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Category Archives: Transhuman News

Doomsday bunkers, Mars and ‘The Mindset’: the tech bros trying to outsmart the end of the world – The Conversation Indonesia

Posted: October 8, 2022 at 4:06 pm

Douglas Rushkoffs newest book, Survival of the Richest: Escape Fantasies of the Tech Billionaires, grew out of a brilliant 2018 Medium article of the same name, which went viral and had people (aka his US editor) clamouring for a full-length treatment.

Review: Survival of the Richest: Escape Fantasies of the Tech Billionaires Douglas Rushkoff (Scribe Publications)

In both pieces, Rushkoff recounts being invited to speak about the future of technology, only to find himself at a luxury desert resort in an undisclosed location, speaking to a select audience of five unnamed hedge fund billionaires. Within minutes, the conversation takes on a distinctly prepper-ish tone. One of the CEOs tells Rushkoff about his newly completed underground shelter, then asks, How do I maintain authority over my security force after the event?

Rushkoff is bemused, but also grimly amused by it all. Here they were, asking a Marxist media theorist for advice on where and how to configure their doomsday bunkers, he writes. Thats when it hit me: at least as far as these gentlemen were concerned, this was a talk about the future of technology.

Read more: With threats of nuclear war and climate disaster growing, America's 'bunker fantasy' is woefully inadequate

So far, so head-spinningly good. Unfortunately, however, Rushkoff moves away from the billionaires and their intriguingly delusional self-preservation tactics, into a realm of high ideas.

Over the next 12 and a half chapters, Rushkoff offers a Grand Unified Theory of tech billionaire ideology. Inspired by a 1995 article, The Californian Ideology, he chooses to call this The Mindset a frustratingly vague term that doesnt really clarify things.

At times, The Mindset is roughly synonymous with the ideology of libertarianism; at others, it is much more amorphous referring to everything from growth-based capitalism, to colonialism, to narcissism. And as Hugo Rifkind notes in The Times, while the Mindset is interesting, its not nearly as interesting as the bonkers escape plans to which it leads.

If youre after a primer on the various ills of late capitalism, then strap yourself in and enjoy this wide-ranging, freewheeling romp by one of the USs most entertaining digital culture raconteurs.

His subjects include but not are not limited to monopolies, financialisation, behavioural science, scientism (Richard Dawkins, Steven Pinker et al.) and the sex crimes of Jeffrey Epstein. Theres the 1980s business savvy of General Electric CEO Jack Welch and the Western, linear drive towards progress. Our estrangement from nature. The persistence of Aristotelian plot structures. And even Western language systems, which tend to be more noun-based than many of their counterparts.

Rushkoff is an accessible, pithy writer, with no shortage of examples, analogies and anecdotes to string together. That said, his relentless synthesising and breathless proclamations also make the book feel a bit shambolic, a bit over-reachy. (For instance, The Mindset prefers straight lines, linear progress and infinite expansion over the ebbs and flows in the real world.)

This is especially so if youre searching for the what-it-says-on-the-label bits the tech bros and their bizarre survival plans.

Case in point: Rushkoff tells a quite-long story about arguing with Richard Dawkins about morality at a Manhattan dinner party in the 1990s. Great. He then claims that Stephen Pinker and Daniel Dennett believe the brain is mere hardware and humans are just robots running programs. Sure. Next, he points out that Dawkins, Pinker and Dennett were all photographed on Jeffrey Epsteins private jet on their way to a TED talk. Guilt by association fallacy, but okay. As a finale, Epstein is described as truly the model, self-sovereign, transhumanist billionaire prepper.

Heres the problem: while Jeffrey Epstein was a lot of terrible things, he wasnt a prepper, in the proper sense of that word. Theres no record of him saying he thought society was about to collapse, or that he was making any just-in-case plans. More generally, none of the aforementioned four are Silicon Valley titans, or billionaires theyre three scientists and one multimillionaire Wall Street financier/paedophile. And theyre only tangentially relevant to the matter at hand.

Read more: How to survive a tactical nuclear bomb? Defence experts explain

Also, given how much other ground is covered, it is a little surprising that Rushkoff doesnt name check that ur-text of cyber libertarianism, The Sovereign Individual: How to Survive and Thrive During the Collapse of the Welfare State (1997), by James Dale Davidson and William Rees-Mogg.

Davidson and Rees-Mogg dream of a time when individuals will be freed from the shackles of government, fiat currency (government-issued paper money, not backed by a commodity such as gold) and law in general. (William Rees-Moggs son, UK politician Jacob Rees-Mogg, was one of the most vocal cheerleaders for Brexit.)

In this thrilling new age, a cognitive elite will be able to rule or ignore the rest of the world, as they see fit. The Sovereign Individual is a hugely influential text in the start-up world; early Facebook backer, Paypal co-founder and conservative libertarian Peter Thiel, who is infamous in New Zealand for buying his citizenship and attempting to build luxury bunkers in the wilderness wrote the foreword to the 2020 reprint.

Survival of the Richest contains an excellent anecdote about Rushkoff being in a Zoom meeting with some tech developers on 6 January 2021, which is derailed by the breaking news of an attempted coup at the Capitol building (if you think thats bad, wait till you hear how the programmers react!).

Theres this jaw-dropping factoid:

Jeff Bezos has a yacht with a helipad that serves as a companion yacht to his main yacht, which has large sails that would get in the way of his helicopter during takeoff and landing.

There are some extremely sharp reflections on artificial intelligence:

Whether AI will develop human and superhuman abilities in the next decade, century, millennium, if ever, may matter less right now than AIs grip over the tech elite, and what this obsession tells us about The Mindset.

Regarding the prospect of artificial intelligence putting millions of people out of work in the near future, entrepreneurs such as Reid Hoffmann (LinkedIn CEO) and Mark Cuban (startup dude, billionaire) are worried that unemployed humans might coalesce into vengeful, billionaire-resenting mobs and attack them. Though theyre not worried about ruining all those peoples lives in the first place.

But and this is a little ironic theres precious little biographical detail about Mark Cuban, or Reid Hoffmann, or any of the other bros in the book. Their function is purely as symbols of rapacious greed: embodiments of The Mindset. They are not examined as deeply flawed, but nonetheless complex human beings.

Read more: What do we owe future generations? And what can we do to make their world a better place?

In some ways, this is a question of method, and access. While Rushkoff mixes in some pretty wild company on his global speaking gigs, and has serendipitous encounters with some outlandish figures, hes not doing any journalistic or enthnographic legwork here.

In short: he hasnt interviewed any of tech billionaires he writes about. He doesnt really know what motivates them or at least, not all of it. When it comes to these wealthy, selfish peoples strategies to survive the event, Rushkoff is dismissive rather than curious. He is adamant that a billionaires prepper scheme any scheme just wont work.

In Chapter One, he contends that the probability of a fortified bunker actually protecting its occupants from the reality of, well, reality, is very slim, because the closed ecosystems of underground facilities are preposterously brittle. If your underground hydroponic garden is overrun by mould or bacteria, theres no do-over; youll just die.

Similarly,

small islands are utterly dependent on air and sea deliveries for basic staples [] the billionaires who reside in such locales are more, not less, dependent on complex supply chains than those of us embedded in industrial civilization.

