Category Archives: Gene Therapy Clinics

Cancer gene therapy backed by Blackstone gets trial win – BioPharma Dive

A gene therapy for bladder cancer that recently received $400 million in support from the private equity company Blackstone Group helped more than half of treated patients with resistant disease achieve remission.

The therapy, called nadofaragene firadenovec, was discovered by a Finnish-based research institute and first entered clinical study in 2012. The data revealed today at the Society of Urologic Oncology meeting came from a Phase 3 trial that is part of the agent's Biologics License Application now before the FDA.

Licensed by its original owner, FKD Therapies Oy, to Switzerland-based Ferring Pharmaceuticals, nadofaragene firadenovec is now in the hands of the U.S. subsidiary FerGene. That company was created with the Blackstone investment and an additonal $170 million from Ferring. FerGene will commercialize the gene therapy in the U.S., with Ferring holding rights elsewhere.

Nadofaragene firadenovec is an an adenovirus-based gene therapy encoding production of the immunity-stimulating protein interferon alfa-2b. Viral vectors containing the gene are administered by catheter once every three months into the bladder, where they are absorbed into cells in the organ's walls and begin stimulating interferon.

Delivery through a catheter, called intravesical administration, limits systemic exposure to both the viral vectors and to inteferon, said Neal Shore, medical director for the Carolina Urologic Research Center and an investigator in the trial.The side-effects of interferon include flu-like symptoms in patients who inject it for other conditions like multiple sclerosis.

The clinical trial enrolled 157 patients with bladder cancer that has not spread to muscle walls and has stopped responding to treatment with Bacillus Calmette-Gurin vaccine.

Alternative treatments for these patients include chemotherapy or a procedure called "complete cystectomy." This surgery entails complete removal of the bladder, which in men means removal of the prostate and seminal vesicles and in women the uterus, ovaries, fallopian tube and part of the vagina.

"Radical cystectomy is one of the most invasive surgeries we do not just in urology but in all of surgery," Shore said, requiring a lengthy hospital stay and having a high rate of post-procedural complications.

Out of a group of 103 patients with superficial tumors in the bladder wall, just over half were in complete remission at three months, 41% at six months, and 24% at one year. In a group of 48 patients whose cancer had spread to the connective tissue outside the bladder, 73% had no recurrence of serious disease at three months, which fell to 44% at 12 months.

In this type of bladder cancer, the FDA has said a single-arm trial, without a placebo control, using complete remission is sufficient to be considered for approval, and the study does not need to pre-specify a rate that would define success. "The natural history of [disease]is well understood, and the complete response rate is negligible in the absence of therapy," the agency said in guidelines published in February 2018.

One chemotherapy agent, called Valstar (valrubicin), is approved for this patient group. It won FDA approval on a complete response rate of 18%.

In seeking FDA approval, nadofaragene firadenovec is in a race with Merck & Co.'s Keytruda (pembrolizumab) to achieve approval first. That immuno-oncology agent tested Keytruda in a similar population in the Keynote-057 trial, in which it achieved a 39% complete response rate.

Keytruda will be the subject of a meeting of the FDA's Oncologic Drugs Advisory Committee on Dec. 17.

Aside from the remission rates,Shore said nadofaragene firadenovec would differentiate itself from Keytruda in practice because its intravesical delivery means it could be administered by community-based urologists at outpatient clinics.

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Cancer gene therapy backed by Blackstone gets trial win - BioPharma Dive

Counterculture 73: Summer Jam, Timothy Leary and the Sexual Revolution – Rolling Stone

In the new book 1973: Rock at the Crossroads, writer Andrew Grant Jackson gives a comprehensive account of the year of 1973 and its legendary music and momentous social change. He breaks down the iconic year chronologically, from the release of Led Zeppelins Houses of the Holy in March to The Exorcist hitting theaters in December. Read a chapter below, titled Counterculture 73, in which Jackson breaks down the pivotal counterculture moments of the summer.

The Summer Jam at Watkins Glen, New York, on July 28 makes the Guinness Book of World Records for largest concert with the Grateful Dead, Allman Brothers, and the Band. Esalen fuels the Human Potential Movement. Time puts Carlos Castaneda on the cover while the authorities put Timothy Leary in a cell next to Charles Manson. George Harrison and Steve Jobs pay heed to Ram Dass. The Sexual Revolution reaches a peak with New York Yankee wife swappers, key parties, streakers, and Deep Throat court cases. The New Hollywood filmmakers bring visionary realism to the big screen.

Woodstock, Isle of Wight, and Watkins Glen those were the big three for us, said the Bands Rick Danko. They played Watkins Glens Grand Prix Racecourse after two long sets by the Grateful Dead, interrupted by a thunderstorm. The Allmans played last, as they were the biggest draw, a few days away from releasing Brothers and Sisters, which sold 760,000 in less than a month. All three jammed for the encore on Not Fade Away, Mountain Jam, and Johnny B. Goode.

The Dead had inspired the Allmans to incorporate jazz into their extended blues rock improvisations, while the Band had inspired the Dead to explore their Americana roots on Workingmans Dead and American Beauty. The Dead was moving away from Americana now toward a smooth jazz sound with the arrival of keyboardist Keith Gordchaux. The cover of their new album, Wake of the Flood, featured a benign reaper, reflecting the loss of their original organist, the blues-oriented Pigpen (Ron McKernan), who died on March 8 from gastrointestinal hemorrhage due to alcohol abuse. It also reflected how the band was beginning to reap the rewards of their endless trip. They were now able to fill stadiums, and theyd done it all their way: through touring, regardless of record sales, establishing the economic model for jam bands like the Dave Matthews Band and Phish.

For a time, Watkins Glen was listed in the Guinness Book of World Records as largest audience for a pop festival, with a crowd estimated at 600,000. It beat Woodstock by approximately 200,000 but carried none of the cultural resonance. No movie was released, and only a couple songs made it onto record: Come and Go Blues on the Allmans Wipe the Windows, Check the Oil, Dollar Gas and an eighteen-minute sound check on the Deads So Many Roads box set.

It had already been done: the hordes getting in for free, dancing in the nude, breastfeeding. There was no longer any war they needed to bond together against. But its very meaninglessness revealed the extent to which the counterculture had been absorbed into the culture. Documentarian Michael Moore wrote in his memoir that by 1971 the longhairs outnumbered the jocks in his high school, though hippies still had to travel in packs or get jumped. Even the hair of conservative kids jutted out from behind their neck in yearbook photos. Richard Carpenter visited Nixon in the White House with hair over his ears. Merle If you dont love it, leave it Haggards thick muttonchops puffed down to his neck.

The original hippie mecca Haight-Ashbury had fallen on hard times. The New York Times reported that a third of its shops were boarded up. But the Dead transformed the neighborhoods spirit into a movable holiday through its tours. Believers could check in once every few years, or follow them around in a raggedy caravan of Volkswagen buses for months at a time. As Robert Christgau noted, Regulars greeted other regulars, remembered from previous boogies, and compared this event with a downer in Boston or a fabulous night in Arizona. Dead Heads sold items in the parking lots to finance their treks: jewelry, fanzines, burritos, dope, tie-dye shirts (a tradition carried over from Ken Keseys Merry Pranksters, who made tie-dye shirts on their own 1964 cross-country road trip).

One thing they didnt sell but traded was tapes of Dead shows. The tradition started when fans hungered to replay the music the Dead performed in concert but realized they couldnt find it in their studio albums. The band seldom played a song the same way twice and made a point of playing at least one different song a show. Fans started taping shows off radio broadcasts or sneaking recording equipment into gigs. The Dead had been close to the Haight-Ashbury activists the Diggers, who promoted the radical policy that everything should be for free, so they did not complain when mic stands rose above the crowds, reaching for better sound. One of the central figures in the Dead tape exchange was Dick Latvala; decades later, his favorite shows were officially released through the Dead under the name Dicks Picks. The first concert he chose to release was their December 19, 1973, concert in Tampa, Florida, because it included Nobodys Fault but Mine, a track prized for its rarity.

The Dead officially released one live album in 1973, and it introduced two of their most enduring logos. Bears Choice was named for their soundman Owsley Bear Stanley, originally one of the biggest acid manufacturers, and featured marching bears on the back cover. The front showed a skull with a lightning bolt in the brain cavity, representing the effect of his lysergic product. Stanley originally designed the image to print on stickers that he slapped on band equipment, to identify it as theirs when they played gigs with other bands.

The Dead community propagated another hallucinogen-related tradition that spread far beyond their own scene. Bassist Phil Lesh had a personal manager who was brother to a San Rafael high school student who ran with a clique that called themselves the Waldos, after the wall they sat on between classes. One day in 71 the Waldos gave each other the code 420 Louis meaning meet at the schools statue of Louis Pasteur at 4:20 p.m. in order to get high and search for a marijuana patch they heard had been planted in the area. 420 became the teens go-to term for pot, so parents or teachers wouldnt know what they were referring to, and spread into the Deads orbit. Years later, the Oxford English Dictionary credited the Waldos with originating the term, after studying a 1974 issue of their school paper in which they used it.

The main Dead Head tradition, of course, was going to a show, ingesting hallucinogens to block the serotonin receptors, and somehow hitting that chord of realization of the unity of God in you all, as comparative religion scholar Joseph Campbell put it in his symposium with Dead drummer Mickey Hart called Ritual and Rapture: From Dionysus to the Grateful Dead.10 As Tom Wolfe noted in The Electric Kool-Aid Acid Test, hallucinogens created a chemical reaction in the brain analogous to religious awe.

Or a plunge into the abyss, depending on how your trip was going. But Wake of the Flood included Eyes of the World, which became the new happy anthem to bring audience members back from staring at their shoes on the edge of freaking out. Wake now, discover that you are the song the morning brings, and look around at the concert and realize holy shit how beautiful everything is and were all made of atoms and were all just one field of energy endlessly permutating on the surface and everything is one, and WHOOOOOOOO!

Dr. Timothy Leary displays a big smile as hes escorted by U.S. Narcotics Bureau agents on his arrival at Los Angeles airport. The former Harvard professor escaped in September, 1970 from prison in San Luis Obispo County, Calif., where he was serving a 10-year sentence on a drug conviction. Photo credit: AP/Shutterstock

The fates of the original Dynamic Duo of Acid, Timothy Leary and Richard Alpert, illustrated with jarring clarity just how well or how bad the great mental/spiritual experiment could go. They had been professors at Harvard investigating the benefits of psychedelics until the university fired them because the program had grown too controversial, and because Alpert gave a hallucinogen to an undergraduate. (He was an attractive kid, said Alpert.) With the help of theorist Marshall McLuhan Leary concocted the slogan Turn on, tune in, drop out and proclaimed it at the San Francisco Human Be-In, which might have been fine, but he followed the line with I mean drop out of high school, drop out of college, drop out of graduate school. They gave him twenty years in prison for two roaches of marijuana. The acid cartel the Brotherhood of Eternal Love paid the Weather Underground militants to help him escape from prison. But officials nabbed him again in Kabul International Airport on January 17. As the authorities dragged him past the news cameras, it was terrifying to look at him. Hed always been handsome, known for his smile. McLuhan advised him always to smile to the press, so he did so now, to show that they couldnt crush him. But he looked crazy, like the Joker or Dracula, or a scary beaten dog. They took him to Folsom two days before Nixons second inauguration and stashed him in the cell next to Charles Manson.

