Category Archives: Human Genetic Engineering

Earth is great and all, but with climate change and the extremely highly likely reemergence of dinosaursdue to genetic engineering, we might need to consider inhabiting other planets. Sending out a pioneering colony of carefully-selected humansis today science fiction but, someday, it might save our species.And, if we ever actually docolonize space, were going to need to have babies up there, which might turn out to be more complicated than it is on Earth.

Im not concerned about the actual baby making part we can figure that out with practice. The part thats tricky is the fine-tuned and carefully orchestrated process of human development, particularly in the brain. Cells inmicrogravitydontgrowexactly like cells on Earth, and a whole bunch of them in a developing babys brain may not grow exactly the same either.

Thankfully, theres a researcher for that.UC San Diego scientist Alysson Muotriisusingblossoming clumps of brain cells called brain organoids to understand how neurons proliferate, form synapses, and communicate but in space.

Inlate July, Muotri and his team sent a bunch of organoids to the International Space Station. Previous research has documented the proliferation ofHeLA cells,cancer cells,bone cellsand more, but there is limited information about the gravity-free growth of early brain cells, known as neural progenitor cells, or brain organoids. Suchorganoidshave proven to be a useful model for understanding brain development, so understanding how they develop in the microgravity of space could demonstrate the ways in which human brain development might be affected if we ever become a space-faring society.

Muotri has long been intrigued by research in space, especially theNASA twins study. A while ago, he half-seriously talked about the idea of doing his own biology space study with one of his collaborators, but nothing quite came of it. He dreamed of sending organoids to space, but didnt know if it was possible. Once he met an engineer who convinced him it was feasible to actually build a device to keep organoids alive in space, he decided it was time for takeoff.

Still, he had some trouble selling others, particularly granting organizations, on the idea. Hes funding the project out of his own salary savings and gifts to the lab, with the hope that his first wave of findings will draw attention to his work and convince funding agencies that his research is valuable.

Backed by his own money, the first task was figuring out how to keep the organoids healthyat the International Space Station.

Even on Earth, the organoids require a lot of care to ensure that they are at the proper temperature and growing conditions. For one, theyre kept in a shaker so that they are constantly suspended in a solution, without anchoring down to anything (though that wont be a problem in microgravity). But like living cells in a body, organoids require nutrients, and they also spit out waste. To support these processes, their solutions need to be changed, and the temperature and pH needs to be carefully maintained, like fish in a tank. Organoids require a lot of babysitting, and Muotri simply cant expect the astronauts to spend as much time caring for his cells as he and his students do back on Earth.

So, he collaborated withan engineering team from Kentucky that specializes in sending biological material into space.They developed a shiny red box called theSpace Tango CubeLab.

Space Tango may sound like abad 80s science fiction filmstarringAntonio Banderas, butits actually the name of the company, and the productsthey make aresomuch cooler than 80s sci-fi. The CubeLab essentially functions like a fully automated, climate-controlled mini-laboratory: it can change the media for the cells, monitor their growth, and send the data back to Earth. The astronauts just need to plug it in.

For this very first mission with the organoids, Muotri wants to see how the cells grow and proliferate. Based onprevious research,he predicts that The progenitor cells will proliferate faster and will probably generate a bigger organoid. Although a bigger brain sounds better, this might actually be a problem: if the brain and surrounding skull are too big, it might prevent birth through the birth canal. Its still speculation, but its entirely possible that maybe humans cannot have natural deliveries in space.

The other issue with faster brain development is that large brain volumes have been implicated in the development of autism spectrum disorder. In fact, having a larger brain circumference is one of the mostrobust biomarkers of autism. We dont fully understand how cell proliferation may later in life lead to intellectual problems or cognitive disability, so this gives us a model to understand that, Muotri hopes.

At the moment, we dont know much about the cellular mechanisms that microgravity could directly impact. Using genome sequencing and techniques to detectepigenetic signatures, Muotris team will look to see if the genomes of the organoids have changed. There is definitely an epigenetic signature that changes neurons in space, Muotri insists, thats what we want to figure out.

Of course, organoids cant capture brain developmentin uteroin its full complexity. However, this study could point us to important considerations before we pack our space bags. For example,itspossible that people with certain genetic backgrounds are less susceptible to the (lack of) pressures of microgravity and might fare better in space. However far-fetched, the social implications are staggering. If it turns out that some genetic backgrounds are better adapted to have babies in space, would this dictate who could become space-faring?

