If you notice flakes in your hair or it's simply looking drab, chances are there's something making its home on your head that you definitely don't want there. Depending on your own pH levels, it could be the oil from clogged follicles creating dandruff, but even if you consider your scalp on the normal-to-dry side, product buildup can still linger on the scalp long after you've showered with shampoo and conditioner.

If you'd like to say a final farewell to product buildup, dead skin cells, and excess sebum, using a purifying scalp scrub once a week can exfoliate away dirt and flakes and leave your hair feeling cleaner than you've ever imagined. Beyond scrubs, other treatments like serums and oils can also help fortify follicles so hair grows back in healthier and stronger, plus treat the protective cuticle layer that locks in moisture and keeps hair looking shiny, too.

Check out the best hair-care products at Sephora that tackle everything from itchiness to dullness ahead, and give your scalp the special treat it's not-so-secretly seeking.

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Don't Be Flaky: Try 1 of These Scalp Treatments From Sephora, and Get Your Scalp Right - POPSUGAR

Recommendation and review posted by Bethany Smith

Dublin, April 08, 2020 (GLOBE NEWSWIRE) -- The "Hormone Replacement Therapy Market Size, Share & Trends Analysis Report by Product (Estrogen, Human Growth), by Route Of Administration (Oral, Parenteral), by Type Of Disease, by Region, and Segment Forecasts, 2020 - 2027" report has been added to ResearchAndMarkets.com's offering.

The global hormone replacement therapy market size is expected to reach USD 39.6 billion by 2027, expanding at a CAGR of 7.7%. A significant rise in the incidence rate of hormonal disorders in the newborns, adults, and elderly and populations is driving the market. The Prader-Willi syndrome (PWS) affects one in every 15,000 newborns, thereby boosting the demand for the therapy.

Estrogen replacement hormone therapy helps in reducing the vaginal indications of menopause, such as dryness, burning, itching, and pain during intercourse. Estrogen is available in the forms of pill, gel, skin patch, cream or spray form. It is highly successful for treating problematic menopausal night sweats and hot flashes. Around 45% of women between the ages of 40 to 60 years of age were reported taking counseling sessions from a physician regarding the advantages and disadvantages of using hormone replacement therapy (HRT) after menopause.

Growing awareness about menopausal signs and the treatment options is growing the HRT market. Owing to the significant development for ERT, there has been an initiation of very safe treatment options for the patients situated in various geographies of the world. For example, augmentation of innovative drug delivery systems like transdermal estrogen patches and vaginal estrogen drugs.

Further key findings from the report suggest:

Key Topics Covered:

1. Methodology and Scope

2. Executive Summary2.1 Market Outlook2.2 Segment Outlook2.2.1 Product2.2.2 Route of Administration2.2.3 Type of Disease2.2.4 Region2.3 Competitive Insights

3. Market Variables, Trends & Scope3.1 Market Segmentation3.2 Penetration & Growth Prospect Mapping3.2.1 Market Driver Analysis3.2.2 Market Restraint Analysis3.3 Hormone Replacement Therapy Market: Business Environment Analysis Tools3.3.1 Porter's Five Forces Analysis3.3.1.1 Bargaining power of suppliers3.3.1.2 Bargaining power of buyers3.3.1.3 Threat of new entrants3.3.1.4 Competitive rivalry3.3.1.5 Threat of substitutes3.3.2 PESTEL Analysis3.3.2.1 Political & legal3.3.2.2 Economic3.3.2.3 Technological

4. Hormone Replacement Therapy Market: Product Analysis4.1 Hormone Replacement Therapy Product Market Share Analysis, 2019 & 20274.2 Hormone Replacement Therapy Product Market: Segment Dashboard4.3 Market Size & Forecasts and Trend Analyses, 2016 to 2027 for the Product Segment4.3.1 Estrogen Hormone Replacement Therapy4.3.1.1 Estrogen Hormone replacement therapy market, 2016 - 2027 (USD Million)4.3.2 HGH Replacement Therapy4.3.2.1 HGH replacement therapy market, 2016 - 2027 (USD Million)4.3.3 Thyroid Hormone Replacement Therapy4.3.3.1 Thyroid hormone replacement therapy market, 2016 - 2027 (USD Million)4.3.4 Testosterone Hormone Replacement Therapy4.3.4.1 Testosterone hormone replacement therapy market, 2016 - 2027 (USD Million)

5. Hormone Replacement Therapy Market: Route of Administration Analysis5.1 Hormone Replacement Therapy Route of Administration Market Share Analysis, 2019 & 20275.2 Hormone Replacement Therapy Route of Administration Market: Segment Dashboard5.3 Market Size & Forecasts and Trend Analyses, 2016 to 2027 for the Route of Administration Segment5.3.1 Oral5.3.1.1 Oral market, 2016 - 2027 (USD Million)5.3.2 Parenteral5.3.2.1 Parenteral market, 2016 - 2027 (USD Million)5.3.3 Transdermal5.3.3.1 Transdermal market, 2016 - 2027 (USD Million)5.3.4 Others5.3.4.1 Others market, 2016 - 2027 (USD Million)

6. Hormone Replacement Therapy Market: Type of Disease Analysis6.1 Hormone Replacement Therapy Type of Disease Market Share Analysis, 2019 & 20276.2 Hormone Replacement Therapy Type of Disease Market: Segment Dashboard6.3 Market Size & Forecasts and Trend Analyses, 2016 to 2027 for the Type of Disease Segment6.3.1 Menopause6.3.1.1 Menopause market, 2016 - 2027 (USD Million)6.3.2 Hypothyroidism6.3.2.1 Hypothyroidism market, 2016 - 2027 (USD Million)6.3.3 Male Hypogonadism6.3.3.1 Male hypogonadism market, 2016 - 2027 (USD Million)6.3.4 Growth Hormone Deficiency6.3.4.1 Growth hormone deficiency market, 2016 - 2027 (USD Million)6.3.5 Others6.3.5.1 Others market, 2016 - 2027 (USD Million)

7. Hormone Replacement Therapy Market: Regional Analysis7.1 Hormone Replacement Therapy Regional Market Share Analysis, 2019 & 20277.2 Hormone Replacement Therapy Regional Market: Segment Dashboard7.3 Regional Market Snapshot (Market Size, CAGR, Top Verticals, Key Players, Top Trends)7.4 Market Size, & Forecasts, and Trend Analysis, 2016 to 20277.4.1 North America7.4.1.1 North America hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.1.1.1 U.S.7.4.1.1.1.1 U.S. hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.1.1.2 Canada7.4.1.1.2.1 Canada hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.2 Europe7.4.2.1 Europe Hormone Replacement Therapy market, 2016 - 2027 (USD Million)7.4.2.1.1 U.K.7.4.2.1.1.1 U.K. hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.2.1.2 Germany7.4.2.1.2.1 Germany hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.3 Asia Pacific7.4.3.1 Asia Pacific hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.3.1.1 Japan7.4.3.1.1.1 Japan hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.3.1.2 China7.4.3.1.2.1 China hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.4 Latin America7.4.4.1 Latin America hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.4.1.1 Brazil7.4.4.1.1.1 Brazil hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.4.1.2 Mexico7.4.4.1.2.1 Mexico hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.5 Middle East and Africa (MEA)7.4.5.1 MEA hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.5.1.1 South Africa7.4.5.1.1.1 South Africa hormone replacement therapy market, 2016 - 2027 (USD Million)7.4.5.1.2 Saudi Arabia7.4.5.1.2.1 Saudi Arabia hormone replacement therapy market, 2016 - 2027 (USD Million)

8. Competitive Analysis8.1 Strategic Framework/ Competition Categorization (Key innovators, Market leaders, emerging players8.2 Vendor Landscape8.3 Company market position analysis (Geographic Presence, Product Portfolio, Strategic Initiatives, Employee Strength)8.4 Company Profiles

Companies Mentioned

Story continues

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Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

CONTACT: ResearchAndMarkets.comLaura Wood, Senior Press Managerpress@researchandmarkets.comFor E.S.T Office Hours Call 1-917-300-0470For U.S./CAN Toll Free Call 1-800-526-8630For GMT Office Hours Call +353-1-416-8900

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If you're struggling to sleep during the outbreak of Covid-19, experts have some advice on how to get more shut-eye. OcusFocus/ Istock.com pic via AFP

PARIS, April 9 You might find yourself struggling to sleep during the current Covid-19 outbreak, as stress, uncertainty and changes in our usual routine make it more difficult to relax at night and drop off.

Here, we round up some expert advice on how you can try to maintain a regular sleep pattern and get a more restful night's shut-eye.

Try to stick to the same bedtime and wake-up time

Waking up and starting your day at the same time every day is the most important way to stabilise your body clock, says Professor Greg Murray, at Swinburne University of Technology, Australia. He advises sticking to consistent sleep and wake times which fit your natural rhythm.

If you're a night owl, it's okay to stay up a little later and get up a little later, just make sure these bedtimes and wake up times are the same every day, he says.

Dr Elizabeth Cozine, a Mayo Clinic family medicine physician, agrees, Try to go to bed at the same time every night, maybe sleeping in a little bit later than you normally would because you're not rushing to get to the office. And see if you can try to get somewhere between seven and nine hours of sleep, which is what most adults need, and make that a regular part of your day.

Avoid napping

Professor Murray also advises trying not to nap during daylight hours, as it can make it hard to fall asleep at night. If you must nap, he says to restrict your sleep to just 30 minutes.

Get some sunlight during the day

Professor Kevin Morgan, who is a sleep expert at the University of Loughborough, UK, says that staying indoors means we don't soak up enough sunlight, and this can affect our sleep patterns and our need to nap during the day.

To help synchronise our body clock, we should try to get enough sunlight during the day, particularly in the morning, to let our body know it's daytime. He recommends exercising outdoors, if you can, or at least just walking to the grocery store or sitting in the garden.

And avoid bright light in the evening

In the evening, Professor Murray says we should avoid bright light, as this suppresses the production of the hormone melatonin, which makes us feel sleepy. This also includes avoiding the blue light from computer screens and smartphones, so try to read a book or take a bath instead of watching TV to help you relax.

Avoid alcohol and caffeine

Be careful how much caffeine you have every day, says Professor Morgan, who adds that working from home, or just being at home, offers more opportunities for tea and coffee breaks. Caffeine suppresses the chemical adenosine which contributes to sleepiness and promotes sleep.

He also advises limiting your alcohol intake, as although it can help you fall asleep it can also cause you to wake up early, as well as affect the quality of your sleep so you actually feel more tired the next day.

Try to relax

Psychiatry professor Adam Abba-Aji at the University of Alberta, Canada, says that if you're feeling anxious during the Covid-19 outbreak, usually the first sign of it will be a lack of sleep.

It becomes difficult to switch our brains off, he said. Where there's a lack of sleep, people sometimes resort to ... alcohol or some other sedatives.

Instead, Abba-Aji suggests trying to relax and switch off with some yoga before you head to bed.

Try meditation

You might not have tried meditation before, but Dr. Cozine says there's a lot of evidence to suggest it can improve sleep, as well as help ease stress and anxiety.

I've found that it helps me turn off those hamster wheels of thoughts that are rolling in my brain, and it also helps me to get ready for the next step, she says.

I'm not talking about sitting Zen, cross-legged for three hours thinking about I don't know like a desert or something. I'm talking about maybe five minutes where you just reset. AFP-Relaxnews

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How to sleep better during the Covid-19 outbreak - Malay Mail

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Women have to deal with a fair share of health inconveniences that come across as the sign of being healthy but can be equally disturbing and painful. One such inevitable function of the female body is menopause. Menopause is a stage that comes during aging where the female body diminishes its reproductive abilities, and the long period of menstrual cycles come to an end. It might sound convenient to some, but it often goes far from that, and each woman can have a different experience. Menopause induces several changes in a female body, which can be hard to deal with. Along with the decline in the production of hormones such as Progesterone and Estrogen, there are various side effects of this natural process.

The changes that menopause brings with it are not only limited to being physical but it also drastically affects mental well being. Most women don't take it seriously, though when it crashes upon them, things can get a little tough to handle. Medications, for sure, offer benefits and help to heal the symptoms, but some can also achieve the same through the usage of natural remedies. One such ingredient, called CBD, is gradually gaining popularity among women to treat symptoms of menopause.

What is CBD?

CBD or cannabidiol is the non-psychoactive component of the plant cannabis, which is rich in innumerable healing properties. The therapeutic product is widely used worldwide to treat health ailments, and women are gradually accepting it to treat various menstrual conditions as well. Being a completely natural ingredient, it can provide benefits for some while furnishing minimal side effects. The good thing is that you can get CBD products from various websites that offer high-quality products, ranging from providing seeds used in medical treatments to CBD infused products, the choices are endless.

Here are five menopause symptoms that CBD might help with:

1. Reducing depression and anxiety

The hormonal changes that menopause brings with it, give rise to a hormonal imbalance in the female. Estrogen and progesterone have a direct influence on the mental well being of a woman, and in the series of its fluctuation during menopause, it is very likely for a woman to feel depressed or deal with anxiety. CBD is an excellent ingredient to help one with these symptoms. This powerful ingredient owns anti-anxiolytic properties that help in reducing anxious thoughts. It also influences the production of Serotonin, which is a happy hormone that helps to reduce frequent mood swings and make you feel pleasant.

2. Promotes a healthy sleeping pattern

Lack of sleep can leave you feeling groggy and disoriented, imagine experiencing it when you need it the most to ease your already worn-out body. Tragic, isn't it? A widespread symptom of women going through menopause is experiencing disturbances in their regular sleeping pattern. Sleep is a significant function that our body needs to carry out both as a healing method and to regulate several body functions. Still, menopause can make it hard to fall into deep slumber easily. CBD is known to offer a good night's sleep without any side effects. So if you are experiencing a disturbed sleeping pattern, then it may be worth taking into consideration the help of CBD products.

