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AVITA Medical Teams With Gates Center to Advance Therapeutic Skin Restoration – CU Anschutz Today

By daniellenierenberg

AVITA Medical (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, and scientists at the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine have announced a preclinical research collaboration to establish proof-of-concept and explore further development of a spray-on treatment of genetically modified cells for patients with epidermolysis bullosa (EB), with potential applicability to other genetic skin disorders.

The partnership will pair AVITA Medicals patented and proprietary Spray-On Skin Cells technology and expertise with the Gates Centers innovative, patent pending combined reprogramming and gene editing technology to allow cells to function properly. Under the terms of the Sponsored Research Agreement (SRA), AVITA Medical retains the option to exclusively license technologies emerging from the partnership for further development and commercialization. The Gates Center team is further supported by the EB Research Partnership in New York, the Los Angeles-based EB Medical Research Foundation, the London-based Cure EB Charity and government grants, in a collaborative effort to rapidly develop and translate this technology to the clinic for meaningful impact on patient lives.

The Gates Center is a leader in developing therapeutic approaches for genetic skin diseases. Researchers at the Gates Center have developed a powerful new approach for treating genetic skin disorders and improving the lives of patients with epidermolysis bullosa, said Mike Perry, PhD, chief executive officer of AVITA Medical and adjunct professor at the Gates Center for Regenerative Medicine. We look forward to collaborating with the team at the Gates Center on the expanded use of our technology. This agreement marks an important milestone in AVITAs mission to harness the potential of regenerative medicine to address unmet medical needs across a broad range of dermatological indications, including genetic disorders of the skin.

Epidermolysis bullosa is a group of rare and incurable skin disorders caused by mutations in genes encoding structural proteins resulting in skin fragility and blistering, leading to chronic wounds and, in some sub-types, an increased risk of squamous cell carcinoma or death. There are no approved curative therapies, and current treatment is palliative - focused primarily on pain and nutritional management, itching relief, wound care, and bandaging.

Its very exciting to partner with AVITA Medical to help advance our epidermolysis bullosa program, said Director of the Gates Center for Regenerative Medicine Dennis Roop, PhD. Were looking forward to exploring a novel approach to delivering gene-edited skin cells to patients that addresses current treatment challenges.

We believe that Spray-On Skin Cells technology combined with our genetically corrected cells has the potential to be game changing in the treatment of this disease. This combination could reduce time to treatment, lower manufacturing complexity, reduce costs and improve patient outcomes, said Ganna Bilousova, PhD, assistant professor of dermatology, who is a co-principal investigator on this research program.

ABOUT THE CHARLES C. GATES CENTER FOR REGENERATIVE MEDICINE

The Charles C. Gates Center for Regenerative Medicine was established in 2006 with a gift in memory of Denver industrialist and philanthropist, Charles C. Gates, who was captivated by the hope and benefit stem cell research promised for so many people in the world. The Gates Center aspires to honor what he envisionedby doing everything possible to support the collaboration between basic scientific researchers and clinical faculty to transition scientific breakthroughs into clinical practice as quickly as possible.

Led by Founding Director Dennis Roop, PhD, the Gates Center is located at the University of Colorados Anschutz Medical Campus, the largest new biomedical and clinical campus in the United States. Operating as the only comprehensive Stem Cell Center within a 500-mile radius, the Gates Center shares its services and resources with an ever-enlarging membership of researchers and clinicians at the Anschutz Medical Campus, which includes University of Colorado Hospital, Childrens Hospital Colorado and the Veterans Administration Medical Center, as well as the Boulder campus, Colorado State University, the Colorado School of Mines, and business startups. This collaboration is designed to draw on the widest possible array of scientific exploration relevant to stem cell technology focused on the delivery of innovative therapies in Colorado and beyond.

ABOUT THE UNIVERSITY OF COLORADO SCHOOL OF MEDICINE

Faculty at the University of Colorado School of Medicine work to advance science and improve care. These faculty members include physicians, educators and scientists at University of Colorado Hospital, Childrens Hospital Colorado, Denver Health, National Jewish Health, and the Denver Veterans Affairs Medical Center. The school is located on the CU Anschutz Medical Campus, one of four campuses in the University of Colorado system. To learn more about the medical schools care, education, research and community engagement, visit its web site.

ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES), an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. Burn Centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

Photo at top: From left, Igor Kogut, PhD, Ganna Bilousova, PhD, and Dennis Roop, PhD.

Guest contributor: Gates Center for Regenerative Medicine/ASX

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Seven Products Our Beauty Editor Used to the Last Drop – Sarasota

By daniellenierenberg

When it comes to our beauty and skincare products, it's easy for years to pass without an updateor even an upgrade. But because advances in beauty technology are happening at the speed of light, its always important to pause and reassesswhat we're usingfrom dog shampoo to stem-cell skincare. SoI've rounded up the best of the latest trends that have earned a place inmymakeup bag.

Its no secret that Ima major fan of Kjaer Weisthere is something utterly fresh and clean about everything for the face and body, and its as organic as it can get. Enter the latest additions to the line: the cleanser ($95) and toner ($85, both pictured above). Not only does the soft, gel-like cleanser effectively remove all makeup, but its also calming. Follow it with a quick spritz of the toner and you have hydrated and re-balanced skin. Plus, the scents aredreamy.If I could accurately describe them, I would. But I was in Bluemercury downtown recently they have sample bottles to give it a go yourself.Bluemercury, 1500 Main Street, Sarasota. (941) 365-0020

Two things on my must-do-better list: Sunscreen and preventing this neck from aging. Addressing the first, Alastin Skincares HydraTint Pro Mineral Sunscreen SPF 36 ($55) is a revelation. Not only is it lightweight, with broad-spectrum UVA/UVB sun protection, it also protects against environmental pollution and it has a universal tint that enhances most skin tones. Its the first thing Iput on in the morning before taking the dogs for a walk; I love the just-right tinted coverage.

Second, that neck thing. As much as I prefer organic and natural skincarewhen possible, I tend to lean on science for combatting aging. Enter: Nectifirm Advanced ($133). Its next-gen technology based on the ecosystem of the skins microbiome, plus eight peptides that helps skin appear firmer and lifted while lessening the appearance of lines and wrinkles. Not to mention that those in the know at Sarasota Facial Aesthetics rave about the results. Get both products atSarasota Facial Aesthetics, 1445 South Osprey Ave., Suite 2, (941) 955-8384.

I was of the mind that a razor is a razoris a razor. Well, thats changed since theFlamingo razor($9.99) came on my radar. The team raised the bar on shaving after spending years talking to women (what a concept!) who shared the nuances of their personal care rituals and how typical razors fell short. Use this once and it will be clear that they did not overlook those edges of our bodies that need extra attention.Target, 101 N. Cattlemen Road, (941) 360-7520

Speaking of: here's another kind of sunscreen, this time for the eye area. Who knew? I recently discovered Colorescience Total Eye3-in-1 Renewal Therapy SPF 35 ($74)they say it visibly improves the appearance of dark circles, puffiness, fine lines and wrinkles, while protecting the delicate eye area against photoaging with 100 percent SPF 35 mineral sunscreen. I say its great coverage, and if it comes with all of those benefits then...yay!L. Spa, 556 Pineapple Ave., (941) 906-1358

Brace yourself (and maybe your credit card) because Augustinus Baders The Cream ($265) is right there at the cutting edge for stem cell skincare. Get this: the stem cells found in skin lie dormant, awaiting an activation signal to repair the damage inflicted by life and environmental factors.The patented technology TFC8Bader's proprietary "Trigger Factor Complex"is comprised of natural amino acids, high-grade vitamins and synthesized molecules that are found naturally in the skin. Its a repairing force in an ultra-lightweight cream that guides key nutrients and powerful natural ingredients to the skin cells, creating an optimal environment for the body's innate processes of repair and renewal.Thats a lot, but all I know is that I can see the results after a lotta life has happened to my skin. Its crazy good, and I guess for the price it should be. Saks Fifth Avenue, 120 University Town Center Drive, Sarasota. (941) 364-5300

Lastly, this one is for the love of our fur kids, especially those with sensitive skin. The Malin + Goetz Dog Shampoo ($28) is infused with natural botanical amino acids to gently cleanse fur and skin without drying, stripping or irritating. And I can attest that fur dries soft and oh-so-shiny. Malin + Goetz, malinandgoetz.com

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AVITA Medical and the Gates Center for Regenerative Medicine at the University of Colorado Anschutz Medical Campus Enter into Collaboration to Explore…

By daniellenierenberg

Nov. 24, 2019 23:45 UTC

VALENCIA, Calif., MELBOURNE, Australia & AURORA, Colo.--(BUSINESS WIRE)-- AVITA Medical (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, and scientists at the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine announced today a preclinical research collaboration to establish proof-of-concept and explore further development of a spray-on treatment of genetically modified cells for patients with epidermolysis bullosa (EB), with potential applicability to other genetic skin disorders.

The partnership will pair AVITA Medicals patented and proprietary Spray-On Skin Cells technology and expertise with the Gates Centers innovative, patent-pending combined reprogramming and gene-editing technology to allow cells to function properly. Under the terms of the Sponsored Research Agreement (SRA), AVITA Medical retains the option to exclusively license technologies emerging from the partnership for further development and commercialization. The Gates Center team is further supported by the EB Research Partnership in New York, the Los Angeles-based EB Medical Research Foundation, the London-based Cure EB Charity, and government grants in a collaborative effort to rapidly develop and translate this technology to the clinic for meaningful impact on patient lives.

The Gates Center is a leader in developing therapeutic approaches for genetic skin diseases. Researchers at the Gates Center have developed a powerful new approach for treating genetic skin disorders and improving the lives of patients with epidermolysis bullosa, said Dr. Mike Perry, Chief Executive Officer of AVITA Medical and adjunct professor at the Gates Center for Regenerative Medicine. We look forward to collaborating with the team at the Gates Center on the expanded use of our technology. This agreement marks an important milestone in AVITAs mission to harness the potential of regenerative medicine to address unmet medical needs across a broad range of dermatological indications, including genetic disorders of the skin.

Epidermolysis bullosa is a group of rare and incurable skin disorders caused by mutations in genes encoding structural proteins resulting in skin fragility and blistering, leading to chronic wounds and, in some sub-types, an increased risk of squamous cell carcinoma or death. There are no approved curative therapies, and current treatment is palliativefocused primarily on pain and nutritional management, itching relief, wound care, and bandaging.

