Google has diversity problems

Kim Kulish/Corbis via Getty

By Lara Williams

Sexism in the tech sector has been a long-standing problem. The latest manifestation of an industry in which machismo reigns and women are grossly underrepresented came as an internal memo written by James Damore an engineer employed by Google (Google has since fired Damore).

The essay, which has been described as an anti-diversity manifesto, is titled Googles Ideological Echo Chamber. It comprises 10 pages of bad science and biological determinism.

Damore outlines research that he says supports his view that women are intrinsically different to men, broadly less likely (and capable) of working in the same careers and industries. Women, on average, have more: he begins, before listing various attributes as innate to women: openness, interest in people over things, preference for social and artistic work, neuroticism and anxiety, extraversion expressed as gregariousness and a harder time negotiating salaries.

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Philosophically, he reasons, I dont think we should do arbitrary social engineering of tech just to make it appealing to equal portions of both men and women.

Some of the science Damore uses to prop up his argument, as Angela Saini points out in The Guardian, is valid; but only insofar as there is a school of neuroscientific thought venturing theories of anatomical differences in men and womens brains. Equally, there is a school of thought dismissing this idea. There are published scientific papers out there to support every possible opinion, Saini states. Science is a slow process, not a growing string of truths.

One truth though is that biological determinism has a history of being trotted out to justify sexism and it is problematic for a number of reasons. Damores manifesto portrays women as a product of inherited traits; understanding womanhood as an expressly anatomical concept without social and cultural influence. He needs to heed French intellectual and feminist Simone de Beauvoirs famous line, one is not born, but rather becomes, a woman.

Feminist identity politics are, broadly speaking, concerned with the ways female identity and prescriptive modes of femininity are shaped and constructed. Damores assertions presume gender identity happens in a cultural vacuum.

We ask why we dont see women in top leadership positions, but we never ask why we see so many men in these jobs, Damore states. These positions often require long, stressful hours that may not be worth it if you want a balanced and fulfilling life.

But we absolutely do ask. Men do not have biological predisposition towards stressful hours any more than women do; likewise, a balanced and fulfilling life comes with different expectations if it is likely you are the half of a partnership required to pick up the majority of the domestic labour and child-rearing duties. The structural differences that create inequality are more nuanced than genitals and genetics.

Damore outlines Googles diversity strategies, such as mentoring and classes for marginalised candidates, as harmful, stating they actually increase race and gender tensions. Such strategies increase tensions only for those with a sense of privilege and entitlement, threatened by the usurping of a status quo they benefit from.

What he does not address is the widely discussed prevalence of an aggressively masculine bro-culture, making those long office hours even less palatable for women. A 2016 survey found that 60 per cent of female employees in tech roles reported unwanted sexual advances and 87 per cent reported demeaning comments from male colleagues.

Damore will no doubt, however, be heartened to know Google presently has a 69 per cent male employee majority and so the damaging culture of gender parity he evidently fears is still a long way off. Phew.

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Memo to all tech bros: Sexism, not biology, holds women back - New Scientist

Recommendation and review posted by Bethany Smith

Says Debra Soh, a scientist who specializes in sexual neuroscience. Excerpts:

Despite how its been portrayed, the memo was fair and factually accurate. Scientific studies have confirmed sex differences in the brain that lead to differences in our interests and behaviour.

As mentioned in the memo, gendered interests are predicted by exposure to prenatal testosterone higher levels are associated with a preference for mechanically interesting things and occupations in adulthood. Lower levels are associated with a preference for people-oriented activities and occupations. This is why STEM (science, technology, engineering and mathematics) fields tend to bedominatedby men.

We see evidence for this in girls with a genetic condition called congenital adrenal hyperplasia, who are exposed to unusually high levels of testosterone in the womb. When they are born, these girls prefer male-typical, wheeled toys, such as trucks, even if their parents offer morepositive feedbackwhen they play with female-typical toys, such as dolls. Similarly, men who are interested in female-typical activities were likely exposed to lower levels of testosterone.

As well, newresearchfrom the field of genetics shows that testosterone alters the programming of neural stem cells, leading to sex differences in the brain even before its finished developing in utero. This further suggests that our interests are influenced strongly by biology, as opposed to being learned or socially constructed.

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As the memo suggests, seeking to fulfill a 50-per-cent quota of women in STEM is unrealistic. As gender equity continues to improve in developing societies, we should expect to see this gender gap widen.

This trend continues into the area of personality, as well. Contrary to what detractors would have you believe, women are, on average, higher in neuroticism and agreeableness, and lower instress tolerance.

Some intentionally deny the science because they are afraid it will be used to justify keeping women out of STEM. But sexism isnt the result of knowing facts; its the result of what people choose to do with them.

This is exactly what the mob of outrage should be mobilizing for, instead of denying biological reality and being content to spend a weekend doxxing a man so that he would lose his job. At this point, as foreshadowed in Mr. Damores manifesto, we should be more concerned about viewpoint diversity than diversity revolving around gender.

Read the whole thing.Gender non-essentialists are the young earth creationists of the Left.

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Damore Has Science On His Side - The American Conservative

Recommendation and review posted by simmons

A Google employee recently published an anti-diversity manifesto on an internal discussion board that has gone viral and stirred furious debate both inside and outside the company.

In the essay, James Damore claimed that differences in the number of women and men in tech companies such as Google can be largely explained by biological differences, rather than sexism. As a result, some diversity efforts aimed at increasing the representation of women and other minorities are discriminatory against men, he argued. (After the memo went public, Google fired Damore for perpetuating gender stereotypes, Reuters reported.)

But what does science have to say about the biological differences between men and women, and how do they affect the gender gap in tech?

"It would be foolish to say there are no biological differences between men and women," said Margaret McCarthy, a neuroscientist at the University of Maryland who studies gender differences in the brain. "Sex is the most potent of all biological variables." [Men vs. Women: Our Key Physical Differences Explained]

However, pinning the lack of women in tech to biological differences is on much shakier ground, when socialization or sexism are much likelier explanations, several experts told Live Science.

In Damore's manifesto, he claimed that, compared with men, women on average are more attracted to aesthetics than to ideas, more empathizing than systematic and more extroverted than introverted, but less assertive and less competitive. As a result, he said, women may have more difficulty negotiating higher salaries, speaking up or asking for raises.

He also claimed that women exhibited higher neuroticism, which is manifested in lower stress tolerance and higher anxiety, and that women are less willing to work the long hours necessary to achieve high-paying, high-status jobs. In another section of the manifesto, he said people on the ideological left deny biological differences when they are tied to IQ and sex differences.

It turns out, there are extensive neuroanatomical differences between men's brains and women's brains on average, said Larry Cahill, a neurobiologist at the University of California, Irvine. This shouldn't be surprising; after all, humans are mammals, and mammals exhibit extensive sex-based differences in brain chemistry, anatomy, genetics and function, Cahill told Live Science.

McCarthy agreed.

"We are biologically different," McCarthy told Live Science. "It would be crazy to say that difference in biology doesn't to some degree extend to our brains. To think that we have somehow escaped millions of years of evolution because we're modern humans, I think, is just folly."

For instance, women on average have more gray matter, the computational workhorse of the brain, while men have more white matter, which connects brain cells in different regions of the gray matter. Men and women also have different connective networks between brain cells, on average, according to a 2013 study in the journal Proceedings of the National Academy of Sciences. What's more, men's brains tend to be larger than women's. And sex hormones such as testosterone and estrogen, which vary dramatically between men and women, also bind differently to receptors in the brain. [10 Surprising Facts About a Man's Brain]

However, these average differences do not make it possible to type individual brains: A 2015 study in the same journal found it was impossible to categorize most brains as stereotypically male or female based on gray matter in several brain regions.

"Gender differences, small or large, do not 'add up' to create two types of people," said Daphna Joel, a neuroscientist at Tel Aviv University in Israel who was one of the authors of the 2015 study. "Rather, each person has a unique mosaic of feminine (that is, more common in women than in men) and masculine (that is, more common in men than in women) psychological characteristics."

Once scientists make the leap from brain anatomy to function, the connection gets even shakier. For instance, bird brains are smaller than mammalian brains, and they're wired very differently. Yet many birds can tackle brainy feats that stymie the smartest nonhuman mammals. Clearly, brain anatomy does not reveal the whole story, McCarthy said. [Are Big Brains Smarter?]

What's more, many differences in the structure of men's brains versus women's brains may actually counteract gender differences in behavior,a 2004 study in the journal Endocrinologyfound. For instance,women inherit two X chromosomes,while men inherit an X and a Y. But in women's brains,one of the X chromosomes is almost completely silenced to keep them from getting a double dose of gene expression,meaning that men's and women's brains express roughly the same number of X chromosome genes even though, genetically, they have this chromosome difference.

Still, there's no reason to discount the possibility that anatomical or biological differences translate to behavioral differences, Cahill told Live Science.

"Is it inherently plausible that biologically based sex-related influences affect all aspects of human behavior, including careers people choose?" Cahill asked. "The answer is yes."

Still, many of the average differences between men and women that were described in the manifesto are either small or near zero, according to a 2005 study in the journal American Psychologist. Some, if not all, of the average differences could be due to socialization rather than biology, several experts said.

For instance, across cultures, men tend to be better at rotating objects in their mind than women are. However, in India, tribal women in matrilineal societies who hold the purse strings perform better at this task than women in nearby, genetically similar tribes, which are patrilineal. Education also dramatically shrinks this gap in spatial abilities, the researchers found.

In the United States, men outperform women on the math SAT, while in Japan, men and women perform equally well on the math portion of this standardized test and outperform both their male and female American counterparts, McCarthy said. Meanwhile, in some Nordic countries, women outperform men on the math portion of the SAT.

Similar disparities in science versus reading abilities exist across countries, said Bernd Frick, a professor of organizational economics at Paderborn University in Germany. [6 Myths About Girls and Science]

"Girls are told that reading abilities are important. Boys are told that sciences are important, and you see that reflected in standardized tests with young kids ages 8 to 9 or 10 to 12," Frick told Live Science.

However, more patriarchal societies show a much larger gap in these test scores, while egalitarian cultures show only a tiny gap, he added. That suggests that culture, rather than brain differences, explains most of the gap, he added.

As for women's versus men's average intelligence (IQ), there is no average difference.

"That has been shown over and over and over with millions and millions of data points," McCarthy said.

Women do tend to exhibit higher rates of diagnosis with certain types of neuropsychiatric diseases, such as major depressive disorder, anxiety and obsessive compulsive disorder, McCarthy said. However, the difference in the gender ratio for anxiety is quite small compared with differences for other diseases such as anorexia nervosa or autism. Men are also less likely to seek out diagnoses and more likely to self-medicate with alcohol and drugs, meaning at least some of the gender difference in the rates of depression or anxiety could be due to underdiagnosis in men, not a differential response to stress, she added. [7 Ways Depression Differs in Men and Women]

"Is the gender difference in the level of stress you're manifesting, or is it that you're willing to admit you're feeling that stress and anxiety?" McCarthy asked. "These are very complex questions [that] we don't know the answer for."

Also, gender differences may wax or wane through the life span, making it difficult to tease out the effects of socialization versus biology. For instance, young girls tend to start out being much more aggressive and assertive but become less so by the adolescent years.

"Is it because they are punished for getting out of their 'gender lane,' or is it because they go through puberty?" McCarthy said. Right now, there's no way to know, she said.

Other work has shown that women are less competitive than men on average. However, a 2011 study of ultramarathoners, published in the Journal of Sports Economics, showed that as societies become more egalitarian and the prize money women compete for approaches the pots for men, the competitiveness gap disappears.

"So it's a matter of culture," Frick said.

The manifesto goes way out on a limb, however, when it aims to explain the gender gap in tech to biology when other factors such as sexism or outmoded family structures clearly play a role, McCarthy said.

For instance, several studies have shown that a powerful way to attract more women to leadership positions is to have more women in leadership roles, McCarthy said. So the dearth of senior women in tech could lead to a vicious cycle of under-representation, she added.

What's more, women do not inherently want to work fewer hours. Rather, many are expected to shoulder a second shift of childcare and chores when they get home, McCarthy said.

"They have two jobs," McCarthy said.

And sexism in the tech world isn't benign either, Cahill said.

"I always hear about a bro cultulre [in tech]," Cahill said. "It's probably the case that the average woman will chafe more at the average bro culture than the average man."

What's more, no studies have shown that the skills and personality traits needed for tech jobs are uniquely male. For instance, no studies suggest that being agreeable, empathetic or extroverted (the traits Damore ascribed to women) are liabilities for those in the tech field, McCarthy said.

"If Google needed only people with only extremely masculine characteristics, then there would be more suitable male candidates than female candidates," Joel said. "But even in the relatively narrow field of tech, there are many different combinations of characteristics (some more common in women and some more common in men) that fit, so sex differences in the prevalence of these mosaics is unlikely to explain the gender gap in tech."

Originally published on Live Science.

Read more from the original source:
Google Manifesto: Does Biology Explain Gender Disparities in Tech? - Live Science

Recommendation and review posted by sam

CAMBRIDGE, Ontario--(BUSINESS WIRE)--BWX Technologies, Inc. (NYSE:BWXT) announced today that its subsidiary BWXT Canada Ltd. (BWXT Canada) has been awarded a CA$48 million amendment to its existing steam generator purchase agreement from Bruce Power. The amendment reflects the addition of steam drums to Bruce Powers steam generator agreement with BWXT Canada previously announced July 2016.

The steam drums and associated steam separation internals will be designed and fabricated in BWXTs Cambridge, Ontario facility as part of eight steam generators that will be supplied to Bruce Powers Bruce B Unit 6 reactor. The supply of steam generators is part of Bruce Powers Life-Extension Program that will extend the life of six of its reactors.

BWXT values its contributions to Bruce Powers Life Extension Program, which is critical to ensuring the supply of low-cost, clean and reliable energy for Ontario, said John MacQuarrie, President of BWXT Canada. As a major supplier of nuclear products and services, BWXT is committed to ensuring its customers are successful in completing their projects on-time and on-budget.

BWXT has been a proud supplier of products and services to the Bruce Nuclear Generating Station since it went online in 1977.In December 2015, Bruce Power and the Independent Electricity System Operator (IESO) announced an amended long-term agreement that will see Units 3 through 8 refurbished over the next two decades to extend the life of the site to 2064 and secure 6,400 megawatts to fulfill commitments to Ontarios Long-Term Energy Plan (LTEP).

The addition of steam drums integrally manufactured with the steam generators will add to the efficiency of our Steam Generator Replacements that are part of our life extension outage in Unit 6 in 2020 and will be crucial in helping us to safely and reliably operate the site through to 2064, said Mike Rencheck, Bruce Powers president and CEO. Partnerships such as this one with BWXT will help us to continue to deliver innovations that keep our life extension project on time and on budget, benefitting the people of Ontario.