Alpert embodied a preferable trajectory: Western academic psychiatry to psychedelics to Eastern mysticism. He traveled to India and met fellow seeker Kermit Riggs, who had renamed himself Bhagavan Dass. When my mind would go off into Jewish neuroticism, Bhagavan Dass would say, Come back here and be here now. Alpert renamed himself Ram Dass (servant of God) and published Be Here Now in 1971. He hit the lecture circuit in a white robe, sponsored retreats, and sold tapes. Be Here Now sold two million copies and was followed by Doing Your Own Being in 1973.

George Harrison included a song called Be Here Now on Living in the Material World. On the title track Harrison proselytized for the Hare Krishnas. The Krishna teacher Srila Prabhupada had arrived in the States in 1965, the year the US ended its policy of severely restricting non-European immigrants. Prabhupada started chanting in Tompkins Square Park with Allen Ginsberg. Not long after, Harrison and Lennon heard his first album, Krishna Consciousness.

After the passage of the Immigration and Nationality Act of 1965, many swamis and yogis arrived in the States, often teaching yoga, an Indian tradition since 1500 BC. By 1975, Time estimated that 600,000 Americans including Mike Love, Shirley MacLaine, and Joe Namath practiced it. On January 13, Cat Stevenss song about meditation, Sitting, peaked at No. 16.

March saw the release of Lost Horizon, about survivors of a plane crash in the Himalayas who stumble upon the utopia of Shangri-La. The author of the original novel, James Hilton, probably named his city after Shambhala, a Sanskrit word that means peace/serenity/joy. Ancient Tibetan Buddhist scripture referred to it as a fabled city in the Himalayas. The movie didnt perform well, despite a Burt Bacharach/Hal David soundtrack, clanging the death knell for the big Hollywood musical. The songwriters stopped working together. Not very Zen. But perhaps it inspired LA-based songwriter Daniel Moores euphoric Shambala, which Three Dog Night took to No. 3 in July. Its yodeling groove was so uplifting that Moore rewrote it as the secular My Maria and got another hit out of it when it was released a month later by progressive country artist B. W. Stevenson.

Many were still on the road to Shambala in real life, on the hippie trail to India. Tony and Maureen Wheeler traveled from London through the Middle East to India to Australia, arriving down under with $0.27 to their name. They shared what they learned in Across Asia on the Cheap, the first of their Lonely Planet Travel Guide books.

John Lennon celebrated all the journeys hed been on in space and in time, from meditation to primal scream therapy in Mind Games, recorded that summer. He was inspired by a book called Mind Games: The Guide to Inner Space by Robert Masters and Jean Houston, consisting primarily of exercises to increase visionary thinking and intuition (hence another song on the Mind Games album, Intuition).

Houston was a figure in the Human Potential Movement, which had its own Shambala in Esalen, off the winding Pacific Coast Highway in Big Sur. Nude sulphur baths built into the mountains looked out over the ocean as the surf crashed and shimmered in the moonlight. Founders Michael Murphy and Dick Price brought in speakers and held workshops covering the latest advances in Western psychiatry along with Eastern philosophy and psychedelics. That was the Great Synthesis: Western psychiatry + Eastern mysticism + psychotropic shamanism. Buddhist scholar Alan Watts gave the first lecture at Esalen. Aldous Huxley provided the movement with its name when he gave talks on Human Potential before his death in 1963. Leary and Alpert spoke there alongside others promoting self-actualization techniques ranging from Gestalt to Rolfing to biofeedback.

The Esalen encounter group was recreated in Bob & Carol & Ted & Alice (1969) and in the 2015 series finale of Mad Men. It rose out of the Sensitivity Training Group pioneered by social psychologist Kurt Lewin. In 1946, the Connecticut State Interracial Commission asked him to create a program that could help fight racial and religious discrimination.13 He gathered forty-one people together, half of them Jewish or black, so psychologists could analyze their interactions and give them feedback in a group setting, helping them become more sensitive to the other attendees feelings.

Now Marvin Gaye sang, Were all sensitive people, in Lets Get It On. Its all right to cry, Rosie Grier sang on the Free to Be You and Me album, in development for a TV special. In 1970, approximately one million Americans went to therapy. In five years the number was six times as great. Celebrities like Hugh Hefner, John Denver, and Peter Fonda spoke of their sadness at their parents inability to demonstrate affection. Im OK Youre OK and How to Be Your Own Best Friend were on the bestseller list throughout the year.

The No. 1 bestseller from January 1 through March 18 was Jonathan Livingston Seagull, a fable about an outcast yearning to fly on a higher plane. Many readers wondered what religion author Richard Bach himself belonged to (if any). His son said, Dad regards flying as his religion, and hes very serious about that. Bach had been a pilot in the US Air Force Reserve in France, a member of the New Jersey Air National Guard, then a technical writer for Douglas Aircraft and contributor to Flying magazine.

In 1959, Bach heard a voice behind him say Jonathan Livingston Seagull. John Livingston had been a race pilot. Bach asked the voice what it meant, and the story poured out of him onto the page, unfolding like a movie in his mind. Eight years later he published part of it in Private Pilot magazine.

Hed been a Christian Scientist, then decided that organizations can ruin anything and started searching through occult bookstores. It took nerve, just to go in one of those places, he told Time in their cover story on him. Time reported that his interest led him to a medium named Jane Roberts, who claimed to channel a spiritual being with an Indian accent named Seth.

The movie version of Seagull was poorly received by critics, like Lost Horizon, but the Neil Diamond soundtrack went to No. 2 and won the Grammy for Best Original Score, along with a Golden Globe.

Another bestselling writer made the cover of Time in March. Carlos Castaneda was an ethnobotany student whose anthropology professor instructed him to interview a shaman about psychotropic plants. Castaneda supposedly found one named Don Juan on the Arizona/Mexico border. His thesis was eventually published as The Teachings of Don Juan: A Yaqui Way of Knowledge (1968), which made Castaneda a millionaire and inspired three sequels. Castaneda had more surreal visions than Aldous Huxley or Ram Dass; on Don Juans medicine he witnessed giant gnats and talking coyotes and turned into a bird. But his message of enlightenment was the same: stop the world to see, a.k.a. be here now. The Eagles name was partially inspired by his books; Marvin Gaye dug them. But Time and other journalists couldnt find a real Don Juan. The tribe Castaneda said Don Juan belonged to didnt use the same kind of peyote Castaneda said he used. Critics noted that Don Juans personality seemed to change from book to book. After the Time piece, Castaneda claimed Don Juan died in 1973, then retreated from view for the next twenty years, after which he returned to teach seminars about Mexican shamanism.

A third author who combined ancient mysticism with psychedelics was about to join Castaneda on the chart, though he was painfully up-front about his tortured past. Robert Pirsigs Zen and the Art of Motorcycle Maintenance recounted his attempt to reconnect with his son on a motorcycle trip following a nervous breakdown and electroshock therapy, precipitated by his quixotic attempt to create his own system of metaphysics. After serving in Korea, Pirsig had become intrigued by Buddhism and studied in India, then did peyote on a Cheyenne reservation. The next year he was institutionalized on Christmas. When he got out, he grew violent toward his wife and received shock therapy. After recovering, he worked on Zen for four years, the last few months working in a camper in Minnesota. He sold the book in January 1973, and it eventually sold five million copies.

Alongside those authors, the Occult and Astrology bookshelf in bookstores now offered up much of the entire Western mystery tradition, a catalog that once had to be studied in secret, lest the reader incur the wrath of the Church. Samuel Weisers Inc., Specialist in the Occult, Orientalia, and Metaphysics, was one of New Yorks oldest occult bookstores. Weiser started selling Aleister Crowleys papers in the 50s but was not able to expand his operation until the 60s, when he began selling to the new occult bookstores bourgeoning in California. A watershed in occult publishing occurred in 1973 when two competing versions of a book called Pyramid Power sold a million, abetted by chain bookstores in malls rapidly spreading across the country, Waldenbooks and its competitor B. Dalton. Eventually the Trade Association of Independent Bookstores gave the Occult category a new name, New Age, replacing a horror-movie term with one used by theosophists and the Fifth Dimension in their hit from Hair, Aquarius/Let the Sunshine In.

A few rows over in the bookstore, the sexual revolution had arrived with an explicitness unimaginable to earlier authors crushed by obscenity court cases. Alex Comforts More Joy of Sex, his sequel to last years smash The Joy of Sex: A Gourmet Guide to Lovemaking, featured positions illustrated by Chris Foss and Charles Raymond. The New York Times later ranked the author on par with Dr. Spock in terms of impact, while Planned Parenthoods executive Joan Malin said, The groundbreaking publication of this book took us from an era of silence and shame about sexuality to one of greater openness and discussion. It started out as a textbook for medical students by Comfort, who admitted he was hardly an expert on the topic at the outset. Thats the way to find about anything, to write a book about it. He advised that female armpits should on no account be shaved and deodorant should be banned absolutely, and he cautioned, Never fool around sexually with vacuum cleaners.

Next to it on the shelf was George and Nena ONeills Open Marriage: A New Life Style for Couples, which spent over forty weeks on the bestseller chart. We are not recommending outside sex, but we are not saying that it should be avoided, either. The choice is entirely up to you.

By the early 70s there were over 650 swinging publications. Typical was the scene at the Swing Bar in LAs Studio City, with a marquee that read LUV THY NEIGHBOR. The bartender determined whether you got the invite to the mansion party, where men had to arrive with a date. The Swings owner, Greg McClure, told Newsweek, In my first marriage I cheated and never felt comfortable about it. Swinging is way ahead of the infidelity scene. I swing so I wont break up my marriage.

The Club 101 mansion boasted waterbeds and a chamber of mirrors. In a Detroit swingers gathering, guests mingled as at any cocktail party until the appointed time, when the host announced that anything went as long as all partners consented. Some couples waited in line for private rooms; others made do with the rows of cots in the basement. The key party was recreated in the 1997 film The Ice Storm. Attendees threw their car keys in a bowl, then plucked them out at random to see who would go with whom. The National Key Club (NKC) staged hotel events.

Key parties reputedly began on air force military bases during World War II, according to historian Terry Gould, as a kind of tribal bonding ritual, with a tacit understanding that the two-thirds of husbands who survived [the war] would look after the widows. Gould maintained that military bases across the country had swing clubs, which spread into the suburbs in the early 50s, along with swinger magazines.

On March 4, 1973, wife swapping reared its head in the great American pastime when New York Yankees pitchers Mike Kekich and Fritz Peterson figured theyd better get ahead of the story and held separate press conferences to announce they had switched wives.

Peterson later explained, During (a) party, we all had a couple of beers and were having a great time. When we were deciding to leave, we had driven two different cars and happened to park behind each other out in the street. I said to my wife, Marilyn, Why dont you ride with Mike to the diner in Fort Lee, N.J., and Ill take Susanne with me and well meet there and then well go home from there. We did that and we had so much fun together, Susanne and I and Mike and Marilyn, that we decided, Hey, this is fun, lets do it again.