Seasteading the libertarian idea of building autonomous, floating mini-states, which operate outside of state control is mentioned, but not discussed in any detail. And the modest proposals of Elon Musk, Richard Branson, Jeff Bezos et al. to commercialise space travel and colonise Mars are rejected with the observation only trillionaires will actually make it to space to terraform planets, anyway.

This might be true enough but its also the ostensible subject of the book, and as such, perhaps worth spending a bit more time on.

For Rushkoff, then, the billionaire bunker strategy is less a viable strategy for apocalypse than a metaphor for this disconnected way of life a canny insight, to be sure. But those bunkers arent only metaphorical; theyre also very real, and large, and expensive, and fascinating in their logistic intricacies and (im)possibilities.

If Survival of the Richest had told us more about this insane infrastructure, and about the people who dreamed it up, we might be able to better understand the unmistakably phallic spaceships as symbols, too.

Readers with specific interest in doomsday bunkers, and what they might represent in ideological terms, should seek out Bradley Garretts Bunker: Building for the End Times (2020). Mark OConnell writes insightfully about Peter Thiels New Zealand boltholes as a symptom of extreme libertarian misanthropy in Notes from an Apocalypse: A Personal Journey to the End of the World and Back (2020).

Those wishing to learn more personal details about the computer nerds and venture captial bros who hold such outsized sway in contemporary life should read Max Chafkins 2021 biography The Contrarian: Peter Thiel and Silicon Valleys Pursuit of Power, or Ashlee Vances 2015 book Elon Musk: How the Billionaire CEO of SpaceX and Tesla Is Shaping Our Future, as well as David Runciman and John Lanchesters incisive essays about Thiel and Musk respectively in the London Review of Books.

Or, what the hell, rewatch The Social Network.

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Doomsday bunkers, Mars and 'The Mindset': the tech bros trying to outsmart the end of the world - The Conversation Indonesia

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Is the body key to understanding consciousness? –

Posted: at 4:06 pm

A new understanding of the fundamental connection between mind and body explains phenomena such as phantom limbs, and has surprising implications

By Mo Costandi / The Observer

In 2018, billionaire Silicon Valley entrepreneur Sam Altman paid a startup called Nectome US$10,000 to preserve his brain after he dies and, when the technology to do so becomes available, to upload his memories and consciousness to the cloud.

This prospect, which was recently popularized in Amazon Primes sci-fi comedy series Upload, has long been entertained by transhumanists. Although theoretically possible, it is rooted in the flawed idea that the brain is separate from the body, and can function without it.

The idea that the mind and brain are separate from each other is usually attributed to the 17th-century mathematician and philosopher Rene Descartes, who believed that the body is made of matter, and the mind of some other, non-physical substance.

Modern brain research rejects the distinction between the physical and the mental. Most neuroscientists agree that what we call the mind is made of matter. The mind is hard to define, but the consensus now is that it emerges from the complex networks of cells in the brain.

But most people still view the mind and brain as being distinct from the body. In 2016, four prominent brain researchers published an article summarizing what we know about consciousness. It begins: Being conscious means that one is having an experience to see an image, hear a sound, think a thought or feel an emotion.

It is, however, becoming increasingly clear that the mind/brain and body are intimately linked, and that the body influences our thoughts and emotions. Being conscious does not just mean having awareness of the outside world. It means being aware of ones self within ones surroundings. The way we experience our body is central to how we perceive our self.

PHANTOM LIMBS

Phantom limbs are a striking demonstration of the importance of the body for self-consciousness. They were described in the mid-16th century by the barber-surgeon Ambroise Pare, who reportedly amputated several hundred limbs a day during the Italian war of 1542-46.

Verily it is a thing wondrous, strange and prodigious, he wrote. The patients who have many months after the cutting away of the leg grievously complained that they yet felt exceeding great pain of that leg cut off. At that time, however, few survived the operation, so the phenomenon was seen only rarely, and dismissed as a delusion.

Advances in medicine and military technology changed this. The invention of a bullet called the Minie ball with its greater accuracy, range and muzzle velocity, increased the number of amputations, while the introduction of anesthetics and antiseptics improved the survival rates of soldiers who went under the knife.

And so it was that the neurologist Silas Weir Mitchell, who amputated countless arms and legs on the battlefields of the American civil war, came to see that phantom limbs are the rule rather than an exception, experienced by the vast majority of amputees.

The medical community was still skeptical of the phenomenon, however, so Mitchell initially described his observations as a short story, The Case of George Dedlow, published in the Atlantic Monthly in July 1866. The fictional titular character was a composite of the hundreds of thousands of soldiers who were maimed and mutilated during the conflict. He lost all four limbs, one by one, to become a useless torso, more like some strange larval creature than anything of human shape, reduced to [a] fraction of a man.

Mitchells story was so vivid that readers took it as factual, and believed that he was a real patient being treated at Philadelphias South Street Stump hospital. Many wrote him letters of support, some tried to visit him and some even raised money for his care. But the story played a large part in bringing the phenomenon into the realms of medical science, and Mitchell went on to become the first elected president of the American Neurological Association.

Mitchell recognized phantom limbs as a disturbance of bodily self-consciousness, in which the amputee retains awareness of the missing limb, and feels as if it is still attached to their body. In some amputees, the phantom disappears within weeks or months of amputation. In others, it persists for decades.

Phantoms do not appear only in the form of missing limbs. Women may experience phantom breasts after mastectomy; men can experience phantom erections after amputation of a cancerous penis; and there are reports of phantom eyes, noses, teeth and even phantom haemorrhoids, bowel movements and gas after surgical removal of the rectum.

BODY INTEGRITY IDENTITY DISORDER

Phantom sensations occur because the brain creates a dynamic model of the body by integrating tactile and visual information with limb position signals from the muscles and tendons. This model, variously called the body schema or body image, is crucial for both the perception and control of the body. But when a limb or other body part is removed, the schema is not properly updated, and so it retains an imprint of the missing part. As a result, the individual remains conscious of the missing part often, even more so than of their existing body parts.

Most of us could imagine few things worse than having a limb amputated. But some people want nothing more.

Take Australian Robert Vickers. Before I was 10 years old I knew my left leg somehow didnt belong, Vickers told ABC Radio National in 2009, and that my body would not be as I felt it should be until I had the leg amputated precisely halfway up the thigh.

Vickers harbored this strange desire, and suffered in silence, for more than 30 years. It made him severely depressed, and he received psychotherapy. He was prescribed antidepressants, tranquillizers, and antipsychotics, and received electroconvulsive therapy, but to no avail. He tried, without success, to damage his leg in various ways, in order to force an amputation.

Then, at 41, he submerged the unwanted limb in dry ice until the pain became unbearable. His wife drove him to hospital, where he received the amputation he had wanted for so long.

I left hospital two weeks later with my desired stump, and life changed for the better from that day. In the 24 years since, I only regret not doing it sooner.

Vickers is perhaps the best documented case of body integrity identity disorder (BIID), an extremely rare condition, of which fewer than 500 other cases have been reported to date. For most of his life, Vickers believed his experience to be unique, but others suffering from the condition describe it in similar terms.

All report a fascination with amputees, and a desire to amputate, from an early age. The desire usually becomes obsessive, to the extent that they will try self-amputation. Use of dry ice appears to be the most common method, and some have used homemade guillotines or shotguns. In another well-documented case, a 79-year-old New Yorker traveled to Mexico and paid an unqualified doctor US$10,000 to amputate his leg. He died of gangrene a week later.

