontal or vertical orientation Write a prompt & optionally upload a photo to suggest a visual direction Example: Take a look at a parakeet photo I started with and the 5-second video I generated from the photo with Veo 2. Tip: Convert short video clips into gifs for free with Ezgif or Giphy. Unlike vido files, gifs are easy to share and auto-play in an email or presentation. Whats next: Remarkably lifelike clips made with Googles newer Veo 3 model went viral this week. These AI-generated visualswith soundare only available on the $250/month(!) plan for now, so try Veo 2 for free. 5. Explain things with lots of tiny cats This playful mini app creates short, step-by-step visual guides using charming cat illustrations to explain any concept, from how a violin works to the concept behind the matrix. This article is republished with permission from Wonder Tools, a newsletter that helps you discover the most useful sites and apps. Subscribe here.
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