Peterson and Susanne Kekich remained together over the ensuing decades, but Marilyn Peterson soon wished she was back with her former husband and split with Kekich. Marilyns mother lamented to the press, Fritz is not the same person he used to be. We cant understand any of his ideas or his problems anymore. The crowd booed Peterson, both players games suffered, and both were traded within the year. Dr. Joyce Brothers opined, Its very rare that a four-way swap ever works.

Still, curious couples ventured to the Shambala of swinging, Sandstone Retreat, in the mountains of Santa Monica. The fifteen acres in Topanga Canyon looked out at Malibu and the Pacific Ocean. If you were over eighteen, the nude woman at the front desk interviewed you to decide whether you could come in. Sometimes people had sex in the reception room, but more typically downstairs by the fireplace on pillows and mats. Gay Talese wrote that in 1973, often the nude biologist Dr. Alex Comfort, brandishing a cigar, traipsed through the room between the prone bodies with the professional air of a lepidopterist strolling through the fields with a butterfly net. With the least encouragement after he had deposited the cigar in a safe place he would join a friendly clutch of bodies, and contribute to the merriment. Its five hundred members included Bobby Darin and Daniel Ellsberg. Sammy Davis Jr. and Peter Lawford visited.

Alas, the owners had to sell the resort in 73, though it stayed open for another three years. Barbara Peterson, founder with husband John, observed, Sandstone had been a great source of fulfillment, learning, and pleasure. It had been everything, in fact, except financially viable.

Even in the mainstream, Puritan/Victorian conventions were rapidly melting away, such as the need to be a virgin until marriage, the need to be in love to have sex, the need to marry early, the traditions of female subservience. More unmarried couples lived together, as did the protagonists in McCartneys C Moon, though they never told her daddy. There did not seem to be any permanent STDs. If you got the clap, you got a shot. We had a soft spot in our hearts for the free clinics, said Jackson Browne. Steven Tyler wrote about lighting his pubic hair on fire to get the crabs to run out, but that seemed as bad as it got.

In March, a reporter covered a nude run at the University of Maryland with 553 participants and popularized the name for the new trend when he cried, They are streaking past me right now. Its an incredible sight! Time declared streaking a Los Angeles fad, reporting on a female streaker in tennis shoes who led the police on a chase across the ice during a hockey game at the Inglewood Forum.

The braless look graced Carly Simons No Secrets cover and Linda Ronstadts publicity photos, though Ronstadt lamented, In all of the world, outside of California, if you dont wear a bra it supposedly means you want to fuck everybody. When a man at the airport asked her, Hey, chick, you wanna get laid? I just hauled off and slugged him right in the mouth.

Advertisements even hawked bras with nipples built into them. Imagine having that sensual cold weather look all the time. Its so sexy, itll give your shape a whole new eye-opening dimension.

Responding to competition from Penthouse, Playboy showed a few wisps of pubic hair in 1971. Marilyn Cole (later on Roxy Musics Stranded cover) went full frontal a year later, but with a shadow across her. It wasnt until March 1973 that Hugh Hefner presented the first unobstructed view, with Playmate Bonnie Large.

That was the same month Judge Joel Tyler decreed Deep Throat obscene and fined Manhattans New Mature World Theatre $100,000 for screening it. His decision came down after a ten-day trial during which experts argued over whether oral sex was within the bounds of normal behavior. The prosecutor against Deep Throat, William Purcell, argued, A woman seeing this film may think that it is perfectly healthy, perfectly moral to have a clitoral orgasm. She is wrong. She is wrong. And this film will strengthen her in her ignorance. Defense experts countered that educating couples in sexual practices helped prevent divorce.

For a brief moment, before stories of Linda Lovelaces abuse leaked out, seeing porn became an idealistic cause clbre. It was exercising the First Amendment, embracing personal liberation against outmoded Victorian repression, asserting that nudity and sex were beautiful, not sinful. Deep Throats attorney, Herbert Kassner, argued, It indicates that women have the right to a sex life.

The New York Timess Vincent Canby opined, You can argue that Linda in her way is a kind of liberated woman, using men as sex objects the way men in most porno films are supposed to use women.

Even Bob Hope joked about it now. I went to see Deep Throat because Im fond of animal pictures. I thought it was about giraffes. On Maude, Bea Arthur fought to stage a burlesque show for a library benefit.

The groundbreaking sex scenes between Last Tango stars Brando and Schneider emboldened director Nicolas Roeg to attempt to top them in Dont Look Now with Julie Christie and Donald Sutherland. The latter film was shot in Italy just as police were seizing all of the countries copies of Last Tango on grounds on obscenity.

Marquee of The New Mature World Theatre which is showing the porno-film, Deep Throat. on West 49th Street in New York. Photo credit: Bettman Archive/Getty Images

Filmmakers with counterculture sensibilities had, for the moment, the run of Hollywood. After a string of box office bombs, the studios realized they were out of touch with modern sensibilities and (briefly) gave young filmmakers carte blanche to experiment in films like Badlands, American Graffiti, The Long Goodbye, and Paper Moon. Though the studios sometimes drew the line: Hal Ashbys The Last Detail was delayed for six months because the film included the word fuck sixty-five times, until praise for Jack Nicholsons performance as a navy lifer forced Columbia to release it.

Many of the New Hollywood directors gathered in Nichols Beach Canyon along the Pacific Ocean (a few minutes from where Neil Young lived at Zuma), at the homes of Julia and Michael Phillips (producers of The Sting) or actresses Margot Kidder and Jessica Salt, who lived down the block, where they flew a tie-dye flag and sunbathed topless. Hitchcock disciple Brian De Palma wrote Sisters as a vehicle for them. Steven Spielberg worked on Watch the Skies, his concept based on a great wave of UFO sightings that spiked in the fall of 1973, with the Phillipses and screenwriter Paul Schrader. In the end he didnt like the script Schrader wrote. Spielberg wanted the film to be about how average Americans yearned to transcend their mundane lives of quiet desperation through contact with mystical higher beings. Schrader nevertheless interested the Phillipses and Martin Scorsese in his script for Taxi Driver. Scorsese meanwhile was inspired to use the tracking-shot technique he saw in the Pink Floyd concert film Live at Pompeii for his new film Mean Streets. His use of classic songs by artists like the Stones and Ronettes changed the way the movies used rock in soundtracks, as did George Lucass American Graffiti. Lucas was already working on the script for his follow-up, a science-fiction epic loosely based on Akira Kurosawas The Hidden Fortress by way of Flash Gordon. It was really about the Vietnam War, and that was the period where Nixon was trying to run for a [second] term, which got me to thinking historically about how do democracies get turned into dictatorships? John Milius surfed and shot off his guns. He was the token conservative in the clique, a script doctor for Dirty Harry and writer of Apocalypse Now and Big Wednesday.

Even big-budget studio soap operas that year had radical heroines. The Way We Were starred Barbra Streisand as a Communist idealist who pushes her screenwriter husband (Robert Redford) to stand up to the blacklist and write art instead of easy entertainment. He doesnt want to work that hard, however, and they split a conflict that resonated with activists who had to decide if they wanted to keep on pushing or become proto-yuppies. Arthur Laurents wrote the screenplay; hed been blacklisted for years before bouncing back with West Side Story.

Along with daring to play a sympathetic Commie, Streisand led the vogue for actors who broke the WASP mold of beauty that dominated the industry. Her own mother had warned her she wasnt pretty enough to make it, and others had advised her to change her nose and accent, but she ignored them. Movie historian Lester Friedman wrote, Streisands name and nose in their unaltered state represents a turning point in the cinematic portrayal of Jews, one that shows Jewishness as something to be proud of, to exploit, and to celebrate. Cher, too, turned her unconventional, half-Armenian beauty into an asset, making it the theme of her hits Gypsys, Tramps & Thieves, Half-Breed (which made No. 1 in October), and Dark Lady.

Dustin Hoffmans success in The Graduate also helped open the doors to performers who never would have been offered leads before: Al Pacino, Elliot Gould (Streisands husband), Richard Dreyfuss, Donald Sutherland, Gene Wilder, Robert De Niro, Jill Clayburgh. The vogue for cinematic authenticity paralleled the ascendance of offbeat musicians like Bob Dylan, Mick Jagger, Janis Joplin, and Neil Young, whose appeal was partly based on the fact that they looked and sounded real, not like airbrushed product. For Redford, The Way We Were was a cautionary tale he spent the second half of his career refuting. His character mused uneasily that everything came too easily to him . . . he was a fraud. Redford turned that into the theme of the movies he directed, which centered on the guilt of golden boys who have everything handed to them while their brothers struggle. He became the patron saint of the Sundance Film Festival, which became the haven for artistically ambitious films after the studios lost their brief interest in funding experimental directors.

The bte noir of the counterculture was, of course, the military-industrial complex. But in a mind-boggling twist, the antagonists merged toward a great synthesis that determined the next phase of human evolution.

Significant milestones in computer technology that year included the first TV typewriter and the first computer monitor. Motorolas Martin Cooper made the first call with his invention, the handheld cell phone, inspired by Dick Tracys wrist radio. Xerox Palo Alto Research Center employees created the Ethernet when they linked all the computers and printers in their network with a coaxial cable. The forty-three high-powered US computers linked in the Advanced Research Projects Agency (ARPA) network made their first connection to computers outside the US in England and Norway.

Author Dean Koontz riffed off the Rosemarys Baby premise with his bestselling novel Demon Seed, about a computer that takes a woman hostage and impregnates her, creating a cyborg. But the Dead Heads who worked in Silicon Valley found benign uses for the technology, employing proto-messaging boards to arrange rides to concerts and compile lyrics to Grateful Dead songs, a resource the band itself eventually used. Merry Prankster Stewart Brand, creator of the commune-oriented Whole Earth Catalogue, wrote in Rolling Stone, Ready or not, computers are coming to the people. Thats good news, maybe the best since psychedelics. Half or more of computer science is heads. The rest of the counterculture is laid low and back these days, showing none of this kind of zeal.

In the article, Brand asked Alan Kay of the Xerox Research Center to describe the standard Computer Bum. About as straight as youd expect hotrodders to look. Its that kind of fanaticism. A true hacker is not a group person. Theyre kids who tended to be brilliant but not very interested in conventional goals. And computing is just a fabulous place for that, because its a place where you dont have to be a Ph.D. or anything else. Its a place where you can still be an artisan. People are willing to pay you if youre any good at all, and you have plenty of time for screwing around.

The man who most famously epitomized the archetype walked around barefoot, dropped out of college, read Be Here Now, ate at the Hare Krishna Temple, saved up to go to India, lived at his friends commune, and pruned the communes apple orchard, which inspired the name of the computer he eventually created with compadre Steve Wozniak. I came of age at a magical time. Our consciousness was raised by Zen, and also by LSD, Steve Jobs said. LSD shows you that theres another side to the coin, and you cant remember it when it wears off, but you know it. It reinforced my sense of what was importantcreating great things instead of making money, putting things back into the stream of history and of human consciousness as much as I could.

U2s Bono said of the techies, The people who invented the twenty-first century were pot-smoking, sandal-wearing hippies from the West Coast like Steve, because they saw differently. The hierarchical systems of the East Coast, England, Germany, and Japan did not encourage this different thinking. The sixties produced an anarchic mind-set that is great for imagining a world not yet in existence.