AMPUTATION LOVE

BIID first appeared in medical literature in a 1977 study published in the Journal of Sex Research. The authors of this study including Greg Furth, himself a wannabe amputee described the condition as a paraphilia, or an abnormal sexual behavior, in which the stump is fetishized because it resembles a phallus, and named it apotemnophilia, meaning amputation love.

Some BIID sufferers do indeed report a sexual aspect to their desire to amputate. But they invariably describe their experience in terms of self-identity. One participant in Melody Gilberts 2003 documentary Whole says that he finally became a person late in life after blowing his own leg off with a shotgun. Another participant told the film-makers that by taking the leg away, Im actually more of a person than I was before Ive corrected the body that was wrong.

Vickers has stated that he felt incomplete with his left leg, and that he only became whole after its removal.

The condition was renamed body integrity identity disorder to reflect this. BIID is a disturbance of bodily self-consciousness with a neurological basis, as are phantom limbs. There is evidence to suggest that it occurs because the affected limb is not incorporated into the body schema as it develops in early childhood. Amputation is not offered as a treatment for BIID sufferers, but it could be argued that making it available to them would minimize their risk of self-harm.

NATURE OF CONSCIOUSNESS

Research into bodily awareness is leading us to rethink the nature of consciousness. Our understanding of how the brain works will progress only when we stop observing the brain in isolation, and start thinking of it as one part of a system that includes the body and its environment.

An understanding of how brain and body interact is critical for understanding the phenomena of phantom limbs and BIID. Such interactions also play a key role in mental health conditions such as anxiety and depression, and in eating disorders such as anorexia nervosa. All of these conditions cause symptoms in the body that may be accompanied by disturbances in how the brain interprets those symptoms.

Yet the links between the brain and body are still under-appreciated. Only by taking the body into consideration will we gain a better understanding of these conditions and, it is to be hoped, develop effective treatments for them.

The new understanding of bodily self-consciousness leads us to some surprising conclusions. If bodily awareness is the basis of self-consciousness, then it follows that bumblebees, and even robots, may possess basic consciousness.

A study published in 2020 by researchers in Germany showed that bees can accurately judge gaps between obstacles relative to their wingspan, and reorient their bodies accordingly to avoid inflight collisions. Researchers at Columbia Universitys Creative Machines Lab have developed a starfish-shaped robot with an in-built body schema, which can adjust its gait after having a limb removed. The latest version of this robot creates its own body schema from experience.

If self-consciousness is based in bodily awareness, then it is unlikely that a lab-grown mini-brain could ever become conscious, as some ethicists have claimed. By the same token, transhumanists claim that we will one day gain immortality by uploading our brains to supercomputers will probably always be science fiction.

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Nvidia and the 3D Future of the Internet – TechNewsWorld

Posted: at 4:05 pm

There is a lot of work going into creating the next generation of the web. Most of it is focused on the concept that, rather than traditional web pages, well have a very different experience that is far more immersive. Lets call it Web 3D.

I had a chance to talk with Nvidias CEO Jensen Huang who shared his view of Web 3D. While it blends elements of the metaverse, its tied more to the AI implementation that will front-end the next generation of the web than it is to the emulation of reality increasingly fund on that new web.

Confused? You arent alone, let me try to untangle the concept.

Then well look at my product of the week, a very different Amazon Kindle called Scribe. It shows promise but needs a couple of tweaks to become a great product.

Interestingly, I think Microsofts Halo game series got this right to begin with because Cortana, Microsofts fictional AI universal interface, is closest to what Huang indicated was his vision of the future web.

In the game and TV series Halo, Cortana is what Master Chief interacts with to access the technology around him. Sadly, even though prototypes like the one in this YouTube video were built, Microsoft hasnt yet taken Cortana to where it could be.

Right now, Cortana lags behind both Siri, Apples digital assistant, and Google Assistant.

Huang envisions that an AI front end will become reality with the next generation of the web. Youll be able to design your AI interface or likely license an already created image and personality from different providers as they step up to this opportunity.

For instance, if you wanted the AI to look like your perfect boyfriend or girlfriend, you could initially describe what you want to an interface and the AI would design one based on what you trained that AI to look for.

Alternatively and this isnt mutually exclusive it could design it based on your known interests, pulling from the cookies and web posts youve made during your life. Or you could choose a character from a movie or an actor, which would come with a recurring charge, that would, in character, become that personal interface.

Imagine having Black Widow or Thor as your personal guide to the world of information. Theyd behave just as they do in the Avenger movies while getting you to the information youre looking for. Rather than seeing a web page, youd see your chosen digital assistant which would magically bring up metaverse elements to address your questions.

Search as we know it would change as well.

For instance, when looking for a new car, you might go to different manufacturers web sites and explore the options. But in the future, you might instead say what car should I now buy? and, based on what the AI knows about you, or how you answer questions about your lifestyle, it would then provide its recommendation and pull you into a metaverse experience where you virtually test drive the car that is based on the options the AI thinks youll want.

During this virtual drive, it will add other options that you might like, and youll be able to convey your interest, or lack thereof, to come to a final choice. Finally, it will recommend where you should buy your car, faving whatever outlook optimized to whether you valued things like low price or good service more. These options would include both new and used offerings depending again on what the AI knows about your preferences.

Time and effort spent on the project would be massively reduced while your satisfaction, assuming the information the AI has on you is accurate, is maximized. Over time, this Web 3D interface would become more of a companion and trusted friend than anything youve seen on the web so far.

Once it reaches critical mass, care will need to be taken to assure it isnt compromised to favor the interests of a political party, vendor, or bad actor.

This last is important. It may turn out that instead of being free like browsers are today, the interface ends up being a paid service to make sure no other entity can take advantage of your trust, because there is a substantial opportunity to use this new interface against you. Assuring that wont happen should be getting more focus than it is currently.

According to Huang, the future of this front end call it the next generation browser is an increasingly photorealistic avatar that is based on your personal preferences and interests; one that can behave in character when needed; and one that will provide more focused choices and a far more personalized web experience.

Perhaps we should be talking less about the next generation of the web in terms of its visual aspects, the 3D part, and more about its behavioral aspects, the Transhumanist Web. Something to noodle on this week.

Ive been using Kindles since they were first released. Mine had both a keyboard and a free cellular connection.

Theyve proven to be interesting products when traveling, have days-long battery life, and perform better in the sun than LCD-based tablets or smartphones. Some are water resistant, allowing you to use them during water recreation activities. For instance, when I float on the river near my home, Ill bring my water-resistant Kindle with me so that I can read during the boring parts (for me, the entire float is the boring part).

But they have always been limited to being able to read books and certain digital files (you could email .pdf files to Amazon to put on your Kindle). That just changed with the new Kindle Scribe. Its similar in size to the 10-inch Amazon Fire tablet and allows you to mark up the documents and books you are reading.

While the Kindle Scribe is still a reading-focused product, this latest version has optional pens that can be used to draw or annotate things you are reviewing and it will, as most similar products do, allow you to draw pictures if that is your interest.

Kindle Scribe (Image Credit: Amazon)

As with all Kindles, it leads with the e-paper display that works well in the sun, and the large size means that you can better adjust the font to address sight problems, potentially removing the need for reading glasses for folks who have only slight vision loss.

