How MDMA and Psilocybin Became Hot … – The New York Times

Even some Republicans, a group that has traditionally opposed the liberalization of drug laws, are starting to come around. Last month, the former Texas governor Rick Perry, citing the high rates of suicide among war veterans, called on his states legislators to support a Democratic-sponsored bill that would establish a psilocybin study for patients with PTSD.

Weve had 50 years of government propaganda around these substances, and thanks to the research and a grass-roots movement, that narrative is changing, said Kevin Matthews, a psilocybin advocate who led Denvers successful ballot measure.

Long before Nancy Reagan warned the nation to just say no to drugs and President Richard Nixon supposedly pronounced Timothy Leary the most dangerous man in America, researchers like William A. Richards were using psychedelics to help alcoholics go dry and cancer patients cope with end-of-life anxiety.

The drugs were legal, and Dr. Richards, then a psychologist at the Maryland Psychiatric Research Center, was among scores of scientists studying the therapeutic prowess of entheogens, the class of psychoactive substances that humans have used for millenniums. Even years later, Dr. Richards and other researchers say, many early volunteers called the psychedelic sessions the most important and meaningful experiences of their lives.

But as the drugs left the lab in the 1960s and were embraced by the counterculture movement, the countrys political establishment reacted with alarm. By the time the Drug Enforcement Administration issued its emergency ban on MDMA in 1985, funding for psychedelic research had largely disappeared.

We were learning so much, and then it all came to an end, said Dr. Richards, 80, and now a researcher at Johns Hopkins University School of Medicine.

These days, the Center for Psychedelic and Consciousness Research at Johns Hopkins, created two years ago with $17 million in private funding, is studying, among other things, psilocybin for smoking cessation and the treatment of depression associated with Alzheimers as well as more spiritual explorations involving religious clergy.

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How MDMA and Psilocybin Became Hot ... - The New York Times

The Public Is Being Primed To Feel Groovy About Psychedelic Drugs – CBN News

ANALYSIS

Right now, there is a concerted effort to change the American public's attitude towards psychedelic drugs. Turn on Netflix, Hulu, or other streaming services, and you're likely to find shows and documentaries on the usefulness of drugs like LSD (acid), DMT (spirit molecule), MDMA (ecstasy or mollies), and psilocybin (magic mushrooms). These shows are the first public signs that we are being primed to accept the recreational and "prescription" use of psychedelics to solve both our mental and spiritual ills.

Since the Nixon years, the U.S. Drug Enforcement Administration has marked psychedelics as schedule 1 substances because they lack clinical value, can be addictive, and hold the potential for long-term physiological and psychological damage, including schizophrenia-type symptoms.Given this classification, how does one change public opinion about a class of drugs associated with images tucked firmly in the American consciousness of spun-out flower children whirling around the grass at Woodstock or loitering aimlessly on the streets of Haight-Ashbury?

According to Edward Bernays, the father of public relations and nephew to Sigmund Freud, in order to "manipulate the public to think a certain way, it needs to be taught how to ask for what it (the manipulator) wants." Robert Worchester, a political analyst, described public opinion by making a distinction between attitudes, opinions, and values. He noted that a person's values are the most impervious to change; however, through continued exposure, thought, and discussion, these too can be shaped.

When it comes to influencing our view about psychedelics, what could possibly compete with the images of dancing hippies? What about a growing body of scientific literature that claims the use of these drugs can help resistant anxiety, posttraumatic stress, depression, alcohol, and tobacco abuse?For the past 30 years, research studies involving psychedelics were not backed by public fundsuntil recently. Studies have been popping up in clinicaltrials.gov. There have even been several reports, with small sample sizes, touted as "success stories" for reducing mental health symptoms by microdosing these drugs.

Mental health is certainly a concern for Americans. This week, a Gallup poll found that Americans rated their mental health at an all-time low, with only 34 percent giving themselves an excellent score. Aside from this poll, we know that our society is facing significant mental health challenges, with nearly 20 percent of the population suffering from anxiety disorders and suicide ranked as one of the top 10 causes of death in the United States.

The media is not the only group riding high on our mental health problems. Groups like Mind-Medicine, a pharmaceutical start-up, are seeking FDA (national) approval for psychedelics, under the expectation that the drugs will provide an alternative treatment to the aforementioned mental health conditions. Veterans and first responders have already been enlisted in these studies.

The co-founder of Mind Medicine stated their goal is to "get the average person to realize that these are not evil drugsthey can be used as medicines and be successful at treating unmet medical needs."

Aside from the attempt to lend credibility to these drugs through science, there has already been a push to legalize psilocybin (magic mushrooms). Some states and cities have already moved to legalize these substances for recreational use. These places include Denver, Colorado; Oakland and Santa Cruz, California; Ann Arbor and Washtenaw County, Michigan; Somerville, Cambridge, and Northampton, Massachusetts; Washington, D.C.; and Oregon. Seattle is the largest city to decriminalize all psychedelic plants and fungi for religious, spiritual, healing, or personal growth practices.

California is currently proposing its own measures to legalize psilocybin mushrooms, truffles, sclerotia, and mycelium. Iowa is following suit, but with an additional bill that would reclassify psilocybin, ibogaine, and MDMA for medicinal purposes.

The real goal here is to nationalize the use of these drugs, which have the potential to significantly alter our society and offer bad treatment for those suffering from trauma, anxiety, and depression. The strategy we are seeing to promote psychedelics has been taken right out of the playbook of Big Marijuana. Rather than fight the arduous battle of changing the schedule 1 designation at the federal level, there's a major push to make these drugs respectable. Research studies and popular media will continue to promote medical benefits associated with these drugs, but the endgame is for psychedelics to be legalized at every local and state level for recreational use.

Fighting major pharmaceutical and research industries may seem like an uphill battle. However, there are important steps that we can take to slow this fast-moving train:

Dr. Jennifer Bauwens serves as Director of the Center for Family Studies at Family Research Council. In her role, she researches and advocates for policies that will best serve the health and well-being of families and communities.

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The Public Is Being Primed To Feel Groovy About Psychedelic Drugs - CBN News

Looking Into The Florida Bill That Proposes Decriminalization Of Psychedelics (And Every Other Illegal Dr – Benzinga

This article by Emily Jarvie was originally published on Psychedelic Spotlight, and appears here with permission.

A new bill filed in Florida has proposed the decriminalization of psychedelics, along with the rest of currently illegal drugs, and the promotion of rehabilitation instead of criminalization for drug-related offenses.

Democratic RepresentativeDotie JosephfiledHB 725, titled the Collateral Consequences of Convictions and Decriminalization of All Drugs Act, last Tuesday.

The bill proposes that crimes associated with the personal use and possession of controlled substances that do not involve production, distribution, or sales be decriminalized in favor of civil fines or referral for drug rehabilitation.

The Legislature intends the prioritization of rehabilitative health intervention in lieu of criminalization for personal usage of controlled substances, including but not limited to, stimulants, including cocaine, methamphetamine, opioids, heroin, fentanyl, depressants or benzodiazepines, and other addictive controlled substances, the bill states.

It would also compel the Department of Health to conduct a study on more effective methods of addressing drug addiction instead of criminalization. This study shall include but not be limited to supervised drug consumption in facilities, which have been proven to reduce public disorder associated with drugs, and lead to a drop in the behaviors linked to HIV and Hepatitis C transmission; programs that have been successful in Seattle, San Francisco, and Philadelphia; and any other rehabilitative centered solutions, the bill says.

The aim of the legislation is prioritizing treatment and safety in an effort to preserve lives rather than discard them through criminalization and incarceration . . . in the interest of the health and public safety of the residents of Florida, preserving individual freedoms without sacrificing community costs, allowing law enforcement to focus resources on violent and property crimes, generating revenue for education, substance abuse prevention and treatment, freeing public resources to invest in communities and other public purposes rather than continuing to overburden prisons with a population that needs medical attention, seeking corrective equity on the impact of the war on drugs, and identifying real people-centered solutions to various drug crises like the opioid epidemic.

There is evidence that the widespread decriminalization of all drugs can lead to a dramatic drop in drug overdoses, HIV infection, and drug-related crime, as demonstrated by Portugal, whichdecriminalized all drugsin 2001.

Should this legislation go into force, Florida would become the second state in the United States to decriminalize all drugs. This comes after Oregon passedMeasure 110on November 3, 2020, which downgraded the personal non-commercial possession of controlled substances to a Class E violation a maximum fine of $100 whichcan be waivedif a person undergoes a health assessment that leads to addiction counseling.

Abillintroduced in the U.S. Congress in June has also proposed an end to criminal penalties on a federal level for the personal use of illegal substances, including Schedule I and II drugs.

To date, other jurisdictions in the United States have adopted less radical drug decriminalization measures, with cities such asDetroit,Seattle, andWashington, D.C.voting for the decriminalization of psychedelics including fungi and plant-based entheogens.

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Looking Into The Florida Bill That Proposes Decriminalization Of Psychedelics (And Every Other Illegal Dr - Benzinga

Thats an Old Story – The Cut

Mind. Body. Control. Uncover the dark truth inPower Trip, a new investigative series with original reporting fromNew YorkMagazine.

Photo-Illustration: by The Cut; Photos: Provided

In the second episode ofCover Story, Lily Kay Ross recounts her trip to the Ecuadoran Amazon to the podcasts host, iO Tillett Wright. Relating the multiple instances of rape and sexual abuse she experienced at the hands of an ayahuasca shaman and the aftermath when she decided to come forward, Ross portrays a community unwilling to support her or confront its own systemic issues.

Ross: People didnt say, This is your fault. They said things like You manifested this experience so that you could grow as a person. What if he did what he did to heal you?

Not until someone reached out asking for information about the very abuse Ross had experienced did she realize she could find help outside the system that had silenced her. That someone was Dave Nickles, a moderator and editor who runs psychedelic-harm-reduction and education projects. Together, they began to investigate larger issues within the community alongside other testimonies like Rosss. Nickles helped Ross realize that her story was part of a much bigger one one dealing not only with sexual abuse but with power and manipulation in the psychedelic community. Together, they are ready to share what they uncovered.

Mind. Body. Control. Uncover the dark truth inPower Trip, a new investigative series with original reporting fromNew YorkMagazine.

To hear more about Rosss harrowing experience in the Amazon, listen and follow on Apple Podcasts, or wherever you listen, and find the full transcript below.

Just a quick note: This series deals with sexual assault, so please keep that in mind when you decide when and where to read or listen.

iO Tillett Wright: Lily, I know you left the psychedelic world, and I would love for you to talk about the moment where it went from being something safe and something growthful and beautiful to something treacherous and bad.

Lily Kay Ross: Oh boy. That shit was dark theres so much. [Laughs.] The turning point was actually when I had been deeply hurt, and the response I got was if I told the story of what had happened to me, if I kept beating this drum, that I was going to single-handedly destroy the psychedelic renaissance.

Wright: On the off chance that youve never heard of Burning Man, picture 50,000 people in thongs and goggles and furry leg warmers on Technicolor Mad Max bicycles, dancing and tripping in the middle of the Nevada desert. All vehicles there have to be approved by the DMV, the Department of Mutant Vehicles. I am not kidding. Hundred-foot sculptures of sharks and fantasy creatures roll through a temporary city erected and deconstructed every year in celebration of radical self-expression. Naturally, its been a magnet for psychonauts of all kinds and a beacon of outsider culture. But just over a decade ago, tech people started flocking. They were interested in mind optimization, starting to microdose. They wanted shamans to come to their mansions to guide private journeys. That was all part of how the modern psychedelic renaissance started. And Lily was there for it. Literally. In 2008, she was at Burning Man. And slightly annoyed by this one tech guy.

Ross: And this creepy guy was hitting on me.

Wright: Shes there attending some lectures on cool, new psychedelic research.

Ross: One of the things he was puffing himself up about was like he was a wealthy guy, and, you know, funding, psychedelic research, and whatever. Oh, there are these researchers, and theyre trying to do blah blah blah.

