Archive for October, 2020

ST. PAUL, Minn. Chrysal International is announcing a partnership with Verdant Technologies to bring a step change solution to the floral industry. This new product, a 1-MCP-based solution, will be available across the industrys international markets with initial focus on Colombia, one of the largest floral growers in the world, and Miami, one of the largest receiving areas in the United States for floral products.

Chrysal International is committed to offering innovative solutions for the floral supply chain, from growers to consumers. Through our partnership with Verdant Technologies, we are expanding our product offering to our customers and are able to explore new possibilities in the industry. It is exciting for us to be part of this new venture, said Peter Vriends, CEO of Chrysal International, the worldwide market leader in flower food and post-harvest flower and plant care.

For Verdant Technologies, an emerging leader in the biotechnology industry, a partnership

with Chrysal is an exciting introduction of HarvestHold to the floral market segment.

Chrysal has a long history of providing premium flower care products with proven results for growers, packers, supermarkets, florists and consumers. This along with Chrysals mission to reduce waste in the horticultural supply chain make their partnership a natural fit, said Gordon Robertson, Chief Revenue & Marketing Officer of Verdant Technologies.

Chrysal and Verdant Technologies are actively working together to bring a patented 1-methylcyclopropene (1-MCP) based solution to market that delivers superior stability, efficacy and consistency throughout the horticultural supply chain.

1-MCP has proven to be an effective tool to extend the quality of fresh cut flowers and potted plants to date, said Jon Fobes, President of Verdant Technologies. What Chrysal and Verdant are developing is a shelf-stable solution and superior delivery method for 1-MCP. Our product is extremely reliable, easier to store, does not require wetting and can be applied where it is needed throughout the supply chain process.

Chrysal and Verdant Technologies have focused their technologies around the 1-MCP products flexibility, which will allow Chrysals global customer base of growers and packers to spend more time getting more product to market and lessen the impact of horticultural wastage.

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Chrysal is a global company. The flexibility of our product makes it a global product with the reach and ability to be applied anywhere in the world at any step of the supply chain process, said Robertson. We have ideas. Chrysal is aware of the challenges in the industry. By working together, we can solve the immediate needs of their customers and develop future solutions to make the global floral industry more efficient, sustainable, and deliver better quality products.

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About Verdant Technologies

Verdant Technologies is an emerging leader to the biotechnology industry, offering HarvestHold product life extension technology for floral and produce products. Verdant Technologies and its partners work hand-in-hand to reduce negative environmental impacts while delivering fresher, more nutritious produce and enhanced florals to more people in more places. Verdant Technologies has corporate offices in St. Paul, Minnesota. For more information, visitwww.verdant-tech.com.

About Chrysal International

Chrysal is a main driving force in the flower and plant industry and worldwide market leader in flower food and post-harvest flower and plant care. Whether you grow, transport, sell, or simply enjoy the beauty of cut flowers and potted plants in your own home, Chrysal has products to keep them looking fresh for longer. Through more than 85 years of experience and innovation, a commitment to quality and an on-going search for sustainable solutions, we aim to meet our customers needs today and tomorrow. The result? Flowers and plants that last longer, happy customers and, in the end, a more beautiful world.Chrysal. Nurturing beauty.For more information about Chrysal International, visitwww.chrysal.com.

Original post:
Chrysal International and Verdant Technologies Announce Partnership - PerishableNews

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The province's oil and gas association is heralding anew drilling contract in the Flemish Pass as a rarevictory for the struggling Newfoundland and Labrador offshore oil industry.

CNOOC Petroleum North America is set to create a single exploration well in the area next spring.

"It is certainly positive news for our industry and for the supply and service sector that Noia represents," said Charlene Johnson, chief executive officer for the Newfoundland and Labrador oil and gas industries association.

The Chinese company has contracted U.K.-based Stena Drilling Ltd. to drill the Pelles A-71 well, with work starting between April and June2021, and lasting for some 90 days.

The company will use the Stena Forth, a harsh-environment drill ship capable of drilling in water depths up to 3,000metres. The campaign will create roughly 370 direct and indirect jobs, said Johnson, and inject tens of millions into the province's economy.

It's the latest step in efforts to expand oil production beyond the four producing fields in the Jeanne d'Arc Basin.

But it's the only exploration activity planned for next year, despite some $4 billion in exploration commitments having been made by oil companies in recent years.

The global pandemic has threatened that activity, and industry boosters are hoping CNOOC's continued confidence in the offshore will motivate other oil majors to take similar action.

"We would love to see more than one well being drilled next year," said Johnson.

Johnson is hoping thata program announced by the provincial government last month will encourage companies like CNOOC, BP and others to drill more wells in frontier areas like the Flemish Pass and the Orphan Basin intheir quest to find the next big discovery.

The province has promised to provide cash to companies to help defer the cost of an exploration well, which can cost up to $100 million each.

The money will come from downpayments made by companies on exploration projects that have been defaulted because the work was not done in a specified period of time, typically six years.

A company must hand overa 25 per cent down paymentonwork commitments to the offshore petroleum board when it is awarded exploration rights on a land parcel. As such, the board is now holding roughly $1 billion in cash from oil giants like ExxonMobiland BP.

Under this new program, if companies forfeit that cash, the province will use it to entice other companies to drill wells.

It's conceivable that up to $46 millionin security payments could become available next year alone, with thatfigure steadily increasing in future years.

The province is still working out the details of how companies can access these funds, and no approvals have yet been made.

In a statement to CBC News, an official with the Department of Industry, Energy and Technology said CNOOC is "very interested" in the program.

Johnson is hoping the program will be the incentive needed for CNOOC to do a second or even a third exploration well next year.

But she said it's vital for the province to reveal the program parameters as soon as possible so companies can have some certainty.

"That may have an impact in terms of influencing the number of wells next year if it's attractive enough," she said.

CNOOC has a 100 per cent working interest in two exploration licenses, and has described the area it plans to explore as "world-class" with a "large hydrocarbon potential."

The company has already acquired 3D seismic information on the area it plans to drill, andhas said it aims to "build long-term, sustainable success in the region."

CNOOC had planned to drill what's known in the business as a wildcat well this past spring and summer in the same area, using the Stena IceMax at a reported daily fee of $299,000.

But that campaignwas shelved because of thepandemic.

It was one of a long list of setbacks that have rocked the oil industry this year.

With oil prices cratering this past spring because of a combination of the pandemic and an oil price war between Russia and Saudi Arabia, oil companies began slashing spending.

Drilling on the Hibernia platform and work on a series of extension tiebacks have been suspended, a long-planned life extension project for the Terra Nova FPSOis under review, Equinor's Bay du Norddevelopment has been deferred, and the West White Rose extension project is stalled at roughly 60 per cent completion.

As a result, the industry has been shedding jobs in large numbers, and the supply and service sector is reeling, said Johnson.

With climate changes worries as a backdrop, there's widespread agreement that the transition away from hydrocarbons will occur in the coming decades in order to reduce greenhouse gas emissions.

That's why it's vitally important that exploration drilling is intensified, said Johnson, so the province and its citizens can benefit from the resource before it's too late.

The sooner new discoveries are made, she said, the sooner construction on new oil producing platforms would commence.

Read more from CBC Newfoundland and Labrador

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Drilling contract seen as an N.L. oil industry win following a series of pandemic setbacks - CBC.ca

Global Oral Probitoics Market Report Details Out Market Overview, Market Valuation, And Future Market Prospective

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By some accounts, Timothy Leary is the most productive and prolific evangelist for psychedelic drugs in human history. At the height of the 1960s counterculture, he was a prophet (or a pied piper, depending on who you ask) who inspired millions of young people to take LSD and go out of their minds.

He coined a mantra, Turn On, Tune In, Drop Out, which was adopted as a PR slogan and a life philosophy for scores of hippies. He sparked and featured in classic works by The Beatles, The Who, Allen Ginsberg and The Moody Blues. He was also a womanizer and a brazen narcissist, as well as an IQ-tested genius. President Nixon reportedly called him the most dangerous man in America.

Though he died 24 years ago, in 1996, there may be no better time to consider Timothy Learys life and legacy. Thousands are turning on to the psychedelic renaissance every year, and when they dive deeper into the LSD wormhole theyll no doubt land on Learys name as one of the guys responsible for it all.

As a clinical psychologist at Harvard University, Leary worked on the Psilocybin Project with his colleague and friend, Richard Alpert, and a close circle of graduate students. Their controversial studies aimed to demonstrate the therapeutic and mystical applications of psychedelics, but Leary and Alpert were eventually fired amid allegations they had pressured students into taking hallucinogens. Leary later took his studies to the Millbrook Estate, a 64-room mansion in New York, where he and a communal group freely experimented with LSD and spiritual practice.

By the end of his life, Leary had left a sizeable mark on American culture. He had influenced psychedelic rock, the hippie trail, spiritual seekers, Steve Jobs, Silicon Valley, painters, poets and the very scientists leading the psychedelic renaissance today. At the same time, Leary's careless peddling of LSD as an intense aphrodisiac it could give women several hundred orgasms, he claimed and something children could enjoy dealt sometimes life changing blows. Many under Leary's influence were guided on voyages from which they never returned.

On what would have been the month of his 100th birthday, VICE presents an oral history of Timothy Learys long, strange trip, via interviews with those who knew, loved and hated the man.

Interviews have been edited for length and clarity.

1955: Leary wasnt always drawn to drugs. He started his career as a strait-laced psychologist who researched personality theory and preferred Martini and red meat to pills. But something was missing. Things came to a head in 1955 when his first wife took her own life on his 35th birthday, leaving Leary a single father to two young children.

He had a traumatic childhood, too, with an abusive father, an absent mother and a conman grandfather rendering him deeply suspicious of authority figures. It seems a rebellion was only a matter of time. Robert Forte, the author of Outside Looking In and a longtime friend of Learys, shares more:

When Frank Barron [a psychologist and friend of Learys] first told him about psychedelic drugs, Tim said, I'm not going anywhere near that ship. And I think you should stay away from it, too, Frank.

He had to talk Tim into it. It took a year for Frank to convince him to do it. But also, Tim was very against authority, and there was a lot of it in the 1950s in American society. When you put him in with an authority figure, he would kind of go nutty. That was the way his psyche was set up since he was a young boy.

I found some letters that Tim wrote to his mother when he was at West Point [school], about what his goals in life were. He just wanted to have a good time. He wanted to be famous. He just wanted to have a normal, healthy, happy life.

Summer, 1960: Leary has his first psychedelic trip in Cuernavaca, Mexico, with psilocybin mushrooms. The trip is a life-changing experience. It was in Cuernavaca that he met Michael Maccoby, a psychology researcher who'd just left Harvard.

Tim had asked me if I wanted to experience hyperconsciousness. I said, Tim, theres white magic, and theres black magic. Black magic is when you get something and pay the price later. White magic, you do the work first.

Autumn, 1960: Leary returns to Harvard and re-acquaints himself with Richard Alpert, a faculty member who would become his right-hand man in psychedelic research, and eventually rechristen himself as Ram Dass. Leary and Alpert found the Harvard Psilocybin Project, a pioneering programme of studies into psilocybins potential to map the fineries of human consciousness.Don Lattin, author of The Harvard Psychedelic Club and Changing Our Minds, remembers the Harvard Psilocybin Project:

It was revolutionary from the beginning. From the very, very beginning. They were never really doing the serious clinical trials with psychedelics that had already been happening in the 1950s. No, they had a whole other idea, an agenda.