Shortcomings that limit the product are that it currently doesnt support magazine or newspaper subscriptions, it doesnt play music (probably better left to your smartphone anyway), and, as noted, the refresh rate on the technology is too low for video. It doesnt currently do email either.

It has a web browser, but that browser doesnt display web pages as intended. Instead, it lists the stories vertically like a small-screened smartphone might. In fact, using it, you get a lot of page load problems. For instance, I was not able to bring up Office 365 or Outlook web sites.

Finally, it doesnt support handwriting conversion to text, making it less useful for note taking than products that have this functionality, but I expect this will improve as the product matures.

The person that will most appreciate this product is someone who wants a bigger reader and occasionally needs to markup documents as part of an editing or review process. If you want a more capable tablet, the Amazon Fire tablet remains one of the best values in the market, but it wont work as well outside, nor does it have battery life anywhere near what the Kindle Scribe provides.

For the right person, the Kindle Scribe could be a godsend. But for most, the Amazon Fire tablet is likely the better overall choice. In any case, the new Kindle Scribe tablet is my product of the week. At $339, its a good value that I expect will get better over time.

Kindle Scribe will be released Nov. 30. You can pre-order it now at Amazon.

The opinions expressed in this article are those of the author and do not necessarily reflect the views of ECT News Network.

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Lineage to Present at Alliance for Regenerative Medicine 2022 Cell & Gene Meeting on the Mesa – businesswire.com

Posted: at 4:03 pm

CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Brian M. Culley, Lineages Chief Executive Officer, will present at the Alliance for Regenerative Medicine 2022 Cell & Gene Meeting on the Mesa, on October 12th, 2022 at 2:15pm PT / 5:15pm ET at the Park Hyatt Aviara, Carlsbad, CA. Virtual meeting attendance is available and includes a livestream of Lineages presentation and the ability to view all conference sessions on-demand. Interested parties can visit the 2022 Cell & Gene Meeting on the Mesa website for full information on the conference, including registration.

The Cell & Gene Meeting on the Mesa is the sectors foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies. The program features expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and dedicated presentations by the leading publicly traded and privately held companies in the space. This conference enables key partnerships through more than 3,000 one-on-one meetings while highlighting the significant clinical and commercial progress in the field.

About the Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-engineered therapies. In its 13-year history, ARM has become the global voice of the sector, representing the interests of 450+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include five allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineages VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit http://www.lineagecell.com or follow the company on Twitter @LineageCell.

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The Next Crispr Gene Editing IPO Could Be Near – Henry Herald

Posted: at 4:03 pm

Country

United States of AmericaUS Virgin IslandsUnited States Minor Outlying IslandsCanadaMexico, United Mexican StatesBahamas, Commonwealth of theCuba, Republic ofDominican RepublicHaiti, Republic ofJamaicaAfghanistanAlbania, People's Socialist Republic ofAlgeria, People's Democratic Republic ofAmerican SamoaAndorra, Principality ofAngola, Republic ofAnguillaAntarctica (the territory South of 60 deg S)Antigua and BarbudaArgentina, Argentine RepublicArmeniaArubaAustralia, Commonwealth ofAustria, Republic ofAzerbaijan, Republic ofBahrain, Kingdom ofBangladesh, People's Republic ofBarbadosBelarusBelgium, Kingdom ofBelizeBenin, People's Republic ofBermudaBhutan, Kingdom ofBolivia, Republic ofBosnia and HerzegovinaBotswana, Republic ofBouvet Island (Bouvetoya)Brazil, Federative Republic ofBritish Indian Ocean Territory (Chagos Archipelago)British Virgin IslandsBrunei DarussalamBulgaria, People's Republic ofBurkina FasoBurundi, Republic ofCambodia, Kingdom ofCameroon, United Republic ofCape Verde, Republic ofCayman IslandsCentral African RepublicChad, Republic ofChile, Republic ofChina, People's Republic ofChristmas IslandCocos (Keeling) IslandsColombia, Republic ofComoros, Union of theCongo, Democratic Republic ofCongo, People's Republic ofCook IslandsCosta Rica, Republic ofCote D'Ivoire, Ivory Coast, Republic of theCyprus, Republic ofCzech RepublicDenmark, Kingdom ofDjibouti, Republic ofDominica, Commonwealth ofEcuador, Republic ofEgypt, Arab Republic ofEl Salvador, Republic ofEquatorial Guinea, Republic ofEritreaEstoniaEthiopiaFaeroe IslandsFalkland Islands (Malvinas)Fiji, Republic of the Fiji IslandsFinland, Republic ofFrance, French RepublicFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabon, Gabonese RepublicGambia, Republic of theGeorgiaGermanyGhana, Republic ofGibraltarGreece, Hellenic RepublicGreenlandGrenadaGuadaloupeGuamGuatemala, Republic ofGuinea, RevolutionaryPeople's Rep'c ofGuinea-Bissau, Republic ofGuyana, Republic ofHeard and McDonald IslandsHoly See (Vatican City State)Honduras, Republic ofHong Kong, Special Administrative Region of ChinaHrvatska (Croatia)Hungary, Hungarian People's RepublicIceland, Republic ofIndia, Republic ofIndonesia, Republic ofIran, Islamic Republic ofIraq, Republic ofIrelandIsrael, State ofItaly, Italian RepublicJapanJordan, Hashemite Kingdom ofKazakhstan, Republic ofKenya, Republic ofKiribati, Republic ofKorea, Democratic People's Republic ofKorea, Republic ofKuwait, State ofKyrgyz RepublicLao People's Democratic RepublicLatviaLebanon, Lebanese RepublicLesotho, Kingdom ofLiberia, Republic ofLibyan Arab JamahiriyaLiechtenstein, Principality ofLithuaniaLuxembourg, Grand Duchy ofMacao, Special Administrative Region of ChinaMacedonia, the former Yugoslav Republic ofMadagascar, Republic ofMalawi, Republic ofMalaysiaMaldives, Republic ofMali, Republic ofMalta, Republic ofMarshall IslandsMartiniqueMauritania, Islamic Republic ofMauritiusMayotteMicronesia, Federated States ofMoldova, Republic ofMonaco, Principality ofMongolia, Mongolian People's RepublicMontserratMorocco, Kingdom ofMozambique, People's Republic ofMyanmarNamibiaNauru, Republic ofNepal, Kingdom ofNetherlands AntillesNetherlands, Kingdom of theNew CaledoniaNew ZealandNicaragua, Republic ofNiger, Republic of theNigeria, Federal Republic ofNiue, Republic ofNorfolk IslandNorthern Mariana IslandsNorway, Kingdom ofOman, Sultanate ofPakistan, Islamic Republic ofPalauPalestinian Territory, OccupiedPanama, Republic ofPapua New GuineaParaguay, Republic ofPeru, Republic ofPhilippines, Republic of thePitcairn IslandPoland, Polish People's RepublicPortugal, Portuguese RepublicPuerto RicoQatar, State ofReunionRomania, Socialist Republic ofRussian FederationRwanda, Rwandese RepublicSamoa, Independent State ofSan Marino, Republic ofSao Tome and Principe, Democratic Republic ofSaudi Arabia, Kingdom ofSenegal, Republic ofSerbia and MontenegroSeychelles, Republic ofSierra Leone, Republic ofSingapore, Republic ofSlovakia (Slovak Republic)SloveniaSolomon IslandsSomalia, Somali RepublicSouth Africa, Republic ofSouth Georgia and the South Sandwich IslandsSpain, Spanish StateSri Lanka, Democratic Socialist Republic ofSt. HelenaSt. Kitts and NevisSt. LuciaSt. Pierre and MiquelonSt. Vincent and the GrenadinesSudan, Democratic Republic of theSuriname, Republic ofSvalbard & Jan Mayen IslandsSwaziland, Kingdom ofSweden, Kingdom ofSwitzerland, Swiss ConfederationSyrian Arab RepublicTaiwan, Province of ChinaTajikistanTanzania, United Republic ofThailand, Kingdom ofTimor-Leste, Democratic Republic ofTogo, Togolese RepublicTokelau (Tokelau Islands)Tonga, Kingdom ofTrinidad and Tobago, Republic ofTunisia, Republic ofTurkey, Republic ofTurkmenistanTurks and Caicos IslandsTuvaluUganda, Republic ofUkraineUnited Arab EmiratesUnited Kingdom of Great Britain & N. IrelandUruguay, Eastern Republic ofUzbekistanVanuatuVenezuela, Bolivarian Republic ofViet Nam, Socialist Republic ofWallis and Futuna IslandsWestern SaharaYemenZambia, Republic ofZimbabwe