Wright: At this point in her life, shes already into critiques of money and power and authority. Shes thinking about how that stuff plays out in the psychedelic world all these white people appropriating Indigenous cultures, questions about who profits. By 2011, thats a lot of what shes studying at Harvard.

Ross: I nerded out, hard-core, on postcolonial theory.

Wright: Thats when she hears about a project in the Ecuadoran Amazon that piques her interest. An Indigenous community wants audio equipment to tell their own stories.

Ross: Which I thought was cool. Even though it was tangential to the guide work and the things I felt called to and pulled to, it was something I was very passionate about and interested in.

Wright: In 2012, she got a grant to go for the summer. Shes going to be working with a local guy who is leading the project there.

Ross: The man who was hosting me was also an ayahuasca shaman, which I didnt know until a few days before I was going down there.

Wright: Should we go to the Amazon?

Ross: Yeah, I guess so. So I got on the plane, it was like six in the morning, and then got into Ecuador late that night. Then I woke up in the morning, and I took a taxi across town to a bus depot. The taxi ride was like an hour. The bus was like eight. And we went out of the Andes and down the mountain into the Amazon.

Wright: This is when Lily first saw the guy she was there to work with, someone were going to call T. She describes him as wearing black jeans and a button-down shirt, a rainbow-beaded headband, and a giant anaconda-skin necklace. He takes her on another two-hour bus ride, they walk across a bridge, and then ride another bus up a mountain.

Ross: And then finally, T kind of indicates to the bus driver who stops and lets us off. Theres no bus stop and theres no city and theres no anything. I dont know if youve gotten this impression yet, but it was remote. We were out there.

Wright: Theres one last car ride, the only taxi around.

Ross: Hes agreed to take us out to the village. And we get out of this car and there I am with T in the dark, and the taxi drives off. Then we had to walk about a mile.

Wright: Its literally four structures in the jungle.

Ross: I was tired. I was thirsty. I was hungry. I was a bit relieved that I didnt have to travel anymore.

Wright: First, T sits her down and talks to her about the village how their whole way of life is under threat and that her role is to document it. Then he takes Lily to a hut with nothing but a little bed and a pallet for her stuff, and she finally gets to sleep. Two days later, she finds T doing a kind of cleansing plant bath on some of the men in the community. Its a ceremonial thing, and he wants to do one on her.

Ross: It was like, Well, this is a thing he does with people. I went into the hut, and I went to my bed. And I was wearing my undergarments, as he had said, and he came in and he had some kind of very aromatic liquid that hed put onto these branches, like leaves. So he covers me head to foot in this stuff and then he says, Just wait here and put your clothes back on. And Ill be back in 30 minutes to come to talk to you.

And then everything just became very, very weird. It felt like my eyes were drying and my mouth was drying and the walls were doing this pulse-y, wavy thing. And I was alone, so I got up and I walked to the door and I was having a really hard time standing up. He saw me standing in the door, and he rushed right over to me, and he kind of took me by the arm and led me back to the bed and kind of had me lie down.

Then he started on this whole thing where he was telling me about our relationship and how this was all meant to be and that uh, that were in love? That was a thing that he declared at that time. And that this was all the will of God. I dont even believe in God, what the fuck is going on?

I couldnt move. I was physically incapable of moving my body, and I had no concept of what was happening. He was sitting behind me and had wrapped his arm around my neck, and he was humping me, he was trying to kiss me, he was I was totally frozen. It took me about ten minutes, from my sense of time, to collect myself and to turn away from him, which I finally did. And then he kind of got up and laughed and got into his bed and went to sleep.

And there was silence. Then there were words, which is not how I usually talk to myself. And the words said, You have to run, you have to get out. Youre being brainwashed. And I heard those words, and I honestly felt paralyzed. I was not the same person after that.

Oh, this is hard. It was like he had commandeered my will. I would have done anything that he told me to do.

Wright: For the next few days, Lily felt like she was in a fog, not in control of her own thoughts. And totally attached to T.

Ross: I was utterly dependent on him, terrified to be away from him, terrified to be near him as well. Bewitched?

Wright: Lily was there 26 days, and T raped her six times, though it took her months to call it that. She told me he kept repeating that their love was the will of the god, the spirits, and his ancestors. That they were in danger, but if she stayed near him, he would keep her safe. He also started giving her ayahuasca.

At some point, an American family came to visit. They were taking their kids on a South American tour, and a local suggested they go off-road and visit an authentic village with a real-life shaman. The mom in the family, her name is Ainlay Dixon. Ainlay and Lily got friendly right away.

Ainlay Dixon: After a while, I realized that she was really out of it. She was really stilted and kind of stoned but in a kind of zombielike way.

Ross: I was a shell by that point. It felt like somebody else had taken over my brain.

Dixon: We had our conversation, and thats when I realized something was really wrong.

Ross: I had pulled aside the mom at one point.

Dixon: We went up to a kind of crawl space at the top of the hut where no one could find us.

And she told me

Ross: So I have this sexual relationship with this guy.

Dixon: And that the shaman had told her that he had four wives and that he was going to leave them all and marry her, and that

Ross: It was like I was watching somebody else talk through my mouth.

Dixon: She explained that this is a person with whom she has a professional relationship but then has come into her bedroom at night. And this is what happened. And dah, dah, dah, dah, dah. I was very taken aback, not by what she was saying but the way she was speaking.

Ross: I was trying to get somebody to help me, but I wasnt in a place where I could articulate I think I need help.

Dixon: I mean, this is the ultimate isolation. She saw nobody. She only saw the three or four people who were in this little compound.

Ross: Meanwhile, he was telling me overtly, Im going to get you pregnant, and were going to have all these children and youre going to live in the Amazon.

Dixon: And I was like, You know, honey, I think you might not trust everything hes telling you.

Ross: She seemed a bit like, Oh yeah, I mean, hes handsome. I could see it, just be careful and dont get too caught up.

Wright: So Ainlay and her family leave, and Lilys still in the village. A couple of days later, T takes Lily to his wifes house in a city about an hour away. She borrows his computer to check her email and sees that she has a message.

Ross: I got this email from Ainlay Dixon, and it says, Hey, Lily, Ive been wondering about sending this email for a while and finally decided to do it.

Dixon: We met some people, and they seemed to have a very different impression of T and not a good one.

Wright: Ainlay lays out that once she left the village, she couldnt get Lily out of her mind. Shed started poking around, asking questions about T. And what the locals told her was really dark.

Dixon: [Reading the email.] The Indigenous group he is part of, themselves find him to be a disgraceful charlatan wearing a jaguar skin, exaggerated feather headdress, exaggerated face paint, and playing supposed native music with non-native guitars and charangos.

Ross: Some of what they said was too fantastical to believe, such as being mixed up in trading shrunken heads and a local leader being killed when he tried to investigate.

Wright: T was investigated in connection to that killing, but he was never charged. Some Ecuadoran papers had covered it.

Ross: As I was finally getting to the point of going, Holy shit, like, I think this guy is a murderer,I started to hear his footsteps walking up the footpath.

Wright: This is where this becomes like an escape scene in a movie. In a split second, Lily comes up with a story about her dad being sick.

Ross: Ive just heard from the doctors, and my dads in the hospital and theres something wrong with his prostate and Im scared and they dont know whats wrong.

Wright: She tells T that she needs to stay in the city for the night to sort out the details. She convinces him. She frantically makes a call and gets American Airlines to waive the change fee and put her on the next flight she can catch. And in the morning, she makes a break for it.

Ross: I was looking over my shoulder every step of the way, thinking, Is somebody following me?

Wright: With nothing more than her purse which, at the last minute, shed thrown her passport into Lily hops on a bus, gets herself to the airport, on a plane, and to her family in L.A.

Ross: The further I got away from him and the village, the more that I felt that, This is real. And some really bad stuff has just happened.

Wright: That whole escape saga was all very dramatic. But its what happened next that changed the course of Lilys life.

Dave Nickles presenting at the 2012 Psychedemia conference, where he met Lily Kay Ross. Photo: Provided

Ross: My dad picked me up from the airport, and I remember how warm his hug was. I got home, took a shower, and did everything I could to just feel normal. I put on my favorite clothes and my favorite earrings and tried to do what I could to have a sense of my identity and feel like myself again.

Wright: For a while, Lily was just trying to make sense of what happened to her.

Ross: Like, Was this a consensual relationship? There were periods where I did resist it. I was really clear, like, This is not what I want. When I went to the crisis center for my intake, I was sort of like, Are they even going to take me? Because I dont know if what I went through counts.

Wright: It took Lily months and months before she even talked to her dad about what happened.

Ross: I remember what I said to him. I said, During my time in the Amazon, T was raping me. And my dad was there for me. He said, You know, Lily, Ive tried to say this before, but I think he drugged you. At first, I was very resistant. I was like, Well, I took ayahuasca, but that was after. And it was this whole other thing, and he kept pressing the issue. That was when something started to dawn on me: Well, there was that one night where I was paralyzed, and everything was going all wompy and wonky and weird. Then I remembered that he had covered my body with this liquid thing.

I had this conversation with Dad, realized I had been drugged, and did some research. I went, Holy fucking God, this is so much worse than I thought it was. This makes so much more sense. This asshole drugged me and brainwashed me.

Wright: Lily came to believe that the plant bath contained this drug called scopolamine, which, after our interview, I had to look up. I highly recommend you give it a Google yourself because this drug is batshit. They call it the zombie drug because high doses can put you in a state where its hard to assert your free will. Gangsters love it because people will just hand over their bank cards or car keys when they demand them.

By the way, New York Magazine called T, and he denied drugging or raping Lily. He basically said in his culture it was natural to have sex with lots of women but said it was never by force.

But after that conversation with her dad and her research, Lily was clear: This man had used his authority as a shaman, in combination with drugs, to control and rape her. The idea of someone, anywhere, of any culture, using these drugs to control another person makes me think of something Dr. Grob said. Remember that UCLA researcher who took us to Mr. Rogerss Psychedelic Neighborhood? He was telling me about some research he did in 93, observing how ayahuasca was used in religious ceremonies in the Amazon, and he noticed this particular way this minister would use the drug. Once his congregants were in a suggestible state of mind from the ayahuasca, he would give them life tips.

Charles Grob: To be responsible to their spouses, their parents, their children, their employers, across the board. I remember one night, I was at a ceremony and my translator had kind of snoozed off, so I gave her a nudge and asked what they were talking about. Oh, she said, theyre talking about how important it is that if you say youre going to be somewhere, you are there. And I thought, This explains a lot. Individuals who had started at the bottom rung of the socioeconomic ladder had risen to be successful in their jobs, in their family lives. I thought, Wow, so much has seemed to do with this heightened receptivity they must have had.

Wright: These drugs can give a person so much power to influence others. So the thing to look at is how do they use that power, and what are they influencing others to do? In the next breath, Dr. Grob was reminding me of a story I already know, that you probably know too, about a famous group of Californians in the 1960s.

Grob: You have an old example of the Manson Family. He would dole out LSD to his followers and then he would launch into these bizarre fantasy-ridden speeches that eventually led to their following his instructions to go commit murder and mayhem. It was a horrible situation, but I think probably a telling example of what could happen when these compounds are employed by an unscrupulous, unethical, immoral cult leader.

Wright: Basically, Dr. Grob was warning me that these drugs can be tools to manipulate people, whether among all the different groups in the Amazon or in the overwhelmingly white underground world of psychedelics that Lily was part of. And that was the worry that started to bubble up for Lily after she came out of the very dark hole she was stuck in.

Ross: I was quite fixated on what had happened. I was not sleeping at night and sleeping during the day. I am in a lot of pain and I am drinking too much whiskey and it was just all pain all the time.

Wright: Eventually Lily started talking to her circle of friends a little about it, and it went fine. They were sympathetic and horrified. But then she started to go and tell people in the psychedelic community.