[From his first trip], Leary was convinced that psychedelics were going to revolutionise the practice of psychology, psychiatry, and change the world.

Elliot Aronson was a Harvard faculty member they contacted for advice:

The [first] major time I heard about psilocybin was at a lunch with Alpert and Tim. Tim was talking in a rather grandiose way about all that psilocybin could accomplish. And so I made a snide crack: All that from a little mushroom? or whatever it was he had in his hand.But he was serious. And he didn't like my joking about it. And he was right. It was a powerful little mushroom, a powerful little pill.

1962: Leary and his colleague Walter Pahnke devise the Marsh Chapel Experiment, to test psilocybins ability to trigger religious experiences. Leary and the graduate students also dose themselves with the drug. Reverend Randall Laakko looks back on the test as a participant:

I got down to the door and I busted out of there and went out into the side yard of the chapel. And Leary came out after me. I just wanted to immerse myself in life and the world. I buried my face in the shrubs and I took a big bite out of the leaves. They were very bitter. I probably spat them out.

When we were starting to come down, I lay on the floor for a while. Leary was laying right beside me. I remember the smell of his hair. I reached on to his body with my hand, and he took it gently. It was just a sense of oneness with everything.

Allan Cohan, a member of Learys Harvard circle, says: Interestingly, all of this is now being rediscovered by psychologists at Johns Hopkins University, for example, who are using psychedelics for depression, for end of life experiences, etc. I wish they'd consulted us. We could have saved them a lot of time.

Towards the end of 1962, Leary and the Harvard group begin to question their aims. They found the International Federation for Internal Freedom (or IFIF) to support their research.Paul Lee, a Harvard theologian, a participant at Marsh Chapel and a member of the Leary circle, reflects on the crews aims:

There was a big discussion about whether to go underground with it and make it a kind of secret initiation issue, or go public. But Leary was an Irish revolutionary and he wanted to shout it from the rooftops. So it went that way. It simply became a tsunami.

As Leary and Alpert evangelised other faculty members, some tried it and had terrible experiences, remembers Allan Cohan. But Leary, when faced with that even when we had a suicide or two said, Well, in the exploration of outer space, you're going to lose some astronauts. Same with inner space. There was a lot of care and concern from Alpert. But Leary was simply willing to take many more risks.

Herbert Kelman was a department member at the time:

The faculty organised a meeting. It was packed, absolutely packed. I outlined why these drug experiments Leary was conducting were lax in scientific validity. They weren't doing research at all.

We heard of graduate students having mental health issues. There were a couple of students in that class who had bad trips. I can't remember any details, but somebody who was on the brink [anyway] almost tumbled from a window.

1963: After failing to arrive at classes, Learys contract at Harvard is terminated. He seeks the support of benefactors like Peggy Hitchcock, the heiress to the Mellon fortune. She gives Leary and his circle a sprawling estate, Millbrook, from which to conduct further research.

When I first met Tim, I thought he was one of the most interesting people I'd ever met, says Peggy Hitchcock. I thought he was absolutely fascinating. I fell in love with him quickly, and we had a funny kind of swinging door relationship. But his relationship with his kids convinced me we couldnt be together.

He tried to be a good father. But really, when he got involved with psychedelics and everything, I mean, he really wasn't. Teenagers need a parent. He wasn't able to be there for them. [Tims] daughter later committed suicide in jail and his heart was really trashed. His son never, never spoke to him again. Hardly.

Years later [in 1992], when we reconnected, we spent most of the night talking. He was staying at a hotel. And that was as close as I ever got to his talking to me about the sadness in life.

1963-66: Millbrooks early years are promising. Publishing research, holding talks and staging retreats, it places emphasis on integration and non-drug-related spiritual practice. Leary founds his own religion, The League for Spiritual Discovery, which holds LSD as its primary sacrament. Bill Richards, who now works as a psychedelics researcher at John Hopkins, looks back on those days at Millbrook:

It was fun. It was loose. It was a little bit chaotic, but it was warm and genuine and playful and open to new ideas, you know, and appreciative of the transcendental state of consciousness. The seminars I attended there were really very sober, academically-oriented workshops. So, you know, Millbrook wasn't just a bunch of crazy hippies having a party.

This would change. Returning from a trip to India, Leary found that Millbrook had descended into a psychedelic squat.Ted Druch, who lived in an ashram on the Millbrook site, remembers how out of control things got:

Millbrook was a gold rush. But with Timothy Leary and acid instead of gold. There were horses painted psychedelic colours running through the woods. Girls were running around naked, fucking everything in sight. Tim Leary had an aura. But he really was an asshole.

We ended up having a huge fight with Leary. He was into this God will provide, everything will provide. Everything will come. You never have to worry about anything kind of attitude. Except the problem was that we didn't have money to put oil in the furnace. His daughter even fled and moved into our ashram. We gave her a room, and she spent the next five days in her room crying.

Over the course of two years, things went from bad to worse. The cops got involved. Dutchess County was a Republican stronghold and we went through about a year of constant raids.

Vanessa Hollingshead is the daughter of Michael Hollingshead, the man who first gave Leary LSD:

I never liked living at Millbrook Mansion. Most of the time, Leary, my dad, hippie men and women, everyone, was on something.

I [accidentally] did between nine and 19 hits of acid at five years old. I didn't even know what was going on. It was on sugar cubes. I was jumping up and down on a trampoline and all of a sudden I looked down and I just saw all these coloured fluorescent worms. I started screaming and Britta [my dads girlfriend] grabbed me off the trampoline. I remember them holding me up and giving me a shot of [the anti-psychotic medicine] Thorazine right in the behind.

1967: Alpert leaves for India, where he met his guru. Leary moves to the West Coast and finds a largely receptive audience among the burgeoning hippie movement. It was at the historic Human Be-In in San Francisco in January of that year where Leary coined his famous mantra, Turn on, tune in, drop out, remembers Jay Stevens, the celebrated author of Storming Heaven__**:**

[In Tim], LSD found the perfect salesman: charming, personable, able to coin phrases. He was an advertising genius in a way. He could have made a lot of money in advertising.

Eugene Schoenfeld was Learys personal physician at the time:

I remember the moment when Tim came out with the 'turn on, tune in, drop out' slogan. A lot of young people followed his advice and dropped out. In fact, I said to him a little bit afterwards, 'You've got a PhD. I have a medical degree. And all these kids are dropping out of college. You know, is this good? He just shrugged it off. It was a great slogan. But, I mean, he would take acid before giving public talks. So sometimes, unless you were in the same state, it just seemed like gibberish, you know?

Bill Richards has other thoughts:

I think it should be Turn on, tune in, jump in work within the structures of society to change them.

James L Penner, the author of Timothy Leary: The Harvard Years__**, says Learys famous slogan has been misread:**

It's not simply drop out of society and never pay attention to politics or anything, and go be a hermit. He asks us to drop out of the games we play. I'm playing the professor game. You're playing the journalists game. He was playing the Timothy Leary game all the time himself. And psychedelics allow you to step back from the game and question it, deflate it, not take it so seriously.

1967: Learys advocacy for psychedelic drugs reaches fever pitch during the 1967 Summer of Love. He is adopted as the spiritual leader of the Brotherhood of Eternal Love, a drug ring that manufactured Orange Sunshine, the world-famous acid strain that fuelled the counterculture.

Michael Horowitz was Learys close friend and personal archivist:

I and at least 5 million other people can say that we would never have taken LSD if it weren't for Tim Leary. He used to quip later in his life, I turned on 5 million people and only 5,000 ever thanked me.

In the history of every religion, it's the priests who controlled the sacraments, whatever the sacrament happened to be. In the mid-20th century, the priests were the psychiatrists. Leary was a psychologist who became a shaman.

Norman Watt was Learys replacement at Harvard. A researcher in schizophrenia, he became acquainted personally with the costs of Learys revolution.

I met many [casualties]. I treated them in hospitals and veterans hospitals in California and Ohio and elsewhere. There were so many. And the research was still beginning. Its only in the decades since that weve learnt about how LSD impacts the nervous system of human beings. It's all come out since then.

James Kent, a psychedelic thinker and host of the Dose Nation podcast, reflects on Learys negative impact:

How dangerous was Tim? I don't think he was Manson dangerous. But he helped make Manson, no doubt. There would be no Charlie Manson without Tim Leary.

1970: The War on Drugs is launched. LSD is made federally illegal and many promising avenues in psychedelic research are banned.Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies, says:

Learys reputation is pretty low [among psychedelic scientists]. I think that a lot of people blame him for the crackdown. But I really think the crackdown on psychedelics happened because psychedelics were going right. They motivated people to get involved in social justice activities, protests. And Tim did a lot of good work generating people to have those kinds of experiences. I think, on balance, he did way more good than harm. Though I fault him for twisting the data in his studies.

Robert Forte agrees:

Well, it's such bullshit. He didn't ruin research. Yeah, he was outrageous. But I mean, the government was the one that fucking ruined research with their idiotic move. How come nobody is saying that? Tim didn't just tell people to take psychedelic drugs. The most continuous message throughout his whole life was to question authority and think for yourselves.

After running for Governor of California during which he got The Beatles to write Come Together as his campaign song Leary is arrested in 1970 on drug charges after two stubbed roaches are found in his car ashtray. He is sentenced to ten years in jail.

He didn't do anything, nothing, to ingratiate himself with any kind of establishment, says Peggy Hitchcock. He didn't care. And so, of course, when they arrested him, that was just the way it was going to happen. I kind of knew it was going to happen. It was a question of time. No one can say 'Fuck you' to everybody all the time. It just doesn't work.

Leary escapes from jail and is shipped by a radical left wing group, The Weather Underground, to Algeria. He makes his way to Switzerland and lives in exile, but is captured in 1973 and taken back to the USA by the CIA. He faces nearly a century behind bars.

I knew Joanna Harcourt-Smith [Tims new wife] very well, remembers Eugene Schoenfeld. But when she moved to San Francisco, I noticed that she would be asking questions about people's drug habits, for example. And one time she asked me how she could obtain a large quantity of LSD. It just didn't seem right. As it turned out, Joanna was scooping up the information because she and Timothy were cooperating with the federal government.

When I first heard the rumours, I didnt believe it. When I found out? Shock, dismay, disappointment. Yes, all those things. I visited Tim in prison. He certainly did not have a posh cell like some of the Mexican drug lords had in their prisons, but he was protected, I think, especially after he began cooperating with the feds.

I really just reduced my contact with him greatly [after this].

Doug Rushkoff, a writer and later friend of Learys, is more balanced:

Towards the end [of his life], a lot of journalists were really getting into whether or not he had turned in the Weathermen to the CIA. And he was a little upset by that. But he told the CIA stuff only what they already knew or stuff that was no longer current. And, you know, there are always these efforts to recast heroes.

1976: After his early release from prison in 1976, Tims work moves to other areas: space exploration, life extension and, predominantly, computers and technology.

You've got to understand that his work with psychedelics was sort of like a greatest hit, says Zach Leary, Tims son. You go see a rock and roll band play their hit single, but their career is about so much more than that. And that was very much the same with him. Tune in, turn on, drop out, the psychedelic years, were really just one step on a much larger path and a much larger vision.