This agreement also supports BWXT as a major employer providing highly skilled jobs within the Kitchener-Waterloo-Cambridge region.

Executives from Bruce Power and BWXT, along with the Member of Provincial Parliament for Cambridge, Ontario and Minister of Natural Resources and Forestry, Kathryn McGarry, will tour the Bruce Power site tomorrow.

"The ongoing collaboration between BWXT and Bruce Power is creating safe, clean and low-cost electricity for the people of Ontario, McGarry said. This partnership is an example of how we can continue to make Ontario a hub for advanced manufacturing providing stable jobs and economic benefits in communities like Cambridge, and right across this great province of ours.

Bruce Power supplies 30% of Ontarios electricity at 30% less than the average cost to generate residential power. Extending the operational life of the Bruce Power units to 2064 will create and sustain 22,000 direct and indirect jobs every year, create $4 billion in annual Ontario economic benefit, and will ensure low-cost, clean and reliable energy for Ontario families and businesses.

Forward Looking Statements

BWXT cautions that this release contains forward-looking statements, including statements relating to the performance, timing, impact and value, to the extent contract value can be viewed as an indicator of future revenues, of the Bruce Power amendment. These forward-looking statements involve a number of risks and uncertainties, including, among other things, modification or termination of the contract and delays. If one or more of these or other risks materialize, actual results may vary materially from those expressed. For a more complete discussion of these and other risk factors, please see BWXTs annual report on Form 10-K for the year ended December 31, 2016 and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. BWXT cautions not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and undertakes no obligation to update or revise any forward-looking statement, except to the extent required by applicable law

About BWXT Canada Ltd.

BWXT Canada Ltd. (BWXT Canada) has over 60 years of expertise and experience in the design, manufacturing, commissioning and service of nuclear power generation equipment. This includes CANDU and Pressurized Water Reactor steam generators, nuclear fuel and fuel components, critical plant components, parts and related plant services. Headquartered in Cambridge, Ontario, BWXT Canada has approximately 850 employees at locations in Cambridge, Peterborough, Toronto and Arnprior, Ontario. BWXT Canada is a subsidiary of BWX Technologies, Inc. (NYSE:BWXT). BWXT is a leading supplier of nuclear components and fuel to the U.S. government; provides technical, management and site services to support governments in the operation of complex facilities and environmental remediation activities; and supplies precision manufactured components, fuel and services for the commercial nuclear power industry. Learn more at http://www.BWXT.com.

About Bruce Power

Formed in 2001, Bruce Power is an electricity company based in Bruce County, Ontario. We are powered by our people. Our 4,200 employees are the foundation of our accomplishments and are proud of the role they play in safely delivering clean, reliable, low-cost nuclear power to families and businesses across the province. Bruce Power has worked hard to build strong roots in Ontario and is committed to protecting the environment and supporting the communities in which we live. Learn more at http://www.brucepower.com and follow us on Facebook, Twitter, LinkedIn, Instagram and YouTube.

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BWXT Awarded CA$48 Million Amendment to Steam Generator Purchase Agreement from Bruce Power - Business Wire (press release)

Recommendation and review posted by Bethany Smith

Bad news from the U.S. Defense Intelligence Agency: North Korea has developed a miniaturized nuclear warhead that can fit inside its missiles.

The Hermit Kingdom is not alone in its nuclear pursuits. Russia and China have also committed to exploring new weapons capabilities, and Iran still harbors nuclear aspirations. In the United States, however, attempts to modernize our nuclear arsenal face tremendous resistance.

The scale, scope and capacity of the Russian and Chinese nuclear modernization programs far outstrip current U.S. efforts. Failing to modernize our aging warheads and platforms carries tremendous risk that goes well beyond those posed by not keeping up with the Joneses.

U.S. nuclear weapons are old. The warheads are based on 1970s designs, and they have not been physically tested in a quarter of a century. The nuclear triad of bombers, submarines, and long-range missiles is long in the tooth, as well. The Minuteman long-range missiles were deployed in the 1970s.

B-52 bombers, introduced in the 1950s, are so old that occasionally a grandson jockeys the same tail number that his grandfather flew. Even our newest systems, the Ohio-class ballistic missile submarines and B-2 bombers, are more than two decades old.

The nuclear triad is the bedrock of U.S. strategic deterrence and a core component of U.S. security assurances to over 30 allies around the world. It must be modernized regardless of the fate of the New Strategic Arms Reduction Treaty, also known as New START. The centerpiece of the Obama administrations failed Russian reset policy, New START has not served the strategic security interests of the United States.

It called for and delivered disproportionate reductions to the U.S. nuclear weapons arsenal. Moreover, the Russians have flagrantly violated the spirit of the treaty, deploying more than 200 nuclear warheads more than the treaty permits. (Nothing new there. Russia is also violating several other arms control agreements, including the Intermediate-Range Nuclear Forces Treaty.)

Former officials of the Obama administration, who had a hand in the 2010 Nuclear Posture Review, now recognize that the strategic environment has become significantly more dangerous since that review was concluded. The review was based on two questionable assumptions: that Russia was no longer a threat and that Russia (or any other country, for that matter) would not be a major adversary in the future.

But much has changed since those calculations were made. Russia, for example, has annexed Crimea, sent troops into Ukraine and propped up Bashar Assad in Syria. China has become more aggressive and belligerent in the South China Sea. And then theres North Korea. No one can know the future, of course. International developments have a way of taking the United States by surprise. And this unpredictability is precisely why the U.S. must maintain a credible, viable and robust nuclear deterrent.

Modernization is essential because the determined efforts of Russia, China and even North Korea leave the United States at risk of losing its competitive edge and thus its strategic deterrent. Both Moscow and Beijing reportedly include nuclear warhead testing as components of their modernization programs. And both are likely pursuing innovative design and development work to create warheads capable of generating special effects, such as enhanced radiation or electromagnetic pulse.Robust modernization programs also mean that their warhead workforce and production facilities remain skilled, capable and agile.

This is another area where the United States risks falling behind.U.S. scientists and nuclear engineers primarily focus their work (and thinking) on warhead maintenance and life extension programs a different set of skills than actually designing and building new warheads. The former attempts to sustain what is already known, while the latter explores new possibilities and leads to new designs and potential uses critical things to know if only to know what to defend against.

At present, the U.S. national laboratories are doing little to improve their understanding of foreign nuclear weapon designs. Those limited efforts should be expanded. Not only would it educate the current and upcoming generation of nuclear weapon designers, it would help ensure that the next generation tasked to certify our nuclear stockpile reliable has the experience and know-how of designing, building and testing actual warheads.

It made no sense for the French, British and Americans to remain committed to horse cavalry while the Germans were developing mobile tank warfare. So, today, it makes no sense for the U.S. to remain committed to merely certifying vintage nuclear weapons while our competitors race forward with new research and development efforts.

U.S. nuclear weapons policy must evolve as the nuclear threat evolves. Making changes to the U.S. nuclear posture as the threat environment grows more challenging will ultimately put the United States and its allies in a better strategic position. Congress and the Trump administration must not waver in their support for the U.S. nuclear modernization program.

Michaela Dodge is a senior policy analyst specializing in missile defense and arms control in the Center for National Defense at The Heritage Foundation.

The views expressed by contributors are their own and are not the views of The Hill.

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America desperately needs to modernize its nuclear weapons - The Hill (blog)

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Zoltan Istvan is launching his campaign to become Libertarian governor of the American state of California with two signature policies. First, hell eliminate poverty with a universal basic income that will guarantee US$5,000 per month for every Californian household for ever. (Hell do this without raising taxes, he promises.)

The next item in his in-tray is eliminating death. He intends to divert trillions of dollars into life-extending technologies robotic hearts, artificial exoskeletons, genetic editing, bionic limbs and so on in the hope that each Californian man, woman and AI (artificial intelligence) will eventually be able to upload their consciousness to the Cloud and experience digital eternity.

What we can experience as a human being is going to be dramatically different within two decades, Istvan says, when we meet at his home in Mill Valley, California. We have five senses now. We might have thousands in 30 or 40 years. We might have very different bodies, too.

I have friends who are about a year away from cutting off their arm and replacing it with a prosthetic version. And sure, pretty soon the robotic arm really will be better than a biological one. Lets say you work in construction and your buddy can lift a thousand times what you can. The question is: do you get it?

For most people, the answer to this question is likely to be, Erm, maybe Ill pass for the moment. But to a transhumanist such as Istvan, 44, the answer is, Hell, yes! A former National Geographic reporter and property speculator, Istvan combines the enthusiasm of a child whos read a lot of Marvel comics with a parodically presidential demeanour. Hes a blond-haired, blue-eyed father of two with an athletic build, a firm handshake and the sort of charisma that goes down well in TED talks.

Like most transhumanists (there are a lot of them in California), Istvan believes our species can, and indeed should, strive to transcend our biological limitations. And he has taken it upon himself to push this idea out of the Google Docs of a few Silicon Valley dreamers and into the American political mainstream.

Twenty-five years ago, hardly anybody was recycling, he explains. Now, environmentalism has conditioned an entire generation. Im trying to put transhumanism on a similar trajectory, so that in 10, 15 years, everybody is going to know what it means and think about it in a very positive way.

What were saying is that over the next 30 years, the complexity of human experience is going to become so amazing, you ought to at least see it

Zoltan Istvan

I meet Istvan at the home he shares with his wife, Lisa an obstetrician and gynaecologist with Planned Parenthood and their two daughters, six-year-old Eva, and Isla, who is three. I had been expecting a gadget-laden cyber-home; in fact, he resides in a 100-year-old loggers house built from Californian redwood, with a converted stable on the ground floor and plastic childrens toys in the yard. If it werent for the hyper-inflated prices in the Bay Area (Its sort of Facebook yuppie-ville around here, says Istvan) youd say it was a humble Californian homestead.

Still, there are a few details that give him away, such as the forbidding security warnings on his picket fence. During his unsuccessful bid for the presidency last year he stood as the Transhumanist Party candidate and scored zero per cent a section of the religious right identified him as the Antichrist. This, combined with Lisas work providing abortions, means they get a couple of death threats a week and have had to report to the FBI.

Christians in America have made transhumanism as popular as its become, says Istvan. They really need something that they can point their finger at that fulfils Revelations.

Istvan also has a West Wing box set on his mantelpiece and a small Meccano cyborg by the fireplace. Its named Jethro, after the protagonist of his self-published novel, The Transhumanist Wager (2013). And there is an old Samsung phone attached to the front door, which enables him to unlock the house using the microchip in his finger.

A lot of the Christians consider my chip a mark of the beast, he says. Im like, No! Its so I dont have to carry my keys when I go out jogging.

Istvan hopes to chip his daughters before long for security purposes and recently argued with his wife about whether it was even worth saving for a university fund for them, since by the time they reach university age, advances in artificial intelligence will mean they can just upload all the learning they need. Lisa won that argument. But hes inclined not to freeze his sperm and Lisas eggs, since if they decide to have a third child, 10 or 20 or 30 years hence, theyll be able to combine their DNA.

Even if theres a mischievous, fake-it-till-you-make-it quality to Istvan, theres also a core of seriousness. He is genuinely troubled that we are on the verge of a technological dystopia that the mass inequalities that helped fuel US President Donald Trumps rise will only worsen when the digital revolution really gets under way. And he despairs of the retrogressive bent of the current administration: Trump talks all the time about immigrants taking jobs. Bulls**t. Its technology thats taking jobs. We have about four million truck drivers who are about to lose their jobs to automation. This is why capitalism needs a basic income to survive.

And hes not wrong in identifying that emerging technologies such as AI and bio-enhancement will bring with them policy implications, and its probably a good idea to start talking about them now.

Stephen Hawkings question to China: will AI help or destroy the human race?

Certainly, life extension is a hot investment in Silicon Valley, whose elites have a hard time with the idea that their billions will not protect them from an earthly death. Google was an early investor in the secretive biotech start-up Calico, the California Life Company, which aims to devise interventions that slow ageing and counteract age-related diseases. Billionaire venture capitalist Peter Thiel has invested millions in parabiosis: the process of curing ageing with transfusions of young peoples blood.

Another biotech firm, United Therapeutics, has unveiled plans to grow fresh organs from DNA. Clearly, it is possible, through technology, to make death optional, the firms founder, Martine Rothblatt, told a recent gathering of the National Academy of Medicine in Los Angeles.

In attendance were Google co-founder Sergey Brin, vegan pop star Moby and numerous venture capitalists. Istvan fears that unless we develop policies to regulate this transition, the Thiels of this world will soon be hoarding all the young blood for themselves.

Clearly, it is possible, through technology, to make death optional

Martine Rothblatt

Istvan was born in Oregon in 1973, the son of Hungarian immigrants who fled Stalins tanks in 1968. He had a comfortable middle-class upbringing his mother was a devout Catholic and sent him to Catholic school and an eye for a story. After graduating from Columbia University, he embarked on a solo round-the-world yachting expedition, during which, he says, he read 500 works of classic literature. He spent his early career reporting for the National Geographic channel from more than 100 countries, many of them conflict zones, claiming to have invented the extreme sport of volcano boarding along the way.

One of the things he shares in common with Americas current president is a fortune accrued from real estate. While he was making films overseas in the noughties, his expenses were minimal, so he was able to invest all of his pay cheques in property.

AlphaGos China showdown: Why its time to embrace artificial intelligence

So many people in America were doing this flipping thing at the time, explains Istvan. I realised very quickly, Wow! I could make enough money to retire. It was just quite easy and lucrative to do that.

At his peak, he had a portfolio of 19 fixer-upper houses, most of which he managed to sell before the crash of 2008. He now retains nine as holiday rentals and uses the proceeds to fund his political campaigns (he is reluctant to name his other backers). Still, he insists hes not part of the 1 per cent; the most extravagant item of furniture is a piano, and his groceries are much the same as you find in many liberal, middle-class Californian households.

Istvan cant think of any particular incident that prompted his interest in eternal life, other than perhaps a rejection of Catholicism.

Fifty per cent of me thinks after we die we get eaten by worms, and our body matter and brain return unconsciously to the cosmos [] The other half subscribes to the idea that we live in a holographic universe where other alien artificial intelligences have reached the singularity, he says, referring to the idea, advanced by Google engineer Ray Kurzweil, that pretty soon we will all merge with AI in one transcendental consciousness.

However, when Istvan first encountered transhumanism, at university via an article on cryonics (the practice of deep-freezing the recently dead in the hope that they can be revived at some point), he was sold. Within 90 seconds, I realised thats what I wanted to do in my life.

After a near-death experience in Vietnam he came close to stepping on a landmine Istvan decided to return to America and make good on this vow. I was nearing 30 and Id done some great work, but after all that time Id spent in conflict zones, seeing dead bodies, stuff like that, I thought it would be a good time to dedicate myself to conquering death.