Ross: At that point, I considered psychedelics part of what was helping me heal. So it seemed to me like a way to be nuanced and be like, Look, theres this potential and then theres this other, darker potential. Lets consider that. But it was the people that I knew through psychedelics and psychedelic conferences and the Guild of Guides who were responding in really weird ways.

Wright: The Guild of Guides a.k.a. the Convivium is that underground conference where people who practice psychedelic therapy met to discuss their work. Some of these people were saying things that messed with Lilys mind.

Ross: I was on the phone with somebody I had met at the Guild of Guides. He said something like, You cant call it rape because if you call it that, then youre giving all your power away. If you call it rape, then you make yourself a victim.

Wright: It did not get better from there.

Ross:People didnt say, Well, this is your fault. They said things like You manifested this experience so that you could grow as a person. What if he did what he did to heal you? That reshapes it as a positive thing. Oh, good on you. Arent you such a brave soul? You gave yourself this opportunity for growth and healing.

Wright: And she thought about that. Like, maybe there was some weakness in her that he exploited.

Ross:I wanted to figure out if this was mommy issues? Was this daddy issues? Was this me looking for safety? Was there something about the fact that my mom had died that meant I was seeking something that I thought he could provide?

Wright: Lily went around and around like that for a while. Is it me? Do they suck? Or is it me? And eventually, it was this one particular line she heard from a few people that set something off in Lily.

Ross: It was, Oh yeah, thats an old story. Shamans or people sleeping with their clients or whoever is an old story. Oh, this has been going on since the beginning.

Wright: An old story? Thats been going on from the beginning? Meaning there are rapists in our midst? And everyone knows it? When she put that chain of thoughts together, another part of Lilys brain kicked in. The skeptical, questioning part. The part of her that, throughout all her years in the psychedelic underground, had been a little concerned about certain dynamics between guides and their clients.

Ross: Who are these people that are dispensing these drugs to a roomful of people? What kind of training do they have? Is this wise? Is this safe? Is this a good idea? People would call themselves shamans; is that a thing that one calls themselves? Are these people doing a good job? And who decides? Is there somebody that authorizes this? That says you have the seal of approval that we know youre not a dick and youre competent in this? Where do people go if they get hurt or if somebody does something wrong?

To my mind, these realms are real and good. Intentions are not enough when it comes to claims to shamanic power because power is seductive, and without proper guidance, claiming power is a slippery slope.

Wright: Lily gave this talk a couple of months after she got home from the Amazon. And its weird to listen to now because its from a period when she was still in a daze and hadnt processed anything or even figured out the basics of what happened to her. But in her words, you hear hints of a future Lily the one who is past looking inward, inward, inward.

There are a few reported deaths now from ayahuasca in Peru and Ecuador and increasing reports of sexual transgressions and rape. If we are not willing to address this, what does this say about us as a community who love psychedelic plant medicines and what they have to offer us? If we dont talk about this, if we are silent, are we not then complicit?

Wright: To Lily, these questions felt more important than ever. Because the psychedelic renaissance was becoming an actual thing which meant that more and more vulnerable people might be turning to psychedelic guides. Which meant that what happened to Lily could happen to them. But the guides themselves, some of them seemed focused on a different danger, which became clear to Lily during this one last twisted conversation she had with a woman who was known as a teacher and a scholar. An adviser to a lot of important groups. A well-respected elder. Lily told her she wanted to speak to the press about the danger of abuse.

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Thats an Old Story - The Cut

Trip to Sustainability? This Company Is Developing Synthetic Psychedelics To Attempt to Fight Mental Illn – Benzinga

Photo by Raimond Klavins on Unsplash

The following post was written and/or published as a collaboration between Benzingas in-house sponsored content team and a financial partner of Benzinga.

Researchers have long experimented with hallucinogenic drugs for the treatment of mental illness.

While many people may be familiar with psychedelic drug advocate Timothy Learys experiments with LSD or the known effects of magic mushrooms, what they may not know is that there are a variety of hallucinogens that scientists are studying today in the hopes they will be able to treat addiction and mental illness.

Reportedly among the most promising drugs being studied today is ibogaine, a naturally occurring psychedelic substance derived from the bark and roots of the West African shrub Tabernanthe iboga.

Ibogaine has the potential to treat mental health issues like addiction, depression, and anxiety, but a lack of resources is preventing the research and clinical trials from bringing ibogaine treatment to the United States and Canada.

The legal status of ibogaine varies around the globe. Its illegal in ten countries, including the United States and nine European countries. Its regulated in three countries Australia, Israel, and Canada. Countries that have deemed it legal as a prescription pharmaceutical substance include New Zealand, South Africa, and Brazil.

As the substance becomes more widely known as a potentially effective treatment for addiction and mental illness, demand for the natural resource could lead to its depletion. Lack of sustainability is one reason ibogaine hasnt entered mainstream treatment for the conditions its believed to help with. The iboga shrubs root bark contains the highest concentration of ibogaine, and while its possible to harvest the root bark without killing the plant, the method used results in slower growth.

Thats why Mind Cure Health Inc. (CSE:MCUR) has created a synthetic version of the drug that will enable researchers to continue their work without killing the shrubs. MINDCURE, a Vancouver, British Columbia-based life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health, has successfully synthesized ibogaine. The company will be entering pre-clinical trials in Q1 2022 to see if the efficacy of the synthetic version is the same as the semi-synthesized molecule that is currently being used for research purposes.

Earlier this year, MINDCURE announced The Ibogaine Project, a research and development program for manufacturing synthetic ibogaine and conducting preclinical explorations. By manufacturing pharmaceutical-grade ibogaine, MINDCURE wants to provide researchers and clinicians with a sustainable, reliable and regulated supply of the compound to conduct studies and improve knowledge about its potential benefits.

Only a handful of companies are directly working with psychedelics to help solve addiction and mental health issues. Atai Life Sciences (NASDAQ:ATAI) is developing several drugs based on psychedelic substances, including ibogaine and ketamine, and Mind Medicine (NASDAQ:MNMD) is developing 3 clinical-stage programs, 2 of which focus on LSD and the 3rd on ibogaine.

The preceding post was written and/or published as a collaboration between Benzingas in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

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Trip to Sustainability? This Company Is Developing Synthetic Psychedelics To Attempt to Fight Mental Illn - Benzinga

This isnt the 60s again: psychedelics business takes off amid culture clash – The Guardian

The Wonderland psychedelic business conference, held recently in Miami, Florida, drew large crowds and big-name keynote speakers such as former heavyweight boxing champion Mike Tyson with the promise of a booming new sector. It is being suggested that the next big development in mental healthcare will come in the form of psychedelic drugs: substances such as psilocybin (magic mushrooms), ayahuasca (a plant-based mixture from South America), and DMT (a naturally occurring hallucinogenic).

While these substances have been illegal and primarily associated with countercultures such as the hippies of the 1960s and ravers of the 1990s, changes in laws and scientific breakthroughs in psychedelic treatments for depression and anxiety have created a new industry projected to be worth 8bn by 2027.

Much as happened with the cannabis industry a decade ago, a culture clash is now developing between social justice activists who fought for the legalisation of psychedelics and wealthy white men, often new to the drugs, who have the resources to dominate an emerging industry.

Two years ago in the US, the city of Denver voted to decriminalise psilocybin mushrooms. It was quickly followed by Oakland and Santa Cruz in California, the state of Oregon, and then Seattle, which added ayahuasca, ibogaine and non-peyote-derived mescaline to the list. Some of these campaigns enjoyed financial support from large companies such as the organic soap producer Dr Bronners.

Celebrities including actors Megan Fox, Will Smith and Jada Pinkett-Smith and talk show host Chelsea Handler have testified to the psychologically transformative powers of a psychedelic trip. As the buzz around these drugs heralds a new industry, will those profiting maintain the countercultural ideals of the people who popularised the drugs?

This isnt the 1960s all over again, the former chief executive of MindMed, JR Rahn, told Forbes as his company was attempting to get approval from the FDA, the US regulator, for its specific types of LSD to treat anxiety. I want nothing to do with those kinds of folks who want to decriminalise psychedelics.

Much of the effort to legalise such substances is centred on offsetting the damage that the war on drugs has caused in impoverished communities often by promising people of colour an economic path into this new, lucrative industry. However, for many of the early investors in psychedelics who are able carry the legalisation baton to the finishing line, the strategy is often to craft a limited version of the industry that places them exclusively in charge.

The idea that psychedelics should only be used to heal something that is broken within you rather than as a way to communally understand our world is the narrow definition that will get FDA approval, says Jason Ortiz, co-founder of the Minority Cannabis Business Association, and executive director of Students For Sensible Drug Policy. That communal bonding will be lost if were only pressing it into pills.

Ortiz fears that if psychedelics fall exclusively into the hands of big pharma, plants often deemed sacred by Native Americans and the surely lucrative industry awaiting them will follow the same path as the legal marijuana industry. Legalisation here has seen the rich get richer, while minorities and psychedelic pioneers were left out in the cold.

Theres an institutionalisation of psychedelic drugs happening that will make them less accessible to the common person, Ortiz says. A lot of these corporations come from big pharma and have established networks within the FDA. Movements for justice threaten that monopoly by saying that folks should be able to cultivate, sell and consume these substances on their own.

Ortiz is pursuing decriminalisation for all psychedelics, allowing individuals to make their own choices about whether and how to take them. He views the pharmaceuticals industry as a threat to that.

However, the chief executive of Enveric Biosciences in Florida, Joseph Tucker, says that to do it the pharma way will simply provide users with more confidence, a better experience and fewer side effects. He points to the synthesis of willow bark into aspirin in the 19th century turning a traditional cure into a more effective, less toxic medicine.

Enveric is creating psychedelic-derived molecules and synthetic cannabinoids for the treatment of mental health disorders, and is currently pursuing FDA approval for its products.

With psilocybin, there can be cardiotoxic effects if its taken every day, and theres also serotonin syndrome [caused by excessive levels of the neurotransmitter in the body], Tucker says. But the biggest issues are with the trip itself. Bad trips rely on three major variables: dose, [mind]set and setting. So people try to really control the mindset and setting, and that constrains how youre able to utilise those therapeutics. In many clinical trials, 90% of patients are screened out for having the wrong mindset, and so it wont work for them.

Tucker points to ketamine an anaesthetic that is often erroneously characterised as a psychedelic because of its history as a club drug as an example of a drug with psychedelic effects that has been shown to be effective in mental health treatments, independent of therapy.

Ketamines approval for off-label use, and its proven efficacy in treating depression and anxiety, has led to a number of clinics popping up across the US where those suffering can legally access it in a medically supervised environment.

Elsewhere, the head of Los Angeles-based Irwin Naturals, Klee Irwin, says: What Ive done for 27 years is collect the best of whats around and put it together into something accessible for all people. So Ill take what indigenous people have discovered through some herbal concoction, and Ill take it and put it into a bottle that you can get at Walmart.

As a publicly traded company and health supplement supplier for big US names such as Costco, Walgreens, CVS and Walmart, Irwin Naturals certainly has the track record to commercialise and legitimise psychedelics. In 2018, Irwin had to convince his more conservative investors that cannabis-derived CBD products were a smart, and not too risky, endeavour: he was proved right when the company became one of the largest CBD wholesalers in the nation.

Before the Wonderland conference, Irwin made headlines by announcing that his company would be entering the markets for psychedelics and THC, the psychoactive component of cannabis.

I wouldnt have been able to do this two years ago: it wouldve been too scary, Irwin says. But right now theres this perfect quiet before the storm an opportunity for us to slip in [to the psychedelics industry] as the first truly household-name brand, which can be viewed publicly as a validation of plant medicine. Soon it will be far less demonised and therell be a whole bunch of people dogpiling in just to make money.

Irwin distinguishes himself from those motivated exclusively by profit by his intention to keep prices low and thereby make the products accessible to all income groups. In this way, he feels the necessary social justice goals can be achieved via big business.