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Counterculture 73: Summer Jam, Timothy Leary and the Sexual Revolution - Rolling Stone

Precision Cancer Therapies Market Size, Status and Forecast 2025 Trends, Size, Drivers, Strategies, Products and – The Market Stats News

Precision Cancer Therapies Market research now available at Brand Essence Research encompasses an exhaustive Study of this business space with regards to pivotal industry drivers, market share analysis, and the latest trends characterizing the Precision Cancer Therapies industry landscape. This report also covers details of market size, growth spectrum, and the competitive scenario of Precision Cancer Therapies market in the forecast timeline.

The Precision Cancer Therapies Market Report provides key strategies followed by leading Precision Cancer Therapies industry manufactures and Sections of Market like- product specifications, volume, production value, Feasibility Analysis, Classification based on types and end user application areas with geographic growth and upcoming advancement. The Precision Cancer Therapies market report provides comprehensive outline of Invention, Industry Requirement, technology and production analysis considering major factors such as Revenue, investments and business growth.

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The well-established players in the market are:

Abbott Laboratories, Bayer HealthCare, GlaxoSmithKline, OncoGenex Pharmaceuticals, Hospira, Boehringer Ingelheim, AstraZeneca, Aveo Pharmaceuticals

This report for Precision Cancer Therapies Market discovers diverse topics such as regional market scope, product market various applications, market size according to specific product, sales and revenue by region, manufacturing cost analysis, Industrial Chain, Market Effect Factors Analysis, market size forecast, and more.

Drivers & Hindrances of the Precision Cancer Therapies market: How does the report explicate on the same

The report unveils the driving parameters affecting the commercialization chart of this industry.

The Precision Cancer Therapies market research report further illustrates the various challenges that this market is prone to as well as its impact on the market trends.

An important aspect that the report sets focus on is the market concentration ratio for the predicted timeframe.

Important Points Mentioned In the Precision Cancer Therapies Market

Manufacturing Analysis:The report comprises descriptive information after analyzing multiple segments of Precision Cancer Therapies market, which include product type and applications, among others. Precision Cancer Therapies market report includes a separate chapter emphasizing thorough analysis of the manufacturing process authenticated via primary information gathered from key officials of reputed industries and several industry analysts.

Sales and Revenue Estimation:By implementing several top-down and bottom-up approaches on the historical sales & revenue data and the current market status, the researchers have forecasted the market growth and size in key regions. Moreover, the report includes a comprehensive study on classified and prominent types as well as end-use industry. The report even provides significant information related to regulatory policies and macroeconomic factors that determine Precision Cancer Therapies industry evolution and predictive analysis.

Demand & Supply Assessment:Precision Cancer Therapies report also offers important information on product & service distribution, manufacturing, Consumption, and Export & Import (EXIM) ** if applicable.

Competitiveness:Precision Cancer Therapies report provides key information based on the product portfolio, company profile, product & service cost, potential, and sales & revenue generated by the global and regional leading companies.

Market segment by Type, the product can be split into

Hormone Therapy, Immunotherapies, Targeted Therapy, Monoclonal Antibody Therapy, Gene Therapy

Market segment by Application, split into

Hospitals, Diagnostic Centers, Oncology Clinics, Research Institutes

Market segment by Regions/Countries, this report covers

North America (United States, Canada and Mexico)

Europe (Germany, UK, France, Italy, Russia and Turkey etc.)

Asia-Pacific (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Malaysia and Vietnam)

South America (Brazil etc.)

Middle East and Africa (Egypt and GCC Countries)

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Key highlights and essential features of the report:

1) Which major players are presently listed in the report?Here are the companies that are presently listed in the report: Abbott Laboratories, Bayer HealthCare, GlaxoSmithKline, OncoGenex Pharmaceuticals, Hospira, Boehringer Ingelheim, AstraZeneca, Aveo Pharmaceuticals

**List of the firms stated above might differ in the final report dependent on a merger, name change, and other factors.

2) Can you list or add new firms as per our requirement?Yes,we can list or add new firm as per the requirement by client in the report. The final confirmation regarding the same must be provided by the research team subject to difficulty of survey.

**Availability of data will be confirmed after research in case of a privately held firm. Maximum 3 companies can be included at no additional charge.

3) Which all regional categorization are covered? Is it possible to add any specific country?Presently, our research report offers special focus and attention on the following areas:Europe, United States, Japan, China, India, Southeast Asia, and Central & South America

**Maximum one country of specific interest can be added at no extra charge. Charges will be applied for the addition of extra countries or regions.

4) Can the addition of extra Market breakdown or segmentation is possible?Yes, the addition of extra Market breakdown or segmentation is possibly dependent on the difficulty of survey and availability of data. On the other hand, detailed sharing of the requirements with our research team is a must before providing final confirmation to the client.

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There are 15 Chapters to display the Global Precision Cancer Therapies market

Chapter 1, Definition, Specifications and Classification of Precision Cancer Therapies , Applications of Precision Cancer Therapies , Market Segment by Regions;

Chapter 2, Manufacturing Cost Structure, Raw Material and Suppliers, Manufacturing Process, Industry Chain Structure;

Chapter 3, Technical Data and Manufacturing Plants Analysis of Precision Cancer Therapies , Capacity and Commercial Production Date, Manufacturing Plants Distribution, R&D Status and Technology Source, Raw Materials Sources Analysis;

Chapter 4, Overall Market Analysis, Capacity Analysis (Company Segment), Sales Analysis (Company Segment), Sales Price Analysis (Company Segment);

Chapter 5 and 6, Regional Market Analysis that includes United States, China, Europe, Japan, Korea & Taiwan, Precision Cancer Therapies Segment Market Analysis (by Type);

Chapter 7 and 8, The Precision Cancer Therapies Segment Market Analysis (by Application) Major Manufacturers Analysis of Precision Cancer Therapies ;

Chapter 9, Regional Marketing Type Analysis, International Trade Type Analysis, Supply Chain Analysis;

Chapter 10, The Consumers Analysis of Global Precision Cancer Therapies ;

Chapter 11, Precision Cancer Therapies Research Findings and Conclusion, Appendix, methodology and data source;

Chapter 12, 13 and 14, Precision Cancer Therapies sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source.

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Precision Cancer Therapies Market Size, Status and Forecast 2025 Trends, Size, Drivers, Strategies, Products and - The Market Stats News

World AIDS Day 2019: 37.9M people worldwide were living with HIV at the end of 2018 – USA TODAY

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People around the world on Sunday observed the 31stannual World AIDS Day, an eventfirst declared in 1981 aimed atraising awareness of the HIV/AIDS epidemic. It was first declared by the World Health Organization.

According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), 37.9 million people around the world were living with HIV at the end of 2018. UNAIDS reports 1.7 million people worldwide were newly infected in 2018.

The CDC reports 1.1 million people were living with HIV in the United States at the end of 2016 and one in seven people nationwide who had the disease didnt know they were infected.

37,832 people received an HIV diagnosis in the United States and dependent areas, according to the CDC.

Worldwide, 770,000 people died from AIDS-related illnesses in 2018, according to UNAIDS. The CDC reports there were 16,350 deaths among people diagnosed with HIV in the United States. The agency added the deaths may be due to any cause.

An activist paints his hand with AIDS awareness message during a campaign on the eve of World AIDS Day in Kolkata, Eastern India.(Photo: PIYAL ADHIKARY/EPA-EFE)

HIV stands forhuman immunodeficiency virus. AIDS stands for acquired immunodeficiency syndrome.

HIV is a virus that can lead to AIDS.AIDS is the lastof thethree stages of HIV infection.

According to the Centers for Disease Control and Prevention, people in the first stage, acute HIV infection, experience a flu-like illness within 2 to 4 weeks after infection.Itcan last a few weeks. People in this stagehavelarge amounts of the virus in their blood,and so are more likely to transmit the infection.

The second stage, clinical latency, marks a period where the virus is active but reproduces only at low levels, HIV.gov says. People in this stagemight not experience symptoms, but can still transmit HIV to others. This stage can last decades, depending on treatment, but can also be shorter.

AIDS, the third stage,leads to the mostsevere illnessesbecause the virus damages the immune system over time, the CDC says. On average, people with AIDS who don't get treatment survive three years, according to the CDC.

Treatment at all three stagescan prevent or slow symptoms and reduce the risk of transmission, the CDC says.

Testing is the best way to determine whether you have HIV, but symptoms can occur beforeHIV shows up on a test. Some experience flu-like symptomsincludingfever, chills, rash, night sweats, muscle aches, sore throat, fatigue, swollen lymph nodesor mouth ulcerswithin two weeks of infection.

HIV attacks your immune system by reducing CD4 cells, or T cells, makingit harder to fight other infections."Over time, HIV can destroy so many of these cells that the body cant fight off infections and disease," according to HIV.gov.

According to HIV.gov, the condition becomesAIDS whenT cellcounts drop below200 cells per cubic millimeter of blood,or certain AIDS-related complications suchassevere infectionsappear.

Students carry a red ribbon during world Aids day campaign in Dharamsala, India on December 1, 2019. World AIDS Day is observed every December 1 with calls from international health and advocacy organizations for the public to get involved in programs for awareness, prevention and treatment of human immunodeficiency virus infection and acquired immune deficiency syndrome. (Photo: Sanjay Baid, EPA-EFE)

A person can become infected with HIV only through certain activities in which they come intocontact with certain bodily fluids.

Blood, semen, pre-seminal fluid, rectal fluids, vaginal fluidsand breast milk can transmit HIV, according to the CDC.

"These fluids must come in contact with a mucous membrane or damaged tissue or be directly injected into the bloodstream (from a needle or syringe) for transmission to occur," the CDC says.

Unprotected anal or vaginal sex with someone who has HIV is one of two main ways the virus is spread in the United States, according to HIV.gov. Use of a contaminated needle or syringe is the other.

A mother may pass the virus on to her child duringpregnancy, birthor breastfeeding. It can also be contracted bybeing struck by an item contaminated with HIV. Other rare but possible ways to spread HIV can be found here.

The Chain Bridge is illuminated in red to mark World AIDS Day in Budapest, Hungary on December 1, 2019.(Photo: Marton Monus, EPA-EFE)

U.S. scientists found the first clinical evidence for the disease that would become known as AIDS in 1981, according to the United Nations. Chimpanzees in Central Africa have been identified as the source of HIV in humans. Their version of the virus, calledSIV,was likely transmitted to humans and then mutated, the CDC says. HIV has existed in the United States since the mid- to late 1970s.

Yes. People with HIV can take a series of drugs, called antiretroviral therapy, or ART,that slows the virus from progressing, keeps them healthy for years and drastically reduces their likelihood of spreading the virus, the CDC says.

epaselect epa08037135 A 3D printed statue of the Dutch AIDS foundation is unveiled in the center of Amsterdam, the Netherlands, 01 December 2019. The image sheds a tear every 40 seconds and was unveiled on the occasion of World AIDS Day. EPA-EFE/ROBIN VAN LONKHUIJSEN ORG XMIT: 402553629(Photo: ROBIN VAN LONKHUIJSEN, EPA-EFE)

Not yet. Researchers are working toward a cure. Ifa cure were to be found, it'd likely take one of two forms, according tothe National Institute of Allergy and Infectious Diseases.