He spent four years writing his novel, which he proudly claims was rejected by more than 600 agents and publishers. Its a dystopian story that imagines a Christian nation outlawing transhumanism, prompting all the billionaires to retreat to an offshore sea-stead where they can work on their advances undisturbed (Thiel has often threatened to do something similar).

Istvan continued to promote transhumanism by writing free columns for Huffington Post and Vice, chosen because they have strong Alexa rankings (ie, they show up high in Google search results).

I wrote something like 200 articles, putting transhumanism through the Google algorithm again and again, he says. I found it a very effective way to spread the message. I covered every angle that I could think of: disability and transhumanism; LGBT issues and transhumanism; transhumanist parenting.

Hes proud to say hes the only mainstream journalist who is so devoted to the cause. A lot of people write about transhumanism, but I think Im the only one who says, This is the best thing thats ever happened!

Why your biological age may hold the key to reversing the ageing process

Istvans presidential campaign was an attempt to take all of this up a level. It sounds as if he had a lot of fun. He toured Rust Belt car parks and Deep South mega-churches in a coffin-shaped immortality bus inspired by the one driven by Ken Kesey and his Merry Pranksters to promote LSD in the 1960s.

His platform Make America Immortal Again earned a fair amount of publicity, but Americans seemed ill-prepared for such concepts as the AI imperative (the idea that the first nation to create a true AI will basically win everything, so America had better be the first) and the singularity. At one point, he and his supporters were held at gunpoint by some Christians in Alabama.

The experience taught him a salutary lesson: unless you are a billionaire, it is simply impossible to make any kind of dent in the system. Hence his defection to the Libertarian Party, which vies with the Greens as the third party in American politics. Every town I go to, theres a Libertarian meet-up. With the Transhumanists, Id have to create the meet-up. So theres more to work with.

The Libertarian presidential candidate, Gary Johnson, received 3.27 per cent of the votes last year, including half a million votes in California. About seven or eight million are likely to vote in the California governor race, in which context, half a million starts to become a lot of votes, Istvan explains.

His own politics are somewhere between Hillary Clinton and Bernie Sanders, he admits, and he has a hard time converting the right wing of his new party to causes such as basic income. (The general spirit of libertarian America is, Hands off!) But he believes transhumanism shares enough in common with libertarianism for the alliance to be viable; the core precepts of being able to do what you like as long as you dont harm anyone else are the same. And the gubernatorial campaign serves as a primary for the 2020 presidential election, when he believes the Libertarian candidate will have a feasible chance of participating in the television debates.

But whats wrong with death? Dont we need old people to die to make space for new people? And by extension, we need old ideas and old regimes to die, too. Imagine if William Randolph Hearst or Genghis Khan were still calling the shots now. And imagine if Mark Zuckerberg and Vladimir Putin were doing so in 200 years. Innovation would cease, the species would atrophy, everyone would get terribly bored. Isnt it the ultimate narcissism to want to live forever?

Istvan does concede that transhumanism is a very selfish philosophy. However, he has an answer for most of the other stuff.

Im a believer in overpopulation Ive been to Delhi and its overcrowded, he says. But if we did a better job of governing, the planet could hold 15 billion people comfortably. Its really a question of better rules and regulations.

And when discussing the desirability of eternal life, he turns into a sort of holiday rep for the future.

What were saying is that over the next 30 years, the complexity of human experience is going to become so amazing, you ought to at least see it, Istvan says. A lot of people find that a lot more compelling than, say, dying of leukaemia.

Still, it comes as little surprise that hes finding live for ever an easier sell than give money to poor people in 21st-century America.

I cant imagine basic income not becoming a platform in the 2020 election, he insists. And if not then, at some point, someone is going to run and win on it. The Republicans should like it because it streamlines government. The Democrats should like it because it helps poor people. Right now, Americans dont like it because it sounds like socialism. But it just needs a little reframing.

Basic-income experiments are already under way in parts of Canada, Finland and the Netherlands, but how would he fund such an idea in the US? He cant raise taxes libertarians hate that. And he doesnt want to alienate Silicon Valley.

If we did a better job of governing, the planet could hold 15 billion people comfortably

Zoltan Istvan

How do you tell the 1 per cent youre going to take all this money from them? It wouldnt work, he says. They control too many things. But Istvan has calculated that 45 per cent of California is government-controlled land that the state could monetise.

A lot of environmentalists are upset at me for that, saying, Woah, Zolt, you want to put a shopping mall in Yosemite? Well, the reality is that the poor people in America will never be able to afford to go to Yosemite. Im trying to be a diplomat here.

And he insists that if Americans miss those national parks when theyve been turned into luxury condos and Taco Bells, theyll be able to replenish them some day if they want.

Theres nanotechnology coming through that would enable us to do that, Istvan argues. We have GMOs [genetically modified organisms] that can regrow plants twice as quick. In 50 or 100 years, were not even going to be worried about natural resources.

Such is his wager that exponential technological growth is around the corner and we may as well hurry it along, because its our best chance of clearing up the mess weve made of things thus far.

The safety of genetically-modified crops is backed by science

Didnt the political developments of 2016 persuade him that progress can be slow and sometimes go backwards? Actually, Istvan argues that what were witnessing are the death throes of conservatism, Christianity, even capitalism.

Everyone says the current pope is the best one weve had for ages, that hes so progressive and whatever. Actually, Catholicism is dying, says Istvan. Nobodys giving it any money any more, so the pope had better moderate its message. As for capitalism, all of this nationalism and populism are just the dying moments.

Its a system that goes against the very core of humanitarian urges. And while its brought us many wonderful material gains, at some point we can say, Thats enough. In the transhumanist age, we will reach utopia. Crime drops to zero. Poverty will end. Violence will drop. At some point, we become a race of individuals who are pretty nice to each other.

But now weve talked for so long that Istvan needs to go and pick up his daughters from childcare. He insists that I join him. What do his family make of all of this?

My wife is a bit sceptical of a lot of my timelines, he says. Lisa comes from practical Wisconsin farming stock, and its a fair bet that her work with Planned Parenthood keeps her pretty grounded. They met on dating website match.com. Does she believe in all this stuff?

I dont want to say shes not a transhumanist, he says, but I dont think shed cryogenically freeze herself tomorrow. I would. Im like, If you see me dying of a heart attack, please put me in a refrigerator. She thinks thats weird.

We arrive at the community centre where Istvans daughters are being looked after. They come running out in summer dresses, sweet and sunny and happy to be alive. Both of them want to be doctors when they grow up, like their mum.

The Times/The Interview People

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Immortality: Silicon Valley's latest obsession ushers in the transhumanist era - South China Morning Post

Recommendation and review posted by sam

Cuorips, a Japan-based cardiac therapy developer spun out from Osaka University, has secured an undisclosed amount from pharmaceutical firm Daiichi Sankyo.

The investment was made as part of an agreement that gives the corporate an option right for the worldwide commercialisation of Cuorips technology, called iPS-derived cardiomyocyte sheet, a cell therapy for patients suffering from severe heart failure.

The treatment uses induced pluripotent stem (iPS) cells, which can be generated directly from a donors mature cells and differentiated into any organ. It offers an alternative to patients who would otherwise require a heart or artificial heart transplant.

The technology is based on research led by Yoshiki Sawa, professor at the Graduate School of Medicines Department of Cardiovascular Surgery.

Sawa developed the therapy through his participation in the Research Center Network for Realization of Regenerative Medicine, operated by the research organisation Japan Agency for Medical Research and Development.

Cuorips is currently gearing up for clinical research and an investigator-initiated clinical trial.

See more here:
Daiichi Sankyo hearts Cuorips - Global University Venturing

Recommendation and review posted by simmons

With the usual mix of anticipation and apprehension, Kaitlyn Johnson is getting ready to go to her first summer camp. She's looking forward to meeting new friends and being able to ride horses, swim and host tea parties. She's also a little nervous and a little scared, like any 7-year-old facing her first sleepaway camp.

But the wonder is that Kaitlyn is leaving the house for anything but a medical facility. Diagnosed with leukemia when she was 18 months old, her life has been consumed with cancer treatments, doctors' visits and hospital stays.

Acute lymphoblastic leukemia is the most common cancer among young children, accounting for a quarter of all cancer cases in kids, and it has no cure. For about 85% to 90% of children, the leukemia can, however, be effectively treated through chemotherapy.

If it is not eliminated and comes back, it is, more often than not, fatal. Rounds of chemotherapy can buy patients time, but as the disease progresses, the periods of remission get shorter and shorter. "The options for these patients are not very good at all," says Dr. Theodore Laetsch, a pediatrician at the University of Texas Southwestern Medical Center.

When Kaitlyn's cancer wasn't controlled after three years and round after round of chemotherapy drugs, her doctors had little else to offer. "They said, 'This did nothing, it didn't touch it,'" says Kaitlyn's mother Mandy, a dental assistant from Royce City, Texas. "My stomach just dropped." Kaitlyn could receive a bone-marrow transplant, but only about half of those procedures are successful, and there was a good chance that she would reject the donor cells. If that happened, her chances of surviving were very small.

In a calculated gamble, her doctors suggested a radical new option: becoming a test subject in a trial of an experimental therapy that would, for the first time, use gene therapy to train a patient's immune system to recognize and destroy their cancer in the same way it dispatches bacteria and viruses. The strategy is the latest development in immunotherapy, a revolutionary approach to cancer treatment that uses a series of precision strikes to disintegrate cancer from within the body itself. Joining the trial was risky, since other attempts to activate the immune system hadn't really worked in the past. Mandy, her husband James and Kaitlyn traveled from their home in Texas to Children's Hospital of Philadelphia (CHOP), where they stayed in a hotel for eight weeks while Kaitlyn received the therapy and recovered. "The thought crossed my mind that Kaitlyn might not come home again," says Mandy. "I couldn't tell you how many times I would be in the bathroom at the hospital, spending an hour in the shower just crying, thinking, What are we going to do if this doesn't help her?"

But it did. After receiving the therapy in 2015, the cancer cells in Kaitlyn's body melted away. Test after test, including one that picks up one cancer cell in a million, still can't detect any malignant cells lurking in Kaitlyn's blood. What saved Kaitlyn was an infusion of her own immune cells that were genetically modified to destroy her leukemia. "You take someone who essentially has no possibility for a cure--almost every single one of these patients dies--and with [this] therapy, 90% go into remission," says Dr. David Porter, director of blood and bone-marrow transplantation at the University of Pennsylvania. Such radical immune-based approaches were launched in 2011 with the success of intravenous drugs that loosen the brakes on the immune system so it can see cancer cells and destroy them with the same vigor with which they attack bacteria and viruses. Now, with the genetically engineered immune cells known as chimeric antigen receptor (CAR) T cells that were used in Kaitlyn's study, doctors are crippling cancer in more precise and targeted ways than surgery, chemotherapy and radiation ever could. While the first cancer immunotherapies were broadly aimed at any cancer, experts are now repurposing the immune system into a personalized precision treatment that can not only recognize but also eliminate the cancer cells unique to each individual patient.

What makes immune-based therapies like CAR T cell therapy so promising--and so powerful--is that they are a living drug churned out by the patients themselves. The treatment isn't a pill or a liquid that has to be taken regularly, but a one-hit wonder that, when given a single time, trains the body to keep on treating, ideally for a lifetime.

"This therapy is utterly transformative for this kind of leukemia and also lymphoma," says Stephan Grupp, director of the cancer immunotherapy program at CHOP and one of the lead doctors treating patients in the study in which Kaitlyn participated.

Eager to bring this groundbreaking option to more patients, including those with other types of cancers, an advisory panel for the Food and Drug Administration voted unanimously in July to move the therapy beyond the testing phase, during which several hundred people have been able to take advantage of it, to become a standard therapy for children with certain leukemias if all other treatments have failed. While the FDA isn't obligated to follow the panel's advice, it often does, and it is expected to announce its decision in a matter of weeks.

Across the country, doctors are racing to enroll people with other cancers--breast, prostate, pancreatic, ovarian, sarcoma and brain, including the kind diagnosed in Senator John McCain--in hundreds of trials to see if they, too, will benefit from this novel approach. They are even cautiously allowing themselves to entertain the idea that this living drug may even lead to a cure for some of these patients. Curing cancers, rather than treating them, would result in a significant drop in the more than $120 billion currently spent each year on cancer care in the U.S., as well as untold suffering.

This revolutionary therapy, however, almost didn't happen. While the idea of using the body's immune cells against cancer has been around for a long time, the practical reality had proved daunting. Unlike infection-causing bacteria and viruses that are distinctly foreign to the body, cancer cells start out as healthy cells that mutate and grow out of control, and the immune system is loath to target its own cells.

"Only a handful of people were doing the research," says Dr. Carl June, director of the Center for Cellular Immunotherapy at the University of Pennsylvania's Abramson Cancer Center and the scientist who pioneered the therapy. A graduate of the U.S. Naval Academy, June is all too familiar with the devastating effects of cancer, having lost his first wife to ovarian cancer and battled skin cancer himself. Trial after trial failed as reinfusions of immune cells turned out to be more of a hit-or-miss endeavor than a reliable road to remission.

After spending nearly three decades on the problem, June zeroed in on a malignant fingerprint that could be exploited to stack the deck of a cancer patient's immune system with the right destructive cells to destroy the cancer.

In the case of leukemias, that marker turned out to be CD19, a protein that all cancerous blood cells sprout on their surface. June repurposed immune cells to carry a protein that would stick to CD19, along with another marker that would activate the immune cells to start attacking the cancer more aggressively once they found their malignant marks. Using a design initially developed by researchers at St. Jude Children's Research Hospital for such a combination, June and his colleague Bruce Levine perfected a way to genetically modify and grow these cancer-fighting cells in abundance in the lab and to test them in animals with leukemia. The resulting immune platoon of CAR T cells is uniquely equipped to ferret out and destroy cancer cells. But getting them into patients is a complex process. Doctors first remove a patient's immune cells from the blood, genetically tweak them in the lab to carry June's cancer-targeting combination and then infuse the modified cells back into the patient using an IV.

Because these repurposed immune cells continue to survive and divide, the therapy continues to work for months, years and, doctors hope, perhaps a lifetime. Similar to the way vaccines prompt the body to produce immune cells that can provide lifelong protection against viruses and bacteria, CAR T cell therapy could be a way to immunize against cancer. "The word vaccination would not be inappropriate," says Dr. Otis Brawley, chief medical officer of the American Cancer Society.

June's therapy worked surprisingly well in mice, shrinking tumors and, in some cases, eliminating them altogether. He applied for a grant at the National Cancer Institute at the National Institutes of Health to study the therapy in people from 2010 to 2011. But the idea was still so new that many scientists believed that testing it in people was too risky. In 1999, a teenager died days after receiving an experimental dose of genes to correct an inherited disorder, and anything involving gene therapy was viewed suspiciously. While such deaths aren't entirely unusual in experimental studies, there were ethical questions about whether the teenager and his family were adequately informed of the risks and concerns that the doctor in charge of the study had a financial conflict of interest in seeing the therapy develop. Officials in charge of the program acknowledged that important questions were raised by the trial and said they took the questions and concerns very seriously. But the entire gene-therapy program was shut down. All of that occurred at the University of Pennsylvania--where June was. His grant application was rejected.