Its very exciting to partner with AVITA Medical to help advance our epidermolysis bullosa program, said Director of the Gates Center for Regenerative Medicine Dr. Dennis Roop. Were looking forward to exploring a novel approach to delivering gene-edited skin cells to patients that addresses current treatment challenges.

We believe that Spray-On Skin Cells technology combined with our genetically corrected cells has the potential to be game changing in the treatment of this disease. This combination could reduce time to treatment, lower manufacturing complexity, reduce costs, and improve patient outcomes, said Dr. Ganna Bilousova, assistant professor of dermatology, who is a co-principal investigator on this research program.

ABOUT THE CHARLES C. GATES CENTER FOR REGENERATIVE MEDICINE

The Charles C. Gates Center for Regenerative Medicine was established in 2006 with a gift in memory of Denver industrialist and philanthropist Charles C. Gates, who was captivated by the hope and benefit stem cell research promised for so many people in the world. The Gates Center aspires to honor what he envisionedby doing everything possible to support the collaboration between basic scientific researchers and clinical faculty to transition scientific breakthroughs into clinical practice as quickly as possible.

Led by Founding Director Dennis Roop, Ph.D., the Gates Center is located at the University of Colorados Anschutz Medical Campus, the largest new biomedical and clinical campus in the United States. Operating as the only comprehensive Stem Cell Center within a 500-mile radius, the Gates Center shares its services and resources with an ever-enlarging membership of researchers and clinicians at the Anschutz Medical Campus, which includes University of Colorado Hospital, Childrens Hospital Colorado, and the Veterans Administration Medical Center, as well as the Boulder campus, Colorado State University, the Colorado School of Mines, and business startups. This collaboration is designed to draw on the widest possible array of scientific exploration relevant to stem cell technology focused on the delivery of innovative therapies in Colorado and beyond.

ABOUT THE UNIVERSITY OF COLORADO SCHOOL OF MEDICINE

Faculty at the University of Colorado School of Medicine work to advance science and improve care. These faculty members include physicians, educators, and scientists at University of Colorado Hospital, Childrens Hospital Colorado, Denver Health, National Jewish Health, and the Denver Veterans Affairs Medical Center. The school is located on the Anschutz Medical Campus, one of four campuses in the University of Colorado system. To learn more about the medical schools care, education, research, and community engagement, visit its web site.

ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES), an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. Burn Centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information, including contraindications, warnings, and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications, including burns, chronic wounds, and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191124005098/en/

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Star Trek’s William Shatner Receives Stem Cell Treatment to Restore his Youth – Magazine of Santa Clarita

By daniellenierenberg

The 88-year-old actor known for his role as Captian James T. Kirk on the popular cinema and television series Star Trek, William Shatner recently Tweeted, Today I received restorative stem cells and told his followers Is it possible to turn back the clock? I will let you know.Mr. Shatner also tweeted the Stem Cells are manufactured by Invitrx.Center for Regenerative Medicine & Stem Cell Therapy at Valencia Medical Center is a pioneer in stem cell regenerative medicine in Santa Clarita Valley has been producing PRP and stem cell treatments for cosmetic treatments for cosmetic rejuvenation, hair restoration and chronic knee pain due to arthritis knee meniscus injury, cartilage, ligaments (ACL, MCL), osteoarthritis treatment. Invitrx, a California native is a global research-based company in regenerative medicine and is a major source of stem cell products for Valencia Medical Center.Non-surgical regenerative cell-based treatment uses the bodys natural healing ability to repair damaged bones, muscles, cartilage, tendons and ligaments. Knee injuries are painful and often patients are unable to walk. Our treatment protocol always uses products following FDA guidelines. Injections done with ultrasound guided needle recognition capability to ensure safety as well target the area needing treatment. Plasma; Alpha-2-Macroglobulim (A2M) is the new biologic treatment for your arthritic knee (osteoarthritis)When your hips hurt, or your knee is stiff, or your back is throbbing, that means your joint is bone on bone and there is no lubrication to ease movement.Regenerative medicine giving new hope to patients suffering from painful joint injuries such as knee, shoulder and hip with a chance to live a pain free life.Regenerative cell-based ultrasound guided injection now available to treat pain associated with joint injury. There are indications that it reduces the pain and swelling of the joints and helps lubricating and improve movements.Commonly Treated Conditions: Osteoarthritis of the Hips, Knee, and Shoulders Rotator Cuff tears of the Shoulder Meniscus, ACL and PCL tears of the kneeOur stem cell treatment using your own stem cells and with using imaging guidance ensures precise injection of stem cell, it is a highly-specialized practice.Besides treating above injuries we have advance stem cell micro-needling treatment for the following: Cell-based PRP Hair Restoration combining micro-needling with growth factors and hair follicles voluma vitamins plus BLotinyl T1, Biotin, Anti-aging and Kopexil. Non-toxin facial renewal Anti-Aging APGF Advanced Peptide Micro-needling PRP, Dual Anti-Aging Ampoules for deep hydration, more collagen to reduce wrinkles and firm skin.Dr. Ibrahim is the staff physician at Valencia Medical Center specializing in regenerative medicine, pain management, and rejuvenation. Call for a consultation at 661-222-9117.

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Hatching disease in a dish: The new frontier in drug testing – Maclean’s

By daniellenierenberg

Over lunch at the Canadian Centre for Alternatives to Animal Methods (CCAAM), Charu Chandrasekera nonchalantly mentions one of the projects her team is working on. We are just printing some human liver tissue right now, she says.

Chandrasekera launched the CCAAM at the University of Windsor in 2017, with help from the schools vice-president of research and innovation, Michael Siu, and dean of science, Chris Houser. The centre promotes non-animal methods in biomedical research, education, and regulatory (chemical safety) testing. In October 2019, the centre received a million-dollar gift from the Eric S. Margolis Family Foundation, which Chandrasekera says was instrumental in establishing the state-of-the art research laboratory, and in launching a number of important initiatives.

Chandrasekera says the move away from animal testing to human-based research models isnt radical but inevitable. After many years working in biomedical research with mouse models of heart disease and diabetes, It became very obvious that the work I was doing was not translatable [to humans], she says. Nothing was really reproducible; there were so many discrepancies and contradictions, even among the top-notch researchers.

Ninety-five per cent of drugs tested to be safe and effective in animal models fail in human clinical trials, says Chandrasekera. Alzheimers disease99.6 per cent drug failure rate, she says. It has been cured in mice. But we dont even understand the molecular mechanisms of this disease in humans, much less a cure.

RELATED:I am mine: This is what Alzheimers is like at 41

Empirical evidence from across a whole host of biomedical science disciplines shows us that animal models are failing both science and human health, echoes Elisabeth Ormandy, co-founder and executive director of Animals in Science Policy Institute, a registered Canadian charity working to promote better science without animals. Animal models can falsely show that a drug is effective, she says. They can also falsely show no effect, in which case a drug that would have been shown to be effective in humans never gets advanced to human clinical trials.

The result, she says, is billions of public tax dollars being wasted on research using ineffective animal models, and diversion of precious research funding away from other lines of scientific inquiry that might hold greater promise in terms of predicting drug safety, risk, and effectiveness.

Those other promising lines of scientific inquiry, say Ormandy and Chandrasekera, are human biology-based models. We can use human cells and tissues from cadavers, biopsies, and explanted organs [from surgeries], says Chandrasekera. And we can also engineer them. With adult stem cell technology, you can take a small biopsylike two-to-three millimetres from a persons skinto create any cell type in your body, she says. And if that person has a disease, such as Alzheimers, it will still be present in these cells. These cells can then be assembled to form tissue-like structures called organoids, or engineered through 3D-bioprinting to create more complex tissues, all of which can be combined to create what has become known as disease-in-a-dish. At present,Chandrasekera iscreating diabetes-in-a-dish.

Further, those cells and tissues can also be placed onto computer chips the size of thumb drives, where a large number of drugs can be tested to select whats most appropriate for youpersonalized medicine based on your cells, your tissues, your biologynot mouse biology, Chandrasekera explained in her April 2019 TedX Talk. The goal of the scientific community at large is to create a human-on-a-chip to emulate human biology better than animals, she says, which I think will happen over the next decade.

Currently there is no data on the success rates of human biology-based methods, because there are no drugs that have been approved without animal testing, since animal testing was mandated by regulatory guidelines several decades ago, says Chandrasekera.

However, a growing body of scientific data and internationally approved guidelines in chemical safety testing, indicate that alternative methods are equal or superior to animal models in predicting human biology, Chandrasekera says. Even computer simulations are out-predicting animal-derived data.

RELATED:Health care cannot modernize unless health policy changes first

Ifdisease-in-a-dish and toxicity-on-a-chip effortscontinue to advance at a fast pace with a sense of urgencybacked by global scientific, financial, legislative, and ethical mandates, she says, we will come to a point where we can test drugs without relying on animals.

And while Chandrasekera is busy both in the lab and on the global stage promoting her work, she is also focused on enlightening future scientists. Shes working the development of courses and degrees to train the next generation, she says, to think outside the cage.

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Vampire facials and other medical witchcraft you can buy to stay youthful today – Citizen

By daniellenierenberg

You can maintain your youthful appearance and be less likely to have more invasive procedures later on in life if you put it effort to maintain the appearance. The same with skincare, if you put more effort now, with daily sunscreen, look after the skin and rejuvenate the skin, the likelihood of you having wrinkly sun-damaged skin later on is obviously much less.

This is the view of Dr Alexandra Grubnik, a plastic and reconstructive surgeon from Nip Tuck at the Netcare Milpark Hospital and Netcare Rosebank Hospital.

While surgical facial procedures are still being requested by South Africans, Dr Grubnik says there has been a rise in non-surgical procedures, with botox being one of the commonest procedures.

All the non-surgical procedures are done in rooms and theres absolutely no downtime. This is why theyre gaining popularity worldwide. There are people who say that in 20 years we will be doing no surgical operations.

A botox procedure involves injecting a serum that weakens the muscles to avoid getting wrinkles, while some use it to get rid of frown lines.

There is a very good twin study identical twins who participated in the study. One of them had regular botox injections every three to four months and the other just had it once upfront and did not have any for 10 years. The difference is absolutely remarkable. The other one without botox looks 20 years older than their sister, says Dr Grubnik.