Anytime somebody came around who was really trying to wax nostalgic about [that time], he would get really feisty. He'd say, 'Hey, man, that's the past. You're on some old trip, man. It's not 'tune in, turn on, drop out' anymore. Its 'turn on, boot up, jack in' now."

From the 80s onward, he saw technology as the next psychedelic, the new LSD, recalls Doug Rushkoff. He believed that that digital would be as powerful or more powerful, and plus you don't have to eat it. They just log on.

1996: At 75 years old, on the 31st of May, Leary dies in the Hollywood Hills. Amid the growth of early PC and cyberpunk culture, he had enjoyed a resurgence in popularity.

I remember the day he died, says Zach. We all knew that was going to be the day. I was very clear. We were being guided by Ram Dass [Alpert] on the telephone.

Doug Rushkoff was there, too. In the last half hour or so of his life, he started to say, 'Why not?' And he repeated 'Why not?' in all these weird ways. 'Why not? Why not? Why not? Why not?' 'Why not die?' he was suggesting. 'You know, this is it.' And in life, when someone is telling you not to do something, ask 'Why not?' That's the core question.

2020: Early reports suggest that psychedelic use has increased considerably amid the pandemic lockdown. Doug Rushkoff wonders what Tim would have thought.

He was saying 'tune in, turn on' and all that, but he was painfully aware of the downside to people doing psychedelics in the wrong set and setting without proper tutelage.

But, I mean, of course he'd be happy that maybe it took a pandemic and the crash of capitalism or something for people to have the safe time and space to explore and seize the opportunity. You know, it's like, 'Oh, wait a minute, I'm going to be alone in my house or in my apartment with my girlfriend for the next month. Let's take acid and fuck a lot.' I don't think he would think that's a bad thing. It's a sacred thing.

James L. Penner agrees: He would have advocated tripping during a time of popular upheaval and political unrest like today. No doubt. Think of the cataclysms of the 60s and how often he tripped then. I mean, he was optimistic to a fault. He always felt that tripping could provide insight and a life-changing experience like the one he had [in Mexico].

@EdPrideaux

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Timothy Leary Turns 100: Americas LSD Messiah, Remembered By Those Who Knew Him - VICE UK

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The Anabolic Steroids market to go the reverse transversal way in the next decade - The Think Curiouser

Oct. 21, 2020 11:00 UTC

FREIENBACH, Switzerland--(BUSINESS WIRE)-- EffRxSA, a commercial-stage company that commercializes niche and orphan medicines in Switzerland and Europe, today announced it has recently entered into an exclusive license agreement with Diurnal Group plc, a specialty pharmaceutical company targeting patient needs in chronic endocrine diseases, for the registration and commercialization of Alkindi for pediatric adrenocortical insufficiency (AI) in Switzerland. Under the terms of the agreement EffRx has received the exclusive rights to register and commercialize Alkindi in Switzerland.

Alkindi is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenocortical insufficiency (AI). Alkindi is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from pediatric AI and the related condition congenital adrenal hyperplasia (CAH).

Alkindi is already approved and marketed in the European Union and is the first preparation of hydrocortisone specifically designed for use in children suffering from AI. On September 29th, 2020 the US Food and Drug Administration (FDA) has also approved Alkindi for AI.

EffRx has recently submitted to Swissmedic (Switzerland) a Market Authorization Application for the registration of Alkindi. Pending successful regulatory registration, this new treatment approach is expected to be available on the Swiss market by 2022. In Switzerland there are approximately 200 patients suffering from pediatric AI.

We are extremely pleased to announce this partnership with Diurnal which demonstrates EffRx capability to expand its portfolio with promising niche and orphan medicines, commented Lorenzo Bosisio, CEO of EffRx Pharmaceuticals. We look forward to bringing this novel therapeutic approach to Switzerland. We are confident that Alkindi provides a tangible advancement for young patients suffering from AI and their carers.

Martin Whitaker, CEO of Diurnal, commented: This partnership with EffRx further validates the quality of our products and broadens the future availability of Alkindi. EffRx is well-placed to register and market our product Alkindi in Switzerland. We have made strong progress with the sales of Alkindi across Europe since its approval and subsequent launch in 2018, and we are confident this agreement will enable further growth.

Pediatric AI, including the genetic condition CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone).

About EffRx Pharmaceuticals

EffRx Pharmaceuticals is a commercial-stage pharmaceutical company focused on the late stage development and commercialization of prescription medications for niche and orphan indications. The business model is centered around providing superior clinical and commercial value propositions for physicians, payers and patients.

EffRx pro-actively seeks in-licensing opportunities for Europe in niche therapeutic areas, with a primary interest for rare diseases, where EffRx has received an orphan drug designation (ODD) from the FDA for a pipeline asset.

EffRxs go-to-market competence is proven by the development, launch and lucrative expansion of Binosto in a highly competitive European market. Our lead commercialized product, Binosto for the treatment of osteoporosis, is marketed in the US as well as selected European and Asian countries.

About Diurnal Group plc

Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.

For further information about Diurnal, please visit http://www.diurnal.co.uk

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EffRx Pharmaceuticals Signs Exclusive License Agreement with Diurnal for the Registration and Commercialization of Alkindi and Submits Market...

First, Katie Stoll sent the company a swab from her mixed-breed dog; later, a sample of tap water from her kitchen sink. Neither sample was identified as non-human by Orig3n lab employees.

Genetic counselor Katie Stoll was skeptical when she bought an at-home genetics test kit from a company called Orig3n in December 2017.

The kit was advertised to parents looking to better understand their childrens genetic profiles.

From food allergies to natural abilities for language and learning, the results help you get to know your child even better, Orig3n said of its Childhood Development genetic test kit.

Stoll purchased the test kit not to learn more about her child, but to learn more about Orig3n, a Boston-based consumer genetics company that pivoted to COVID-19 testing last spring and is now facing sanctions from the Centers for Medicare & Medicaid Services after the lab produced at least 383 false positive coronavirus test results last summer.

Stoll, working on her own, eventually submitted two samples to Orig3n for analysis. First, she sent the company a swab from her mixed-breed dog, Ginger; then later, a sample of tap water from her kitchen sink. Neither sample was identified as non-human by Orig3n lab employees.

Stoll is a board-certified genetic counselor who now works as executive director for the Genetic Support Foundation, an Olympia, Washington-based nonprofit that aims to provide independent information about genetics.

In a 2018 complaint she wrote to the Massachusetts Department of Public Health spurred by Orig3ns failure to identify the dog and tap water samples as non-human Stoll said that in ordering the kits, she as a consumer wanted to see if the company was forthright about the potential risks and limitations of the kind of genetic testing it offered. She also wanted to know if the company required a consent form, since the test was for children.

Orig3n CEO Robin Smith said last week that while the type of DNA analysis his company offers is relatively new, it provides one tool among many to help people make decisions about their lives.

The philosophy and culture here is, let's optimistically look at how you make yourself better, which is what everybody's interested in, he said. It's just another tool in that approach.

Scientists skeptical

But direct-to-consumer genetic testing continues to be viewed with skepticism in the scientific community.

Sarah Nelson is a senior research scientist at the University of Washington specializing in the ethical and social implications of genomics the study of all of an individuals genes and direct-to-consumer genetic testing. The university'sMolecular Biology and Genetics programs were ranked sixth in the world by U.S. News & World Report.

Theres a wide range in the quality and validity of direct-to-consumer genetic testing companies and the products they offer, Nelson said, but overall, the genetics community has reservations about genetic tests billed as being able to advise people about their predisposition to certain traits.

There's skepticism that we even understand the genetic basis of diseases and traits well enough to be reporting back to individuals, just the scientific credibility, she said. Maybe in 20 years we'll know enough to give people that type of information, but right now, it's premature.

Lindsay Farrer, a medical geneticist and Boston Universitys chief of biomedical genetics, said direct-to-consumer genetic testing often misleads customers because the companies use population-level data from studies about genetic links to certain traits or diseases and wrongly applies that data into risk assessments for random individuals.

Usually, the studies used by companies like Orig3n are based on very specific populations, such as older white European women, that dont always represent the range of people ordering the tests.

The information they give, even if it's of limited applicability, the accuracy of it is, at best, modest, he said. I guess my conclusion would be buyer beware.

Orig3n fails to flag samples as non-human

Stoll watched Orig3n advertise at sporting events including NFL and NHL games with concern, but it was the companys online advertisements for its Childhood Development test kits that prompted her to place an order herself.

Stoll thinks consumer genetic test kits like the ones offered by Orig3n also push important ethical boundaries, especially when it comes to children. Children cant consent to learning information about their DNA that has the potential to shape the rest of their lives, she said, even if their parents can.

Stoll said she didnt trust Orig3n with her childs DNA or her own, so instead, she swabbed the cheek of her dog, Ginger. After sending the kit containing Gingers DNA to Orig3n, she got a full report back from the company on Jan. 18, 2018 about the dogs genetic profile, which showed, among other things, that she was likely to have mild struggles with reading.

She said she gave the company a second chance. She ordered another Childhood Development kit, and sent in a sample of tap water from her kitchen sink on March 17, 2018. Again, she got a full report back from Orig3n. According to the report, the tap water would need longer to develop skills required for language learning.

Farrer laughed out loud when he learned that Orig3n had returned profiles for Stolls dog and the sample of tap water from her kitchen sink.

I can't think of a word to describe it, but it is beyond incompetence, he said. If that's the case, they are not competent to do what they're doing. If theyre getting DNA out of tap water, then thats bacterial DNA and that is clearly different from human DNA.

If they cant generate results reliably, then its worse than snake oil, Farrer said. Its downright chicanery.

A lab in transition

The companys report on Stolls sample of tap water was signed by Orig3ns then-lab director, a board certified geneticist, which deeply disturbed Stoll.

She reached out to the lab director, who told Stoll that she had resigned from the company, and that when the tap water sample was submitted, Orig3n was transitioning to a new director.

The lab director was not on-site at the laboratory when the test was performed and she had very limited visibility into the testing operations at that time, Stoll wrote in her complaint letter.

Stoll told the DPH that she was concerned about Orig3ns ethics, its technical proficiency and its professional oversight.

I hope that (the Centers for Medicare & Medicaid Services) will investigate these concerns and act as necessary in the interest of public safety, Stoll wrote in the complaint, dated Sept. 24, 2018.

In an emailed response to a similar complaint Stoll sent to the federal Food & Drug Administration, Tim Stenzel, writing on behalf of FDA Commissioner Scott Gottlieb, said the agency takes reports like hers seriously.

...We will evaluate this matter to determine what follow-up action is appropriate, Stenzel wrote. The type and extent of any follow-up is dependent upon the nature of the problem, the possible impact on the public health, and the availability of our resources.

A DPH investigation into Orig3n conducted before Stoll filed her complaint found the lab had fixed lab issues that led to the companys failure to identify dog DNA as non-human.

In April 2020, despite three previous investigations by other agencies into quality control problems in Orig3ns lab, the FDA gave the company emergency authorization to conduct coronavirus testing.

In May, the DPH recommended Orig3n as a testing option for nursing homes facing deadly outbreaks.