Viral eradication would mean HIV was eliminated from a patient's body. The approachwould involve "prodding the virus out of its latent state so that an enhanced immune system or administered therapies can target and eliminate HIV-infected cells," the NIAID says. Researchers are also studying gene mutations in certain people whose immune cells resist HIV.

A functional cure, or sustained ART-free remission, would mean that HIV wasnot eliminated, but rather suppressed to a point at which daily medication would no longer be longer required.

No, but there have been a number of developments. The National Institutes of Health opened the first clinical trial with138 healthy, HIV-negative volunteers in 1987, according tothe National Institute of Allergy and Infectious Diseases.

In 2016,the NIH announced avaccine-efficacy trial in South Africa of 5,400 people, the largest in the country's history. Researchers are building on a 2009 success in Thailand, where for the first time ever a vaccine showed modest success in preventing HIV infections.

Princy Mangaika, executive director of Positive Women's Network (PWN), herself an HIV-infected patient, makes AIDS awareness ribbons at her residence in Colombo, Sri Lanka, on Sunday.(Photo: Chamila Karunarathne, EPA-EFE)

The CDC recommends everyone from ages 13 to 64 get tested at least once.

People at greater risk of infection, such as sexually active gay or bisexual men, people who have had sex with an HIV-positive partner, people who have shared needles and sex workers, among othersshould get tested more often.

The CDC recommends testing once a year for people engaging in these higher-risk behaviors. Forsexually active gay and bisexual men, the CDC says testing every three to six months is beneficial.

If you are pregnant, and even if you are in a monogamous relationship, the CDC recommends testing to be sure and to reduce the risk of transmitting HIV to your child or partner. The sooner a pregnant woman starts treatment, the less likely she is to transmit HIV to her child.

Most HIV tests involve blood or oral fluid. Clinics, hospitals, community health centers and many other locations provide HIV testing. Home testing equipment is also available.

HIV does not always show up right away in a test. Your body and the test type determinehow long HIV can take to be detected. Here's a useful guide from theSan Francisco AIDS Foundation on testing windows.

For more information on local testing sites,call1-800-CDC-INFO (1-800-232-4636) or

visitgettested.cdc.gov.

The red ribbon was created in 1991 by artists in New York workingto increase awareness of HIV/AIDS. The artists saw the red ribbon as an easy-to-copy way to show compassion for those living with HIV, given the stigma surrounding it.

"They chose red for its boldness, and for its symbolic associations with passion, the heart and love," according toWorld AIDS Day organizers.

Contributing: Jordan Culver, USA TODAY

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World AIDS Day 2019: 37.9M people worldwide were living with HIV at the end of 2018 - USA TODAY

Global Parkinsons Disease Treatment Market 2019 Analysis by Industry Growth, Size, Share, Trends and Forecast by 2025 – Eastlake Times

Global Parkinsons Disease Treatment Market 2019-2025 Overview

The Parkinsons disease treatment market growth was driven because of increase in the geriatric population and the rise in the occurrence of the Parkinsons disease and the funding for research.

Global Parkinsons disease treatment market is anticipated to experience the substantial growth during the forecast period. Growth in the occurrence of the Parkinsons diseases is projected to supplement the growth of global Parkinsons disease treatment market in the coming future. In addition, the combined treatments supporting in the long action of constant dopaminergic stimulation medicines, neural transplantation and gene therapy is expected to fuel the Parkinsons disease treatment market growth.

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Parkinsons disorder is a neurological disorder affecting the movements of body. There are five stages of this disease and can hamper the individuals leg & hand movements, facial expressions getting worse with the growing age. Increase in the elderly population related to the rise in the investments in the activities of research & development, growth in the awareness for healthcare and the neurological disorders are the factors driving the global Parkinsons disease treatment market growth over the forecast period. On the other hand, due to the presence of the other treatments is hampering the Parkinsons disease treatment market growth.

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Current developments in the Parkinsons disease treatment, for example, combined treatment to continue the effect of constant dopaminergic stimulation medicines, gene therapy, neural transplantation, neuroprotective treatment to reduce the disease prediction and support for the neurostimulation tools are estimated to provide large development in the global Parkinsons disease treatment market growth during the forecast period. Moreover, major characteristics that are fueling the requirement and demand for the global parkinsons disease treatment market are prevalence of parkinsons disease and growth in the geriatric population. Two important characteristics that are responsible to boost the Parkinsons disease treatment market development are prevalence of the neurodegenerative syndrome and rise in the elderly population. Although, increase in the medicines in the pipeline and growth in the R&D activities are anticipated to surge the Parkinsons disease treatment market size. In addition, lack of skills for the early diagnosis and large spending on treatment is projected to bolster the development of global Parkinsons disease treatment market.

Key factor driving the growth of Parkinsons disease treatment market is the growth in the acceptance of the treatment for Parkinson disease in healthcare sector. For treating and detecting the dysfunctioning of the human beings central nervous system and the neurological damage because of lack of cells and nerves are the main function of Parkinsons disease treatment market.

Global Parkinsons disease treatment market is segmented into end-use, distribution channel, drug class and region. Based on end-use, market is divided into clinics and hospitals. On the basis of distribution channel, market is divided into retail pharmacies, online pharmacies and hospital. On considering the drug class, market is divided into MAO inhibitors, Levopoda/ Carbidopa and Dopamine Receptor Agonists.

Geographically, regions involved in the development of Parkinsons disease treatment market growth are Europe, North America and Asia Pacific. Asia Pacific is anticipated to show the rapid growth because of the increase in the trend of medical tourism and medical infrastructure. North America holds the largest

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Parkinsons disease treatment market share. Europe is dominating the Parkinsons disease treatment market because of the maximum market revenue in the coming years.

Key players involved in the Parkinsons disease treatment market analysis are Teva Pharmaceutical Industries, Novartis AG, Impax Laboratories and GlaxoSmithKline.

Key Segments in the Global Parkinsons Disease Treatment Market are-

By End-Use, market is segmented into:

By Distribution Channel, market is segmented into:

By Drug Class, market is segmented into:

By Regions market is segmented into:

What to expect from the Global Parkinsons Disease Treatment Market report?

Predictions of future made for this market during the forecast period.

Information on the current technologies, trends, devices, procedures, and products in the industry.

Detailed analysis of the market segmentation, depending on the types, devices, and products.

Government regulations and economic factors affecting the growth of the market.

An insight into the leading manufacturers.

Regional demographics of the market.

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Venture capitalists, Investors, financial institutions, Analysts, Government organizations, regulatory authorities, policymakers ,researchers, strategy managers, and academic institutions looking for insights into the market to determine future strategies

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Global Parkinsons Disease Treatment Market 2019 Analysis by Industry Growth, Size, Share, Trends and Forecast by 2025 - Eastlake Times

Diabetic foot wounds kill millions, but high-tech solutions and teamwork are making a difference – Thehour.com

(The Conversation is an independent and nonprofit source of news, analysis and commentary from academic experts.)

David G. Armstrong, University of Southern California

(THE CONVERSATION) What if someone told you that theres a disease you could catch where you couldnt feel any symptoms coming on? And that this occurs every 1.2 seconds somewhere in the world?

What if you were stricken with this disease then there would be a 5% chance youd lose a limb within a year and a 50-70% chance youd be dead in five years? What if you were told that this problem cost more than the five most expensive cancers in the U.S. but far less than one one-thousandth of comparative federal and private funding is spent on attacking it?

Ladies and gentlemen, please allow me to introduce you to the humble diabetic foot ulcer. While the problem may strike at the end of the body, far away from the heart or the brain, its effects are far-reaching.

I have spent my career treating and researching the lower extremity complications of diabetes. Based on my research and experience, I believe our society could eliminate immeasurable suffering if we collectively paid more attention to this problem.

How do diabetic foot ulcers occur?

OK, I know this isnt a sexy topic. Foot wounds are ugly. Many people who have them are poor. But bear with me. They are a reality for far too many Americans and people across the globe. The ages of these patients are bimodal, in that there is one population of people who are old and getting older. Conversely, with more and more people being diagnosed with Type 2 diabetes earlier, there is a population that is younger than ever being afflicted with wounds, infections and amputation. Ignoring the problem is an example of ignoring the needs of a silent and vulnerable population.

About 31 million people in the U.S. have diabetes, and about half a billion worldwide.

Diabetic foot ulcers develop because people with diabetes slowly lose the gift of pain. Over many years, people with diabetes lose feeling in their extremities. This occurs first and generally most profoundly in their feet.

Once this occurs, people with diabetes might wear a hole in their foot, just as you or I might wear a hole in a sock or shoe. This hole is called a diabetic foot ulcer.

About half the time, the ulcer will become infected. This increases the risk of further tissue damage and, in the face of frequent vascular disease, high-level amputation. Often all of this occurs with few, if any, symptoms until it is too late.

Solutions and hope

There is also good news. Studies have suggested that high-level amputations seem to decrease when interdisciplinary care is in place, regardless of the country.

Interdisciplinary teams consist of podiatric and vascular surgeons, the so-called Toe and Flow model. The concept is simple; these two specialists, can manage a great deal of the medical, surgical and biomechanical aspects of healing and aftercare.

When we add core physical therapy to this, then the threesome (what we in the field call Toe, Flow and Go) is really quite formidable. For example, our clinics at the University of Southern California and Rancho Los Amigos in Los Angeles have active participation from more than eight specialists ranging from plastic surgery to prosthetics/orthotics, to occupational therapy to nutrition to general practice to infectious disease to diabetology to nurse case management.

Truly, it takes a village to preserve a limb.

Smart boots, high-tech vacuums and sheets of stems cells

It has long been said in wound care that its not what one puts on a wound that heals it, but what one takes off. That maxim is absolutely true in the diabetic foot. Protection of the wound is key.

The gold standard for protecting the wound has been, believe it or not, to put the patient into a special cast. This device works so well because it protects the foot in a process known as offloading, or taking the burden off the foot. By its design, this cast is not easy to remove.

While this has been my personal favorite device to heal these foot wounds, patients dont like it and most doctors dont, either. In fact, fewer than 2% of centers in the country use this as their primary means of offloading. Reasons for this include fear of putting an open wound into a cast (even though the data largely refute this), the time required to apply and remove it and patients being miserable in a hot and heavy device.

Very recently, tech company offshoots have begun to partner with prosthetic/orthotic companies to create next-gen devices that can coax patients into wearing their protective device rather than forcing it upon them. They are using phone calls and a smartwatch.

After focusing on offloading pressure, the next question is what can be done to heal the wound.

Technologies ranging from fancy vacuums, to donated placental tissue, to repurposing blood cells into a dressing to topical oxygen systems have shown recent promise. Active research is being conducted with stem cell sheets consisting of specialized cells seeded on a clear sheet, spread-on skin, and gene therapy.

Remission

As challenging as healing the wound heals, the real challenge is whats next. Following healing, 40% of foot wounds will recur in one year, about two-thirds at three years, and nearly three out of four at five years.

At USC, along with colleagues in the National Health Service in the U.K., we have developed remission clinics designed to extend and promote an active life for this high-risk patient population.

This has also been combined with things like smart insoles, socks and home-based bathmats that can identify wounds before they occur. These technologies will likely initially be subscription-based but may expand beyond that.

