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Live stage productions seem to be leading the pack in the entertainment and cultural events field this weekend as we move into the middle of November.

Playhouses that have been preparing their season openers are ready to take them to the stage. Student actors at Florida Atlantic University will present their second production of the season, a 180-degree jump to comedy from the theater-of-mood wrought by Anton Chekov's Uncle Vanya, the troupe's season opener.Plus, the newly renovated Kravis Center in West Palm Beach will offer a Broadway phenomenon.

The Museum of Discovery and Science will deliver a nontheatrical package: an uplifting tale of animals saved from extinction.

Heres a closer look at whats happening this weekend:

Friday, November 15

Youre in luck if your Halloween mask hasnt been packed away for next year. Its time for another fabulous party to benefit Beyond Nine Cat Rescue. This time, the theme of the festivities is Masquerade Madness, and prizes will be awarded for the best mask. Your $20 donation at the door Friday night includes valet parking, a cocktail of your choice, dinner, and dessert. Therell be a lot of great stuff in raffles and a silent auction.Established in 2007, Beyond Nine Cat Rescue is a nonprofit, all-volunteer group dedicated to giving felines the opportunity to live safe, healthy, and happy lives. It has about 200 cats waiting for forever homes, so give adoption serious thought. 6:30 to 9:30 p.m. Friday, November 15, at Marriott Pompano Beach Resort & Spa, 1200 N. Ocean Blvd., Pompano Beach; beyondninecatrescue.org. Admission is a donation of $20 at the door.

Student thespians at Florida Atlantic University are set to stage a production that Bostonians would call "a wicked pissa." Urinetown, a play by Mark Hollmann and Greg Kotis, will run this Friday through next Sunday, November 24, at FAUs Studio One Theatre on the Boca Raton campus. Set during a catastrophic water shortage when the use of private toilets has been banned, this hysterical musical satire of corporate greed and political malfeasance has an unlikely hero: a man who needs to pee and refuses to pay for it. The winner of three Tony Awards, Urinetown is an outrageous, modern comedic romp. Make sure you visit the restroom before you take your seat. 7 p.m. Friday, November 15; 2 and 7 p.m. Saturday, November 16; and 2 p.m. Sunday, November 17, through Sunday, November 24, at FAU's Studio One, 777 Glades Rd., Boca Raton; 561-297-6124. Tickets cost $22 via fauevents.com.

Fiddler on the Roof runs through Sunday at the Kravis Center.

Photo by Joan Marcus

Not many plays earn the descriptor beloved. Fiddler on the Roof is among the few and it's a distinction well earned and enduring. The tale of hard-working families in a small Russian village circa 1905, with music by Jerry Bock, lyrics by Sheldon Harnick, and a book by Joseph Stein, is about to conclude its run at the revamped Kravis Center in West Palm Beach.Fiddler is based on Tevye and His Daughters, a series of stories written in Yiddish by Ukrainian writer Sholem Aleichem and first published in 1894. The musical centers on Tevye, the father of headstrong daughters seemingly bent on flouting his Jewish religious and cultural traditions. The classic production is rich with Broadway hits, including To Life (LChaim), If I Were a Rich Man, Sunrise, Sunset, Matchmaker, Matchmaker, and Tradition. The original Broadway show, which opened in 1964, was the first musical in history to surpass 3,000 performances. 8 p.m. Friday, November 15; 2 and 8 p.m. Saturday, November 16; and 2 p.m. Sunday, November 17, at the Kravis Center for the Performing Arts, 701 Okeechobee Blvd., West Palm Beach; 561-832-7469; kravis.org. Tickets start at $39.

Experience an unforgettable evening as South Floridas top female impersonators transform into legendary music stars. The show, Icons: The Art of Celebrity Illusion, brings Cher, Bette Midler, Barbra Streisand, Whitney Houston, Celine Dion, Judy Garland, and Liza Minelli together for one night only. Join host and drag superstar Nicole Halliwell for an hour of fabulousness, glamour, outrageous costumes, musical hits, and plenty of surprises. 8 p.m. Friday, November 15, at Mizner Park Cultural Center, 201 Plaza Rd., Boca Raton; 844-672-2849; miznerparkculturalcenter.com. Tickets cost $29.

The cast of Andy and the Orphans, a new comedy by Lindsey Ferrentino, opening Friday in Boca Raton.

Photo courtesy of Primal Forces

The theater troupePrimal Forces will open its sixth season this Friday (its second in Boca Raton) with a powerful and poignant comedy by Lindsey Ferrentino, Andy and the Orphans. The play, which debuted last year at New Yorks Roundabout Theatre, follows a Jewish family on a road trip that uncovers an old scandal and some shattering family secrets. I am honored to bring together such a distinguished ensemble cast for this production, director Keith Garsson says. Though the play is often hilarious, Garsson says it also "explores a real family drama and lays bare topics that are not as readily discussed." The plot involves a couple of unhinged siblings who, after their fathers death, reunite with Andy, their movie-loving brother neither has seen in years. Together they careen down the Long Island Expressway while navigating strip malls, traffic jams, and some serious and not-so-serious family drama. The cast includes Edward Barbanell, a longtime Coral Springs resident, who understudied his role in its original incarnation in New York City. 8 p.m. Friday, November 15, and Saturday, November 16, and 2 p.m. Sunday, November 17, through December 8 at Sol Theatre, 3333 N. Federal Hwy., Boca Raton. Tickets start at $40 via primalforces.com or 866-811-4111.

Saturday, November 16

The Distinguished Speaker Series at the Museum of Discovery and Science in Fort Lauderdale is back for its 2019 autumn season. Visitors of all ages are invited to learn from renowned researchers and scholars, who will educate, entertain, and inspire new ways of thinking about marine-related topics. This event will include an AutoNation IMAX 3D Theater screening Saturday of the critically acclaimed documentary Back From the Brink, which explores true stories of animals rescued from the edge of extinction. Several screenings are planned for Saturday, along with a distinguished speaker presentation at 2:30. 9 a.m. Saturday, November 16, at Museum of Discovery and Science, 401 SW Second St., Fort Lauderdale. Admission is free to museum members; nonmember tickets cost $16 to $19.

In an effort to face our nations growing health crisis, curb the opioid epidemic, and deal with mental health issues, Integrative Medicine US and Lost Legacy Martial Arts will host their second-annual Integrative Health Expo and Legacy Kung Fu Tournament this Saturday and Sunday. The goal is to engage the community in exercise, mindfulness, andlifestyle and dietary changes aspreventative healthcare. The free event will include classes forbeginners on tai chi, qi gong, yoga, boot camp fitness, break dancing, and stationary surfing, as well as exhibitors providing information about and treatments in acupuncture, chiropractic, massage, dentistry, CBD, and more. For details, visit integrativemedicine.us or lostlegacysystems.com. 9 a.m. to 5 p.m. Saturday, November 16, and Sunday, November 17, at Coral Springs City Gym, 2501 Coral Springs Dr., Coral Springs. Admission free.

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The Seven Best Things to Do in South Florida This Weekend - New Times Broward-Palm Beach

Deepak Chopra is one of the most influential integrative medicine and meditation experts in the world. However, he wasnt always the epitome of calm. Early in his medical career, as a resident, Chopra turned to smoking and alcohol to combat the stress he was feeling. But noticing that these habits werent working, on an impulse, he decided to change the course of his life. I was very busy taking care of patients. I wanted them to feel better, but I couldnt give them any advice because of my own situation, he tells Thrive. So I decided to be the change I was seeking in others. I started getting good sleep, cultivating healthy emotions like compassion, joy, kindness, and peace, changed my diet to a more plant-based diverse diet, exercised, and started yoga.

This was over 50 years ago. Since then, Chopra has written over 85 books, founded The Chopra Foundation and Chopra Global, serves as a Clinical Professor of Medicine at the University of California in San Diego, and hosts the podcast Deepak Chopras Infinite Potential. TIME has described him as one of the top 100 heroes and icons of the century.

Chopra sits down with Thrive to discuss his latest book, Metahuman: Unleashing Your Infinite Potential, how you can be present anywhere, how to handle criticism, and his advice for managing your relationship with technology.

Thrive Global: What is your morning routine?

Deepak Chopra: I wake up anywhere between 4:00 to 6:00 in the morning, depending on what time I go to sleep, but I get eight hours of sleep every night. Then I do about two hours of a combination of meditation, reflection, breathing, yoga, and I set my intentions for the day, which are always the same joyful, energetic body, love and compassion in the heart, reflective alert mind, and lightness of being. Then, I just do what needs to be done.

TG: For someone who wants to start meditating, what are your tips to begin the practice?

DC: Meditation simply means going beyond the conditioned mind or thought. You can be in that state any moment by being fully aware of any experience, like attending to your breath, to a thought, to a sensation in the body, to an image in the mind, or to using a mantra. So if you want to be in that space right now, close your eyes and ask yourself, I wonder what my next thought is going to be. And there is silence. Thats meditation. You can be in that state all the time.

