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Biotech

US Approves Chicken Made From Cultivated Cells, the Nation's First 'Lab-Grown' Meat (apnews.com) 110

An anonymous reader quotes a report from The Associated Press: For the first time, U.S. regulators on Wednesday approved the sale of chicken made from animal cells, allowing two California companies to offer "lab-grown" meat to the nation's restaurant tables and eventually, supermarket shelves. The Agriculture Department gave the green light to Upside Foods and Good Meat, firms that had been racing to be the first in the U.S. to sell meat that doesn't come from slaughtered animals -- what's now being referred to as "cell-cultivated" or "cultured" meat as it emerges from the laboratory and arrives on dinner plates. The companies received approvals for federal inspections required to sell meat and poultry in the U.S. The action came months after the U.S. Food and Drug Administration deemed that products from both companies are safe to eat. A manufacturing company called Joinn Biologics, which works with Good Meat, was also cleared to make the products.

Cultivated meat is grown in steel tanks, using cells that come from a living animal, a fertilized egg or a special bank of stored cells. In Upside's case, it comes out in large sheets that are then formed into shapes like chicken cutlets and sausages. Good Meat, which already sells cultivated meat in Singapore, the first country to allow it, turns masses of chicken cells into cutlets, nuggets, shredded meat and satays. But don't look for this novel meat in U.S. grocery stores anytime soon. Cultivated chicken is much more expensive than meat from whole, farmed birds and cannot yet be produced on the scale of traditional meat, said Ricardo San Martin, director of the Alt:Meat Lab at University of California Berkeley. The companies plan to serve the new food first in exclusive restaurants: Upside has partnered with a San Francisco restaurant called Bar Crenn, while Good Meat dishes will be served at a Washington, D.C., restaurant run by chef and owner Jose Andres.

Biotech

Health Firm 'Grail' Wrongly Told Hundreds of People They Might Have Cancer (cbsnews.com) 27

An anonymous reader quotes a report from CBS News: A biotechnology company selling a $949 blood test that it bills as a "first of its kind" to detect cancer said it incorrectly informed about 400 customers that they might have the disease. The Menlo Park, California, company, called Grail, said it sent a form letter to some customers who had bought its Galleri test, which detects a marker for more than 50 types of cancer, "stating incorrectly that a cancer signal was detected," a company spokeswoman told CBS MoneyWatch in a statement. The company blamed a vendor, PWN Health, for the error, citing a "software configuration issue."

In a statement, PWN Health said it said the problem was due to "a misconfiguration of our patient engagement platform used to send templated communications to individuals." It added that it has added processes to make sure such a mistake doesn't occur again, and started contacting the people who received the erroneous letters within 36 hours. The error comes amid an increased demand for health care screening tests, especially for chronic diseases such as cancer.

Grail is billing its service as a complement to routine single-cancer tests for diseases such as colon or breast cancer, and said that the blood test can detect forms of the disease that aren't routinely screened for, such as in the gallbladder and pancreas. Grail said it hasn't received reports of patient harm or "adverse events" due to the erroneous letters.
"After being notified of the incident, Grail immediately began outreach by phone or email to all individuals who received the PWNHealth letter, and we continued our efforts until we confirmed we successfully reached each individual via phone, email or letter," the spokeswoman said. "The issue was in no way related to or caused by an incorrect Galleri laboratory test result."

More than half the erroneous letters were sent to customers who hadn't had their blood drawn yet for the Galleri test, the spokeswoman added.

On Monday, Illumina filed an appeal against a FTC order, "demanding that it divest cancer diagnostic test maker Grail over competition concerns in the U.S. market for cancer tests," reports Reuters. According to the filing, Illumina is arguing that the FTC "violated due process by depriving Illumina and Grail of a fair proceeding before an impartial tribunal."
Medicine

Pancreatic Cancer Vaccine Shows Promise In Small Trial 91

A personalized cancer vaccine made by BioNTech, the German company that produced the Pfizer-BioNTech COVID-19 vaccine, has shown promising results against pancreatic cancer. The vaccine, which teaches patients' immune systems to attack their tumors, provoked an immune response in half of the 16 patients treated, and those patients did not experience relapses of their cancer during the study. The New York Times reports: Researchers at Memorial Sloan Kettering Cancer Center in New York, led by Dr. Vinod Balachandran, extracted patients' tumors and shipped samples of them to Germany. There, scientists at BioNTech, the company that made a highly successful COVID vaccine with Pfizer, analyzed the genetic makeup of certain proteins on the surface of the cancer cells. Using that genetic data, BioNTech scientists then produced personalized vaccines designed to teach each patient's immune system to attack the tumors. Like BioNTech's COVID shots, the cancer vaccines relied on messenger RNA. In this case, the vaccines instructed patients' cells to make some of the same proteins found on their excised tumors, potentially provoking an immune response that would come in handy against actual cancer cells.

The study was small: Only 16 patients, all of them white, were given the vaccine, part of a treatment regimen that also included chemotherapy and a drug intended to keep tumors from evading people's immune responses. And the study could not entirely rule out factors other than the vaccine having contributed to better outcomes in some patients. [...] But the simple fact that scientists could create, quality-check and deliver personalized cancer vaccines so quickly -- patients began receiving the vaccines intravenously roughly nine weeks after having their tumors removed -- was a promising sign, experts said.