3. Heals body pain

Body ache is a common condition that people face while aging though if you have recently started facing it, then it can be due to the several hormonal changes that your body is undergoing. Menopause brings body pain with it that can sometimes leave a woman bed-ridden. Other than ingesting medications based on the recommendation of a physician, CBD can be highly beneficial in easing pain to a great extent. The anti-inflammatory properties of cannabidiol can help to protect your joints against inflammatory damage that can take the shape of severe arthritis.

4. Improves genital health conditions

Deteriorating genital health in females is one of the concerns that the majority of menopause medications might fail to improve. The imbalance of hormones can reduce the blood flow in the pelvis area, which, as a result, can reduce the elasticity and health of the vagina. Surprisingly, CBD products offer its benefits to improve genital health as well. Being an efficient vasodilator, CBD helps to increase the blood flow in the pelvic region to regain the lost elasticity. At the same time, the anti-inflammatory properties help to combat inflammation.

5. Adjusts hormonal homeostasis

Hormonal imbalance is one of the major concerns during menopause, which leads to almost every other condition that women suffer during this period. Hormones have a significant role in shaping and regulating our body functions, and fluctuation in hormones generally invites several ailments with itself. Edibles and other products containing CBD can directly influence the hormonal balance, but it has an active role in regulating the endocannabinoid system of the body. With supplementation of efficient fuel, the endocannabinoid system regulates the homeostasis in the body to produce different hormones, hence creating a healthy balance.

These are a few of the ways that CBD might be able to help to heal menopause symptoms. It is recommended to consult an expert regarding its safe usage, to help you make a plan to manage these symptoms.

Go here to read the rest:
5 Menopause Symptoms That CBD Might Help With - Anti Aging News

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Right now, our homes are our safe havens. They keep us protected, healthy, and hopefully virus-freeeven if they can get pretty boring at times. But in order to make sure that our homes remain safe sanctuaries, it means that we have to maintain their cleanliness every single day, too. Whether it's the first time you've ever spent this long at home or you're a working-from-home pro, you could likely use a lesson on how to disinfect for coronavirus from those who know best: doctors and cleaning experts.

We rounded up a few of the leading experts in healthy cleaning practices for their top advice on keeping your home clean during quarantine. Get ready to turn that boredom into inspiration with these expert cleaning tips. And for more advice on what could use a wipe down, check out25 Things You Should Clean Every Day and How to Do It.

There's a big difference between cleaning your space and disinfecting, says Marcela Barraza, founder of MB Green Cleaning. Cleaning removes germs without killing them whereas disinfecting stops them in their tracks. That's why she recommends cleaning first and then disinfecting for coronavirus.

"It is very important that you clean [to] remove dirt and debris from surfaces first, because germs and bacteria might hide under the dirt. Once the surface is clean with the least amount of bacteria, the disinfectant will do its purpose by killing them," Barraza says.

Allow the disinfectant to sit for three to five minutes so it can do its job. "If you spray and wipe right away, you are taking the disinfectant away before it can do its job," she says.

It's imperative right now to clean all the surfaces you touch every day. "We all know we have to disinfect areas like the bathrooms, light switches, and doorknobs, but we should also focus on not-so-obvious areas," Barraza says. Think about laptops, kitchen cabinet handles, toilet handles, sink faucets, remote controls, and desks (especially if you're working from home at the moment). Remember: Clean first, then disinfect. And for more surfaces that could use your attention, check out 15 Things in Your House Experts Say You Should Wipe Down Every Day.

Not all cleaners are made with the right ingredients. Audrey Sue, MD, internal medicine physician in Southern California, says to "be sure to check out this list of EPA-approved detergents, which meet criteria for use against SARS-CoV-2, the virus that causes COVID-19." And for more ways to keep your home safe, here are 15 Ways to Protect Yourself From Coronavirus at Home.

Whether you're using hand sanitizer or alcohol-based cleaners on your kitchen counter, you'll want to make sure the alcohol content is strong enough to kill germs. "Make sure they consist of at least 70 percent alcohol in order to be effective," advises Sue. You can tell by checking the back of the container.

Just because two types of cleaners are good on their own, it doesn't mean they're meant to be mixed together. "Some common household cleaning products when mixed together can become lethal, literally," explains former critical care nurse Robert Lambert, RN, founder and owner of Iatric Professional Cleaning Service. "These combinations can cause eye, nose, throat, and lung problems, nerve damage, and in some cases, explosives." For example, bleach mixed with ammonia can release chloramine vapors. So leave the mixing up to the chemists and just use that multi-surface cleaner you already know and love.

Right now, it can be easy to feel the need to go overboard with disinfecting surfaces for coronavirus. But this isn't necessarily a good thing, especially when it comes to bleach. "Using more bleach is not going to be better," says Lambert. "Bleach is a skin and eye irritant [and] can cause respiratory issues if [you're] breathing vapors in a poorly ventilated space." And for more cleaning products to be wary of, check out 15 Cleaning Products You Should Keep Far from Your Kids.

You might be used to reusing your gloves when you clean, but now's not the time for that. "Wear disposable gloves when cleaning and disinfecting and discard them immediately after," Barraza recommends.

You might be wearing mostly loungewear these days, but that shouldn't stop you from keeping up with your laundry. In addition to your usual loads, Barraza recommends disinfecting your hamper and washing its fabric lining if it has one. And for more on your clothes and COVID-19, check out Is Coronavirus on My Clothes? Experts Weigh In.

"Consider washing your sheets and towels more often than you normally do," Barraza says. Plus, you'll want to change hand towels daily.

The sanitize setting on your laundry machine is key. "The sanitize cycle is designed to reduce the amount of microorganisms on clothing, like germs and bacteria," explains Barraza.

Don't double dip, Lambert says. No, he isn't talking about chips and salsahe's referring to rags. "I am talking about wringing out a dirty cloth and using it again," he says. If you do this, you're introducing germs into your cleaner and then rubbing them onto new surfaces.

"This is especially true with the COVID-19 situation. Have a stack of clean clothspreferably microfibersubmerged into a bucket of solution," he says. Once you've used one, toss it into a laundry bag and repeat.

None of us clean our sponges as much as we should, but now is the time to change that. "You can kill the germs on your sponge by nuking it in the microwave for about a minute," says Natasha Bhuyan, MD, regional medical director at One Medical. Just be careful to soak the sponge in water first so it doesn't catch on fire in the microwave.

It's important to use your hands in addition to your eyes to make sure that you're cleaning things thoroughly. For example, Lambert says that some kitchen counters made with stone or granite can look deceivingly clean when they're not. "If you think you can 'see' that your counter is clean after scrubbing it, you may be fooling yourself," he says. So use your gloved hand to see if there's a spot you missed.

"There are many myths about household items that can be used against COVID-19 that are not accurate," explains Bhuyan. "Hand dryers, spraying chlorine on yourself, and using a UV disinfection lamp on your skin are not effective ways to kill coronavirus. They're also potentially unsafe for your health." So keep to the cleaners that are recommended by health professionals and the CDC instead.

"This may sound counterintuitive coming from a cleaning service owner, but don't lose your mind about cleaning while you're quarantined at home," says Jonathan Browne of Sparkle Clean Maids. "Being overly anxious has scientifically studied effects on your immune system. Cortisol, the stress hormone, causes your immune system to become dramatically more vulnerable to infection from viruses." So, yes, it's important to keep your home clean, but don't stresstoo much over making it absolutely perfect.

Read this article:
How to Disinfect for Coronavirus in Your House, According to Experts - Best Life

Recommendation and review posted by Bethany Smith

With change and situations out of our control comes stress. It's a natural response during crisis, and the novel coronavirus pandemic is no different.

Adding a quick gratitude exercise to your day could help reduce stress, allowing your immune system to function at its best.

Image Credit: MundusImages/E+/GettyImages

As the uncertainties surrounding COVID-19 keep mounting, so do our anxieties. And unfortunately, stress can come with some serious consequences for the immune system.

"When we're chronically stressed, we stay in red-alert mode practically full time," Tanya Peterson, certified counselor and author of The 5-Minute Anxiety Relief Journal: A Creative Way to Stop Freaking Out, tells LIVESTRONG.com. "This harms our immune system by either weakening it so we are less effective at fighting off viruses or sending it into overdrive, potentially leading to serious autoimmune conditions."

The good news? A little bit of gratitude can go a long way in combatting the effects of stress.

Read on for more on the connection between stress and immunity and the five-minute gratitude practice that can help you recenter.

Psychological stress leads to high cortisol levels, which impairs the immune system's functions, according to the Mayo Clinic.

Cortisol, the hormone produced in response to stress, is released by the adrenal glands to manage acute stressors, explains Brandi Moore, NMD, a naturopathic physician with Reclaim Integrative Health in Scottsdale, Arizona.

"When used this way, it works to support immune function by decreasing inflammation," Moore says. "However, when a person is chronically stressed, cortisol can suppress the immune system, making them more susceptible to becoming sick."

Chronic stressors such as financial problems, caregiving or worries related to the current coronavirus pandemic can elicit a "threat response," according to the University of California. That response physiologically wears out our cells, making it more difficult for our bodies to recover.

Decreasing stress is the best way to lower cortisol and in turn bolster the immune system. Moore says one easy way to do this is by practicing gratitude.

Many studies agree. Practicing gratitude, which means acknowledging the goodness in life, was linked to significantly lowered levels of stress in an October 2018 study in Psychology, Health & Medicine.

A February 2019 study in Clinical Psychological Science also linked a positive mindset to a stronger immune system.

"When an individual practices gratitude, it shifts their perspective, giving them a more positive outlook on life and decreasing stress," Moore says.

You can change anxious thoughts to grateful thoughts, which pulls your attention away from whats wrong and onto whats right."

Image Credit: Leonardo De La Cuesta/Moment/GettyImages

Being grateful and having a positive outlook may be easier said than done, especially when you're feeling overwhelmed by stress.

"Thankfully, we're not at the mercy of our stress response but can actually control it," Peterson says. "Journaling is a powerful tool to help us intentionally slow our thoughts and change our perspective."

Moore also recommends journaling to her patients. It's a simple idea: Write down how you feel or what you're thinking. And to get the most out of it, have a clear goal in mind for why you're doing it.

"You can change anxious thoughts to grateful thoughts, which pulls your attention away from what's wrong and onto what's right," Peterson says. "When you journal, you not only rein in your racing thoughts but you guide them and develop new perspectives."

It's especially helpful to focus on the mind-body connection, she adds. "What happens to one manifests in the other," she says. "When your body is stiff and sore, what is often going on in your mind? How do your beliefs affect you physically?"

Read more stories to help you navigate the novel coronavirus pandemic:

See more here:
A Gratitude Exercise to Reduce Stress and Support Immunity - LIVESTRONG.COM

Recommendation and review posted by Bethany Smith

Thank you," "To Our Heroes" and "We Love You," read some of the signs. Hundreds of cars drove past Robert Wood Johnson University Hospital Friday evening to give thanks to medical staff. Bridgewater Courier News

The coronavirus is causing fear, stress and anxiety for many, potentially preventing them from getting a good nights sleep.

Xue Ming, a professor of neurology at Rutgers New Jersey Medical School and a specialist in sleep disorders, said in a statement that sleep helps the immune system fight inflammation, infection and disease while producing proteins that are needed to recover from illness.

"The COVID-19 pandemic has increased anxiety, often fueled by reading news on screens, which is extending bedtimes, exposing people to blue light and keeping the adrenaline system up," Ming said. "Also, our daily routines have changed work and school hours are less structured, and people are sleeping in later than usual. Without strong discipline, a person could sleep later, following their biologic circadian rhythm, which is more than 24 hours."

Reduce stress:NJ mental health efforts, tips to combat stress during coronavirus crisis

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Making sure your child gets enough quality sleep is important for health and development.(Photo: PeopleImages, Getty Images)

Ming offered the following suggestions toavoidsleep disruption:

The earliest sign of depression is sleep disruption, Ming stated, and depression makes sleep fragmented even though some depressed persons sleep longer.

"Anti-depressants can further suppress the quality REM sleep," she said. "Sleep deprivation also can lead to irritability, hyper-reactivity and mood swings."

Among the supplements that help with insomnia include amino acids, such as glutamate, Ming stated, and they are involved in the production of GABA, a major sleep neurotransmitter.

Coronavirus tips: : How to handle groceries during the pandemic

When insomnia persists, Ming suggested herbal supplements, such as tryptophan, which also is an amino acid; melatonin or valerian root.

"A balanced diet rich in proteins ensures GABA synthesis," Ming said. "Vitamins and essential minerals are important to bodily functions that maintain sleep health. For example, vitamin B and D play important roles in biochemical pathways in the cells.

"Sleep aids should not be used frequently or long-term, however," she continued "Always seek the advice of your physician before using these sleep aids. For example, valerian root has been reported to cause liver damage in some people."

When sick, the body needs more sleep to increase immunity, Ming stated, and a natural defense mechanism adapts inflammation-induced sleep, which helps fight infection.

"If your sleep is disrupted by a chronic cough, use cough medicine at bedtime under a physicians guidance," Ming suggested.

Keeping a bedtime routine and regular sleep time can condition your body to fall and stay asleep, she stated.

About two hours before bedtime, Ming suggested dimming the lights; practicingmeditation, yoga and deep breathing; listen to light music; wear a visor or sunglasses if in a lighted environment,and wear earplugs if necessary.