Lastly, Muotri would like to compare organoids generated from cells of healthypatients to those from people with Alzheimers or Parkinsons disease. In 2011, a lab down the hall from Muotris at UC San Diego showed thatneurons derived from schizophrenic patientswere different than those derived from neurotypical patients. However, similar in-the-dish research on diseases of the aging brain have been limited. Organoids closelyresembleyoung neural tissue, and it is a lot of work to keep them alive until they start to look like an aging brain. When Muotricompared neurotypical and Alzheimers organoids in Earths gravity, they were indistinguishable. However,this might not be true in space: Maybe in the microgravity of space the organoids will age faster, and we could reveal their [Alzheimers] phenotypes.

Muotri would also like to send the organoids up with even more sensors, including recording arrays that can actually measure the electrical activity of the organoids while theyre in space. Such data could provide clues about the functionality of these brain clumps, in addition to their genetic and anatomical signatures.

Muotris energy and enthusiasm for the project is palpable. But he has one big concern: when the mini-brains were sent into space, there was a 24-hour black out period during launch preparation over which the Space Tango couldnt send back data. Muotri confessed that this was his biggest worry for the mission. But, he still laughed heartily, We just have to hope that everything is going to be okay.

Ashley Juavinett, PhD is a neuroscientist, educator, and writer. She currently works as an Assistant Teaching Professor at UC San Diego, where she is developing novel approaches to teaching and mentoring folks in neuroscience. Follow her on Twitter @analog_ashley

A version of this article was originally published on Massives website as There might be some problems when we try to make babies in space and has been republished here with permission.

More:
Why making healthy babies in space should be quite the adventure - Genetic Literacy Project

Washington D.C., Nov 9, 2019 / 05:00 am (CNA).- Food trends come and go, and the trend du jour is plant-based meat that is partially made in a laboratory.

Many vegans and vegetarians have rejoiced at the growing popularity and relative mainstream success of both the Beyond and Impossible brands, and there is a growing claim that eschewing meat choices in favor of these new products is a more ethical choice for consumers.

CNA spoke to Catholic moral theologians to discuss the ethics of eating meat, and the morality of eating faux meat during penitential fasts. And, lest CNA coverage of these products seem incomplete, we conducted a taste test.

According to Dr. Joseph Capizzi, a professor of moral theology at the Catholic University of America a person is not morally obligated to choose a vegan patty, like the Impossible Burger, over a beef or chicken burger.

Theres no reason, in my opinion, to think the consumption of products so dependent upon technology are superior to the consumption of animal products, said Capizzi.

I do think, however, in both cases, ethically relevant issues include the production of the foods, including not merely the environmental impact, but also the ways technologies might distance the human being from creation, he added.

Capizzi told CNA that while he does not think it is ethically superior for people to stick to eating mostly plant-based food, he does think that people need to reflect on the ethical nature of eating.

Though eating is a basic human need, how we eat, what we eat, with whom we eat--including whom we exclude--are all questions that need our reflection, said Capizzi. While these alternative products have done some work to address some of these concerns, there is much work to be done.

One thing Ive noticed is the lack of hospitality that can accompany over-restrictive diets, he explained, recounting the experience of seeing a poor person offer meat to guests, presented as a luxury, only to see the meat rejected because of the guests vegetarianism.

Dr. Charles Camosy, a professor at Fordham University who has written extensively about veganism and vegetarianism, disagreed with Capizzis take. Camosy told CNA that these new products make it harder for American Catholics to justify eating meat.

The Catechism of the Catholic Church insists we have a moral duty not to cause animals to suffer or die needlessly, said Camosy.

With good-tasting protein available from so many sources now, including from new imitation meat products, the teaching of the Church would seem to indicate that the necessity of participating in the suffering of death of animals, for most of us, isn't what it might have been in the past.

Camosy noted that the Bible states that in the new Kingdom of God that will come with Christs second coming, animals are to be our companions, not our food.

The new kingdom will be a Peaceable Kingdom among all creatures: lambs, lions, snakes, and babies, he said, and there will be no need to slaughter animals.

The faux hamburger market is dominated by two companies: Beyond Meat makes the Beyond Burger patty, Beyond Beef ground meat substitute, Beyond Sausage, and Beyond Beef Crumbles. Impossible Foods sells the Impossible Burger patty and the Impossible Sausage.

Protein, fat, minerals, carbohydrates, and water are the five building blocks of meat, says Beyond Meats website. Beyond uses plant-based versions of protein--including protein from peas, mung beans, fava beans, brown rice, and sunflowers--and fats to create its products. Additionally, Beyond uses beet juice to create a burger that bleeds.