In patients who did not appear to respond to the vaccine, the cancer tended to return around 13 months after surgery. Patients who did respond, though, showed no signs of relapse during the roughly 18 months they were tracked. Intriguingly, one patient showed evidence of a vaccine-activated immune response in the liver after an unusual growth developed there. The growth later disappeared in imaging tests. "It's anecdotal, but it's nice confirmatory data that the vaccine can get into these other tumor regions," said Dr. Nina Bhardwaj, who studies cancer vaccines at the Icahn School of Medicine at Mount Sinai.
"This is the first demonstrable success -- and I will call it a success, despite the preliminary nature of the study -- of an mRNA vaccine in pancreatic cancer," said Dr. Anirban Maitra, a specialist in the disease at the University of Texas MD Anderson Cancer Center, who was not involved in the study. "By that standard, it's a milestone."

The study has been published in the journal Nature.
Biotech

The First IVF Babies Conceived By a Robot Have Been Born (technologyreview.com) 55

An anonymous reader quotes a report from MIT Technology Review: Last spring, engineers in Barcelona packed up the sperm-injecting robot they'd designed and sent it by DHL to New York City. They followed it to a clinic there, called New Hope Fertility Center, where they put the instrument back together, assembling a microscope, a mechanized needle, a tiny petri dish, and a laptop. Then one of the engineers, with no real experience in fertility medicine, used a Sony PlayStation 5 controller to position a robotic needle. Eyeing a human egg through a camera, it then moved forward on its own, penetrating the egg and dropping off a single sperm cell. Altogether, the robot was used to fertilize more than a dozen eggs. The result of the procedures, say the researchers, were healthy embryos—and now two baby girls, who they claim are the first people born after fertilization by a "robot."

The startup company that developed the robot, Overture Life, says its device is an initial step toward automating in vitro fertilization, or IVF, and potentially making the procedure less expensive and far more common than it is today. Right now, IVF labs are multimillion-dollar affairs staffed by trained embryologists who earn upwards of $125,000 a year to delicately handle sperm and eggs using ultra-thin hollow needles under a microscope. But some startups say the entire process could be carried out automatically, or nearly so. Overture, for instance, has filed a patent application describing a "biochip" for an IVF lab in miniature, complete with hidden reservoirs containing growth fluids, and tiny channels for sperm to wiggle through.

"Think of a box where sperm and eggs go in, and an embryo comes out five days later," says Santiago Munne, the prize-winning geneticist who is chief innovation officer at the Spanish company. He believes that if IVF could be carried out inside a desktop instrument, patients might never need to visit a specialized clinic, where a single attempt at getting pregnant can cost $20,000 in the US. Instead, he says, a patient's eggs might be fed directly into an automated fertility system at a gynecologist's office. "It has to be cheaper. And if any doctor could do it, it would be," says Munne.

Businesses

Remote Working Increases VC Investments in Other Areas Besides Silicon Valley (msn.com) 8

Silicon Valley had $74.9 billion in venture-capital investments just in 2022, reports the Washington Post (citing data from PitchBook). With 3,206 deals, "that's about $45.36 billion and 1,058 deals more than New York, the second highest region for VC fundraising." And in addition, the Silicon Valley region "was also the home of 86% of start-ups, up from 53% last year, funded by famed start-up accelerator Y Combinator."

And yet Silicon Valley's share of U.S. venture capital investments last year was its lowest since 2012, "as lenient remote work policies and a spate of layoffs have fueled the departures of workers and cleared the way for rising investment in other tech hubs across the United States, notably Austin and Miami.... [N]early 250,000 people left the Silicon Valley region during the pandemic, according to census data from April 1, 2020, to July 1, 2022." Funding for companies in Miami has nearly quadrupled in the past three years, totaling $5.39 billion in 2022, while deal volume jumped 81 percent. Austin venture capital investments rose 77 percent to $4.95 billion with the number of deals jumping 23 percent. New York, Seattle, Philadelphia, Chicago, Denver and Houston also saw relatively large increases in investment and deals, data shows....

"There's no doubt that [Silicon Valley's] sort of exemplary, center-of-the-universe status has really absorbed some blows," said Mark Muro, senior fellow at Brookings Institution. Miami and Austin both benefited from fewer restrictions during the coronavirus pandemic. Early on, cryptocurrency and Web3 — a broad term for the next generation of the internet that would give people more control and ownership — were major drivers of Miami's growth. Seattle benefited from having Amazon and Microsoft in its backyard, attracting more enterprise technology and also biotech, said Kyle Stanford, lead venture capital analyst at PitchBook. "A redistribution [of funding] has definitely started. The pandemic, the fleeing of start-ups and remote work helped catalyze growth in those smaller markets," he said.

Brianne Kimmel, founder of investment firm Worklife Ventures, has noticed a change in identity for the Silicon Valley region as many tech workers have moved out of San Francisco to other places like Austin or Seattle. "That's really created room for young, very technical, traditional hacker types to come to San Francisco," she said. "It's giving the city a personality it may have lost in years prior."

The Post got this assessment from a VC company partner focused on investing in AI and software infrastructure. "Five years ago, 90 percent of companies would've been founded in San Francisco. Now it might be more like 70 percent, with others starting in places like Seattle and New York."
Biotech

Synthetic Embryos Have Been Implanted Into Monkey Wombs (technologyreview.com) 28

An anonymous reader quotes a report from MIT Technology Review: Embryos made from stem cells -- instead of a sperm and egg -- have been created from monkey cells for the first time. When researchers put these "synthetic embryos" into the uteruses of adult monkeys, some showed the initial signs of pregnancy. It's the furthest scientists have ever been able to take lab-grown embryos in primates -- and the work hints that it may one day be possible to generate fetuses this way. The team behind the research, Zhen Liu at the Chinese Academy of Sciences in Shanghai and his colleagues, started with embryonic stem cells originally taken from macaque monkey embryos. These cells have been grown in labs for multiple generations and, given the right conditions, have the potential to develop into pretty much any type of body cell, including those that make up organs, blood, and nervous system.