This is sometimes confused with a filler, which is done to restore volume to the face and make it look more youthful.

As you age there is some resorption on the bone in the face, because theres bone loss and the soft tissues hang. When these people maintain themselves with filler, when they get to their 60s they may not need a facelift because they didnt have that droopiness that the previous generation would have had.

A filler injection (per millimetre) can cost you up to R3,000 each, while botox (per unit) is around R60.

A facelift, also common among South African women, is a procedure that involves removing excess facial skin from the lower half of the face including the chin and neck and tightening loose skin in different areas in the face.

According to Dr Grubnik, this is a big operation and requires recovery time.

There will be bruising, swelling in the face.

You can expect to pay around R95,000 for a facelift.

Also read: They do it for sexual satisfaction, says surgeon on rise in vaginal rejuvenation

Another common facial procedure in South Africa is blepharoplasty (eyelid surgery). This involves taking out excess skin in the upper and lower eyelid to remove bags in the eyelids.

Model and businesswoman Kim Kardashian shocked her social media followers a few years ago after telling them she regularly got vampire facials to keep her face looking younger.

The procedure has gained popularity among women, and Dr Grubnik says its because the procedure actually works.

A vampire facial involves taking blood from parts of your body (apart from the face), and spinning it to separate the red blood cells and the plasma.

In the plasma the platelets are in the blood. Its called platelet red plasma and this platelet red plasma is a stem cell. Stem cells have growth factors, so they rejuvenate the skin. We inject it in the face we can micro-needle it in the face.

Youre allowed to have it once every six weeks. It definitely works, theres a reason why Kim Kardashian is having it, explains Dr Grubnik.

A vampire treatment could cost you at least R3,300 per procedure and R4,200 with PRP (platelet-rich plasma) injections.

Other skin care procedures include acne and oily skin treatments (R880), skin brightening treatment (R880), hydrating treatment (R880) and the red carpet peel for R1,300.

While Dr Grubnik encourages the use of these procedures for those who are willing, she also advocates for good skin care with the use of a sunscreen.

Sunscreen is paramount because the sun damages skin skin quite badly, so before you know it you will have very bad wrinkles and sun damage with pigmentation, regardless of the skin tone or colour everybody suffers equally.

People say there is a genetic predisposition to how you age and, to a certain extent it is true. If your mother looks fantastic at 70, youre blessed with those genes as well, but its not only the genetics. Looking after yourself always makes a difference.

For more news your way, download The Citizens app foriOSandAndroid.

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The SEVEN myths and truths about healthy skin – Stock Daily Dish

By daniellenierenberg

Skin is our largest organ and something we may take for granted when its healthy.

As an academic dermatologist I frequently hear misleading facts that seem to be stubbornly enduring.

Here are some of the most commonly shared myths that can be cleared up immediately, and some truths you can rely on.

TRUE Skin constantly renews itself

The skin provides a dynamic barrier between your bodys internal environment and the outside world.

Cells called keratinocytes in the epidermis (the outer layer of skin) are constantly dividing to produce a supply of cells that move up through this layer and are shed from its surface.

Skin is a rich source of stem cells with the capacity to divide and renew themselves.

FALSEDrink two litres of water a day for healthy skin

The amount of water you drink does not directly affect your skin.

Water is supplied to the skin by blood flowing through the dermis, the inner layer of skin; water is lost from the epidermis, especially in a dry environment.

Water is needed to maintain skin hydration and when you become seriously dehydrated your skin appears dull and is less elastic.

In a healthy person the internal organs kidneys, heart and blood vessels control the amount of water reaching the skin.

There is no fixed volume of water that you need to drink, it simply depends on the amounts you are using and losing.

TRUE Stress can make skin unhealthy

There are many health issues in modern life that we blame on stress, but several skin conditions have been shown in scientific studies, to be worsened by life events, possibly via stress hormones including cortisol (a steroid hormone made in the adrenal glands).

Notable examples are alopecia areata, an auto-immune condition where the bodys immunity begins to attack the hair follicles, causing hair to fall out; psoriasis, another auto-immune condition that causes skin thickening, scaling and inflammation; and eczema, itchy red skin inflammation often occurring alongside asthma, hay fever and other allergies.

Unfortunately a flare up of these skin conditions is exactly what you dont need when you are feeling stressed or under pressure.

FALSE Eating chocolate causes acne

Acne vulgaris, the common teenage acne which can actually persist into your 30s and 40s, occurs as a result of the interaction between hormonal effects on grease glands in the skin, plus the skins immune response to blocked pores and microbes living on the skin.

Eating a high fat diet is unhealthy for many reasons, but it doesnt cause acne.

In fact some tablets prescribed for severe acne such as oral isotretinoin are better absorbed when pills are swallowed with a fatty meal and that could include chocolate.

FALSE Washing powder causes eczema

Eczema is a condition where the skin is dry, itchy and red. It is caused by a combination of genetic factors (how your skin is made) and environmental effects, leading to inflammation.

Soap, detergents and washing powders can irritate the skin and contribute to dryness because they remove oil from the skin (just as washing-up liquid removes grease from your dishes).

Biological washing powders contain enzymes proteins that break down fats and other proteins to remove stains and these can irritate sensitive skin, so they may worsen eczema.

It is important that any washing power is thoroughly rinsed out of clothing before it is worn, to avoid skin irritation.

FALSE White marks on nails = calcium deficiency

Itchiness usually occurs due to dry skin, an infection or an allergic reaction.

However, it can also be a sign of cancer.

Although it is unclear how some forms of the disease cause itchiness, medics believe it may be due to substances released by the tumour or how the body reacts to the growth.

This itching tends to be all over the body but worse on the legs and chest.

It usually goes away once cancer treatment starts.

But cancer drugs themselves can also cause itchiness, which can be a sign they are working.

Certain anti-depressants, steroid creams and complementary therapies like foot massages can help ease the irritation.

To cope people should limit the numbers of baths they have, apply unscented moisturisers, wear natural fabrics and keep rooms cool.

Keeping nails short also reduces the damage scratching the skin can cause.

Source:

Nails are manufactured in the nail matrix, an area under the skin at the top edge of your nail.

If the matrix is traumatised, bumped or bitten, an irregularity in the developing nail occurs and air can become trapped.

This appears as a white mark as the nail grows out. Calcium is important for healthy nails (as well as bones and teeth) but these white marks are not a sign of deficiency.

TRUE AND FALSE Sunshine is good for you

Many people have experienced the feel-good factor of a sunny day, but there are good and bad effects of sunlight.

Light from the sun includes a mixture of different wavelengths of light: some are visible to the human eye, some are shorter than the colours we can see these are called ultraviolet (UV) and some are longer, the infrared. Different wavelengths have different effects on skin.

UVB is used by skin to manufacture vitamin D which is essential for bone health. Without sun exposure this vitamin must be obtained from the diet.

Dermatologists use specific wavelengths of UVA and UVB in carefully controlled doses to reduce skin inflammation, a valuable treatment for some skin conditions.

But when the skin is exposed to too much UV it can damage the skin cells DNA, leading to uncontrolled growth the basis of cancer.

As a simple rule, unless you have a disease or treatment that suppresses your immune system, sunshine is good for you in moderation, but always avoid getting sunburned.

KEEP IT SIMPLE

The basic principles of keeping skin healthy are mainly common sense. You should wash your skin regularly to remove dirt, but not so much that you remove the essential moisture and water-proofing substances.

Use a moisturiser if your skin feels tight or dry a greasy ointment works best unless you have acne-prone skin, in which case you should use a non-greasy water-based cream.

Avoid stress if possible, eat a healthy diet and drink water when you feel thirsty. And finally, protect your skin from too much sun with a hat and clothing or sunscreen.

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This is why you should switch to vegan skin care products – Hindustan Times

By daniellenierenberg

The era of environmentally conscious users has hit the market; and theres a sharp increase of customers who prefer sustainable life choices. They tend to seek out and promote cruelty-free products and brands. Consumers today are becoming more and more vigilant about the ingredients used in their favourite merchandise, the technology, and science behind it all, especially when it comes to cosmetics.

This change in mindset has created a completely new sector of skincare: vegan products. Completely warding off any animal products or by-products, veganism is becoming the popular choice of the modern world. Having a vegan outlook helps in the detoxing of your body and gives great health benefits to your skin. Plabita Sharma, a skincare expert at The Body Shop, India, underlines some benefits of vegan skincare products:

Skin-friendly: Vegan products are a rich source of nourishment and natural goodness as they are made from plants, minerals, and some safe synthetic ingredients.

Animal-friendly/not tested on animals: While not everyone is an animal rights activist, but knowing the essentials used on your skin are not tested on animals is guilt-free in itself.

Safe from harmful chemicals: Choosing vegan products will save you from harmful chemicals and cruel cosmetics and give you glowing skin.

Prevents various skin problems: Vegan products decreases the chances of skin problems such as rashes, allergies, eczemas, acne, skin inflammation and skin diseases due to lack of chemicals used. These are perfect for sensitive skin.

Remedy for all skin concerns: Ingredients such as Vitamin E, Vitamin A, Red Algae, Coconut Oil, Plant stem cells and alike products benefit the skin addressing all kinds of concerns. Like Vitamin C for radiance, Tea tree oil for grumpy acne, aloe vera to soothe the skin, wheat germ oil to nourish the skin and many more.

(This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed.)

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Discovery of New Method Speeds Up Precision 3D Bioprinting – ENGINEERING.com

By daniellenierenberg

Discovery of New Method Speeds Up Precision 3D BioprintingAndrew Wheeler posted on November 19, 2019 |

In the world of additive manufacturing (AM), the promises of bioprinting would be truly groundbreaking if they were to be kept and fully realized. The unscalable mountain is the ability to 3D print patient-specific organs. There would be no more organ rejection from transplants in post-operative care. In 2017, Gartner predicted that this medical innovation would occur within a decade.

Currently, simple tissues are 3D printed by various companies. For example, Poietis established and commercialized a laser methodology for 3D printing biological matter like skin cells and liver tissue. They released a commercial skin product in 2018 and established a partnership with LOral and BASF. Another example comes from the company CELLINK. It makes bioprinters used by pharmaceutical researchers in order to test the effects of drugs on living human tissue.