Impossible Food uses heme, a protein that is found in nearly all living things, to make its plant-based burgers taste like meat. This heme also mimics a bleeding effect.

Impossible Burger gets its heme from the protein soy leghemoglobin, which is naturally found in soy roots. Impossible Foods produces soy leghemoglobin through genetic engineering and fermentation. Thanks to heme, Impossible Burger has a rich, beefy flavor that satisfies the most discerning meat-eaters but it contains no animal products whatsoever, the companys website says.

Dunkin, the restaurant once known as Dunkin Donuts, launched a Beyond Sausage sandwich nationwide Nov. 6 after a successful test market in Manhattan. Customers can choose to substitute a veggie egg white patty for the fried egg. CNA paid $3.99 for the Beyond Sausage sandwich.

An ordinary pork sausage, egg, and cheese sandwich on an English muffin from Dunkin costs $4.99.

CNA recruited three journalists for a blind taste test of the Beyond Sausage sandwich and pork sausage sandwich. Two out of the three testers were unable to determine at first glance if the sandwich they were eating contained Beyond or pork sausage, and one mistakenly thought the pork sausage she was eating was actually the Beyond Sausage.

Two out of the three testers said they preferred the pork sausage sandwich to the Beyond sandwich, but one said she liked that the Beyond sandwich reminded her of a falafel. This tester was the only one who said she would order the sandwich again in the future.

The sandwich was not extremely popular among testers. But some Catholics have asked whether it would be good enough to eat on a Friday, when Catholics are instructed to abstain from (actual) meat.

CNA asked Fr. Thomas Petri, O.P., the academic dean and vice president of the Dominican House of Studies, to weigh in on whether or not an Impossible Burger (or similar product) would be appropriate for a day when Catholics abstain from meat.

The Churchs universal norms say that we should abstain from meat on Fridays, especially Fridays in Lent, explained Petri. The Impossible Burgers are not technically meat. So, of course, someone could argue that we can eat them on Fridays.

Still, he said that giving up meat but having Impossible Burgers that taste like meat seems to me to be a technicality to get out of the spirit of the penance, he said.

We should remember the point here is to give up something in union with Christ crucified. If a person is seeking Impossible meat to skirt the penance, its hard to believe theyve really understood the point of it all.

It is important for Catholics to remember that fasting and abstinence are not done for purposes of dieting, or to respect animals, said Petri. The purpose of fasting is to unite our offerings to the perfect offering of Christ, and so to prepare for the great feast of his coming.

And for those who are still struggling (or hungry) on a Friday, Petri had some advice.

If youre craving meat on a Friday, offer it up.

Continue reading here:
The Impossible Burger: Ethics and a CNA taste test - Catholic News Agency

The facility lies midway between Munichs city center and its international airport, roughly 23 miles to the north. From the outside, it still looks like the state-run farm it once was, but peer through the windows of the old farmhouse and youll see rooms stuffed with cutting-edge laboratory equipment.

In a newer building at the back of the farm, Barbara Kessler pulls off her sneakers and sprays her bare feet and hands with antiseptic. The wiry veterinarian steps over a taped line in the shower room, leaving behind everything she can from the outside world: clothes, watch, earrings. She scrubs her body and haira buzz cut, so its easier to manage these frequent washings.

After the shower, she finds her size among the neat stacks of supplied clothes and pulls on a pair of black pants, a red shirt, and black Crocs. Outside the dressing room, she adds a black knit cap to keep even her short-cropped hair from passing on germs, and then strides down the hall to the boot room, where she carefully steps into knee-high rubber boots that are power-washed after each wearing.

LAETITIA VANCON

All these precautions are to protect animals not known for their cleanliness: pigs. And once Kessler opens the door to the indoor pens, the smell is unmistakable. Its a pigsty, after all.

When Kessler unlocks one pen to show off its resident, a young sow wanders out and starts exploring. Like other pigs here, the sow is left nameless, so her caregivers wont get too attached. She has to be coaxed back behind a metal gate. To the untrained eye, she acts and looks like pretty much any other pig, but smaller.

Its whats inside this animal that matters. Her body has been made a little less pig-like, with four genetic modifications that make her organs more likely to be accepted when transplanted into a human. If all goes according to plan, the heart busily pumping inside a pig like this might one day beat instead inside a person.