The team used a set of lab conditions, which they tweaked and improved, to encourage embryonic stem cells to develop further. Over several days, the cells began developing in a very similar way to embryos. The resulting blobs of cells are called blastoids, because they look like early embryos, which are called blastocysts. After the blastoids had been growing in a dish for seven days, the researchers put them through a series of tests to figure out how similar they were to typical embryos. In one test, the team separated the individual cells in the blastoids and checked to see which genes were expressed in each one. The team analyzed over 6,000 individual cells this way.

These tests revealed close similarities between the stem-cell-derived embryos and conventional monkey embryos. Some of the blastoids were grown for longer -- up to 17 days. These structures looked very much like typical embryos, the researchers say, although other scientists not involved in the study say more evidence is needed to prove just how similar they are. The only way to find out how embryo-like these blastoids really are is to test whether they can develop in a monkey's uterus. So the team put between eight and 10 seven-day-old blastoids into the uteruses of each of eight adult monkeys. The researchers then monitored the transferred blastoids for three weeks. The researchers believe that in three of these monkeys, the blastoids successfully implanted in the uterus and appeared to generate a yolk sac -- one of the very first signs of pregnancy. These monkeys also had elevated levels of pregnancy hormones. In other words, they would have had a positive pregnancy test. But within 20 days of transfer, the monkey blastoids stopped developing and seemed to come apart, say Liu and colleagues, who published their results in the journal Cell Stem Cell.
The results suggest that blastoids still aren't perfect replicas of normal embryos. "That might be because a typical embryo is generated from an egg, which is then fertilized by sperm," reports MIT Technology Review. "A blastoid made from stem cells might express genes in the same way as a normal embryo, but it may be missing something crucial that normally comes from an egg."

"There's also a chance that the team might have seen more progress if the experiment had been done in more monkeys. After all, of the 484 blastoids that were developing at day seven, only five survived to day 17."
Government

San Francisco Faces 'Doom Loop' from Office Workers Staying Home, Gutting Tax Base (sfchronicle.com) 218

Today a warning was published from the editorial board of the San Francisco Chronicle. "Experts say post-pandemic woes stemming from office workers staying home instead of commuting into the city could send San Francisco into a 'doom loop' that would gut its tax base, decimate fare-reliant regional transit systems like BART and trap it in an economic death spiral...." Despite our housing crisis, it was years into the COVID pandemic before our leaders meaningfully questioned the logic of reserving some of the most prized real estate on Earth for fickle suburbanites and their cars. Downtown, after all, was San Francisco's golden goose. Companies in downtown offices accounted for 70% of San Francisco's pre-pandemic jobs and generated nearly 80% of its economic output, according to city economist Ted Egan. And so we wasted generous federal COVID emergency funds trying to bludgeon, cajole and pray for office workers to return downtown instead of planning for change. We're now staring down the consequences for that lack of vision.

The San Francisco metropolitan area's economic recovery from the pandemic ranked 24th out of the 25 largest regions in the U.S., besting only Baltimore, according to a report from the Bay Area Council Economic Institute. In the first quarter of 2023, San Francisco's office vacancy rate shot up to a record-high 29.4% — the biggest three-year increase of any U.S. city. The trend isn't likely to end anytime soon: In January, nearly 30% of San Francisco job openings were for hybrid or fully remote work, the highest share of the nation's 50 largest cities. Amid lower property, business and real estate transfer taxes, the city is projecting a $728 million deficit over the next two fiscal years. Transit ridership remains far below pre-pandemic levels. In January, downtown San Francisco BART stations had just 30% of the rider exits they did in 2019, according to a report from Egan's office. Many Bay Area transit agencies, including Muni, are rapidly approaching a fiscal cliff.

San Francisco isn't dead; as of March, it was home to an estimated 173 of the country's 655 companies valued at more than $1 billion. Tourism is beginning to rebound. And new census data shows that San Francisco's population loss is slowing, a sign its pandemic exodus may be coming to an end. But the city can't afford to wait idly for things to reach equilibrium again. It needs to evolve — quickly. Especially downtown. That means rebuilding the neighborhood's fabric, which won't be cheap or easy. Office-to-housing conversions are notoriously tricky and expensive. Demolishing non-historic commercial buildings that no longer serve a purpose in the post-pandemic world is all but banned. And, unlike New York after 9/11, San Francisco is a city that can't seem to stop getting in its own way.

So what's the solution? The CEO of the Bay Area Council suggests public-private partnerships that "could help shift downtown San Francisco's focus from tech — with employees now accustomed to working from home — to research and development, biotech, medical research and manufacturing, which all require in-person workers."

And last week San Francisco's mayor proposed more than 100 changes to streamline the permitting process for small businesses, and on Monday helped introduce legislation making it easier to convert office buildings to housing, expand pop-up business opportunities, and fill some empty storefronts. This follows a February executive order to speed housing construction. The editorial points out that "About 40% of office buildings in downtown San Francisco evaluated in a study would be good candidates for housing due to their physical characteristics and location and could be converted into approximately 11,200 units, according to research from SPUR and the Urban Land Institute San Francisco."