The technology and techniques of 3D bioprinting still have a long way to go before patient-specific organ transplants transform from fantasy to reality. Recent developments from TU Wien in Austria highlight one of the main factors in achieving what is now impossible: speed.

These are living cells photographed in a 3D scaffold. Weeks 1, 3 and 5 are pictured from left to right. The top images show the 3D setup and the bottom shows just one layer. The indications for increased precision and speed are significant for bioprinting and the ultimate goal of 3D printing patient-specific organs for transplants. (Image courtesy of TU Wien.)

The 3D scaffold and bioink developed at TU Wien will allow researchers to achieve new levels of accuracy in ongoing studies about the behavior of cells. The cell behavior as diseases spread is an important aspect of discovering new treatment methods. The introduction of stem cells to the new process makes it possible to create fully customized tissue.

3D bioprinting techniques differ in many ways. Some are less precise while others produce cells that do not last very long. Some cells produced through 3D bioprinting have material properties that limit their efficacy.

Cell behavior can differ greatly depending the chemical properties, shape and mechanical nature of the environment. For example, it is important for the environment to be permeable in order to ensure the survival and multiplication of cells embedded within. Countering that, the environment must strike the right type of balance in respect to stiffness and flexibility so that the structures do not degrade.

The key is to have new environments for embedding the cells, either liquids or gels, that solidify exactly where they are shot with a focused laser beam. The catch-22 is that the laser beam and the materials must not in any way harm the embedded living cells, and it has to happen as rapidly as possible.

TU Wien researchers solved this complex issue by using two-photon polymerization methods. These methods use a chemical reaction that has specific prerequisites for activation. When a molecule of the material that makes up the environment where the living cells are embedded absorbs two photons, an extremely intense laser beam activates a chemical reaction. At the precise point where the two photons are absorbed, the environmental substance stiffens but the surroundings remain liquid. The level of precision and intricacy at which structures can be constructed increases.

This process alone is slow, but using scaffolds has helped researchers develop a method that enables them to print structures in a few hours. Additionally, these new structures have an increased likelihood of surviving and living longer.

Researchers can now define exactly how an environmental structure should behave to foster specific types of cell migration and growth. They also can predict with greater accuracy how long a structure will last and when it will degrade.

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"I was 18 when I came home and told my mum I was being sexually harassed at work." – Mamamia

By daniellenierenberg

Tonight, the ABC will air a three-part documentary series tackling sexual harassment in the workplace.

Among many other brave and formidable women, one of the people featured in the documentary is me.

Except, ironically, you cant actually know what happened to me. What precisely was done to me, which led me to being on your TV screens. You also cant know how my employers handled the situation. You cant know what happened to that perpetrator.

Despite the name of the documentary, Silent No More, I, for a large part, am legally silenced.

This is absolutely through no fault of the incredible documentary makers, who fought so hard for the inclusion of my story. Rather, the non-disclosure agreement (NDA) I signed when I resigned from the workplace after experiencing ongoing sexual harassment from this one employee.

I suppose one of the questions on your mind must be what compelled me to sign an NDA. I had just turned 18 when the perpetrator walked into my life. I was also 18 when I resigned and the settlement, including the NDA, was processed.

Now 21, I dont think Im far enough away from the experience to truly understand how my age impacted the situation. However, I am certain that when youre 18 and your employers, colleagues and perpetrator arent, the imbalance of power between all parties is only tipped further.

At no age is it easy to stare down the barrel of a sexual harassment case, but when youre 18 years old and receiving letters from lawyers, my mind said to get out. Fast.

When I first told my mum what this man was doing to me at work, I just wanted to resign. I didnt want to report. I just so desperately wanted to get out. I had become terrified and physically sick with fear at work, that I wanted the fastest one-way route out of that place: resignation.

With some convincing from my mum and a lawyer, we started some very simple proceedings. Opening up conversations with the employer about my options. To be transparent, I could have escalated my claim to the states Workplace Health and Safety regulator or taken it to court. It was explained that both of those could be quite long and rigorous processes to endure.

And, like many people who dont report allegations of violence, they were simply processes I could not endure. Few people warned me the process of reporting, which I cant talk about, would incur a different type of trauma to the harassment itself. I still had uni to go to the next day, work in my other jobs, and also be an 18-year-old who didnt run home fuelled by bottled panic from the train station.

So, thats how we came to me resigning and settling. Settlement involves a whole bunch of things and agreements, which you cant know about, but the biggest part of the settlement is the NDA inclusion.

I balanced what the settlement gave me; my safety, against what it took away from me; my ability to explain what had been done to me, and I chose my safety.

Despite the way it tears at my heart that people cant know about my experiences, I would choose my safety again. Because, unfortunately, we still do live in a cruel structure that makes many of us choose.

Safety.

Or, your voice.

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The fountain of youth? I tested a better anti-ageing program in Switzerland – Metro.co.uk

By daniellenierenberg

In Switzerland we know how to make watches. We also know how to stop time, reads the giant poster in the lobby.

Im at Victoria-Jungfrau Grand Hotel and Spa in Interlaken to sample their Better Aging program and find out if you really can stop the clock and stay looking young or if such ideas are just cuckoo.

The area certainly has a feel of youthful exuberance about it when I arrive Im greeted by paragliders, their colourful canopies drifting down onto the green across from the hotel. During my stay, not a day goes by without seeing the red and yellow wings in death-defying loops.

I can watch them from my room a smart black, brown and gold chamber housing a hard double bed with two single duvets, the traditional Swiss arrangement presumably designed to prevent greedy partners from hogging the covers. Every evening theres a Swiss truffle on my pillow.

The balcony looks out towards the Bernese Alps and the snowy peaks of Jungfrau, which means young woman or maiden. The setting of my anti-ageing quest really couldnt be better.

My journey begins at Nescens Spa, a bright space with lots of natural light, candles and trailing plants.

Spa director Hans-Peter notes down my vitals and bids me stand on a body analysis machine before Im whisked off to a room with personal trainer Brigitte, an intimidatingly fit-looking 49-year-old with a blonde crop.

Its not all bad news I have more muscle than her but I have a lot of body fat (not exactly news to me). She tells me my visceral fat is of particular concern and, among other things, advises me to avoid fruit with a high sugar content such as pineapple and grapes.

The next step is easier to take a de-stressing massage using anti-ageing Nescens oil. This should smoothe the skin and boost cell recapitalisation. The massage is gentler than others Ive had, and quite relaxing, but I cant say my skin looked different afterwards.

The spa does boast outstanding relaxation areas, however. Comfortable couches with mountain views, a smart sauna and the apex of steam rooms with twinkly lights in its starry ceiling, a fountain in middle and a gentle mint scent wafting through the air.

The next morning we come at the ageing issue via exercise with a morning of gentle Pilates. Its run by another uber-fit blonde, Iris.

Then its time for a Better Aging lunch beetroot, goats cheese and orange salad followed by a delicious sea bream with basillicum and vegetables.

Usually guests on the programme stay for at least four days, during which time meals are matched to help them achieve their fitness goals but this cant be easy with a pizzeria, Sapori, as part of the hotel.

The afternoon is dedicated to more exercise a brisk 5km walk with Iris again, through woodland and along the river, emerald with glacier water.

I have the highest hopes for todays anti-ageing treatment a classic silk bliss facial using Sensai products.

My beautician, Nicole, explains how the silk in the range was previously reserved for the Emperor of Japan. Apparently the products can activate your stem cells to help remove wrinkles.

The facial begins with Sensai Silky Purifying Creamy Soap followed by a steamer to open the pores, and some seriously thorough extraction work.

Next came the Silky Purifying Silk Peeling Mask and a mud soap wash and mask, left for six minutes. Finally came four more serums and creams.

My skin looked blotchy but felt very soft afterwards like a velvety cushion. The blotchiness was gone within half an hour, replaced with a glow. The next morning I could feel a spot coming on my neck but my face was plump, smooth and even.

The next day, after a Better Aging breakfast of light bites including tomatos, olives and smoothies, Im back with Brigitte for Nescens Full Body Training. Im cheered by the sight of some pensioners in the class. How hard can it be?

Quite hard, is the answer a full-on but not unbearable 45 minutes of planks, sit ups, star jumps and stretching giant blue elastic bands.

Afterwards I reward myself with a swim in the stunning pool. The main spa has a white, black and gold theme and incredible views.

It also has a lovely outdoor jacuzzi which you swim out to, with bubble beds, jets to massage your feet and back, and a clearer look at the mountains.

At the end of my trip I was more relaxed, my skin felt smoother and I felt fitter. While I may not look younger, as someone approaching 40 Im certainly less stressed about ageing.

Victoria-Jungfrau Grand Hotel and Spa (Picture: Yvette Caster/Metro.co.uk)

Where to stay in Switzerland

Rooms at Victoria-Jungfrau Grand Hotel and Spa cost from 296 per night, with breakfast. Better Aging guests get a 50 per cent discount in high season and 25 per cent discount in low season.

The Better Aging program lasts from four days and costs from 2,499 per person, which includes treatments, personal training and meals.

I flew with Swiss Air from Heathrow to Zrich. Flights cost from 177 return.

To get to the spa I took the train from Zrich airport to Interlaken OST via Bern. Return tickets cost from 116 via Switzerland Tourism. The hotel was about five minutes from the station by taxi.

A Swiss Travel Pass offers unlimited travel throughout the rail, bus and boat network. It includes entrance to 500 museums and costs from 185.

For more on Switzerland visit http://www.MySwitzerland.com.

Where to stay in Heathrow

I stayed at the Radisson Blu Edwardian Heathrow a decadent way to extend the spa experience.

The lobby features an impressive chandelier and theres dark wood and bronzes throughout.

The hotels spa has just had a revamp, and has a relaxation area, cosy sauna, powerful jacuzzi and beautiful blue and gold steam room.

The revamped Radisson spa at the hotel (Picture: Yvette Caster/Metro.co.uk)

I loved the showers you use between each part of the spa. Im sure they would delight fellow Pratchett fans, bringing to mind the Archchancellors bathroom as they do. There were buttons for cold mist, Caribbean storm and waterfall (but thankfully no Old Faithful).

I also tried their chocolate orange massage a thorough, full body treatment. I wasnt overpowered by scent and only really noticed the mild smell of cocoa when it was applied to my chest. It left me feeling refreshed and smelling sweet.