TG: Often, people are hesitant resistant, really to change. What advice would you give to someone to embrace change?

DC: I think one can be stuck in a rut and a routine because of the addiction to security. Actually, the addiction to security is the biggest cause of insecurity. We dont live in the past. The past is the known. We live in the present that actually creates the future. So if youre not present to experience right now if youre not enjoying experience right this moment, because youre constantly thinking of the future then when the future arrives, even the future that you want, you wont be present for it. The key to actually creating a more meaningful life, a life of purpose, and ultimately a life of success, is to know that we live, breathe, and move in the unknown. Take a risk, otherwise youll be a victim of the past. If you want to be a pioneer of the future, take a little risk.

TG: You have written over 90 books, which is remarkable. What inspires you to come up with new material and new ways of sharing your experience?

DC: My training. Im a physician. My career has evolved from being an internist to being an endocrinologist to a neuroendocrinologist, to somebody interested in mind-body medicine, which then evolved to integrative medicine. Now, Im going a little bit beyond that, into a deeper understanding of what is fundamental reality. We think that reality is this body, this mind, and this world, but actually, theres a more fundamental reality beyond the conditioned mind. I am obsessed with what the wisdom traditions call higher states of consciousness. So every book that I write is actually just a little step further than the previous book, because I think of evolution as a spiral staircase. When I write books, I dont actually think about who Im writing for, or who the exact audience is. Im sharing my own evolution as it has occurred over the last 50 years.

TG: Are there any principles that have really remained steadfast from book one to book 90?

DC: The main principle that has stood through the whole range of books that Ive written, numbers one through 90, is healing. The word healing comes from the word wholeness, which means all-inclusive mind, body, spirit, environment, personal relationships, social interactions, work, well-being, social well-being, community well-being, financial well-being, physical well-being, emotional well-being, and spiritual well-being. Theres a lot to cover, but it all has to do with healing.

TG: With so many distractions around, whats the best way to quiet the noise?

DC: You can quiet your internal dialogue just by being present in the moment to any sensory experience. Right now, even with your eyes open, just be aware of sound, without labeling it, or be aware of your breath, or be aware of the sensations in your body, or simply ask yourself, Am I present? We are distracted by experience without ever being aware of who or what is having the experience.

TG: What is your relationship with technology?

DC: I believe technology is neutral. Technology can destroy the world, but technology today can also help us in rewiring. The internet is the global brain. Everything about the human condition is there. When we personally evolve in the direction of joy, empathy, and compassion, and we share our spiritual practice with others, then we create a sangha. A sangha is a community. Today, with technology, I personally have a sangha, or a community, of 15 million people and its growing. If we keep doing that, then technology becomes a divine tool to create joy and healing. You use technology, dont allow it to use you. Its that simple.

TG: How do you handle criticism?

DC: Social media is a reflection of who we are, collectively, just like the world is a mirror of who we are collectively. So if you really want to make a difference in the world, then you have to be independent of both the criticism and the flattery you get from people who engage with you. If somebody flatters me, I just acknowledge them with a thank you, but internally, it doesnt make a difference. If somebody criticizes me, sometimes I also acknowledge them with a thank you, but internally Im independent of both. If youre dependent on other peoples opinions of yourself, then be prepared to be offended for the rest of your life.

TG: What is your evening routine?

DC: I stop working at around 5:00. I engage with friends and family for a little bit. Usually I also go for a little walk, eat a very light meal before sunset, and ideally go to bed before 10:00 in a totally dark room with total silence and no technology.

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Deepak Chopra On Finding Calm Anywhere You Are - Thrive Global

Deepak Chopra, Special to SFGate

By Deepak Chopra, MD

It would be ideal if reality and our model of reality merged into the same thing. A model of reality explains how the universe was created and how it operates. You might think that this is a definition of reality itself, but it isnt, which can be illustrated by looking at the most popular model, known as nave realism.

In a nutshell, nave realism says that what you see is what you get. In other words, the reality presented by the five senses is reliable. Such a view appeals to common sense. It rests on experiences we take for granted. There is a physical world out there separate from our subjective experience in here. The physical world predates human beings by 13.8 billion years, going back to the Big Bang. If both of those things are true, then obviously what we think, feel, and desire in here has no effect on reality out there.

As unimaginably sophisticated as modern science has become, most scientists accept nave realism, usually without question, even though each of the common-sense facts just mentioned is known to be false.

Leave aside the obvious ways we cannot trust our five senses, which tell us mistakenly that the sun rises in the East, that a thunderclap happens after a flash of lightning, and that there could be no such things as small as bacteria and viruses, since they are invisible to our eyesight. Nave realism is wrong at a much deeper level, which has been grappled with by the most eminent physicists. It is wrong about mind; it cannot connect mind and brain; it has nothing to tell us about the origins of space, time, matter, and energy it is contradicted by the strange behavior of the quantum field; and it has no chance of linking the microscopic world with the macroscopic worldin other words, the so-called building blocks of reality live in a separate, totally closed-off domain from everyday reality.

These multiple failures are widely known among physicists but just as widely ignored. A great deal of science and most of technology can advance without a theoretical model of reality. Before he died Stephen Hawking published a book, The Grand Design, in which he conceded the high probability that scientific models will not succeed in matching the reality they are supposed to describe.

If science rolls along without a viable model of reality, that lack isnt incidental. We celebrate Galileo, Copernicus, Newton, and Einstein for getting something right, not simply for issuing metaphysical suppositions. So it is important to get things right now. If the present model of reality is, in fact, an abstruse collection of mathematical formulas suspended in a theoretical mathematical space, clearly something is amiss. In medieval times the world had to conform to divine law; now it must conform to mathematical law, yet the fallacy remains the same.

There is a way out. First, we acknowledge a simple truth: Models are right about what they include and wrong about what they exclude. Nave realism is dead wrong about consciousness because it excludes mind in favor of physical explanations. Secondly, we must accept that reality cannot be modeled. The whole enterprise of reducing the physical world into tinier and tinier building blocks has reached its useful limit. Leading theorists suggest that quarks and superstrings might not actually exist. More to the point, we live with space, time, matter, and energy and yet have no origins story for where any of them came from.

Without a model, whats left? Still standing is the one thing that permeates reality, brings the five senses to life, allows thoughts to arise in our heads, gives the world color and form, and tells us that we are alive: consciousness. The very thing that nave realism leaves out is the thing that holds all the answers.

There was a lamentable decline after the earliest decades of the quantum revolution, when all the greatest physicists tackled the problem of mind. In place of great thinkers physics turned to number crunching and atom smashing, which remains its chief occupation, now on a billion-dollar scale. There were exceptions like John von Neumann, John Archibald Wheeler, and David Bohm, who continued the search for a link between mind and matter.

Respected but sidelined in favor of bigger particle accelerators and telescopes, all of these thinkers now enjoy a latter-day revenge, so to speak. Having exhausted the models of reality that discounted and ignored consciousness, forward-looking physicists now realize that mind must be accounted for, which seems like a simple realization except that it was clouded behind a screen, the biggest factor being nave realism. Satisfied with the common-sense view of reality in their everyday life, physicists were happy to think of mind as not my job.

A huge hurdle remains, however, which is the enormous seduction of physical explanations. What is science without them? What is life if we get rid of relying on the five senses? These arent rhetorical questions. Life would be transformed if we abandoned the lure of the physical world and the mistaken data of the five senses. The human mind is uniquely able to go beyond appearances, and when we do, the destination is always consciousness. Theres no need to call it higher consciousness. A better term is total consciousness, the ground state of everything in existence.

Account for consciousness and you explain everything. No models are needed. The everyday mind is the arena of consciousness. Stick with it, experience it deeply, and be self-aware. Only then will reality be fully comprehended, absent any model at all.

DEEPAK CHOPRA MD, FACP, founder of The Chopra Foundation, a non-profit entity for research on well-being and humanitarianism, and Chopra Global, a modern-day health company at the intersection of science and spirituality, is a world-renowned pioneer in integrative medicine and personal transformation. He is a Clinical Professor of Family Medicine and Public Health at the University of California, San Diego. Chopra is the author of over 89 books translated into over forty-three languages, including numerous New York Times bestsellers. His 90th book and national bestseller, Metahuman: Unleashing Your Infinite Potential (Harmony Books), unlocks the secrets to moving beyond our present limitations to access a field of infinite possibilities. TIME magazine has described Dr. Chopra as one of the top 100 heroes and icons of the century.

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The Most Popular Model of Reality Is Wrong - SFGate

Mayor Chris Cheshire

For the second year in a row, former mayor Chris Bell voted against having Chris Cheshire lead the City Commission.

Cheshire was selected by the majority of his fellow commissioners on Thursday night to serve a fourth year as the citys mayor. Vice Mayor John Gunter, who has been on the commission for 25 years, also was reappointed and said he was honored to serve because it might be his last term on the commission.