"Do not drink caffeinated or hot beverages or take a shower as that can rev up your adrenaline system," she suggested. "Stop using any blue light-emitting device, which can affect your bodys production of melatonin, a sleep hormone. Avoid anything that prompts anxiety, such as an argument, watching horror movies, vigorous exercise, hot beverages or shower/bath, which are all counter-productive for falling and staying asleep.

Also avoid alcohol at bedtime. While alcohol can induce sleep, when the alcohol level drops a few hours later, your sleep becomes fragmented. Likewise, eating close to bedtime can lead to gastric reflux due to a full stomach, which can disrupt sleep."

Circadian rhythm dictates the optimal times for falling asleep effortlessly and can vary by age, Ming stated.

The best time for adults is to go to sleep is from 9 to 11 p.m. earlier if elderly and they should get seven to nine hours of sleep, she suggested. For older teens and young adults, the optimal time to go to sleep is between 10 p.m. to midnight and haveeight to 10 hours of sleep, she continued. For young children and those who are school age, a bedtime between 7 and 8 p.m. is optimal, with nine to 11 hours of sleep, she concluded.

Email: bmakin@gannettnj.com

Bob Makin covers Rutgers for MyCentralJersey.com and the USA TODAY NETWORK New Jersey. To get unlimited access to his informative and entertainingwork,please subscribe or activate your digital account today.

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Coronavirus tips: How to maintain healthy sleeping habits during the pandemic - My Central Jersey

Recommendation and review posted by Bethany Smith

CAMBRIDGE, England--(BUSINESS WIRE)--Metrion Biosciences Limited (Metrion), the specialist ion channel CRO and drug discovery company, today announced it has contributed to two new peer-reviewed papers under the U.S. Food and Drug Administrations (FDA) CiPA (Comprehensive in vitro Proarrhythmia Assay) initiative. The papers, in Nature Scientific Reports1 and Toxicology and Applied Pharmacology2, focus on application of improved cardiac safety testing protocols and recommendations for best practice for the drug discovery industry.

The CiPA Initiative (www.cipaproject.org), which began in July 2013 following a workshop at the US FDA, has the objective to revise and enhance the regulatory framework assessing cardiac safety of new chemical entities. Under current guidelines, new therapeutics undergo initial assessment of proarrhythmic risk by measuring activity against the hERG cardiac ion channel, before progressing to studies in preclinical animal models and ultimately, a Thorough QT interval study in the clinic. The CiPA initiative aims to extend the use of advances in early electrophysiology-based cardiac ion channel screening, in silico predictive modelling, and human induced pluripotent stem cell derived cardiomyocytes to improve the accuracy and reduce the cost of predicting the cardiac liability of new drug candidates. Metrions research forms part of the first stage of the proposed harmonisation work, to provide clarity on how to standardise cardiac ion channel assays to ensure they deliver consistent data for in silico models of clinical cardiac arrythmia risk.

The first paper1, published in Nature Scientific Reports on 27th March 2020 by an international group of authors drawn from 20 different commercial and academic laboratories, including Metrion Biosciences, was coordinated by the Health and Environmental Sciences Institute (HESI). It reviews data from a multi-year, multi-site collaboration across industry, academia and the FDA regulatory agency to optimize experimental protocols and reduce experimental variability and bias. The goal of the study was to guide the development of best practices for the use of automated patch clamp technologies in early cardiac safety screening. High quality in vitro cardiac ion channel data is required for accurate and reliable characterisation of the risk of delayed repolarisation and proarrhythmia in the human heart and to guide subsequent clinical studies and regulatory submissions.

The second paper2, to be published formally in Toxicology and Applied Pharmacology paper on 1st May 2020 but currently available online, uses automated patch clamp data from the CiPA consortium to address the lack of statistical quantification of variability, which hinders the use of primary hERG potency data to predict cardiac arrhythmia. The consortium establishes a more systematic approach to estimate hERG block potency and safety margins.

Dr Marc Rogers, CSO, Metrion Biosciences, said: The Metrion team has been a participant in the international CiPA Initiative since inception and we are now pleased to be able to announce the publication of our data from this global collaborative scientific effort. We believe these projects will make a significant contribution to the eventual revision of cardiac safety testing guidelines by the FDA and other international regulatory agencies. They also contribute to deepening our knowledge of the underlying causes of proarrhythmia, which will help prevent early attrition of potentially promising drugs.

Contributing organisations to the Nature Scientific Reports CiPA study include: Charles River Laboratories; Bayer AG; Sophion Bioscience A/S; Nanion Technologies; GlaxoSmithKline PLC; Pfizer; Sanofi R&D; Astra Zeneca; BSYS GmbH; Bristol-Myers Squibb Company; Eurofins Discovery; Merck; Metrion Biosciences Ltd.; Natural and Medical Science Institute at the University of Tbingen; Northwestern Feinberg School of Medicine, Chicago; Roche Innovation Center Basel; Novoheart; Health and Environmental Sciences Institute, Washington, DC; AbbVie.

Contributing organisations to the Toxicology and Applied Pharmacology hERG study include: Center for Drug Evaluation and Research, Food and Drug Administration; Eli Lilly and Company; AstraZeneca; CiPA LAB; NMI-TT GmbH; Sophion Bioscience A/S; B'SYS GmbH; The Ion Channel Company; F. Hoffmann-La Roche AG; Eurofins Discovery; Bristol-Myers Squibb; Merck & Co., Inc; Metrion Biosciences Ltd.; Nanion Technologies; Charles River Laboratories; Bayer AG; University of Nottingham; Universit de Lille.

For more information on Metrions fully integrated Cardiac Safety Screening / CiPA Screening service, please visit: https://www.metrionbiosciences.com/services/cardiac-safety-screening/

Merion Biosciences comprehensive cardiac safety testing White Paper The changing landscape of cardiac safety will also be available on the Companys website from 13th April 2020.

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Metrion Biosciences and International Scientific Consortium Publish Data and New Recommendations for in Vitro Risk Assessment of the Cardiac Safety of...

Recommendation and review posted by Bethany Smith

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Recommendation and review posted by Bethany Smith

Evotec has allied with Takeda to expand into gene therapy research. The move sees Evotec establish a 20-person team in Austria, the focal point of Takedas gene therapy operation, and sign up to work on programs for its Japanese partner.

Takeda acquired a gene therapy center in Orth an der Donau, Austria, through its acquisition of Shire, which picked up the site two years earlier in its takeover of Baxalta. Throughout the series of changes in ownership, which began when Baxter spun out Baxalta in 2014, a team at the site has worked on gene therapies.

Now, Evotec is set to start playing a role in those efforts. The German drug discovery shop has set up a gene therapy unit, Evotec GT, staffed by a team of more than 20 scientists in Orth an der Donau who have worked together for many years.

Virtual Clinical Trials Online

This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.

Evotec disclosed news of the move into gene therapies alongside details of a multiyear partnership with Takeda. The deal, which features an undisclosed upfront fee and other payments over time, tasks Evotec with applying its new gene therapy capabilities and broader drug discovery platform to Takedas cancer, rare disease, neuroscience and gastroenterology programs.

Neither Evotec nor Takeda referred directly to a transfer of employees in the statement to disclose the deal. However, Evotec did reveal that Friedrich Scheiflinger is leading its gene therapy unit. Until recently, Scheiflinger headed up drug discovery for Takeda in Austria, with a particular focus on gene therapies. In light of Evotecs comments about its new gene therapy team having worked together for years, it is likely that other gene therapy researchers made the move from Takeda with Scheiflinger.

The agreement gives Evotec a beachhead in the fast-growing gene therapy sector. In explaining(PDF) the rationale for moving into the space, Evotec expressed a desire to be "modality agnostic" and develop wholly and co-owned candidates.

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Evotec allies with Takeda to move into gene therapy R&D - FierceBiotech

Recommendation and review posted by Bethany Smith

Located on the Tufts University Medford, MA campus, this new donor center will enable delivery of fresh blood, leukopaks and buffy coats for COVID-19, cell and gene therapy research within hours of collection

WESTBURY, NY - Apr 6, 2020 - BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced the opening of its new blood donor center on the Tufts University campus in Medford, MA to support academic and pharmaceutical researchers involved in COVID-19, cell and gene therapy research.

BioIVT wants to play a leading role in supporting COVID-19 research efforts and blood donations are a vital resource for the research and development of new therapies, vaccines, and diagnostics. We have many years experience developing blood products, including blood-derived immune cells for cell and gene therapy research, and we want to make that expertise count, said BioIVT CEO Jeff Gatz. Researchers recognize and appreciate BioIVTs rapid response and commitment to high quality, fresh blood products and this new donor center will allow us to offer those attributes and services to additional US clients.

BioIVTs new Boston blood donor center is its seventh. The company has similar facilities located in California, Tennessee and Pennsylvania to serve US clients and in London, UK for EU-based clients.

While the initial focus at our Boston donor center will be on delivering fresh blood, leukopaks and buffy coats within hours of collection, we plan to add more capabilities and donors over time, said Jeff Widdoss, Vice President of Donor Center Operations at BioIVT.

Leukopaks, which contain concentrated white blood cells, are used to help identify promising new drug candidates, assess toxicity levels, and conduct stem cell and gene therapy research. They are particularly useful for researchers who need to obtain large numbers of leukocytes from a single donor.

BioIVT blood products can be supplied with specific clinical data, such as the donor age, ethnicity, gender, BMI and smoking status. Its leukopaks are also human leukocyte antigen (HLA), FC receptor and cytomegalovirus typed. HLA typing is used to match patients and donors for bone marrow or cord blood transplants. FC receptors play an important role in antibody-dependent immune responses.

COVID-19-related Precautions

Blood donor centers are considered essential businesses and will remain open during the COVID-19 quarantine. BioIVT is taking additional safety measures to protect both blood donors and its staff during this difficult time. It has instituted several social distancing measures, including increasing the space between chairs in the waiting room and between donor beds, and limiting the entrance of non-essential personnel. The screening rooms are disinfected between donors and all areas of the center continue to be cleaned at regular intervals.

As soon as each blood donor signs their informed consent form, their temperature is taken. If they have a fever, their appointment is postponed, and they are referred to their physician. Any donor who develops COVID-19 symptoms after donating blood is required to inform the center immediately.

All BioIVT blood collections are conducted under institutional review board (IRB) oversight and according to US Food and Drug Administration (FDA) regulations and American Association of Blood Banks (AABB) guidelines.

Those who would like to donate blood at BioIVTs new Boston-area donor center should call 1-833-GO-4-CURE or visit http://www.biospecialty.com to make an appointment.

Further information about the products available from BioIVTs new donor center can be found at https://info.bioivt.com/ma-donor-ctr-req.

About BioIVT

BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. Our PHASEZERO Research Services team works collaboratively with clients to provide target and biomarker validation, phenotypic assays to characterize novel therapeutics, clinical assay development and in vitro hepatic modeling solutions. And as the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly-discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science. For more information, please visit http://www.bioivt.com or follow the company on Twitter @BioIVT.

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BioIVT Opens New Blood Donor Center to Support Boston-area Research into COVID-19 Therapies, Vaccines and Diagnostics - Bio-IT World

Recommendation and review posted by Bethany Smith

DetailsCategory: More NewsPublished on Tuesday, 07 April 2020 18:36Hits: 263

MARTINSRIED, Germany I April 07, 2020 ISIRION Biotech GmbH announced today that Beam Therapeutics licensed rights to use SIRION Biotechs LentiBOOST for use in their CAR-T cell products.

CAR-T cell therapy represents a promising and future-defining shift in cancer treatment. Beam Therapeutics is developing a new generation of CAR-T product candidates using its proprietary base editing technology.

Under the terms of this agreement, SIRION agreed to provide Beam with non-exclusive access to its proprietary lentiviral transduction enhancer LentiBOOST for clinical development and commercialization of Beams portfolio of CAR-T programs. SIRION will be entitled to undisclosed upfront and milestone payments and is eligible to receive royalties on future product net sales plus license fees tied to commercial success.

Dr. Christian Thirion, CEO and founder of SIRION Biotech GmbH explains: LentiBOOST was engineered to improve lentiviral transduction of difficult cell types like T-cells and hematopoietic stem cells. This technology enables robust upscaling of the T-cell production process, and helps to reduce manufacturing costs by lowering the amount of lentiviral vectors needed for production of the cell product while at the same time improving clinical efficacy by increasing vector copy numbers (VCN) per cell. We are delighted that the LentiBOOST technology may help Beam further enhance the clinical success of its CAR-T pipeline.

LentiBOOST is used in an increasing number of clinical trials in the US and in Europe and the technology is more and more considered as a gold standard in manufacturing of cell products. Our non-exclusive licensing strategy makes our technology available to a wide range of companies and research hospitals to boost the efficiency of their various clinical programs, says SVP of Business Development & Licensing, Dr. Sabine Ott.

About SIRION Biotech GmbH

SIRION Biotech was founded in 2005 to lead the next generation of viral vector technologies for gene and cell therapy as well as vaccine development. Now SIRION offers one of the worlds most comprehensive viral vector technology platforms based on lenti-, adeno-, and adeno-associated viruses which expedites gene therapy research and advances drug development. SIRION is becoming a partner of choice in this growing sector. LentiBOOST has been used in a number of clinical trials from early stage clinical Phase 1/2 through late stage clinical Phase 3 trials and demonstrated clinical success in improving transduction of the therapeutic vector.

SOURCE: SIRION Biotech

Continue reading here:
Beam Therapeutics Licenses SIRION Biotech's LentiBOOST Technology for its CAR-T pipeline | More News | News Channels - PipelineReview.com

Recommendation and review posted by Bethany Smith

Genprex Inc. () is a clinical-stage gene therapy company developing a new approach to treating cancer, based upon a novel proprietary technology platform, including initial product candidate, Oncoprex immunogene therapy for non-small cell lung cancer.