Diabetic foot ulcers are common, complex and costly. Theyre sinister in that they come on quietly. Perhaps, though, it is now up to us to alert our own families, communities and leaders to this condition. It is, I believe, only by teaming up that we can stem the tide and preserve not only limbs, but extend lifespan, healthspan and hope.

[ Youre smart and curious about the world. So are The Conversations authors and editors. You can read us daily by subscribing to our newsletter. ]

This article is republished from The Conversation under a Creative Commons license. Read the original article here: http://theconversation.com/diabetic-foot-wounds-kill-millions-but-high-tech-solutions-and-teamwork-are-making-a-difference-127218.

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Macular Degeneration Treatment Market and its Future Outlook and Trend During the Period of 2019 2026 – The Chicago Sentinel

The sources of data and information mentioned in the MACULAR DEGENERATION TREATMENT report are very reliable and include websites, annual reports of the companies, journals, and mergers which are checked and validated by the market experts. It also includes strategic profiling of top players in the market, wide-ranging analysis of their core competencies, and their strategies

This Market Report by Material, Application, and Geography Global Forecast to 2026 is a professional and comprehensive research report on the worlds major regional market conditions, focusing on the main regions (North America, Europe, Middle East and Asia-Pacific)

Click Here to Get Sample Report Of Macular Degeneration Treatment Market

Here are the names of top key players which are covered in this report: Neurotech, Gilead Sciences, Inc., F. Hoffmann-La Roche Ltd, Adverum, Allergan, Regeneron Pharmaceuticals, Inc, STEMCELL Technologies Inc, IVERIC bio, Kubota Pharmaceutical Holdings Co., Ltd, Bayer AG, Novartis AG, Sanwa Kagaku Kenkyusho Co., Ltd, others

By Types (Wet Macular Degeneration, Dry Macular Degeneration), Treatment (Drugs, Surgery), Route of Administration (Oral, Injectable and Others), End- Users (Hospitals, Homecare, Specialty Clinics, Ophthalmic Clinic and Others), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies)

According to the statistics published in the press release by Neurotech, an estimated population of Macular telangiectasia type 2 is nearly around 1 per 22,000 worldwide. High demand of novel treatment and huge investment on research and development are drivers for market growth.

Regional Analysis

North America: US, Canada, Mexico

South America: Brazil, Argentina, Rest of South America

Asia-Pacific: Japan, China, South Korea, India, Australia, Singapore, Malaysia

Middle East and Africa: South Africa, Egypt, Saudi Arabia, United Arab Emirates, Israel

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Research Methodology:

In September 2019, Adverum reported positive 24-week clinical data from the first cohort of patients treated with a one-time intravitreal (IVT) dose of ADVM-022, gene therapy in the OPTIC phase I clinical trial in wet age-related macular degeneration (wet AMD).The trial demonstrated sustained improvements in retinal anatomy. The clinical trial results indicating potentially significant clinical benefits for patients with wet age-related macular degeneration.

In February 2019, Neurotech received Fast Track designation from the FDA for NT-501 or Renexus, a encapsulated cell therapy for the treatment of macular telangiectasia type 2 (MacTel). The FDA Fast Track designation enables the company to accelerate the development process which helps patients to have access on the treatment as quickly as possible.

Highlights following MARKET DRIVERS AND RESTRAINT:

Table of Contents

INTRODUCTION

KEY TAKEAWAYS

RESEARCH METHODOLOGY

MACULAR DEGENERATION TREATMENT LANDSCAPE

MACULAR DEGENERATION TREATMENT KEY MARKET DYNAMICS

MACULAR DEGENERATION TREATMENT GLOBAL MARKET ANALYSIS

MACULAR DEGENERATION TREATMENT REVENUE AND FORECASTS TO 2026 TECHNOLOGY TYPE

MACULAR DEGENERATION TREATMENT REVENUE AND FORECASTS TO 2026 SERVICES

MACULAR DEGENERATION TREATMENT REVENUE AND FORECASTS TO 2026 APPLICATION

MACULAR DEGENERATION TREATMENT REVENUE AND FORECASTS TO 2026 END-USER

MACULAR DEGENERATION TREATMENT REVENUE AND FORECASTS TO 2026 GEOGRAPHICAL ANALYSIS

INDUSTRY LANDSCAPE

MACULAR DEGENERATION TREATMENT, KEY COMPANY PROFILES

APPENDIX

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Macular Degeneration Treatment Market and its Future Outlook and Trend During the Period of 2019 2026 - The Chicago Sentinel

Edited Transcript of BLFS earnings conference call or presentation 12-Nov-19 9:30pm GMT – Yahoo Finance

Bothell Nov 20, 2019 (Thomson StreetEvents) -- Edited Transcript of BioLife Solutions Inc earnings conference call or presentation Tuesday, November 12, 2019 at 9:30:00pm GMT

* Michael P. Rice

BioLife Solutions, Inc. - President, CEO & Director

BioLife Solutions, Inc. - CFO & Secretary

H.C. Wainwright & Co, LLC, Research Division - Research Analyst

Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst

Good afternoon, ladies and gentlemen, and welcome to the Q3 2019 BioLife Solutions, Inc. Earnings Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Mr. Roderick de Greef, Chief Financial Officer. You may begin.

Roderick de Greef, BioLife Solutions, Inc. - CFO & Secretary [2]

Thank you, JP. Good afternoon, everyone, and thank you for joining us for the BioLife Solutions conference call to review the operating and financial results for the third quarter of 2019. Earlier this afternoon, we issued a press release which summarizes our financial results for the 3 and 9 months ended September 30, 2019. We also issued a press release this afternoon announcing our asset purchase of Custom Biogenic Systems or CBS.

As a reminder, during this call, we will make certain projections and other forward-looking statements regarding future events or the future financial performance of the company. These statements are subject to risks and uncertainties that may cause actual results to differ materially from expectations. For a detailed discussion of the risks and uncertainties that affect the company's business and that qualifies forward-looking statements, I refer you to our periodic and other public filings filed with the SEC. Company projections and forward-looking statements are based on factors that are subject to change, and therefore, these statements speak only as of the date they are given. The company assumes no obligation to update any projections or forward-looking statements except as required by law.

During this call, we will speak to non-GAAP or adjusted results and guidance. Reconciliations of GAAP to non-GAAP or adjusted financial metrics are included in the press release we issued this afternoon. These non-GAAP or adjusted financial metrics should not be viewed as an alternative to GAAP. However, in light of our M&A activity, we believe that the use of non-GAAP or adjusted metrics provides investors with a clearer view of our current financial results when compared to prior periods.

Now I'd like to turn the call over to Mike Rice, President and CEO of BioLife.

Michael P. Rice, BioLife Solutions, Inc. - President, CEO & Director [3]

Thank you, Rod, and good afternoon, everyone. Thank you for joining the call. I'm very pleased to discuss our Q3 results and activities. We have a lot to share, so I'll jump right in.

I'll start by sharing our vision of success for BioLife and our next major milestone we're focused on. First, some history. Over the last nearly 15 years, we built BioLife into a leading supplier of critical biopreservation media products used in cell and gene therapy manufacturing. We created the product categoryclinical-grade biopreservation media and worked very hard to convince developers in the cell and gene therapy space that traditional preservation cocktails and methods are not robust enough to best ensure commercial success. Our proprietary and optimized CryoStor and HypoThermosol media products have now been used in more than 400 customer clinical applications. Once we scaled our media business and reached profitability in 2018, we began to seek complementary growth opportunities. We, of course, considered a number of internal R&D projects, but on balance, a long time to market and then transposition we hold with CryoStor and HypoThermosol caused us to identify external opportunities to scale the business even faster and to take advantage of the current roll-up environment for bioproduction tools.

Earlier this year, we acquired Astero Bio and gained the ThawSTAR automated thaw product line. Later, we acquired the remainder of SAVSU Technologies that we didn't own and added the evo Cold Chain management system to our portfolio.

Our outlook for these initial acquisitions is very positive. And coupled with our just announced acquisition of Custom Biogenic Systems or CBS, we've defined our next major milestone for success as reaching $100 million in revenue. The vision of success we're focused on looks like this: BioLife will scale to become an even more deeply entrenched partner to cell and gene therapy companies by offering a diversified and differentiated portfolio of novel products and services that can improve quality by reducing risk in the manufacture, preservation, storage, delivery and thawing of these biologic therapies. I'll have more to say about CBS later in the call, so now I'll provide some comments about our existing business.

Turning to Q3 revenue. We experienced a soft quarter due to 2 customers ordering less media products than anticipated. Our media revenue and current total revenue is highly concentrated from less than 100 customers with about 50 generating the lion's share. This concentration is a primary driver for our M&A strategy to derisk our reliance on a concentrated customer base and a limited product portfolio.

In Q3, a large distributor had a significant sequential decrease in order volume due to it being the start of their fiscal year and a changeover to a new ERP system. On a positive note, we expect total 2019 calendar revenue from this distributor to nearly double from 2018. Also, one large therapy -- one large cell therapy contract manufacturer had a significant sequential decrease in order volume. We attribute this to the cyclical nature of contract work and the CMOs' dependence on end-user customer order patterns, which can be affected by the pace of enrollment in their clinical trials. Together, these 2 customers accounted for a nearly $1 million sequential revenue decrease from Q2. So far in Q4, order volume from these customers has returned to typical levels. But again, it's worth repeating that from time to time, we expect to experience sequential swings like this. And we're obviously working hard on the M&A front to expand our portfolio to not only derisk but also grow top line revenue.

Our other internal metrics for assessing how our regen med franchise is performing were on track in Q3. We gained 41 new direct cell and gene therapy customers, and we processed 18 new FDA master file cross-reference requests supporting customer use of CryoStor or HypoThermosol in pending human clinical trials of cell and gene therapies.

Integration of the Astero thaw products is on track. And to date, we've shipped over 200 ThawSTAR products, with most of these to the cell and gene therapy market segment. Progress continues on our new ThawSTAR CB automated thaw product for biologic materials frozen in bags. We plan to formally introduce ThawSTAR CB at the Phacilitate Cell and Gene Therapy Conference in Miami in January.

Updating you now on adoption of the evo Cold Chain management system. We continue to win new customers, including Adaptimmune, Autolus, Janssen, KBI Pharma, Mustang Bio, Nanjing Legend and Tessa Therapeutics. Product validations by several leading cell and gene therapy companies continue, and we look forward to sharing some new customer wins when appropriate. It's clear we've emerged as a new competitor in the cold chain management segment of cell and gene therapy manufacturing. As such, we're being put through a very robust qualification process by several multibillion-dollar worldwide biopharma companies, we believe, much more so than incumbent suppliers as our technology is truly innovative and is expanding the conversation to include quality aspects that prospective customers have not thought of before.

Our indirect network of distributors continued to perform well in Q3, generating 36% of total revenue, with 38% growth over Q3 last year. Key worldwide distributors for our media products include MilliporeSigma, STEMCELL Technologies, Thermo Fisher and VWR.