Different types of tissues from genetically engineered pigs are already being tested in humans. In China, researchers have transplanted insulin-producing pancreatic islet cells from gene-edited pigs into people with diabetes. A team in South Korea says its ready to try transplanting pig corneas into people, once it gets government approval. And at Massachusetts General Hospital, researchers announced in October that they had used gene-edited pig skin as a temporary wound covering for a person with severe burns. The skin patch, they say, worked as effectively as human skin, which is much harder to obtain.

But when it comes to life-or-death organs, like hearts and livers, transplant surgeons still must rely on human parts. One day, the dream goes, genetically modified pigs like this sow will be sliced open, their hearts, kidneys, lungs and livers sped to transplant centers to save desperately sick patients from death.

Laetitia Vancon

The death of Baby Fae

Today in the United States, 7,300 people die each year because they cant find an organ donortwo-thirds of them for want of a kidney. In many cases, the only hope is someone elses tragedy: an accident that kills someone whose organs can be harvested.

Surgeons looking for another source of organs at first looked to monkeys, because theyre the animals most similar to us. In 1984, a little girl known as Baby Fae received a baboon heart but died 20 days later, after her immune system attacked it. Baby Faes short life and quick death received global attention; many condemned the idea of killing our closest animal relatives to save ourselves. An opinion piece by a cardiologist in the Washington Post described the procedure as medical adventurism. Another, in the Journal of Medical Ethics, was headlined Baby Fae: A beastly business.

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Then, in the 1990s, researchers and biotech companies turned to pigs as the donor of choice. Since we eat pigs (120 million of them a year in the US alone), taking their organs seemed less morally fraught to many. Scientifically, their organs are roughly the right size, with similar anatomy, and pigs reach adulthood in about six monthsmuch faster than primates. But a problem arose: pigs harbor viruses that might make the jump to people. Whats more, with the simple genetic engineering available at the time, the transplanted organs didnt last long when they were tested in monkeys. They were simply, genetically speaking, too foreign.

When it comes to life-or-death organs, like hearts and livers, transplant surgeons still must rely on human parts.

More than two decades later, advances in genetic engineering have revived the prospect of so-called xenotransplants. The hottest source of debate in the field: exactly how many gene edits are needed in pigs like these to overcome the species barrier. A well-funded US company, eGenesis, which leads the more-is-better-camp, says it has made a double-digit number of changes to the pigs it raises with a sister company in China.

The Germans at the Munich facility are in the less-is-more camp. The pigs they work with have three key genetic modifications originally made more than a decade agoall designed to keep baboons and humans from rejecting their organs. Knocking out a gene that produces a sugar called galactosyltransferase prevented the recipients immune system from immediately rejecting an organ from a different species. The second change added a gene expressing human CD46, a protein that helps the immune system attack foreign invaders without overreacting and causing autoimmune disease; the third introduced a gene for a protein called thrombomodulin, which prevents the blood clots that would otherwise destroy the transplanted organ.

A smaller number of edits can be better controlled and measured, and their effects are easier to document, says Eckhard Wolf, who runs this former state farm on the outskirts of Munich, now called the Center for Innovative Medical Models. If something goes wrong, as often happens in xenotransplantation, it will be clear where the issue lies. With more edits come more potential problems. At some point, you are in a situation that you have no idea what an additional genetic modification does, he says.

The size of a heart

In 2018, the hearts of pigs from the Munich center were transplanted into 14 baboons. Two of the monkeys survived for six months, the longest any animal has lived with a heart from another species. In a report in Nature last December, the German researchers described their achievement as a milestone on the way to clinical cardiac xenotransplantation.

Laetitia Vancon

Of the first five baboons to get a pig heart, four died within a day or two, and when the fifth died after a month, its heart was diseased. In the next batch of baboons, Wolfs collaborator Bruno Reichart, a retired heart transplant surgeon, flooded the organ with nutrients, hormones, and red blood cells from the time it was removed from the pig until it was fully functional in the recipient animal. Three baboons treated with this approach lived for 18, 27, and 40days.

The last five baboons had the same procedure but were also kept on an immunosuppressant drug. Two lived for 182 and 195 days, but they had to be euthanized last year when still in good health, because it was so challenging to continue the anti-rejection therapy.It isnt practical to leave an intravenous line in a baboon for longer than six months. But neither is it a simple thing to convince a baboon to take drugs. Like young children, they resist drinking anything that smells like medication.