The Austin, Texas-based firms platform technologies are designed to administer cancer-fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities.

Oncoprex works partly by interrupting the cell signaling pathways that prompt cancer cells to multiply as well as controlling the immune response against cancer cells.

It is basically the tumor suppressor candidate 2 (TUSC2) gene wrapped in a cholesterol nanoparticle that is engineered to target cancer cells.

The nanoparticles are attracted by the opposite electrical charge of tumors, and they pass more easily through immature blood vessels that grow quickly around tumors.

Thats a big advantage because the nanotechnology can be injected intravenously, so it goes through the whole body, as opposed to many traditional gene therapies using viral delivery systems that have been injected directly into tumors.

Thus, Oncoprex can attack metastatic tumors in hard to reach places or are too small to detect. The Nanoparticles are absorbed by tumor cells at rate 10 times to 25 times higher than normal cells, but have little or no effect on normal cells, so toxicity to patients is low relative to other lung cancer drugs.

Genprex went public in April 2018, listing on the Nasdaq under the ticker GNPX and raising US$6.4 million. A private investment in public equity, or PIPE, in May that year raised an additional US$10 million.

Genprex had a great start to 2020, announcing on January 21 that the US Food and Drug Administration had granted Fast Track Designation for its Oncoprex immunogene therapy to treat lung cancer.

The FDA gave its approval to the therapy combination with EGFR inhibitor osimertinib - PLCs (NYSE:AZN) Tagrisso. That drug had worldwide sales in 2018 of $1.86 billion, $2.31 billion in the first nine months of 2019 and is currently s highest grossing product for the treatment of non-small cell lung cancer (NSCLC) patients with EFGR mutations that progressed after treatment with osimertinib alone.

FDA may award Fast Track Designation if it determines that a drug demonstrates the potential to address unmet medical needs for a serious or life-threatening disease or condition. This provision is intended to facilitate development and expedite the review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.

Genprex said a few weeks later on February 5 that it plannedto initiate a Phase I/II clinical trial of Oncoprex combined with osimertinib in mid-2020 at multiple cancer centers across the US.

It added that it did not at that time intend to reopen enrollment in its current Phase I/II trial using a combination of Oncoprex and EGFR inhibitor erlotinib (marketed by Genentech in the US and elsewhere by Roche as Tarceva) against NSCLC.

However, the group noted that tumor shrinkage in patients resistant to erlotinib enrolled in that trial showed that Oncoprex can overcome resistance to TKIs and provided support for the Fast Track Designation for the combination with osimertinib.

Genprex also said it planned to file an amendment to its Investigational New Drug (IND) application with the FDA for the Oncoprex and osimertinib combination therapy trial within the first quarter of 2020.

The group said it would also proceed with a plan to file an Investigational New Drug (IND) application for the additional combination therapy of Oncoprex combined with the immunotherapy drug pembrolizumab -- marketed as Keytruda by Merck & Co Inc () in the US for NSCLC.

The FDA fast track designation for NSCLC came after a good run of data for Oncoprex use against other cancers.

In September last year, a study by an independent researcher reported that the active ingredient in Oncoprex had been shown to prevent tumor growth in triple-negative breast cancer (TNBC).

The study,published in the medical journal 'Nature', showed that researchers found TUSC2, the lead component of the drug, acts as a tumor-preventing gene.

Then in November, Genprex revealed positive preclinical data for the treatment of some of the most resistant metastatic lung cancers using its immunogene therapy.

Its collaborators from The University of Texas MD Anderson Cancer Center presented the data at the American Association of Cancer Research Tumor Immunology and Immunotherapy 2019 Meeting.

And at the end of January, Genprex noted that independent researchers had reported in a study that TUSC2, a tumor suppressor gene and the active agent in Oncoprex, is a potential target and biomarker for thyroid carcinoma.

Published in the International Journal of Molecular Sciences, the study found that TUSC2 overexpression decreased thyroid cancer proliferation, migration and invasion. Cell proliferation, migration and invasion ability are essential steps in tumor metastasis

Away from cancer, in February, Genprex also revealed that it has signed a licensing agreement with the University of Pittsburgh for a diabetes gene therapy that could have the potential to cure Type 1 and Type 2 diabetes.

The gene therapy, developed at the Rangos Research Center at UPMC Childrens Hospital of Pittsburgh, works by reprogramming beta cells in the pancreas to restore their function, allowing them to replenish insulin levels.

Genprex has also added to its cash coffers. At the end of February, the company closed a $17.5 million offering of 5 million shares, at a price of $3.50 per share, and said it planned to use the proceeds to advance its drug development programs, for working capital and for general corporate purposes.

That followed an at-the-market stock offering at the end of January that raised $8 million through the sale of 7.6 million shares at a price of $1.05 per share.

On the management front, near the end of March, Genprex appointed two experienced life sciences executives, with Catherine MVaczy becoming executive vice president and chief strategy officer, while Michael TRedman was appointed executive vice president and chief operating officer.

Vaczy has over 20 years' experience as a founder and senior executive of life science companies. Her CV includes experiences with NeoStem Inc (now Caladrius Biosciences), a Nasdaq-listed clinical-stage biotechnology company and ImClone Systems Incorporated (sold to Eli Lily and Company).

Meanwhile, Redman brings more than 30 years of experience in the life sciences industry, having been president, CEO and director of OncolixInc, a publicly-traded clinical-stage biopharma focused on developing therapies for womens and childrens cancers.

In 2001, he co-founded Opexa Pharmaceuticals, a company developing immunotherapies for a variety of diseases, and served as its president and CEO until 2005. He has worked at Zonagen (now , which is a part of ), Aronex Pharmaceuticals, Biovail Corporation and American Home Products (acquired by ).

A few days later, the group bolstered its board further with the appointment of three new directors. The trio were Brent Longnecker, CEO of Longnecker & Associates; Jose A. Moreno Toscano, CEO at LFB USA Inc; and William R. Wilson, Jr, chairman, president and CEO of Wilson Land & Cattle Co.

In a statement with the FDA Fast Track news in January, CEO Rodney Varner said: Genprex is excited to receive this important FDA designation.

In addition to potentially facilitating and expediting our pathway to approval, we believe that this FDA designation validates our plan to commercialize Oncoprex immunogene therapy in combination with EGFR inhibitors for the treatment of lung cancer. We hope that Fast Track Designation helps us bring our gene therapy to patients more rapidly and that our unique gene therapy platform is more widely recognized for its potential in cancer treatment, he added.

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Genprex gene therapy candidate Oncoprex fast-tracking for non-small cell lung cancer treatment - Proactive Investors Australia

Recommendation and review posted by Bethany Smith

The Report Provides detailed knowledge of upcoming market trends and current conditions in the global market. This report covers the past, present and forecast period for the long-term and collective examination.

ReportsnReports added a new report on The Gene Therapy in CVMD Marketreport delivers the clean elaborated structure of the Report comprising each and every business related information of the market at a global level. The complete range of information related to the Gene Therapy in CVMD Market is obtained through various sources and this obtained the bulk of the information is arranged, processed, and represented by a group of specialists through the application of different methodological techniques and analytical tools such as SWOT analysis to generate a whole set of trade based study regarding the Gene Therapy in CVMD Market.

Report at: http://www.reportsnreports.com/contactme=1591140

Gene therapies have been a point of discussion during the last several years as a potential curative option for a variety of disease indications. While mainly still in preclinical stages, gene therapy aims to treat or alleviate a disease by genetically modifying the cells of a patient.

This report focuses on gene therapies in development across the 8MM for cardiovascular and metabolic disorders, including coronary artery disease, critical limb ischemia, diabetic foot ulcers, and Pompe Disease. In addition, this report provides an assessment of the pipeline, clinical, and commercial landscape of gene therapies in CVMD supplemented with a variety of KOL and payer perspectives.

Reason to access this Report:

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline, Develop business strategies by understanding the trends shaping and driving the global CVMD gene therapy market, Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CVMD gene therapy market in the future, Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors, Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage, Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Report:

http://www.reportsnreports.com/.aspx?name=1591140

Scope of Gene Therapy in CVMD Market Report:

Overview of CVMD and Gene Therapies: epidemiology and regulatory oversight, Pipeline Assessment: regional breakdown, promising late-stage products, early-stage pipeline by molecule type, Clinical Trials Assessment: trial breakdown by phase, leading industry and non-industry sponsors, Market Access: considerations for reimbursement, pricing, and unmet needs, Market Outlook: competitive assessment and key market events (2018-2025).

Table of contents for Gene Therapy in CVMD Market:

1.1 Related Reports 4

1.2 Upcoming Related Reports 5

1.3 Abbreviations 6

2.1 Key Findings 10

2.2 KOL and Payer Insight on CVMD Gene Therapy Competitive Landscape 11

3.1 What is Gene Therapy? 14

3.2 Gene Transfer Methods and Vectors Used for Gene Therapy 18

3.3 Viral Vectors vs. Non Viral Vectors 20

3.4 Therapeutic Gene Therapy Strategies Employed in CVMD 24

3.5 Gene Therapy in the 8MM 25

4.1 Coronary Artery Disease 33

4.2 Peripheral Artery Disease 34

4.3 Peripheral Artery Disease with Critical Limb Ischemia 35

4.4 Systolic Heart Failure 36

4.5 Diabetic Foot Ulcers 37

4.6 Diabetic Neuropathy 38

4.7 Pompe Disease 39

5.1 CVMD Gene Therapy Pipeline in the 8MM 42

5.2 Pipeline Products - Phase III 43

5.3 AnGes MGs Collategene 44

5.4 Angionetics Generx 45

5.5 ViroMeds Donaperminogene Seltoplasmid 46

5.6 Renovas RT-100 49

5.7 Pipeline Products - Phase II 50

5.8 ID Pharmas DVC-10101 51

5.9 Juventas JVS-100 52

5.10 UFs Gene Therapy to Activate Acid Alpha Glucosidase for Pompe Disease 54

6.1 Clinical Trial Mapping 57

6.2 Clinical Trial Design 59

7.1 Current CVMD Space 62

7.2 Challenges Associated with Reimbursement of Novel CVMD Therapies 63

7.3 Prospective Payer Strategies for CVMD Gene Therapies 64

8.1 Phase III CVMD Gene Therapy Pipeline 67

8.2 Key Launch Dates for Phase II and III CVMD Gene Therapy Pipeline 71

9.1 Sources 73

9.1 Methodology 74

9.2 Primary Research 75

9.3 About the Authors 76

And more...

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Gene Therapy in CVMD Market report made possible by top research firm - WhaTech Technology and Markets News

Recommendation and review posted by Bethany Smith

Investigators have identified genomic alterations that appear to be associated with prognosis in men with metastatic castration-sensitive prostate cancer (mCSPC).

Astudy of 424 patients with mCSPC treated at a tertiary care center revealedthat alterations in the androgen receptor (AR), TP53, cell-cycle, MYC oncogenicsignaling pathways occur more commonly in tumors with worse overall survivaland decreased time to castration-resistant disease, whereas alterations in theSPOP and MNT pathways occur more frequently in tumors with a better prognosis,according to findings published in ClinicalCancer Research.

Thegenomics of metastatic castration-sensitive prostate cancer have not been wellcharacterized in the literature, but it is now clear that upfront treatmentintensification with taxanes or next-generation AR-directed therapies offerbenefit in the overall patient population, said the studys co-senior authorWassim Abida, MD, a medical oncologist at Memorial Sloan Kettering CancerCenter in New York. The question remains whether treatment selection ortargeted therapies can be employed based on genomic characteristics.

Theassociation between alterations in cell-cycle genes and TP53 and MYC pathwaygenes and worse outcomes may pave the way for targeted therapy in thesehigher-risk groups, Dr Abida said.

Thestudy compared genomic alterations according to clinical phenotypes: high- vslow-volume disease and de novo vsmetastatic recurrence. Of the 424 patients in the study, 213 men (50%) hadhigh-volume disease (4 or more bone metastases or visceral metastases) and 211(50%) had low-volume disease; 65% had de novometastases and 35% had metastatic recurrence. At the time of sample collection, patients had a medianage of 66 years. The investigators conducted gene sequencing from May 2015 to September2018.

High- vs low-volume disease

Inadjusted analyses, men with higher-volume disease had significant 1.8- and3.7-fold increased risks of castration-resistant disease and death,respectively, compared with men who had low-volume disease. Tumor specimensfrom men with high-volume disease had more copy number alterations.

Amongmen with high-volume disease, the highest-ranking pathways were the NOTCH,cell-cycle, and epigenetic modifiers pathways.

Althoughthe prevalence of CDK12 alterations differed between patients with de novo metastatic and those with metastaticrecurrences, the groups had similar prognoses. I was actually surprised therewere not more dramatic genomic differences between de novo and relapsed disease, said study co-senior author PhilipKantoff, MD, a medical oncologist and Chair of the Department of Medicine atMemorial Sloan Kettering Cancer Center in New York.

Afteradjusting for disease volume and other genomic pathways, the researchers foundthat the rates of castration resistance differed by 1.5-fold and up to 5-fold accordingto alterations in the AR, SPOP (inverse), TP53, cell-cycle, WNT (inverse), andMYC pathways. Overall survival (OS) rates varied from 2- to 4-fold according toalterations in the AR, SPOP (inverse), WNT (inverse), and cell-cycle pathways.PI3K pathway alterations were not associated with prognosis.