But without some action, the editorial's headline argues that "Downtown San Francisco is at risk of collapsing — and taking much of the Bay Area with it."
Biotech

Meatball From Long-Extinct Mammoth Created By Food Firm (theguardian.com) 72

An anonymous reader quotes a report from the Guardian: A mammoth meatball has been created by a cultivated meat company, resurrecting the flesh of the long-extinct animals. The project aims to demonstrate the potential of meat grown from cells, without the slaughter of animals, and to highlight the link between large-scale livestock production and the destruction of wildlife and the climate crisis.

The mammoth meatball was produced by Vow, an Australian company, which is taking a different approach to cultured meat. There are scores of companies working on replacements for conventional meat, such as chicken, pork and beef. But Vow is aiming to mix and match cells from unconventional species to create new kinds of meat. The company has already investigated the potential of more than 50 species, including alpaca, buffalo, crocodile, kangaroo, peacocks and different types of fish. The first cultivated meat to be sold to diners will be Japanese quail, which the company expects will be in restaurants in Singapore this year. [...]

Vow worked with Prof Ernst Wolvetang, at the Australian Institute for Bioengineering at the University of Queensland, to create the mammoth muscle protein. His team took the DNA sequence for mammoth myoglobin, a key muscle protein in giving meat its flavor, and filled in the few gaps using elephant DNA. This sequence was placed in myoblast stem cells from a sheep, which replicated to grow to the 20 billion cells subsequently used by the company to grow the mammoth meat. "It was ridiculously easy and fast," said Wolvetang. "We did this in a couple of weeks." Initially, the idea was to produce dodo meat, he said, but the DNA sequences needed do not exist.
Tim Noakesmith, cofounder of Vow, said: "We chose the woolly mammoth because it's a symbol of diversity loss and a symbol of climate change." Bas Korsten at creative agency Wunderman Thompson added: "Our aim is to start a conversation about how we eat, and what the future alternatives can look and taste like. Cultured meat is meat, but not as we know it."

No one has yet to taste the mammoth meatball, notes the report. "We haven't seen this protein for thousands of years," said Wolvetang. "So we have no idea how our immune system would react when we eat it. But if we did it again, we could certainly do it in a way that would make it more palatable to regulatory bodies."
Biotech

FDA Clears Lab-Grown Chicken As Safe To Eat (cbsnews.com) 136

An anonymous reader quotes a report from CBS News: The Food and Drug Administration on Monday cleared cultured "cultured chicken cell material" made by GOOD Meat as safe for use as human food. While the FDA said the lab-grown chicken was safe to eat, GOOD Meat still needs approval from the Agriculture Department before i can sell the product in the U.S. If approved, acclaimed chef Jose Andres plans to serve GOOD Meat's chicken to customers at his Washington, D.C. restaurant. He's on GOOD Meat's board of directors.

The FDA previously gave the green light to lab-grown chicken made by Upside Foods in November. Upside Foods and GOOD Meat both use cells from chickens to create the cultured chicken products. Once cells are extracted, GOOD Meat picks the cells most likely to produce healthy, sustainable and tasty meat, the company explained. The cells are immersed in nutrients inside a tank. They grow and divide, creating the cultured chicken, which can be harvested after four to six weeks. GOOD Meat's chicken is already sold in Singapore.
"Today's news is more than just another regulatory decision -- it's food system transformation in action," says Bruce Friedrich, president and founder of the Good Food Institute, a non-profit think tank that focuses on alternatives to traditional meat production.

"Consumers and future generations deserve the foods they love made more sustainably and in ways that benefit the public good -- ways that preserve our land and water, ways that protect our climate and global health," Friedrich says.
Biotech

Three-Parent Baby Technique Could Create Babies At Risk of Severe Disease (technologyreview.com) 48

MIT Technology Review has revealed two cases in which babies conceived with the three-parent baby technique have shown what scientists call "reversion." "In both cases, the proportion of mitochondrial genes from the child's mother has increased over time, from less than 1% in both embyros to around 50% in one baby and 72% in another," they report. From the report: When the first baby born using a controversial procedure that meant he had three genetic parents was born back in 2016, it made headlines. The baby boy inherited most of his DNA from his mother and father, but he also had a tiny amount from a third person. The idea was to avoid having the baby inherit a fatal illness. His mother carried genes for a disease in her mitochondria. Swapping these with genes from a donor -- a third genetic parent -- could prevent the baby from developing it. The strategy seemed to work. Now clinics in other countries, including the UK, Greece, and Ukraine, are offering the same treatment. It was made legal in Australia last year. But it might not always be successful. [...]

Fortunately, both babies were born to parents without genes for mitochondrial disease; they were using the technique to treat infertility. But the scientists behind the work believe that around one in five babies born using the three-parent technique could eventually inherit high levels of their mothers' mitochondrial genes. For babies born to people with disease-causing mutations, this could spell disaster -- leaving them with devastating and potentially fatal illness. The findings are making some clinics reconsider the use of the technology for mitochondrial diseases, at least until they understand why reversion is happening. "These mitochondrial diseases have devastating consequences," says Bjorn Heindryckx at Ghent University in Belgium, who has been exploring the treatment for years. "We should not continue with this." "It's dangerous to offer this procedure [for mitochondrial diseases]," says Pavlo Mazur, an embryologist based in Kyiv, Ukraine, who has seen one of these cases firsthand.