Reichart says he is working on a better delivery system that will enable the baboons to stay on the anti-rejection drugs for at least a yearthe amount of time he says is needed to prove that xenotransplantation is ready to be tested in people.

Midway through their baboon study, however, Wolf and Reichart noticed an unanticipated problem: the hearts, harvested from juvenile pigs to make sure they were small enough for baboons, kept on growing as if they were still destined to keep alive a 600-pound (270-kilogram) pig. The transplanted heart weighed 62% more than a typical baboon heart: massive cardiac overgrowth, as their paper described it. In the baboons, the new hearts crowded out other essential organs and, in a few cases, caused the animals death.

Laetitia Vancon

At the pig facility, Kessler showed me Wolfs solution to this problem: two sister sows, created with one more CRISPR gene edit. Researchers have turned off the animals growth hormone receptor(GHR) gene, leaving them roughly half the weight of a typical pig. Both tip the scales at about 175 pounds (79 kg),compared with nearly 400 pounds for a normal sow. The pregnant sister stood across the hall, alone in a pen facing the wall. Metal bars kept her from lying down against the wallsa precaution to protect the piglet litter. Though she was bred with a full-sized male pig, roughly half of her offspring should be missing their GHR gene.

The cost of saving a life

It isnt cheap to create a gene-edited pig and then raise it to the standard required by the US Food and Drug Administration and other agencies that would regulate pig-to-human transplants around the world. Kessler and her colleagues clone pig embryos by putting the desired genetic material into eggs collected Mondays and Tuesdays from a local slaughterhouse. To minimize germs, every new line of pigs must start by conceiving the animal in a lab dish, delivering it by Caesarean section, and separating it from its mother at birth. Later germ-free generations dont require as many precautions and cost only about 10 times the price of raising a pig for bacon and pork, Kessler says.

About 120 gene-edited adult pigs and 150 piglets live on this pig farm (one of only a handful worldwide), but even it cant afford to raise pigs to the standard that will be needed before an organ is transplanted into a person. Wolfs government grant wont cover the cost of HEPA filters to clean the air in every room of the pig facility, or to irradiate the special vegetarian feed pellets that are trucked in. The researchers lobbied for years for funding to build a perimeter fence to keep wild boarsand their germsoff the property.

LAETITIA VANCON

Reichart says he just needs funding to complete one more trial, keeping baboons alive for a full year with the pigs hearts, before hell be ready to test them in people. Other groups are also getting close. In Florida, transplant surgeon Joseph Tector, newly relocated to the University of Miami, says he just needs time to build a pig facility like Wolfs only stricter, and then hell be ready to test pig kidneys in people. The University of Alabama-Birmingham has a pig facility to support clinical transplants, with experts looking at both hearts and kidneys. Their first clinical trial of xenotransplantation might be in babies born with congenital heart malformations. A pig heart could serveas was hoped for Baby Faea bridge until they can receive a human heart.

Reichart says he doesnt need to be the first to successfully do a xenotransplant. But he believes hes likely to be among the first, since hes so close. After decades of research, the pigs in the Munich lab just might be the ones that allow surgeons to break the species barrier.

Read more here:
Meet the pigs that could solve the human organ transplant crisis - MIT Technology Review

October 31stwill mark the 37th anniversary of one of biotechnologys most significant milestones -- the approval by the FDA of human insulin synthesized in genetically engineered bacteria.It launched a revolutionary new era in pharmaceutical development, and as the FDA medical reviewer of the product and the head of the evaluation team, I had a front-row seat.

The saga is remarkable in several ways, not least of which is that although both the drugmakers and regulators were exploring unknown territory, the development of the drug and its regulatory review progressed smoothly and rapidly.

Insulin in crude form was first produced in 1922 by Canadian researchers Frederick Banting and Charles Best, which lifted the death sentence that had previously been imposed on diabetics. By the end of that year drug company, Eli Lilly and Company had devised a method for much higher purification. Over the next half-century or so, the purified insulins obtained from pig or cow pancreases, which differ slightly in chemical composition from human insulin, were constantly improved in purity and formulated in ways that refined their performance.

During the early 1970s, as the supply of animal pancreases declined and the prevalence of insulin-requiring diabetes grew, there were widespread fears of possible future shortages of insulin.Fortuitously, around the same time, a new and powerful tool recombinant DNA technology, also known as genetic modification, genetic engineering, or gene-splicing became available and offered the promise of unlimited amounts of insulin that was identical to the molecule produced by humans.