Docetaxeland next-generation AR axis-directed therapies have been shown to prolong OS, butit remains uncertain which patients benefit the most from intensifiedtherapies. We did not find any obvious genomic reason to explain thedifferences in docetaxel sensitivity between high- and low-volume disease, DrKantoff said.

Theauthors pointed out that genomic landscape studies of tumor DNA profiling inprostate cancer in general have excluded metastatic castration-sensitive tumors.Instead, most studies have focus on localized disease or metastaticcastration-resistant disease.

DrAbida and his colleagues acknowledged that their study has inherent biases becauseit was hospital based and enrolled patients at an academic referral center.

Moleculardeterminants of castration resistance or survival in patients with mHSPC have beenunclear, but the new study sheds new light on molecular alterations associatedwith poor outcomes in men with mHSPC, particularly alterations in the AR, cellcycle genes, MYC, and TP53 genes, said Joshi Alumkal, MD, the Leader of theProstate/Genitourinary Medical Oncology Section and Associate Division Chieffor Basic Research in the Hematology-Oncology Division at the University ofMichigan School of Medicine.

Severalrandomized phase 3 clinical trials now show a benefit of escalating treatmentin men with mHSPC by adding novel AR-targeting agents or chemotherapy plusmedical castration versus medical castration alone, Dr Alumkal said. Whetherthe addition of any of these specific agents to medical castration isassociated with improved outcomes in patients with poor-risk molecularalterations identified by the new study is a critical next question, he said.

Urologiconcologist James Mohler, MD, Senior Vice President for Translational Researchat Roswell Park Comprehensive Cancer Center in Buffalo, New York, said the new study found relativelysmall differences among the clinical phenotypes, but that is not surprisingbecause the temporal differences in the evolution of tumor biology occur overlong periods of time, much of which precedes clinical presentation. The hazardratios for association between mutational analysis and oncologic outcome insome cases were statistically significant, but are so small as to not beclinically significant. Part of the reason for this may be that prostatecancer, once metastatic, is so complex that no single mutation or single genepathway is driving growth and hence targetable at a high rate beyond the long provenbenefit from androgen deprivation therapy, Dr Mohler said.

The results reported by these authors may be disappointing to many clinicians, but are important because they represent a comprehensive analysis of mCSPC. The authors appropriately acknowledge that better tumor sampling and more comprehensive genetic analysis and larger numbers of patients may be required to find any benefit to genomic or somatic sequencing, Dr Mohler said. I am afraid that these limitations are not just of their work but a biological limitation of aggressive prostate cancer, which makes improving treatment of advanced prostate cancer in an individual patient extremely challenging.

Reference

Stopsack KH, Nandakumar S, Wibmer AG, et al. Oncogenic genomic alterations, clinical phenotypes, and outcomes in metastatic castration-sensitive prostate cancer [published online March 27, 2020]. Clin Cancer Res. doi: 10.1158/1078-0432.CCR-20-0168

This article originally appeared on Renal and Urology News

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Genomic Alterations Linked to Outcomes in mCSPC - Cancer Therapy Advisor

Recommendation and review posted by Bethany Smith

New knowledge derived from the study by NUS researchers opens up opportunities for personalised treatment against aggressive head and neck, and lung cancers in Asian population

Researchers from the Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore (NUS) have uncovered a genetic variant in a gene called MET that is responsible for more aggressive growth of head and neck, and lung cancers. A further probe into the finding revealed therapeutic strategies that could potentially target this genetic alteration, thereby paving the way for clinicians to develop better and more effective treatments for cancer patients of such profile.

The study, published in the prestigious scientific journalNature Communicationson 25 March 2020, was conducted in close collaboration with clinicians from the National University Cancer Institute, as well as researchers from the National Cancer Centre Singapore and the Bioinformatics Institute at the Agency for Science, Technology and Research, Singapore.

The MET gene encodes for a cancer-promoting protein that relays growth, survival and transmission of signals in cancer cells. In the study led by Professor Goh Boon Cher and Dr Kong Li Ren from CSI Singapore, the team of researchers identified a form of MET protein, which showed ethnic preference with a higher incidence among Asians, and is associated with poorer prognosis in patients diagnosed with head and neck squamous cell carcinoma or lung squamous cell carcinoma. Even though the MET variant does not seem to predispose an individual to cancer, it leads to the more aggressive growthof cancers that have already developed.

Unlike other MET mutants, this genetic variant also does not appear to be inhibited by existing MET-blocking drugs that have been developed and approved in the clinical setting, prompting the researchers to conduct further investigation on the mechanism behind the genetic alteration.

Leveraging the research teams multi-disciplinary expertise and state-of-the-art molecular modelling, the team found that the single amino-acid change in the MET receptor from the genetic alternation leads to preferential strong binding to another cancer-promoting protein, HER2. Both proteins then work cooperatively to drive cancer aggression and enable cancer cells to survive therapies involving MET-blocking drugs.

The mechanism of this MET variant is novel and unreported. This finding contributes to the growing evidence of the role of genetic variants in affecting clinical outcome, and underscores the importance of diving deep into our genetic inheritance in cancer research, said Dr Kong, Research Fellow at CSI Singapore who initiated the study.

Knowledge of this unique mechanism also facilitated the team in identifying several HER2 inhibitors capable of blocking cancer progression caused by this genetic alteration using laboratory models.

Prof Goh, Deputy Director and Senior Principal Investigator at CSI Singapore, said, Our study represents a conceptual advancement to cancer research, as we have shown that it is possible to block the activity of a cancer-driving gene by administrating a targeted therapy directed not against the mutant protein in question, but rather, a corresponding protein with which it binds to. The remarkable anti-tumour responses observed in our experimental models, coupled with the availability of FDA-approved HER2 inhibitors also presents a huge opportunity for clinicians to improve the disease outcome of this genetic alteration via precision medicine.

The research team is now translating the findings to a clinical trial where patients tested positive for this MET variant gene are treated with suitable medications that have shown effectiveness in the laboratory

Read the original here:
Singapore uncovers cancer-causing hereditary mutation in Asians - BSA bureau

Recommendation and review posted by Bethany Smith

The next frontier for university technology transfer will likely be in the transformation of data-rich sectors using artificial intelligence (AI) and machine learning technologies. One area largely accumulating data is the healthcare sector. Medical knowledge is doubling every 73 days, yet we are barely scratching the surface of utilizing this data.

Over $71 billion USD was spent in federally sponsored research at universities in 2018 in the US alone. Approximately $2.94 billion in licensing revenue was generated in 2018 directly from the process of taking academic inventions to market, otherwise known as technology transfer (TT). Including federal laboratories, the US invests more than $100 billion each year in federal research funding, with a cumulative spending of more than a trillion dollars over the last 15 years. In this article, we report trends in academic TT from surveys and literature and provide perspective on the future directions of the field.

Figure 1. This dashboard shows the metrics reported by AUTM for 2018, exhibiting the impact of technology transfer in the US.

There have been several high-profile hot takes on academic TT in the past several years, claiming that by-the-numbers TT is a failing endeavor. Leaders of TT argue, with merit, that this criticism misses the point and overlooks the fact that TT is able to improve the public good through commercializing federally funded inventions. We agree with the latter viewpoint and examine TT numbers to shed more light into this field. University administrations and other stakeholders evaluate technology transfer offices (TTO) via 1) revenue generated, 2) licenses executed, 3) startups created, 4) invention disclosure forms (IDF) received, and 5) patents issued. In this piece we examine AUTMs STATT survey data that measures these indicators for all years in which most data is available (20082018) and provide context and graphics of interest.

While revenue is a cornerstone performance indicator in business, its use as an indicator of performance is a touchy subject for TTOs. Only a small proportion of the total sales from the licenses goes back to the university TTO. For example, consider a university TTO with a $10 million annual budget: according to a survey conducted by AUTM, the median royalty received by universities is approximately 2% of product sales. The TTO typically receives around 25% of those royalty revenues that is received by a university. Therefore, for the TTO to break even the university needs to receive $40 million in royalties, which requires $2 billion in cumulative sales for the companies licensing university IP! That is a lofty goal and most universities fall short. The exceptions are unicorns, where single licenses earn the university hundreds of millions (e.g., Lyrica from Northwestern brought $1.4 billion). This is why revenues do not tell the whole story of academic technology commercialization; most revenues are generated by a miniscule subset of licenses. Yet, STATT reports $2.94 billion in total revenues in 2018. Assuming the median 2% royalty rate, that implies about $147 billion in sales of products derived from academic technology. Not bad in terms of ROI from $71 billion. In line with the spirit of the Bayh-Dole Act of 1980, another measure of efficiency for the TTOs are the number of licenses.

Figure 2. The top 20 individual universities with the most gross licensing revenue compared with the number of executed licenses from 20082018 according to STATT data. Three university systems had high revenue number but are excluded because they dont report individual statistics: The University of California System with $1,513,052,284 in revenue and 2448 licenses, The University of Texas System with $694,903,592 in revenue and 1601 licenses, and The University of Massachusetts System with $387,504,344 in revenue and 280 licenses. Missing data: City of Hope NMC (201415), Princeton University (200810).

It is no surprise that there is a positive correlation between patents issued and licenses executed (and startup creation and revenues earned). Despite this, the federal government disallows any of the $71 billion in research funding to be spent on filing patents to protect inventions. Yet, in 2018, universities spent over $425 million in patent-related legal expenses. Anyone who has worked at a TTO can attest to the challenge of managing a portfolio of patents on a shoestring budget. Patents are expensive and there are never enough funds to file for patents on all of the inventions that warrant protection. As a result, more than 95% of foreign rights are never protected, and less than 30% of patents are ever converted to a full patent from the provisional filing. This problem is compounded by other challenges including the inability to protect some gene-based and software inventions through patenting, which has an outsized effect on academic research institutions.

Figure 3. The top 20 individual universities with the most patents issued from 20082018 compared with legal expenditures according to STATT data. Two university systems had high numbers of patents issued but are excluded because they dont report individual university statistics: University of California with 4335 patents issued and $ $426,655,283 in legal fees and The University of Texas System with 1883 patents issued and $99,084,203 in legal fees. Missing data: University of South Florida (2009).

In recent years there has been a paradigmatic shift towards commercializing technology through startups. There is a universal understanding that university inventions are in early technology readiness level and need substantial development to be ready to go to market. Many universities have taken it upon themselves to fund some of the startups, sometimes co-funding alongside venture funds. The trend of the top-20 universities for initiated startups (20082018) provides several trends of interest. As expected, the Silicon Valley, Cambridge and other mature startup ecosystems create a huge number of startups. Yet other noteworthy regions have built strong reputations for startup creation as well. Factors that influence the rankings include 1) access to funding, 2) access to entrepreneurs, and 3) an ecosystem of other startups and similar companies. Critical factors that enhance startup success is the stability of the parent TTO (e.g., Columbia University), leadership and support from the university (e.g., Purdue University), support from the alumni (e.g., University of Florida and University of Michigan), and size of available research funding (e.g., University of Washington and University of Pennsylvania).

Figure 4. The top 20 universities with the most startups initiated from 20082018 according to AUTM STATTs database. Four university systems had high numbers of startups issued but are excluded because they dont report individual university statistics: University of California System with 785 startups, University of Texas System with 277 startups, University System of Maryland with 121 startups, and the Research Foundation of SUNY with 108 new startups. Missing data: University of Colorado (2014), University of Utah (2016).

Although the total number of startups from the academic world is very small compared to the overall national numbers, the impact of these spinouts on the economy is substantial. Stanford University alone originated giants including Google, Cisco, and HP. Survival rates, funds raised, and successful exits are all higher among university/alumni-based startups that are based on university-licensed technology. Furthermore, in addition to high technology, startups from universities include a large number of impactful biotechnology and gene therapy companies, such as Juno Therapeutics (Fred Hutchison Cancer Research Center, Memorial Sloan-Kettering Center, and Seattle Childrens Research Institute). When Juno sold to Celgene for $9 billion, the primary investor in the company (ARCH Ventures) received 23x return on their 15% stake. Endocyte Inc. from Purdue University (acquired by Novartis AG for $2.1 billion) and AveXis from Nationwide Childrens Hospital and Ohio State University (acquired by Novartis AG for $8.7 billion) are other notable examples. While the dollar figures might be astonishing for some of these exits, the impact of these life science companies over the last four decades has also been enormous. A study by Dr. Ashley Stevens et. al. of Boston University found 153 new drugs and vaccines were developed by public research institutions between 1981 and 2011.

Figure 5. The number of startups more than tripled in 20 years, from 306 in 1998 to almost 1098 in 2018. This can be attributed to a sustained effort by universities to incubate early-stage technologies through startups.

If patents are the finished goods of university technology commercialization, then invention disclosures are the raw materials that must first be processed and refined. We examined the cumulative number of invention disclosures between 20062017 at these universities and found, as would be expected, that the universities with the highest numbers of IDFs also have the highest number of patents, with several notable exceptions. University of South Florida, Northwestern University, NYU and USC have high patent numbers although they are not in the top 20 for IDFs. On the other hand, University of Minnesota, University of Pittsburgh, and Ohio State University, do not appear on the top 20 for patents although they are in the top 20 for IDFs. We analyzed the IDFs from 2006-2017 because we wanted to comparethose numbers to the total number of publications from those institutions using the Leiden CWTS publication data which displays total number of publications from 20062017. The most startling observation was that the number of IDFs were largely predicted by the number of publications in a 1:10 ratio. The outliers were Harvard University and University of Michigan.The smallest ratios were from engineering-focused California Institute of Technology, Massachusetts Institute of Technology, Georgia Institute of Technology, and Purdue University.