It would take two more years before private funders--the Leukemia and Lymphoma Society and an alumnus of the university who was eager to support new cancer treatments--donated $5 million to give June the chance to bring his therapy to the first human patients.

The date July 31 has always been a milestone for Bill Ludwig, a retired corrections officer in New Jersey. It's the day that he joined the Marines as an 18-year-old, and the day, 30 years later, that he married his wife Darla.

It was also the day he went to the hospital to become the first person ever to receive the combination gene and CAR T cell therapy, in 2010. For Ludwig, the experimental therapy was his only remaining option. Like many people with leukemia, Ludwig had been living on borrowed time for a decade, counting the days between the chemotherapy treatments that would hold the cancer in his blood cells at bay for a time. Inevitably, like weeds in an untended garden, the leukemia cells would grow and take over his blood system again.

But the periods of reprieve were getting dangerously short. "I was running out of treatments," says Ludwig. So when his doctor mentioned the trial conducted by June and Porter at the University of Pennsylvania, he didn't hesitate. "I never thought that the clinical trial was going to cure me," he says. "I just wanted to live and to continue to fight. If there was something that would put me into the next month, still breathing, then that's what I was looking for."

When Ludwig signed the consent form for the treatment, he wasn't even told what to expect in terms of side effects or adverse reactions. The scientists had no way of predicting what would happen. "They explained that I was the first and that they obviously had no case law, so to speak," he says. So when he was hit with a severe fever, had difficulty breathing, showed signs of kidney failure and was admitted to the intensive care unit, he assumed that the treatment wasn't working.

His condition deteriorated so quickly and so intensely that doctors told him to call his family to his bedside, just four days after he received the modified cells. "I told my family I loved them and that I knew why they were there," he says. "I had already gone and had a cemetery plot, and already paid for my funeral."

Rather than signaling the end, Ludwig's severe illness turned out to be evidence that the immune cells he received were furiously at work, eliminating and sweeping away the huge burden of cancer cells choking up his bloodstream. But his doctors did not realize it at the time.

It wasn't until the second patient, Doug Olson, who received his CAR T cells about six weeks after Ludwig, that Porter had a eureka moment. When he received the call that Olson was also running a high fever, having trouble breathing and showing abnormal lab results, Porter realized that these were signs that the treatment was working. "It happens when you kill huge amounts of cancer cells all at the same time," Porter says. What threw him off initially is that it's rare for anything to wipe out that much cancer in people with Ludwig's and Olson's disease. June and Porter have since calculated that the T cells obliterated anywhere from 2.5 lb. to 7 lb. of cancer in Ludwig's and Olson's bodies. "I couldn't fathom that this is why they both were so sick," says Porter. "But I realized this is the cells: they were working, and working rapidly. It was not something we see with chemotherapy or anything else we have to treat this cancer."

Ludwig has now been in remission for seven years, and his success led to the larger study of CAR T cell therapy in children like Kaitlyn, who no longer respond to existing treatments for their cancer. The only side effect Ludwig has is a weakened immune system; because the treatment wipes out a category of his immune cells--the ones that turned cancerous--he returns to the University of Pennsylvania every seven weeks for an infusion of immunoglobulins to protect him from pneumonia and colds. Olson, too, is still cancer-free.

While the number of people who have received CAR T cell therapy is still small, the majority are in remission. That's especially encouraging for children, whose lives are permanently disrupted by the repeated cycles of treatments that currently are their only option. "It's a chance for these kids to have a normal life and a normal childhood that doesn't involve constant infusions, transfusions, infections and being away from their home, family and school," says Dr. Gwen Nichols, chief medical officer of the Leukemia and Lymphoma Society.

The hope is that while CAR T cell therapy will at first be reserved for people who have failed to respond to all standard treatments, eventually they won't have to wait that long. As doctors learn from pioneers like Kaitlyn, Ludwig and Olson, they will have more confidence in pushing the therapy earlier, when patients are stronger and the cancer is less advanced--perhaps as a replacement for or in combination with other treatments.

The severe immune reaction triggered by the therapy remains a big concern. While it can be monitored in the hospital and managed with steroids or antibodies that fight inflammation, there have been deaths in other trials involving CAR T cells. One drug company put one of its studies on hold due to the toxic side effects. "I am excited by CAR T therapy, but I'm also worried that some people might get too excited," says the American Cancer Society's Brawley. "It's important that we proceed slowly and do this meticulously so that we develop this in the right way."

For now, CAR T cells are expensive--some analysts estimate that each patient's batch of cells would cost hundreds of thousands of dollars--because they require a bespoke production process. If approved, Novartis, which licensed the technology from the University of Pennsylvania, will provide the therapy in about 35 cancer centers in the U.S. by the end of the year. Other companies are already working toward universal T cells that could be created for off-the-shelf use in any patient with cancer. "This is just the beginning," says June.

Since Ludwig's cancer has been in remission, he and his wife have packed their RV and taken the vacations they missed while he was a slave to his cancer and chemotherapy schedule. This year, they're visiting Mount Rushmore, Grand Teton National Park and Yellowstone National Park before taking their granddaughter to Disney World in the fall. "When they told me I was cancer-free, it was just like someone said, 'You won the lottery,'" he says. "If somebody else with this disease has the chance to walk in my shoes and live past it, that would be the greatest gift for me."

Original post:
Cancer's Newest Miracle Cure - TIME

Recommendation and review posted by Bethany Smith

On track to file for clinical trial application(CTA) for lead program in beta-thalassemia in 2017Rapid progress in immuno-oncology including a lead program in allogeneic CAR-T cell therapyExpanded foundational and therapeutic intellectual property positionStrong financial position to support development of pipeline and fund operations

ZUG, Switzerland and CAMBRIDGE, Mass., Aug. 10, 2017 (GLOBE NEWSWIRE) -- CRISPR Therapeutics, (NASDAQ:CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today reported financial results for the second quarter ended June 30, 2017 and provided a business update.

CRISPR Therapeutics has had a very productive first half of the year across all aspects of our business and we remain on track to achieve the goals we set at the beginning of the year, said Dr. Rodger Novak, CEO of CRISPR Therapeutics. Our lead program in hemoglobinopathies remains on track for a CTA submission in late 2017, with clinical trials beginning in 2018. We are advancing our immuno-oncology portfolio and other in vivo applications supported by the signing of key collaborations, and we remain focused on building an organization with top notch talent.

Recent Highlights and Outlook:

Lead hemoglobinopathies program remains on track to file CTA by year-end 2017, and begin clinical trials in 2018. CRISPR Therapeutics highlighted the most recent progress of its hemoglobinopathies program during the Presidential Symposium at the 22nd European Hematology Association Annual Congress in June. The data presented provided further support for CRISPRs approach of re-creating the natural condition of hereditary persistence of fetal hemoglobin (HPFH) that is protective in sickle cell disease and in beta-thalassemia. The presentation described the ability to re-create specific HPFH gene variants in the intended target tissue, human CD34+ stem cells, and demonstrated that these gene variants increase the expression of protective fetal hemoglobin. The data presented continues to support the development of the lead product candidate for beta-thalassemia and sickle cell disease and the Company remains on track to file a clinical trial application (CTA) in Europe by year-end 2017 for beta-thalassemia.

Advancing immuno-oncology program through lead allogeneic CAR-T program and collaborations. CRISPR Therapeutics is rapidly advancing its lead immuno-oncology program through pre-IND studies and process development for manufacturing. The lead program, CTX101, is an allogeneic CAR-T cell therapy being developed for the treatment of CD19-positive malignancies. CRISPR has demonstrated the use of its proprietary gene editing technology to make targeted modifications in T cells, thereby creating an allogeneic or off-the-shelf product that is designed for a broader patient population and addresses several challenges of the current generation of autologous therapies. In June, the Company announced an agreement with MaSTherCell SA, a full-service contract development and manufacturing organization, to develop and manufacture CTX101 under cGMP conditions for use in future clinical trials. Beyond its lead program, CRISPR announced a research collaboration with Neon Therapeutics (Neon) to explore the combination of its CRISPR gene editing platform with Neons neo-antigen platform to develop novel T cell therapies.

Advancing in vivo applications through in-licensing and collaborations. In May, CRISPR Therapeutics announced the signing of an exclusive license to a family of proprietary lipid nanoparticle (LNP) technologies from the Massachusetts Institute of Technology. Utilizing this technology, the Company demonstrated high-efficiency elimination of a target protein produced in the liver. These data were presented at the Cold Spring Harbor Laboratory Genome Engineering conference in July. Additionally, CRISPR and its collaborators at the University of Florida were awarded a two-year grant from Target ALS Foundation, a non-profit organization dedicated to accelerating new treatments for ALS, to support discovery and validation of CRISPR/Cas9-based therapeutic approaches for ALS and frontotemporal dementia (FTD). In April, CRISPR announced a collaboration with StrideBio, a leading developer of adeno-associated virus (AAV) based technologies, to co-develop new vectors for the in vivo delivery of CRISPR/Cas9-based therapeutics to various organ systems.

Strengthened international intellectual property around the foundational and therapeutic CRISPR/Cas9 gene editing technology. Following recent patent grants in the United Kingdom and Europe that broadly cover its in-licensed gene editing technology, CRISPR Therapeutics announced it has received a similarly broad patent from Chinas State Intellectual Property Office (SIPO), and it has recently received additional grants or notices of allowance from Australia, New Zealand and Singapore. The claims being granted in these jurisdictions are directed to CRISPR/Cas9 single-guide gene editing methods for modifying target DNA in both non-cellular and cellular settings, including cells from vertebrate animals such as human or mammalian cells as well as composition of matter and system claims for use in any setting, including claims for the use in producing medicine for treating disease. The growing international recognition of the broad applicability of CRISPRs patent applications for use in all settings, including in human and other eukaryotic cells, continues to reinforce the Companys position as a leader in the rapidly evolving gene editing industry.

In the U.S., CRISPR announced, jointly with its licensors and other sub-licensees, that it had filed the opening brief to the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit) seeking reversal of a decision by the U.S. Patent and Trademark Offices Patent Trial and Appeal Board (PTAB) in an interference proceeding relating to CRISPR/Cas9 gene editing technology. In the appeal, University of California (UC) requests reversal of the PTABs decision terminating the interference between certain CRISPR/Cas9 patent claims owned by UC and claims of the Broad Institute, Harvard University and the Massachusetts Institute of Technology (collectively, Broad). In parallel with the appeal, CRISPR is pursuing other patent applications in the U.S. to pursue patents claiming the CRISPR/Cas9 technology and its use in non-cellular and cellular settings, including eukaryotic cells.

Organizational growth and senior leadership additions. CRISPR Therapeutics continues to enhance its team by attracting and hiring experts across all critical functions including research and development, manufacturing, clinical operations and other areas. In June, CRISPR appointed James R. Kasinger as General Counsel. Mr. Kasinger will oversee the companys corporate legal and governance matters. Prior to joining CRISPR, Mr. Kasinger was General Counsel and Secretary at Moderna Therapeutics. Recently, in August, CRISPR announced the appointment of Dr. Tony Ho as the new Head of Research and Development for the company. Tony brings over 20 years of experience in the industry across both research and development in multiple therapeutic areas. Most recently, Tony was SVP and Head of Oncology Integration and Innovation at AstraZeneca. Currently CRISPR Therapeutics employs 114 people across its three locations. In July, the Companys global headquarters was moved from Basel to Zug, Switzerland, as approved by shareholders at the Companys recent annual meeting.

Financial Results for Three and Six Months Ended June 30, 2017 (U.S. GAAP):

As of June 30, 2017, CRISPR Therapeutics had $272.3 million in cash as compared to $315.5 million in cash as of December 31, 2016. Based on its current operating plan, CRISPR expects its existing cash resources will be sufficient to fund operating expenses and capital expenditure requirements for at least the next two years.

Three Months Ended June 30, 2017

CRISPR Therapeutics reported a net loss of $22.3 million for the three months ended June 30, 2017 as compared to a net loss of $17.2 million for the three months ended June 30, 2016. The increase in net loss of $5.1 million resulted primarily from an increase in loss from operations of $4.7 million, an increase in the provision for income taxes of $0.3 million and an increase in other expense of $0.1 million.

Collaboration revenue for the three months ended June 30, 2017 was $3.6 million, compared to $0.8 million for the three months ended June 30, 2016. The increase of $2.8 million was primarily due to an increase in research and development service revenue under our collaboration agreements with Casebia and Vertex of $1.5 million and $1.3 million, respectively.

Research and development expenses for the three months ended June 30, 2017 were $17.1 million, compared to $8.6 million for the three months ended June 30, 2016. The increase of $8.5 million was primarily attributable to increases of $3.2 million of variable process and platform development costs, $2.1 million of facilities costs including rent and utilities at our new research facility, $2.1 million of employee-related costs and $1.1 million of employee stock based compensation costs.

General and administrative expenses were $7.8 million for the three months ended June 30, 2017, compared to $8.8 million for the three months ended June 30, 2016. The decrease of $1.0 million was primarily due to decreases of $2.0 million in costs associated with a 2016 passive foreign investment company (PFIC) tax liability and $0.9 million in employee stock based compensation costs. The decreases were offset by increases of $1.0 million in employee-related costs to support our overall growth, $0.6 million in professional and consulting expenses, and $0.3 million in facilities costs including rent and utilities at our new facility.

Six Months Ended June 30, 2017

CRISPR Therapeutics reported a net loss of $43.8 million for the six months ended June 30, 2017, compared to a net loss of $25.6 million for the six months ended June 30, 2016. The increase in net loss of $18.2 million resulted primarily from an increase of $13.8 million in loss from operations, an increase of $0.5 million in the provision for income taxes, an increase of $0.3 million in the loss from equity method investment, an increase of $0.1 million in other expense and a decrease of $11.5 million on the gain on extinguishment of the convertible loan with Vertex offset by a decrease in interest expense of $8.0 million from the convertible loan with Bayer.

Collaboration revenue for the six months ended June 30, 2017 was $6.3 million, compared to $1.3 million for the six months ended June 30, 2016. The increase of $5.0 million was primarily due to an increase in research and development service revenue under our collaboration agreements with Casebia and Vertex of $2.6 million and $2.4 million, respectively.

Research and development expenses for the six months ended June30, 2017 were $31.9 million, compared to $14.6 million for the six months ended June 30, 2016. The increase of $17.3 million was primarily attributable to increases of $5.9 million in variable process and platform development costs, $4.7 million in facilities costs including rent and utilities at our new research facility, $4.5 million in employee-related costs, and $2.2 million in employee stock based compensation costs.