Bell, who also has served on the commission for 25 years and was a longtime mayor until redistricting took place in 2014 because of the expansion of The Villages into the city, said he voted against Cheshire again this year because the commissioners are supposed to take turns serving as mayor.

Its nothing against our current mayor, Bell said. I talked to quite a few people and assured them that the mayor was going to be selected on a rotating basis. So sooner or later, their district would actually be represented by the mayor.

For his part, Cheshire said hes honored to serve a fourth year as mayor and will continue to push for continued growth, commercial expansion and lower taxes. He said he believes there are plenty of opportunities ahead for the city, which can prosper with the correct kind of growth.

Im happy to continue serving the citizens of Fruitland Park and continue the way the city has been running, Cheshire said. Hopefully, were going to catch up with the growth and keep going. Its a good streak and I want to make sure it continues.

Cheshire is a longtime advocate of transparency in government and has been at the helm of the commission as it put the citys checkered past behind it. Those past issues included costly lawsuits, accusations of corruption and police officers with alleged ties to the Ku Klux Klan, among other things.

The city is looked upon a lot more highly than it was five, eight years ago, said Cheshire, who was first elected in 2012. For the police department, for the fire department and for the city in general, the level of respect is just much higher.

Cheshire, a doctor of Oriental Medicine who owns Mulberry Integrative Medicine and Faeve Plant Therapies in The Villages along with his wife, Meredith, also led the commission through tumultuous budget hearings in 2018 that saw large crowds of Villagers raise issues about how the city was spending money, especially when it came to the millage rate and the budget for the new library. At two different meetings in September 2018, Cheshire spent quite a bit of time educating the audience on the citys budget and why decisions were being made.

This past July, Cheshire oversaw the grand opening of the $3 million, 12,000-square-foot library as a large crowd gathered for the official ribbon-cutting ceremony. He said that having such an outstanding library facility would make the city an even more desirable choice for families moving to the area. And he expressed thanks to everyone who came out to welcome the new library to the city.

As vice mayor in December 2014, Cheshire unveiled an aggressive agenda for the coming year in a speech that took some commissioners by surprise. In that meeting, he made it clear that his priorities would center on the County Road 466A corridor, the citys inadequate sewer treatment system, upgrading the volunteer fire department to professional status, improving public works, making changes in the police department as it geared up to provide protection in The Villages portion of the city, upgrading recreation facilities and programs to attract more working families and improving the citys code enforcement efforts.

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Ex-mayor votes against Cheshire's reappointment as mayor of Fruitland Park - Villages-News

MINNEAPOLIS--(BUSINESS WIRE)--For Hennepin Healthcare, breaking ground on the Redleaf Center for Family Healing means healing and hope are just ahead for Twin Cities' moms, babies and families.

About 1 in 7 mothers experience depression and anxiety during and after pregnancy, according to Dr. Helen Kim, medical director for the Mother-Baby Program and co-founder of the Redleaf Center. Without treatment, the impact on a mothers mental health can be devastating and sometimes fatal. It can affect the entire family including future generations.

The Redleaf Center will expand on the space and services of Hennepin Healthcares Mother-Baby Program. The program is Minnesotas first intensive mental health program for pregnant and postpartum moms.

The Redleaf Center will support families through services that nurture the mind, body and spirit from comprehensive mental health and relationship support to on-site childcare, integrative medicine, a teaching kitchen, gathering space and more.

When a new mother is dealing with severe depression or anxiety at this critical time in her babys physical, emotional and cognitive development she may be unable to provide the care and attention her infant needs, said Kim. Thats why the Redleaf Center is so vital for childrens and families' well-being.

Todays groundbreaking ceremony drew leaders from health care, the community and local government, including Hennepin County Commissioner Marion Greene, District 3. Families who have benefited from the Mother-Baby Program also attended the ceremony.

The Center is a $30 million endeavor initiated by a $10 million donation from the Lynne & Andrew Redleaf Foundation. The ceremony took a moment to publicly announce a new gift of $2.25 million from the Pohlad family. Allie Pohlad, a member of the Pohlad family was in attendance.

The Redleaf Center is at the heart of Hennepin Healthcares investment in the health of our community, and it is only possible because of our donors' transformational gifts, said Theresa Pesch, president of Hennepin Healthcare Foundation.

Their compassionate and visionary philanthropy means that more moms across the Twin Cities will get the support they need to raise strong families. And we all know that strong families are the bedrock of strong communities.

The groundbreaking took place on Hennepin Healthcares Minneapolis campus, at the future site of the new 9,000-square-foot facility. It will be connected to Hennepin Healthcares HCMC Purple Building on the corner of Chicago Avenue and Sixth Street.

We see all kinds of moms from across the Twin Cities struggling to cope, added Kim. Treatment and care make a dramatic difference in the way they are able to connect with and care for their infants and themselves. It is absolutely lifechanging, said Kim. And soon we will be able to help many more families grow stronger together with the service and treatments they need.

Redleaf Center building construction is expected to be completed in November of 2020.

About Hennepin Healthcare FoundationThe Hennepin Healthcare Foundation guides those in the community who wish to support the mission of Hennepin Healthcare to provide outstanding care for everyone, while improving health and wellness through teaching, patient and community education, and research.

About Hennepin HealthcareHennepin Healthcare is an integrated system of care that includes HCMC, a nationally recognized Level I Adult Trauma Center and Level I Pediatric Trauma Center and acute care hospital, as well as a clinic system with primary care clinics located in Minneapolis and across Hennepin County.

IMAGES/RENDERINGS/B-ROLL at hcmcnews.org

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Hennepin Healthcare Breaks Ground on Healing Center for Expectant and New Moms with Depression, Anxiety - Business Wire

Three scientists, along with their colleagues, seem to have made a pioneering discovery able to change the very definition of life expectancy and the concept of age. No, they didn't devise an elixir able to turn humanity into immortal Elves butthey did finda super-strong presence of a very rare kind of T-helper (immune) cells in the blood of people known as 'supercentenarians' (aged 110 and up). It appears very likely that the secret of those folks' longevity lies in the shield these shells form against cancer, viruses and the like, keeping their owners in excellent health their whole lives

The authors of the research Nobuyoshi Hirose (Centre for Supercentenarian Medical Research, Keio University School of Medicine, Tokyo),Kosuke HashimotoandPiero Carninci (both of Riken Center for Integrative Medical Sciences) wrote toLive Science:'The key will be to understand what is their [these cells'] natural target which may help to reveal what is needed for a healthy, long life.'

The person officially recognized to have lived the longest was FrenchwomanJeanne Calment who passed away in 1997, aged 122.

The census held in Japanin 2015 registered 61,763 of 100-plus-year-old citizens, with only 146 of them having hit 110. In 2018, average life expectancy in the country was 81 year for men and 87, for women.

Hirose, Hashimoto and Carninciused full blood tests from seven supercentenarians, as well as test subjects aged from 50s to 80s, separating immune cells, and, with the help of the single-cell transcriptomics method, monitored the activity of each and every single immune cell, 'reading' the messenger RNA that hundreds of thousands genes created inside each cell, taking DNA's genetic instructions to the cell,where proteins form.

All in all, they got over 41,000 supercentenarian immune cells, and 20,000 from the other five.

According to the researchers, what made supercentenarian immune cells different is that they independently could attack and kill other cells.

The scientists emphasized that this was a very rare sort of cell, admitting to their own surprise. Normally, T helpers give orders to other immune cells, rather than fight. However, these T-helper cells, the CD4 CTLs, are cytotoxic, which means they can, and do, deal with enemies directly.

Interestingly, the group of 50-80 y.o.'s had a much lower concentration (2.8%) of such cells.

Compare to the 25% of super militant cells in supercentenarians - and you will understand why the report published on November 12 in Proceedings (the National Academy of Sciences journal) is sensational.

Does this mean that now scientists can just go ahead and mix up an elixir that will - if not make us ultimately immortal, then, at least - prolong our lives by decades? No. Not yet.

It's a big goal, and big goals need to start small. The researchers have already tried experiments on mice, and seen cytotoxic T cells go for viruses and cancers. Will they be able to observe the same in people?

The collaborators admit they hold their hopes high for learning all about why some people live past 110.

They say the answer may be 'some cancer antigens or some virus protein, but these are all speculations right now.'

The work is in progress. Let's just do our best to stay healthy and wait for the further, hopefully even more baffling, results of this promising research.

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Scientists Have the Key to Living Past 110, and They Aren't Letting it Slip - Asgardia Space News

As the official medical partner of the Chicago Red Stars for the last five seasons, IBJI has become more than just a supporter--we have developed a very close and integrated relationship with the team.

"With every win and loss the Red Stars encounter, IBJI is there by their side through the highs and lows," stated Matt Repa, IBJI Sports Medicine Business Development. "But this year was really something special, the teamwork and energy they've shown throughout the finals is a testament to the high level of commitment and dedication these athletes have."