Biotech

US Regulators Rejected Neuralink's Bid To Test Brain Chips In Humans, Citing Safety Risks (reuters.com) 68

According to Reuters, Elon Musk's medical device company, Neuralink, was denied permission last year to begin human trials of a revolutionary brain implant to treat intractable conditions such as paralysis and blindness. The U.S. Food and Drug Administration (FDA) outlined dozens of issues the company must address before human testing can begin, according to seven current and former employees. From the report: The agency's major safety concerns involved the device's lithium battery; the potential for the implant's tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue, the employees said. A year after the rejection, Neuralink is still working through the agency's concerns. Three staffers said they were skeptical the company could quickly resolve the issues -- despite Musk's latest prediction at a Nov. 30 presentation that the company would secure FDA human-trial approval this spring.

Neuralink has not disclosed details of its trial application, the FDA's rejection or the extent of the agency's concerns. As a private company, it is not required to disclose such regulatory interactions to investors. During the hours-long November presentation, Musk said the company had submitted "most of our paperwork" to the agency, without specifying any formal application, and Neuralink officials acknowledged the FDA had asked safety questions in what they characterized as an ongoing conversation. Such FDA rejections do not mean a company will ultimately fail to gain the agency's human-testing approval. But the agency's pushback signals substantial concerns, according to more than a dozen experts in FDA device-approval processes.

The rejection also raises the stakes and the difficulty of the company's subsequent requests for trial approval, the experts said. The FDA says it has approved about two-thirds of all human-trial applications for devices on the first attempt over the past three years. That total rose to 85% of all requests after a second review. But firms often give up after three attempts to resolve FDA concerns rather than invest more time and money in expensive research, several of the experts said. Companies that do secure human-testing approval typically conduct at least two rounds of trials before applying for FDA approval to commercially market a device.

Biotech

Researchers Have Successfully Grown Electrodes In Living Tissue 16

Researchers at Linkoping, Lund and Gothenburg universities in Sweden have successfully grown electrodes in living tissue using the body's molecules as triggers. The result, published in the journal Science, paves the way for the formation of fully integrated electronic circuits in living organisms. Phys.Org reports: Linking electronics to biological tissue is important to understanding complex biological functions, combating diseases in the brain, and developing future interfaces between man and machine. However, conventional bioelectronics, developed in parallel with the semiconductor industry, have a fixed and static design that is difficult, if not impossible, to combine with living biological signal systems. To bridge this gap between biology and technology, researchers have developed a method for creating soft, substrate-free, electronically conductive materials in living tissue. By injecting a gel containing enzymes as the "assembly molecules," the researchers were able to grow electrodes in the tissue of zebrafish and medicinal leeches.

"Contact with the body's substances changes the structure of the gel and makes it electrically conductive, which it isn't before injection. Depending on the tissue, we can also adjust the composition of the gel to get the electrical process going," says Xenofon Strakosas, researcher at LOE and Lund University and one of the study's main authors. The body's endogenous molecules are enough to trigger the formation of electrodes. There is no need for genetic modification or external signals, such as light or electrical energy, which has been necessary in previous experiments. The Swedish researchers are the first in the world to succeed in this.

In their study, the researchers further show that the method can target the electronically conducting material to specific biological substructures and thereby create suitable interfaces for nerve stimulation. In the long term, the fabrication of fully integrated electronic circuits in living organisms may be possible. In experiments conducted at Lund University, the team successfully achieved electrode formation in the brain, heart, and tail fins of zebrafish and around the nervous tissue of medicinal leeches. The animals were not harmed by the injected gel and were otherwise not affected by the electrode formation. One of the many challenges in these trials was to take the animals' immune system into account.
Education

Internal Review Found 'Falsified Data' in Stanford President's Alzheimer's Research, Colleagues Allege (stanforddaily.com) 34

Stanford University president Marc Tessier-Lavigne was formerly executive vice president for research and chief scientific officer at biotech giant Genentech, according to his page on Wikipedia. "In 2022, Stanford University opened an investigation into allegations of Tessier-Lavigne's involvement in fabricating results in articles published between 2001 and 2008."

But Friday Stanford's student newspaper published even more allegations: In 2009, Marc Tessier-Lavigne, then a top executive at the biotechnology company Genentech, was the primary author of a scientific paper published in the prestigious journal Nature that claimed to have found the potential cause for brain degeneration in Alzheimer's patients. "Because of this research," read Genentech's annual letter to shareholders, "we are working to develop both antibodies and small molecules that may attack Alzheimer's from a novel entry point and help the millions of people who currently suffer from this devastating disease."

But after several unsuccessful attempts to reproduce the research, the paper became the subject of an internal review by Genentech's Research Review Committee (RRC), according to four high-level Genentech employees at the time... The scientists, one of whom was an executive who sat on the review committee and all of whom were informed of the review's findings at the time due to their stature at the company, said that the inquiry discovered falsification of data in the research, and that Tessier-Lavigne kept the finding from becoming public.

Tessier-Lavigne denies both allegations. Genentech said in a statement that "as part of our diligence related to these allegations, we reviewed the records from that November 2011 RRC meeting and saw no allegations of fraud or wrongdoing." The company acknowledged that "given that these events happened many years ago ... our current records may not be complete."

After the review, which began in 2011, Genentech canceled research based on the paper's findings. Till Maurer, a senior scientist at the company from 2009-2018 who said he was assigned to develop drugs based on the 2009 paper, told The Daily that his superior informed him that, in Maurer's words, "the project is being canceled and it's because they found falsified data...."