The seminal molecular genetic engineering experiment wasreported in a 1973 research articleby academic scientists Stanley Cohen, Herbert Boyer and their collaborators. They isolated a ringlet of DNA called a plasmid from a bacterium, used certain enzymes to splice a gene from another bacterium into that plasmid, and then introduced the resulting recombinant, or chimeric, DNA intoE. colibacteria.

When these now recombinant bacteria reproduced, the plasmids containing the foreign DNA were likewise propagated and produced amplified amounts of the functional recombinant DNA. And because DNA contains the genetic code that directs the synthesis of proteins, this new methodology promised the ability to induce genetically modified bacteria (or other cells) to synthesize desired proteins in large amounts.

The scientists at Lilly immediately saw the promise of this technology for the production of unlimited quantities of human insulin in bacteria. After obtaining from startup Genentech, Inc., the recombinantE. colibacteria that contained the genetic blueprint for and that synthesized human insulin, they developed processes for the large-scale cultivation of the organism (in huge fermenters similar to those that make wine or beer) and for the purification and formulation of the insulin.

Insulins had long been Lillys flagship products, and the companys expertise was evident in the purification, laboratory testing and clinical trials of human insulin. The companys scientists painstakingly verified that their product was extremely pure and identical to pancreatic human insulin (which differs slightly in chemical composition from beef and pork insulin).

Lilly began clinical trials of its human insulin in July 1980. The product performed superbly. There were no systematic problems with treating naive patients (who had never before received injections of insulin) or those switched from animal to human insulin. A small number of patients who had had adverse reactions of some kind to the animal insulins tolerated the human insulin well.

The dossier that provided evidence of safety and efficacy was submitted in May 1982 to the FDA, where I was the medical reviewer and head of the evaluation team. Over many years the FDA had had prodigious experience with insulins and also with drugs derived from various microorganisms, so it was decided that no fundamentally new regulatory paradigms were necessary to evaluate the recombinant human insulin.

In other words, recombinant DNA techniques were viewed as an extension, or refinement, of long-used and familiar methods for making drugs. That proved to be a historic, precedent-setting decision.

Based on my teams exhaustive review of Lillys data, which were obtained from pre-clinical testing in animals and clinical trials in thousands of diabetics, FDA granted marketing approval for human insulin in October 1982. The review and approval took only five months when the agencys average approval time for new drugs was 30.5 months.

In retrospect, that rapid approval was particularly remarkable for a drug that was produced with a revolutionary new technology, and that after approval would be available in pharmacies nationwide to millions of American diabetics.

The back story, however, is revealing. My team and I were ready to recommend approvalafterfour months review. But when I took the packet to my supervisor, he said, Four months? No way! If anything goes wrong with this product down the road, people will say we rushed it, and well be toast. Thats the bureaucratic mind-set. I dont know how long he would have delayed it, but when he went on vacation a month later, I took the packet to his boss, the division director, and he signed off.

That anecdote illustrates Milton Friedmans observation that to understand the motivation of an individual or organization, you need to follow the self-interest. A large part of regulators self-interest lies in staying out of trouble. One way to do that, my supervisor understood, is not to approve in record time products that might experience unanticipated problems, even if it is the right thing to do.

The Humulin approval had significant effects. A New York Timesarticlementioned my prediction that the speedy approval was a major step forward in the scientific and commercial viability of recombinant DNA technology. We have now come of age, I said, and potential investors and entrepreneurs agreed. Seeing that biopharmaceuticals would compete with other medicines on a level playing field, the biotechnology industry was on the fast track.

Scores of genetically engineered drugs have been approved over the years, but the rapidity of the human insulin approval proved to be an anomaly. Even with a toolbox of improved technologies available to both the FDA and industry, bringing a new drug to market on average now takes 10-12 years and costs, on average, over$2.5 billion.Regulators are highly risk-averse, few new drugs are approved without convening extramural advisory committees, and decisions are sometimes hijacked by political forces exerted on the FDA.

Other FDA-regulated biotech sectors have fared worse.Incomprehensibly, the FDAdeclined to grant Generally Recognized As Safe (GRAS) statusto two proteins that would be life-saving as additives to oral rehydration solution administered to children with diarrhea.

In addition, FDA officials have made a horrendousmessof the regulation of genetically engineered animals, which FDA chose to regulate as new animal drugs, including a grotesquely prolonged, 20-plus year review of a faster-growing Atlantic salmon, and genetically engineered mosquitoes to control mosquitoes that carry viral diseases.(It took FDA more than five years to realize that the latter were actually pesticides which are outside the Agencys purview -- and that jurisdiction should, therefore, be turfed to EPA.)As a result, the entire biotech sector of genetically engineered animals is moribund.