Just as winning teams are developed over the course of many seasons, in 2019, IBJI expanded the care services offered to the Red Stars to strengthen and promote a playoff-ready lineup. Our goal, throughout the season, was to support the team in all areas and be a comprehensive sports medicine provider. The strength of IBJI lies in the "total package," which is a group of seven, led by medical director Roger Chams, MD, a board-certified orthopedic surgeon; primary care sports medicine physician Angelo Savino, MD; physician assistant Molly Uyenishi, PA-C, MSMS; sports neurologist Anthony Savino, MD; head physical therapist Bria Wanzung, PT, DPT, ATC; high performance director Megan Young, PhDc, CSCS, USA-SPC, and head athletic trainer Megan Blackburn, ATC.

High performance director Megan Young, PhDc, CSCS, USA-SP, joined the group this year to contribute her expertise in strength and conditioning.

"In my first year with the club, it was a privilege to provide data-driven context around training and match demand for the coaching staff and individual athletes. Working on the performance side with some of the most elite footballers in the world; to assist and support them in physical training and development was a joy. These players, staff and club have a passion for the game and bringing home championships," Young said in regards to working with the Red Stars.

Medical director Roger Chams, MD, said, "It has been an honor and a privilege to take care of such incredible, dedicated athletes and phenomenal women role models. [The team] definitely put up a great fight! I am proud of everyone."

Integrative care and collaborative partnerships are important for any team to be successful. In IBJI's position, we have collaborative care, top to bottom. The players don't have to go out to different resources for everything--they have it all in-house. That allows the athlete to feel secure in communication and the collaboration of care.

General Manager of IBJI's Health Performance Institute, Cory Leman, MS, CSCS, states, "We've worked diligently to develop a model that not only improves athlete performance but also strives to reduce and treat injuries with cutting edge science. We take pride in helping to produce not only powerful athletes, but athletes that are marked by longevity and health."

We look forward to assisting in the health and training for the Chicago Red Stars, so that they can come back even stronger next season! IBJI also thanks Sam Kerr for her contributions to the team. We wish her the best of luck in her future endeavors! Learn more about our sponsorship with the Chicago Red Stars at ibji.com.

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IBJI Stands by Chicago Red Stars Through Their First Championship Game and Wishes Sam Kerr Luck - Chicago Daily Herald

Yoga will eventually improve your flexibility, but you need to do it frequently to make a differenceGETTY IMAGES

1. Strengthen rather than stretch musclesPhysiotherapists say there are better things than stretching to improve muscle flexibility. Im not a huge fan of stretching, says Tom Goom, a physiotherapist and spokesman for the Chartered Society of Physiotherapy. Its actually not massively effective for lasting improvements in flexibility.

A far better route to better flexibility is through eccentric loading, or strengthening muscles when they are in a lengthened position and against a resistance, which often means using weights. Think of your muscles as a spring that needs to be able to store and release energy to move efficiently, Goom says. To do this muscles need a certain amount of stiffness and while prolonged stretching will temporarily increase the length of a muscle, its not a lasting

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Three ways to get more flexible | Times2 - The Times

Homemade sweets: Sugar is definitely bad for your health. But there's always scope for portion control and moderation. Diabetes, obesity, inflammation and high cholesterol are all conditions caused by a multiple factors, and not just sugar intake. Even if you want to lose weight, a little sugar in your diet will not harm your health. This stands true for diabetics as well.Highlighting the same is lifestyle coach Luke Coutinho on Facebook. In his live video, he talks about homemade Indian sweets as compared to commercially prepared sweets and desserts, and why the former is a clear winner.

Celebrity nutritionist Rujuta Diwekar is of the belief that you should eat homemade traditional sweets, especially during festivals. It is a way to bring families together and should be looked at as an opportunity to share culture with the younger generation. Laddoos, barfis, chikki, and multiple other sweets can be prepared at home with wholesome and nourishing ingredients that are not going to affect your weight or your health.

It is better to have homemade sweets rather than chocolates or fancy dessertsPhoto Credit: iStock

When you cook sweets, or any other food at home, it gives you complete control over what you are going to put in it. Ghee, jaggery, besan, nuts, sesame seeds, cardamom, cinnamon and a variety of other spices go in making Indian sweets. We have discussed health benefits of these ingredients at length previously.

Also read:People With Diabetes, Sugarcane Juice Can Be Your Best Friend: Here's Why

In one of her recent posts featuring kada prasad on the occasion of Gurupurab 2019, Rujuta informs that going gluten-free can increase risk of chronic inflammation, type-2 diabetes with obesity. Well, these aren't these the exact same condition you avoided gluten in the first place?

Kada Prasad on #GuruPurab If we go by the food and weight loss industry, Kada Prasad shouldn't exist. At various points in your life you must have come across the gluten-free, dairy-free, low-fat and sugar is poison trends. The food industry was always ready with alternatives though, profits over people is their motto after all. But Kada Prasad is still here and will continue to always be. Just like Guru Nanak and the essence of his teachings staying strong and true to your beliefs against all odds and leading a label-free life. Science as usual has come around, it may be a few steps behind common sense and time tested wisdom, but it always catches up. This is what we know in 2019 - - going gluten-free led to increased risk to chronic inflammation, type-2 Diabetes along with obesity (diabesity), the exact same conditions for which you avoided it in the first place. - avoiding ghee led to an epidemic of Vitamin D deficiency amongst many other issues. - avoiding sugar made from cane led to increased consumption of artificial sweeteners and the associated illnesses. Hopefully, we will listen to our inner voice, give up looking for health in packets, hashtags and labels and embrace a life of eating and cooking according to the region, season and tradition. #GuruNanakJayanti #Kadaprasad

A post shared by Rujuta Diwekar (@rujuta.diwekar) on Nov 12, 2019 at 3:35am PST

She goes on to add that removing ghee from your diet can lead to Vitamin D deficiency. Ghee contains fats that are essential for fat-soluble vitamins A, D, E and K. Assimilation of these vitamins in the body happen only in the presence of good fats in ghee, coconut oil, olive oil, etc.

Ghee includes fats that can promote assimilation of Vitamins A, D, E and KPhoto Credit: iStock

Also read:The Truth About Fats And Why They Are Extremely Important For You

Furthermore, if you go completely off sugar, then it can increase cravings and make you switch to artificial sweeteners-which come with their share of side effects and health risks.

The idea is to understand the importance of eating according to your location, culture and tradition for a healthy weight, blood sugar levels, digestion and much more.

Thus, you can have homemade sweets made with natural ingredients used in the right quantity, while practice portion control. This is including diabetes patients, people who are obese and those looking forward to lose weight.

If you are having commercially prepared sweets, chocolates and desserts, make sure they are prepared with minimum ingredients, suggests Luke.

Also read:Attention Diabetics! These Superfoods Are A Must For You To Control Your Blood Sugars Easily And Effectively

(Luke Coutinho, Holistic Lifestyle Coach - Integrative Medicine)

(Rujuta Diwekar is a nutritionist based in Mumbai)

Disclaimer: This content including advice provides generic information only. It is in no way a substitute for qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.

Get Breaking news, live coverage, and Latest News from India and around the world on NDTV.com. Catch all the Live TV action on NDTV 24x7 and NDTV India. Like us on Facebook or follow us on Twitter and Instagram for latest news and live news updates.

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Homemade Sweets: Here's Why You Must Eat Them Without Worrying About Weight Gain Or Diabetes - NDTV News

Gene therapy is an emerging field and industry is yet to work out how best to manufacture these life-saving products says expert. Interest in gene therapy is growing, says Andrew Powaleny, public affairs director at the Pharmaceutical Research and Manufacturers of America (PhRMA).

As of December 2018, the last time we did our analysis, there were 289 cell and gene therapies in development either in clinical trials or awaiting FDA approval, he adds.

And the interest is understandable. Gene therapies let doctors treat the root causes of disease, potentially curing patients. Also judging by products like Zynteglo and Zolgensma, which cost $1.7m and $2.1m, respectively, gene therapies will generate significant revenue for firms able to commercialize them successfully.

But manufacturing a gene therapy remains a complex technical challenge. Just ask Zynteglo developer, Bluebird Bio.

Zynteglo is designed to treat patients with transfusion-dependent -thalassemia (TDT). Development has not always been smooth. For example, in 2017 Bluebird announced it had made manufacturing process improvements for Zynteglo after the product disappointed in an earlier trial. However, in June this year it appeared Bluebird had turned things around when the EMA granted Zynteglo conditional clearance. But, in the approval presentation Bluebird announced it would not be able to launch the product until 2020.

Bluebird explained the delay was to allow it to work with the EMA to finalize commercial drug product specifications and manufacturing parameters. The situation changed again last month. The EMA accepted refined commercial drug product manufacturing specifications for Zynteglo. And Bluebird now expects the therapy to launch this year.

Similarly, Novartis, owner of the spinal muscular atrophy therapy Zolgensma, has encountered manufacturing issues. In October the firm said the EMA and Japans PMDA had extended their assessments of Zolgensma and asked for more CMC information.