For Stoll, the eventual finding by regulators that problems at Orig3ns lab led to the reporting of hundreds of false positive COVID-19 tests showed a dangerous weakness in how governmental agencies are overseeing labs that test human samples, whether those tests are used for diagnostic purposes or personal betterment. False diagnostic test results can pose a danger to patients because doctors make medical decisions based on those results.

That weakness needs to be addressed so Americans can trust the results of their lab tests, especially amid a deadly pandemic, she said.

I feel discouraged, Stoll said last week. What does the system mean when you do things the right way and you file complaints to the right agencies and nothing happens, and then something horrible like this happens? It just feels terrible, really.

Jeannette Hinkle is a reporter for The MetroWest Daily News. Reach her at jhinkle@wickedlocal.com.

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Skepticism led woman to send dog DNA to Orig3n. Scientists question the reliability of direct-to-consumer genetic testing and analysis. -...

Hereditary Testing Services Market: Introduction

Hereditary testing is usually referred to as genetic testing or DNA testing. Hereditary testing is employed to spot alterations in the DNA sequence that correlate with a disease or higher risk to develop a disease. This kind of test is often used for diagnosis before any symptoms of the disease are recognizable in order to work out the personal risk for certain multifactorial diseases. Thus, the results of hereditary testing can have far-reaching effects on a person's life.

Hereditary testing can provide important information for diagnosis, treatment, and prevention of illness; however, there are limitations. For instance, a positive result from DNA testing in a healthy individual doesn't generally mean that he would develop a disease, while in some situations, a negative result doesn't guarantee that the individual won't have a particular disorder.

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Key Drivers, Restraints, and Opportunities of Hereditary Testing Services Market

The global hereditary testing market is estimated to expand significantly in the near future, due to a rise in incidence of hereditary disorders and cancer and a rise in awareness & acceptance of personalized medicines. For instance, hereditary testing has been widely utilized in pharmacogenomics, also referred to as drug-gene testing. Additionally, advancements in hereditary testing techniques are expected to boost the hereditary testing market during the forecast period. However, standardization concerns of hereditary testing-based diagnostics and stringent regulatory requirements for product approvals are anticipated to hamper the hereditary testing market during the forecast period. Conversely, untapped emerging markets in developing countries are expected to offer significant opportunities for market players. For instance, healthcare systems in developing countries such as Brazil, India, and China have witnessed a significant increase in investments in healthcare and infrastructure, which boosts the demand for hereditary testing in the region.

Technological advancements in hereditary testing are likely to boost the global market during the forecast period. Advances in sequencing techniques have reduced the sequencing time and cost of hereditary testing. For instance, microarrays substantially reduce the sequencing time by utilizing microchips. These microchips employ fluorescein to spot mutations within the chromosomes. Furthermore, innovations such as exome sequencing and next-generation sequencing have reduced the cost of hereditary testing. Hence, technological advancements are projected to propel the global hereditary testing market during the forecast period.

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North America to expand significantly during forecast period

North America is projected to dominate the global hereditary testing services market during the forecast period. Increased demand for hereditary testing to understand ancestry, a rise in the demand for in-vitro fertilization (IVF), and pre-implantation testing are key factors augmenting the share held by the region. Technological advancements, presence of key players, launch of new products, the demand of diagnostics for cancer detection, and rise in prevalence and incidences of autoimmune, infectious diseases in the region are major factors driving the market in the region.

The hereditary testing services market in Asia Pacific is anticipated to expand at a notable growth rate during the forecast period. Increase in patient burden suffering from chronic diseases and recent mergers & acquisitions among key players offering hereditary testing and services are estimated to propel the market in the Asia Pacific region during forecast period.

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Top Companies in Hereditary Testing Services Market

The global hereditary testing services market is consolidated in terms of the number of players. Key players in the global hereditary testing services market include

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Hereditary Testing Services Market: Advancements in hereditary testing techniques are expected to boost the market - BioSpace

Global Predictive Genetic Testing & Consumer/Wellness Genomics Market: Snapshot

The use of genetic test, as pre-symptomatic testing of diseases, has gained popularity in predicting future risks by providing information on an individuals chromosomes and genetic mutations. Predictive genetic testing is relatively new but rapidly emerging arena in public health practices, especially in developed nations. It is increasingly being used to guide nutritional strategies and training outcomes for a number of disorders. Common disorders include Huntingtons disease, cystic fibrosis, phenylketonuria, Downs syndrome, breast cancer, and sickle cell anemia.

Usually conducted in healthy persons, it involves identifying certain genetic traits that may cause disease in later years of life. Some of the most common types of predictive genetic testing can be genetic susceptibility testing, predictive diagnostic, and population screening. They may be useful in persons who have family history of some treatable genetic disorders. Consumer genomics usually involves the application of whole genome sequencing essentially to classify individuals in various risk types for a variety of diseases.

While wellness genomics is used to assist persons to take appropriate health decisions that promotes their wellness and help in maintenance of better health. It typically includes various genotypic and clinical information. Coupled with preventive medicines, wellness and consumer genomics form a key role in guiding health and wellness decisions in various populations.

The offerings of predictive genetic testing and consumer/wellness genomics market is expected to play a seminal role in the ultimate discovery of personalized therapies and medicines. World over, several direct-to-consumer (DTC) genetic testing and healthcare providers offer genetic testing products and services that are not essentially focused on disease risk but offer information that are being used by individuals, to offer information, with different levels of scientific validity, to guide their decision in fitness, diet, and athletic ability.

The type of genetic testing which is employed to diagnose or predict the gene mutation or genetic changes linked to a disease is called predictive genetic testing. It is usually used in a symptomatic person to check future risks. The branch of genomics concerned with the sequencing and interpretation of the individual is called consumer genomics, while the one which predicts the genetic factors contributing to healthy living is called wellness genomics. This type of testing enables a person to make good lifestyle changes and choices.

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The rising health care awareness and shifting population preference toward a healthy lifestyle have led to the expansion of the market for predictive genetics testing & consumer/wellness genomics. Factors such as the rising attention of the government and other private regulatory bodies toward public health care, increased effectiveness & quality of genetic testing, prevalence of chronic diseases & genetic diseases such as Parkinsons & cystic fibrosis are expected to drive the global predictive genetics testing & consumer genomics market during the forecast period. Furthermore, the rising need to understand ones family history is propelling the global market as well. However, stringent regulatory rules and ethics for the approval of genetic testing could limit the markets development through 2025.

In terms of test type, the global predictive genetics testing & consumer/wellness genomics market can be categorized into the predictive testing, consumer genomics, and wellness genomics segments. Predictive testing can be further divided into the genetic susceptibility testing, predictive diagnostic, and population screening sub-segments. On the basis of application, the global market can be split into the following groups: cancer screening, cardiovascular screening, musculoskeletal screening, diabetic screening, Parkinsons / Alzheimer disease screening, and others.

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Potential Impact of COVID-19 on Predictive Genetic Testing & Consumer/Wellness Genomics Market - The Think Curiouser

Final Report will add the analysis of the impact of COVID-19 on this industry.

The report provides the forecast of the Genetic Testing Services Market for the next four years which assist Genetic Testing Services industry analyst for building and developing business strategies. The Genetic Testing Services market report contains industry top manufacturers discussion based on the companys profiles, financial analysis, overview, market revenue, and opportunities by top geographical regions.

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The Genetic Testing Services Market Report is an in-depth assessment of current state of industry and estimates forecast based on actual facts and figures. The Genetic Testing Services Market report provides analysis based on segmentations, market potential, influential trends, and the challenges that the market is facing during this COIVD- 19 pandemic. The data (tables, figures, statistics, numbers) about the Genetic Testing Services market are taken from trustworthy sources such as websites, yearly reports of the enterprises, journals, and others and were tested and validated by the expert`s.

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This research consists of market segmentation by Types, Application and Genetic Testing Services market division based on geographical locations. Report also segmented by top vendors provides data about company introduction, product specification and major types analysis, production market performance, sales market performance and contact information:

By Market Players:Laboratory Corporation of America Holdings, CENTOGENE AG, Illumina, Inc., F. Hoffmann-La Roche Ltd, Ambry Genetics, Eurofins Scientific, NeoGenomics Laboratories, Inc., Genomic Health, Inc., Quest Diagnostics Incorporated, 23andMe, Inc.

By Test TypePrenatal Testing, Newborn Screening, Predictive & Presymptomatic Testing, Pharmacogenomic Testing, Others

By Service ProviderHospital-based Laboratories, Diagnostic laboratories, Specialty Clinics, Others,

By ApplicationOncology, Infectious Diseases, Autoimmune Diseases, Others,

Regional Analysis Covers: USA, Europe, China, India, Southeast Asia, Japan, South America, South Africa, Others.

The Genetic Testing Services market research report is a resource, which provides current as well as upcoming technical and financial details of the industry. The detailed study in this report enables CEOs, traders, investors, and dealers to realize the market in a better way and based on that data make knowledgeable decisions.

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Points Covered in the Genetic Testing Services Market Report:

Who are Key Manufacturers: Major market players that are concerned within the market like manufacturers, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.

Data regarding Key Companies: Genetic Testing Services Capability, production, price, revenue, cost, gross, profit margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and also the technological developments.

Segmentation Analysis: Genetic Testing Services Information and data by manufacturer, by region, by type, by application and etc. The report contains the SWOT analysis of the market.

Important Questions Answered in Genetic Testing Services Market Report:

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In short TOC of 2019-2024 Global and Regional Genetic Testing Services Industry Production, Sales and Consumption Status and Prospects Professional Market Research Report

-Genetic Testing Services overview includes Brief Introduction by Major Type, Application, Region

-Production analysis includes Capacity, Production, Capacity Utilization Rate, Ex-Factory Price, Revenue, Cost, Gross and Gross Margin Analysis

-Genetic Testing Services Sales analysis contains Global Sales Volume, Sales Price and Sales Revenue Analysis

-Consumption of Genetic Testing Services Market Analysis by Regional Market Performance and Market Share

-Genetic Testing Services Regional Market Performance and Market Share

-New Project Investment Feasibility Analysis contains SWOT Analysis

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Global Man Portable Military Electronics Market 2020 Segmentation and Analysis by Recent Trends, Development and Growth by Trending Regions by 2026

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Genetic Testing Services Market 2020 Is Growing with Highest Size, Share of Top Key Players in the Industry and Forecast Survey Till 2024 - PRnews...

The research analysis of Predictive Genetic Testing And Consumer (Wellness) Genomics market offers significant information regarding the major trends that define this business landscape with regards to the regional outlook and competitive scenario. The report also highlights the limitations & challenges that could hamper the industry remuneration alongside the key opportunities that will aid in business expansion. Moreover, the document provides crucial insights regarding the effect of COVID-19 pandemic on the overall market outlook.

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Table of Contents for market shares by application, research objectives, market sections by type and forecast years considered:

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Predictive Genetic Testing And Consumer (Wellness) Genomics Market Analysis, Revenue, Share, Growth Rate & Forecast To 2025 - Express Journal

The latest market report published by Emergen Research, titled Global Direct-to-Consumer Genetic Testing Market, presents an accurate analysis of the estimated market size, share, revenue, and sales & distribution networks of the global Direct-to-Consumer Genetic Testing market over the forecast period. The report offers an exhaustive overview of the market, along with a precise summary of the markets leading regions. Our team of analysts has studied the existing competitive landscape of the market inside out, focusing on the leading companies and their business expansion strategies. The report ends with conclusive data offering useful insights into the market growth on both regional and global levels.