When we started selling CBD, we collapsed the pricing floor by selling it at half the price per milligram of the lowest-priced producer, he says. Since we are the largest, we can bully our competitors to chase us to the floor in terms of pricing, and we are about to do the same thing with marijuana.

Irwin sees the mental health crisis in America as an emergency that warrants an FDA fast-track for psychedelic drug approval as was achieved with Covid vaccines. And he believes companies with the power to drive the prices down should do so as a public good. There are around 600 ketamine clinics in the US, and theyre all mom-and-pop-owned, like video stores before Blockbuster, Irwin says. What we want to do is acquire some of them, and open up some new ones.

For psychedelics such as psilocybin and ayahuasca, which are not approved in America, Irwin is opening retreats in nearby countries such as Costa Rica and Jamaica, preparing his company for what he sees as inevitable drug-law shifts in the US.

Ortiz of the Minority Cannabis Business Association says that, on the whole, large investments in the psychedelic industry are not inherently a bad thing so long as people of all levels of privilege have access to the substances, and the chance to enter the industry. That will help dissolve the stigma around these substances, and there will be countless people who have their mental health issues addressed, and thats a good thing for society in general. That being said, its important that its not solely owned by anyone.

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This isnt the 60s again: psychedelics business takes off amid culture clash - The Guardian

When Lincoln Center Comes Down From This Trip, Theyre Going to Feel Weird – Vulture

From Flying Over Sunset, at the Vivian Beaumont. Photo: Joan Marcus

I spent the morning after seeing Flying Over Sunset the same way I assume everyone else did surfing Wikipedia. There was so much history, referenced so sloppily, during James Lapine, Tom Kitt, and Michael Kories ill-conceived musical about psychedelics that I needed a next-day huddle with my computer. Those hours I spent with my laptop were the best ones that the musical brought me. Footnotes! Cross-references! I believe that internet binge gave me the same high the creative team must once have felt the intoxication of learning about real people and diving into the details of their lives.

In interviews, the musicals book-writer and director James Lapine has spoken about finding the inspiration for Flying Over Sunset in a biography of Clare Boothe Luce, the mid-century playwright and politician who became a towering figure of American conservatism. Luce took LSD for psychiatric reasons, and she was linked to the consciousness pioneer Gerald Heard, himself a dear friend of the writer Aldous Huxley. This daisy-chain acquaintanceship interested Lapine. The real Cary Grants own interest in acid then offered him a fourth LSD-curious celeb running around California in the 50s, and as anyone knows, once four celebrities (possibly) meet, youve got to make a show about it. (You do not.)

Our first voyager, Huxley, played by Harry Hadden-Paton, has his initial drug experience in a Rexall Drug. (So far, so true: Huxleys book The Doors of Perception contains the account of this experiment with mescaline.) As his wife (Laura Shoop) and Heard (Robert Sella) try to tug him out of the magazine aisle, Huxley sing-talks about imagining the Biblical Judith as she emerges from a Botticelli painting. Hes tripping hard: The curving white walls of Beowulf Boritts set invert; projected images crawl all over them; a little video fish wriggles inside a spherical lamp. But for all this visual hullabaloo, were not meant to think about Judith beheading Holofernes. The image does not set up a theme or a motif or illuminate some unseen truth. The shows songs lush but dull music by Kitt, lyrics by Korie all show us acid trips, yet the grindingly inert and ineffectual Judith number makes you keen never to share one of these hallucinations again.

Huxleys wife quickly expires slowly tap-dancing chorus members remind you of Deaths steady tread and she haunts him by drifting in and out of his LSD experiences. For the rest of the show, Huxley will have one directive: to dance again with her. Like Huxley, Luce (the dazzling Carmen Cusack) is also in mourning. We see her sad about any number of things: her sexually loose mother, a contentious Senate hearing over her appointment as an ambassador, and her teenage daughters death in a car wreck. As with Huxley, the things that make the historic person fascinating are subsumed by the show into one basic therapy revelation Luces Senate stuff vanishes fast, but we spend a lot of time on the dead daughter, whose absolution she craves. At one point or another, characters will raise their divisions on issues of public morality or war, but theyre hushed by Gerald. No politics! he cries, which effectively cuts off anything that might stimulate conflict or conversation. Just as Huxleys wife dogs his steps, ghosts tailgate Luce. Again Lapine calls upon choreographer Michelle Dorrance to set the vibe. The gloomy dead tap-walk in a gloomy tap-circle. Step drag step drag.

Cary Grant may never have met the other three, but Lapine distorts reality to get him there. Even within the spaced-out logic of the show, its never plausible that the star would meet these other seekers and decide to get high with them on a beach. (Tripping in Malibu is the entirety of the deadly second act.) Certainly Tony Yazbecks Grant seems ill at ease, even apologetic, throughout. Though to be fair, he has the hardest job of the four: Cary Grant is a known quantity even in 2021, so theres the familiar accent and the stiff-spined, gliding grace to try to copy. Yazbeck makes a hash of the voice, and he displays a different, more percussive grace, but at least he has barrels of that: The moments when the show stops to let him tap-dance with a vision of his precociously talented child self (Atticus Ware) are by far its best. Its too bad that baby Cary has to then join the Baggage Parade (step drag step drag), and eventually, in a watery vision, get washed out to sea.

The key post-show discussion question in my small group was How did this get made? The Vivian Beaumont is a big house to sign over to a musical so dramaturgically inept, so lacking in connection, philosophy, or fire. I can understand if at first the Lincoln Center folks were persuaded by the teams collective resum: the performers are strong, Lapine wrote the book for Sunday in the Park With George, and Tom Kitt composed Next to Normal. But there were workshops! There were opportunities to see Yazbeck blush his way through a number in which Grant thinks he is a giant penis blasting off from earth like a spaceship, and to see how bland and puerile such a scene winds up being in execution.

The most you can say for the shows acid-trip stuff is that it sometimes shows a juvenile, snickering humor: After Carys phallic blastoff, we see Clares vision of the afterlife, which looks like a huge ferny mandala, a giant green yonic symbol with her dead mother sitting right at the center. Tee-hee! I can picture someone thinking. Clares slutty mother is in a purgatory that looks like a big vagina! Im not saying this was a wonderful moment: I would need to be extremely high myself to think this was hilarious stuff. But I can at least imagine a version of the show in which it was funny. Thats the thing, really our conscious imagination is more powerful than the subconscious. We learn early in the production that a trip, like a dream, is a private experience, full of the minds rich colors. Make something up, tell a story, you can keep us interested for hours. But other peoples drug experiencesand if you have stoner friends, you will recognize thisdie the moment you narrate them. Dream-colors fade into gray in the spotlight; all the projections in the world can not make them bright again.

Flying Over Sunset is at the Vivian Beaumont Theater through February 6.

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When Lincoln Center Comes Down From This Trip, Theyre Going to Feel Weird - Vulture

Will this music alter your mind? The most terrifying thing can do that – Sydney Morning Herald

His collaborator Kaelen also runs a company called Waveform, which makes AI-generated soundtracks for use in psychedelic therapy. Hopkins is a Waveform investor. Brian Eno is a mentor of sorts to Hopkins, has collaborated with him many times and is also involved. Kaelen took a high quality Fostex field recorder. Hopkins had with him a Bose portable speaker. He put the Bose at one end of the underground cathedral with Kaelen at the other, and he played pieces of music and sound through the speaker for him to record, 50 metres away. One of them was a drone from a crystal bowl, previously recorded by Hopkins; it became the opening soundscape of Music for Psychedelic Therapy.

If someone is going to invite me to do something that I would never do, in an extraordinary place, then ... it seems you have to go for it.

It was very important to me to use the cave as a way of processing the sound. Like a reverb. That had to be the starting point so that it really felt like the music began with the cave and grew out of it, Hopkins explains.

He had already made music for legitimate psychedelic therapy, for Waveform, for use as an adjunct in clinical settings in university research trials. This album is like a commercially available version of those. It includes, at the end, excerpts of a lost talk by the late spiritual teacher Ram Dass.

Like the sharing circle at the end of the session, says Hopkins. His track [Sit Around The Fire, featuring Das and musician East Forest] is very grounded, so its only piano and voice and fire, and a few little bits of processing, but not very much. Whereas everything else on the record is far more difficult to describe in terms of, well, what instrument is that?

In the spirit of Dass, Hopkins wanted to remove himself from the musics imprint and try for the ultimate musical and psychological goal of absolute purity.

Deep in the woods of Devon, in the far south of England, Hopkins collaborated with musician 7Rays. His name is Dan, he says, we have been friends for a very long time. Hes very literally bought that woodland energy into the work. The pair hung speakers from trees to play sounds through them to be recorded and processed.

To me those pieces sound very, very like the experiences Ive had in the DMT realm, says Hopkins. Thats something that weve shared, so theyre almost like downloads from that space, and very, very in tune with the woods.

Hopkins was a late-bloomer with psychedelics. He only put them (and ketamine) into the mix when he reached 35, about seven years ago, shifting his music production in the process increasingly towards stillness.

Ive always had spiritual experiences dating back to teenage years, but I didnt really understand them particularly well until I meditated for a certain amount of time myself and read a certain amount about what might be going on behind that, he says.

The era that were in has become increasingly fraught and unpredictable. I felt like I had no choice but to make something that was so direct. Purity is certainly what I hope people feel from it. I tried to get myself out of the way and let myself be the vessel.

Jon Hopkins performing in Denmark in 2019. He says he will make dance music again, but his latest work conjures stillness.Credit:Getty Images

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He wanted to eliminate the ego by eliminating the dance beats, the kickdrums. I dont denigrate what Ive done before, and I will definitely want to make dance music again. But to get that out of the way left all this space for really exploring the sonics and the melody and what we can do with illusions and dimensions.

Hopkins involvement in psychedelic-assisted therapy for mental illnesses, such as depression and post-traumatic stress disorder, comes as the field begins to boom worldwide, including in Australia, backed by investors, governments, and institutions including universities. It is only now beginning to be freed from the shackles of Richard Nixons War On Drugs, which created difficulties for clinical researchers testing substances such as MDMA and psilocybin. Research over the past five years has shown them both to be effective in treating depression and PTSD, alongside therapy.

Hopkins calls the substances medicines. The medicines themselves have quite a loud voice in this music. Definitely louder than my own. Theres no actual separation for me between the natural world and those medicines, because they are things that grow in the ground, psilocybin and DMT especially.

I love the poetic idea that this is music that comes from the earth.

Music for Psychedelic Therapy is out now.

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Will this music alter your mind? The most terrifying thing can do that - Sydney Morning Herald

PharmaDrug Announces Addition of Dr. Cindy Hutnik, President of the Canadian Glaucoma Society to Their Scientific Advisory Board to Enhance Ongoing…

Toronto, Ontario--(Newsfile Corp. - December 13, 2021) - PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) ("PharmaDrug" or the "Company"), a specialty pharmaceutical company focused on the development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, pleased to announce the addition of Dr. Cindy Hutnik to its scientific and clinical advisory board. Dr. Hutnik will assist the Company in its ongoing efforts to develop N,N-dimethyltryptamine ("DMT") and other related tryptamine analogues as a potential treatment for glaucoma.

Dr. Hutnik, a full professor in the Departments of Ophthalmology and Pathology at the Schulich School of Medicine and Dentistry, is internationally recognized for the significant contributions she has made in understanding the basic pathophysiology of glaucoma, as well as the practical application of this knowledge in her clinical practice. Dr. Hutnik is the current President of the Canadian Glaucoma Society and is a Board member of the Glaucoma Research Society of Canada. Previously, she served as Medical Director of the Ophthalmology Basic Science Laboratory at the Lawson Health Research Institute in the Center for Clinical Investigation and Therapeutics for 18 years, and Chair of Research in the Department of Ophthalmology for 15 years. Her major research interest is focused on the pathophysiology and management of glaucoma with a sub-interest in ocular surface and macular disease. She has supervised and mentored in focused research activities more than 175 students at all levels of training ranging from high school to graduate science and medicine. Her work has been presented and published both nationally and internationally and has been recognized with over 90 awards. With deep industry connections, Dr. Hutnik continues to have keen interest in translating novel discoveries into innovative treatments for patients with glaucoma.