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10-year CRISPR anniversary: How gene editing revolutionized medicine, and what lies ahead – Genetic Literacy Project

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Ten years ago, a little-known Science paper authoredby Jennifer Doudna, Ph.D., and Emmanuelle Charpentier, Ph.D., proposedusing CRISPR/Cas9 for gene editing. As the first wave of gene-editing-based therapies post clinical data and head to the FDA, biopharma executives at the forefront of the burgeoning field highlighted the innovations and challenges before gene editing is ready for prime time.

Follow the latest news and policy debates on agricultural biotech and biomedicine? Subscribe to our newsletter.

Now, some of the early efforts of turningCRISPRgene editingtechnologyinto viable therapies are coming to fruition. Vertex and partner CRISPR Therapeutics justannouncedtheir plan to file their CRISPR/Cas9-edited cell therapy exagamglogene autotemcel (exa-cel) for a rolling review at the FDA in sickle cell disease and beta thalassemia starting in November. If approved, exa-cel could be the first CRISPR-based therapy available.

Meanwhile, Intellia Therapeutics, after being thefirst to showthat systemic infusion of CRISPR inside the human body could treat disease, recentlyreportedmore positive early data for its in vivo gene editing candidates for transthyretin amyloidosis (ATTR) and hereditary angioedema.

For now, most gene editing projects are focused on rare diseases and some blood or cancer indications with well-established genetic drivers. Those diseases have clear clinical endpoints and risk-benefit understanding to allow for a quick drug development path.

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Blood from a baby at birth can be gene sequenced to prevent diseases – USA TODAY

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Risky at-birth surgery saves baby with rare disorder

Doctors have performed a dramatic surgery to save a baby who was born with a life-threatening rare disorder that hampered his ability to breathe. (Sept. 21) (AP Video: Emma H. Tobin)

Every baby born in the United States is pricked in the heel shortly after birth. A blood sample is then analyzed to look for one of 20 to 30 inherited diseases.

Early identification of a particular disease meanstreatment can start right away, potentially saving or extending thechild's life.

Now, doctors want to go even further: They want to look not just atblood, but atgenes.

A new effort announced Wednesday by a genetic testing company paired withresearchers at NewYork-Presbyterian/Columbia Universityaims to sequence 100,000 newborns in New York City over the next five years.

The sequencing would look for about 250 diseases that strike before age 5 and for which there are treatments or approaches that can make a difference in a child's life.

A similar effort in the United Kingdom is also examining the genes of 100,000 newborns, looking for diseases for which there is a treatment or a cure.

The programs promiseto bring treatments to babies before symptoms become obvious and at a time when something can be done to help them.

"The appetite for this is growing. The awareness of this is growing. We all see it as inevitable," said Dr. Robert Green, a medical geneticist atBrighamand Women's Hospital and Harvard Medical School, both in Boston."We are grossly underutilizing the life-saving benefits of genetics and we have to get past that."

This week,Green is hosting a conference in Boston, bringing together researchers and industry representatives from the U.S., U.K., European Union and Australia to set standards and discuss the challenges and opportunities presented byscaling upnewborn genetic sequencing.

This kind of early sequencing and treatment is possible now for the first time because of dramatic advances in diagnostics, therapies and digital data storage, as well as a reduction in the cost of sequencing, said Dr. Paul Kruszka, a clinical geneticist and chief medical officer of GeneDx at Sema4, which is leading the new program.

"We're entering the therapeutic era and leaving the diagnostic era," Kruszka said. "This potentially has the opportunity to change the way we practice medicine especially in rare disease."

Right now, families with rare diseases often search for a diagnosis for 5, 10 or even 20 years. If the child could be diagnosed at birth, he said, it would short-circuit that process and treatment could begin much earlier hopefully before the child suffers irreversible damage.

Before deciding whether every family should get access to genetic sequencing for their newborn,large studies like Sema4's are needed to justify the cost, Kruszka said.

The price of gene sequencing has dropped precipitiously, with one company, Illumina. announcing last week that its newest-generation sequencing machinescan run a complete sequence for about $200. Kruszka said Sema4 expects to still payabout $1,000 for each sequence of all 20,000 genes.

Gene sequencing at birth should be able to save money over the child's lifetime by preventing illness, Green said. The costs of sequencing are limited, he said, but the benefits will build up over the child's lifetime and may help family members, too.

Green and his team began analyzing the genetic sequences of newborns in 2013, and has found lots of useful information among the first 320 babies sequenced, he said. He now has funding to expand his sequencing researchto 1,000 newborns.

Large numbers are essential because most of the diseases being diagnosed are extremely rare.

Convincing parents to participate in a sequencing research trial "is not easy," Green said. Many are concerned about privacy and the discrimination their child might face if their genome were made public. And it can be a unpleasant for parents to consider the horrible diseases their perfect newborn might be harboring,he said.

"You've gone through all this pregancy and you're sitting there with a healthy baby (and I'm) offering you the opportunity to find out something that's devastating and terrifying," he said. "How fun is that?"

He doesn't think privacy needs to be a major parental concern. Companies can learn more useful information by tracking someone's cell phone or credit card than their genome and most common diseases are the result of many combinations of genes.

"Many people hear 'genetics' and worry somehow that that is a special kind of privacy threat," he said, adding that he doesn't think there is. "We haven't been paying attention to the medical benefits of genetic testing, particularly predictive genetic testing."

if people don't want to know, that's okay, too, Green said. "We canrespect people who don't want to know, but as also respect people who do want to know," he said. "Some families will say 'I treasure the precious ignorance.' Others will say 'If I could have known, I would have poured my heart and soul into clinical trials or spent more time with the child when she was healthy."

In a five-year review of their research, Green and his colleagues found that "terrible things didn't happen" when they sequenced newborn genomes.

Families, he said, "did not in fact have downstream distress," he said. "They did have appropriate medical follow-up and that there were amazing benefits to the babies and the families as a result of the surveillance and treatment."