Its too bad that government regulation hasnt aged as gracefully as genetic engineering technology itself.

Original post:
Record-Time FDA Approval of Human Insulin In 1982: When Genetic Engineering Came of Age - American Council on Science and Health

When I started with Yuval Noah Hararis Homo Deus,I expected to jog along with a fun and clever assessment of human history and its near future as a cyborg-like merger of human and computer.

But I had trouble early on.

Dr. Harari repeatedly throws out a flurry of proclamations, often sweeping claims as arguments, then follows them with his intended conclusion, sometimes sweeping, head scratching and not always adding up. Then there are terms about which he seems to have a slightly skewed understanding.

I collided with his usage of Cognitive Revolution almost from the start. According to Harari, the "Cognitive Revolution" occurred 70,000 years ago causing the homo sapiens mind to shift, turning the species from an insignificant African ape into modern humans as ruler of the world. I looked for supportive context or attribution in the text, but it wasnt there. Nor was there any footnote for the claim.

I knew the term from a different context entirely. I Googled to be sure. "Cognitive Revolution" was the name of a 1950's multidisciplinary movement (now cognitive science) studying the mind and its workings. Noam Chomsky was one of the pioneers of the field.

I could find no reference about Hararis usage until I added Harari or Homo Deus to the search terms. Then I got hits on Homo Deus and "Sapiens" (his previous book, where The Cognitive Revolution is the title of the very first section of Sapiens). This is where Harari sets out his theory of sapiens cognition as a basis for the next brain change.

In Homo DeusHarari states, this revolution resulted from a few small changes in the Sapiens DNA and a slight rewiring of the Sapiens brains. another rewiring of our brain will suffice to launch a second cognitive revolution. Using, he continues, genetic engineering, nanotechnology and brain-computer interfaces.

I looked for further source information on Hararis claim. The best I came up with was an arguable theory about a population bottleneck some 70,000 to 60,000 years ago caused by an extinction when a volcano in Indonesia, Toba, erupted 74,000 years ago.

The theory, now mostly refuted, was that Tobas eruption lowered temperatures around the world wiping out many species, dropping the human population drastically.

Recent studies looking at sediment cores around the world for 100 years before and 200 years after Toba erupted, showed no signs of species die offs. Any effect was mild enough that it did not show up in the sediment layers.

Depending on the source, Homo Sapiens is believed to have emerged about 300,000 years ago (or even 400,000 years ago) and was in Europe at least by 200,000 years ago. A skull found in Greece was just dated to 210,000 years ago. Throw in speculation about big chills at 195,000 and 150,000 years ago and a possibility that humans dropped to as little as 40 people, or 600 people or a few thousand people or were always not that plentiful or came from a small group which left Africa at some time or other.

In East Asia, human remains in China have been dated to 100,000 years ago. In Japan, there is evidence of watercraft 84,000 years ago, in Honshu. Those early East-Asia dates argue against Hararis theory.

Harari doesnt tell us where he got the term. Did he hear it somewhere and misunderstand it, making assumptions? Could he have stumbled on Cognitive Revolution on his own? Fact checking at the publisher should have revealed this term in prior use. Nor could I find any reference by Harari referencing the 1950s movement of that name in either Sapiens or Homo Deus or elsewhere, including numerous videos.

The same doubt goes for assumptions about brain changes 70,000 years ago. What we have of skulls doesnt show a change in brain dimensions. Harari uses the brain-change at 70,000 years ago version of pre-history to bolster the viability of humans making the next change in our species.

There is very little we can say with certainty about our origins. That makes doubtful Hararis prediction that we are about to re-design our own species by attaching computing devices to our brains.

The real Cognitive Revolution:https://courses.lumenlearning.com/waymaker-psychology/chapter/reading-the-cognitive-revolution-and-multicultural-psychology/

A nice, brief synopsis of Homo Sapiens:https://australianmuseum.net.au/learn/science/human-evolution/homo-sapiens-modern-humans/

Revisiting and refuting a theory about an extinction at 74,000 years ago:https://www.smithsonianmag.com/smart-news/ancient-humans-weathered-toba-supervolcano-just-fine-180968479/

Concept of Behavioral Modernityhttps://en.wikipedia.org/wiki/Behavioral_modernity

Read more:
Radio Readers BookByte: Cognitive Revolution - HPPR

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Imagine designing the perfect device for the internet of things. What functions must it have? For a start, it must be able to communicate, both with other devices and with its human overlords. It must be able to store and process information. And it must monitor its environment with a range of sensors. Finally, it will need some kind of built-in motor.