Turning now to our other significant news of the day. We announced the acquisition of nearly all of the assets of privately held Custom Biogenic Systems or CBS. CBS, based in a Northern Detroit suburb, is a leading designer, manufacturer and supplier of advanced liquid nitrogen freezers and related racks and accessories. We started a dialogue with CBS' CEO and founder in June of this year and immediately recognized several potential benefits of an acquisition, including adding a meaningful amount of revenue from the sale of complementary products, the ability to leverage our relationships in the cell and gene therapy space to accelerate adoption of CBS products and an opportunity to improve quality and reduce cost in our evo Cold Chain products by vertically integrating a U.S.-based supplier.

Recall that our vision is to supply products to our cell and gene therapy customers along as much of the longitudinal workflow as possible. With the acquisition of CBS assets, we now plug into the following workflows. Starting with the acquisition of source material, this includes preservation, cold chain transport, cryogenic storage and thawing before manufacturing. And now continuing with the manufactured biologic product, we play in the following work processes: preservation, cryogenic storage, cold chain shipment and on-site thawing before patient administration.

CBS is a great fit, and we look forward to integrating their operations into BioLife to realize the synergies we identified. CBS has several marquee customers in the cell and gene therapy space, and we see tremendous leverage to scale the business.

I'd like to make one last comment about our M&A strategy. While we've been very active this year and would not rule out some additional activity next year, our focus for 2020 will be on integrating the businesses we acquired.

Now I'll turn the call back over to Rod to present our financial highlights for Q3, some additional detail on CBS and our updated guidance for 2019 and preliminary revenue guidance for 2020. Rob?

--------------------------------------------------------------------------------

Roderick de Greef, BioLife Solutions, Inc. - CFO & Secretary [4]

--------------------------------------------------------------------------------

Thanks, Mike. Before reviewing our third quarter financial results, I'd like to make a few comments about our acquisition of CBS, which we announced earlier today. We purchased substantially all of the assets of CBS for $11 million in cash and issued 234,000 unregistered common shares having a value of $4 million. We have structured an earnout over 5 years whereby the owner of CBS could realize another $15 million in cash or stock if certain new product-related revenue levels are exceeded. We anticipate that CBS will have full year 2019 revenue of between $10 million to $11 million and a modest but positive adjusted EBITDA. We expect to realize $1 million to $2 million of incremental revenue contribution to our P&L for the balance of 2019.

Based on the introduction of a new line of liquid nitrogen freezers in 2020, we expect solid revenue growth over 2019. And although our gross margin will realize additional compression in the near term, based on the margin profile of capital equipment, we fully expect the acquisition will be accretive on an adjusted EPS basis and provide a positive adjusted EBITDA contribution in 2020.

Moving to our quarterly results. Total revenue for the third quarter of 2019 reached $6.6 million, representing a 25% increase over last year's third quarter revenue of $5.3 million. This quarter's revenue included $324,000 of sales related to the automated thaw products we acquired last April and $211,000 of evo-related revenue, which was acquired in early August. Biopreservation media revenue for the third quarter of 2019 was $6 million, up 15% compared to last year and lower than expected based on 2 customers ordering approximately $1 million less than expectations. As Mike mentioned, order volume from these 2 customers in Q4 is back in line with our internal expectations but unlikely to make up the order shortfall we realized in Q3.

Total revenue for the 9-month period in 2019 was $19.1 million, up 34% over revenue of $14.3 million in 2018. The adjusted gross margin for the third quarter of 2019 was 69.2% compared with 69.7% in the third quarter of last year. The slight decrease in gross margin reflects the lower margin profile of the automated thaw and evo product lines. Adjusted gross margin for the 9 months was 71% compared to 68.5% in 2018.

Adjusted operating expenses for Q3 totaled $4.5 million compared with $2.5 million in Q3 of 2018. The increase in adjusted operating expenses is primarily the result of the acquisitions of Astero and SAVSU and secondarily to increased head count necessary to support our overall growth and higher performance-based compensation. Adjusted operating expenses for the 9-month period in 2019 totaled $11.6 million compared with $7.2 million in 2018.

Adjusted operating profit for the third quarter of 2019 was $106,000 compared with $1.2 million in the third quarter of 2018. Adjusted operating profit for the 9-month period was $2 million compared to $2.6 million in 2018.

Adjusted net income attributable to common shareholders for the third quarter of 2019 was $215,000 or $0.01 per diluted share compared with $1.2 million or $0.05 per diluted share in 2018. For the 9-month period in 2019, adjusted net income attributable to common shareholders was $2.4 million or $0.10 per diluted share compared with $2.5 million or $0.12 per diluted share in 2018.

GAAP net income and EPS for the 3- and 9-month periods included a onetime gain on the acquisition of SAVSU of $10.1 million and $0.40 and $0.41 per share, respectively. Adjusted EBITDA for the third quarter totaled $925,000 compared to $1.7 million in the same period in 2018. And for the 9-month period, adjusted EBITDA was $4.3 million compared to $4 million in 2018.

With respect to our current outlook for 2019, we have updated the guidance we provided in August of this year, which includes the impact of acquiring Astero beginning on April 2, SAVSU from August 8 and now CBS from November 12. We expect total revenue for 2019 will be between $27.5 million to $31.5 million, reflecting year-over-year growth of 39% to 60%. This includes $1.2 million from the thaw product line, $500,000 from the evo technology and $1 million to $2 million from CBS.

Our adjusted gross margin for 2019 should be between 68% to 69%. Based on the acquisitions of SAVSU and CBS, we do expect the near-term compression of our gross margin of between 6 to 8 percentage points, ultimately climbing back into the mid-60s with increasing product revenue.

We expect 2019 adjusted operating expenses to be in the range of $16.5 million to $17.5 million. We expect that the additions of SAVSU and CBS will add between $1.2 million to $1.5 million in additional quarterly operating expenses above the $4.5 million we realized in Q3.

Finally, we expect to be positive on the operating, net income and EBITDA lines on an adjusted basis for the full year of 2019.

I would like to end my remarks with a summary of our share count. We currently have 20.7 million common shares issued and outstanding and a fully diluted share count of 27.2 million.

Now I'd like to turn the call back over to Mike.

--------------------------------------------------------------------------------

Michael P. Rice, BioLife Solutions, Inc. - President, CEO & Director [5]

--------------------------------------------------------------------------------

Thanks, again, Rob. In summary, I'm very bullish on the potential to grow BioLife to our next interim milestone of reaching $100 million in revenue. Our preliminary revenue guidance for next year has us more than halfway to this goal. The opportunity in the cell and gene therapy space is tremendous. We have a very solid reputation in the space as a trusted supplier. We worked very hard building customer relationships that have rewarded us with growth and the satisfaction of playing a part in helping our customers bring life-changing and life-saving biologic-based therapies to the clinic. I'd like to thank all of our shareholders for your support of BioLife.

Now we'll turn the call back over to the operator to take your questions. JP?

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) First question comes from the line of Jason McCarthy of Maxim Group.

--------------------------------------------------------------------------------

Unidentified Analyst, [2]

--------------------------------------------------------------------------------

It's Dave on the line for Jason. So I don't think I quite caught this here. Could you please repeat how many new customers did you guys get in the third quarter? Was it 41? I just wanted to make sure I heard that correctly.

--------------------------------------------------------------------------------

Michael P. Rice, BioLife Solutions, Inc. - President, CEO & Director [3]

--------------------------------------------------------------------------------

Yes. This is Mike. 62 total, 41 in the cell and gene therapy space.

--------------------------------------------------------------------------------

Unidentified Analyst, [4]

--------------------------------------------------------------------------------

62 total.

--------------------------------------------------------------------------------

Michael P. Rice, BioLife Solutions, Inc. - President, CEO & Director [5]

--------------------------------------------------------------------------------

62, 6-2 total with 41 in the cell and gene therapy segment.

--------------------------------------------------------------------------------

Unidentified Analyst, [6]

--------------------------------------------------------------------------------

Okay. Great. And then if you could please just shed some more color on, in your opinion, what the synergies are between the Custom Biogenic Systems freezing and cryogenic equipment and SAVSU's evo smart containers, I'd appreciate that.

--------------------------------------------------------------------------------

Michael P. Rice, BioLife Solutions, Inc. - President, CEO & Director [7]

--------------------------------------------------------------------------------

Sure, Dave. Good question. So here's how it goes. CBS' product line is for stationary freezing containers that would be at cell and gene therapy manufacturing sites, biorepositories, clinics and whatnot. The SAVSU evo line of dry vapor shippers and the other products are for transport at cryogenic temperatures and other temperatures of biologic therapies that are both time-sensitive and temperature-sensitive. So one is stationary. One is for movement across time and space.

--------------------------------------------------------------------------------

Roderick de Greef, BioLife Solutions, Inc. - CFO & Secretary [8]

--------------------------------------------------------------------------------

We believe that rather than sourcing the evo hardware from abroad, that we have the opportunity to have the products made in Detroit at CBS because fundamentally, the technology around building what is essentially a can and a can is absolutely doable at CBS.

--------------------------------------------------------------------------------

Operator [9]

--------------------------------------------------------------------------------

Our next question comes from the line of Paul Knight of Janney.

--------------------------------------------------------------------------------

Paul Richard Knight, Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst [10]

--------------------------------------------------------------------------------

Mike, on the $1 million, was it 2 customers? And what was going on in each of those 2 customers if it was 2?

--------------------------------------------------------------------------------

Michael P. Rice, BioLife Solutions, Inc. - President, CEO & Director [11]

--------------------------------------------------------------------------------

Yes, Paul, correct. The softness in Q3 media was a result of 2 customers that together accounted for a nearly $1 million sequential decrease in order volume. One customer was a distributor who was transitioning into a new ERP system. Concurrently with that, Q3 is their Q1 of their fiscal year. So that's kind of a normal reload process. So those 2 dynamics were the reason there for the softness in their order volume.

The other customer, Paul, is a cell and gene therapy CMO or a contract manufacturing organization. And the CMOs, they're really at the mercy of their end customers and the clinical trial enrollment for those customers, which dictate how much product they're going to buy from any of the bioproduction tool suppliers that are supplying them critical reagents, manufacturing tools and whatnot.

--------------------------------------------------------------------------------

Paul Richard Knight, Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst [12]

See the original post here:
Edited Transcript of BLFS earnings conference call or presentation 12-Nov-19 9:30pm GMT - Yahoo Finance

U.S. stem cell clinic offering unapproved therapies brings direct-to-consumer marketing to Ottawa – Ottawa Citizen

Just a few months after Health Canada began cracking down on private clinics offering unapproved stem cell therapies, at least one U.S. clinic has moved in to fill the vacuum with direct marketing to Canadian consumers.

The clinic from Burlington, Vermont, even offers shuttle buses to transport people from Ottawa to the clinic four hours away for treatment it suggests will end joint pain, among other things. Lunch and dinner are free, but each injection costs $6,880. Two for $10,880.

The treatments, using umbilical cord-derived mesenchymal stem cells, are not approved in either Canada or the United States. Health Canada warns that Canadians who travel abroad for stem cell treatments may put themselves at risk.

While stem cells, which were discovered at the University of Toronto in 1961 by James Till and Ernest McCulloch, promise to revolutionize many treatments and could offer breakthroughs for diseases, almost all are still considered experimental and have yet to be proven safe or effective. Clinical trials on numerous potential stem cell therapies are under way, including in Ottawa.