Dr. Hutnik, commented, "I am very excited to work with PharmaDrug in supporting their research and development initiatives in discovering novel uses and formulations of 5-HT receptor agonists, as a potential treatment of glaucoma and other underserved ophthalmology indications. PharmaDrug's candidate molecule studies, currently being conducted at the renowned Terasaki Institute, represent an exciting, paradigm shifting approach to improving outcomes for patients suffering from glaucoma."

PharmaDrug's Candidate DMT-Analogue Molecules Display Low Cytotoxicity

Under an ongoing sponsored research agreement with Terasaki Institute of Biomedical Innovation, the Company has initiated in vitro studies to assess the impact (cytotoxicity, potency and duration of activity) of its two candidate molecules on specific cell types known to regulate pressure disequilibrium in the eyes of patients suffering from glaucoma. Initial in vitro cytotoxicity studies on the Company's two candidate tryptamine molecules have now been completed and the data shows exceedingly low/absent impact on cellular viability across a concentration range that exceeds what is expected to be used clinically. Further functional data from the ongoing 2-dimensional cell culture studies is expected in January. Those data will be extended by investigating the impact of the lead candidate molecule in 3-dimensional microtissue studies aimed at specifically assessing smooth muscle contractility; a response understood to be critical in maintenance of healthy eye function.

The company believes with the engagement of Dr. Hutnik, its access to world class basic science and clinical expertise in ophthalmology has been significantly enhanced. Following the completion of in vitro studies, the company will proceed to IND-enabling efficacy studies using a well accepted animal model of glaucoma. The in vivo studies are expected to begin in the second quarter with a focus on evaluating tolerability and efficacy (ability to lower intraocular pressure "IOP") when applied as a topical eyedrop in animal models of glaucoma. These studies will then be followed by development and testing of a purpose-built medical device capable of delivering sustained, local, sub-psychotropic levels of the development candidate to patients afflicted with glaucoma.

"We are very pleased to have Dr. Hutnik join us as a scientific and clinical advisor for our ophthalmology program, and we look forward to her contributions as we advance the research and development of our novel formulation in the treatment of glaucoma," said Daniel Cohen, Chairman and CEO of PharmaDrug. "Dr. Hutnik is a highly regarded, leader in the field of glaucoma, and she brings invaluable guidance and clinical trial experience having served as Principal Investigator on various clinical trials in the glaucoma space."

Unmet Medical Need For Glaucoma

Glaucoma is the second most common cause of blindness around the world. The global prevalence of glaucoma in people aged 40-80 years is estimated to be 3.5%1. Currently there are over 3 million people living with glaucoma in the US. In addition to the significant personal toll glaucoma takes on sufferers, the related costs and productivity losses now approach $3 billion in the US annually2. Increased IOP is a common feature noted in multiple types of glaucoma, that when left untreated, results in progressive and irreversible vision loss as a result of damage to the optic nerve.

Current treatments for glaucoma consist of surgery and/or topically administered eye drops that are aimed at lowering IOP. Despite widespread use of topical agents, protection from the cumulative harm of elevated IOP remains significant. As such, opportunities related to improved patient care and outcomes are sorely needed. Development of novel IOP lowering agents formulated using approaches that reduce common side effects and improve patient compliance continue to represent the cornerstone of novel treatments.

The Potential For DMT In Ophthalmology

Serotonin receptor 2a (aka 5-HT2a) is prominently displayed in areas of the eye that are known to be vital in the control of IOP. Basic research has shown that topical application of 5-HT2A agonists, including several analogues of DMT, potently reduce IOP in animal models of glaucoma3. DMT belongs to a class of compounds collectively referred to as tryptamines. Multiple different tryptamine family members have previously been shown to improve experimental models of glaucoma, however poor metabolic stability and solubility made them poor development candidates3. Leveraging existing knowhow in the DMT space, PharmaDrug intends to develop a metabolically stable, controlled release analogue of DMT for lowering elevated IOP. Our formulation will reduce the need for frequent re-application and in so doing, improve patient convenience and compliance.

A half century ago, with the passing of the Controlled Substances Act, almost all research directed at harnessing the promising therapeutic potential of psychedelics to treat serious, unmet medical needs all but ceased. The recent resurgence of research in psychedelics is just now beginning to take shape. We believe that our ongoing investment in high quality, foundational academic research combined with our translational activities focused outside of the neuropsychiatric space has strong strategic merit and is backed by sound mechanistic understanding.

About PharmaDrug Inc.

PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs. PharmaDrug owns 100% of Pharmadrug Production GmbH ("Pharmadrug Production"), a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the European Union. PharmaDrug recently acquired Sairiyo Therapeutics ("Sairiyo"), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of COVID-19 and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. The Company also owns 100% of Super Smart, a company building a vertically integrated retail business with the goal to elevate the use of functional mushrooms, and psilocybin mushrooms where federally legal, as natural based medicines.

For further information, please contact:

Daniel Cohen, Chairman and CEO dcohen@pharmadrug.co (647) 202-1824

Caution Regarding Forward-Looking Information:

THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This press release contains "forward-looking information" within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. Generally, forward-looking information may be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "proposed", "is expected", "budgets", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. In particular, this press release contains forward-looking information in relation to: the development and commercialization of cepharanthine, the results of the Company's research and development in the psychedelics space and the development of the Supersmart business . This forward-looking information reflects the Company's current beliefs and is based on information currently available to the Company and on assumptions the Company believes are reasonable. These assumptions include, but are not limited to the ability of the Company to successfully execute on its plans for the Company and its affiliated entities; the ability to obtain required regulatory approvals and the Company's continued response and ability to navigate the COVID-19 pandemic being consistent with, or better than, its ability and response to date.

Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company's future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals; risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions; and a deterioration of financial markets that could limit the Company's ability to obtain external financing.

A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company's disclosure documents on the SEDAR website at http://www.sedar.com. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

The Company's securities have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or "U.S. Persons", as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.

Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

References:

1) Kang JM, Tanna AP. Glaucoma. Med Clin North Am. 2021 May;105(3):493-510. doi: 10.1016/j.mcna.2021.01.004. Epub 2021 Apr 2. PMID: 33926643.

2) https://www.brightfocus.org/glaucoma/article/glaucoma-facts-figures

3) May JA, McLaughlin MA, Sharif NA, Hellberg MR, Dean TR. Evaluation of the ocular hypotensive response of serotonin 5-HT1A and 5-HT2 receptor ligands in conscious ocular hypertensive cynomolgus monkeys. J Pharmacol Exp Ther. 2003 Jul;306(1):301-9. doi: 10.1124/jpet.103.049528. Epub 2003 Apr 3. PMID: 12676887.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/107336

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PharmaDrug Announces Addition of Dr. Cindy Hutnik, President of the Canadian Glaucoma Society to Their Scientific Advisory Board to Enhance Ongoing...

"The New Cannabis" the present and future of psilocybin as a medical treatment in Canada – Lexpert

Recent research has shown that psilocybin has the potential to treat a number of mental illnesses. These include suicidality, anxiety disorders, obsessive-compulsive disorder, alcohol dependence, tobacco cessation, and post-traumatic stress disorder, among others. Studies have also found that psilocybin can allow patients, with the help of trained therapists, to confront fears and feelings that are otherwise too traumatic. This ongoing research aims to assess the immediate and long-term psychological effects of psilocybin use.

One area of particularly strong focus in Canada has been on the potential use of psilocybin for relieving end-of-life distress for palliative patients. Proponents view psilocybin as providing relief from mental distress when traditional treatment options fail for terminally ill patients as is often the case. This interest in psilocybin as a treatment also extends into the potential for treatment of the bereaved.

Given its potential benefits, why is the use of psilocybin illegal in most cases today?

As mental health awareness grows, psilocybin has become the focus of increased attention by Canadian health authorities and researchers as a possible treatment for a variety of mental illnesses. However, this has not always been the case.

Psilocybin is a psychedelic. Psychedelics, also known as hallucinogens, are psychoactive substances that produce changes in perception, mood, and cognitive processes. While most people consider psychedelics to be a recreational drug and often associate them with the counterculture of the 1960s, psychedelics have a long history of medicinal use. Unfortunately, due to negative public and political perceptions, little research occurred in this area for decades.

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"The New Cannabis" the present and future of psilocybin as a medical treatment in Canada - Lexpert

Gene Therapy Successes – University of Utah

Cavazzano-Calvo, M. (2010). Transfusion independence and HMGA2 activation after gene therapy of human beta-thalassaemia. Nature 467, 318-322. doi:10.1038/nature09328

Cideciyan, A.V. et al (22 January 2013). Human retinal gene therapy for Leber congenital amaurosis shows advancing retinal degeneration despite enduring visual improvement. Proceedings of the National Academy of Sciences of the United States of America, Earline Online Publication. doi: 10.1073/pnas.1218933110

MacLaren, R.E. et al (16 January 2014). Retinal gene therapy in patients with choroideremia: initial findings from a phase 1/2 clinical trial. The Lancet, Early Online Publication. doi:10.1016/S0140-6736(13)62117-0

Nathwani, A.C. (2011). Adenovirus-associated virus vector-mediated gene transfer in hemophilia B. The New England Journal of Medicine, 365(25), 2357-2365.

Nienhuis, A.W. (2013). Development of gene therapy for blood disorders: an update. Blood 122(9), 1556-1564. doi: 10.1182/blood-2013-04-453209

Palfi, S. et al (10 January 2014). Long-term safety and tolerability of ProSavin, a lentiviral vector-based gene therapy for parkinson's disease; a dose escalation, open-label, phase 1/2 trial. The Lancet, Early Online Publication. doi: 10.1016/S014006736(13)61939-X

Penn Medicine (7 December 2013). Penn medicine team reports findings from research study of first 59 adult and pediatric leukemia patients who received investigational, personalized cellular therapy CTL019. Retrieved from http://www.uphs.upenn.edu/news/News_Releases/2013/12/ctl019/

Persons, Derek A. (2010). Gene therapy: Targeting beta-thalassaemia. Nature 467, 277-278. doi: 10.1038/467277a

Petrs-Silva, H. & R. Linden (2014). Advances in gene therapy technologies to treat retinitis pigmentosa. Clinical Opthalmology 2014(8), 127-136. doi: 10.2147/OPTH.538041

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Gene Therapy Successes - University of Utah

Gene Therapy Pros and Cons – Biolyse

Over the years genetic disorders and gene-related illness have been responsible for high mortality rates and reduced quality of life. Some of the congenital abnormalities manifest quite early, and there are minimal hopes for survival in these children, this causes much pain to their families because management option is limited and there is very little at their disposal to modify such conditions. Scientists are developing a relatively new technique that will give hope to the hopeless and make life better. Genetic disorders can be due to misalignment, missing genes or excess of a gene. Genetic therapy works at the elementary level of heredity to replace the defective genes with new ones.

Gene therapy is the insertion of new functional genes into an individuals cell or tissue to replace the defective one and modify a hereditary disease. This is a new research area, and much research projects are still in the infancy or trial stages; however, expectations are high, and we would potentially do away with genetic diseases soon enough. Developed in 1972, gene therapy can be of two type; somatic gene therapy and germline gene therapy. It is especially promising in treating genetic disorders such as muscular dystrophy and cystic fibrosis. Critics have their say and look at the two sides of the story will lead us to weigh risk: benefit ration. Gene therapy pros and cons can be quite decisive on whether or not we should embrace gene therapy.