The baby sequencing identified several parents who had inherited illnesses and received risk-reducing surgery, he said, as well as a baby who had a narrowed aorta that wouldn't have been detected if its genetics hadn't indicated the need for an echocardiogram.

"Even in a small sample we found much to act on," he said.

At Rady Children's Hospital in San Diego, they're trying to rapidly sequence the genomes of babies who already have problems and are being treated in one of 83 children's hospitals acrossCanada and the U.S.

Every morning, samples arrive by Fedex. In some cases, the baby is in such dire shape than an answer is needed immediately. For those children, "we've got to drop what we're doing and go,"said Dr. Stephen Kingsmore, the president and CEO of Rady's Institute for Genomic Medicine."Even a day can cost a child's life or brain function."

For babies who are stable, sequencing still happens rapidly, but a little less so."Every sample gets onto a sequencer the same day," he said.

So far, the institute, which is also collaborating on a newborn sequencing study in Greece,has been able to provide a 1,500 children with a diagnosis in the first weeks of life in addition to a life-saving treatment.

"That idea, that future is where a child never experiences a sick day, even though they have a fatal condition," the institute's former director of marketing,Graciela Sevilla,said earlier this year. "We'd love to see that on a regular basis."

Contact Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

Air pollution could be contributing to millions of premature births

Estimates in a new study say air pollution could be a factor in up to 3.4 million preterm births.Video provided by Newsy

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What doctors wish patients knew about breast-cancer prevention – American Medical Association

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Its natural for women to worry about breast cancer, especially since many people know someone who was touched by the disease. While there is no foolproof way to prevent breast cancer, there are things you can do to lower your risk. Some factors you cant change, but knowing what can help is key to lowering your risk of breast cancer.

Breast cancer is the second most common cancer among women in the U.S.some types of skin cancer are the most common. Between 1989 and 2020, breast cancer death rates decreased by 43%, but racial and ethnic inequities still exist. While breast cancer incidence is lower among Black women than white women, the death rate is 40% higher among Black women than white women, according to the American Cancer Society. That is because about one in five Black women with breast cancer have triple-negative breast cancermore than any other racial or ethnic group. Meanwhile, Asian American and Pacific Islanders have the lowest death rate from breast cancer while Native Americans and Alaska Natives have the lowest rates of developing breast cancer. And while rare, men can get breast cancer too.

The AMAsWhat Doctors Wish Patients Knew series provides physicians with a platform to share what they want patients to understand about todays health care headlines.

In this installment, Jill Jin, MD, an internist at Northwestern Medicine and clinical assistant professor of medicine at Northwestern University Feinberg School of Medicine, took time to discuss what patients need to know about what to do to reduce their risk of breast cancer. She is also a senior physician adviser for the AMA and an associate editor forJAMA.

Know the risk factors

While risk factors for breast cancer are broad, we think primarily about agearound the age of menopause and after menopause is when breast cancer risk goes up in women, said Dr. Jin. Family history, of course, is another big one. That includes genetic mutations that we know of such as BRCA1 and BRCA2.

Theres also this whole concept of estrogen exposure, which can be both endogenouswithin the body or how much your body producesversus exogenous, from medications she said. Then other things like alcohol and smoking are thought to be associated somewhat with breast cancer as well.

Start screening between 40 and 50

Overall, the recommended age to start screening for breast cancer in average-risk women would be anywhere from 40 to 50 years old, said Dr. Jin. It is important to convey to patients that most professional societies do recommend later than 40, either 45 or 50, as the age to start screening. But most physicians are still starting on the earlier end of this spectrum because it can be a tough sell for patients to say, wait until 50 years old when, to be honest, most people around them are probably getting screened earlier.

Almost everyone knows somebody these days who has had breast cancer, whether its a friend or a family member, and when you have that personal connection its scary, she added. Thats why I usually tell women who are at average riskwho dont have family history of breast cancerthat I am comfortable waiting until 45 years old to start screening.

If they do have a family history of breast cancer or other risk factors, we certainly can and should start screening earlier, Dr. Jin said. Its very individualized at the end of the day.

Different screening tests are available

There are several different screening modalities, said Dr. Jin, noting that a mammogram is the most common one. Other methods of screening include ultrasounds, as well as a breast magnetic resonance imaging.

But for most people, we start with mammograms, she said.

Earlier screening isnt always better

It always begins with getting to know the patient, asking about their history and their lifestyleits definitely an individualized risk assessment first, said Dr. Jin. And if there is nothing that suggests they are at higher risk than average, then you can have a discussion with patients about potentially waiting to start screening.

It comes down to the benefits versus the harms of screening, she added, noting the younger you start screening, the more lives you will save because you will catch more cancers at earlier stages, especially the more aggressive ones.

But on the flip side, the younger people are, the more you pick up things that are not cancer, which is called a false positive finding. Younger women have denser breast tissue, and when breast tissue is dense, it is very hard to differentiate normal tissue from something that may look like cancer, Dr. Jin explained. And then you go down this whole path of follow-up testing which includes additional mammograms and sometimes biopsy, which very often ends up being an unnecessary biopsy because everything will turn out normal.

This causes a lot of anxiety. It upends patients lives for a couple months while this whole process is going on, and that amount of anxiety affects many other parts of patients livesit is not trivial, she added. And then you do it all over again the next year. The younger you start, the more the potential harms of these false positives start to outweigh the potential benefit of earlier diagnosis.

Maintain a healthy lifestyle

For all womenreally for everyoneit is important to maintain a healthy lifestyle, said Dr. Jin. That means eating a balanced diet, not drinking too much alcohol, not smoking, maintaining regular physical activity and a normal body mass index.

All of those things are likely helpful for prevention of not just breast cancer, but other cancers as well, along with cardiovascular diseasea lot of things, she added.

There are medications to reduce risk

Chemoprevention, or the use of medications, is another option to reduce breast-cancer risk, said Dr. Jin. For chemoprevention, there are two classes of medications that are used. One is called selective estrogen receptor modulators, or SERMs.

Tamoxifen is probably the most common one that is used. SERMs medications block the effects of estrogen in the breast, she added. Another class is called aromatase inhibitors. Those are usually used in older women after menopause and stop other hormones in the body from becoming estrogen.

However, both have other side effects. While tamoxifen blocks the effects of estrogen in breast tissue, it can actually enhance estrogen effects in other parts of the body, so we do worry about blood clots as well as uterine cancer, said Dr. Jin. And then aromatase inhibitors can cause other side effects related to low estrogen such as hot flashes, bone pain, decreased bone density, and increased risk of osteoporosis and fractures.

Thats why we dont use these medications in everyone to decrease breast cancer risk, and reserve them for high-risk women only. Again, as with every decision in medicine, we want to make sure the balance of potential benefits versus harms is in favor of benefits, she said.

Surgical prevention is also an option

The other kind of prevention would be surgical prevention, said Dr. Jin. This is also done for women who are high risk, most commonly because of the BRCA gene mutation.

People who have a known BRCA gene mutation, which puts them at an increased risk for both breast and ovarian cancer, are candidates for surgery to remove the breasts. Thats called prophylactic mastectomy, she said. They also may be candidates for surgery to remove the ovaries to decrease the risk of ovarian cancer as well.