The hotel has two places to dine, Indian restaurant Anayu and Steak and Lobster. My T-bone steak was pleasant, although the blue cheese sauce was a bit bland, while the skinny fries were deliciously seasoned.

I enjoyed chatting to Radissons virtual host, Edward. You can text him anything 24/7 order room service, ask for late checkout and enquire about hotel services. It was like having my own PA.

Rooms at Radisson Blu Edwardian cost from 76.50 per night. They are offering Stay, Park and Fly packages from 102.50 per night, including parking for trips for eight to 15 days.

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Solve Your Problem (Skin) With These Top-Rated Acne Products From Sephora – POPSUGAR

By daniellenierenberg

Acne is a bummer, whether it shows up on your big day . . . or just a Monday. Chances are you've had to deal with it at some point in your life. (That's why you're reading this, right?) Whether the problem is hormonal, cystic, or something else entirely, it's pretty safe to say no one is excited when they see a new pimple in the mirror.

Now's the time to break up with breakouts for good. Here are top-rated products to add to your clear skin arsenal, straight from Sephora.

You'll find solutions to brighten and treatments to lighten (old scars), not to mention products that exfoliate skin and zap zits. There's even makeup for pimple-prone skin, too.

If you're ready to stage an acne attack (that's an attack on acne, not of acne), find the blemish-blasting products from Sephora that other shoppers are loving ahead.

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Scientists find a cell that helps tadpoles tails regrow – Fourways Review

By daniellenierenberg

Aristotle already observed in the fourth century B.C. that some animals can regrow their tails after losing them, but the mechanisms that support this kind of regeneration remain difficult to understand.

Using single-cell genomics, scientists at the Wellcome Trust / Cancer Research UK Gurdon Institute at the University of Cambridge developed an innovative strategy to show what happens in different tadpole cells when they regenerate their tails.

Recent advances at Cambridge in next-generation single-cell sequencing mean that scientists can now track which genes are turned on throughout a whole organism or tissue, at the resolution of individual cells. This technique, known as single-cell genomics, makes it possible to distinguish between cell types in more detail based on their characteristic selection of active genes.

These groundbreaking discoveries are beginning to reveal a map of cellular identities and lineages, as well as the factors involved in controlling how cells choose between alternative pathways during embryo development to produce the range of cell types in adults.

Using this technology, Can Aztekin and Dr Tom Hiscock under the direction of Dr Jerome Jullien made a detailed analysis of cell types involved in regeneration after damage in African clawed frog tadpoles (Xenopus laevis). Details were published in the journal Science.

Dr Tom Hiscock said: Tadpoles can regenerate their tails throughout their life; but there is a two-day period at a precise stage in development where they lose this ability. We exploited this natural phenomenon to compare the cell types present in tadpoles capable of regeneration and those no longer capable.

The researchers found that the regenerative response of stem cells is orchestrated by a single sub-population of skin cells, which they named Regeneration-Organizing Cells, or ROCs.

Can Aztekin said: Its an astonishing process to watch unfold. After tail amputation, ROCs migrate from the body to the wound and secrete a cocktail of growth factors that coordinate the response of tissue precursor cells. These cells then work together to regenerate a tail of the right size, pattern and cell composition.

In mammals, many tissues such as the skin epidermis, the intestinal epithelium and the blood system, undergo constant turnover through life. Cells lost through exhaustion or damage are replenished by stem cells. However, these specialised cells are usually dedicated to tissue sub-lineages, while the ability to regenerate whole organs and tissues has been lost in all but a minority of tissues such as liver and skin.

Professor Benjamin Simons, a co-author of the study said: Understanding the mechanisms that enable some animals to regenerate whole organs represents a first step in understanding whether a similar phenomenon could be reawakened and harnessed in mammalian tissues, with implications for clinical applications.

This research was funded by the University of Cambridge, the Cambridge Trust andthe Wellcome Trust;and supported by theEuropean Molecular Biology Organization, the Royal Society,theEuropean Molecular Biology Laboratory, and Cancer Research UK.

Source: University of Cambridge Research

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Calquence approved in the US for adult patients with chronic lymphocytic leukaemia | Small Molecules | News Channels – PipelineReview.com

By daniellenierenberg

DetailsCategory: Small MoleculesPublished on Friday, 22 November 2019 14:04Hits: 311

Two Phase III Calquence trials demonstrated superior progression-free survival across multiple settings while maintaining favourable tolerability

Calquence combined with obinutuzumab and as monotherapy reducedthe risk of disease progression or death by 90% and 80%, respectively in ELEVATE-TN

LONDON, UK I November 21, 2019 I AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).1 The US approval was granted under the FDAs Real-Time Oncology Review and newly established Project Orbis programmes.

The approval is based on positive results from the interim analyses of two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL. Together, the trials showed that Calquence in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death versus the comparator arms in both 1st-line and relapsed or refractory CLL. Across both trials, the safety and tolerability of Calquence were consistent with its established profile.1

Dave Fredrickson, Executive Vice President, Oncology Business Unit said: With over 20,000 new cases anticipated this year in the US alone, todays approval of Calquence provides new hope for patients with one of the most common types of adult leukaemia, offering outstanding efficacy and a favourable tolerability profile. The chronic lymphocytic leukaemia patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment.

Dr Jeff Sharman, Director of Research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for The US Oncology Network, and a lead author of the ELEVATE-TN trial, said: Tolerability remains an issue in the current treatment landscape of chronic lymphocytic leukaemia, which may require ongoing therapy for many years. In the ELEVATE-TN and ASCEND trials comparing Calquence to commonly used treatment regimens, Calquence demonstrated a clinically meaningful improvement in progression-free survival in patients across multiple settings, while maintaining its favourable tolerability and safety profile.

The results of the interim analysis of the ELEVATE-TN trial will be presented at the upcoming American Society of Hematology congress.2

The trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with either Calquence in combination with obinutuzumab or Calquence monotherapy versus chlorambucil chemotherapy plus obinutuzumab, a current standard-of-care combination used in the control arm.1

In the Calquence combination arm, risk of disease progression or death was reduced by 90% (HR 0.10; 95% CI, 0.06-0.17, p<0.0001) and in the monotherapy arm it was reduced by 80% (HR 0.20; 95% CI, 0.13-0.30, p<0.0001).1

The median time to disease progression for patients treated with Calquence in combination with obinutuzumab or as a monotherapy has not yet been reached versus 22.6 months (95% CI, 20-28) for chlorambucil plus obinutuzumab.1

ELEVATE-TN safety overview (most common ARs, 15%):1

Includes multiple ADR terms.

In patients treated with the combination of Calquence plus obinutuzumab, adverse reactions (ARs) led to treatment discontinuation in 11% of patients and a dose reduction of Calquence in 7% of patients. In the monotherapy arm, ARs led to discontinuation in 10% and dose reduction in 4% of patients.1 In the control arm, ARs led to regimen discontinuation in 14% of patients with a dose reduction of chlorambucil in 28% of patients.3 There were no dose reductions for obinutuzumab.1,3

In 1,029 patients with haematologic malignancies who were treated with Calquence 100mg approximately every 12 hours across multiple clinical trials, where 88% received treatment for at least six months and 79% received treatment for at least one year, serious or Grade 3 infections occurred in 19%, and Grade 3 atrial fibrillation and flutter occurred in 1.1% of patients.In the same patient population, major haemorrhage occurred in 3.0% (serious or Grade 3 bleeding or any central nervous system bleeding), with fatal haemorrhage occurring in 0.1% of patients. Second primary malignancies (all grades) including skin cancers occurred in 12% of patients.1

The US approval is among the first to be granted under Project Orbis, an initiative of the US FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicines among international partners. The FDA, the Australian Therapeutic Goods Administration, and Health Canada collaborated on this review. 4

About Calquence

In the US, Calquence (acalabrutinib) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). In the US, Canada, Australia, Brazil, Qatar, the United Arab Emirates, Mexico, Argentina, Singapore, Chile, and recently India, Calquence is indicated for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Approved under accelerated review in the US, continued approval for previously treated MCL is contingent upon verification and confirmation of clinical benefit in confirmatory trials.

Calquence is a next-generation selective inhibitor of Brutons tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.1,5,6,7 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.1

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in 23 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenstrm macroglobulinaemia and follicular lymphoma and other haematologic malignancies. Several Phase III clinical trials in CLL are ongoing, including ASCEND, ELEVATE-TN, ELEVATE-RR (ACE-CL-006) evaluating Calquence versus ibrutinib in patients with previously treated high-risk CLL, and ACE-CL-311 evaluating Calquence in combination with venetoclax and with/without obinutuzumab versus chemoimmunotherapy in patients with previously untreated CLL without 17p deletion or TP53 mutation.

About ELEVATE-TN

ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy ofCalquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone versus chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg twice daily until disease progression or unacceptable toxicity) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity).1,8

The primary endpoint is PFS in the Calquence and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint is IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Other secondary endpoints include objective response rate, time to next treatment and overall survival.1,8

About ASCEND

ASCEND (ACE-CL-309) is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in previously treated patients with CLL. In the trial, 310 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity). Patients in the second arm received investigators choice of either rituximab, a CD20 monoclonal antibody, in combination with idelalisib, a PI3K inhibitor, or rituximab in combination with bendamustine, a chemotherapy.1,9

The primary endpoint is PFS assessed by an IRC, and key secondary endpoints include physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as overall survival, patient-reported outcomes and time to next treatment.1,9

About CLL

Chronic lymphocytic leukaemia (CLL) is one of the most common types of leukaemia in adults, with an estimated 105,000 new cases globally each year and 20,720 new cases in the US in 2019, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.10,11,12,13 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.10 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets.10 This could result in anaemia, infection and bleeding.10 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

About AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Companys haematology franchise includes two US FDA-approved medicines and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZenecas haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients lives and the Companys future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZenecas main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

References

1. CALQUENCE (acalabrutinib) [prescribing information]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.

2. Sharman JP, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Abstract 31 at: American Society of Hematology 2019 Annual Meeting and Exposition. Available online. Accessed November 2019.