Bluebird and Novartis travails are the high-profile examples, but the wider gene therapy sector faces manufacturing challenges according to Ashleigh Wake, laboratory director, Intertek Pharma Services Manchester.

Given the newness of medicines of this type there is limited historic information available on which to build strategy and as such adds extra uncertainty to any regulatory submission, says Wake. When considering how to build an effective CMC for a gene therapy IND, selection of critical assays will depend on the specific product but may include assays for concentration, purity such as determination of residual cellular DNA or empty viral particles, identity, activity, potency and stability.

Understanding which tests are critical to determining product quality is a key part of winning approval, continues Wake. From a regulatory perspective, an understanding of the critical quality attributes (CQAs) which impact product safety, purity, and potency are required. For gene therapy products this means developing and validating analytical assays to assess, vector productivity, vector purity, biological activity and safety.

With this in mind Intertek recently announced plans to expand its service center in Manchester in the UK.

Our expansion in laboratory footprint and recruitment of specialists in gene therapy analytics coupled with our integrated approach to analytical method lifecycle will mean we can develop methods which are best suited for the intended use at the various clinical stages on the way to commercialization, he points out.

The challenges will keep coming, according to Wake. She says therapies that use viral vectors will increase demand for quality control expertise and analytical technology.The inherent complexity of viral vector-based products makes physical and biological characterization highly challenging, she explains, citing the ability to differentiate between full capsids and empty ones as an example. In order to provide a complete quality control package, a range of analytical methods and technology are required, which incorporate instrumentation such as cryoelectron microscopy, qPCR or DDPCR which are not commonly associated with pharmaceutical quality control, in addition to techniques such as HPLC or analytical ultracentrifugation.

See more here:
Gene Therapy Production and Quality Control - Genetic Engineering & Biotechnology News

NEW YORK, Nov. 18, 2019 /PRNewswire/ --

The global cell and gene therapy market is growing at a CAGR of over 24% during the forecast period 20182024.

Read the full report: https://www.reportlinker.com/p05827567/?utm_source=PRN

The major drivers contributing to the growth of the global cell and gene therapy market are the growing incidence of several chronic and terminal diseases, including cancer, the launch of new products, the increasing availability in clinical evidences of these products in terms of safety and efficacy, the rapid adoption of CAR T-cell therapy, favorable regulatory support in the development of these treatment, and improved manufacturing expertise in these products.

The following factors are likely to contribute to the growth of the cell and gene therapy market during the forecast period: Increased Pool of Patient Population with Several Ailments Favorable Regulatory Support and Increasing Special Designations for Cell and Gene Therapy Products Growing Demand for CAR T-cell Therapy Products Increasing Strategic Acquisition Activities

The study considers the present scenario of the cell and gene therapy market and its market dynamics for the period 2018?2024. It covers a detailed overview of several market growth enablers, restraints, and trends. The study covers both the demand and supply aspects of the market. The report profiles and examines leading companies and other prominent companies operating in the market.

Cell and Gene Therapy Market: Segmentation

This research report includes detailed market segmentation by product, application, end-user, and geography. The global cell therapy market is growing at a steady rate, and this trend is expected to continue during the forecast period due to the increased patient base with a wide range of diseases/ailments. The segment is likely to witness upward growth on account of expanded expertise in the manufacturing of stem cell-based products.

The gene therapy segment is expected to witness faster growth as the penetration of these products is increasing at a significant rate, especially in developed economies. The market is expected to grow during the forecast period due to the increased patient base for the existing gene remedy products, expected the launch of other gene therapy-based products for several indications, and expanded indication approvals for existing commercially available products.

The oncology segment accounts for the highest share of the global market. The growth of the oncology segment is increasing at a fast rate on account of the growing prevalence of several types of cancers. Currently, the available products not only modify the disease but also improve the quality of the patient's life, thereby decreasing the mortality rate. The market in the dermatology segment is increasing at a steady rate. This segment owns its growth to the increasing incidence and prevalence rate of several types of wounds, which are difficult to treat under normal conditions and the launch of innovative products. The dermatology segment is likely to showcase growth due to the high product availability of wound care products in the market.Hospitals are the leading end-user segment. The segment is growing mainly due to the increasing incidence/prevalence of chronic diseases such as cancer, cardiovascular diseases, diabetes, and chronic wound on account of diabetes feet, pressure ulcers, and other injuries.

Market Segmentation by Products Cell Therapy Gene TherapyMarket Segmentation by Distribution Channel Type Oncology Dermatology Musculoskeletal OthersMarket Segmentation by End-users Hospitals Wound Care Centers Cancer Care Centers Ambulatory Surgical Centers Others

Geographical Insights

The US market dominates the cell and gene therapy market in North America due to the high prevalence of chronic diseases and other conditions, which require these treatment methods. There is also comparably high utilization and wide accessibility of these therapies. The oncology segment is likely to witness significant growth in North America.The market in Europe is expected to witness upward growth in the near future on account of the growing prevalence of chronic diseases and rising elderly population. In Europe, cell and gene therapy products are considered to be part of the Advanced Therapy Medicinal Products (ATMPs), which are commonly known as regenerative medicine globally.

Market Segmentation by Geography North Americao USo Canada APACo Japano Chinao South Koreao Australia Europeo Germanyo Franceo UKo Spaino Italy Latin Americao Brazilo Mexico MEAo Turkeyo Saudi Arabiao UAE

Key Vendor AnalysisThe global market is characterized by the presence of a few global, large-scale companies and several small to medium-scale companies offering one or two cell and gene therapy products. Global players are majorly offering innovative products with the potential of disease-modifying characteristics that are generating significant revenues, especially in Europe and US regions. Most innovative and breakthrough products are approved in the European countries and the US. Vendors are targeting mostly developed economies such as the US, Germany, France, the UK, Spain, and Japan as the uptake of these products is higher in these countries than low and middle-income countries. However, the market in these regions is at the nascent stage.

Key Vendors Gilead Sciences Spark Therapeutics Novartis AG Organogenesis Amgen Osiris Therapeutics Dendreon Vericel

Other Prominent Vendors Anterogen Tego Sciences Japan Tissue Engineering JCR Pharmaceuticals Medipost MolMed AVITA Medical CollPlant Corestem Biosolution Stempeutics Research Orchard Therapeutics Takeda Pharmaceutical Company CHIESI Farmaceutici CO.DON AnGes GC Pharma JW CreaGene APAC Biotech Nipro Corp. Terumo Orthocell bluebird bio

Key Market InsightsThe report provides the following insights into the market for the forecast period 20192024. Offers sizing and growth prospects of the market for the forecast period 20192024. Provides comprehensive insights on the latest industry trends, forecast, and growth drivers in the market. Includes a detailed analysis of growth drivers, challenges, and investment opportunities. Delivers a complete overview of segments and the regional outlook of the market. Offers an exhaustive summary of the vendor landscape, competitive analysis, and key strategies to gain a competitive advantage.

Read the full report: https://www.reportlinker.com/p05827567/?utm_source=PRN

About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

__________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001

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The global cell and gene therapy market is growing at a CAGR of over 24% during the forecast period 2018-2024 - Yahoo Finance

The Food and Drug Administration has halted a clinical trial involving a Duchenne muscular dystrophy gene therapy from Solid Biosciences (SLDB) after a patient suffered serious kidney and blood-related injuries, the company said Tuesday.

This is the third time that the Cambridge, Mass.-based Solid has run into a serious safety problem with its gene therapy, called SGT-001. The FDA placed similar clinical holds on the same clinical trial after each prior incident, but later allowed the company to proceed with patient dosing.

SGT-001 uses an inactivated virus to deliver a miniaturized but functional version of the dystrophin gene to muscle cells. The gene therapy is designed to be a one-time and potentially curative treatment for all Duchenne patients, regardless of the mutation that causes their disease.

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Sarepta Therapeutics (SRPT) and Pfizer (PFE) are also developing their own gene therapies targeted at Duchenne.

Six patients have been dosed with SGT-001, starting with three at a lower dose; interim results in those patients were previously reported and found to be disappointing. Three more patients were then treated at a higher dose of SGT-001.

The sixth patient became ill soon after being treated in October, experiencing an over-activation of the immune system, an acute kidney injury, reductions in platelets and red blood cells, and cardio-pulmonary insufficiency, Solid said.

All of the toxicities were deemed related to SGT-001 by the patients treating doctor. The patient is being treated and is recovering, Solid said.

Solid reported the patients status to the FDA, which then placed the clinical trial on hold. In a statement, the company said it will work with the FDA in an effort to resolve the hold and determine next steps for the clinical trial.

Pfizers Duchenne gene therapy has also been tied to similar immune system over-activation and related kidney toxicity, although its clinical trial remains active.

See the article here:
Solid's Duchenne gene therapy trial halted after patient suffers toxicity - STAT

18 November 2019

A gene therapytrial for Duchenne muscular dystrophy (DMD) has been halted after a patient experienced serious side effects.