Research into gene therapy has been ongoing for decades now, and there is light at the end of the tunnel as gene therapy is associated with the following advantages;

Genetic defect occur even after thorough screening and many people have their lives compromised or limited by such disorders. In the United States alone as at 2009, 3% congenital disabilities were recorded in all births, the joy of having a child is suddenly lost and replaced with the agony and struggle of maintaining such demanding life. Individual patient and family are pessimistic as efforts to change the condition by traversing through different levels of healthcare are always thwarted since no cure exists for such situations. Gene therapy intent to correct such birth defects responsible for more than half of infant mortality is laudable. We can be confident that all the unborn babies will be delivered safely and grow to their prime. Besides, gene therapy promises a cure for the chronic illnesses that are currently incurable for example cancer that causes agonizing pain in many.

By replacing a defective gene with a functional gene in a disease like cystic fibrosis, there are limited chances of remission, and this is usually a one-off treatment that will see you symptom-free for life. Furthermore, gene therapy is not just a remedy to the individual suffering from a given condition, but it covers the entire generation. When you remove a gene predisposing one to breast cancer they wont transfer the defective genes to their offspring but the new functional gene.

Some of the initially incurable diseases can be managed and possibly eliminated when we involve gene therapy. Alterations to gene especially the reproductive genes using the germline method can help in avoiding transmission of defective genes and thus no further incidences of disease. Parkinsons disease, Huntingtons disease, and Alzheimers disease are but a few conditions that are likely to be eliminated by gene therapy.

Not only does gene therapy focus on diseases. Conditions that may make life unlimited such as infertility are also accounted for, and it is projected that soon enough gene therapy should activate reproductive genes and allow you to have children.

Gene therapy promises much potential in the medical field ranging from relieving the pill burden to modifying phenotypes in cosmetology.

Although gene therapy has a potential for treating several ailments and improving life, this is a relatively new technique and involve several safety concerns thus it should be carefully embraced. Some of the notable disadvantages of gene therapy include;

As at now, gene therapy is at the developmental stages, and most experiments are done on the animals with the hope that success will be reflected in humans. However, anything can happen, and gene therapy can fail to work thus limit your capabilities or even worsen the condition. Incompatibility issues and immune response can also lead to failure of the procedure. The massive ongoing research will leverage the concerns and provide a technological-based method with a high certainty of results.

The cost of performing gene therapy is likely to be high because it involves sophisticated equipment and high-level expertise. Such a fee may not be affordable to many, and this will create socioeconomic segregation as the rich will be disease-free while the poor remain to bear the burden of such illness. A solution to this would possibly be extensively integrating technology in the process since technologically based therapy may prove more cost-effective even when compared to the other therapeutic options.

Superb as it may look, gene therapy may be short-lived. Nature is unpredictable, and sometimes it may take its course for the worse. Just like the antibiotics were novel at the time of invention, it is possible that the use of gene therapy may gain resistance as well. There is no guarantee that gene therapy will fulfill its expectations to treat explicit disorders, performing gene adjustments could create new defects for future generations without realizing it; thus it can be a double-edged sword.

One of the greatest hindrance to the advancement of gene therapy is the opposition on the basis that it can open room for unethical science which may be demeaning to the human race. The thoughts that gene therapy creates a perfected human has been very controversial.

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Gene Therapy Pros and Cons - Biolyse

Syrian refugee is thriving five years after last-gasp gene therapy – STAT – STAT

In the summer of 2015, a 7-year-old named Hassan was admitted to the burn unit of the Ruhr University Childrens Hospital in Bochum, Germany, with red, oozing wounds from head to toe.

It wasnt a fire that took his skin. It was a bacterial infection, resulting from an incurable genetic disorder. Called junctional epidermolysis bullosa, the condition deprives the skin of a protein needed to hold its layers together and leads to large, painful lesions. For kids, its often fatal. And indeed, Hassans doctors told his parents, Syrian refugees who had fled to Germany, the young boy was dying.

The doctors tried one last thing to save him. They cut out a tiny, unblistered patch of skin from the childs groin and sent it to the laboratory of Michele de Luca, an Italian stem cell expert who heads the Center for Regenerative Medicine at the University of Modena and Reggio Emilia. De Lucas team used a viral vector to ferry into Hassans skin cells a functional version of the gene LAMB3, which codes for laminin, the protein that anchors the surface of the skin to the layers below.

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Then the scientists grew the modified cells into sheets big enough for Ruhr University plastic surgeons Tobias Hirsch and Maximilian Kueckelhaus to graft onto Hassans raw, bedridden body, which they did over the course of that October, November, and the following January.

It worked better than the boys doctors could have imagined. In 2017, de Luca, Hirsch, Kueckelhaus, and their colleagues reported that Hassan was doing well, living like a normal boy in his lab-grown skin. At the time though, there was still a big question on all their minds: How long would it last? Would the transgenic stem cells keep replenishing the skin or would they sputter out? Or worse could they trigger a cascade of cancer-causing reactions?

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Today, the same team is out with an update. Five years and five months after the initial intervention, Hassan is still, for the most part, thriving in fully functional skin that has grown with the now-teenager. He is attending school, and playing sports with his friends and siblings, though he avoids swimming due to blistering in the areas that werent replaced by the lab-grown skin. One of his favorite activities is a pedal-powered go kart. There are no signs his modified stem cells have lost their steam, and no traces of tumors to be found.

The encouraging follow-up data has been instrumental in moving forward a larger clinical trial of the approach, offering hope to the 500,000 epidermolysis bullosa patients worldwide currently living without treatment options.

We were astonished by the speedy recovery, Kueckelhaus, now at University Hospital Muenster, told STAT via email. But experience from skin transplantation in other settings made him and his colleagues wary of the grafts failing as the months and years wore on. Thankfully, wrote Kueckelhaus, those fears never materialized. We are very happy to be able to prove that none of these complications appeared and the genetically modified skin remains 100% stable. The chances are good that he will be able to live a relatively normal life.

Over the last five years, Hassans team of doctors and researchers has put his new skin through a battery of tests checking it for sensitivity to hot and cold, water retention, pigmentation and hemoglobin levels, and if it had developed all the structures youd expect healthy skin to have, including sweat glands and hair follicles. Across the board, the engineered skin appeared normal, without the need for moisturizers or medical ointments. The only flaw they found was that Hassans skin wasnt as sensitive to fine touch, especially in his lower right leg. This mild neuropathy they attributed not to the graft itself, but to how that limb was prepared doctors used a more aggressive technique that might have damaged the nerves there.

The team also used molecular techniques to trace the cells theyd grown in the lab as they divided and expanded over Hassans body. They found that all the different kinds of cells composing the boys new skin were being generated by a small pool of self-renewing stem cells called holoclone-forming cells, carrying the Italian teams genetic correction.

This was quite an insight into the biology of the epidermis, said de Luca. Its an insight he expects will have huge consequences for any efforts to advance similar gene therapies for treating other diseases affecting the skin. You have to have the holoclone-forming cells in your culture if you want to have long-lasting epidermis, he said.

The approach pioneered by de Lucas team will soon be headed for its biggest clinical test yet, after nearly a decade of fits and starts. They expect to begin recruiting for a multi-center Phase 2/3 trial sometime next year.

De Luca first successfully treated a junctional EB patient in 2005. But then a change to European Union laws governing cell and gene therapies forced his team to stop work while they found ways to comply with the new rules. It took years of paperwork, building a manufacturing facility, and spinning out a small biotech company called Holostem to be ready to begin clinical research again. Hassan came along right as they were gearing up for a Phase 1 trial, but data from the boys case, which was granted approval under a compassionate use provision, convinced regulators that the cell grafts could move to larger, more pivotal trials, according to de Luca.

We didnt cure the disease, he told STAT. But the skin has been restored, basically permanently. We did not observe a single blister in five years. The wound healing is normal, the skin is robust. From this point of view, the quality of life is not even comparable to what it was before.

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Syrian refugee is thriving five years after last-gasp gene therapy - STAT - STAT

New Technology is One Step Closer to Targeted Gene Therapy – Caltech

Gene therapy is a powerful developing technology that has the potential to address myriad diseases. For example, Huntington's disease, a neurodegenerative disorder, is caused by a mutation in a single gene, and if researchers could go into specific cells and correct that defect, theoretically those cells could regain normal function.

A major challenge, however, has been creating the right "delivery vehicles" that can carry genes and molecules into the cells that need treatment, while avoiding the cells that do not.

Now, a team led by Caltech researchers has developed a gene-delivery system that can specifically target brain cells while avoiding the liver. This is important because a gene therapy intended to treat a disorder in the brain, for example, could also have the side effect of creating a toxic immune response in the liver, hence the desire to find delivery vehicles that only go to their intended target. The findings were shown in both mouse and marmoset models, an important step towards translating the technology into humans.

A paper describing the new findings appears in the journal Nature Neuroscience on December 9. The research was led by Viviana Gradinaru (BS '05), professor of neuroscience and biological engineering, and director of the Center for Molecular and Cellular Neuroscience.

The key to this technology is the use of adeno-associated viruses, or AAVs, which have long been considered promising candidates for use as delivery vehicles. Over millions of years of evolution, viruses have evolved efficient ways to gain access into human cells, and for decades researchers have been developing methods to harness viruses' Trojan-Horse-like abilities for human benefit.

AAVs are made up of two major components: an outer shell, called a capsid, that is built from proteins; and the genetic material encased inside the capsid. To use recombinant AAVs for gene therapy, researchers remove the virus's genetic material from the capsid and replace it with the desired cargo, such as a particular gene or coding information for small therapeutic molecules.

"Recombinant AAVs are stripped of the ability to replicate, which leaves a powerful tool that is biologically designed to gain entrance into cells," says graduate student David Goertsen, a co-first author on the paper. "We can harness that natural biology to derive specialized tools for neuroscience research and gene therapy."

The shape and composition of the capsid is a critical part of how the AAV enters into a cell. Researchers in the Gradinaru lab have been working for almost a decade on engineering AAV capsids that cross the blood-brain barrier (BBB) and to develop methods to select for and against certain traits, resulting in viral vectors more specific to certain cell types within the brain.

In the new study, the team developed BBB-crossing capsids, with one in particular AAV.CAP-B10that is efficient at getting into brain cells, specifically neurons, while avoiding many systemic targets, including liver cells. Importantly, both neuronal specificity and decreased liver targeting was shown to occur not just in mice, a common research animal, but also in laboratory marmosets.

"With these new capsids, the research community can now test multiple gene therapy strategies in rodents and marmosets and build up evidence necessary to take such strategies to the clinic," says Gradinaru. "The neuronal tropism and decreased liver targeting we were able to engineer AAV capsids for are important features that could lead to safer and more effective treatment options for brain disorders."

The development of an AAV capsid variant that works well in non-human primates is a major step towards the translation of the technology for use in humans, as previous variants of AAV capsids have been unsuccessful in non-human primates. The Gradinaru lab's systematic in vivo approach, which uses a process called directed evolution to modify AAV capsids at multiple sites has been successful in producing variants that can cross the BBBs of different strains of mice and, as shown in this study, in marmosets.

"Results from this research show that introducing diversity at multiple locations on the AAV capsid surface can increase transgene expression efficiency and neuronal specificity," says Gradinaru. "The power of AAV engineering to confer novel tropisms and tissue specificity, as we show for the brain versus the liver, has broadened potential research and pre-clinical applications that could enable new therapeutic approaches for diseases of the brain."

The paper is titled "AAV capsid variants with brain-wide transgene expression and decreased liver targeting after intravenous delivery in mouse and marmoset." Goertsen; Nicholas Flytzanis (PhD '18), the former scientific director of the CLARITY, Optogenetics and Vector Engineering Research(CLOVER)Center of Caltech's Beckman Institute; and former Caltech postdoctoral scholar Nick Goeden are co-first authors. Additional coauthors are graduate student Miguel Chuapoco, and collaborators Alexander Cummins, Yijing Chen, Yingying Fan, Qiangge Zhang, Jitendra Sharma, Yangyang Duan, Liping Wang, Guoping Feng, Yu Chen, Nancy Ip, and James Pickel.

Funding was provided by the Defense Advanced Research Projects Agency, the National Institutes of Health, and the National Sciences and Engineering Research Council of Canada.