General and administrative expenses were $16.4 million for the six months ended June 30, 2017, compared to $14.9 million for the six months ended June30, 2016. The increase of $1.5 million was primarily due to the increases of $2.1 million in employee-related costs to support our overall growth, $1.5 million in facilities costs including rent and utilities at our new research facility, and $0.3 million in employee stock based compensation costs. The increases were offset by a reduction of $2.4 million in our 2016 PFIC tax obligation and franchise taxes on the convertible preferred stock financings.

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 gene editing platform. CRISPR/Cas9 is a revolutionary technology that allows for precise, directed changes to genomic DNA. The company's multi-disciplinary team of world-class researchers and drug developers is working to translate this technology into breakthrough human therapeutics in a number of serious diseases. Additionally, CRISPR Therapeutics has established strategic collaborations with Bayer AG and Vertex Pharmaceuticals to develop CRISPR-based therapeutics in diseases with high unmet need. The foundational CRISPR/Cas9 patent estate for human therapeutic use was licensed from the company's scientific founder Emmanuelle Charpentier, Ph.D. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in London, United Kingdom. For more information, please visit http://www.crisprtx.com.

CRISPR Forward-Looking Statement

Certain statements set forth in this press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the intellectual property coverage and positions of the company, its licensors and third parties, and the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: uncertainties regarding the intellectual property protection for our technology and intellectual property belonging to third parties; uncertainties inherent in the initiation and completion of preclinical studies for the Companys product candidates; availability and timing of results from preclinical studies; whether results from a preclinical trial will be predictive of future results of the future trials; expectations for regulatory approvals to conduct trials or to market products; and those risks and uncertainties described under the heading Risk Factors in the companys most recent annual report on Form 10-K, and in any other subsequent filings made by the company with theU.S. Securities and Exchange Commission(SEC), which are available on the SECs website atwww.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made.

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CRISPR Therapeutics Announces Second Quarter 2017 Financial Results and Provides Business Update - GlobeNewswire (press release)

Recommendation and review posted by simmons

On August 2nd, scientists achieved a milestone on the path to human genetic engineering. For the first time in the United States, scientists successfully edited the genes of a human embryo. A transpacific team of researchers used CRISPR-Cas9 to correct a mutation that leads to an often devastating heart condition. Responses to this feat followed well-trodden trails. Hype over designer babies. Hope over new tools to cure and curb disease. Some spin, some substance and a good dose of science-speak. But for me, this breakthrough is not just about science or medicine or the future of humankind. Its about faith and family, love and loss. Most of all, its about the life and memory of my brother.

Jason was born with muscle-eye-brain disease. In his case, this included muscular dystrophy, cerebral palsy, severe nearsightedness, hydrocephalus and intellectual disability. He lived past his first year thanks to marvels of modern medicine. A shunt surgery to drain excess cerebrospinal fluid building up around his brain took six attempts, but the seventh succeeded. Aside from those surgeries complications and intermittent illnesses due to a less-than-robust immune system, Jason was healthy. Healthy and happy very happy. His smile could light up a room. Yet, that didnt stop people from thinking that his disability made him worse off. My family and those in our religious community prayed for Jason. Strangers regularly came up to test their fervor. Prayer circles frequently had his name on their lists. We wanted him to be healed. But I now wonder: What, precisely, were we praying for?

Jasons disabilities fundamentally shaped his experience of the world. If praying for his healing meant praying for him to be normal, we were praying for Jason to become someone else entirely. We were praying for a paradox. If I could travel back in time, Id walk up to young, devout Joel and ask: How will Jason still be Jason if God flips a switch and makes him walk and talk and think like you? The answer to that question is hard. Yes, some just prayed for his seizures to stop. Some for his continued well-being. But is that true of most? Is that what I was praying for?

The ableist conflation of disability with disease and suffering is age-old. Just peruse the history of medicine. Decades of eugenic practices. Sanctioned torture of people with intellectual disability. The mutilation of otherwise healthy bodies in the name of functional or aesthetic normality. These stories demonstrate over and over again how easily biomedical research and practice can mask atrocity with benevolence and injustice with progress. Which leads me to ask: What, precisely, are we editing for?

Although muscle-eye-brain disease does not result from a single genetic variant, researchers agree that a single gene, named POMGNT1, plays a large role. Perhaps scientists will soon find a way to correct mutations in that and related genes. Perhaps people will no longer be born with it. But that means there would never be someone like Jason. Those prayers I mentioned above? Science will have retroactively answered them. That thought brings me to tears.

I wish we could cure cancer, relieve undue pain and heal each break and bruise. But I also wish for a world with Jason and people like him in it. I want a world accessible and habitable for people full stop not just the people we design. I worry that in our haste to make people healthy, we are in fact making people we want. We, who say we pray for healing, but in fact pray for others to be like us. We, who say were for reducing disease and promoting health, but support policies and practices aimed instead at being normal. We, who are often still unable to distinguish between positive, world-creating forms of disability and negative, world-destroying forms between Deafness, short stature or certain types of neurodiversity and chronic pain, Tay-Sachs or Alzheimers. It is with great responsibility that we as a society balance along the tightrope of biomedical progress. I long for us to find that balance. Ive certainly not found it for myself. Lest I forget how often weve lost it and how easy it is to fall, I hold dearly onto the living memory of Jason. I no longer pray for paradoxes, but for parity for the promise of a world engineered not for normality, but equality.

But that world will never come if we edit it away.

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Gene Editing Might Mean My Brother Would've Never Existed - TIME

Recommendation and review posted by Bethany Smith

Los Angeles Police Officer Matthew Medina. AJPRESS

LOS ANGELES Its been almost five months since Matthew Medina first learned about his rare blood disease and how his Filipino heritage is affecting his chances of being cured.

Earlier this year, the 40-year-old police officer was going about his normal duties as part of the Los Angeles Police Departments (LAPD) Harbor Division gang unit. By his side was his close friend, Dante Pagulayan, also an officer with the department.

The two have known each other since they were about 14 years old in high school and ended up going to Cal State Long Beach together, before eventually joining the LAPD. It was at the college, Pagulayan shared, where Medina met his wife Angelee with whom the latter now has two beautiful daughters.

Matt is one of the funniest guys I know, Pagulayan said about his friend during a recent interview with the Asian Journal. If you want to have a good time, hes going to be your guy.

Currently, Medina remains in quarantine after having been diagnosed with aplastic anemia, a rare disease that claims 600-900 people in the United States each year, according to the Aplastic Anemia and MDS International Foundation (AA/MDS). The fact that hes Filipino presents a larger challenge.

Finding a donor

Aplastic anemia, or bone marrow failure, is a blood disease in which bone marrow fails to make enough blood cells for the body.

According to AA/MDS, it can affect anyone regardless of race or gender but is diagnosed more often in children, young adults, and older adults. It also appears more often in Asian Americans.

For Medina, the disease seemed to come out of nowhere. Matt was a very precautious guy, said Pagulayan about Medinas health habits. He always took care of himself, took vitamins, went to the doctor He was that kind of guy.

Radiation and chemotherapy, toxic chemical exposure, use of certain drugs, and autoimmune disorders are some factors known to injure bone marrow, thus affecting blood cell reproduction. But for the most part, theres no telling what causes aplastic anemia.

Getting a bone marrow transplant is the only cure for aplastic anemia. However, finding a match is a major obstacle that those diagnosed are forced to face.

In order for a transplant to be successful, both the donor and beneficiary need to share eight human leukocyte antigens (HLA), or cell markers. This explains why more chances of success happen between a donor and receiver of the same ethnic background.

Chances of recovery

For Medina and many others, chances of recovery are greatly reduced simply due to the number of minority-group members registered to be potential bone marrow matches.

Out of the 12 million people registered, only 0.5 percent were Filipino, said Pagulayan. It was quite a surprise.

As of 2016, the number of Asians recorded in Be The Matchs registry made up only six percent of the total registered, shared Ayumi Nagata, Recruitment Manager of Asians for Miracle Marrow Matches (A3M).

The lowest percentage came from those who identified as Native Hawaiian/Other Pacific Islander their percentage hovered at 0.1 percent. The largest group at 57 percent with 7.8 million comprise of those who are white.

While transplants between family members have worked, its rarely the case, according to Mixed Marrow, a foundation dedicated to increasing bone marrow and blood cell donors for patients of multi-ethnic descent. Finding a match within the family is only successful 30 percent of the time, leaving 70 percent searching elsewhere.

Nagata has encountered a number of cultural and religious reasons that explain the low number of Asian registrants, but the lack of familiarity and awareness remain the biggest culprits.

Organizations like Mixed Marrow and A3M are working together to disprove these misconceptions by focusing on increasing awareness through outreach within cultural contexts.

One common misconception is that donating marrow is painful. Nagata informed that most procedures are done through nonsurgical Peripheral Blood Stem Cell (PBSC) donations where cells are collected through the blood rather than the bone itself.

Umbilical cord blood is another source, and Be The Match lists a number of hospitals that collect the blood for a public cord blood bank.

Hope for Medina

There are now currently 1,270 ethnically diverse, and 101 Caucasian registrants through Medinas campaign, reported Nagata. With the help of Medinas support group and community, theres hope that the numbers can increase.

Since the start of Medinas match campaign, two others in need of bone marrow transplants were able to find a match.

On June 25, Medina personally posted on his Match4Matt Facebook campaign page, Even if they never find a match for me, I can say that this campaign has been a success since it has already helped save the lives of at least two people (so far).

For Medina, the search continues but he remains optimistic. On his Facebook post, he reported that his blood cell counts have increased and he hopes that the upward trend continues toward remission. I am not out of the woods yet, he added. There is still a long road to recovery ahead, but the proverbial light at the end of the tunnel is definitely getting brighter.

But as Pagulayan said, the only way to really revert it is through a bone marrow transplant. Medinas condition can change just as quick as how he found out he had the disease.

To those thinking about registering to be a match, Pagulayan said to think of a loved one and what would happen if you woke up and found out they had the disease.

To join a registry, anyone up to 60 years old can sign up, but donors between ages 18-44 are preferred. There are also medical conditions that may make someone ineligible. The process itself takes less than five minutes, according to Nagata. As Pagulayan put it, It takes less time to swab your cheeks than it takes to fill out the paperwork.

More information on registering can be found on Be the Matchs website. To join Medinas registry, visit http://www.join.bethematch.org/match4mat

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Fil-Am LAPD officer still in need of bone marrow match - Inquirer.net

Recommendation and review posted by simmons

Bone Marrow Donors Needed

Paula (Fitzgerald) Silvia of Middletown has been diagnosed with myeloid dysplasia syndrome (MDS), a form of blood cancer where the bone marrow cells do not mature into healthy blood cells. Paula received this devastating news at the end of June. Nothing seemed particularly out of sorts; she was travelling with her family, working, going to the beach and doing all her volunteer activities. Only indications were catching more colds and a little tired but Paulas life was always busy and she does so much for everyone, she should be tired.

Paula has started her first round of chemotherapy. Every four weeks, she has five consecutive days of chemotherapy infusion. However, it is only a temporary treatment. A bone marrow transplant is needed to cure the disease.

A bone marrow registration drive is being held on Sunday, September 17 from 4:00pm to 7:00pm at Fenner Hall, 15 Fenner Ave, Newport, for this purpose. It is being organized by her family and friends and is in conjunction with Dana-Farber Cancer Institute and http://www.BeTheMatch.org, a national bone marrow donor registry.

The first source for bone marrow matches is a sibling or child, if they fall in the age range, but Paulas family members were not a match. More than 35,000 people in the United States are diagnosed each year with leukemia, anemias, myelodysplastic disorders and other life-threatening diseases requiring treatment with a blood stem cell or bone marrow transplant. About 70 percent of bone marrow transplant recipients must rely on an unrelated donor. Finding a compatible donor is a challenge. The opportunity to register and/or donate will help many patients in need..

Donors must be 18 to 44, and be willing to donate to any patient in need.To join the registry, potential donors must complete paperwork at the drive and have a cheek swab taken. If unable to attend, donors are asked to go towww.bethematch.orgto sign up, or visit any RI Blood Center.

Paula (Fitzgerald) grew up in Newport in the Fifth Ward, attending Newport schools, graduating from Rogers in 1968. Her father, Jim Fitzgerald, was the Dean of Boys at Thompson and football coach and her mother Meg also worked in the school system. She has an older sister, Maureen, and younger siblings, Nancy and Bill. Paula is an outstanding athlete, tennis and golf being her games of recent years. After graduating from college, Paula continued working at Salas until it closed and now works for private catering companies. TR McGrath and Kitchen Companion.

Paula is married to Manny P Silvia, a retired lieutenant in Middletown police department and retired supervisor in DCYF Protective Services. They have two children, Corrine and Greg.

Paula does an amazing amount of volunteering although never wanting any recognition for her efforts. She volunteers for many organizations such as the MLK Community Center, Relay for Life, the Ladies Ancient Order of Hibernians, Mosaic Club, AARP school programs, and Vasco deGama Society. Shes a communicant of St. Augustins Church.

The news of her diagnosis is a shock, but Paula continues with her active, involved life, giving it her best. She wants to send the message that everyone should be proactive about their health and always follow up on lab work. Paula is now awaiting a bone marrow transplant!

Any questions, please contact Nancy Fitzgerald, nancyfitz53@gmail.com, 401-855-1985. To learn more please contact Dana-Farbers Bone Marrow Donor Program at866-875-3324, email nmdpdonor@dfci.harvard.edu or visit online http://www.bethematch.org

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Bone Marrow Drive To Benefit Paula Fitzgerald Silvia On Sunday, September 17th - Newport Buzz

Recommendation and review posted by simmons

Dr. Gurmukh Singh, vice chair of clinical affairs for the Department of Pathology and Walter L. Shepeard Chair in Clinical Pathology at the Medical College of Georgia at Augusta University. Credit: Phil Jones

It's a cancer of the plasma cells, which normally make an array of antibodies that protect us from infection.

With multiple myeloma, the cells start primarily producing instead a singular product, called a monoclonal antibody, or M spike, that leaves patients vulnerable for serious infections, like pneumonia, and can even eat away at their bones.

Sophisticated laboratory tests used to both diagnose the disease then follow treatment response, can send confusing messages to patients and their physicians, particularly after stem cell therapy to try to restore a healthy antibody mix, says Dr. Gurmukh Singh. Singh, vice chair of clinical affairs for the Department of Pathology and Walter L. Shepeard Chair in Clinical Pathology at the Medical College of Georgia at Augusta University, is corresponding author of the study highlighting reasons for potential confusion in the Journal of Clinical Medicine Research.

The tests, serum protein electrophoresis and serum immunofixation electrophoresis, or SPEP/SIFE, and serum free light chain assay, or SFLCA, separate proteins into groups according to their electrical charge.

The M spike stands out as a distinctive, dense band of color among the layers of protein groups, while typical antibody levels create bands of lighter smears.