The clinical trial, run by the US life science company, Solid Biosciences, was put on hold by the FDA (Food and Drug Administration)after the patient had an adverse reaction in response to the experimental gene therapy, called SGT-001. The symptoms included a decrease in red blood cell count, acute kidney injury, over-activation of the immune system and reduced heart and lung function.

'We are encouraged that this patient is recovering,' said Ilan Ganot, chief executive officer and co-founder of Solid Biosciences in Cambridge, Massachusetts. 'In the coming weeks, we anticipate that we will have a better understanding of the biological activity and potential benefit of SGT-001.'

DMD is a severemuscle-wasting disease that affects around one in every 3500 newborn boys. The disease is caused by a mutation in the gene responsible for making an essential muscle protein, called dystrophin. The resulting deficiency or absence of dystrophin leads to a progressive decline in muscle strength. There is currently no cure for the disease.

To date, six patients in the IGNITE DMD clinical trial, taking place at the University of Florida, have received a one-off intravenous infusion of SGT-001. The treatment is an adeno-associated virus (AAV)-based gene therapy, in which an inactivated virus is designed to deliver a synthetic, functional form of dystrophin, called microdystrophin, to muscles.

The first three patients, aged between fourand 17 years, were given the lowest dose outlined in the study protocol. A second cohort of three patients subsequently received a higher dose, which was believed to have led to the adverse reaction reported to the FDA.

The trial waspreviously halted in March 2018, after a patient receiving the low dose of the therapy experienced a similar reaction, from which he later recovered. The trial was resumed in June of the same year after the study design was amended.

Solid Biosciences have reported that all five other patients dosed in the trial are doing well and continue to be examined. They added that they will work with the FDA to determine the next steps for the trial, including how best to manage administration of the therapy.

'We remain committed to bringing meaningful new therapies to the Duchenne community and continue to believe in the differentiated construct of SGT-001 and the potential benefits it may offer to patients,' Ganot said.

Visit link:
Duchenne gene therapy trial halted after serious reaction - BioNews

Tokyo-based FUJIFILM will invest 13 billion yen (about $120 million) to expand the companys gene therapy business and establish anew Gene Therapy Innovation Center adjacent to its current facility in College Station, Texas and add about 100 jobs.

The investment will include the addition of dedicated gene therapy laboratories and will be part of the existing FUJIFILM Diosynth Biotechnologies (FDB) in Texas, which opened last year. That site has been the companys center for excellence in gene therapy since 2014. The company is expanding its contract and development services for gene therapies as the market for CDMOs in gene therapy is expected to increase to $1.7 billion by 2025, the company said in its announcement.

The Gene Therapy Innovation Center, supported by a $55 million investment, will be approximately 60,000 square feet and will house state-of-the-art upstream, downstream and analytical development technologies. The facility is expected to be operational in the fall of 2021. Gene Therapy remains a strategic investment area for FUJIFILM.

Gerry Farrell, COO at FUJIFILM Diosynth Biotechnologies in Texas, said they anticipate breaking ground on the new facility in the first quarter of 2020. The new Texas sit will triple the companys gene therapy development capabilities and will add approximately 100 jobs to its Texas campus, Farrell said.

Martin Meeson, president and chief operating officer of the U.S. division of FUJIFILM Diosynth Biotechnologies, said the investment will allow FUJIFILM to support the incredible growth that the gene therapy sector has experienced over the past few years.

We know that we need to invest now, in technology, assets and people in order to achieve a market leadership position. The expansion through the construction of the Gene Therapy Innovation Center demonstrates our ongoing commitment for growth, Meeson said in a statement.

FUJIFILMs main goal behind its new strategy is to position itself as a key provider of leading, future-proofed end-to-end gene therapy solutions, from pre-clinical to commercial launch. For the company, this investment builds on earlier plans to introduce its gene therapy fill finish services.

For FUJIFILM, this investment in Texas comes several months after it snapped up Biogens biologics manufacturing operations in Denmark. FUJIFILM paid the Cambridge, Mass.-based company $890 million for the site that had about 800 employees. The acquisition is part of the companys expanded manufacturing strategy. Last year, the company acquired two biotechnology units from JXTG Holdings Inc. for about $800 million.

More here:
FUJIFILM Expands Texas Holdings with New Gene Therapy Center - BioSpace

Dive Brief:

The companies identified Rett, Angelman and Dravet syndromes and Niemann-Pick disorder as the first four conditions that the new collaboration will try to treat. Four more could emerge, which would trigger an additional $42.5 million in additional payments.

Sarepta is paying the initial $48 million upfront fee in the form of combined cash and shares. StrideBio will be eligible for additional undisclosed development, regulatory and sales milestones, as well as royalties. The privately-held partner also will have an option to co-commercialization rights to one of the gene therapies, if successful.

The four StrideBio agents will join a Sarepta pipeline that already has 23 identified projects in clinical or pre-clinical development.

Cambridge, Massaschusetts-based Sarepta stated the collaboration will utilize StrideBio's "unique approach" to engineering capsids, the shells surrounding the adeno-associated virus (AAV) used by many researchers to deliver genes to cells.

StrideBio's technology tries to better target which cells their AAV-based therapies reach, as well as avoid triggering neutralizing antibodies, which can reduce the effectiveness of a gene therapy.

Immune responses to some AAV-based therapies have raised safety concerns. On Tuesday, Solid Biosciences announced the Food and Drug Administration had put a hold on its AAV9-based gene therapy for Duchenne muscular dystrophy (DMD) because of immune responses, although Sarepta's own DMD gene therapy has not seen anything similar.

As part of the agreement, Sarepta and StrideBio "plan to focus on strategies intended to address re-dosing challenges in patients who have received AAV-delivered gene therapy."

Re-treatment of patients who don't respond or have unlimited response to gene therapies is an unanswered question in this quickly evolving field, and drug developers and payers alike will closely watch any developments that emerge from the Sarepta-StrideBio re-dosing work.

More here:
Sarepta brings in more gene therapies with StrideBio deal - BioPharma Dive

GERMANTOWN, Md., Nov. 18, 2019 /PRNewswire/ --Triple-Gene LLC, a clinical stage cardiovascular gene therapy company and majority owned subsidiary of Intrexon Corporation (NASDAQ: XON), yesterday presented preliminary data from the Phase I trial (clinical trial identifier: NCT03409627) of INXN-4001, a multigenic investigational therapeutic candidate under evaluation for the treatment of heart failure, in a poster at the American Heart Association (AHA) Annual Meeting.1 On November 7, 2019, Triple-Gene announcedthat enrollment in this Phase I study has been completed.

"We are pleased to have had the opportunity to share our early clinical data from this first-in-human study with the cardiology community at this prestigious meeting," stated Thomas D. Reed, PhD, Co-founder and Managing Director of Triple-Gene. "The data presented yesterday suggest that the combination of our transiently expressed, non-integrating naked plasmid DNA with the focused cardiac delivery enabled by Retrograde Coronary Sinus Infusion (RCSI) has the potential to open a new biologics treatment paradigm for treating cardiovascular diseases."

Triple-Gene's investigational therapy uses non-viral delivery of a constitutively controlled multigenic plasmid designed to express human S100A1, SDF-1, and VEGF165 gene products, which affect progenitor cell recruitment, angiogenesis, and calcium handling, respectively, and target the underlying molecular mechanisms of pathological myocardial remodeling. The plasmid therapy is delivered via RCSI, which allows for cardiac-specific delivery to the ventricle.

Dr. David Bull, who was the first investigator to dose a patient with INXN-4001, stated, "Having carefully reviewed the science behind Triple-Gene's product candidate, I was very excited to initiate the INXN4001 clinical trial at the University of Arizona. Heart failure is a devastating disease, and my patients on Left Ventricular Assist Devices (LVAD) have very few therapeutic treatment options. Triple-Gene's novel triple-effector plasmid, as delivered by the minimally invasive RCSI procedure, represents a potential game-changing approach for addressing disease pathology in this high-risk patient population."

Amit N. Patel, MD, MS, Co-founder and Clinical Director of Triple-Gene added, "We are pleased to have completed dosing of the twelve patients in this clinical trial between our two clinical sites at the University of Arizona, Tucson, AZ and The Christ Hospital, Cincinnati, OH, and look forward to sharing additional data for this investigational therapy once the trial is complete. Based upon the promising early results to date, we are now exploring clinical trial designs that contemplate repeat dosing as well as additional orphan-like heart failure subtypes."

1Jaruga-Killeen E, Bull DA, Lotun K, Henry T, Egnaczyk G, Reed TD and Patel AN. Safety of first-in-human triple gene therapy for heart failure patients. Presented at the American Heart Association Annual Meeting, November 17, 2019.

About Triple-GeneTriple-Gene LLC is a clinical stage gene therapy company focused on advancing targeted, controllable, and multigenic gene therapies for the treatment of complex cardiovascular diseases. The Company's lead product is a non-viral investigational gene therapy candidate that drives expression of three candidate effector genes involved in heart failure. Triple-Gene is a majority owned subsidiary of Intrexon Corporation(NASDAQ: XON) co-founded by Amit Patel, MD, MS, and Thomas D. Reed, PhD, Founder and Chief Science Officer of Intrexon. Learn more about Triple-Gene at http://www.3GTx.com.