According to the executive who was part of the committee that reviewed the paper, the inquiry was thorough and left little room for doubt. Laboratory technicians and assistants were interviewed while scientists independent of the lab attempted to verify the findings of the study. "None of [the research review committee members] believed that these data were true by the time people had attempted to reproduce it," the executive said. He said that the understanding of the research committee was that the paper's supposed finding of N-APP's role in Alzheimer's had been "faked," and used "made up" figures as evidence.

Biotech

For the First Time, Genetically Modified Trees Have Been Planted in a US Forest (nytimes.com) 79

Genetically modified seedlings from biotechnology company Living Carbon have been planted in a low-lying tract of southern Georgia's pine belt. According to a paper that has yet to be peer reviewed, these trees are engineered to grow 50 percent faster than non-modified ones over five months in the greenhouse. The New York Times reports: The poplars may be the first genetically modified trees planted in the United States outside of a research trial or a commercial fruit orchard. Just as the introduction of the Flavr Savr tomato in 1994 introduced a new industry of genetically modified food crops, the tree planters on Monday hope to transform forestry. Living Carbon, a San Francisco-based biotechnology company that produced the poplars, intends for its trees to be a large-scale solution to climate change. "We've had people tell us it's impossible," Maddie Hall, the company's co-founder and chief executive, said of her dream to deploy genetic engineering on behalf of the climate. But she and her colleagues have also found believers -- enough to invest $36 million in the four-year-old company.

The company's researchers created the greenhouse-tested trees using a bacterium that splices foreign DNA into another organism's genome. But for the trees they planted in Georgia, they turned to an older and cruder technique known as the gene gun method, which essentially blasts foreign genes into the trees' chromosomes. In a field accustomed to glacial progress and heavy regulation, Living Carbon has moved fast and freely. The gene gun-modified poplars avoided a set of federal regulations of genetically modified organisms that can stall biotech projects for years. (Those regulations have since been revised.) By contrast, a team of scientists who genetically engineered a blight-resistant chestnut tree using the same bacterium method employed earlier by Living Carbon have been awaiting a decision since 2020. [...]

In contrast to fast-growing pines, hardwoods that grow in bottomlands like these produce wood so slowly that a landowner might get only one harvest in a lifetime, said [Vince Stanley, a seventh-generation farmer who manages more than 25,000 forested acres in Georgia's pine belt]. He hopes Living Carbon's "elite seedlings" will allow him to grow bottomland trees and make money faster. "We're taking a timber rotation of 50 to 60 years and we're cutting that in half," he said. "It's totally a win-win." [...] The U.S. Forest Service, which plants large numbers of trees every year, has said little about whether it would use engineered trees. To be considered for planting in national forests, which make up nearly a fifth of U.S. forestland, Living Carbon's trees would need to align with existing management plans that typically prioritize forest health and diversity over reducing the amount of atmospheric carbon, said Dana Nelson, a geneticist with the service. "I find it hard to imagine that it would be a good fit on a national forest," Dr. Nelson said. Living Carbon is focusing for now on private land, where it will face fewer hurdles. Later this spring it will plant poplars on abandoned coal mines in Pennsylvania. By next year Ms. Hall and Mr. Mellor hope to be putting millions of trees in the ground.
The report notes that the modified trees are all female, "so they won't produce pollen."

"They're also being planted alongside native trees like sweet gum, tulip trees and bald cypress, to avoid genetically identical stands of trees known as monocultures; non-engineered poplars are being planted as experimental controls."
Biotech

Americans Are Ready To Test Embryos For Future College Chances, Survey Shows (technologyreview.com) 188

An anonymous reader quotes a report from MIT Technology Review: Imagine that you were provided no-cost fertility treatment and also offered a free DNA test to gauge which of those little IVF embryos floating in a dish stood the best chance of getting into a top college someday. Would you have the test performed? If you said yes, you're among about 40% percent of Americans who told pollsters they'd be more likely than not to test and pick IVF embryos for intellectual aptitude, despite hand-wringing by ethicists and gene scientists who think it's a bad idea. The opinion survey, published in the journal Science, was carried out by economists and other researchers who say surprisingly strong support for the embryo tests means the US might need to hurry up and set policies for the technology.

The new poll compared people's willingness to advance their children's prospects in three ways: using SAT prep courses, embryo tests, and gene editing on embryos. It found some support even for the most radical option, genetic modification of children, which is prohibited in the US and many other countries. About 28% of those polled said they'd probably do that if it was safe. The authors of the new poll are wrestling with the consequences of information that they helped discover via a series of ever larger studies to locate genetic causes of human social and cognitive traits, including sexual orientation and intelligence. That includes a report published last year on how the DNA differences among more than 3 million people related to how far they'd gone in school, a life result that is correlated with a person's intelligence.

The result of such research is a so-called "polygenic score," or a genetic test that can predict from genes whether -- among other things -- someone is going to be more or less likely to attend college. Of course, environmental factors matter plenty, and DNA is not destiny. Yet the gene tests are surprisingly predictive. In their poll, the researchers told people to assume that around 3% of kids will go to a top-100 college. By picking the one of 10 IVF embryos with the highest gene score, parents would increase that chance to 5% for their kid. It's tempting to dismiss the advantage gained as negligible, but "assuming they are right," Carmi says, it's actually "a very large relative increase" in the chance of going to such a school for the offspring in question -- about 67%.
"The current poll found only 6% of people are morally opposed to IVF today, only about 17% have strong moral qualms about testing embryos, and 38% would probably do to boost education prospects if given the opportunity," adds the report.
Biotech