Test for the BRCA gene mutation

There are calculators that can be used to calculate whether someone, based on their family history and ethnicity, should get genetic testing for the BRCA gene mutation, which is a blood test said Dr. Jin. If you have a first-degree family membersuch as your mom or siblingwho has breast cancer and is known to have BRCA, then you should get tested for it.

If you just have a family history of breast cancer with unknown BRCA status, thats when the calculators come into play, she added, noting they look at how many first-degree and second-degree relatives, whether you are of Ashkenazi Jewish descent, and certain other risk factors to decide whether you should get the genetic testing.

Breastfeeding may reduce risk

While there are no clinical trials on this topic, there is observational data that does suggest that breastfeeding is protective against breast cancer, said Dr. Jin. The same goes for having children versus not having children; pregnancy does seem to be protective as well.

Were not saying go get pregnant and breastfeed to reduce your risk of having breast cancerits not practical, she added. But it does seem to be an association.

Birth control is OK to take

This is also somewhat controversial, but overall, the link between birth control and breast cancer is very small to none, Dr. Jin said. When I talk with my patients about this, I share that using birth control pills most likely does not increase the risk of breast cancer in a clinically significant way.

Furthermore, this very small potential increase in risk is limited to the time that youre actually taking birth-control pills, she said. So, its not a permanent effect. Its temporary.

Be cautious with self-breast exams

There has not been any good evidence to show that self-screening has any overall benefit in mortality, said Dr. Jin. Breasts are just lumpy to begin with and a lot of people end up feeling lumps that just end up being normal breast tissue.

And you may end up, again, going down that path of all the imaging and the biopsies and in the end, it is nothing, she added. So, self exams are not recommended by clinical guidelines.

However, some people are going to be wanting to do that anyways and that is fine. If someone really wants to stay on top of their body, I will explain that breasts can feel lumpy or bumpy, and what they are looking for is a change from baseline. At the end of the day, you still know your own breasts and your own body the best, said Dr. Jin. So, if you feel something that is different, that you have not felt before, then you should let me know and we can decide at that point what to do,

If they are in the office with me, I am happy to do a quick exam of the breast and tell them this is what your normal breast tissue feels like, dont be alarmed if you feel this or if you feel this. It is just normal.

Dont hesitate to talk to your doctor

While screening is recommended for between 40 and 50 years old, if at any point you do notice something like a lump or you see something weird on the skin or if you have pain or any symptoms that are different than normal, that takes you out of the typical screening category, she emphasized. As with all cancer screening, when a symptom is detected that is different, and you should never hesitate to bring that up to your doctor.

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What doctors wish patients knew about breast-cancer prevention - American Medical Association

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Growth in Cell and Gene Therapy Market – Pharmaceutical Technology Magazine

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Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

Cell and gene therapies (CGTs) offer significant advances in patient care by helping to treat or potentially cure a range of conditions that have been untouched by small molecule and biologic agents. Over the past two decades, more than 20 CGTs have been approved by FDA in the United States and many of these one-time treatments cost between US$375,00 and US$2 million a shot (1). Given the high financial outlay and patient expectations of these life-saving therapies, it is essential that manufacturers provide integrated services across the whole of the supply chain to ensure efficient biomanufacturing processes and seamless logistics to reduce barriers to uptake.

The following looks at the who, what, when, and why of biomanufacturing and logistics in CGTs in the bio/pharmaceutical industry in more detail.

According to market research, the global gene therapy market will reach US$9.0 billion by 2027 due to favorable reimbursement policies and guidelines, product approvals and fast-track designations, growing demand for chimeric antigen receptor (CAR) T cell-based gene therapies, and improvements in RNA, DNA, and oncolytic viral vectors (1).

In 2020, CGT manufacturers attracted approximately US$2.3 billion in investment funding (1). Key players in the CGT market include Amgen, Bristol-Myers Squibb Company, Dendreon, Gilead Sciences, Novartis, Organogenesis, Roche (Spark Therapeutics), Smith Nephew, and Vericel. In recent years, growth in the CGT market has fueled some high-profile mergers and acquisitions including bluebird bio/BioMarin, Celgene/Juno Therapeutics, Gilead Sciences/Kite, Novartis/AveXis and the CDMO CELLforCURE, Roche/Spark Therapeutics, and Smith & Nephew/Osiris Therapeutics.

Many bio/pharma companies are re-considering their commercialization strategies and have re-invested in R&D to standardize vector productions and purification, implement forward engineering techniques in cell therapies, and improve cryopreservation of cellular samples as well as exploring the development of off-the-shelf allogeneic cell solutions (2).

The successful development of CGTs has highlighted major bottlenecks in the manufacturing facilities, and at times, a shortage of raw materials (3). Pharma companies are now taking a close look at their internal capabilities and either investing in their own manufacturing facilities or outsourcing to contract development and manufacturing organizations (CDMOs) or contract manufacturing organizations (CMOs) to expand their manufacturing abilities (4). Recently, several CDMOsSamsung Biologics, Fujifilm Diosynth, Boehringer Ingelheim, and Lonzahave all expanded their biomanufacturing facilities to meet demand (5).

A major challenge for CGT manufacturers is the seamless delivery of advanced therapies. There is no room for error. If manufacturers cannot deliver the CGT therapy to the patient with ease, the efficacy of the product becomes obsolete. Many of these therapies are not off-the-shelf solutions and therefore require timely delivery and must be maintained at precise temperatures to remain viable. Thus, manufacturers must not only conform to regulations, but they must also put in place logistical processes and contingency plans to optimize tracking, packaging, cold storage, and transportation through the products journey. Time is of the essence, and several manufacturers have failed to meet patient demands, which have significant impacts on the applicability of these agents.

Several CAR T-cell therapies have now been approved; however, research indicates that a fifth of cancer patients who are eligible for CAR-T therapies pass away while waiting for a manufacturing slot (6). Initially, the manufacture of many of these autologous products took around a month, but certain agents can now be produced in fewer than two weeks (7). Companies are exploring new ways to reduce vein-to-vein time (collection and reinfusion) through the development of more advanced gene-transfer tools with CARs (such as transposon, CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) among others, and the use of centralized organization with standardized apheresis centers (5). Others are exploring the use of the of allogeneic stem cells including Regen Biopharma, Escape Therapeutics, Lonza, Pluristem Therapeutics, and ViaCord (7).

Several gene therapies have also been approved, mainly in the treatment of rare disease (8). Many companies are evaluating novel gene therapy vectors to increase levels of gene expression/protein productions, reduce immunogenicity and improve durability including Astellas Gene Therapies, Bayer, ArrowHead Pharmaceuticals, Bayer, Bluebird Bio, Intellia Therapeutics, Kystal Biotech, MeiraGTx, Regenxbio, Roche, Rocket Pharmaceuticals, Sangamo Therapeutics, Vertex Pharmaceuticals, Verve Therapeutics, and Voyager Therapeutics (8).

While many biopharma companies have established their own in-house CGT good manufacturing practice (GMP) operation capabilities, others are looking to decentralize manufacturing and improve distribution by relying on external contracts with CDMOs and CMOs such as CELLforCURE, CCRM, Cell Therapies Pty Ltd (CTPL), Cellular Therapeutics Ltd (CTL), Eufets GmbH, Gravitas Biomanufacturing, Hitachi Chemical Advances Therapeutic Solutions, Lonza, MasTHerCell, MEDINET Co., Takara Bio, and XuXi PharmaTech (6, 9, 10).