While research progresses, private stem cell clinics have popped up around the world making promises for treatments not yet proven safe or effective.

A 2018 study by Leigh Turner of the University of Minnesota Center for Bioethics found 43 clinics offering stem cell treatments in Canada and 750 in the U.S. Earlier this year, Health Canada sent Canadian clinics, including some in Ottawa, cease-and-desist letters.

Clinics in Vermont, near the Canadian border, appear to have ramped up marketing to Canadians since then. One clinic has been holding back-to-back seminars. Another says it stopped marketing in Canada after receiving a warning from Health Canada.

There have been cases of harm as a result of treatments, including two women who had permanent damage to their sight after stem cells were injected into their eyes at a Florida clinic. Other patients have been infected with unsterilized equipment and others have developed tumours at the site of stem cell injections.

A common harm, critics say, is exploitation.

Dr. Michael Rudnicki is director of the regenerative medicine program and Sprott Centre for Stem Cell Research at the Ottawa Hospital Research Institute, says of stem cell therapy claims: If it sounds too good to be true, it probably is too good to be true.jpg

Health officials say the clinics are misusing the promise of stem cell therapy to exploit vulnerable patients.

These patients are in pain and they are suffering and they are looking for help and they are being exploited, said Dr. Michael Rudnicki, director of the regenerative medicine program and Sprott Centre for Stem Cell Research at the Ottawa Hospital Research Institute.

If it sounds too good to be true, it probably is too good to be true.

At a recent seminar at a west-end Ottawa hotel meeting room, Roseanna Ammendolea of the Vermont Center for Regenerative Medicine told a packed room that her clinic and others like it had successfully treated people for pain related to arthritis, neuropathy and other ailments that affected joints using mesenchymal stem cells from umbilical cords. The stem cells, she claimed, are both effective and safe, saying there had been no issues with cell rejection.

We will not give injections if we feel that this injection will not be beneficial to our patients. This is why we are so successful.

Participants, including some who walked with canes and others who talked about being in pain and having mobility issues, were shown videos of people described as Canadian clients who claimed the treatments worked. One man said it was probably the best money I have spent in my life as far as my health. Another said she would do it again in a heartbeat and was able to do things she hadnt been able to do earlier.

They were also shown a slide showing long wait times for hip and knee replacements in Ontario, We are not a priority, she said. Where does that leave us? Participants werent told exactly how the stem cells were supposed to work, but claimed they had successfully improved pain and mobility issues in clients.

What the seminar goers werent told is that, even in the U.S., the treatment is not covered by health insurance because it remains unproven.

The U.S. Federal Drug Administration has issued a warning to consumers not to use cell therapies that are unapproved or unproven.

Stem cells have been called everything from cure-alls to miracle treatments. But dont believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures and confirm whats really being offered before you consider anytreatment, the FDA said in a statement.

The only stem-cell-based products that are FDA-approved for use in the United States are blood-forming stem cells derived from cord blood for limited use in patients with disorders affecting the body system that is involved in the production of blood. Bone marrow is also used for these treatments, but is generally not regulated by the FDA for that use.

Health Canada has granted market authorization for a stem cell therapy to treat graft-versus-host disease and two cell-based gene therapies to treat certain cancers. Most cell therapies are still experimental.

I totally understand the skepticism of it, Doug Argento, who works at the Vermont Center for Regenerative Medicine, said in a telephone interview, but the fact is that things that are approved now and medically paid for were seen as renegade 20 or 30 years ago.

The treatment employs technology developed by Neil Riordan, founder, chairman and chief science officer of the Stem Cell Institute in Panama, using human umbilical cord tissue-derived mesenchymal stem cells. There are 41 such clinics across the U.S. Riordan also played a role in the development of a nutritional product called Stem-Kine, which producers claim without scientific backing increases the number of stem cells circulating in a persons body.

The stem cells injected in the clinic, Argento said, are from umbilical cord tissue as a result of caesarean births to reduce risk of infection.

Rudnicki, of The Ottawa Hospital Research Institute, says there is no evidence that these sorts of cells are regenerative at all. It would not pass muster in Canada.

The public has to understand that there are people out to remove them from their money.

Rudnicki says he regularly receives inquiries from people desperate to get stem cell treatments. He says he tries to connect them with clinical trials that they might be able to participate in.

Rudnicki noted there were multiple clinical trials in Canada, including treatments of autoimmune diseases, trials involving treatment for Type 1 diabetes and others.

But the use of these inappropriate cell types for treating arthritis and joints and so on is certainly not approved by Health Canada and would not be allowed in Canada under the regulations.

There is some evidence that injections of some stem cell products might have a temporary positive impact on inflammation, he said, but it will not be regenerative and will not restore function to joints. They are being sold a bill of goods.

Leigh Turner of the University of Minnesota Center for Bioethics, meanwhile, says the explosion in clinics offering unproven stem cell therapies in the U.S. is a marketplace that traffics in misrepresentation. It is easy to see how people are taken advantage of and scammed.

It is also difficult to find out about physical harms being done to patients.

There are no safety studies. We dont have good data. But we do know there have been some serious harms.

Stem cell therapies have the potential to become standard treatment in some areas, but they are not there yet, Turner said.

Businesses are tapping into genuine human suffering, desperation and also hope.

Turner also noted there was an excellent chance that the vials of liquid being injected into patients did not actually contain stem cells.

Dr. Jonathan Fenton of another stem cell clinic in Burlington, the Vermont Regenerative Medicine, said he had complained about the new clinic, the Vermont Center for Regenerative Medicine, which has a similar name and employs hard-sell tactics, he said.

His clinic takes bone marrow from patients hips and injects it. The procedure is done the same day. He says he regularly sees Canadian patients for bone marrow aspiration therapy and platelet-rich plasma treatments, using their own blood. The treatments, he says, speed healing and are allowed in the U.S. The use of bone marrow aspiration is neither proven nor allowed in Canada.

Fenton, who is secretary-treasurer of the American Academy of Orthopedic Medicine, acknowledged many people offering stem cell treatments are not doing it to the highest ethical standards.

He has filed complaints with state officials over clinics selling unsafe or fraudulent treatments. I have asked the state and federal judiciary to close down this clinic for committing fraud.

He said his platelet and bone marrow treatments were covered by a major Vermont health insurer because they saw the cost of benefits were going down and patients were requiring fewer surgeries.

He said he was told by Health Canada that he could not market in Canada. Representatives of the Vermont Center for Regenerative Medicine, meanwhile, said they had discussions with Health Canada about what they could and could not say when marketing in Canada before holding seminars in Ottawa and Halifax.

We have looked at the information provided and have not identified any immediate non-compliance with advertising regulations pertaining to Canadian health products, a Health Canada spokesperson said, adding that the agency was continuing to assess.

Back at a west-end Ottawa hotel, some participants in the seminar, including a retired pharmacist, said they were considering getting the treatments. But its expensive.

Another participant said he was skeptical. They seemed very sketchy when I went online.

epayne@postmedia.com

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U.S. stem cell clinic offering unapproved therapies brings direct-to-consumer marketing to Ottawa - Ottawa Citizen

Hemophilia Treatment Market Dynamics, Pin-Point Analysis, Comprehensive Landscape, Demand Key Factors, Market Segments Regions, Therapy For Hemophilia…

(MENAFN - GetNews) Hemophilia Treatment Global Market Research Report: By Type (Hemophilia A, Hemophilia B, Hemophilia C), By Treatment (Recombinant Coagulation Factor, Plasma-Derived Coagulation Factor, Desmopressin, Antifibrinolytic Agents), End User Global Forecast Till 2023

Hemophilia Treatment Market Overview

The global hemophilia market is forecasted to witness a steady growth of 6.10% during the forecast period between 2018 to 2023. The market valuation is slated to jump from USD 11,257.21 in 2017 to USD 16,059.17 by the end of the forecast period.

Request Free Sample Copy Available @ https://www.marketresearchfuture.com/sample_request/5688

The report published by Market Research Future (MRFR) identifies that the prevalence of hemophilia will spring up the demand for hemophilia treatment globally. The emergence of recombinant products for the treatment of hemophilia has blossomed the interest and demand for the market. The absence of a precise cure and the growing setbacks with the treatment of hemophilia has increased the need for discovering and coming up with new and effective solutions. Gene therapy is increasingly being explored and considered as a permanent solution for hemophilia and offers vast opportunities for the growth of the market.

However, the high cost associated with the treatment and the level of expenses required for consistent lab testing and imaging tests can go on to hamper the market growth of hemophilia treatment.

Hemophilia Treatment Market Segmentation

The global hemophilia treatment market segmentation is based in terms of type, end-user, and treatment.

By type, the market is categorized into hemophilia A, hemophilia B, and hemophilia C. The hemophilia A segment holds the largest share of the global market. The valuation of the segment is expected to reach USD 12.697.99 by the end of the forecast period, 2023. The calculated growth rate of the market annually has been projected to be 6.23% during the forecast period.

By treatment, the market comprises of recombinant coagulation factor concentrates, plasma-derived coagulation factor concentrates, desmopressin, gene therapy, and antifibrinolytic agents. The recombinant coagulation factor concentrates is the largest market share holder with an expected CAGR of 7.01% during the review period.

By end-users, the market includes hospitals & clinics, research organization, and others. Hospitals & clinics lead this segmentation of the market and is valued at USD 7594.66 in 2017 and is expected to grow the fastest over the forthcoming years.

Hemophilia Treatment Market Regional Analysis

The regional segmentation of the hemophilia treatment market covers the following regions: North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

The Americas stand tall as the largest market share holder in the global geographical segmentation. This is due to the prevalence of the hemophilia disorder and the presence of a well-established healthcare sector. Growing expenditure in healthcare and increasing support for research and development activities are expected to aid the Americas region to maintain its leadership position. The North American market contributes more to the region than its southern counterpart.

Europe holds the second biggest market share due to a parallel growth pattern like the Americas. Moreover, government support for R & D activities for advanced medical therapies for hemophilia is another important driver to the market growth in this region.

Asia Pacific is expected to grow with the highest CAGR of 8.38% during the review period. The healthcare sector in this region is advancing at a rapid pace owing to the high disposable income in the region and expanding advanced medical facilities. The presence of a vast patient population base and a high healthcare expenditure is expected to positively impact the Asia Pacific market growth.

Hemophilia Treatment Market Competitive Landscape

The global hemophilia treatment market includes various noteworthy players like Baxter, F.Hoffmann-La Roche Ltd, Octapharma, Swedish Orphan Biovitrum AB, Pfizer Inc, CSL Behring, Sanofi, Kedrion, Novo Nordisk A/S, Bayer AG, Grifols International S.A, and Shire.

Feb 19th, 2019, Novo Nordisk announced in a press release about the US FDA approval of N8-GP, turoctocog alfa pegol, to help treat children and adults with hemophilia A in the United States. The therapy will be under the brand name of Esperoct

Feb 7th, 2019, Roche announced its joining with the World Federation of Hemophilia (WFH) Humanitarian Aid Program. The program will see the company treating more than 1,500 people with Hemophilia A across various developing countries.

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Hemophilia Treatment Market Dynamics, Pin-Point Analysis, Comprehensive Landscape, Demand Key Factors, Market Segments Regions, Therapy For Hemophilia...