The report draws the focus of the reader on the grave impact of the ongoing COVID-19 pandemic on the Direct-to-Consumer Genetic Testing industry and its vital segments and sub-segments. It elaborates on the adverse effects of the pandemic on the global economic scenario, as well as this particular business sphere. The report takes into account the key influencing factors influencing market performance in the present COVID-19 times. The market has been substantially affected by the pandemic, and significant changes have been observed in the market dynamics and demand trends. The report examines the major financial difficulties brought about by the pandemic and offers a future COVID-19 impact assessment.

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Key Market Players:

23andMe, Full Genome Corporation, Color Genomics, Genesis Healthcare, Helix OpCo LLC, FamilyTreeDNA, MyHeritage, Identigene, Pathway genomics, and Living DNA

Direct-to-Consumer Genetic Testing Market Segmentation:

The report categorizes the market into different key segments based on types and applications, along with key regional segmentation. The report offers insights into the segment expected to garner traction during the forecast period, and the region expected to dominate the market in the coming years.

Test Type Outlook

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The market intelligence study takes the reader through the key parameters of the Direct-to-Consumer Genetic Testing market, including the strengths and weaknesses of the leading players, using analytical tools like the SWOT analysis and Porters Five Forces analysis. The report includes broad market segmentation based on the different product types, a wide application spectrum, the key regions, and the existing competition among players. The investigative study further assesses the market on the basis of market reach and consumer base in the key geographical segments. Alongside reviewing the sales network, distribution channels, pricing analysis, profit margins, cost and demand volatility, import/export dynamics, gross revenue, and various other aspects of the market, the report studies several factors affecting market growth over the forecast period, such as drivers, restraints, limitations, growth prospects, and numerous macro- and micro-economic indicators. Moreover, it extensively examines the top market players and their estimated market size and share, sales volume, production and consumption rates, expansion strategies, and competitive edge.

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Direct-to-Consumer Genetic Testing Market is anticipated to Reach USD 3.33 billion by 2027 Growing at a CAGR of 13.1% | Emergen Research - PRnews...

Prophecy Market Insights presented the Genetic Testing market which severs comprehensive and iterative research methodology. The company focuses on minimizing deviance in order to offer the most accurate estimations and forecast possible. The company utilizes a combination of bottom-up and top-down approaches for calculation and authenticate of the market size and for estimating quantitative aspects of the market.

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Genetic Testing Market: Applications and Regional Insights During the Forecasted Period 2020-2030 - TechnoWeekly

News Release

Thursday, October 22, 2020

NIH-funded therapy will now be tested in humans.

A newly developed light-sensing protein called the MCO1 opsin restores vision in blind mice when attached to retina bipolar cells using gene therapy. The National Eye Institute, part of the National Institutes of Health, provided a Small Business Innovation Research grant to Nanoscope, LLC for development of MCO1. The company is planning a U.S. clinical trial for later this year.

Nanoscopes findings, reported today in Nature Gene Therapy, show that totally blind micemeaning they have no light perceptionregain significant retinal function and vision after treatment. Studies described in the report showed that treated mice were significantly faster in standardized visual tests, such as navigating mazes and detecting changes in motion.

Opsins are proteins that signal other cells as part of a cascade of signals essential to visual perception. In a normal eye, opsins are expressed by the rod and cone photoreceptors in the retina. When activated by light, the photoreceptors pulse and send a signal through other retinal neurons, the optic nerve, and on to neurons in the brain.

A variety of common eye diseases, including age-related macular degeneration and retinitis pigmentosa, damage the photoreceptors, impairing vision. But while the photoreceptors may no longer fully function, other retinal neurons, including a class of cells called bipolar cells, remain intact. The investigators identified a way for bipolar cells to take on some of the work of damaged photoreceptors.

The beauty of our strategy is its simplicity, said Samarendra Mohanty, Ph.D., Nanoscope founder and corresponding author of a report on the mouse study that appears today in Nature Gene Therapy. Bipolar cells are downstream from the photoreceptors, so when the MCO1 opsin gene is added to bipolar cells in a retina with nonfunctioning photoreceptors, light sensitivity is restored.

The strategy could overcome challenges plagued by other approaches to retinal regeneration, according to the researchers. Gene replacement therapy has thus far worked principally in rare diseases that leave photoreceptors intact, such as Luxurna for Leber congenital amaurosis. Bionic eyes, such as the Argus II retinal prosthesis, require invasive surgery and wearable hardware. Other opsin replacement therapies require the intensification of light in order to reach the threshold required for signal transduction. Intense light risks further damage to the retina. Nanoscopes therapy requires a one-time injection into the eye and no hardware. MCO1 is sensitive to ambient light, so no need exists for strong light to be shined into the eye. And therapy with MCO1 could treat a wider range of degenerative retinal diseases, since photoreceptor survival not required.

The researchers found no concerning safety issues in treated mice. Examination of blood and tissues found no signs of inflammation due to treatment and the therapy had no off-target effect only bipolar cells expressed the MCO1 opsin.

Under a best-case scenario, the therapy could help patients achieve 20/60 vision, according to the researchers; however, no one knows how the restored vision will compare to normal vision.

A clinical study in people will help us understand how signaling through bipolar cells affects vision quality; for example, how well treated eyes can pick out fast-moving objects., said Subrata Batabyal, Ph.D., lead author of the manuscript. The therapy will likely be limited for treatment of patients with severe retinal disease.

If this optogenetic approach using cells spared in degenerated retina can prove to be effective in vision restoration in humans, beyond light perception, it could offer a valuable alternative to the retinal prosthesis approach for people with late-stage retinitis pigmentosa, said PaekGyu Lee, Ph.D., NEIs program officer for the Small Business Innovation Research program.

This press release describes a basic research finding. Basic research increases our understanding of human behavior and biology, which is foundational to advancing new and better ways to prevent, diagnose, and treat disease. Science is an unpredictable and incremental process each research advance builds on past discoveries, often in unexpected ways. Most clinical advances would not be possible without the knowledge of fundamental basic research.

The Small Business Innovation Research (SBIR) program is a competitive awards-based funding mechanism that supports U.S.-based small businesses engaged in research and development that has the potential for commercialization. The NEI SBIR program specifically provides funding to companies developing technologies and innovations relating to blinding eye diseases, visual disorders preservation of sight, and addressing the special health problems and requirements of individuals with impaired vision.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH): NIH, the nations medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov/.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

DOI is 10.1038/s41434-020-00200-2

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Scientists use gene therapy and a novel light-sensing protein to restore vision in mice - National Institutes of Health

Research published in Nature Gene Therapy today shows how the light-sensing protein (MCO1 opsin) can restore vision in blind mice when attached to retina bipolar cells using gene therapy.

Nanoscope LLC received a Small Business Innovation Research grant from the US National Eye Institute (part of the National Institutes of Health) to develop MC01.

The research opens up the field for gene therapy for a number of degenerative retinal diseases where photoreceptors are damaged.

Opsins are proteins that signal other cells as part of a series of signals needed for sight. In a normal eye, opsins are expressed by the rod and cone photoreceptors in the retina.

A number of common eye diseases - including age-related macular degeneration and retinitis pigmentosa - damage the photoreceptors.

But while the photoreceptors may no longer fully function, other retinal neurons, including bipolar cells, remain intact. The researchers have found a way for bipolar cells to take on some of the work of damaged photoreceptors.

Biopolar cells are downstream from photoreceptors, so when the MC01 opsin gene is added to these biopolar cells, light sensitivity can be restored.

The researchers used AAV2 assisted delivery of highly photosensitive multi-characteristic opsin (MC01) onto ON-bipolar cells of mice with retinal degradation to allow activiation by ambient light.

Researchers explored the delivery efficacy by using different doses of AAV2 carrying MCO1 (vMCO1) into targeted cells and analysed the results over the 6 months after delivery. They found that treated mice were able to perform significantly faster in standardized visual tests, such as navigating mazes and detecting changes in motion.

To date, gene replacement therapy has worked mainly in diseases that leave photoreceptors intact (such as Luxturna for Leber congenital amaurosis).

The new research means that therapy with MC01 could be investigated for a wider range of degenerative retinal diseases, without requiring photoreceptors to survive.

It could also offer a better option that other solutions: bionic eyes require invasive surgery and wearable hardware; while other opsin replacement therapies require intense light to be strong enough to create a signal (with intense light risking further retina damage).

Researchers suggest that, in a best-case scenario, the therapy could help patients achieve 20/60 vision. It is likely to be limited to patients with severe retinal disease: and further research will explore how bipolar cells can be used.

Subrata Batabyal, Ph.D., lead author of the study, said: "A clinical study in people will help us understand how signaling through bipolar cells affects vision quality; for example, how well treated eyes can pick out fast-moving objects."

Source:Batabyal, S., Gajjeraman, S., Pradhan, S.et al.Sensitization of ON-bipolar cells with ambient light activatable multi-characteristic opsin rescues vision in mice.Gene Therapy(October 22, 2020). https://doi.org/10.1038/s41434-020-00200-2

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Gene therapy and light-sensing protein used to restore sight in mice - BioPharma-Reporter.com

SparingVision has raised 44.5 million ($52.5 million) to develop its mutation-agnostic gene therapy treatment for retinitis pigmentosa (RP). The financing positions SparingVision to fund clinical trials of an AAV gene therapy that could stop vision deterioration in the 2 million RP patients.

Gene therapies including Spark TherapeuticsLuxturna are designed to address genetic drivers that cause some patients to develop RP and suffer vision loss. However, with at least 65 distinct RP-causing mutations of three different types, the numbers of patients that can be helped with any one gene-replacement therapy are relatively small. SparingVision, in contrast, is going after the whole RP market.

Its gene therapy but its mutation agnostic. The market potential is very large, unlike most gene therapies being developed, which address very specific mutations [in the eye]. The commercial viability of those mutation-specific gene therapies is kind of questionable, Stphane Boissel, who recently took over as CEO of SparingVision, said.

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The mutation-agnostic approach is built on an understanding of RP. The deterioration of the vision of RP patients begins with the degeneration of rod photoreceptors. That causes night blindness. Over time, cone photoreceptors start to degenerate, causing vision to deteriorate to the point that a patient is legally blind, despite most known genetic mutations only affecting the rods.

SparingVisions scientific founders identified an explanation for the loss of cones. As the number of rods falls, cones receive lower levels of the neurotrophic factors released by the photoreceptors. The loss of rods leads to lower levels of the neurotrophic factors, which in turn causes the loss of cones.

The research led to a novel gene therapy approach. Unlike treatments such as Luxturna, the gene therapy does not seek to replace a faulty or missing gene. Rather, the therapy is designed to ensure cones have access to the molecules that support their preservation. The gene therapy encodes for neutrophil factor RdCVF and an enzyme, potentially enabling it to restore aerobic glycolysis in cones and protect them from oxidative stress.

The idea is not to restore vision. The idea is to slow or stop the progression of the disease by preventing the cones from further degenerating, Boissel said.

SparingVision has raised 44.5 million to pursue that idea, bringing its total series A financing haul up to around 60 million. With GMP manufacturing almost done and IND-enabling studies underway, the money will enable SparingVision to move into a clinical trial to assess the safety of its candidate next year. Once SparingVision has safety data, it will run an efficacy trial using the series A funds.