3. Data on File. REF-64711. AstraZeneca Pharmaceuticals LP, Wilmington, DE.

4. US Food and Drug Administration. Project Orbis. Available online. Accessed November 2019.

5. Wu J, Zhang M & Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).

6. Khan Y & OBrien S. Acalabrutinib and its use in treatment of chronic lymphocytic leukemia. Future Oncol. 2018;15(6).

7. Byrd JC, et al. Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016; 374:323-332.

8. ClinicalTrials.gov. Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL. NCT02475681. Available online. Accessed November 2019.

9. ClinicalTrials.gov. A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL. NCT02970318. Available online. Accessed November 2019.

10. National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)Patient Version. Available online. Accessed November 2019.

11. Global Burden of Disease Cancer Collaboration. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016. JAMA Oncol. 2018;4(11):1553-1568.

12. American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Available online. Accessed November 2019.

13. Jain N, et al. Prevalence and Economic Burden of Chronic Lymphocytic Leukemia (CLL) in the Era of Oral Targeted Therapies. Blood. 2015;126:871.

SOURCE: AstraZeneca

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Scientists find a cell that helps tadpoles tails regrow – North Coast Courier

By daniellenierenberg

Aristotle already observed in the fourth century B.C. that some animals can regrow their tails after losing them, but the mechanisms that support this kind of regeneration remain difficult to understand.

Using single-cell genomics, scientists at the Wellcome Trust / Cancer Research UK Gurdon Institute at the University of Cambridge developed an innovative strategy to show what happens in different tadpole cells when they regenerate their tails.

Recent advances at Cambridge in next-generation single-cell sequencing mean that scientists can now track which genes are turned on throughout a whole organism or tissue, at the resolution of individual cells. This technique, known as single-cell genomics, makes it possible to distinguish between cell types in more detail based on their characteristic selection of active genes.

These groundbreaking discoveries are beginning to reveal a map of cellular identities and lineages, as well as the factors involved in controlling how cells choose between alternative pathways during embryo development to produce the range of cell types in adults.

Using this technology, Can Aztekin and Dr Tom Hiscock under the direction of Dr Jerome Jullien made a detailed analysis of cell types involved in regeneration after damage in African clawed frog tadpoles (Xenopus laevis). Details were published in the journal Science.

Dr Tom Hiscock said: Tadpoles can regenerate their tails throughout their life; but there is a two-day period at a precise stage in development where they lose this ability. We exploited this natural phenomenon to compare the cell types present in tadpoles capable of regeneration and those no longer capable.

The researchers found that the regenerative response of stem cells is orchestrated by a single sub-population of skin cells, which they named Regeneration-Organizing Cells, or ROCs.

Can Aztekin said: Its an astonishing process to watch unfold. After tail amputation, ROCs migrate from the body to the wound and secrete a cocktail of growth factors that coordinate the response of tissue precursor cells. These cells then work together to regenerate a tail of the right size, pattern and cell composition.

In mammals, many tissues such as the skin epidermis, the intestinal epithelium and the blood system, undergo constant turnover through life. Cells lost through exhaustion or damage are replenished by stem cells. However, these specialised cells are usually dedicated to tissue sub-lineages, while the ability to regenerate whole organs and tissues has been lost in all but a minority of tissues such as liver and skin.

Professor Benjamin Simons, a co-author of the study said: Understanding the mechanisms that enable some animals to regenerate whole organs represents a first step in understanding whether a similar phenomenon could be reawakened and harnessed in mammalian tissues, with implications for clinical applications.

This research was funded by the University of Cambridge, the Cambridge Trust andthe Wellcome Trust;and supported by theEuropean Molecular Biology Organization, the Royal Society,theEuropean Molecular Biology Laboratory, and Cancer Research UK.

Source: University of Cambridge Research

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AI helps cells pull themselves together – Cosmos

By daniellenierenberg

By Paul Biegler

US scientists have overcome a major stumbling block in the creation of mini-organs, programming cells to take on the desired shape rather than relying on 3D printing or external scaffolds.

This inside out approach, described in a paper in the journal Cell Systems, could signal a paradigm shift in how mini-hearts, kidneys and brains are grown on the lab bench a technique used to study disease that may one day lead to personalised organ transplants.

The team, led by bioengineer Todd McDevitt at Gladstone Institutes in the US, was driven by an enduring issue with state-of-the-art ways of producing mini-organs such as 3D printing. The cells just wont stay put.

Making a mini-organ or organoid starts when scientists take a persons skin cell and, using the right mix of agents, turn it into an induced pluripotent stem cell. This IPS cell is the blank cheque of biology, capable of becoming almost any cell type.

Grow it into a mini-kidney, say, and you can reproduce kidney diseases and test treatments in a dish sitting on your lab bench. But how faithful that model is depends on the physical organisation of the cells; to mimic a real deal kidney, 3D printing is often used.

But cells, much like unruly teenagers, have a mind of their own and will often wander away from their printed position.

McDevitts team wanted to own those cellular minds and so took control of two genes that together make up something of a joystick that directs how the cells organise.

CDH1 and ROCK1 figure heavily in the complex moves that lead to the final configuration of a group of cells. The pair influences stickiness and repulsion between cells, the surface tension that makes them spherical and their overall speed of migration.

The researchers used the editing tool CRISPR to knock out the two genes at various stages in the evolution of a clump of cells. Their aim was to make a bulls eye pattern, a shape thats common in human development, including in early embryo formation.

To detect that aspirational pattern, they engineered another tweak making the cells fluoresce when CDH1 and ROCK1 were neutralised.

But there was a problem.

Factor in all the potential time points where the genes could be knocked out, the proportion of cells to be targeted, and a host of other variables, and the researchers calculated theyd need to do nearly 9000 trial-and-error experiments.

So they called on AI. They trained a machine learning model to compute the precise pattern of gene knockouts needed to realise their dream shape.

Machine learning can predict what movie you might like based on your viewing history, but it can also generate new insights into biological systems by mimicking them, says co-author Demarcus Briers, from the Boston University Bioinformatics Program.

Our machine-learning model allows us to predict new ways that stem cells can organise themselves, and produces instructions for how to recreate these predictions in the lab.

That model hit a bulls eye, quite literally, allowing the team to produce the concentric pattern of cells they were aiming at.

"We've shown how we can leverage the intrinsic ability of stem cells to organise," says McDevitt. "This gives us a new way of engineering tissues, rather than a printing approach where you try to physically force cells into a specific configuration."

Ultimately, that concrete target shape will give way to a target in the abstract, one with potential to shift the life course.

"We're now on the path to truly engineering multicellular organization, which is the precursor to engineering organs," McDevitt says. "When we can create human organs in the lab, we can use them to study aspects of biology and disease that we wouldn't otherwise be able to."

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Ten brands blurring boundaries in personal care and beyond – The Drum

By daniellenierenberg

They always say time changes things, but you actually have to change them yourself. Andy Warhol

As the early adopter mindset filters out into mainstream thinking and behaviors, brands need no longer target their innovations towards a small group of consumers the floor is open and the consumer demand growing across all demographics for brand innovation.

The boundaries of what we might have traditionally considered as personal care are shifting with brands exploring new territories and opportunities to take care of the body and mind from a more holistic perspective.

Here we take a look at a selection of ten current and emerging trends from brands leading notable movements of change.

New occasions

Brands developing targeted personal care solutions for the more active amongst us are on the rise. Natural luxury spa brand Espa have launched a new body care collection designed for use post workout, and include a Muscle Rescue Balm and Fitness Shower Oil specially formulated to sooth tired muscles.

Mantastic expressions

Practical and affordable male grooming brand Harrys questions conventional definitions of what it means to be a man, celebrating the messiness of masculinity and championing social causes that challenge outdated stereotypes. The subtle and playful illustration of a Mammoth on the pack calls attention to the brand's message that extinct perceptions of masculinity need to be abolished.

Sustainable living

Born from a belief that small changes can have a big impact, Eco + Amour has collaborated with some of the trendiest eco-conscious brands to offer a refillable, more sustainable, beauty, personal care and home care shopping experience. No doubt Im not the only one with at least three different moisturizers and deodorants in the bathroom at any one time - refreshingly, Eco + Amour encourages consumers to only buy what they need.

Eco-friendly packaging

Netherlands based designer Don Yaw Kwaning is exploring sustainable innovation using the soft rush plant. Through a process of separating the pith from the fibers, you are left with a foam which has lightweight, shock-resistant and insulating properties all without the need for bonding agents. The fibers can be developed into materials such as paper and corrugated cardboard, a fantastic new eco-packaging solution.

Clean living, clean design

The broader trend towards clean living (both in terms of health and sustainability) and clean beauty has been broadly adopted across the personal care category particularly by more agile brands. For the most part, the fragrance category has been slow to respond, continuing to follow traditional premium colours, codes and cues. Minimalism is the new luxury and Le Labo is a great benchmark - a sight for sore eyes and indeed has clear stand out on shelf against the swathe of rose gold and metallic designs of other fragrance super brands. Taking cues from the premium spirits category with the bottles heavy foot, the label design also mimics tasting notes as though from a distillery. A fantastic example of the value in looking cross-category for design inspiration.

Leveraging health and wellness

In support of the ever-popular self-care movement, personal care brands have an opportunity to incorporate health and wellness solutions into their product functionality and design. Japanese haircare brand Feather Aqua explores holistic health and wellness for the scalp founded on the premise that taking care of your head takes care of your hair. The brand uses amino acids and natural plant extracts coupled with aromatherapy fragrances to also elevate the state of mind and mood of the consumer.

New wave supplements

Wellness start-up Hello.me has recently launched a special natural supplement designed to combat the negative effects of using contraceptive pills. The Top Up Tonic reportedly relives symptoms such as bloating, mood swings and breast tenderness.

Harnessing advances in technology

World leader in regenerative medicine, Professor Augustinus Bader has utilized the restorative power of stem-cell technology to provide consumers with the ultimate solution in high-end anti-ageing skincare. The TFC8 patented technology activates the bodys stem cells to biologically repair damage to the skin caused by lifestyle and environmental factors mobilizing our bodys natural abilities to renew.

Delicious derrires

Never has Sir Mix-A-Lot been more relevant. Products aimed at targeting elasticity, firmness, dry skin and sagging of the bottom have flooded the market over the last year. Masks in particular are on the rise. Niche Los Angeles brand Anese brings us Down with the thickness, a collagen mask that detoxes, plumps and softens your bottom.