'De-Extinction' Company Will Try To Bring Back the Dodo 123

An anonymous reader quotes a report from Gizmodo: Genetic engineering company Colossal Biosciences said Tuesday that it will try to resurrect the extinct dodo bird, and it's received $150 million in new funding to support its "de-extinction" activities. The dodo was already part of Colossal's plans by September 2022, but now the company has announced it with all the pomp, circumstance, and seed funding that suggests it will actually go after that goal. The $150 million, the company's second round of funding, was led by several venture capital firms, including United States Innovative Technology Fund and In-Q-Tel, a VC firm funded by the CIA that first put money into the company in September. Adding the dodo to its official docket brings Colossal's total de-extinction targets to three: the woolly mammoth (the company's first target species, announced in September 2021), and the thylacine, a.k.a. the Tasmanian tiger, the largest carnivorous marsupial. Adding the dodo to its official docket brings Colossal's total de-extinction targets to three: the woolly mammoth (the company's first target species, announced in September 2021), and the thylacine, a.k.a. the Tasmanian tiger, the largest carnivorous marsupial.

Colossal's stated goal is not to simply bring these creatures back for vibes; its contention is that reintroducing the species to their respective habitats would help restore a certain amount of normalcy to those environments. Mammoths died out about 4,000 years ago on Wrangel Island, off the northeastern coast of Russia. The dodo, a species of flightless bird native to the island of Mauritius, was gone by 1681. The last known thylacine died at a zoo in Tasmania in 1936. Scientists have sequenced the genomes of all three species -- the mammoth's in 2015, the dodo's in 2016, and the thylacine's in 2018. The latter species were driven to extinction by humankind; humans hunted the dodo, introduced predators and pests to its environment, and contributed to its habitat loss. Humans may have played a role in mammoth extinction as well, but the dodo and the thylacine are classic examples of our ability to wipe out species at extraordinary speed. [...]

If the company's work pans out -- and that's a big if -- proxy species of those extinct animals will be brought to bear. That's because the genetically engineered animals produced by Colossal would not be a bonafide mammoth, dodo, or thylacine. In 2016, the International Union for Conservation of Nature's Species Survival Commission published a report (PDF) denoting ground rules for creating proxy species. "Proxy is used here to mean a substitute that would represent in some sense (e.g. phenotypically, behaviorally, ecologically) another entity -- the extinct form," the commission stated, adding that "Proxy is preferred to facsimile, which implies creation of an exact copy." De-extinction is something of a misnomer, as this process, if successful, will yield science's best analogue for an extinct creature, not the creature itself as it existed in the past. De-extinction methods generally rely on using a living creature's genetics in the resurrection process. That means any 21st-century mammoth will have at least some modern elephant DNA imbued in it, and any nascent thylacine would be produced from the genome and egg of a related species.
Biotech

Impossible Foods Plans To Lay Off About 20% of Workers (techcrunch.com) 174

Impossible Foods, which makes plant-based nuggets, burgers and patties, is reportedly laying off 20% of its staff, Bloomberg reported first. TechCrunch reports: According to the story, the 12-year-old company currently employs about 700 workers, which could then affect over 100 employees. This comes as the company made a 6% reduction in its workforce last October. While we know layoffs can happen anytime, it seems like the company was doing well. Earlier this month, the Redwood City, California-based company reported a year of record sales that included over 50% dollar sales growth in 2022. The company also touted that its Impossible Beef product was "the best-selling product by volume of any plant-based meat brand in the U.S."

Months before that, CEO Peter McGuinness said in an interview with Bloomberg Technology that the company had a strong balance sheet, good cash flow and growth of between 65% to 70%. In total, Impossible raised $1.9 billion in venture capital, according to Crunchbase data. The last time the company raised capital was a $500 million Series H round in November 2021, and it was at that time that the company was valued at $7 billion. [...] Impossible is not the only plant-based meat alternative company to make layoffs in recent months. In a regulatory filing made last October, Beyond Meat said it planned to lay off about 200 employees, or 19% of its workforce, as part of cost-saving measures as sales were slumping.

Biotech

A Drug Company Made $114 Billion Gaming America's Patent System (msn.com) 92

The New York Times looks at the AbbVie's anti-inflammatory drug Humira and their "savvy but legal exploitation of the U.S. patent system." Though AbbVie's patent was supposed to expire in 2016, since then it's maintained a monopoly that generated $114 billion in revenue by using "a formidable wall of intellectual property protection and suing would-be competitors before settling with them to delay their product launches until this year." AbbVie did not invent these patent-prolonging strategies; companies like Bristol Myers Squibb and AstraZeneca have deployed similar tactics to maximize profits on drugs for the treatment of cancer, anxiety and heartburn. But AbbVie's success with Humira stands out even in an industry adept at manipulating the U.S. intellectual-property regime.... AbbVie and its affiliates have applied for 311 patents, of which 165 have been granted, related to Humira, according to the Initiative for Medicines, Access and Knowledge, which tracks drug patents. A vast majority were filed after Humira was on the market.

Some of Humira's patents covered innovations that benefited patients, like a formulation of the drug that reduced the pain from injections. But many of them simply elaborated on previous patents. For example, an early Humira patent, which expired in 2016, claimed that the drug could treat a condition known as ankylosing spondylitis, a type of arthritis that causes inflammation in the joints, among other diseases. In 2014, AbbVie applied for another patent for a method of treating ankylosing spondylitis with a specific dosing of 40 milligrams of Humira. The application was approved, adding 11 years of patent protection beyond 2016.