About Intrexon CorporationIntrexon Corporation (NASDAQ: XON) is Powering the Bioindustrial Revolution with Better DNAto create biologically-based products that improve the quality of life and the health of the planet through two operating units Intrexon Health and Intrexon Bioengineering. Intrexon Health is focused on addressing unmet medical needs through a diverse spectrum of therapeutic modalities, including gene and cell therapies, microbial bioproduction, and regenerative medicine. Intrexon Bioengineering seeks to address global challenges across food, agriculture, environmental, energy, and industrial fields by advancing biologically engineered solutions to improve sustainability and efficiency. Our integrated technology suite provides industrial-scale design and development of complex biological systems delivering unprecedented control, quality, function, and performance of living cells. We call our synthetic biology approach Better DNA, and we invite you to discover more at http://www.dna.comor follow us on Twitter at @Intrexon, on Facebook, and LinkedIn.

TrademarksIntrexon, Powering the Bioindustrial Revolution with Better DNA,and Better DNA are trademarks of Intrexon and/or its affiliates. Other names may be trademarks of their respective owners.

Safe Harbor Statement Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.

For more information contact:

Investor Contact:

Steven Harasym

Vice President, Investor Relations

Intrexon Corporation

Tel: +1 (301) 556-9850

investors@dna.com

Corporate Contact:

Marie Rossi, PhD

Vice President, Communications

Intrexon Corporation

Tel: +1 (301) 556-9850

publicrelations@dna.com

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Triple-Gene Presented Preliminary Phase 1 Trial Data of Investigational Multigenic Therapeutic Candidate INXN-4001 for Treatment of Heart Failure at...

NEW YORK and BASEL, Switzerland, Nov. 18, 2019 (GLOBE NEWSWIRE) -- Axovant Gene Therapies Ltd. (NASDAQ: AXGT), a clinical-stage company developing innovative gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Companys investigational gene therapy, AXO-AAV-GM1, for the treatment of GM1 gangliosidosis. GM1 gangliosidosis is a progressive and fatal pediatric lysosomal storage disorder caused by mutations in the GLB1 gene leading to impaired production of the beta-galactosidase enzyme. The Company is planning to complete enrollment of patients in Part A of the AXO-AAV-GM1 registrational program evaluating safety and efficacy and expects to announce 6-month data from Part A in mid-2020.

We are pleased to receive orphan drug designation for our GM1 gangliosidosis program as we advance the development of this potentially transformative, one-time gene therapy, said Dr. Gavin Corcoran, chief R&D officer at Axovant. There are currently no FDA approved therapies for patients with GM1 gangliosidosis, and the orphan drug designation underscores the significant unmet medical need. We look forward to increased interaction with the FDA to facilitate the development of AXO-AAV-GM1 and address this unmet need.

FDA orphan drug designation is granted to investigational therapies which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation provides several benefits to drug developers, which in addition to others, include increased FDA interaction, eligibility for 7-year market exclusivity, potential for tax credits towards the cost of clinical trials, and prescription drug user fee waivers at the time of filing a biologics license application (BLA). For more information about orphan drug designation, please visit the FDA website at http://www.fda.gov.

About AXO-AAV-GM1

AXO-AAV-GM1 is an investigational gene therapy that delivers a functional copy of theGLB1gene via an adeno-associated viral (AAV) vector, with the goal of restoring -galactosidase enzyme activity for the treatment of GM1 gangliosidosis. The gene therapy is delivered intravenously, which has the potential to broadly transduce the central nervous system and treat peripheral manifestations of the disease as well. Preclinical studies in murine and a naturally-occurring feline model of GM1 gangliosidosis have supported AXO-AAV-GM1s ability to improve -galactosidase enzyme activity, reduce GM1 ganglioside accumulation, improve neuromuscular function, and extend survival.

About Axovant Gene Therapies

Axovant Gene Therapies, part of the Roivant family of companies, is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurodegenerative diseases. Our current pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2 gangliosidosis (including Tay-Sachs disease and Sandhoff disease), and Parkinsons disease. Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations. For more information, visitwww.axovant.com.

In 2018, Axovant licensed exclusive worldwide rights from the University of Massachusetts Medical School for the development and commercialization of gene therapy programs for GM1 gangliosidosis and GM2 gangliosidosis, including Tay-Sachs and Sandhoff diseases.

About Roivant

Roivantaims to improve health by rapidly delivering innovative medicines and technologies to patients.Roivantdoes this by buildingVants nimble, entrepreneurial biotech and healthcare companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. Roivant today is comprised of a central technology-enabled platform and 20 Vants with over 45 investigational medicines in clinical and preclinical development and multiple healthcare technologies. For more information, please visitwww.roivant.com.

Forward Looking Statements and Information

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as may, might, will, would, should, expect, believe, estimate, and other similar expressions are intended to identify forward-looking statements. For example, all statements Axovant makes regarding the initiation, timing, progress, and reporting of results of its preclinical programs, clinical trials, and research and development programs; cash to be used in operating activities; its ability to advance its gene therapy product candidates into and successfully initiate, enroll, and complete clinical trials; the potential clinical utility of its product candidates; its ability to continue to develop its gene therapy platforms; its ability to develop and manufacture its products and successfully transition manufacturing processes; its ability to perform under existing collaborations with, among others, Oxford BioMedica and theUniversity of Massachusetts Medical School, and to add new programs to its pipeline; its ability to enter into new partnerships or collaborations; its ability to retain and successfully integrate its leadership and personnel; and the timing or likelihood of its regulatory filings and approvals are forward-looking. All forward-looking statements are based on estimates and assumptions by Axovants management that, although Axovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Axovant expected.Such risks and uncertainties include, among others, the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the expectations for regulatory submissions and approvals; the continued development of its small molecule and gene therapy product candidates and platforms; Axovants scientific approach and general development progress; and the availability or commercial potential of Axovants product candidates. These statements are also subject to a number of material risks and uncertainties that are described in Axovants most recent Quarterly Report on Form 10-Q filed with theSecurities and Exchange CommissiononNovember 8, 2019, as updated by its subsequent filings with theSecurities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made.Axovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts:

Media and Investors

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

Originally posted here:
Axovant Gene Therapies Receives Orphan Drug Designation from FDA for AXO-AAV-GM1 for the Treatment of GM1 Gangliosidosis - BioSpace

CHICAGO, Nov. 13, 2019 /PRNewswire/ -- According to Arizton's recent research report, Cell and Gene Therapy Market - Global Outlook and Forecast 2019-2024 is expected to grow at a CAGR of more than 24% during the forecast period.

Key Highlights Offered in the Report:

Key Offerings:

Get your free sample today! https://www.arizton.com/market-reports/cell-and-gene-therapy-market

Cell and Gene Therapy Market Segmentation

Market Segmentation by Products

Market Segmentation by Distribution Channel Type

Market Segmentation by End-users

Cell and Gene Therapy Market Dynamics

CAR T-cell therapy has gained significant traction in recent years. It is the single most rapidly growing type of product in the market that generates revenue at a phenomenal rate. At present, it is the fastest advancing technology in cancer treatment and has the capability to replace many existing therapies. CAR T-cell therapy addresses current challenges in cancer care through superior efficacy, safety, and delivery mechanisms. CAR T-cell therapy has brought itself into focus due to the personalized nature of this therapy and the utilization of advanced genetic engineering technology. The wide acceptance and use of CAR T-cell therapy is fueling the growth of the global cell and gene therapy market.

Key Drivers and Trends fueling Market Growth:

Cell and Gene Therapy MarketGeography

The US dominates the cell and gene therapy market in North America due to the high prevalence of chronic diseases and other conditions. There is also comparably high utilization and wide accessibility of these therapies. In Europe, cell and gene therapy products are considered to be part of the Advanced Therapy Medicinal Products (ATMPs), which are commonly known as regenerative medicine globally. The major factors leading to the growth in APAC region are the growing prevalence of cancers, osteoarthritis, burns, and other chronic wounds, the introduction of advanced products in Japan, advanced R&D activities in countries such as South Korea, India.

Get your free sample today! https://www.arizton.com/market-reports/cell-and-gene-therapy-market

Market Segmentation by Geography

Major Vendors

Other vendors include - Anterogen, Tego Sciences, Japan Tissue Engineering, JCR Pharmaceuticals, Medipost, MolMed, AVITA Medical, CollPlant, Corestem, Biosolution, Stempeutics Research, Orchard Therapeutics, Takeda Pharmaceutical Company, CHIESI Farmaceutici, CO.DON, AnGes, GC Pharma, JW CreaGene, APAC Biotech, Nipro Corp., Terumo, Orthocell, and bluebird bio.