A sculpting revolution

The onslaught of easily accessible fitness solutions across social media and personalized app technologies has begun to filter out into the personal care market. Be for Beauty brings us a BOD range (Body on Demand), a ritual of products designed to tighten and sculpt the body through the reduction of water retention. The range includes bath salts which are designed to tone the body, clear out excess toxins and can supposedly eliminate up to 3lbs of excess water retention weight all within a 20-minute soak.

Kirsty Cole, head of growth at Anthem Amsterdam & Brussels.

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Regenerative Medicine: Overcoming The Supply Chain Challenges – Contract Pharma

By daniellenierenberg

Regenerative medicine is one of modern sciences most exciting developments. Defined by the Medical Research Council, regenerative medicine is an interdisciplinary field that seeks to develop the science and tools that can help repair or replace damaged or diseased human cells or tissues to restore normal function.

In the human body, the liver is the only organ capable of regenerating itself spontaneouslyeven after serious injurybut in the future, any part of the human body may be capable of doing so. Our own cells will also be able to treat and cure diseases and conditions of the blood and immune system, as well as restore the blood system after treatments for specific cancers.

Once only imaginable in science fiction, the latest applications include engineered skin tissue to treat burn victims, custom-grown bones for implants and joint replacements, personalized dietary treatments using gut bacteria and just recently, the worlds first 3D vascularized engineered heart was created using a patients own cells and biological materials.

As scientists understanding and the tools at their disposal become more advanced, the closer to the widespread commercialization of regenerative medicine the pharmaceutical industry finds itself.However, offering regenerative medicine therapies at scale requires one of the biggest shake-ups to the global pharmaceutical supply chain ever seen. Without it, the world risks missing out on the curative promises of this next-generation medical technology.

Regenerative medicine is one of, if not the most, exciting advancements in modern science which has far-reaching benefits for big pharma, healthcare systems and patient outcomes.

Regenerative medicine is a growth industry in more than one sense of the word; as a sector, its growing from strength to strength. In fact, last year the global regenerative medicine market was worth $28 billion and its expected to grow to $81 billion by 2023.

As a more efficient and less invasive alternative to transplanting cells or organs to replace damaged or lost tissue, established pharma companies alongside small biotech start-ups are racing to discover and bring to market medicine-based approaches that stimulate the bodys natural ability to repair itself.The cutting-edge innovations of regenerative medicine generally fall into three distinct categories:

Replenish Replace Rejuvenate

Stem cells can generate vital growth factors to naturally reduce inflammation, increase muscle mass, repair joints, grow hair and boost the immune system, replenishing the body. Organ regeneration and 3D printing are replacing the reliance on the failing donor system and overcoming the issue of organ rejection. The root causes of aging are being better understood and delayed by using stem cells to rejuvenate the body.

Marking a new era in healthcare and one which has the promise of addressing the needs of an aging population challenged by escalating chronic diseases, regenerative medicine is certainly a game-changer. Beyond more effective medical treatments that can be applied routinely despite age, comorbidities, or disease severity, it also has the potential to cure many of todays incurable diseases and support healthcare systems to move towards a preventative model.

Today, regenerative medicine is largely confined to a research environment. In fact, according to a recent report, there were 1,028 clinical trials for regenerative therapies taking place globally at the end of 2018.

Regenerative medicine is poised to transform healthcare as we know it, offering potential cures for deadly diseases which before would require long-term treatment to manage. However, while billions are being spent on regenerative medicine research and clinical studies, little resource has, so far, been allocated to the management and delivery of innovative medical therapies at scale.

Currently, the race appears to be on between smaller Medtech companies and large multi-national pharmaceutical companies to see who wins first-mover advantage in the regenerative medicine market. Today, many established pharmaceutical companies prefer to partner with Medtech startups to in-license products in early clinical development stages as opposed to conducting early development on their own which comes at a huge cost. This is a risk-reduction tactic, but it could mean big pharma misses the boat.

The question remains unanswered as to whether a peer-to-peer collaborative model will prosper where Medtech companieswho are in some instances one step ahead of big pharma in terms of drug developmentare happy to be a third-party provider to big pharma who have the budgets and networks to truly deliver the regenerative medicine revolution.

Regulation is, and will continue to, play a hugely important role in delivering regenerative medicines from a lab setting to a clinical setting. Only recently, the FDA announced a new policy framework for the development of regenerative medicine products, taking into account the dynamic and fast-moving nature of the field.

Ultimately, the governments aim is to protect patients from products that pose potential significant risks, while accelerating access to safe and effective new therapies according to Former FDA Commissioner Dr. Scott Gottlieb. The FDA plans to achieve this over the coming years by driving stakeholder engagement with the developing regulatory framework in order to efficiently advance access to safe and effective regenerative medicine advanced therapies.

However, so far, progress by the pharma industry in coming into compliance with FDAs regulations for regenerative medicines has been slow, despite the grace period set by the FDA before it fully exercises enforcement fast approaching (ending in November 2020).

In order to speed up the process of bringing novel medicines to market, the FDA is toying with the idea of fast-tracking products that are deemed low risk to patients if sponsors have engaged with the regulatory process and demonstrated responsibility by filing Investigational New Drug Applications (INDs).

The FDA has also promised to strengthen its enforcement action against drug developers who are marketing unapproved products, prioritizing cases where the threat to patient health and safety is largest.For example, last November the FDA stepped in where a Californian business was selling stem cell products using umbilical cord blood for the treatment of arthritis and other conditions, despite this form of treatment not having FDA approval for that particular use. Several patients (at least 12) undergoing this treatment were hospitalized after developing infections of the bloodstream and joints, as well as abscesses along the spine and skull.

In summary, one of the FDAs central aims over the coming years is to drive stakeholder engagement with the developing regulatory framework for regenerative medicine advanced therapies in order to efficiently advance access to safe and effective new products.

The promise of regenerative medicine requires an innovative look at the complete product lifecycle, including the development of an efficient distribution network.

Once these novel drugs become mainstream, the entire healthcare ecosystem will have to adapt. Regulatory approval for any drug relies on it safely and successfully fulfilling its medical intent. As such, information about supply chain management needs to be submitted to the regulator after the completion of phase three clinical trials, including packaging, labeling, storage and distribution.

The clinical supply chains required to deliver these therapies are arguably the most complex the industry has seen so far, even more so than for biologic medicine. Thats because, unlike many mass-market drugs, regenerative medicine is either personalized or matched to a unique donor-recipient.

The distribution of regenerative medicine therapies is further complicated by the fact they are also extremely sensitive to exogenous factors like time and temperature. Therefore, there are strict conditions under which these therapies must be transported and received.

Advanced IT solutions and monitoring systems are being developed and employed to ensure end-to-end traceability across the pharma supply chain. These are giving clinicians access to view the progress of therapies and their distribution in real-time and allow users to automatically schedule or amend material collections in line with manufacturing capacity, helping to keep the supply chain as agile as possible and avoid costly wastage.

The live tissues and cells which form the basis of regenerative medicine products are highly sensitive and some have a shelf life of no more than a few hours, making distribution a complex task. Therefore, materials need to be transported from the site of harvest to manufacturing facilities, and from manufacturing facilities to medical institutions under strictly controlled conditions, within certain time periods and temperatures, according to different cell and tissue requirements which can vary from product to product.

Temperature-controlled logistics solutions are vital to ensure a safe, effective and financially viable supply chain network for these high-value shipments. Cryopreservation is one technique increasingly being used to deliver medicines at optimum temperature using vapor phase nitrogen, however, many clinical settings remain ill-equipped to handle such equipment.

Onsite production is an alternative manufacturing arrangement, particularly for autologous products which are derived from a patients own cells. However, this throws up a number of compliance and infrastructure challenges, as the hospital would need to comply with a host of regulations including installing a licensed clean room which may not be possible given budget restrictions and limited space onsite.As a first-generation technology, stakeholders will have a greater tolerance for higher pricing, but only for a limited time period. By streamlining the currently very expensive manufacturing process and improving supply chain management, yields will automatically get larger and costs will slowly come down.

While there are many challenges in the road ahead, 2019 certainly appears to be the start of regenerative medicines move to the big time. Just like big data and artificial intelligence is transforming the practice of medicine, regenerative medicine holds the promise of extending the bodys natural ability to replenish, replace and rejuvenate itself.

If the global health industry can work collaboratively on overcoming the challenges presented by delivering safe and effective advanced therapies, a dramatic extension of the human healthspan is possible. We may even reach the point where no disease is considered incurable, transforming healthcare as we know it.

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What it means to be a cyborg in 2019 – Quartz

By daniellenierenberg

I have a four-foot-tall robot in my house that plays with my kids. Its name is Jethro.

Both my daughters, aged 5 and 9, are so enamored with Jethro that they have each asked to marry it. For fun, my wife and I put on mock weddings. Despite the robot being mainly for entertainment, its very basic artificial intelligence can perform thousands of functions, including dance and teach karate, which my kids love.

The most important thing Jethro has taught my kids is that its totally normal to have a walking, talking machine around the house that you can hang out with whenever you want to.

Given my daughters semi-regular use of smartphones and tablets, I have to wonder how this will affect them in the future. Will they have any fear of technologies like driverless cars? Will they take it for granted that machine intelligences and avatars on computers can be their best friends, or even their bosses?

Will marrying a super-intelligent robot in 20 years be a natural decision? Even though I love technology, Im not sure how I would feel about having a robot-in-law. But my kids might think nothing of it.

This is my story of transhumanism.

Courtesy of Zoltan Istvan

My transhumanism journey began in 2003 when I was reporting a story for National Geographic in Vietnams demilitarized zone and I almost stepped on a landmine.

I remember my guide roughly shoving me aside and pointing to the metal object half sticking out of the ground in front of me.

I stared at the device that would have completely blown my legs off had my boot tripped the mine. I had just turned 30. The experience left me shaken. And it kept haunting me.

That night as I lay tense and awake in my hotel room, I had the epiphany that has helped define the rest of my life: I decided that the most important thing in my existence was to fight for survival. To put it another way: My goal was to never die.

Because I was not religious, I immediately turned to the thing that gave meaning to my world: science and technology. I took a leap of faith and made a wager that day. I later called this (and even later, dedicated a book to it) the transhumanist wager.

The life extension business of transhumanism will be a $600 billion industry by 2025.