The potential to take a mutation-agnostic RP gene therapy to clinical proof of concept has attracted a diverse group of investors. Advanced therapy VC 4BIO Capital led the round with UPMC Enterprises, the venture arm of healthcare provider and insurer UPMC. Jeito Capital, Ysios Capital, Bpifrance and Foundation Fighting Blindnessa charity that funded research into RdCVFalso participated.

The syndicate that we put together is not the typical VC syndicate. This is a well-balanced group of typical VCs but also very long-term, patient-centric investors. We have no pressure to, for example, exit. The only pressure we have is to deliver a drug to the patients, Boissel said.

Boissel has taken upthat challenge after two years at Sangamo Therapeutics, which bought the last company he led, TxCell, for 72 million. The CEO is now building out the rest of the team, with a chief technical officer set to join soon and a chief medical officer slated to arrive in the new year. The team will work to advance the lead candidate into the clinic and expand into the U.S.

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SparingVision raises 44.5M to develop mutation-agnostic gene therapy - FierceBiotech

In anticipation of our Pfizer Gene Therapy Career Event scheduled for Wednesday, October 28, 2020, BioSpace spoke with Alison Ricci, Pfizers Senior Business HR Partner- Global Sciences, Business HR for Bioprocess Research and Development, and HR Site Lead for the companys four locations in Chapel Hill and Morrisville, North Carolina, Chesterfield, Missouri and Lake Forest, Illinois.

In late August, Pfizer announced it was investing an additional $500 million into its state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina. This is in addition to the companys continuing investment into gene therapy research and development and other areas going on throughout the company, but specifically in its North Carolina sites in Chapel Hill and Kit Creek. The companys presence in North Carolina currently exceeds 3,600 people, with 650 in Sanford. The expanded facility is expected to add over 100 new jobs.

Ricci told BioSpace the company has been investing heavily in gene therapy and in the Raleigh-Durham Research Triangle Park area. They have three facilities in and around the area that focus specifically on gene therapy, including a research facility in Morrisville, its existing clinical manufacturing site in Chapel Hill, and a very large manufacturing site in Sanford.

And in recognition of the continued investment and commitment to gene therapy, the company acquired a 60,000-square-feet building and 16 acres in Durham, which they are renovating into a clinical manufacturing site, essentially doubling our clinical manufacturing capacity.

*Rendering of Durham location

As such, the company has numerous positions in the area currently open with many more expected as the new site comes online.

Right now, we have 30 positions that were going to be advertising for that directly support gene therapy in those three different campuses, Ricci said.

The roles they will be looking to fill include what Ricci calls a multitude of individual contributor, team lead and management roles."

"For instance, weve got our R&D and analytical scientist roles; we have manufacturing engineering roles; we have technical specialist roles; and different types of manufacturing support and technology transfer roles, Ricci said.

They also have training specialist positions because there are a variety of supporting functions that go into the magic of making gene therapy work.

Ricci seemed excited about gene therapy and the part it is playing increasingly in Pfizers core mission. Speaking of Duchenne muscular dystrophy (DMD), increasingly a target of gene therapies, she noted how exciting and important it is to be able to provide a therapy that extends quality of life, that doesnt just treat symptoms, but that potentially marks a minimization of those symptoms and the elongation of life. Thats one of the central core components of who Pfizer is. Our patients are our North Star.

She also emphasized not only the science and motivation of Pfizer as an employer, but its culture.

People typically equate large organizations with a level of bureaucracy, that results in less risk and less innovation opportunities, Ricci said. In my five years with Pfizer Ive seen the culture shift to focus on innovation, inclusion, quality and smart resourcing figuring out how to free up resources so we can focus on bold moves and exciting new therapies allowing our scientists to stretch and grow, and make a difference for the patients that count on us.

The company has also structured rewards and recognition around those types of approaches, not only for people theyre bringing into the organization, but with its current staff.

Were still maintaining our focus on a combination of productivity and doing it right the first time while encouraging innovation, taking bold moves and trying new things," Ricci said. "Because thats the best way that good science is done, and patients win in the process.

She also notes that the Pfizer Gene Therapy Career Event is a great opportunity to have direct contact not only with Pfizer hiring managers, but with colleagues who are working in those same roles theyre hiring for.

Its a unique experience in terms of really understanding who Pfizer is and what we have to offer, Ricci said.

And, of course, the company is hiring throughout its worldwide operations in support of not only its COVID-19 clinical research trials and manufacturing processes, but in the numerous other areas the company focuses on.

The expansion in Sanford, North Carolina is only a part of the companys focus on building out capacity. It has committed about $5 billion in U.S.-based capital projects over the next several years.

But the North Carolina area is expanding end-to-end capabilities in gene therapy. The Kit Creek facility focuses on small scale production, from 2L flasks up to 250L bioreactors to develop the early processes that will later be used in larger scale manufacturing. The Chapel Hill facility is where the process is optimized, and staffers work at a 250L scale while developing and implementing quality control measures that include Good Manufacturing Practice (GMP) standards. The Sanford facility is designed for high-quality, efficient supply of gene therapies at clinical- and commercial-scale.

Ricci also points to Paul Mensah, Pfizers Vice President of Bioprocess Research and Development.

He has a nice, pragmatic style and approach in terms of how he continues to foster and leverage innovation, but also the science of how everyone works together to collaborate and deliver. He instills that in the leaders on the team. Ricci said.

Were continuing to focus in terms of career development and the aspirations of each colleague. There are opportunities for colleagues at Pfizer to do anything they want within the realms of the organization." Ricci said. "You can be on the frontlines of early stage development, you can work on the late stage, you can have opportunities for clinical manufacturing. You can run the gamut in terms of different roles with the scientific profile within Pfizer.

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Pfizer: Expanding North Carolina Gene Therapy Facility and Adding Jobs - BioSpace

CAMBRIDGE, Mass., Oct. 22, 2020 (GLOBE NEWSWIRE) -- A premier syndicate of life sciences investors including Perceptive Advisors, Bain Capital Life Sciences (Bain Capital), and RA Capital Management (RA Capital) (collectively the Investor Group) together with Sarepta Therapeutics, Inc. (Sarepta) (NASDAQ: SRPT), a leader in precision genetic medicine for rare diseases, today announced a $107 million Series A financing to create AavantiBio, a gene therapy company focused on transforming the lives of patients with rare genetic diseases. The private financing round includes a $15 million equity investment from Sarepta.

Alexander Bo Cumbo, a seasoned biopharmaceutical executive, has been appointed AavantiBios Chief Executive Officer and President, effective immediately. Mr. Cumbo joins the Company after eight years at Sarepta, where he served as Chief Commercial Officer and Executive Vice President. He will continue to serve as an advisor to Sarepta through December 31, 2020.

Headquartered in the greater Boston area, AavantiBio is co-founded by renowned gene therapy researchers Barry Byrne, M.D., Ph.D., and Manuela Corti, P.T., Ph.D., who together bring thirty years of experience to the Company. AavantiBios lead program is in Friedreichs Ataxia (FA), a rare inherited genetic disease that causes cardiac and central nervous system dysfunction. AavantiBios research efforts expand on foundational research conducted by Drs. Byrne and Corti in Friedreichs Ataxia, among other rare genetic disorders. AavantiBio will benefit from strategic partnerships with the University of Floridas renowned Powell Gene Therapy Center and the MDA Care Center at UF Health where Drs. Byrne and Corti maintain their research and clinical practices. Initial funding in AavantiBio was provided by GoFAR, an Italian patient advocacy group, and the Muscular Dystrophy Association Venture Philanthropy Fund.

The past eight years have been some of the most rewarding of my career as Sarepta has emerged as a pioneer for Duchenne muscular dystrophy and limb-girdle muscular dystrophy patients and transformed into a genetic medicine leader, Mr. Cumbo stated. It has been a privilege to contribute to this growth and play a role in serving these communities. As I look ahead to the bright future of AavantiBio and the exciting opportunity to lead this innovative Company, this same dedication to serving unmet patient needs and to leveraging deep scientific expertise will be core to our mission. I am also thrilled to continue to collaborate with the talented team at Sarepta.

Our equity participation in AavantiBio serves our strategy to build our gene therapy engine through targeted investment in potentially life-enhancing therapies as well as partnering with renowned genetic medicine pioneers such as Drs. Byrne and Corti, stated Doug Ingram, president and CEO, Sarepta Therapeutics. Mr. Ingram continued: Bo Cumbo has built a first-in-class rare disease commercial organization and has made tremendous contributions to Sarepta. We look forward to continuing to work with Bo as he builds a strong AavantiBio team and advances therapies to treat FA and other rare diseases.

Prior to joining Sarepta in 2013, Mr. Cumbo served as Vice President of Sales and Treatment Education at Vertex Pharmaceuticals where he built a sales force to market their first commercial drug, Incivekan oral treatment for hepatitis C. Previously, he spent nine years at Gilead Sciences where he served in multiple commercial roles supporting the companys HIV, HBV, and cardiovascular franchises. Mr. Cumbo has extensive experience building global commercial infrastructure, and throughout his career, he has contributed to the launch of 11 specialty products across multiple organizations. He received his Bachelor of Science in Laboratory Technology from Auburn University.

AavantiBio has a unique opportunity to change the lives of those living with FA and other rare diseases, Mr. Cumbo added. Central to our mission is building on the advancements in gene transfer therapies and harnessing these revolutionary technologies to realize their potential as life-altering medicines. Im excited to build a company focused on deep science, innovation, and collaboration, and grateful for the partnership with three of the biotechnology industrys most respected investors in Perceptive Advisors, Bain Capital, and RA Capital.

Our investment in AavantiBio represents a truly unique opportunity to thoughtfully advance a differentiated pipeline of innovative gene transfer therapies in areas of high unmet medical need, the Investor Group said in a statement. We are excited to collaborate with Bo Cumbo, an accomplished executive leader, and to provide the necessary resources to enable the Company to build a best-in-class gene therapy platform that brings transformative products to patients and families impacted by these devastating diseases.

The AavantiBio Board of Directors will be comprised of 8 Directors, including Mr. Cumbo, Drs. Byrne and Corti, representatives of the Investor Group, and two Independent Directors. Louise Rodino-Klapac, Ph.D., senior vice president of gene therapy for Sarepta, will serve as a Board Observer.

About Friedreichs Ataxia

Friedreichs Ataxia (also known as FA or Friedreich Ataxia) is a rare inherited genetic disease that causes movement problems and nervous system damage.Over time, the disease leads to degeneration in the spinal cord, peripheral nerves and cerebellum (the part of the brain that controls synchronization and balance) and causes impaired muscle coordination (ataxia) that gets worse over time. Poor coordination is one of the first noticeable features of FA.The neurological degeneration caused by the disease results in unsteady movements, impaired sensory function, and even the loss of speech. Affected individuals can also develop heart problems, diabetes, or curvature of the spine.However, the disorder does not affect cognitive ability. Though rare, FA affects 1 in every 40,000-50,000 people and is the most common form of hereditary ataxia in the United States.

About AavantiBio, Inc.