A challenge faced by all university TTOs is the huge number of research publications describing inventions that are not reported as IDFs. As we state above, most TTOs do not have the budget to file patent applications on every promising IDF. This is discouraging for faculty who in turn do not report subsequent inventions. There are also faculty members who do not believe in filing patents and want their research to remain in the public domain. These factors are perhaps the biggest opportunity in the field of technology commercialization; if the research is not disclosed, then less intellectual capital reaches the market.

Figure 6. The top 20 universities with the most invention disclosure forms (IDFs) (green) and number of publications (orange) for 20062017. Note that hospital publications are not tracked by Leiden and they were excluded, as were the university systems University of California with 18636 IDFs, University of Texas with 7293 IDFs, Research Foundation of New York with 3409, and University System of Maryland with 2742 IDFs. Publication numbers were not available for the Mayo Foundation of Medical Education and Research and the Massachusetts General Hospital.

In the early days of TT, universities could not have predicted how this profession would change the face of the US economy and the impact it would have overall. Consider the following revolutionary changes that have taken place at universities and TTOs:

Dr. Dipanjan DJ Nag is the Chief Investment Officer at Ventech Solutions, a healthcare technology company that manages quality data for the Center for Medicare and Medicaid Services (CMS). He has successfully led Ohio State University, Rutgers University and University of Nebraskas technology transfer operations that included licensing, startup and investments. As an entrepreneur he led a number of start-ups in the intellectual property strategy, artificial intelligence, and medical device space. As a consultant in patent monetization and intellectual property strategy he has worked with many Fortune 500 companies, universities, and national governments. He was a Director of Ocean Tomo and a Vice President at ICAP Ocean Tomo leading patent transaction markets. He was recognized as one of the top IP strategists by IAM300 in 2019. DJ was on the Board of AUTM from 2012-14 focused on educating the members around world the importance of technology transfer and intellectual property. He is widely recognized as a global intellectual property strategist working with government and universities in Poland, Japan, India, Turkey, Brazil, South Korea, Ukraine and many other countries. Currently he teaches intellectual property strategy and negotiations as a Professor of Practice at Rutgers University and a Visiting Professor at Shizuoka University. He volunteers as the first Executive-in-Residence at the Dublin City Schools leading a startup academy for high school students and serves on the foundation board at the Dublin Methodist Hospital.

Antara Gupta graduated from Case Western Reserve University in 2017 with a bachelors degree in Finance with a minor in Economics. She acquired her Series 7 license in 2017 before she began a financial analyst job at Sycamore Growth Group. She was a financial analyst calculating R&D tax credits, job creation tax credits, and training grants for manufacturers. She worked alongside the president of the company communicating with current and potential clients. Antara then went on to Ventech Solutions, Inc as the Strategic Venture Analyst in March of 2019. She provided due diligence, market analysis and IP landscape reports for the leadership team. In the beginning of 2019, Antara began a volunteer analyst position at the Dublin City Schools helping prepare the financial projections and structure for the Entrepreneurship Program for High School students. Antaras main passions are in the field of finance, entrepreneurship, education, economic development, and intellectual property analysis.

Alex Turo is the Intellectual Property Fellow at Ventech Solutions, a healthcare technology company that manages quality data for the Center for Medicare and Medicaid Services (CMS). He has worked in technology commercialization and business development at The Ohio State University where he is also a graduate research fellow in life sciences. He is a subject matter expert in biotechnology and bioinformatics with a masters degree from Binghamton University (SUNY) and 7 years of experience in the analysis of next-generation sequencing data.

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The Evolution of University Technology Transfer: By the Numbers - IPWatchdog.com

Recommendation and review posted by Bethany Smith

A new coronavirus was spreading in the U.S., and with social distancing orders going into place, talk immediately turned to finding a treatment that could stop the spread.

In Maryland, companies jumped into action. Work began on a vaccine at Gaithersburg-based Novavax, and the company partnered with Emergent Biosolutions on initial development and manufacturing. Gaithersburgs Altimmune is also developing a vaccine, and announced plans last week for a preclinical testing collaboration with the University of Alabama Birmingham.

In all, Maryland Tech Council President Marty Rosendale now counts 28 Maryland companies working on the response in some form, whether they are developing new vaccines, therapeutics and tests, or providing lab space and clinical expertise thats key to bringing those forward. And a collaborative spirit is taking root.

This is about getting the job done, said Rosendale, who is connecting companies whether they are members of his organization or not. This is about making sure that we build these vaccines and diagnostics and get them cleared by the FDA as fast as we can and get out there and serve the public.

As the race against the virus is on among scientists and CEOs, its worth it for the rest of us to take a moment to remember that the ability to spin up operations that can develop life-saving treatments doesnt get built overnight. That manufacturing center from Emergent Biosolutions in Baltimores Bayview? It was already established as one of three federal centers to make new products to stop public health threats, and doubled in size in 2017.

With the need for years of research, lab space and stringent requirements to meet safety since theyre creating things that are put into peoples bodies, life sciences and biotech work takes longer to roll up to the general public. Equally, the region is home to work in biotech and life sciences that has developed over decades, and it has been gaining more and more influence in recent years.

Its also at the center of some of the most groundbreaking work to advance human ingenuity in the region and save lives. And, economically, its been home to some of the biggest news about M&A activity, venture capital and job growth.

When it comes to growing industries, the life sciences sector is among the most impactful in the area. Spanning hospital research labs and manufacturing centers where production takes place, harnessing living cells to create new treatments and other biotech, biomedical and pharma work is happening in a footprint that knits together Baltimore, the Maryland suburbs, D.C. and Northern Virginia.

Its an area that is home to key assets. That includes federal government institutions where research needs are identified such as the Bethesda-based National Institutes of Health, the White Oak-based U.S. Food and Drug Administrationand the Gaithersburg-based National Institute of Standards and Technology (NIST), while Frederick-based Fort Detrick is home to a base of biomedical work.

Funding from those institutions flows to universities such as Johns Hopkins Universityand the University of Maryland, where experts and faculty advance research. The response to the crisis offered an example of the leadership role, as noted Hopkins infectious disease expert Arturo Casadevall is leading a collaboration among research centers to explore the potential use of blood plasma from COVID-19 survivors as a therapeutic. The effort was funded to the tune of $4 million by Bloomberg Philanthropies and the State of Maryland, officials said in late March. By last week, the FDA approved a clinical trial that will allow researchers to tell whether the plasma is effective in protecting healthcare workers and first responders.

We are very fortunate that Maryland has some of the top health research facilities in the world, and I am confident in our states ability to be a leader in developing treatments and perhaps even a vaccine for COVID-19, Gov. Larry Hogan said in a statement issued when the announcement was made.

Emergent, too, is working on a plasma-derived therapy that collects donations of plasma from people who recovered. On April 2, the company was awarded $14.5 million from the U.S. Biomedical Advanced Research and Development Authority and was entering into a formal partnership to advance its treatment for severe hospitalized patients and at-risk people. Going forward, NIHs National Institute of Allergy and Infectious Diseases has agreed to incorporate the candidate into future clinical studies of COVID-19 treatments.

Though it is applying to a new coronavirus, the companys work on plasma therapy didnt just start. It is drawing on 40 years of experience working with plasma-derived therapies, said CEO Robert G. Kramer Sr.

Universities also help to get those discoveries to the public, establishing patents and nurturing startups and helping hospital systems offer places to gain new insight in the clinic. And at a collection of publicly traded companies born inside the state and big firms that moved here like GSK and AstraZeneca, work goes on to turn innovations hatched at research labs into products that can be made available widely to the public.

The biohealth industry is one of the top industrial clusters and very important to the Maryland economy, said Richard A. Bendis, president and CEO of Rockville-based BioHealth Innovation Inc.

The collective activity has already identified a name: the BioHealth Capital Region. And theres an ambitious goal: to be one of the top three hubs in the nation for biohealth by 2023. (For context, it was #4 last year, according to a ranking released by GEN.)

But even in the shorter term, there are signs of a new wave of activity thats having an impact everywhere in one metric that matters locally on the ground: job growth. Specifically, thats playing out as companies seek the facilities to make products in the state, and the people who can run the operation.

As the Maryland life sciences industry matures and moves further into clinical development and commercialization, the demand for manufacturing is growing, Rosendale said.

One of the largest exits of the decade arrived heralded from the sector in April 2019, when Catalent acquired Baltimore-based Paragon Bioservices. The $1.2 billion deal came just days after Paragon opened a new manufacturing center near BWI and made big plans to grow hundreds of jobs locally, and the newly branded Paragon Gene Therapy has continued to hire there and at other facilities like its University of Maryland BioPark HQ.

The same month, GileadsKite Pharma announced plans of its own to create jobs in the region with a forthcoming biologics manufacturing facility in Frederick County.

Longtime companies in the area have also opened their own manufacturing facilities. Gaithersburg-based Emergent Biosolutions has a pair of plants in Baltimore where it makes vaccines and recently expanded, while Precigen (formerly Intextron) opened its own gene and cell therapy-focused space in Germantown last year.

The maturity can also be measured in investment: Frederick-based Rooster Bio and BioFactura each made plans to ramp up production with second rounds of funding.

At the same time, Rosendale said, the next generation of life science companies are now beginning to move out of the incubators and into clinical development. Viela Bio spun out of longtime regional stalwart MedImmune (owned by AstraZeneca) and made a splash with a debut on the public market in 2019.

And there are signs that it makes sense to plant seeds for future growth in facilities like the two-year-old Johns Hopkins Fast Forward 1812 in East Baltimore and LifeBridge Health Bioincubator at Sinai Hospital in North Baltimore, as well as plans for a new BioPark building along MLK Boulevard in Southwest Baltimore and the forthcoming JLABS space from Johnson & Johnson Innovation and the Childrens National Health System in D.C.

The wave of growth has brought a job dynamic that has folks looking to fill roles, as well as orders.

Unemployment in the sector is at an all-time low, while the demand for skilled workforce in the sector continues to grow, Rosendale said.

Life sciences is often listed alongside cybersecurity as a growing industry in the state, and they face similar situations when it comes to workforce needs.

With more and more companies advancing their pipelines and seeing success, there is demand across the life science continuum for talent, said Chris Frew, CEO of BioBuzz Media and Workforce Genetics. Especially in the later stage clinical and commercialization fields. Biomanufacturing is in great demand and there are lots of jobs, process engineers are also in demand and hard to find.

The state draws bonafides in the industry from a large cluster of Ph.D.s. And, to be sure, theres room for highly educated experts to have a role in shaping a company. Bendis said tighter alignment between industry and academia to shape curricula and more education on what jobs are available for postdocs who want to stay in the region can help.

And when it comes to the demands of processing and manufacturing, educated folks are needed at many levels.

The running joke with my colleagues is if you can tell the difference between a eukaryote and prokaryote, youre hired, Ben Woodard, who leads an effort to train students at the Biotechnology Research and Education Program at the University of Maryland in College Park, told us prior to the pandemic in early March. (The program is currently working to roll out remote offerings since most lab research at the university has been halted). There are more jobs than people and the ultimate goal is to help healthcare.

More:
The DMV region's life sciences sector jumped into the fight against COVID-19. Here's why it could move quickly - Technical.ly

Recommendation and review posted by Bethany Smith

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Cancer Gene Therapy Market CAGR Status, Segmentation by Revenue, Gross margin, Analysis, Research, Forecast - Northwest Trail

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass., April 03, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, today provided an update on the RESTORE-1 clinical trial of VY-AADC (NBIb-1817) for Parkinsons disease. Voyager and its collaborator Neurocrine Biosciences have temporarily paused screening of new patients in the RESTORE-1 trial to allow clinical trial sites to assess the impact of the COVID-19 pandemic on both the implementation of previously disclosed protocol amendments and on the safety of study participants. The companies plan to resume patient screening and enrollment as soon as the assessment is completed and Neurocrine, as the study sponsor, and Voyager, in consultation with clinical sites, determine that screening can safely and effectively resume. Voyager and Neurocrine Biosciences continue preparations for the initiation of the RESTORE-2 registrational study in Parkinsons disease planned for the second half of 2020.

About Voyager Therapeutics

Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV gene therapy through innovation and investment in vector engineering and optimization, manufacturing, and dosing and delivery techniques. Voyagers wholly-owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinsons disease, Huntingtons disease, a monogenic form of ALS called SOD1, Friedreichs ataxia, Alzheimers disease, and other neurodegenerative diseases related to defective or excess aggregation of tau and alpha-synuclein proteins in the brain. Voyager has strategic collaborations with AbbVie and Neurocrine Biosciences. Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager is headquartered in Cambridge, Massachusetts. For more information, please visit http://www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as may, might, will, would, should, expect, plan, anticipate, believe, estimate, undoubtedly, project, intend, future, potential, or continue, and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding the assessment of the impact of the COVID-19 pandemic on the RESTORE-1 and RESTORE-2 trials, the resumption of screening and enrollment in the RESTORE-1 trial and planned initiation of the RESTORE-2 trial. All forward-looking statements are based on estimates and assumptions by Voyagers management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain. These forward-looking statements are subject to risks and uncertainties, including the risk that the assessment of the impact of the COVID-19 pandemic impact on the RESTORE-1 and RESTORE-2 trials may not be completed or may be substantially delayed, the risk that the consequences of the COVID-19 pandemic may not allow Neurocrine Biosciences to resume screening and enrollment of patients for the RESTORE-1 trial or to commence the RESTORE-2 trial, the risk that the impact of the COVID-19 pandemic on the RESTORE-1 and RESTORE-2 trials could affect Voyagers existing collaboration with Neurocrine Biosciences, or the risk that the COVID-19 pandemic could affect Voyagers ability to develop and commercialize products currently in Voyagers research and development pipeline. These statements are also subject to a number of material risks and uncertainties that are described in Voyagers Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Investors: Paul CoxVP, Investor Relations917-754-0207 pcox@vygr.com

Media: Sheryl Seapy W2Opure949-903-4750 sseapy@purecommunications.com

Original post:
Voyager Therapeutics Provides Update on the RESTORE-1 Parkinson's Disease Trial - Associated Press

Recommendation and review posted by Bethany Smith

A man who spent 11 years living as a trans woman having treatment including hormone therapy and breast implants has trained as a counselor to help people accept their gender, after 'detransitioning' back to being male.