Flytzanis, Goeden, and Gradinaru are co-founders of Capsida Biotherapeutics, a Caltech-led startup company formed to develop AAV research into therapeutics.

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New Technology is One Step Closer to Targeted Gene Therapy - Caltech

BMS and Kite Unveil CAR-T Successes in Lymphoma – BioSpace

Jeremy Moeller/Getty Images

Significant advancements in the treatment of relapsed or refractory large B-cell lymphoma are on the horizon. At the American Society of Hematology meeting, this weekend, both Bristol Myers Squibband Kite Pharma presented promising data from CAR-T programs aimed at this disease.

At ASH, BMS unveiled data that showedBreyanzi(liso-cel), a CD19-directed CAR-T cell therapy, as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma,outperformed the current standard of carefor patients in second-line relapsed or refractory LBCL, significantly improving event-free survival (EFS). BMS said that only a small portion of patients who have relapsed or refractory large B-cell lymphoma (LBCL) experience long-term benefits with high-dose chemotherapy and stem cell transplant. Data from the pivotal Phase III TRANSFORM study showed that Breyanzi significantly improved median event-free survival with a median of 10.1 months. Standard of care treatment only offered an improvement of 2.3 months with a 65% improvement.

Data showed that 86% of Breyanzi patients achieved a complete or partial response, with 66% of patients achieving a complete response. In comparison, only 48% of standard of care patients achieved the same response, with only 39% of those reaching a complete response.

Median progression-free survival was significantly longer withBreyanzicompared to standard of care, 14.8 months vs. 5.7 months.

Additionally, results from an analysis of patient reported outcomes from the TRANSFORM study showed favorable improvement in most patient reported outcomes. That includes an improved or maintained health-related quality of life for patients who were treated with Breyanzicompared to those treated with the standard of care treatment.

Kite Pharma, a subsidiary of Gilead Sciences, showcased its own data in second-line relapsed/refractory large B-cell lymphoma (LBCL), the same indication as BMS Breyanzi. Data from the landmark Phase III ZUMA-7 study of Yescarta (axicabtagene ciloleucel) showed a 2.5 fold increase in patients who were alive at two years and had not required the need for additional cancer treatment or experienced cancer progression. Also, the data showed a four-fold greater median event-free survival for Yescarta compared to standard of care.

Kite said that improvements in EFS with Yescarta were consistent across patient subgroups, including the elderly, those with primary refractory disease, high-grade B-cell lymphoma including double-hit and triple-hit lymphoma and double expressor lymphoma.

Yescarta was the first CAR T-cell therapy to be approved by the U.S. Food and Drug Administrationfor the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

Additionally, Kite announced significant long-term data showcasing the CAR-T therapys ability to provide meaningful improvements in quality of life compared with standard of care. Also at ASH, Kite unveiled data that showed Yescarta provided a five-year overall survival rate of 42%. Among those patients who saw a complete response to the CAR-T treatment, the five-year overall survival rate was 64.4%.

Perhaps most significantly, Kite said that among Yescarta patients who were still alive after five years, 92% needed no additional treatment since that first infusion of the CAR-T therapy. This suggests a potential cure for some of the patients, Kite said, in its announcement.

Other cell therapy data presented at ASH include:

bluebird Gene Therapy Improves Lives of Sickle Cell Patients

bluebird bio'slovo-celis showing promisein a Phase I/II study in sickle cell. Data from two cohorts of the largest sickle cell gene therapy program to date is showing patients treated with lovo-cel are seeing a continued complete resolution of severe vaso-occlusive events (VOE) after six years.

The VOEs are defined as episodes of acute pain with no medically determined cause other than vaso-occlusion. That means that lovo-cel, a lentiviral gene therapy, has the potential to improve day-to-day life in sickle cell patients by eliminating the painful issues associated with the disease that can occur several times per month.

Additionally, the patients have achieved near normal levels of key hemolysis markers and experienced sustained improvements in patient-reported quality of life following treatment.

The bluebird gene therapy is designed to add functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients blood stem cells. Once the gene is added, their red blood cells are able to produce anti-sickling hemoglobin (HbAT87Q), which reduces the sickled blood cells that cause the disease.

Janssens CAR-T Hammers Multiple Myeloma

At ASH, Janssenannounced data from a Phase Ib/II study that showed CAR-T therapy cilta-cel (ciltacabtagene autoleucel) provided anoverall response rate of 98%in patients with relapsed and/or refractory multiple myeloma.

The company said that cilta-cel, an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, showed that patients who received an infusion continued to demonstrate deep and durable responses. Data showed that 83% of patients in the study achieved a stringent complete response (sCR) at 22 months. That is an 80% increase from the 18-month median follow-up presented earlier this year at the American Society of Clinical Oncology meeting.

Also, two-year progression free survival and overall survival rates were 61% and 74%, respectively.

Poseida Sees Promise in CAR-T as it Winds Down Autologous Program

Interim results from Poseida'sPhase I/II PRIME study of P-BCMA-101for the treatment of relapsed/refractory multiple myeloma show strong anti-tumor activity in patients with advanced forms of the disease. P-BCMA-101 in combination with rituximab achieved an improved overall response rate of 78% and 100% overall survival.

P-BCMA-101 is a non-viral transposon-based autologous CAR-T. The data from the PRIME study have been used to inform the companys development of its first allogeneic program, P-BCMA-ALLO1, also being developed in the same indication. In November, Poseida announced that it iswinding down the P-BCMA-101 autologous programin favor of the allogeneic program, P-BCMA-ALLO1.

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BMS and Kite Unveil CAR-T Successes in Lymphoma - BioSpace

CF Foundation Funding Bolsters Gene Therapy Research – Cystic Fibrosis News Today

The Cystic Fibrosis Foundationis funding three new early-stage research awards worth more than $1.8 million to bolster the development of potential gene therapies for cystic fibrosis (CF).

This funding will support critical early steps necessary for the development of genetic therapies for cystic fibrosis, William Skach, MD, executive vice-president and chief scientific officer of the CF Foundation, said in a press release. These promising programs are tackling difficult challenges such as efficient therapeutic delivery of diverse genetic cargos and evasion or modulation of the immune systems response to gene delivery vehicles.

Gene therapy works by adding a new gene or replacing or repairing a mutated gene inside cells in the body. To get gene therapy into the cells, it first must be packed into a carrier, usually a harmless virus. However, other carriers exist that may deliver gene therapy.

Carmine Therapeutics was awarded more than $766,000 to test one such alternative type of carrier. The company plans to use tiny particles, called vesicles, that naturally bud off from red blood cells to deliver a healthy copy of cystic fibrosis transmembrane conductance regulator (CFTR) the gene mutated in people with CF into lung cells. Unlike other carriers, which sometimes trigger an immune response, the vesicles are expected to be well-tolerated by the immune system, even upon repeat administration.

If a viral carrier must be used, the bodys immune response should be blocked to allow repeat administration. GenexGen was awarded close to $595,000 to develop a way to lessen the immune response to a viral carrier. The company is testing an approach that uses CRISPR a kind of molecular scissors that can cut pieces of DNA to target a certain gene that plays a key role in the immune system. The goal is to turn off that gene temporarily, thus allowing gene therapy to be delivered by a virus.

Finally, Specific Biologics was awarded more than $527,000 to test a CRISPR-based approach to make precise changes in DNA and thereby correct (edit) three common CFTR mutations in CF: G542X, R553X, and W1282X. Each of these mutations results in a stop codon in the middle of the gene and a shorter protein that ends up getting degraded by the cells. If successful, the approach is expected to work for any mutation.

The award will support preclinical testing of an inhaled medicine that uses tiny fat particles to help the gene-editing molecules enter the cells more easily.

The awards are part of the foundations Path to a Cure, an initiative whose goal is to accelerate the development of therapeutic strategies that address the root cause of CF.

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CF Foundation Funding Bolsters Gene Therapy Research - Cystic Fibrosis News Today

N4 Pharma to Focus Resources on Advancing Gene Therapy Work – MarketWatch

By Anthony O. Goriainoff

N4 Pharma PLC said Monday that it will focus its resources on advancing its work on gene therapy, and that it will continue its vaccine-delivery efforts in conjunction with partners and working on specific proprietary products.

The AIM-listed pharmaceutical company said the preliminary results from mouse immunogenicity studies carried out by Evotec SE using Covid-19 didn't show meaningful immunological response, and that this brought into question the whole study. The company said it will concentrate future vaccine work through its material transfer agreements [MTA] and that it was in advanced discussions with another company focusing on mRNA delivery with a view to scoping the work to be undertaken under a new MTA.

The company said that although the results on the vaccine work from Evotec were unexpected, the proof-of-concept data collated to date has been sufficient to allow it to sign MTAs with potential vaccine collaborators.

"We expect other collaborations will follow, so it makes sense to continue the vaccine platform optimization with collaborators who own their own DNA plasmids and mRNA compounds. This will allow us to focus internal efforts on developing commercial products in the gene therapy space," Chief Executive Nigel Theobald said.

Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com

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N4 Pharma to Focus Resources on Advancing Gene Therapy Work - MarketWatch

Capsida Biotherapeutics Poised to Capitalize on Industry-leading Gene Therapy Technology With New CEO, CSO, and CTO – PRNewswire

Gene therapy is still in its infancy and has yet to achieve its full potential. First-generation gene therapies have been challenged by safety issues due to their inability to target cells and organs without also penetrating non-targeted cells and organs, especially the liver. Capsida's proprietary, targeted, non-invasive gene therapy technology allows more selective targeting of specific tissues and cells, overcoming many of the problems associated with first-generation gene therapies, specifically off-target cell and organ activity. In addition, it allows the gene therapy to be delivered non-invasively through intravenous (IV) administration. The company's already strong leadership team is poised to actualize the promise of gene therapy with the addition of Mr. Anastasiou and the promotions of Drs. Flytzanis and Goeden.

"I can't imagine a more exciting time to join this organization," said Mr. Anastasiou. "Capsida is enabling gene therapy to become what the industry, physicians, and patients have been dreaming it will be. Our patent-protected technology allows the targeting of cells and organs while limiting the negative impact on non-targeted areas, and can be applied across multiple therapeutic areas. Another important benefit of our technology is that we are able to deliver the gene therapy non-invasively through IV administration. I'm honored to lead this talented team to achieve Capsida's potential and to improve and even save patients' lives."

Mr. Anastasiou joins Capsida from Lundbeck, where he was an executive vice president and a member of the executive committee, reporting to the CEO. As the president of Lundbeck's U.S. and Canadian business operations, Mr. Anastasiou has built organizations from the ground up. He brings significant leadership experience managing diverse organizations and bringing them together to achieve common goals. He led as many as 1,200 employees and achieved net revenues of $1.5 billion. During his 12-year tenure at Lundbeck, Mr. Anastasiou held several progressive leadership positions, playing a pivotal role in developing and launching multiple products and building the company's cross-functional capabilities. Mr. Anastasiou serves on the Board of PhRMA and the global advisory board for the Healthcare Businesswomen's Association. Mr. Anastasiou begins his new role with Capsida on January 3, 2022.

"We're thrilled to welcome Peter as Capsida's new CEO," said Beth Seidenberg, M.D., founding managing director at Westlake Village BioPartners, one of the company's lead investors, and Capsida board member. "Peter has deep industry expertise, a broad network, and significant public company experience, which will be valuable as Capsida grows. In addition, his strong track record of success demonstrates he is a visionary leader who will be able to deliver on the promise of targeted non-invasive gene therapy to help underserved patients and achieve business success."

"During his tenure at Lundbeck, Peter has created significant shareholder value, creating and leading organizations and successful blockbuster product launches," said Clare Ozawa, Ph.D., managing director at Versant Ventures, one of Capsida's lead investors, and Capsida board member."Under Peter's leadership, we will continue to build Capsida as the industry's leading targeted, non-invasive gene therapy company with the ability to transform the lives of patients with life-threatening genetic disorders."