AavantiBios vision is to harness the transformative science of gene transfer therapy and gene editing technologies to improve the lives of people living with fatal diseases. Founded by distinguished gene therapy researchers out of the University of Florida, the Company is advancing a pipeline of innovative gene transfer therapies in areas of high unmet medical need, which have the potential to become the next generation of life-changing medicines. Learn more at: http://www.aavantibio.com.

AboutSarepta Therapeutics

At Sarepta, we are leading a revolution in precision genetic medicine and every day is an opportunity to change the lives of people living with rare disease. The Company has built an impressive position in Duchenne muscular dystrophy (DMD) and in gene therapies for limb-girdle muscular dystrophies (LGMDs), mucopolysaccharidosis type IIIA, Charcot-Marie-Tooth (CMT), and other CNS-related disorders, with more than 40 programs in various stages of development. The Companys programs and research focus span several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visitwww.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

About Perceptive Advisors

Founded in 1999 and based in New York, NY, Perceptive Advisors is an investment management firm focused on supporting the progress of the life sciences industry by identifying opportunities and directing financial resources to the most promising technologies in healthcare. For more information visit http://www.perceptivelife.com.

About Bain Capital Life Sciences

Bain Capital Life Sciences (www.baincapitallifesciences.com) pursues investments in biopharmaceutical, specialty pharmaceutical, medical device, diagnostics and enabling life science technology companies globally. The team focuses on companies that both drive medical innovation across the value chain and enable that innovation to improve the lives of patients with unmet medical needs. Since 1984, Bain Capital has developed global reach, deep expertise and a proven track record in life sciences industries across its Private Equity, Credit, Public Equity, Venture and Real Estate business units.

About RA Capital Management

RA Capital is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare and life science companies that are developing drugs, medical devices, and diagnostics. The flexibility of its strategy allows RA Capital to provide seed funding to startups and to lead private, IPO, and follow-on financings for its portfolio companies, both facilitating the crossover process and allowing management teams to drive value creation from inception through commercialization.

Sarepta Forward-Looking Statements

This press release contains "forward-looking statements." Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding AavantiBios plan to pursue a diversified gene therapy pipeline; the expectation that AavantiBio will maintain strong ties to the University of Florida's Powell Gene Therapy Center; AavantiBios potential to benefit from strategic partnerships with the University of Floridas Powell Gene Therapy Center and the MDA Care Center at UF Health; AavantiBios mission to build on the advancements in gene transfer therapies and harness revolutionary technologizes to realize their potential as life-altering medicines; AavantiBios potential to build a best-in-class gene therapy platform that brings transformative products to patients and families impacted by devastating diseases; and AavantiBios potential to become the next generation of life-changing medicines.

These forward-looking statements involve risks and uncertainties, many of which are beyond Sareptas control. Known risk factors include, among others: the expected benefits and opportunities related to the investment in AavantiBio may not be realized or may take longer to realize than expected due to challenges and uncertainties inherent in product research and development; the investment in AavantiBio may not result in any viable treatments suitable for clinical research or commercialization due to a variety of reasons including the results of future research may not be consistent with past positive results or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates or may never become commercialized products due to other various reasons including any potential future inability of the parties to fulfill their commitments and obligations under the agreements, including any inability bySareptato fulfill its financial commitments to AavantiBio; even if the investment results in new commercialized products,Sareptamay not achieve any significant revenues from the sale of such products; and those risks identified under the heading Risk Factors in Sareptas most recent Annual Report on Form 10-K for the year ended December 31, 2019, and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Companys business, results of operations and the trading price of Sareptas common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

AavantiBio Contact:

Scott Lessne646-502-3569slessne@stantonprm.com

Sarepta Contacts:

For InvestorsIan Estepan617-274-4052iestepan@sarepta.com

For MediaTracy Sorrentino617-301-8566tsorrentino@sarepta.com

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Gene Therapy Company AavantiBio Launches with $107 Million Series A Financing from Perceptive Advisors, Bain Capital Life Sciences, RA Capital...

NEW YORK, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Axovant Gene Therapies Ltd. (Nasdaq: AXGT), a clinical-stage company developing innovative gene therapies, today announced that it will host a virtual R&D Day on Friday, October 30, 2020 at 11:30 AM Eastern time, to discuss the Companys AXO-Lenti-PD gene therapy for Parkinsons disease.

Axovants Parkinsons disease R&D Day will be moderated by Chief R&D Officer, Gavin Corcoran, M.D., and will feature presentations on the current treatment landscape and unmet medical need for people living with Parkinsons disease from the following key opinion leaders:

In addition, the Company will present data from the second cohort of the Phase 2 SUNRISE-PD trial for AXO-Lenti-PD including:

Drs. Adler, Palfi, and Eberling will be joined by Dr. Corcoran to answer questions following the formal presentations.

AXO-Lenti-PD is the only investigational gene therapy for Parkinsons disease that delivers three genes via a lentiviral vector to encode a set of critical enzymes required for endogenous dopamine synthesis, with the goal of improving motor function and restoring steady, tonic levels of dopamine in the brain. The gene therapy aims to provide patient benefit for years following a single administration.

To register for the R&D webcast, please click here.

A live audio webcast of the R&D Day can be accessed through the Events & Presentations section of the company's website at investors.axovant.com. An archived replay of the webcast will be available on the company's website following the event.

Biographies of R&D Day Panelists:

Dr. Adler has received numerous grants to investigate experimental treatments for Parkinson's disease, essential tremor, dystonia, restless legs syndrome, and chronic traumatic encephalopathy (CTE). He serves as an advisory member to many different international medical societies such as the International Parkinson and Movement Disorder Society, MDS Industry Education and Services Committee, and the American Academy of Neurology Section of Movement Disorders. Dr. Adler has a commitment to education having trained residents, 14 fellows and graduate students, and has given many invited lectures. Dr. Adlers main research interests are investigating tissue diagnostic tests for Parkinsons disease, biomarkers for an early diagnosis of Parkinsons disease and PD with dementia, and identification of new treatments for PD and PD with dementia. He also has been investigating essential tremor, restless legs syndrome, and dystonia. He has published over 400 research papers and reviews, and edited a book entitled Parkinson's Disease and Movement Disorders: Diagnosis and Treatment Guidelines for the Practicing Physician. In 2006, Dr. Adler was awarded the Mayo Clinic Distinguished Investigator of the Year Award.

Dr. Palfi has published extensively on trophic factor- and enzyme-based gene therapy in Parkinsons disease and Huntingtons disease. He is a principal investigator on numerous preclinical and clinical studies and has been involved in studies of many novel agents including implanted brain devices, optogenetic, homeoprotein, trophic factors GDNF, CNTF and dopamine lentiviral vectors.

Dr. Eberling earned undergraduate and graduate degrees in biological psychology from the University of California at Berkeley, later moving to the Lawrence Berkeley National Laboratory where she developed expertise in neuroimaging techniques and gene therapy approaches for Parkinsons disease.

About Axovant Gene Therapies

Axovant Gene Therapies is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurodegenerative diseases. Our current pipeline of gene therapy candidates target GM1 gangliosidosis, GM2 gangliosidosis (also known as Tay-Sachs disease and Sandhoff disease), and Parkinsons disease. Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations. For more information, visit http://www.axovant.com.

Contacts:

Investors

Parag MeswaniAxovant Gene Therapies Ltd.(212) 547-2523investors@axovant.com

Media

Josephine Belluardo, Ph.D.LifeSci Communications(646) 751-4361jo@lifescicomms.commedia@axovant.com

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Axovant Gene Therapies to Host Virtual Parkinson's Disease R&D Day on October 30, 2020 - BioSpace

CHAPEL HILL Babies born with a faulty maternal copy of the UBE3A gene will develop Angelman syndrome, a severe neurodevelopmental disorderwith no cure and limited treatments. Now, for the first time, scientists at the UNC School of Medicine show that gene editing and gene therapy techniques can be used to restore UBE3A in human neuron cultures and treat deficits in an animal model of Angelman syndrome.

This work, published inNatureand led by senior author Mark Zylka, PhD, Director of theUNC Neuroscience Centerand W.R. Kenan, Jr. Distinguished ProfessorofCell Biology and Physiology, lays important groundwork for a long-lasting treatment or cure for this debilitating disease, as well as a therapeutic path forward for other single-gene disorders.

Our study shows how multiple symptoms associated with Angelman syndrome could be treated with a CRISPR-Cas9 gene therapy, Zylka said.And we are now pursuing this with help of clinicians at UNC-Chapel Hill.

Left: UBE3A gene is off. Right: Using CRISPR, the gene is expressed and neurons fire (yellow). UNC images

Angelman syndrome iscaused by a deletion or mutation of the maternal copy of the gene that encodes the ubiquitin protein ligase E3A (UBE3A). The paternal copy ofUBE3Ais typically silenced in neurons, so the loss of maternalUBE3Aresults in a complete absence of the UBE3A enzyme in most areas of the brain. Thats crucial because the enzyme targets proteins for degradation, a process that maintains normal function of brain cells. When that process goes awry, the result is Angelman syndrome, a brain disorder with symptoms that include severeintellectual and developmental disabilities, seizures, and problems with speech, balance, movement, and sleep.

Turning on the paternal copy ofUBE3Ais an attractive therapeutic strategy because it could reverse the underlying molecular deficiency of the disease, Zylka said. However, the paternal gene is silenced by a long strand of RNA, produced in the antisense orientation toUBE3A,which blocks production of the enzyme from the paternal copy of the gene.

Members of the Zylka lab, including postdoctoral fellows Justin Wolter, PhD, and Giulia Fragola, PhD, set out to devise a way to use CRISPR-Cas9 to restore the UBE3A enzyme to normal levels by disrupting the antisense RNA. Preliminary data in cell cultures were promising, and Zylka received grants fromthe NIH, theAngelman Syndrome Foundation, and the Simons Foundation to test their findings in human neurons and in a mouse model of the disease.

In theNaturepaper, co-first authors Wolter and Hanqian Mao, PhD, a postdoc in the Zylka lab, and UNC colleagues describe using an adeno-associated virus (AAV) gene therapy to deliver the Cas9 protein throughout the brain of embryonic mice that model Angelman syndrome. Because UBE3A is essential for normal brain development, early treatment is crucial. The researchers found that embryonic and early postnatal treatment rescued physical and behavioral phenotypes that model core deficits found in Angelman syndrome patients. Remarkably, a single neonatal injection of AAV unsilenced paternalUbe3afor at least 17 months, and the data suggest this effect is likely to be permanent. The researchers also demonstrated that this approach was effective in human neurons in culture.

We were blown away when we got these results, Zylka said. No other treatments currently being pursued for Angelman syndrome last this long, nor do they treat as many symptoms. I am confident others will eventually recognize the advantages of detecting the mutation that causes Angelman syndrome prenatally and treating shortly thereafter.

Wolter added, The results of treating early were very promising. Since we learned we could reduce the severity of Angelman syndrome in mice, we are now focused on refining our approach in ways that will be suitable for use in humans.

While working to translate this research into the clinic, the Zylka lab will collaborate with researchers at the Carolina Institute for Developmental Disabilities (CIDD)to identify symptoms in babies that have the genetic mutation that causes Angelman syndrome.

Zylkas lab is working with CIDD researchers led by CIDD director Joseph Piven, MD, to use brain imaging and behavior observations to identify symptoms associated with Angelman syndrome in infants. Anecdotal reports suggest these infants have difficulty feeding and reduced muscle tone, but these and other early symptoms have not been rigorously characterized to date.