But after stem cell therapy, which first destroys cancerous plasma cells then restores healthy ones, follow up profiles often yield a lineup of antibodiescalled an oligoclonal patternthat can look eerily similar to the M spike.

The confusion comes because there again may be a prominent and likely short-lived band of proteins that emerges as the antibody mix begins, ideally, to normalize.

"We want to emphasize that oligoclonal bands should mostly be recognized as a response to treatment and not be mistaken as a recurrence of the original tumor," Singh says.

The key clarifier appears to be the location of the malignant, monoclonal spike when the diagnosis is made compared to the location of new spikes that may show up after stem cell therapy in these oligoclonal bands, says Singh.

"If the original peak was at location A, now the peak is location B, that allows us to determine that it is not the same abnormal, malignant antibody," Singh says, pointing toward different before and after treatment profiles on a patient.

Normally antibodies spread out in a usual sequence in these studies. "If it's in a different location, it's not the same protein," reiterates Singh. "If the location is different, this is just a normal response of recovery of the bone marrow that could be mistaken for recurrence of the disease," Singh says of the oligoclonal bands that can also temporarily show up in response to an infection.

He notes while the prominent bands are typically short-lived following treatment, the recognition that they are non-malignant may occur only in retrospect.

For the study, Singh and his team looked at lab and clinical data on 251 patients with multiple myeloma treated from January 2010 to December 2016; 159 of those patients received autologous stem cell transplants. Each patient had at least three tests, and at least two of the tests were following their transplant.

They found the incidence of oligoclonal patterns was significantly higher in patients who had a stem cell transplant than the patients who had chemotherapy alone: 57.9 percent compared to 8.8 percent. Only five of the 159 patients who received a transplant had an oligoclonal pattern before treatment but 92 had one afterward. More than half of the the oligoconal patterns developed within the first year following a transplant. The earliest pattern was detected at two months - as soon as the first post-transplant tests were doneand a few occurred as long as five years later.

Autologous stem cell therapy is not considered curative for most patients with multiple myeloma. There is no clear cause of the disease but the risk does increase at age 40, Singh says.

Explore further: Excessive tests don't benefit patient, do increase cost in age-related immune disorder

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Test results after stem cell transplant for multiple myeloma can confuse patients and doctors about - Medical Xpress

Recommendation and review posted by sam

(Newser) When Kimberly Mascott Zieselman was 15, she had surgery she now says caused "irreversible harm" due to others' "discomfort with difference." In her op-ed for USA Today, Zieselman explains how, as a young teen, she didn't get her period like other girls, and when her parents took her to get examined, doctors made a surprising discovery: She was intersex, meaning a person born with both male and female characteristics. In Zieselman's case, that meant that even though on the outside she appeared female, she had male XY chromosomes and testes (instead of ovaries and a uterus) inside her body. She had androgen insensitivity syndrome, so that her body resisted male sex hormones called androgens and led to an external appearance of being female.

She says her parents agreed, per physician advice, to have her "healthy gonads" taken out, "without my knowledge or consent." She was also placed on a lifelong hormone replacement therapy, as her natural hormones had halted. She says these types of "non-consensual and medically unnecessary procedures" on intersex kids have been common since the '60s, with "often catastrophic" results and "largely unproven" benefits. "We are erased before we can even tell our doctors who we are," she writes. Zieselman believes most doctors and parents think they're doing the right thingbut she notes the "devastating impact" on patients and says "every human rights organization that has considered this practice has condemned it." "The right thing is to wait until an intersex person can participate in these life-altering decisions," she writes. Read the full piece.

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Parents and Doctors, Hold Off on This 'Devastating' Surgery - Newser

Recommendation and review posted by simmons

Haywood Regional Medical Center (HRMC) is announcing that obstetrician Dr. Jenny Van Winkle joined the medical staff on August 1, 2017.

We are very pleased with the addition of an experienced physician and surgeon like Dr. Van Winkle, said Rod Harkleroad, CEO of Haywood Regional Medical Center. With Dr. Van Winkle on board, we plan to expand upon the services for womens care to meet the needs of Western North Carolina so more patients can get quality and personalized care closer to home.

Van Winkle is board certified in Obstetrics & Gynecology. She received her medical degree from Texas A&M Health Science Center College of Medicine and completed her residency at The Methodist Hospital Houston Obstetrics & Gynecology in Houston, TX. Her special interests and training include prenatal care, contraception, infertility, laparoscopic and vaginal surgery, colposcopy and LEEP (Loop Electrosurgical Excision Procedure) procedures, PCOS, heavy menstrual bleeding, fibroids, incontinence, pelvic organ prolapse and menopause. Van Winkle is also fluent in Spanish.

Dr. Van Winkle, with her husband and children, decided to move to the mountains of Western North Carolina from Houston for a better quality of life. I love that obstetrics and gynecology provides me the opportunity to form long-term relationships with women, managing all stages of their life. My philosophy is to provide high quality patient centered care. I believe in listening and spending as much time with patients to offer individualized care, and Im looking forward to becoming part of the community. Shes also excited about working with the team as the practice service line pursues designation as a center for excellence for minimally invasive gynecological surgery.

Womens care providers at Haywood Regional Medical Center also include Robin Matthews, MD, and David Kirk, MD both board certified physicians. Also the hospital recently welcomed the addition of a certified nurse-midwife, Jody Schmit.

Dr. Van Winkle is accepting new patients. Appointments may be made by calling 828.452.5042. Services include obstetrics, well-women gynecological exams, adolescent gynecological care, ultrasounds, minimally invasive hysterectomy, abnormal pap smear treatments, endometrial ablation, infertility evaluation, breast and cervical cancer screenings, contraceptive management including IUDs, hormone replacement, incontinence, pelvic pain, pelvic prolapse, perimenopausal symptoms, laparoscopic surgery, and treatment of menstrual disorders.

As a part ofDuke LifePoint Healthcare, Haywood Regional Medical Center is supported by Duke University Health Systems world-renowned leadership in clinical excellence and quality care andLifePoint Healths extensive resources, knowledge and experience in operating community hospitals.Visit us at HaywoodWomensCare.

Excerpt from:
Jenny Van Winkle, MD, OB/GYN joins Haywood Regional and Haywood Women's Medical Center - Mountain Xpress (blog)

Recommendation and review posted by Bethany Smith

Skin transplantation could be an effective way to deliver gene therapy to treat type 2 diabetes and obesity, new research in mice suggests.

The technique could enable a wide range of gene-based therapies to treat many human diseases.

We think this can provide a long-term safe option for the treatment of many diseases

We resolved some technical hurdles and designed a mouse-to-mouse skin transplantation model in animals with intact immune systems, says study author Xiaoyang Wu, assistant professor in the cancer research department at the University of Chicago.

We think this platform has the potential to lead to safe and durable gene therapy in mice and, we hope, in humans, using selected and modified cells from skin.

Beginning in the 1970s, physicians learned how to harvest skin stem cells from a patient with extensive burn wounds, grow them in the laboratory, then apply the lab-grown tissue to close and protect a patients wounds. This approach is now standard. However, the application of skin transplants is better developed in humans than in mice.

The mouse system is less mature, Wu says. It took us a few years to optimize our 3D skin organoid culture system.

This study is the first to show that an engineered skin graft can survive long term in wild-type mice with intact immune systems.

We have a better than 80 percent success rate with skin transplantation, Wu says. This is exciting for us.

The researchers focused on diabetes because it is a common non-skin disease that can be treated by the strategic delivery of specific proteins.

They inserted the gene for glucagon-like peptide 1 (GLP1), a hormone that stimulates the pancreas to secrete insulin. This extra insulin removes excessive glucose from the bloodstream, preventing the complications of diabetes. GLP1 can also delay gastric emptying and reduce appetite.

Using CRISPR, a tool for precise genetic engineering, they modified the GLP1 gene. They inserted one mutation, designed to extend the hormones half-life in the blood stream, and fused the modified gene to an antibody fragment so that it would circulate in the blood stream longer. They also attached an inducible promoter, which enabled them to turn on the gene to make more GLP1, as needed, by exposing it to the antibiotic doxycycline. Then they inserted the gene into skin cells and grew those cells in culture.

When these cultured cells were exposed to an air/liquid interface in the laboratory, they stratified, generating what the authors referred to as a multi-layered, skin-like organoid.

Next, they grafted this lab-grown gene-altered skin onto mice with intact immune systems. There was no significant rejection of the transplanted skin grafts.

When the mice ate food containing minute amounts of doxycycline, they released dose-dependent levels of GLP1 into the blood. This promptly increased blood-insulin levels and reduced blood-glucose levels.

When the researchers fed normal or gene-altered mice a high-fat diet, both groups rapidly gained weight. They became obese. When normal and gene-altered mice got the high-fat diet along with varying levels of doxycycline, to induce GLP1 release, the normal mice grew fat and mice expressing GLP1 showed less weight gain.

Expression of GLP1 also lowered glucose levels and reduced insulin resistance.

Together, our data strongly suggest that cutaneous gene therapy with inducible expression of GLP1 can be used for the treatment and prevention of diet-induced obesity and pathologies, the authors write.

When they transplanted gene-altered human cells to mice with a limited immune system, they saw the same effect. These results, the authors wrote, suggest that cutaneous gene therapy for GLP1 secretion could be practical and clinically relevant.

This approach, combining precise genome editing in vitro with effective application of engineered cells in vivo, could provide significant benefits for the treatment of many human diseases, the authors note.

We think this can provide a long-term safe option for the treatment of many diseases, Wu says. It could be used to deliver therapeutic proteins, replacing missing proteins for people with a genetic defect, such as hemophilia. Or it could function as a metabolic sink, removing various toxins.

Skin progenitor cells have several unique advantages that are a perfect fit for gene therapy. Human skin is the largest and most accessible organ in the body. It is easy to monitor. Transplanted skin can be quickly removed if necessary. Skins cells rapidly proliferate in culture and can be easily transplanted. The procedure is safe, minimally invasive, and inexpensive.

There is also a need. More than 100 million US adults have either diabetes (30.3 million) or prediabetes (84.1 million), according the Centers for Disease Control and Prevention. More than two out of three adults are overweight. More than one out of three are considered obese.

Additional authors of the study are from the University of Chicago and the University of Illinois at Chicago. The National Institutes of Health, the American Cancer Society, and the V Foundation funded the study.

Source: University of Chicago

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Skin transplants could treat diabetes and obesity - Futurity: Research News

Recommendation and review posted by sam

LONDON (Reuters) - The science of gene therapy is finally delivering on its potential, and drugmakers are now hoping to produce commercially viable medicines after tiny sales for the first two such treatments in Europe.

Thanks to advances in delivering genes to targeted cells, more treatments based on fixing faulty DNA in patients are coming soon, including the first ones in the United States.

Yet the lack of sales for the two drugs already launched to treat ultra-rare diseases in Europe highlights the hurdles ahead for drugmakers in marketing new, extremely expensive products for genetic diseases.

After decades of frustrations, firms believe there are now major opportunities for gene therapy in treating inherited conditions such as haemophilia. They argue that therapies offering one-off cures for intractable diseases will save health providers large sums in the long term over conventional treatments which each patient may need for years.

In the past five years, European regulators have approved two gene therapies - the first of their kind in the world, outside China - but only three patients have so far been treated commercially.

UniQure's (QURE.O) Glybera, for a very rare blood disorder, is now being taken off the market given lack of demand.

The future of GlaxoSmithKline's (GSK.L) Strimvelis for ADA-SCID - or "bubble boy" disease, where sufferers are highly vulnerable to infections - is uncertain after the company decided to review and possibly sell its rare diseases unit.

Glybera, costing around $1 million per patient, has been used just once since approval in 2012. Strimvelis, at about $700,000, has seen two sales since its approval in May 2016, with two more patients due to be treated later this year.

"It's disappointing that so few patients have received gene therapy in Europe," said KPMG chief medical adviser Hilary Thomas. "It shows the business challenges and the problems faced by publicly-funded healthcare systems in dealing with a very expensive one-off treatment."

These first two therapies are for exceptionally rare conditions - GSK estimates there are only 15 new cases of ADA-SCID in Europe each year - but both drugs are expected to pave the way for bigger products.

The idea of using engineered viruses to deliver healthy genes has fuelled experiments since the 1990s. Progress was derailed by a patient death and cancer cases, but now scientists have learnt how to make viral delivery safer and more efficient.

Spark Therapeutics (ONCE.O) hopes to win U.S. approval in January 2018 for a gene therapy to cure a rare inherited form of blindness, while Novartis (NOVN.S) could get a U.S. go-ahead as early as next month for its gene-modified cell therapy against leukaemia - a variation on standard gene therapy.

At the same time, academic research is advancing by leaps and bounds, with last week's successful use of CRISPR-Cas9 gene editing to correct a defect in a human embryo pointing to more innovative therapies down the line.

Spark Chief Executive Jeffrey Marrazzo thinks there are specific reasons why Europe's first gene therapies have sold poorly, reflecting complex reimbursement systems, Glybera's patchy clinical trials record and the fact Strimvelis is given at only one clinic in Italy.

He expects Spark will do better. It plans to have treatment centers in each country to address a type of blindness affecting about 6,000 people around the world.

Marrazzo admits, however, there are many questions about how his firm should be rewarded for the $400 million it has spent developing the drug, given that healthcare systems are geared to paying for drugs monthly rather than facing a huge upfront bill.

A one-time cure, even at $1 million, could still save money over the long term by reducing the need for expensive care, in much the same way that a kidney transplant can save hundreds of thousands of dollars in dialysis costs.

But gene therapy companies - which also include Bluebird Bio (BLUE.O), BioMarin (BMRN.O), Sangamo (SGMO.O) and GenSight (SIGHT.PA) - may need new business models.

One option would be a pay-for-performance system, where governments or insurers would make payments to companies that could be halted if the drug stopped working.

"In an area like haemophilia I think that approach is going to make a ton of sense, since the budget impact there starts to get more significant," Marrazzo said.

Haemophilia, a hereditary condition affecting more than 100,000 people in markets where specialty drugmakers typically operate, promises to be the first really big commercial opportunity. It offers to free patients from regular infusions of blood-clotting factors that can cost up to $400,000 a year.

Significantly, despite its move away from ultra-rare diseases, GSK is still looking to use its gene therapy platform to develop treatments for more common diseases, including cancer and beta-thalassaemia, another inherited blood disorder.

Rivals such as Pfizer (PFE.N) and Sanofi (SASY.PA) are also investing, and overall financing for gene and gene-modified cell therapies reached $1 billion in the first quarter of 2017, according to the Alliance of Regenerative Medicine.

Shire (SHP.L) CEO Flemming Ornskov - who has a large conventional haemophilia business and is also chasing Biomarin and Spark in hunting a cure for the bleeding disorder - sees both the opportunities and the difficulties of gene therapy.