AbbVie has been aggressive about suing rivals that have tried to introduce biosimilar versions of Humira. In 2016, with Amgen's copycat product on the verge of winning regulatory approval, AbbVie sued Amgen, alleging that it was violating 10 of its patents. Amgen argued that most of AbbVie's patents were invalid, but the two sides reached a settlement in which Amgen agreed not to begin selling its drug until 2023.

Over the next five years, AbbVie reached similar settlements with nine other manufacturers seeking to launch their own versions of Humira. All of them agreed to delay their market entry until 2023.

A drug pricing expert at Washington University in St. Louis tells the New York Times that AbbVie and its strategy with Humira "showed other companies what it was possible to do."

But the article concludes that last year such tactics "became a rallying cry" for U.S. lawmakers "as they successfully pushed for Medicare to have greater control over the price of widely used drugs that, like Humira, have been on the market for many years but still lack competition."
AI

Anti-Microbial Proteins Are Being Developed With AI By... Salesforce? (neowin.net) 13

segaboy81 shares a report from Neowin: What do you get when the world's largest CRM breaks into the research industry and leverages AI to build their products? You get ProGen, a new AI system that can make artificial enzymes from scratch that can work just as well as real ones found in nature. ProGen was made by Salesforce Research (yes, that Salesforce) and uses language processing to learn about biology. In short, ProGen takes amino acid sequences and turns them into proteins....

"The artificial designs are better than ones made by the normal process," said James Fraser, a scientist involved in the project. "We can now make specific types of enzymes, like ones that work well in hot temperatures or acid."

To make ProGen, the scientists at Salesforce fed the system amino acid sequences from 280 million different proteins. The AI system quickly made a staggering one million protein sequences, of which 100 were picked to test. Out of these, five were made into actual proteins and tested in cells. That's just 0.0005% of the generated results....

The code for ProGen is available on Github for anyone who wants to try it (or add to it)

The project shows "how generative AI can lead to potential solutions for addressing challenges in human disease and the environment," argues a statement form Salesforce.

More details from New Scientist: The AI, called ProGen, works in a similar way to AIs that can generate text. ProGen learned how to generate new proteins by learning the grammar of how amino acids combine to form 280 million existing proteins. Instead of the researchers choosing a topic for the AI to write about, they could specify a group of similar proteins for it to focus on. In this case, they chose a group of proteins with antimicrobial activity.

The researchers programmed checks into the AI's process so it wouldn't produce amino acid "gibberish", but they also tested a sample of the AI-proposed molecules in real cells. Of the 100 molecules they physically created, 66 participated in chemical reactions similar to those of natural proteins that destroy bacteria in egg whites and saliva. This suggested that these new proteins could also kill bacteria. The researchers selected the five proteins with the most intense reactions and added them to a sample of Escherichia coli bacteria. Two of the proteins destroyed the bacteria.

The researchers then imaged them with X-rays. Even though their amino acid sequences were up to 30% different from any existing proteins, their shapes almost matched naturally occurring proteins. James Fraser at the University of California, San Francisco, who was part of the team, says it was not clear from the outset that the AI could work out how to change the amino acid sequence so much and still produce the correct shape.... He was surprised to have found a well-functioning protein in the first relatively small fraction of all the ProGen-generated proteins that they tested.

Biotech

An ALS Patient Set a Record For Communicating Via a Brain Implant: 62 Words Per Minute (technologyreview.com) 17

An anonymous reader quotes a report from MIT Technology Review: Eight years ago, a patient lost her power of speech because of ALS, or Lou Gehrig's disease, which causes progressive paralysis. She can still make sounds, but her words have become unintelligible, leaving her reliant on a writing board or iPad to communicate. Now, after volunteering to receive a brain implant, the woman has been able to rapidly communicate phrases like "I don't own my home" and "It's just tough" at a rate approaching normal speech. That is the claim in a paper published over the weekend on the website bioRxiv by a team at Stanford University. The study has not been formally reviewed by other researchers. The scientists say their volunteer, identified only as "subject T12," smashed previous records by using the brain-reading implant to communicate at a rate of 62 words a minute, three times the previous best. [...] People without speech deficits typically talk at a rate of about 160 words a minute. Even in an era of keyboards, thumb-typing, emojis, and internet abbreviations, speech remains the fastest form of human-to-human communication.

The brain-computer interfaces that [co-lead author Krishna Sehnoy's] team works with involve a small pad of sharp electrodes embedded in a person's motor cortex, the brain region most involved in movement. This allows researchers to record activity from a few dozen neurons at once and find patterns that reflect what motions someone is thinking of, even if the person is paralyzed. In previous work, paralyzed volunteers have been asked to imagine making hand movements. By "decoding" their neural signals in real time, implants have let them steer a cursor around a screen, pick out letters on a virtual keyboard, play video games, or even control a robotic arm. In the new research, the Stanford team wanted to know if neurons in the motor cortex contained useful information about speech movements, too. That is, could they detect how "subject T12" was trying to move her mouth, tongue, and vocal cords as she attempted to talk?

These are small, subtle movements, and according to Sabes, one big discovery is that just a few neurons contained enough information to let a computer program predict, with good accuracy, what words the patient was trying to say. That information was conveyed by Shenoy's team to a computer screen, where the patient's words appeared as they were spoken by the computer. [...] The current system already uses a couple of types of machine learning programs. To improve its accuracy, the Stanford team employed software that predicts what word typically comes next in a sentence. "I" is more often followed by "am" than "ham," even though these words sound similar and could produce similar patterns in someone's brain. Adding the word prediction system increased how quickly the subject could speak without mistakes.

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