The idea is to use genetic tests to identify babies that are likely to develop Angelman syndrome, treat prenatally or around the time of birth, and then use these early symptoms as endpoints to evaluate efficacy in a clinical trial, Zylka said. Our data and that of other groups clearly indicate that prenatal treatment has the potential to prevent Angelman syndrome from fully developing.

As part of theNaturestudy, the researchers also found that the gene therapy vector blocked the antisense RNA by integrating into the genome at sites cut by CRISPR-Cas9. This so-called gene trap could be exploited to disrupt other long non-coding RNAs and genes.

Zylka added, We are incredibly excited to keep this work moving forward with the hope of helping children and families overcome this debilitating condition. Support from the NIH, the Simons Foundation, and the Angelman Syndrome Foundation was essential for moving this work forward.

Along with Zylka, Wolter, and Mao, co-authors of the Nature paper are Giulia Fragola, PhD, postdoc in the Zylka lab at the time of this research; Jeremy Simon, PhD, research associate professor; James Krantz, Zylka lab research associate; Hannah Bazick, Zylka lab graduate student; Baris Oztemiz, Zylka lab research technician; and Jason Stein, PhD, assistant professor of genetics and member of the UNC Neuroscience Center; all at UNC-Chapel Hill.

This research was funded by grants from the National Institutes of Health, the Simons Foundation, the Angelman Syndrome Foundation, the Eshelman Institute for Innovation, and the Pfizer-NCBiotech Distinguished Postdoctoral Fellowship in Gene Therapy.

(C) UNC-CH

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Gene editing shows promise as tool to fight neuro disorder in babies, UNC study finds - WRAL Tech Wire

A new research Titled Global Gene Therapy Market 2020 Research Report provides the Professional and In-depth evaluation of scope of current and future market and review of Product Specification, market trend , product type and production analysis considering major factors such as Facts and figure, revenue generated from the sales of this Report, market share and growth rate for each type and application, Gross Margin, key factors driving to the market. and also provides the In-depth evaluation of Gene Therapy Market using Porters five forces, SWOT analysis i.e. Strength, Weakness, Opportunities and Threat to the industry.

The Gene Therapy market will reach Volume Million USD in 2019 and CAGR xx% 2015-2019. The report Primarly enlists the basic details of industry based on the fundamental overview of Gene Therapy market chain structure, and describes industry surroundings, the development of the market through upstream & downstream, industry overall, investment analysis, manufacturing cost structure, industry policies, plans and development, key players will drive key business decisions and makes a scientific prediction for the development industry prospects on the basis of past, present and forecast data related to the Gene Therapy market from 2020-2024.

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Bluebird BioSangamoSpark TherapeuticsDimension TherapeuticsAvalanche BioCelladonVical Inc.Advantagene

The Scope of the global Gene Therapy market mainly focuses on globally, it primarily covers the Gene Therapy Market in USA, Canada and Mexico, Gene Therapy Market in Germany, France, UK, Russia and Italy, global Gene Therapy market in China, Japan, Korea, India and Southeast Asia, global Gene Therapy market in Brazil, Argentina, Columbia, Global market in Saudi Arabia, UAE, Egypt, Nigeria and South Africa.

Gene Therapy Market Segmentation

Gene Therapy Market Segment by Type, covers:

Ex vivoIn Vivo

Gene Therapy Market Segment by Applications can be classified into:

CancerMonogenicInfectious diseaseCardiovascular diseaseOther

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The firstly global Gene Therapy market describes the market overview, Upstream, Technology, Cost Structure. The second part describes global Gene Therapy market by key players, by Application and Type. It also includes Gene Therapy industry competition structure analysis by market revenue of region, sales and by Gene Therapy market by prominent key players. Also Consists of Global Gene Therapy Industry Application Status, Industry SWOT Analysis and Market Demand Forecast and analysis of Production and Sales of the regional market and future forecast analysis. Finally, it includes an analysis of Gene Therapy Market Investment, Market Features, Opportunity, and Calculation.

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Table of Contents:

Global Gene Therapy Market Size, Status and Forecast 2024

1 Industry Overview of Gene Therapy

2 Gene Therapy Competition Analysis by Players

3 Company (Top Players) Profiles

4 Global Gene Therapy Market Size by Type and Application (2015-2019)

5 United States Gene Therapy Development Status and Outlook

6 EU Gene Therapy Development Status and Outlook

7 Japan Gene Therapy Development Status and Outlook

8 Gene Therapy Manufacturing Cost Analysis

9 India Gene Therapy Development Status and Outlook

10 Southeast Asia Gene Therapy Development Status and Outlook

11 Market Forecast by Regions, Type and Application (2020-2024)

12 Gene Therapy Market Dynamics

12.1 Gene Therapy Industry News

12.2 Gene Therapy Industry Development Challenges

12.3 Gene Therapy Industry Development Opportunities (2020-2024)

13 Market Effect Factors Analysis

14 Global Gene Therapy Market Forecast (2020-2024)

15 Research Finding/Conclusion

16 Appendix

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Global Gene Therapy Market A Comprehensive Study Explores Huge Growth and Covers Updated Data Considering Post Impact of Covid-19 on Share, Size and...

Gene Therapy market report discusses the projections of the market covering the global scope and growth potential while providing detailed insights on various aspects essential for the growth of the market stakeholders and new players as well. This report has an evaluation of the Gene Therapy market over the period of 2020 through 2026. The report discusses in detail the all-inclusive landscape of the Gene Therapy Market.

Top Companies covering This Report: SangamoSpark TherapeuticsDimension TherapeuticsAvalanche BioCelladonVicalAdvantagene

The present Market scenario has been discussed and explained in detail in this report for the Gene Therapy market. The market size in terms of volume, share, revenue and growth size has also been discussed in a detailed assessment. The present situation as well as an account of the history of the Gene Therapy market is also explained in this research report.

NOTE: The report has been assessed in accordance with the COVID-19 Pandemic and its impact on the Gene Therapy market.

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Description:

The research report provides detailed insights into the geographical regions covered under the Gene Therapy market. The report has been segmented and classified into various parts to give the client a more structured data profile to increase ease of use and efficiency. The report also has a classification of the Gene Therapy market on the basis of Types and Applications.

The report also profiles the major key players in the Gene Therapy market. With a comprehensive forecast account, the research report also has a detailed historic account on the Gene Therapy market landscape. The analysts have assessed this report in consideration with the top industry experts in the Gene Therapy market.

The Gene Therapy report highlights the Types as follows:Ex vivoIn vivo

The Gene Therapy report highlights the Applications as follows:Cancer DiseasesMonogenic DiseasesInfectious DiseasesCardiovascular DiseasesOthers

The report studies the following Geographical Regions:

Customization of the Report:

The given Gene Therapy market research report can also be customized as per the client requirements. The client can connect and get in touch with our sales team (sales@reportsintellect.com) who will ensure that you get the report as per your requirements and needs.

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Reports Intellect is your one-stop solution for everything related to market research and market intelligence. We understand the importance of market intelligence and its need in todays competitive world.

Our professional team works hard to fetch the most authentic research reports backed with impeccable data figures which guarantee outstanding results every time for you.So whether it is the latest report from the researchers or a custom requirement, our team is here to help you in the best possible way.

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Gene Therapy Market : 2020 Based on Comprehensive Future Insights and Technological Advancement by 2026 - Stock Market Vista

PARP inhibitors like Lynparza from Merck and AstraZeneca have been effective in some patients with ovarian and breast cancers, but many develop resistance to the drugs, and some people dont respond at all. KSQ Therapeutics hopes to provide hope for those patients with a first-in-class drug that may be able to boost Lynparzas effectiveness when used in combination with itand the company has rolled out promising animal data to back up that strategy.

KSQs drug inhibits ubiquitin specific peptidase 1, an enzyme that has been shown to promote the survival of cancer cells by facilitating DNA repair. The drug, dubbed KSQ-4279, inhibited tumor growth both on its own and when combined with Lynparza in mouse models of ovarian and triple-negative breast cancers, the company reported during a presentation at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.

KSQ discovered the drug using a technology platform it calls CRISPRomics, which allows its researchers to identify therapeutic targets by applying CRISPR-Cas9 gene editing to the whole genome. The company has used the platform to study 20,000 human genes in 600 cancer models.

RELATED: KSQ grabs $80M to move T-cell treatment for PD-1 resistance into the clinic

PARP inhibitors work by interrupting DNA repair, but KSQs researchers believe KSQ-4279 inhibits different yet complementary DNA repair pathways, said the companys chief scientific officer, Frank Stegmeier, Ph.D., in a statement.

In multiple animal models of ovarian cancer and triple-negative breast cancer, combining KSQ-4279 with Lynparza was more effective than either drug on its own. The combo approach prompted a complete response in some of the breast cancer models.

PARP inhibitor combinations are gaining steam in the oncology market. In May, the FDA approved a combination of Lynparza with Roches VEGF inhibitor Avastin to treat ovarian cancer with or without BRCA mutations.

Last year, Yale University researchers discovered that AstraZenecas experimental VEGF inhibitor cediranib also prevents DNA repair. The researchers suggested that cediranib could make tumors more responsive to Lynparza and other PARP inhibitors.

As for KSQ, it has grown quickly over the last few years, raising $76 million in 2017 and another $80 million a year later to advance its lead programs, one of which is a T-cell therapy for solid tumors that are resistant to PD-1 immune checkpoint inhibitors. KSQ-4279 is now its lead program, and the new data in ovarian and breast cancers give the company confidence to advance the drug into clinical trials as a novel agent in a new class of targeted oncology treatment, Stegmeier said.

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KSQ boosts PARP inhibition in animal models of ovarian and breast cancers with USP1 inhibitor - FierceBiotech

Stem Cell-Derived Cells Market report 2018, discusses various factors driving or restraining the market, which will help the future market to grow with promising CAGR. The Stem Cell-Derived Cells Market research Reports offers an extensive collection of reports on different markets covering crucial details. The report studies the competitive environment of the Stem Cell-Derived Cells Market is based on company profiles and their efforts on increasing product value and production.

This Report covers the manufacturers data, including: shipment, price, revenue, gross profit, interview record, business distribution etc., these data help the consumer know about the competitors better. This report also covers all the regions and countries of the world, which shows a regional development status, including market size, volume and value, as well as price data.

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The report analyzes the market of Stem Cell-Derived Cells by main manufactures and geographic regions. The report includes Stem Cell-Derived Cells definitions, classifications, applications, and industry chain structure, development trends, competitive landscape analysis, and key regions development and market status.

By Market Players:

key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.

The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:

Segmentation by Product Type

Segmentation by End User

The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.

North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.

Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

Reasons to Purchase This Report:

Market analysis for the global Stem Cell-Derived Cells Market, with region-specific assessments and competition analysis on a global and regional scale.

Analyzing various perspectives of the market with the help of Porters five forces analysis

Which textile, raw material, and application is expected to dominate the market

Which country is expected to witness the fastest growth during the forecast period?

Identify the latest developments, market shares and strategies employed by the major market players.

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Stem Cell-Derived Cells Market to Expand at a Healthy CAGR of XX% Between and 2019 2029 - Eurowire