"Is it something that I think will take market share mid- to long-term if the data continues to be encouraging? Yes. But I think everybody will have to figure out a business model."

Reporting by Ben Hirschler; editing by David Stamp

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Drugmakers' hopes for gene therapy rise despite tiny sales in Europe - Reuters

Recommendation and review posted by simmons

UC San Diego researchers have invented a technology that offers a possible new way to fight genetic diseases, and have built a San Diego biotech company around their discovery.

The scientists adapted the powerful CRISPR/Cas9 DNA editing system, which has transformed the world of biology, to work on RNA, the messenger molecule that carries DNAs instructions into cells.

The system worked in cell cultures to stop production of RNA involved in forms of myotonic dystrophy, ALS and in Huntingtons disease. These are all incurable genetic diseases that can be fatal. This RNA can be toxic in itself, or produce abnormal proteins that cause disease.

About 95 percent of the disease-causing RNA was destroyed in the cell cultures.

The scientists have formed a San Diego biotech company called Locana to bring the technology to patients. Several years of development, including animal testing, is expected before that can happen.

The study was published Thursday in the journal Cell. Go to j.mp/rnacrispr to get the study. Gene Yeo was the senior author. The first authors were David Nelles and Ranjan Batra, postdoctoral researchers in Yeos lab.

CRISPR/Cas9 cuts DNA at specified targets, inactivating or altering gene sequences. It has been used for such feats like editing the genome of human embryos. The adapted system doesnt target the genome, but only RNA.

Scientists led by UC San Diegos Gene Yeo modified CRISPR so it doesnt target DNA and instead attacks specific RNA sequences, while leaving others alone. This specificity is vital for therapeutic purposes. It is delivered by an adenovirus, a virus commonly used in gene therapy.

The study expands on previous research that showed the RNA-adapted CRISPR could track RNA as it moves around cells. It didnt affect RNA production, however.

That study included Jennifer Doudna, a UC Berkeley scientist who helped pioneer the CRISPR system. Doudna is on Locanas scientific advisory board, Yeo said. He and Nelles are co-founders of Locana.

The Cas9 component, a protein that destroys the target, was too large to be delivered by the virus. So the team cut the proteins size by removing unnecessary parts used to cleave DNA. The result, RCas9, is guided by an accompanying RNA molecule to the target site.

Yeo said he expects the viral delivery system will remain effective for perhaps five to 10 years. Thats important because RNA is continually being produced from DNA, so the new disease-causing RNA must likewise be destroyed.

CRISPR star Jennifer Doudna calls for public debate on embryo editing

With embryo gene editing a reality, humanity enters a new era

Gene editing used to find cancer's genetic weak spots

DARPA funds UC gene drive research against mosquito-borne diseases

Can geneticists engineer healthier humans?

UCSD gene drive technology offers life-transforming power

bradley.fikes@sduniontribune.com

(619) 293-1020

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UCSD team adapts CRISPR to edit RNA for disease therapies - The San Diego Union-Tribune

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Dr. Ronald Cohn is the pediatrician-in-chief for Sick Kids Hospital, and he's been receiving calls, emails and visits over the last few months from parents who once denied having their child genetically tested for fear of discrimination.(Rick Madonik / Toronto Star file photo)

By Victoria GibsonStaff Reporter

Wed., Aug. 9, 2017

After a federal bill protecting patients from genetic discrimination passed in the spring, familiar faces began to appear at Dr. Ronald Cohns door.

Cohn is the pediatrician-in-chief for SickKids Hospital, and over the last few months, hes been fielding new conversations with parents of young patients, whove previously sat down with him to discuss genetic testing.

The tests could be recommended for any number of reasons, whether to find the most effective treatment for a known condition or to diagnose a mystery slate of symptoms their child was living through. But, prior to March this year, the results of that test werent legally protected from discrimination, discouraging some parents from giving their consent.

What if their child was later forced to disclose their genetic results to a potential employer, or to an insurance agency? Could they be faced with cripplingly expensive policies? Or denied insurance altogether?

Its paralyzing, it was paralyzing to me, Cohn said. Some of the parents just couldnt get themselves to do it.

But after the Genetic Non-Discrimination Act, or Bill S-201, passed in March ensuring no person can be required to undergo genetic testing or disclose previous results many of those parents are re-appearing at Cohns door.

Theyre asking about the tests, whether theyll really be protected, and whether they can finally begin. Theyre bringing their kids back to the hospital, and getting answers they were scared of before.

As you can imagine, the kind of conversations were having now have significantly changed for the better, Cohn said. Now we can tell parents, you dont have to be concerned about this anymore.

Though SickKids hasnt accumulated any hard data about genetic testing in the five months since the bill passed, Torontos University Health Network has been tracking its numbers for several years. Every year for the last five years, theyve documented a 10 to 20 per cent increase in genetic testing.

Asked about the change since the bill was voted in specifically, Dr. Runjan Chetty, acting medical director of their laboratory medicine program, said that theres been a large increase in genetic tests to determine whether a patient will respond to certain treatment.

Dr. Suzanne Kamel-Reid, chief of the networks three clinical genetics laboratories, believes that rise is part of a larger trend. These increases mirror the increase in genetic and genomic knowledge as well as the increased availability of targeted drugs, she said.

Every day, tests in her labs begin with the arrival of a genetic material sample blood, bone marrow or tissue. Samples often come from hospitals within the network, but not always. Some are shipped in from around the province.

Once the sample is brought into the lab, DNA or RNA is extracted and a hunt for specific biomarkers begins. The biomarkers theyre investigating for any given sample depend on the patients reason for referral or history.

Bill S-201 has the most direct impact on inherited disease testing within the UHN, Kamel-Reid said. When a patient is afflicted with certain symptoms, sometimes the puzzle can be solved by looking at family histories.

Clinical geneticists are the ones that do this. They put the story together, Kamel-Reid explained. They figure out what is most likely going on with the family, and what genes should be tested to solve the mystery.

The results of those targeted tests allow patients to screen early for diseases they may be of particular risk for, which Kamel-Reid says can decrease side effects as well as incidents of the same disease in other relatives.

An individual could alter their lifestyle to avoid developing a disease, or take the precaution of getting screened more regularly than the average patient.

Sometimes you cant even do anything about it, but getting an explanation at least allows you to look for the signs, she said. As Bill S-201 came through parliament, chatter bubbled up in the lab about its implications.

Isnt that a great thing? Everyone should be able to have the testing they require without being afraid, she said. Because knowledge is power.

However, the new law is still on shaky ground. The federal Liberal government has indicated its intent to refer the bill to the Supreme Court to test its constitutionality. Hours before the final reading in the House of Commons, Prime Minister Justin Trudeau called Bill S-201 unconstitutional, that it infringed the jurisdiction of provincial governments.

He recommended that MPs vote against it, but in a free vote, Liberal backbenchers defied Trudeau with a 222-60 vote in the spring. Justice Minister Jody Wilson-Raybould had also made significant attempts to rouse opposition for the bill.

When the bill passed, Cohn said he was hit with emotion. Though it may eventually be challenged in the Supreme Court, inside the halls of Sick Kids, its offering comfort and protection for patients hes spent years with.

Reverting back to how things were, to him, isnt an option. We are watching this closely to make sure that it wont happen.

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Genetic testing back on radar for parents - Toronto Star

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Northwestern Medicine scientists and engineers have invented a range of bioactive tissue papers made of materials derived from organs that are thin and flexible enough to even fold into an origami bird. The new biomaterials can potentially be used to support natural hormone production in young cancer patients and aid wound healing.

The tissue papers are made from structural proteins excreted by cells that give organs their form and structure. The proteins are combined with a polymer to make the material pliable.

In the study, individual types of tissue papers were made from ovarian, uterine, kidney, liver, muscle or heart proteins obtained by processing pig and cow organs. Each tissue paper had specific cellular properties of the organ from which it was made.

This new class of biomaterials has potential for tissue engineering and regenerative medicine as well as drug discovery and therapeutics, corresponding author Ramille Shah said. Its versatile and surgically friendly.

Shah is an assistant professor of surgery at the Feinberg School of Medicine and an assistant professor of materials science and engineering at McCormick School of Engineering. She also is a member of the Simpson Querrey Institute for BioNanotechnology.

For wound healing, Shah thinks the tissue paper could provide support and the cell signaling needed to help regenerate tissue to prevent scarring and accelerate healing.

The tissue papers are made from natural organs or tissues. The cells are removed, leaving the natural structural proteins known as the extracellular matrix that then are dried into a powder and processed into the tissue papers. Each type of paper contains residual biochemicals and protein architecture from its original organ that can stimulate cells to behave in a certain way.

In the lab of reproductive scientist Teresa Woodruff, the tissue paper made from a bovine ovary was used to grow ovarian follicles when they were cultured in vitro. The follicles (eggs and hormone-producing cells) grown on the tissue paper produced hormones necessary for proper function and maturation.

This could provide another option to restore normal hormone function to young cancer patients who often lose their hormone function as a result of chemotherapy and radiation, Woodruff, a study coauthor, said.

A strip of the ovarian paper with the follicles could be implanted under the arm to restore hormone production for cancer patients or even women in menopause.

Woodruff is the director of the Oncofertility Consortium and the Thomas J. Watkins Memorial Professor of Obstetrics and Gynecology at Feinberg.

In addition, the tissue paper made from various organs separately supported the growth of adult human stem cells. Scientists placed human bone marrow stem cells on the tissue paper, and all the stem cells attached and multiplied over four weeks.

"Thats a good sign that the paper supports human stem cell growth, said first author Adam Jakus, who developed the tissue papers. Its an indicator that once we start using tissue paper in animal models it will be biocompatible.

The tissue papers feel and behave much like standard office paper when they are dry, Jakus said. Jakus simply stacks them in a refrigerator or a freezer. He even playfully folded them into an origami bird.

Even when wet, the tissue papers maintain their mechanical properties and can be rolled, folded, cut and sutured to tissue, he said.

Jakus was a Hartwell postdoctoral fellow in Shahs lab for the study and is now chief technology officer and cofounder of the startup company Dimension Inx, LLC, which was also cofounded by Shah. The company will develop, produce and sell 3-D printable materials primarily for medical applications. The Intellectual Property is owned by Northwestern University and will be licensed to Dimension Inx.

An Accidental Spill Sparked Invention

An accidental spill of 3-D printing ink in Shahs lab by Jakus sparked the invention of the tissue paper. Jakus was attempting to make a 3-D printable ovary ink similar to the other 3-D printable materials he previously developed to repair and regenerate bone, muscle and nerve tissue. When he went to wipe up the spill, the ovary ink had already formed a dry sheet.

When I tried to pick it up, it felt strong, Jakus said. I knew right then I could make large amounts of bioactive materials from other organs. The light bulb went on in my head. I could do this with other organs.

It is really amazing that meat and animal by-products like a kidney, liver, heart and uterus can be transformed into paper-like biomaterials that can potentially regenerate and restore function to tissues and organs, Jakus said. Ill never look at a steak or pork tenderloin the same way again.

Monica Laronda, who was a postdoctoral fellow in Woodruffs lab during the study, also is a coauthor. She is now an assistant professor of pediatrics at Feinberg and a researcher at the Stanley Manne Childrens Research Institute, Ann & Robert H Lurie Children's Hospital of Chicago. Laronda and Woodruff also are members of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

The research was supported by grant P50 HD076188-02 from the Center for Reproductive Health After Disease of the National Centers for Translational Research in Reproduction and Infertility, Google and the Hartwell Foundation.

This article has been republished frommaterialsprovided byNorthwestern University. Note: material may have been edited for length and content. For further information, please contact the cited source.

Reference:

Jakus, A. E., Laronda, M. M., Rashedi, A. S., Robinson, C. M., Lee, C., Jordan, S. W., . . . Shah, R. N. (2017). Tissue Papers from Organ-Specific Decellularized Extracellular Matrices. Advanced Functional Materials, 1700992. doi:10.1002/adfm.201700992

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'Origami Organs' Can Potentially Regenerate Tissues - Technology Networks

Recommendation and review posted by Bethany Smith

For patients with severe and end-stage heart failure there are few treatment options left apart from transplants and stem-cell therapy. But a new Israeli study finds that stem-cell therapy may harm heart-disease patients.

The research, led by Prof. Jonathan Leor of Tel Aviv Universitys Sackler Faculty of Medicineand Sheba Medical Center and conducted by TAUs Dr. Nili Naftali-Shani, explores the current practice of using cells from the host patient to repair tissue and contends that this can prove toxic for patients.

We found that, contrary to popular belief, tissue stem cells derived from sick hearts do not contribute to heart healing after injury, said Leor. Furthermore, we found that these cells are affected by the inflammatory environment and develop inflammatory properties. The affected stem cells may even exacerbate damage to the already diseased heart muscle.

Tissue or adult stem cells blank cells that can act as a repair kit for the body by replacing damaged tissue encourage the regeneration of blood vessel cells and new heart muscle tissue. Faced with a worse survival rate than many cancers, many heart-failure patients have turned to stem-cell therapy as a last resort.

But our findings suggest that stem cells, like any drug, can have adverse effects, said Leor. We concluded that stem cells used in cardiac therapy should be drawn from healthy donors or be better genetically engineered for the patient.

The researchers, who published their study in the journal Circulation, also discovered the molecular pathway involved in the negative interaction between stem cells and the immune system as they isolated stem cells in mouse models of heart disease. Afterward, they focused on cardiac stem cells in patients with heart disease.

The results could help improve the use of autologous stem cells those drawn from the patients themselves in cardiac therapy, Leor said.

We showed that the deletion of the gene responsible for this pathway can restore the original therapeutic function of the cells, said Leor. Our findings determine the potential negative effects of inflammation on stem-cell function as theyre currently used. The use of autologous stem cells from patients with heart disease should be modified. Only stem cells from healthy donors or genetically engineered cells should be used in treating cardiac conditions.

The researchers are currently testing a gene editing technique (CRISPER) to inhibit the gene responsible for the negative inflammatory properties of the cardiac stem cells of heart disease patients. We hope our engineered stem cells will be resistant to the negative effects of the immune system, said Leor.

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Stem-cell treatment may harm heart disease patients - ISRAEL21c

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GREENVILLE Onboard the next SpaceX cargo spacecraft launching to the International Space Station (ISS) from Pad 39A at the Kennedy Space Center will be a commercial research system owned and operated by Techshot Inc. The equipment will conduct regenerative medicine experiments onboard the station before returning to Earth in the same capsule for a splashdown off the coast of Southern California approximately 30 days later.

Techshots ADvanced Space Experiment Processor (ADSEP) is a device approximately the size of a microwave oven that contains three separate modules, each of which simultaneously can process experiments in three separate on-orbit replaceable automated mini-laboratory cassettes. Two of the three cassettes on the mission will conduct research for a team led by Robert Schwartz, Ph.D., from the University of Houston.