Prior to Lundbeck, Mr. Anastasiou held management roles at Neuronetics, Inc., Bristol-Meyers Squibb Company, and Eli Lilly and Company. He holds an MBA from the Kelley School of Business at Indiana University, and a B.A. in economics and management from Albion College.

Capsida co-founders Nicholas Flytzanis, Ph.D., promoted to CSO and Nick Goeden, Ph.D., promoted to CTO

In addition to Mr. Anastasiou's appointment, Capsida announced that Dr. Flytzanis has been promoted toCSO and Dr. Goeden has been promoted to CTO.

"The promotions of Drs. Flytzanis and Goeden are in recognition of the significant contributions they have made since co-foundingCapsida in 2019," said Mr. Anastasiou. "Their steadfast commitment to delivering on the promise of Capsida's differentiated, non-invasive gene therapy platform has been a key driver behind many of the company's early achievements."

"Drs. Flytzanis' and Goeden's strong scientific and technical expertise and know-how have already delivered results in the startup of Capsida based on Caltech'sbasic research on targeted non-invasive gene delivery to the brain," said Capsida co-founder Viviana Gradinaru, Ph.D. "Their promotions are timely as Capsida enters the phase of delivering from the lab and for the patients."

Prior to co-founding Capsida, Dr. Flytzanis served as scientific director of the CLOVER research center at the California Institute of Technology (Caltech), leading an interdisciplinary team to develop and disseminate emerging technologies focused on the cross-section of neurological research and gene therapy. His research spans the fields of tissue clearing and imaging, optogenetics and rodent behavior, and adeno-associated virus (AAV) engineering and gene therapy, with collaborations across multiple institutions. During his Ph.D., Dr. Flytzanis applied protein engineering and directed evolution across biological modalities, with a focus on developing AAVs as therapeutic tools for neurological disease.

Dr. Flytzanis holds a Ph.D. in biology from Caltech and a B.S. in biology from the Massachusetts Institute of Technology.

Prior to co-founding Capsida, Dr. Goeden led a team developing the novel adeno-associated virus (AAV) engineering technology underlying Capsida's biologically driven gene therapy platform. During his tenure as a postdoctoral fellow in Dr. Gradinaru's lab at Caltech, he developed high-throughput methods for screening combinatorial libraries to explore the AAV fitness landscape and engineered novel AAVs with high efficiency and specificity for the rodent and primate brain. During his Ph.D., Dr. Goeden developed a novel organ bioreactor to study real-time metabolomics in diseased states, exploring the relationship between gene expression and the pathophysiology of neurodevelopmental disorders.

Dr. Goeden holds a Ph.D. in neuroscience from The University of Southern California and a B.S. in biology from Caltech.

About Capsida Biotherapeutics

Capsida Biotherapeutics Inc. is an industry-leading gene therapy platform company creating a new class of targeted, non-invasive gene therapies for patients with debilitating and life-threatening genetic disorders. Capsida's technology allows for the targeted penetration of cells and organs, while limiting collateral impact on non-targeted cells and organs, especially the liver. This technology allows for the delivery of the gene therapy in a non-invasive way through intravenous administration. Capsida's technology is protected by a growing intellectual property portfolio which includes more than 30 patent applications and one issued U.S. patent 11,149,256. The company is exploring using the technology across a broad range of life-threatening genetic disorders. Its initial pipeline consists of multiple neurologic disease programs. The company has strategic collaborations with AbbVie and CRISPR, which provide independent validation of Capsida's technology and capabilities. Capsida is a multi-functional and fully integrated biotechnology company with proprietary adeno-associated virus (AAV) engineering, multi-modality cargo development and optimization, translational biology, process development and state-of-the-art manufacturing, and broad clinical development experience. Capsida's biologically driven, high-throughput AAV engineering and cargo optimization platform originated from groundbreaking research in the laboratory of Viviana Gradinaru, Ph.D., a neuroscience professor at the California Institute of Technology. Visit us at http://www.capsida.com to learn more.

SOURCE Capsida Biotherapeutics

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Capsida Biotherapeutics Poised to Capitalize on Industry-leading Gene Therapy Technology With New CEO, CSO, and CTO - PRNewswire

URMC & RIT faculty awarded patent for gene transfer technology that could transform cancer therapies – URMC

The carbon nanotube device could streamline some cancer therapies like CAR T-cell therapy.

Researchers at the University of Rochester Del Monte Institute for Neuroscience and Rochester Institute of Technology have received a U.S. patent for technology designed to accelerate development of cell therapies for cancer and other bio-therapies. The technique provides a less toxic alternative to standard gene transfer techniques by using an array of carbon nanotubes to deliver DNA into primary neurons, immune cells, and stem cells.

Our goal is to provide a technology that can lower the cost and increase speed and the range of cell types that can be adapted for therapeutic use, said Ian Dickerson, Ph.D., associate professor of Neuroscience. Many new cell-based therapies depend on changing the gene expression of primary cells. These approaches range from stem cells for production of patient-specific repair tissues, to CAR T-cells used for focused cancer therapy.

Dickerson and Michael Schrlau, Ph.D., associate professor of mechanical engineering in RITs Kate Gleason College of Engineering, were recently awarded a patent for this technology. It delivers biomolecules into cells through carbon nanotube arrays. Their honeycomb of nanotubes device was first described in a 2016 study published in the journal Small.

A scanning electron micrograph (SEM) of a macrophage cell sitting on top of the bed of carbon nanotubes.

The carbon nanotubes aim to be an alternative to conventional gene transfer methods that have a number of limitations including expensive equipment, low efficiency, and results in high toxicity that damages the cells. These methods limit the types of experiments that can be done and many cells like stem cells, primary cells, and immune T-cells. With Dickersons and Schrlaus device cells are able to grow on the carbon nanotube, genes are then transferred through the tubes and taken up by the cells through endocytosis. It has been successful at culturing a number of cell types, including immune cells, stem cells, and neurons, all are typically difficult to grow and keep alive.

The initial research that lead to this device was supported in part by a $50-thousand SchmittProgram in Integrative Neuroscience pilot award from the Del Monte Institute for Neuroscience. It funded Dickersons project entitled High Efficiency Injection of Biomolecules into Uticle Cells by Carbon Nanotube Arrays. This funding enabled us to begin manufacturing these carbon nanotube devices, and test the function on cell lines, which provided preliminary data that proved the concept of carbon nanotube-mediated gene transfer would work, said Dickerson.

The researchers are now collaborating with investigators at Wilmot Cancer Institute to further explore using this device for cancer therapies like CAR T-cells. "Currently CART-cells are manufactured using a viral vector to accomplish gene transfer, said Patrick Reagan, M.D., assistant professor of Medicine at the Wilmot Cancer Institute.Gene transfer via carbon nanotubules represents a novel method of gene transfer that could make the manufacturingprocess more efficient. This is important given that many of the patients treated with CAR T-cell therapy for lymphoma and leukemia have aggressive disease and the time delays associated with CAR T-cell manufacturing can lead to adverse outcomes."

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URMC & RIT faculty awarded patent for gene transfer technology that could transform cancer therapies - URMC

Global Gene Editing Market Research Report 2021 Featuring CRISPR, GenScript, Horizon Discovery Group, Integrated DNA Technologies and New England…

DUBLIN--(BUSINESS WIRE)--The "Gene Editing Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering.

The global gene editing market is expected to grow from $4.25 billion in 2020 to $4.53 billion in 2021 at a compound annual growth rate (CAGR) of 6.6%. The market is expected to reach $7.27 billion in 2025 at a CAGR of 12.6%.

Major players in the gene editing market are CRISPR, GenScript USA Inc., Horizon Discovery Group plc, Integrated DNA Technologies and New England Biolabs.

The gene editing market consists of sales of gene editing technology such as CRISPR/CAS9, zinc finger nucleus, and talens and related services. Gene editing technology allows genetic material to change genetic code at particular location in a genome. It involves cell line engineering, animal genetic engineering and plant genetic engineering.

The gene editing market covered in this report is segmented by technology into CRISPR, TALEN, ZFN. It is also segmented by end users into biotechnology, pharmaceutical, contract research organization and by application into animal genetic engineering, plant genetic engineering, cell line engineering.

Infectious diseases are constantly on the rise. For instance, according to the World Health Organization (WHO), infectious diseases kill more than 17 million people per year. In addition to that, according to the AP-NORC (a research initiative by the Associated Press and the University of Chicago) survey, out of 1,067 adults in the US surveyed, 71% are in favor of gene editing for the treatment of incurable, hereditary diseases such as Huntington's disease and 67% of Americans support the use of gene editing to prevent diseases such as cancer.

Ethical issues in general public with respect to gene editing is one of the major restraining factors for the market. Many researchers and ethicist have argued against gene editing due to different reasons such as off-target effect (edits in the wrong place), mosaicism (when only some of the cells carry the edits) and safety concerns. Some even argued that gene editing will lead to the creation of classes of individuals who will be genetically modified to be able to do things that a normal human being is not supposed to do according to the laws of nature. Due to these reasons, gene editing is still not considered to be safe and effective by many nations and international organizations.

Gene editing (also called genome editing) is a group of technologies that allow the researchers to change an organism's DNA by adding, removing or altering genetic material at particular locations in the genome. The emergence of advanced genome editing techniques is one of the major trend in the gene editing market.

The new techniques in genome editing are relatively inexpensive and can be used in a variety of application areas such as improving the food supply in agriculture, rectifying specific genetic mutations in the human genome and preventing the spread of diseases. For instance, CRISPR-Cas9 is a gene editing technique and stands for Clustered Regularly Interspace Short Palindromic Repeats.

The technique uses a strand of DNA as molecular scissors used to make cuts in DNA at specific points to make space to add new genomes. This technique is faster, cheaper, more accurate and efficient than other existing genome editing methods. Companies investing in CRISPR technology are Crispr therapeutics (CRSP), Intellia Therapeutics (NTLA), and Editas medicine.

The rising infectious diseases acts as one of the major drivers of the gene editing market. Gene editing techniques are used for detection of infectious diseases such as HIV. Infectious diseases are caused by microorganisms like bacteria, viruses, fungi, and parasites. Gene therapy treats the infectious diseases by blocking the replication of the infectious agent that causes the disease at the extracellular level. Gene editing introduces new genetic material into the cells of living organisms with the intention of treating the diseases.

European regulatory framework divided gene therapy into two categories, germline gene therapy, and somatic gene therapy. In germ line gene therapy, modified genes will be passed on to next generations whereas its not the same case with somatic gene therapy. Current regulation by the EU has only allowed somatic gene therapy, therefore, germline gene therapy is banned.

The European Medical Association provides guidelines on gene therapy for preparing market authorization application to obtain approval from the authority to carry on research and development activities in gene therapy. For instance, the EU provides guidance note on gene therapy medicinal product which is intended for use in humans, defines scientific principles and provide guidance for development and evaluation of gene therapy products.

Key Topics Covered:

1. Executive Summary

2. Gene Editing Market Characteristics

3. Gene Editing Market Trends and Strategies

4. Impact Of COVID-19 On Gene Editing

5. Gene Editing Market Size and Growth

5.1. Global Gene Editing Historic Market, 2015-2020, $ Billion

5.1.1. Drivers Of the Market

5.1.2. Restraints On the Market

5.2. Global Gene Editing Forecast Market, 2020-2025F, 2030F, $ Billion

5.2.1. Drivers Of the Market

5.2.2. Restraints On the Market

6. Gene Editing Market Segmentation

6.1. Global Gene Editing Market, Segmentation by Technology, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

6.2. Global Gene Editing Market, Segmentation by End Users, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

6.3. Global Gene Editing Market, Segmentation by Application, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

7. Gene Editing Market Regional and Country Analysis

7.1. Global Gene Editing Market, Split by Region, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

7.2. Global Gene Editing Market, Split by Country, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/ns9rjy

with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Global Gene Editing Market Research Report 2021 Featuring CRISPR, GenScript, Horizon Discovery Group, Integrated DNA Technologies and New England...