Constantly mistaken for a girl, from childhood onwards, Brian Belovitch, 63, decided to transition to a woman when he was just 19 years old, instead of embracing his "effeminate gay identity" as he does today.

Brian, of Brooklyn, New York, said:

She continued:

Brian is speaking out about his extraordinary life, which has seen him battle addiction as he tried to fathom who he really was, just as a British woman has been given the go-ahead to pursue legal action against an NHS gender clinic, saying they should have challenged her more ardently before allowing her to transition from female to male.

Brian aged three in 1959 (PA Real Life/Collect)

Known as a 'detransitioner' a trans person who has reverted back to the sex they were assigned at birth Brian believes we are seeing "the tip of the iceberg" when it comes to people making the decision to change gender in this way.

He said:

He continued:

Brian certainly enjoyed a colorful existence after transitioning living as the showgirl Natalia 'Tish' Gervais, through the late 70s and early 80s and performing in legendary New York nightspots like Dancetaria, the Limelight Club, and Studio 54, made famous by artist Andy Warhol.

But beneath the glamorous surface was a seedy underbelly that saw Brian, who is now happily married to horticulturist Jim Russell, 61, develop crippling drug and alcohol addictions.

Hitting rock bottom in the 1980s and seeking therapy, in 1986 Brian decided he was fundamentally unhappy in his own skin and decided to transition back to being male.

"It was such a relief," he said. "I finally felt at peace in myself for the first time."

"It felt like my world had become a lot simpler by the decision and I could finally live the life I wanted to."

Brian aged five, with his parents Dolores and Isadore (PA Real Life/Collect)

Brian became confused about his gender as a tiny child, when he remembers strangers mistaking him for a girl to his mother's chagrin.

"One of my first memories is being out shopping with my mother and a group of women gathering around and saying, 'Oh how cute, how sweet. Where does she get those curls and thick eyelashes from?'" he said.

"My mom didn't deal with it very well and pulled me away shouting that I was a boy."

He continued:

Targeted by his peers throughout his childhood and into his teenage years, Brian says he was lucky to have survived the experience.

"Kids would follow me home and throw rocks at me," he recalled. "They'd call me 'f***** and queer.'"

He continued:

Exploring the local gay scene at age 16 brought Brian some solace, especially when he made a like-minded friend in Paul Bricker, then 17, who tragically passed away from an aneurysm, aged just 27.

Brian in 1972 (PA Real Life/Collect)

Describing Paul as his 'mentor,' Brian said:

Soon after, Brian moved in with Paul and his mother, Gloria Walker, now 93.

In the bohemian household, he could be open about his sexuality and he and Paul began dabbling in the world of drag.

"By today's standards, I was what would be called a 'gender non-conformist,' meaning that I trod the line between what is seen as male and female," Brian explained.

"It was a mixed bag. We called it 'scare drag,' because we were scaring the straight people that couldn't put us into one of their boxes."

Outgrowing his hometown of Providence, Rhode Island, Brian moved to New York City with $100 in his pocket and started performing with drag queens to "earn an extra buck," alongside working in a thrift store.

Taken under the wing of a group of trans women, Brian was still struggling with his own gender identity and began to question if transitioning from male to female might be the answer to his problems.

So, less than a year after arriving in New York, aged just 19, he was given the name of a "no questions asked" doctor who could help him to transition.

Brian and Paul Bicker in 1973 (PA Real Life/Collect)

"I turned up at this doctor's office no questions asked and handed over $10," he recalled.

"It was pretty much, 'Come in, drop your pants, I'll stick you with a needle.'"

Describing how the hormone therapy worked "very effectively," within a matter of months Brian developed small breasts, had a "softened" appearance and his voice sounded more feminine.

Changing his name legally that year, Brian officially became Natalia going on to spend the next 11 years living as Tish.

In 1979, four years into his hormone therapy and still not feeling like his "authentic self," Brian took the next step in his transition, spending $500 having silicone breast implants fitted.

"It felt like the right thing to do at the time," he said. "In hindsight, it wasn't very well thought out, but none of my decisions were back then."

He continued:

Natalia in a 1977 beauty pageant (PA Real Life/Collect)

Although struggling personally, Brian's professional life as Tish went from strength to strength.

Working seven nights a week, he would run the gauntlet of New York's hottest clubs, performing as a "big, busty showgirl."

"At the height of the 80s, I was a club personality," Brian said. "I had a band and would do a live show with a mix of comedy and musical numbers."

He continued:

Living both as a man and then as a woman also gave Brian a rare insight into the way society treats people based on their gender.

Discussing the downside of life as a woman, he said:

He continued:

Natalia performing at Dancetaria in 1986 (PA Real Life/Collect)

But life as a member of the 'gentler sex' also had benefits, according to Brian.

He continued:

He continued:

But the party scene and life as a showgirl eventually took its toll on Brian's physical and mental health and, in 1986, he hit an all time low.

"I was relying on drugs and alcohol to get through each day," he said.

He continued:

Putting his life back together, with the help of friends, he kicked his alcohol and drug addiction.

But being stone cold sober meant he could no longer ignore what was staring him in the face that he was not happy living as Tish.

Brian at Miami Beach in 1990 (PA Real Life/Collect)

"I was as sober as a judge and that really was the beginning of the end for Tish," Brian said.

"I always wanted to be my authentic, true self and I realized I wasn't."

After having therapy in which he discussed gender issues and what constitutes a male and a female identity, Brian felt his only option was to revert back to the gender he was assigned at birth.

"I was beautiful and young, but I wasn't happy as that person," he said. "I was at a crossroads. I knew I had to have surgery on my genitalia or go back to being Brian."

"There was no question which path to take. Times had changed a lot since I'd made the transition and there were more gay men embracing their effeminate side."

"I was in the gym one day and saw a fellow who reminded me of myself before I transitioned."

He continued:

So, Brian decided after much consideration, to make the transition back to being male, stopping his hormone therapy and cutting off his shoulder-length hair.

Then, six months later, in February 1987, he spent $750 having his silicone implants removed.

Brian and his husband, Jim, in 2002 (PA Real Life/Collect)

"I felt a great sense of relief after the operation," he said. "I woke up crying not from the pain but because it felt like a huge burden had been lifted."

Visiting the gym up to five times a week, Brian slowly built up his muscles and, with his hormone replacement "out of the window," he started growing more body hair and his shape filled out.

He also 'came out' for the third time.

"I've come out as gay, I've come out as a trans woman and now I was coming out as a detransitioner," he said.

"People would come up to me in the street and say, 'Hi Tish,' and I'd have to tell them, 'No it's Brian now.'"

"The whole thing just clicked this was who I was always meant to be."

Saying goodbye to Tish meant leaving the glitz and glamour of the New York drag scene, after which Brian established himself as a successful photography agent and editor.

But, after the economic crash of 2008, he decided to re-train again as a counselor, specializing in drug and alcohol addiction.

Describing his "second time around" at being Brian as the "the best years of his life," recently he has become alarmed about the amount of trans people following in his footsteps, by reverting back to the gender they were assigned at birth.

Brian now (Jay Mathews Photography/PA Real Life)

Hoping to shine a light on the issue, Brian released his autobiography, Trans Figured: My Journey from Boy to Girl to Woman to Man, in 2018.

He said:

Now, Brian who met his husband while walking his Jack Russell Terrier, Bricker, 18 years ago and married in 2013 is hoping to specialize in gender identity counseling, to help other detransitioners with their journey.

He concluded:

Brian now (Jay Mathews Photography/PA Real Life)

He concluded:

See the original post:
Man Who Lived For 11 Years As A Trans Woman Explains Why He Decided To 'Detransition' To Live As A Man Once Again - Comic Sands

Recommendation and review posted by Bethany Smith

BRADFORD singer Abi Otway has turned to music to highlight how her husband saved her life.

Abi discovered she had a lump the size of a pea in her breast after her husband Marc felt it as they cuddled. She was diagnosed with Grade 2-3 breast cancer and had recent surgery to remove the lump.

Now recovering, in self isolation, at her Low Moor home, she and Marc, who are in local band Mookie + the Bab, have posta Cheeky Fondle song on Facebook - to the tune of Matt Lucass Thank You Baked Potato internet hit.

Abi, 34, says that, although their song is fun, it has a serious message. I never checked my boobs because, like a lot of women, I was scared of what I might find. If Marc hadnt found the lump, it might have been too late, she said. I couldnt feel it at all when I was sitting down or standing up. I only felt it while lying down, on my side. When Marc found it I knew it was something sinister, but the doctor initially struggled to find a lump and told me to go back in 14 days. Im young and healthy, with no family history of breast cancer.

Abi was referred to the breast clinic at St Lukes Hospital. I had an ultrasound then a biopsy and a mammogram, which didnt show up the lump. It was under the breast, quite far back. I had to wait a week then I was diagnosed, on February 27.

The next day, she and Marc had a concert booked in Bradford. That was a very hard gig to do, said Abi, who managed to have surgery shortly before the Government put the UK on lockdown. I feel lucky that I had my operation on March 10, because so many people with cancer are now having their treatments put on hold. Its a horrible situation to be in, she said. I was already isolating, as I didnt want to catch the virus from anyone ahead of my surgery. But its at times like this that you really want to see family and friends, and that cant happen right now.

But then I think Im lucky because Marc and I were meant to be spending March singing on a cruise ship in Tahiti. Its something we dont normally do, but we were being paid and thought wed treat it as a holiday too. We could have ended up stuck on a ship, with my lump going untreated.

While Abi doesnt need chemotherapy, because the cancer hasnt spread to her lymph nodes, she is due to start radiotherapy later this month. Thats unless I get the virus, or they dont have enough staff, she said.

She is urging women to check their breasts for lumps or other abnormal signs. If your partner is checking, that helps, but if youre on your own Id say schedule a check into your diary, said Abi. And dont just do it standing up or sitting down - you need to check yourself lying down and on your side too.

I try to eat healthily and Im generally careful about my lifestyle. My cancer was hormone-related, so Ive been looking into what kind of things can affect hormones.

Fitness instructor Abi has worked as an actor, appearing in Coronation Street and Hollyoaks, as well as a singer. As Issimo, she and Marc gained a UK-wide fanbase and now they have a new band, Mookie + the Bab, and plan to release a single shortly.

Were a four-piece, with a stripped back, acoustic folk sound, said Abi. We cant get in the studio at the moment but were going to release a live single, called I Will Be. Its an upbeat song, which I think we all need right now.

Visit link:
Abi Otway's 'Cheeky Fondle' song highlights breast cancer ordeal - Bradford Telegraph and Argus

Recommendation and review posted by Bethany Smith

Highlights from a Q&A with Greg Burel, former director of the Strategic National Stockpile

Washington The coronavirus pandemic has left states from coast-to-coast scrambling to secure ventilators for patients and masks, gloves and gowns for frontline workers as they confront a surge of patients battling COVID-19, the disease caused by the coronavirus.

In response to the deadly illness, which has claimed the lives of more than 11,000 in the U.S., according to Johns Hopkins University, which is tracking coronavirus statistics, the federal government has tapped into its stockpile of medical supplies, known as the Strategic National Stockpile, in an effort to bolster state capabilities.

Many of the details surrounding the stockpile are kept secret, including its precise contents and the locations of strategically placed warehouses, though President Trump revealed Monday that there are 9,000 ventilators left in the national stockpile.

But Greg Burel, who served as the director of the Strategic National Stockpile for 12 years until his retirement in January, answered questions about the country's reserve, which stands at the ready, should the nation face a chemical, biological, radiological or nuclear attack, natural disaster or a pandemic.

When the Strategic National Stockpile was first started in 1999, what was the intention and ultimate goal for having massive amounts of different equipment?

Burel: The initial intention of the Strategic National Stockpile when it was founded in 1999 was to be prepared for potential problems related to, if you recall, Y2K and the concern about computers not working and people not being able to order things they needed and so on.

There was a tie with that to concern with that if a healthcare need arose because of equipment failure with computer systems and that there needed to be some backup of some kind of material that could be provided.

The next thing though to think about is most of that was considered in terms of chemical, biological, radiological and nuclear terrorism preparedness, because the concern was if something happened in that kind of a period, that would be a great time for a terrorist to try to attack you knowing that there would be all of these other issues that existed.

In the years since its start, has the function of the Strategic National Stockpile shifted?

Burel: The primary purpose of the Strategic National Stockpile is still and has always been to be prepared to respond to chemical, biological, radiological and nuclear (CBRM) events. We began to expand to more of an all-hazards mission over time because of the fact that we know some of the materials we hold for those purposes are useful in, say, natural events. We're also at the same time developing federal medical stations. When you see DHS and FEMA saying we're setting up these 250-bed temporary hospital things, those are SNS's federal medical stations they're setting up. All of those things were planned to be used if we had a CBRM event, but they are also useful obviously in any kind of natural event, whether it be a hurricane, flood, fire, pandemic, whatever.