My idea for an immortality wager came from Pascals Wager, the famous bet that caught on in the 17th century that loosely argued it was better to believe in God than not to, because you would be granted an afterlife if there was indeed a God. My transhumanist wager was based in my belief that its better to dedicate our resources to science and technology to overcome death while were still aliveso we dont ever have to find out whether there is an afterlife or not. It turns out I wasnt alone in my passion to live indefinitely through science. A small social movement, mostly of academics and researchers, were tackling similar issues, starting organizations, and funding research.

Some of them called themselves transhumanists.

Fast-forward 16 years from my landmine incident, and transhumanism has grown way beyond its main mission of just overcoming death with science.

Now the movement is the de facto philosophy (maybe even the religion) of Silicon Valley. It encapsulates numerous futurist fields: singularitarianism, cyborgism, cryonics, genetic editing, robotics, AI, biohacking, and others.

Biohacking in particular has taken offthe practice of physically hacking ones body with science, changing and augmenting our physiology the same way computer hackers would infiltrate a mainframe.

Its pretty obvious why it has emerged as such a big trend: It attracts the youth.

Not surprisingly, worrying about death is something that older people usually do (and, apparently, those younger people who almost step on landmines). Most young people feel invincible. But tell young people they can take brain drugs called nootropics that make them super smart, or give them special eye drops that let them see in the dark, or give them a chip implant that enhances human ability (like the one I have), and a lot of young people will go for it.

In 2016, I ran for the US presidency as the Transhumanist Party nominee. To get support from younger biohackers, my team and I journeyed on the Immortality Busmy 38-foot coffin-shaped campaign busto Grindfest, the major annual biohacking meet-up in Tehachapi, California. In an old dentists chair in a garage, biohackers injected me with a horse syringe containing a small radio-frequency-identification implant that uses near-field communication technologythe same wireless frequency used in most smartphones. The tiny deviceits about the size of a grain of ricewas placed just under the skin in my hand. With my chip, I could start a car, pay with bitcoin, and open my front door with a lock reader.

Four years later, I still have the implant and use it almost every day. For surfers or joggers like myself, for example, its great because I dont have to carry keys around.

One thing I do have to navigate is how some religious people view me once they understand I have one. Evangelical Christians have told me that an implant is the mark of the beast, as in from the Bibles Book of Revelations.

Even though Im tagged by conspiracy theorists as a potential contender for the Antichrist, I cant think of any negatives in my own experiences to having a chip implant. But as my work in transhumanism has reached from the US Military to the World Bank to many of the worlds most well-known universities, my chip implant only exasperates this conspiracy.

While people often want to know what other things Ive done to my body, in reality becoming a cyborg is a lot less futuristic and drastic than people think.

For me and for the thousands of people around the world who have implants, its all about functionality. An implant simply makes our lives easier and more efficient. Mine also sends out pre-written text messages when peoples phones come within a few feet of me, which is a fun party trick.

But frankly, a lot of the most transformative technology is still being developed, and if youre healthy like me, theres really not much benefit in doing a lot of biohacking today.

I take nootropics for better brain memory, but theres no conclusive research I know of that it actually works yet. Ive done some brainwave therapy, sometimes called direct neurofeedback, or biofeedback, but I didnt see any lasting changes. I fly drones for fun, and of course I also have Jethro, our family robot.

For the most part, members of the disabled community are the ones who are truly benefiting from transhumanist technologies today. If you have an arm shot off in a war, its cyborg science that gives you a robot arm controlled by your neural system that allows you to grab a beer, play the piano, or shake someones hand again.

But much more dramatic technology is soon to come. And the hope is that it will be availableand accessibleto everyone.

I asked to be added to a volunteer list for an experiment that will place implants in peoples brains that would allow us to communicate telepathically, using AI. (Biohacking trials like this are secretive because they are coming under more intense legal scrutiny.)Im also looking into getting a facial recognition security system for my home. I might even get a pet dog robot; these have become incredibly sophisticated, have fur softer than the real thing (that doesnt shed all over your couch or trigger allergies) and can even act as security systems.

Beyond that, people are using stem cells to grow new teeth, genetic editing to create designer babies, and exoskeleton technology that will likely allow a human to run on water in the near future.

Most people generally focus on one aspect of transhumanism, like just biohacking, or just AI, or just brainwave-tech devices. But I like to try it all, embrace it all, and support it all. Whatever new transhumanist direction technology takes, I try to take it all in and embrace the innovation.

This multi-faceted approach has worked well in helping me build a bridge connecting the various industries and factions of the transhumanist movement. Its what inspired me to launch presidential and California gubernatorial campaigns on a transhumanist platform. Now Im embarking on a new campaign in 2020 for US president as a Republican, hoping to get conservatives to become more open-minded about the future.

The amount of money flowing into transhumanist projects is growing into many billions of dollars. The life extension business of transhumanism will be a $600 billion industry by 2025, according to Bank of America. This is no time for transhumanism to break apart into many different divisions, and its no time to butt heads. We need to unite in our aim to truly change the human being forever.

Transhumanistsit doesnt matter what kind you arebelieve they can be more than just human. The word natural is not in our vocabulary. Theres only what transhumanists can do with the tools of science and technology they create. That is our great calling: to evolve the human being into something better than it is.

Because transhumanism has grown so broadly by now, not all transhumanists agree with me on substantially changing the human being. Some believe we should only use technology to eliminate suffering in our lives. Religious transhumanists believe we should use brain implants and virtual reality to improves our morality and religious behavior. Others tell me politics and transhumanism should never mix, and we must always keep science out of the hands of the government.

We need unity of some significant sort because as we grow at such a fast rate there are a lot of challenges ahead. For example, the conservative Christian Right wants to enact moratoriums against transhumanism. The anarcho-primativists, led by people like the primitivist philosopher and author John Zerzan (who I debated once at Stanford University), want to eliminate much technology and go back to a hunting-gathering lifestyle which they believe is more in tune with Earths original ecology. And finally, we must be careful that the so-called one percent doesnt take transhumanist technology and leave us all in the dust, by becoming gods themselves with radical tech and not sharing the benefits with humanity.

I personally believe the largest danger of the transhumanist era is the fact that within a few decades, we will have created super-intelligent AI. What if this new entity simply decides it doesnt like humans? If something is more sophisticated, powerful, intelligent, and resilient than humans, we will have a hard time stopping it if it wants to harm or eliminate us.

Whatever happens in the future, we must take greater care than we ever have before as our species enters the transhumanist age. For the first time, we are on the verge of transforming the physical structure of our bodies and our brains. And we are inventing machines that could end up being more intelligent and powerful than we are. This type of change requires that not only governments act together, but also cultures, religions, and humanity as a whole.

In the end, I believe that a lot more people will be on board with transhumanism than admit it. Nearly all of us want to eliminate disease, protect our families from death, and create a better path and purpose for science and technology.

But I also realize that this must be done ever so delicately, so as not to prematurely push our species into crisis with our unbridled arrogance. One day, we humans may look back and revel in how far our species has evolvedinto undying mammals, cyborgs, robots, and even pure living data. And the most important part will be to be able to look back and know we didnt destroy ourselves to get there.

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What it means to be a cyborg in 2019 - Quartz

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Seven beauty basics to buy right now that will help you forget winter’s early blast – The GrowthOp

By daniellenierenberg

Were still waiting for CBD-infused skincare products to hit shelves in Canada, but products have been at retail for years containing hemp seed oil and cannabis sativa seed oil that are full of omega fatty acids and can be quite hydrating. They may not have the anti-inflammatory benefits of CBD, but consumers have been relying on their skin-boosting affects for ages.

So, just in time for an early blast of winter, here are some online options available at Well.ca for keeping your skin and complexion in check this season including one for the boys:

Chapped lips are sadly on their way now that temperatures have dipped below zero. Arm yourself with an all-natural, hemp-infused lip balm that is so affordable you may want to buy two one to stash in your purse and the other at your desk. Bonus: It also contains antioxidant-packed matcha green tea. Hurraw! Green Tea Lip Balm, $5

If youre like me, your fingers and hands have already started to show signs of winters wear. My cuticles are tattered and my summer-soft hands are rough and dry. Last winter, I relied on North American Hemp Co.s hand cream, and I am reaching back into my wallet for this one. Aside from cannabis sativa seed oil, it also contains vitamins A and E for a powerful solution to dry digits. North American Hemp Co. Hemp Hang Nail Help Hand & Nail Cream, $21

One of the tricks of the beauty trade is switching up your cleanser in the colder months for one that wont leave your face feeling dry and tight. Enter Andalou Naturals CannaCell Cleansing Foam that contains 100 per cent pure hemp seed oil, as well as hemp stem cells, vitamins C, E, as well as B vitamins for good measure. Already added to cart. Andalou Natural CannaCell Cleansing Foam, $19

This cult favourite serum from clean beauty brand Herbivore contains glow-inducing ingredients like olive-derived squalane and cannabis sativa seed oil to hydrate, soften and tone the complexion. And it will look pretty in your shelfie pics on Instagram. Herbivore Emerald Deep Moisture Glow Oil, $60

Bar soap is back baby! Brands and consumers are focusing once again on bar soap as a way to help reduce plastics. Buck Nakeds Dead Sea Mud and Argan Oil soap is a powerful detoxifier, while also adding hydrating ingredients back into the skin with the help of Argan oil backed up by hemp oil. On top of all of that, the bar is biodegradable, so no icky ingredients are washing down your water drain. Buck Naked Soap Company Dead Sea Mud + Argan Soap, $9

This may be for men, but whos stopping you from slathering on this cedar and Bourbon-scented natural deodorant that also contains skin-soothing cannabis sativa seed oil. A holiday gift perhaps? Olivina Men Bourbon Cedar Deodorant, $11

The sole ingredient in these blotting papers from mass beauty line NYX is cannabis sativa seed oil. While the papers will help take away unwanted shine on your T-zone and forehead, the cannabis oil will add a slight bit of hydration back into your complexion, yet keeping it matte. These blotters, there are 50 in a pack, are perfect for your purse while youre trekking to all those holiday parties. NYX Bare With Me Hemp Seed Oil Blotting Papers, $8

Michelle Bilodeau is a writer and editor about fashion, beauty and cannabis. She is also a co-host on theOn A High podcast

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Seven beauty basics to buy right now that will help you forget winter's early blast - The GrowthOp

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