Funded by the Center for the Advancement of Science in Space (CASIS), the study will evaluate a new approach to growing human tissue for transplant. The microgravity environment onboard the ISS could improve cell growth and development and 3D tissue formation, enabling discoveries that will advance translational disease treatments. Previous studies on Earth by Schwartz and his collaborators at the Texas Heart Institute and the Baylor College of Medicine have found that low gravity environments help specially programmed stem cells move toward becoming new heart muscle cells, which may be used to repair damaged hearts on Earth.

The third cassette contains an experiment conducted by and for Techshot itself. The company is developing a 3D bioprinter for the ISS known as the Techshot BioFabrication Facility (BFF), which it expects to launch to the station near the end of 2018. Critical to the success of the printer will be the ability to provide nutrients and mechanical stress for organs and tissues it manufactures in space strengthening them and keeping them viable for transplantation back on Earth.

Approximately 36 hours prior to launch, Techshot scientists in a laboratory at the Kennedy Space Center will 3D print a one centimeter thick construct consisting of stem cells and heart muscle cells. Theyll then place it inside the prototype BFF cell culturing subsystem, which for this mission is temporarily housed inside an ADSEP cassette. The printer used in the lab will be the same modified nScrypt unit that was the first to 3D print cardiac constructs with adult human stem cells in microgravity aboard an aircraft in parabolic flight. Video captured inside the cassette during the month-long experiment, and the tissue itself which is expected to have developed its own micro blood vessels will be evaluated for effectiveness after return from space.

Techshots space bioprinting program leverages its terrestrially based technologies for cell isolation and vascular graft development, and its decades long experience culturing cells in space, said Techshot Chief Scientist Eugene Boland, Ph.D., in a news release. Being able to test our novel approach for culturing 3D printed cells more than a year before we fly the whole BFF is invaluable. The data from this mission will get us one step closer toward our goal of helping eliminate organ shortages.

Founded in 1988, Techshot Inc., develops technologies used in the aerospace, defense and medical industries. Through its Space Act Agreement with NASA, and its role as an official CASIS Implementation Partner, the company provides equipment and services that help federal, institutional and industrial customers live and work in space. http://www.Techshot.space

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Techshot system headed to space - Evening News and Tribune

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Earlier this year, Texas Heart Institute received Alpha Phi Foundations 2017 Heart to Heart Grant. The $100,000 grant will fund research led by Doris Taylor, Ph.D., director of the Regenerative Medicine Research and the Center for Cell and Organ Biotechnology at the Texas Heart Institute, to study cardiac repair in women at the cellular level.

Were just really passionate about these projects that have long-term clinical relevancy, as a women-driven organization and being committed to womens heart health, said Colleen Sirhal, vice chair of the Alpha Phi Foundation.

The study will explore sex differences in blood, bone marrow and stem cells of patients enrolled in cell therapy clinical trials.

While bone marrow cell therapy has been used to treat cardiovascular disease in clinical trials, very few studies have been conducted to assess the sex differences in efficacy and outcomes. By performing a proteomic analysis of the samples and evaluating the proteins that cells produce and secrete, the results could shed light on unanswered questions related to critical sex-specific differences in cardiovascular disease, potentially leading to improved cell therapies.

Its about time that were paying attention to sex differences, Taylor said. Were not just small men. The biology is different.

Heart disease remains the No. 1 cause of death in both men and women in the United States, yet theres a limited understanding in the scientific community as to why it affects men and women differently. For example, women 45 years old and younger have a higher likelihood than men of dying within a year of their initial heart attack.

In addition, women have a higher risk of developing small vessel disease, in which the walls of tiny vessels within the heart muscle become blocked rather than larger arteries, causing heart-related chest pain. Because the major coronary arteries may look normal, women with small vessel disease can have a heart attack go undiagnosed and untreated.

We know heart disease happens differently in men and women, Taylor said. More young women than men die of heart disease. Why is that? Is there something that happens early? If we only look at these women who are older, are we missing something major? By looking at healthy, normal younger women, were going to be able to do comparisons across time, comparisons by disease, and comparisons by sex. I think thats really exciting.

Historically, women and minorities have largely been underrepresented in research and clinical trials, especially pertaining to cardiovascular disease.

Dr. Taylors colleague at the Texas Heart Institute, Stephanie Coulter, M.D., a cardiologist and the director of the Center for Womens Heart and Vascular Health at Texas Heart Institute and a recipient of the 2013 Heart to Heart Grant, is actively recruiting younger women to participate in her research registry.

Since women are typically affected by heart disease a decade or more later than men, age may also have played a role in this underrepresentation, Coulter said. Our Womens Center research is focusing on women age 18 and older to address this very issue.

Coulter added that trials focusing on prevention in women, such as the Womens Health Initiative and Womens Health Study, have, in fact, had clinical impact. However, the percentage of women enrolling in clinical trials continues to be disproportionate to the prevalence of cardiovascular disease in women, but we are seeing improvements thanks to multiple initiatives in the U.S. that continue to address the issue of women in clinical trials.

Its easy for people to assume that if you study men, itll apply to women, but it seems anathema to people to assume that if you study women it might benefit men, Taylor said. At the end of the day, when it comes time to look at the data and ask, How does this treatment work in women? How does this treatment work in men?, oftentimes there arent enough women enrolled in the trials to split that out. Statistically, youd be doing yourself a disservice.

Taylor has spent nearly two decades studying key contributors to cardiac repair at the cellular level, specifically looking at proteins cells produce and secrete based on gender as a new frontier in cell therapy.

Early on in Taylors career, she studied how bone marrow cells behaved based on gender. She extracted cells from male mice and administered them to female mice and vice versa, allowing her to track the Y chromosome. The results showed that only the males treated with female cells improved. This phenomenon raised the question of whether or not the bone marrow cells were the same.

After measuring the bone marrow cells that were present in males and females, Taylor discovered that the cells were inherently different: In the male mice, there were more inflammatory cells, fewer progenitor and stem cells and a different number of immune cells than in the female mice. In addition, when the bone marrow cells were placed in a petri dish, the female cells produced more growth factors responsible for recruiting repair cells after an injury.

Taylor conducted follow-up experiments in which she gave female and male cells to both female and male mice. The results confirmed her hunch: The only cells that were reparative were the female cells.

It made me realize a critical detail for the first time:Every time we take bone marrow from a different person with the intention of delivering it back to them as a therapy, if we look at the cells present in the marrow, theyd be different, Taylor said. Which means, every time were doing an autologous cell therapytrial, in which you take bone marrow and deliver it back to an individual, you are giving each person a completely different or unique drug in that trial.

Through the Heart to Heart grant, the data from Taylors research will allow her to build upon her early research on sex differences and, hopefully, identify a way to optimize cell therapy.

Already cells are as good as some drugs. If we optimize them and choose the right cells for the right patient at the right time, maybe well hit the home run, Taylor said.

Read more:
Texas Heart Institute Awarded Grant to Study Sex Differences in Cardiac Repair - Texas Medical Center (press release)

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SOUTH SAN FRANCISCO, CA--(Marketwired - August 08, 2017) - VistaGen Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, announced today that the Company has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. Patent Application No. 14/359,517 regarding proprietary methods for producing hematopoietic precursor stem cells, which are stem cells that give rise to all of the blood cells and most of the bone marrow cells in the body, with potential to impact both direct and supportive therapy for autoimmune disorders and cancer.

The breakthrough technology covered by the allowed U.S. patent was discovered and developed by distinguished stem cell researcher, Dr. Gordon Keller, Director of the UHN's McEwen Centre for Regenerative Medicine in Toronto, one of the world's leading centers for stem cell and regenerative medicine research and part of the University Health Network (UHN), Canada's largest research hospital. Dr. Keller is a co-founder of VistaGen and a member of the Company's Scientific Advisory Board. VistaGen holds an exclusive worldwide license from UHN to the stem cell technology covered by the allowed U.S. patent.

"We are pleased to report that the USPTO has allowed another important U.S. patent relating to our stem cell technology platform, stated Shawn Singh, Chief Executive Officer of VistaGen. "Because the technology under this allowed patent involves the stem cells from which all blood cells are derived, it has the potential to reach the lives of millions battling a broad range of life-threatening medical conditions, including cancer, with CAR-T cell applications and foundational technology we believe ultimately will provide approaches for producing bone marrow stem cells for bone marrow transfusions. As we continue to expand the patent portfolio of VistaStem Therapeutics, our stem cell technology-focused subsidiary, we enhance our potential opportunities for additional regenerative medicine transactions similar to our December 2016 sublicense of cardiac stem cell technology to BlueRock Therapeutics, while focusing VistaStem's internal efforts on using stem cell technology for cost-efficient small molecule drug rescue to expand our drug development pipeline."

About VistaGenVistaGen Therapeutics, Inc. (NASDAQ: VTGN), is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders. VistaGen's lead CNS product candidate, AV-101, is in Phase 2 development, initially as a new generation oral antidepressant drug candidate for major depressive disorder (MDD). AV-101's mechanism of action is fundamentally different from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat MDD, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. AV-101 is currently being evaluated by the U.S. National Institute of Mental Health (NIMH) in a small Phase 2 monotherapy study in MDD being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH. VistaGen is preparing to launch a 180-patient Phase 2 study of AV-101 as an adjunctive treatment for MDD patients with an inadequate response to standard, FDA-approved antidepressants. Dr. Maurizio Fava of Harvard University will be the Principal Investigator of the Company's Phase 2 adjunctive treatment study. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including neuropathic pain, epilepsy, Huntington's disease, and levodopa-induced dyskinesia associated with Parkinson's disease and other disorders where modulation of the NMDA receptors, activation of AMPA pathways and/or key active metabolites of AV-101 may achieve therapeutic benefit.

About VistaStemVistaStem Therapeutics is VistaGen's wholly-owned subsidiary focused on applying human pluripotent stem cell (hPSC) technology, internally and with third-party collaborators, to discover, rescue, develop and commercialize (i) proprietary new chemical entities (NCEs), including small molecule NCEs with regenerative potential, for CNS and other diseases and (ii) cellular therapies involving stem cell-derived blood, cartilage, heart and liver cells. VistaStem's internal drug rescue programs are designed to utilize CardioSafe 3D, its customized cardiac bioassay system, to develop small molecule NCEs for VistaGen's pipeline. To advance potential regenerative medicine (RM) applications of its cardiac stem cell technology, in December 2016, VistaStem exclusively sublicensed to BlueRock Therapeutics LP, a next generation regenerative medicine company established in 2016 by Bayer AG and Versant Ventures, rights to certain proprietary technologies relating to the production of cardiac cells for the treatment of heart disease. In a manner similar to its exclusive sublicense agreement with BlueRock Therapeutics, VistaStem may pursue additional collaborations and potential RM applications of its stem cell technology platform, including using blood, cartilage, and/or liver cells derived from hPSCs, for (i) cell-based therapy, (ii) cell repair therapy, and/or (iii) tissue engineering.

For more information, please visit http://www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

Forward-Looking StatementsThe statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the successful launch, continuation and results of the NIMH's Phase 2 (monotherapy) and/or the Company's planned Phase 2 (adjunctive therapy) clinical studies of AV-101 in MDD, and other CNS diseases and disorders, including neuropathic pain and L-DOPA-induced dyskinesia associated with Parkinson's disease, the potential for the Company's stem cell technology to produce NCEs, cellular therapies, regenerative medicine or bone marrow stem cells to treat any medical condition, including autoimmune disorders and cancer, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the AV-101 clinical development activities described above. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

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VistaGen Receives Notice of Allowance from US Patent and Trademark Office for US Patent regarding Breakthrough ... - Marketwired (press release)

Recommendation and review posted by Bethany Smith

There are a number of ways to find out more about your fertility these days including from several at-home fertility test startups that have started to pop up in the last few years.Modern Fertility hopes to soon operate in much the same way, but with a more affordable option for testing 10 key hormones affecting womens fertility.

Though Modern Fertilitys at-home test wont be available till later this year, you can pre-order it on their website for $149 though the price will go up after the pre-order at a yet-to-be determined date. Should you want to get started now, the startup also offers the comprehensive screening through a lab near you, though its not clear what the price is for that.

The kit includes checking your hormone levels for:

Anti-mullerian hormone (AMH)

Follicle stimulating hormone (FSH)

Estradiol (E2)

Luteinizing hormone (LH)

Thyroid stimulating hormone (TSH)

Free thyroxine (FT4)

Progesterone (P4)

Prolactin (PRL)

Free Testosterone (Free T)

Total Testosterone (T)

Modern Fertility competitor Future Family, a startup offering financing optionsfor egg freezing and IVF procedures, also sells two separate fertility tests you can take at home. The first test kit goes for $300 and includes the three most key hormone tests: AMH, FSH and E2. Future Familys second test, Fertility Age Test Plus, includes testing for the first three hormones and three tests for thyroid dysfunctions TSH, TPO (thyroperoxidase) and T3/T4. (triiodothironine andthyroxine levels) for a similar price.

Everlywell, a startup offering myriad home health tests, includes a similarly comprehensive fertility kitas Modern Fertility for $400, but with 11 hormone tests and not all of them are the same ones.

Half the price for more hormone testing seems like a deal. However, theres a hot debate among these startups over just how many of these hormone tests, and which ones, are necessary. Everlywell, for instance, doesnt include AMH because they consider that only necessary if you are about to undergo IVF. Future Family told TechCrunch only the three key tests are necessary unless you need thyroid testing, because the other hormone tests are widely accepted by doctors as not being true indicators of fertility.

How does each startup determine what is necessary? Everlywell and Future Family are staffed with a chief medical officer to guide them. Modern Fertility is currently in search of the same, but says it pulls its information from medical advisors and has held initial conversations with fertility doctors.

Obviously, ask your doctor which kit is right for you (or if theres another they suggest). The overall goal for all three is the same empower women with knowledge about their fertility.

Modern Fertilitys main target is young women who want a family someday, but not necessarily today.

Were building a test that makes this info accessible to women early in their lives,co-founder Afton Vechery said. We believe that information is the first step.

Vechery, who was a product lead at 23andMe before starting Modern Family, says she became interested in the space after doing some due diligence in the infertility space for a healthcare private equity firm earlier in her career.

Thats when I learned the emotional aspect of infertility. Its crazy to me that infertility is not seen as a medical condition in the majority of the U.S. and that such a small percentage of women get the education and services they need to start a family, she said. Thats the part that stuck with me.

She then went through some testing at a clinic to find out more about her own fertility. That was an impactful moment for her. That is, until she got the $1,500 bill in the mail.

As I started talking to more women it was clear there was a lot of anxiety over fertility but no way to afford to test it, Vechery said. Every woman should have access to this information that is a better predictor than just our ages.

Modern Fertility is currently in Y Combinators latest batch. You can catch them later this month at YC Demo Day.

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Modern Fertility is offering a comprehensive fertility test for women who hope to be moms someday - TechCrunch

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