There is no shortage of devices that have many of these features. Most are based on widely available, low-cost devices such as Raspberry Pis, Arduino boards, and the like.

But another set of machines with similar functions is much more plentiful, say Raphael Kim and Stefan Poslad at Queen Mary University of London in the UK. They point out that bacteria communicate effectively and have built-in engines and sensors, as well as powerful information storage and processing architecture.

And that raises an interesting possibility, they say. Why not use bacteria to create a biological version of the internet of things? Today, in a call to action, they lay out some of the thinking and the technologies that could make this possible.

The way bacteria store and process information is an emerging area of research, much of it focused on the bacterial workhorse Escherichia coli. These (and other) bacteria store information in ring-shaped DNA structures called plasmids, which they transmit from one organism to the next in a process called conjugation.

Last year, Federico Tavella at the University of Padua in Italy and colleagues built a circuit in which one strain of immotile E. coli transmitted a simple Hello world message to a motile strain, which carried the information to another location.

This kind of information transmission occurs all the time in the bacterial world, creating a fantastically complex network. But Tavella and cos proof-of-principle experiment shows how it can be exploited to create a kind of bio-internet, say Kim and Poslad.

E. coli make a perfect medium for this network. They are motilethey have a built-in engine in the form of waving, thread-like appendages called flagella, which generate thrust. They have receptors in their cell walls that sense aspects of their environmenttemperature, light, chemicals, etc. They store information in DNA and process it using ribosomes. And they are tiny, allowing them to exist in environments that human-made technologies have trouble accessing.

E. coli are relatively easy to manipulate and engineer as well. The grassroots movement of DIY biology is making biotechnology tools cheaper and more easily available. The Amino Lab, for example, is a genetic engineering kit for schoolchildren, allowing them to reprogram E. coli to glow in the dark, among other things.

This kind of biohacking is becoming relatively common and shows the remarkable potential of a bio-internet of things. Kim and Poslad talk about a wide range of possibilities. Bacteria could be programmed and deployed in different surroundings, such as the sea and smart cities, to sense for toxins and pollutants, gather data, and undertake bioremediation processes, they say.

Bacteria could even be reprogrammed to treat diseases. Harbouring DNA that encode useful hormones, for instance, the bacteria can swim to a chosen destination within the human body, [and] produce and release the hormones when triggered by the microbes internal sensor, they suggest.

Of course, there are various downsides. While genetic engineering makes possible all kinds of amusing experiments, darker possibilities give biosecurity experts sleepless nights. Its not hard to imagine bacteria acting as vectors for various nasty diseases, for example.

Its also easy to lose bacteria. One thing they do not have is the equivalent of GPS. So tracking them is hard. Indeed, it can be almost impossible to track the information they transmit once it is released into the wild.

And therein lies one of the problems with a biological internet of things. The conventional internet is a way of starting with a message at one point in space and re-creating it at another point chosen by the sender. It allows humans, and increasingly devices, to communicate with each other across the planet.

Kim and Poslads bio-internet, on the other hand, offers a way of creating and releasing a message but little in the way of controlling where it ends up. The bionetwork created by bacterial conjugation is so mind-bogglingly vast that information can spread more or less anywhere. Biologists have observed the process of conjugation transferring genetic material from bacteria to yeast, to plants, and even to mammalian cells.

Evolution plays a role too. All living things are subject to its forces. No matter how benign a bacterium might seem, the process of evolution can wreak havoc via mutation and selection, with outcomes that are impossible to predict.

Then there is the problem of bad actors influencing this network. The conventional internet has attracted more than its fair share of individuals who release malware for nefarious purposes. The interest they might have in a biological internet of things is the stuff of nightmares.

Kim and Poslad acknowledge some of these issues, saying that creating a bacteria-based network presents fresh ethical issues. Such challenges offer a rich area for discussion on the wider implication of bacteria driven Internet of Things systems, they conclude with some understatement.

Thats a discussion worth having sooner rather than later.

Ref: arxiv.org/abs/1910.01974 : The Thing with E. coli: Highlighting Opportunities and Challenges of Integrating Bacteria in IoT and HCI

The rest is here:
The scientists who are creating a bio-internet of things - MIT Technology Review