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About Arizton:

Arizton Advisory and Intelligence is an innovation and quality-driven firm, which offers cutting-edge research solutions to clients across the world. We excel in providing comprehensive market intelligence reports and advisory and consulting services.

We offer comprehensive market research reports on industries such as consumer goods & retail technology, automotive and mobility, smart tech, healthcare, and life sciences, industrial machinery, chemicals and materials, IT and media, logistics and packaging. These reports contain detailed industry analysis, market size, share, growth drivers, and trend forecasts.

Arizton comprises a team of exuberant and well-experienced analysts who have mastered in generating incisive reports. Our specialist analysts possess exemplary skills in market research. We train our team in advanced research practices, techniques, and ethics to outperform in fabricating impregnable research reports.

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SOURCE Arizton Advisory & Intelligence

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The Cell and Gene Therapy Market to Reach Revenues of Over $6.6 billion by 2024 - Market Research by Arizton - PRNewswire

COLLEGE STATION, Texas, Nov. 14, 2019 /PRNewswire/ -- FUJIFILM Diosynth Biotechnologies (FDB), a leading global biologics Contract Development and Manufacturing Organization (CDMO) has announced the expansion of its gene therapy services with the addition of dedicated process and analytical development laboratories. As a part of a capital investment of approximately 13 billion yen (approx. $120 million USD) in the gene therapy fieldby FUJIFILM Corporation,aninvestment of approximately $55 million USD will be made to establish anew Gene Therapy Innovation Center adjacent to FDB's existing state-of-the-art cGMP gene therapy manufacturing facility in College Station, Texas and forms part of the company's strategy to meet the growing demands in the Viral Gene Therapy Market. The gene therapy market forecast for CDMOs is expected to grow to $1.7Bn by 2025.1

The Gene Therapy Innovation Center will be approximately 60,000 square feet and will house state-of-the-art upstream, downstream and analytical development technologies. The facility will be operational in the fall of 2021.

"We are very much aware of the incredible growth in such an important therapeutic space," said Martin Meeson, President and COO of FUJIFILM Diosynth Biotechnologies, US. "We know that we need to invest now, in technology, assets and people in order to achieve a market leadership position. The expansion through the construction of the Gene Therapy Innovation Center demonstrates our ongoing commitment for growth."

FDB's main goals behind this new strategy are to provide leading, future proofed end-to-end gene therapy solutions, from pre-clinical to commercial launch. This follows an earlier announcement made by FDB to introduce its gene therapy fill finish services. "We expect to break ground in the first quarter of 2020," said Gerry Farrell, COO at FUJIFILM Diosynth Biotechnologies, Texas, "this new facility will triple our gene therapy development capabilities and will add approximately 100 jobs to our Texas Campus."

Gene Therapy remains a strategic investment area for Fujifilm.

About Fujifilm FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerod, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway microbial and Apollo cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. For more information, go to: http://www.fujifilmdiosynth.com

FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2019, the company had global revenues of $22 billion, at an exchange rate of 111 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: http://www.fujifilmholdings.com.

All product and company names herein may be trademarks of their registered owners.

1 Market research conducted by FUJIFILM Diosynth Biotechnologies strategic business development group.

SOURCE FUJIFILM Diosynth Biotechnologies

http://www.fujifilmdiosynth.com

Excerpt from:
FUJIFILM Diosynth Biotechnologies Announces $55 Million USD Investment To Expand Gene Therapy Development Capabilities - PRNewswire

DUBLIN--(BUSINESS WIRE)--The "Gene Therapy in Neurology" report has been added to ResearchAndMarkets.com's offering.

Gene therapy is an evolving area in healthcare that promises to revolutionize the treatment landscapes across various therapy areas.

In this report, the focus will be on neurology indications. The report provides an analysis of the overall gene therapy pipeline that is being developed for various neurology indications with an emphasis on late-stage pipeline products. In addition to pipeline analysis, the report also focuses on trends observed in clinical trials in this area, unmet needs and challenges, as well as partnership strategies adopted by pharmaceutical companies to keep up with developments in the field of gene therapies.

Recently approved gene therapies for spinal muscular atrophy have reinvigorated the potential of such therapies to transform patient care. While various methodologies can be adopted in order to deliver therapeutic benefits of gene therapy including gene augmentation, gene suppression, and gene editing, an important component of gene therapy is whether to use viral or non-viral vectors in order to deliver such therapies to the point of care.

Ongoing collaborations between different industry players and a buildup of real-world evidence establishing safety and efficacy are expected to drive the growth of gene therapies for neurology indications. Of the 38 pipeline products that are currently in development, 45% are adeno-associated virus (AAV) based delivery platforms. Other types include Lentiviral, which accounts for 13%.

A majority of the current pipeline products are in Phase II development and the most common neurology indications - for which gene therapies are currently being evaluated - include Parkinson's disease, pain and amyotrophic lateral sclerosis. The dominance of viral vectors is expected to continue as such platforms account for the bulk of these pipeline products, with adeno-associated virus being the most common among the viral vectors.

In terms of completed, ongoing and planned clinical trials, academic institutes account for 21% of these trials, despite industry sponsors being most dominant. A deeper analysis of these clinical trials also suggest that across most indications, the average trial duration for a viral based product is longer compared to a non-viral based product such as oligonucleotides or plasmid DNA.

There are also challenges associated with the development of gene therapies, most prominent being their high price points. Key opinion leaders (KOLs) interviewed highlighted the need to create sustainable funding solutions so that such therapies become accessible to patients everywhere irrespective of where patients are located. In terms of unmet needs, KOLs highlighted the need for a favorable route of administration that is both sustainable in terms of usage of healthcare resources and favorable from a patient perspective.

While development of gene therapies are expected to pick up pace, the next wave of such therapies are expected to be ones that target diseases that are more frequent. While monogenic rare diseases are the obvious first-to-go choice for which gene therapies can be developed, targeting more frequent diseases will need a holistic approach in order to address a wider mechanism of action. If gene therapies for frequent diseases do become available, then that will result in a more pronounced effect on healthcare not only in terms of providing better treatment options for patients but also test the ability of healthcare organizations to adapt with high price points of these therapies.

Scope

Reasons to Buy

Key Topics Covered

1 Preface

2 Executive Summary

2.1 Key Findings

2.2 KOL Insights on Competitive Landscape for Gene Therapy for Neurology Indications

3 Overview - Gene Therapy in Neurology

3.1 Objectives of Gene Therapy

3.2 Gene Therapy Versus Conventional Therapies

3.3 Optimization of Gene Expression

3.4 Gene Transfer Methods and Vectors Used for Gene Therapy

3.5 Classifications of Gene Therapy

3.6 Sources

4 Gene Therapy in the 8MM

4.1 Global Regulatory Agencies' Definitions of Gene Therapy

4.2 Gene Therapy in the US

4.3 Gene Therapy in the EU

4.4 Gene Therapy in Japan

4.5 Gene Therapy in China

4.6 Currently Marketed Gene Therapies in Neurology

4.7 Sources

5 Pipeline Assessment in the 8MM

5.1 Pipeline Overview

5.2 Pipeline Products - Phase III

5.3 Pipeline Products - Phase II

5.4 Orchard Therapeutics' OTL-200

5.5 Biogen's Tofersen sodium

5.6 Roche's RG-

5.7 Sylentis' Tivanisiran

5.8 ViroMed's Donaperminogene Seltoplasmid

5.9 Sources

6 Clinical Trials Mapping and Design

6.1 Clinical Trial Mapping for all Pipeline Products by Phase, by Sponsor, and by Location

6.2 Clinical Trial Mapping for all Pipeline Products by Status and by Indication

6.3 Clinical Trial Mapping by Phase and Indication for Phase III Therapies

6.4 Clinical Trial Mapping by Phase for Phase II Therapies

6.5 Clinical Trial Duration by Indication for Phase III Therapies (By Types of Molecules)

6.6 Clinical Trial Duration by Indication for Phase II Therapies (By Types of Molecules)

6.7 Ongoing Clinical Development of Phase III Gene Therapies

7 Unmet Needs, Barriers, and Key Company Strategies

7.1 Unmet Needs Within Gene Therapy for CNS Indications

7.2 Challenges and Other Factors to Consider During Different Stages of Product Development

7.3 Key Company Strategies: Acquisitions

7.4 Key Company Strategies: Strategic Partnerships

7.5 Sources

8 Payer Perspective on Gene Therapies in Neurology

8.1 Current Neurology Space

8.2 Challenges Associated with Reimbursement of Novel Gene Therapies

8.3 Cost of Gene Therapies

8.4 Strategies to Tackle the Cost of Gene Therapies

8.5 Innovative Reimbursement Models and Clinical Comparators

9 Market Outlook

9.1 Phase III Gene Therapy Pipeline for Neurology

9.2 Key Launch Dates for Phase III Gene Therapy Pipeline Products

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/5pahu7

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Gene Therapy in Neurology, 2019: Market Outlook, Pipeline Assessment, Unmet Needs, Barriers, Key Company Strategies & Payer Perspective -...