The top 50 gene therapy start-up companies have attracted more than $11.6 billion in funds in recent years, with the top 10 companies generating US$5.3 billion in series A to D funding rounds (10). US-based Sana Biotechnology leads the field garnering US$700 million to develop scalable manufacturing for genetically engineered cells and its pipeline program, which include CAR-T cell-based therapies in oncology and CNS (Central Nervous System) disorders (11). In second place, Editas Medicine attracted $656.6 million to develop CRISPR nuclease gene editing technologies to develop gene therapies for rare disorders (12).

Overall, CGTs have attracted the pharma industrys attention as they provide an alternative route to target diseases that are poorly served by pharmaceutical and/or medical interventions, such as rare and orphan diseases. Private investors continue to pour money into this sector because a single shot has the potential to bring long-lasting clinical benefits to patients (13). In addition, regulators have approved several products and put in place fast track designation to speed up patient access to these life-saving medicines. Furthermore, healthcare providers have established reimbursement policies and manufacturers have negotiated value- and outcome-based contracts to reduce barriers to access to these premium priced products

On the downside, the manufacture of CGTs is labor intensive and expensive with manufacturing accounting for approximately 25% of operating expenses, plus there is still significant variation in the amount of product produced. On the medical side, many patients may not be suitable candidates for CGTs or not produce durable response due to pre-exposure to the viral vector, poor gene expression, and/or the development of immunogenicity due to pre-exposure to viral vectors. Those that can receive these therapies may suffer infusion site reactions, and unique adverse events such as cytokine release syndrome and neurological problems both of which can be fatal if not treated promptly (14).

Despite the considerable advances that have been made in the CGT field to date, there is still much work needed to enhance the durability of responses, increase biomanufacturing efficiencies and consistency and to implement a seamless supply chain that can ensure these agents are accessible, cost-effective, and a sustainable option to those in need.

Cleo Bern Hartley is a pharma consultant, former pharma analyst, and research scientist.

Pharmaceutical TechnologyVolume 46, Number 10October 2022Pages: 54-55

When referring to this article, please cite it as C.B. Hartley, "Growth in Cell and Gene Therapy Market," Pharmaceutical Technology 46 (10) 5455 (2022).

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Growth in Cell and Gene Therapy Market - Pharmaceutical Technology Magazine

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Tip Sheet: $78 million to support new precision oncology institute, update on experimental gene therapy for herpes and the launch of Fred Hutch’s new…

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SEATTLE Oct. 4, 2022 Below are summaries of recent Fred Hutchinson Cancer Center research findings and other news.

Join us for our next virtual science event focused on precision oncology. The discussion will be 10 a.m. - 11 p.m. PT on Wednesday, Oct. 12 and will feature Drs. Thomas Lynch Jr., Christina Baik, Sujata Jana, Jeff Leek and Colin Pritchard. Please RSVP HERE by Monday, Oct. 10.

And if youre looking for sources for Octobers Breast Cancer Awareness Month, please see our breast cancer page for a list of projects, experts and the latest breast cancer news.

Fred Hutch organizational news

Fred Hutch begins rollout of new brandFred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance formally merged in April 2022 to officially become Fred Hutchinson Cancer Center. In October the organizations new brand was officially launched, with updates to websites, social media channels and banners as well as updated signs around the South Lake Union campus. Patients and providers will see temporary signage and other updates at Fred Hutch clinical care sites around the Seattle region in the coming months.Media contact: Kat Wynn, kwynn@fredhutch.org

Precision oncology

Transformative $78M gift to establish new precision oncology instituteStuart and Molly Sloan have pledged $78 million to support Fred Hutch. The gift will further advance Fred Hutchs work in precision oncology, which integrates fundamental biology, technology, immunology, data science and clinical experience into strategies to prevent, detect and treat cancer.Media contact: Kat Wynn, kwynn@fredhutch.org

Infectious disease

Researchers refine experimental gene therapy for herpesTwo years after scientists showed that an experimental gene therapy for herpes which affects billions of people around the world can knock out most latent infection in mice, new tests reveal that it also suppresses the amount of transmissible virus shed by the treated animals. In a paper posted on bioRxiv, Fred Hutch virologists Drs. Keith Jerome and Martine Aubert report the treatment dramatically reduced or even eliminated viral shedding in treated mice compared to controls.Media contact: Molly McElroy, mwmcelro@fredhutch.org

Health equity

Spokane Regional Health District: Gaps in cancer care experienced in SpokaneFor their podcast Cancer Health Equity Now, members of Fred Hutchs Office of Community Outreach and Engagement in Spokane spoke with Spokane Regional Health District Health Officer Dr. Frank Velazquez. They discussed gaps in access to cancer care in Spokane, collaboration efforts by local organizations, and the feasibility of a sustainable Mobile Mammogram Program locally.Media contact: Kat Wynn, kwynn@fredhutch.org

On Twitter

Follow Dr. Aakansha Singhvi (@SinghviLabGlia) as the Singhvi lab works towards understanding how glia-neurons interact with the nervous system and the key role worms play.

Virus evolution expert Dr. Jesse Bloom (@jbloom_lab) recently shared a study on the evolution of antibody immunity following Omicron BA. He said, Although response to Omicron dominated by preexisting B-cells, antibodies from these cells better at 6 months than 1 month.

Science spotlightScience Spotlight is a monthly installment of articles written by postdoctoral fellows at Fred Hutch that summarize new research papers from Hutch scientists. If youre interested in learning more or covering these topics, contact: media@fredhutch.org

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Fred Hutchinson Cancer Center unites comprehensive care and advanced research to provide the latest cancer treatment options and accelerate discoveries that prevent, treat and defeat cancer and infectious diseases worldwide.

Based in Seattle, Fred Hutch is an independent, nonprofit organization and the only National Cancer Institute-designated cancer center in Washington. We have earned a global reputation for our track record of discoveries in cancer, infectious disease and basic research, including important advances in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services and has network affiliations with hospitals in four states. Fred Hutch also serves as UW Medicines cancer program.

Please note that our organization was renamed Fred Hutchinson Cancer Center in April 2022, following the merger of long-time partners, Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance.

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Tip Sheet: $78 million to support new precision oncology institute, update on experimental gene therapy for herpes and the launch of Fred Hutch's new...

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Category Archives: Transhuman News

Doomsday bunkers, Mars and ‘The Mindset’: the tech bros trying to outsmart the end of the world – The Conversation Indonesia

Is the body key to understanding consciousness? –

Nvidia and the 3D Future of the Internet – TechNewsWorld

Lineage to Present at Alliance for Regenerative Medicine 2022 Cell & Gene Meeting on the Mesa – businesswire.com

The Next Crispr Gene Editing IPO Could Be Near – Henry Herald

10-year CRISPR anniversary: How gene editing revolutionized medicine, and what lies ahead – Genetic Literacy Project

Blood from a baby at birth can be gene sequenced to prevent diseases – USA TODAY

What doctors wish patients knew about breast-cancer prevention – American Medical Association

Growth in Cell and Gene Therapy Market – Pharmaceutical Technology Magazine

Tip Sheet: $78 million to support new precision oncology institute, update on experimental gene therapy for herpes and the launch of Fred Hutch’s new…

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