In 2005, 2006, there were supplemental appropriations to be prepared for pandemic influenza. In 2009, the nation was struck with H1N1 pandemic influenza. So in response to H1N1 pandemic influenza, we deployed material that we had been stockpiling to respond to a pandemic influenza. The plan was to be prepared for a pandemic influenza event. We were, not as high a level as we would like, but we were prepared for pandemic influenza. Pandemic influenza struck, we moved a good portion of our materials forward to the states so they would have those available for pandemic influenza response.

At the same time, the states had been preparing in most cases for pandemic influenza themselves so many of the states at that time had their own pandemic stockpiles. It varied from state to state, some were large, some were small, some didn't have them at all. But in 2009, we were hit with pandemic influenza and we used that material.

Was the material ever replenished?

Burel: Unfortunately, we never received further appropriations designated to replace that material and the funds to replace that were never incorporated in our annual base appropriation. So our mission remains to be prepared for chemical, biological, radiological and nuclear events and we never received additional funding to cover more material for pandemic.

When you say more material for pandemic in particular, is that things like ventilators, vaccines, personal protective equipment?

Burel: You can't buy vaccines for a pandemic disease event because you don't know what the vaccine is going to be, and you know we're currently in this race to make the vaccine. So you couldn't have invested in vaccines had we wanted to. Ventilators also have requirements that relate to CBRN-type events, so we have continued to buy ventilators knowing they have multiple uses.

Some personal protective equipment have been purchased over the years because it's appropriate for other needs as well. But the massive amount that was projected for 1918-type pandemic influenza, 1. could never have been achieved with the supplemental appropriations that were received in '05 and '06, and 2., much of what we had was used in '09 and was never restocked to the level that it had been at that point.

Who oversees the stockpile and who decides what to purchase?

Burel: First, the Strategic National Stockpile is currently in the organization and is responsive under the organization structure of the Assistant Secretary for Preparedness and Response at HHS. Prior to that, it was under CDC. We moved to HHS in 2018, to be closer to the decision-making center about deployment and so on. It also allowed us to consolidate all of HHS material response capability in a single organizational line which I think made a lot of sense.

The formulary, that is, what is held in the Strategic National Stockpile, is determined by a multiagency governance body called the Public Health Emergency Medical Countermeasures Enterprise, and we shorten that as we do everything in government to PHEMCE.

PHEMCE is comprised of experts in various matters related to disease, drug development, device development, regulatory matters and so on from the Centers for Disease Control and Prevention, the Food and Drug Administration, the National institutes of Health, Dr. [Anthony] Fauci's NIAID, and then a number of other departments and agencies including DOD, VA, DHS and others. What the PHEMCE does is it looks at threat projections based on information from Department of Homeland Security. It works to model and consider what the event would look like around those threats that are identified by the DHS, and then we try to identify with the disease experts and the people who know way more about this than I ever will what are the most important things to keep in the stockpile.

There's always a longer list of things that we want to have than there is money to buy, so part of what the PHEMCE does is annually it does a review line item by line item of every product in the stockpile and what we need to spend to keep us at established goals based on models that predict what we would need.

As we try to work through the limited funds that are appropriated against the long list of things that we need, the PHEMCE makes recommendations to the secretary and the assistant secretary about what things are most important to buy.

In terms of what the stockpile looks like today and the supplies that have been compiled over the years based on this long list, what is in it?

Burel: It's over an $8 billion or was before this started going out an $8 billion inventory of various materials including things like antibiotics, antitoxins, antidotes, vaccines, medical surgical material, federal medical stations you see, ventilators and other products.

We never release the precise content of the stockpile or the numbers of each precise item in the stockpile because of the risks that would present in giving to a determined adversary a roadmap to, 'well they have this, so if I do this to them instead of that, I'm going to be more successful.'

Let's take it completely out of the realm of anything that we're prepared for so we don't disclose anything. But if you're prepared for the zombie apocalypse, you don't want to tell people how prepared you are for that because then they'll just say, 'instead of releasing the zombie agent on them, we'll release something else.' That's the risk of letting anybody know exactly what's in it and then the risk of letting anybody know exactly where it is is that that same determined adversary before they did something bad to us could say, 'well I know where it is so I'm going to take it out.'

You don't want somebody who wishes you ill-will to be able to destroy your capability to respond to whatever they're doing to do bad to you. You also don't want people whether they are ill-intentioned or well-intentioned to know where those locations are and suddenly show up there at the time we're trying to move material out of them, trying to get it for themselves or trying to interdict that material so we can't get it where it's going.

There are many risks involved in making the location of SNS material public. It would cause, I fear, an immediate failure.

I would imagine now that we are seeing this stockpile being very quickly depleted. How fast can it be replenished, especially in the midst of a nationwide event?

Burel: When you say being depleted, it is being depleted of materials that are important for this response, so there are things for other types of events obviously still there. To the question of how rapidly it can be replenished, it really is something you have to look at on a line item by line item by line item evaluation.

What the Strategic National Stockpile has to do today is as it continues to acquire additional material, if those material are still being needed outside, and we've always planned for this, we can do several things. We can have suppliers to us take them immediately to where they need to be, dependent upon how many places they need to respond to. We can have them shipped to us and then we can further ship them out to places where they need to go, but what the Strategic National Stockpile I would guess is not doing today is ordering things and putting it on the shelf and not getting it where it needs to go. I would not expect that. That would not be what we are prepared to do.

What is the process for a state like California or Washington or New York to get supplies from the Strategic National Stockpile? Is it the first place they turn or supposed to be later on in the process?

Burel: When there is an event of any type, and this is the fact for all emergency responses in the United States, the federal government's responsibility is to begin to assist in response when state and local capabilities are exhausted. In this type of an event, what I would expect to see is that the medical supply chain should try to surge to meet the needs of the private-sector health care complex.

Secondly, states and locals who can invest monies that they have themselves from their own state budgets or from grant monies from the federal government there have been a lot of public health preparedness grant monies and cooperative agreement funds that have gone to states in the last 10 years or so or more they can invest that in buying and storing materials.

The point is that the way this should work is once the medical supply chain is exhausted, then those health care needs should flow up to the state. Once the state stocks, assuming that there are any, are exhausted, then they turn to the Strategic National Stockpile.

Normally the request process is a state makes a request through the secretary's operations center that's rapidly evaluated and responded to. In a nationwide pandemic event like this, we're still working on that same kind of a theory. We've worked with all the states for pandemic influenza planning and talked to them about this pro-rata approach so it's nothing new.

A chronic problem in public health preparedness is, and it's our chronic problem in emergency preparedness overall, the farther you move away from events that drive that preparedness in the minds of the public and in the mind of the Congress and the mind of the state legislature, it is less of a need to appropriate funds from limited available monies to plan.

I'm not necessarily criticizing the Congress or state legislatures for not doing that because there are many competing priorities for limited funds, but the reality is public health preparedness needs to be a priority and it needs to be routinely funded at a much higher level across the country than it has been for a long time, and then it would be better prepared to deal with these kinds of events.

In terms of supplies, how often is inventory checked to ensure vaccines and other materials haven't expired?

Burel: It's a continuous process. So when we consider what's in the stockpile, we run very large systems that we monitor daily so that we are aware of what is aging, where we stand in terms of needing to make new acquisitions to replace aging material so they can be rotated and so on.

The Strategic National Stockpile also participates in many programs to extend the useful life of our material. One of those is the Shelf Life Extension Program, which is an agreement between DOD and FDA that we ride along with DOD on, where certain drugs can be identified, they can be subject to a chemical assay, where very specialized scientists at the FDA can look at the review of the assay and say, 'yea this is still safe and effective for use and based on the data, we're going to let you extend the expiry date of this drug for x amount of time.'

For chemical drugs, we try to extend it through the Shelf Life Extension Program for the longest possible time that we can make that investment sound, and that means that in addition to looking at rotating things out, we're looking at things that have to go into the Shelf Life Extension Program for sampling and analysis and a determination from the FDA.

The other thing that we do is we do ongoing maintenance on durable medical equipment like ventilators. All of those get rotated back to their manufactures annually for preventative maintenance and all the necessary maintenance to make sure that they're still functional and operational.

As far as some of these medical devices like N95 masks and that kind of thing, there has been limited data available about how long you can use them after their expiry date. We've worked with NIOSH (National Institute for Occupational Safety and Hazard) over the last couple of years to try to study products that not just the SNS held, but that some states were still holding and that some other laboratories were holding old stock to test that stock and see if it was still safe and effective.

You may find on CDC's public-facing website ... data that NIOSH accumulated and studies they did that say those N95s that show an expired date are still safe and effective for use as long as the elastic doesn't break when you try to put it on.

What we try to do is extend the federal government's investments in all of those products as long as we can.

So even though states have said they received expired N95 masks, that doesn't necessarily mean they can't be used or that they're not as effective?

Burel: That is correct.

Is there anything further the general public should know about the Strategic National Stockpile?

Burel: What the general public should think about is that there is a strong need to fund public health at all levels, at the federal, state and local levels, and a part of that is the Strategic National Stockpile, but that's really only a part and pubic health needs advocacy at all levels to assure that it is funded in such a way that the public is protected.

This is not just a matter of whether people are getting sick, but it's actually a matter of national security and it needs to be take as seriously as funding the Department of Defense to be prepared for anything it needs to be prepared for.

Do you think the coronavirus pandemic could lead to a shift in the mindset of lawmakers to put public health front of mind?

Burel: As devastating as this event is, and I don't see this as silver lining or anything, but I hope that it makes some of the people that in the past have said public health preparedness is not as important as whatever will now look at this and say 'you know what, we should be allocating money for this, we should be thinking about this in a different way.'

Dr. Fauci has warned the coronavirus could be seasonal, is there anything Congress can do now to ensure the Strategic National Stockpile is ready in the future, especially as we await a vaccine?

Burel: Congress has appropriated supplemental funds to address this but what Congress must do from this point forward is look at making those supplemental funds not a once and done thing.

If we invest those supplemental funds today in new material to be prepared for a second wave of a next season event or whatever and we don't get that included in our base appropriations for long-term, we will not be able to maintain that preparedness just like the pandemic influenza.

I think there's another piece to this. With Dr. Fauci suggesting this may become a seasonal event, then the private supply chain is going to have to reconsider how it prepares, and I believe we must move away from a purely just-in-time inventory in the health care sector.

It's fantastic if I'm building a car and I don't want to store the parts and the parts arrive the day I build the car and the car comes off the line and I'm done. But health care doesn't work that way. We don't suddenly see the need to build 2,000 more cars than we do in one day on a normal basis, but we do see in health care and in public health the need often in a large outbreak to be able to respond to far more people than we would think we have to take care of.

Link:
Q&A with Greg Burel, former director of the Strategic National Stockpile - CBS News

Recommendation and review posted by Bethany Smith

Cancer, at its simplest, begins with DNA mutations that cause uncontrolled replication of abnormal cells, resulting in tumors and illness. There is no single cancer: each is dependent on the cell type affected and the type of mutation that causes it, which is why there is no single cure for it either. There are standard treatments that can be used for many cancers, such as surgery, chemotherapy, and radiation. Targeted treatments can be highly specific and very successful. For example, Gleevecwhich is used to treat chronic myeloid leukemia (CML)stops the activity of the protein responsible for CML, and can restore patient life expectancy to normal.

Because we share many of the same cell types with our pets, they also develop some of the same cancers: bone (osteosarcoma), skin (melanoma), brain tumors (gliomas), and even prostate cancer (dogs and humans are the only two animals who develop it). Canine cancers are sadly very similar to human cancers, more so than cancer in mice, a traditional model organism of biomedical research. They are also increasingly common: one in four dogs at some point in their lives, and 50% of dogs over 10 years old, will be diagnosed with cancer. While some breeds of dog have a predisposition for particular cancer(s), others may have a higher risk of cancer overall.

Comparative oncology, an interdisciplinary field, builds on these parallels between dogs and humans, and other animals as well: those who also develop spontaneous cancers such as cats and horses, as well as those who dont develop any cancers, or are highly resistant, such as whales, elephants, and crocodiles.

Cancer research for dogs, such as clinical trials, done by veterinary oncologists can not only offer their patients the possibility of life extension or remission, but also allows dog owners who might otherwise be unable to afford costly treatment to provide more extensive care. Once completed, the findings from these trials can then be used to help inform human clinical trials.

Yet, just as human drug trials can be compromised by poor design, or small sample sizes, or lack of randomization, so too can canine trials. A recent meta-analysis of 168 cancer trials found many of these same problems were present, and suggested a number of improvements, including increasing the size of the trials to include more dogs, guidance that not only would improve the data, but might mean more dogs get better.

JSTOR is a digital library for scholars, researchers, and students. JSTOR Daily readers can access the original research behind our articles for free on JSTOR.

By: Joshua D. Schiffman and Matthew Breen

Philosophical Transactions: Biological Sciences, Philosophical Transactions: Biological Sciences Vol. 370, No. 1673, Theme issue: Cancer across life: Peto's paradox and the promise of comparative oncology (19 July 2015)

Royal Society

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Dogs and Cancer - JSTOR Daily

Recommendation and review posted by Bethany Smith

Great Panther Mining Ltd () (NYSEAMERICAN:GPL) became a new intermediate precious metals producer with its acquisition in March last year of Beadell Resources and its Tucano gold mine in Brazil.

Formerly, the company was known as Great Panther Silver Ltd but now that it generates mainly gold (83% of production, having been under 50% previously) the name was changed. The group's market cap is over US$175 million.

Tucano is currently the second-largest gold producer in Brazil, generating around 150,000 ounces per year from several open pits, and is sitting on a multi-million-ounce deposit. The deal turned the company into a 200,000 gold-equivalent ounce per year producer.

Great Panther operates three mines including the Tucano gold mine in Amap State, Brazil, and two mainly silver mines in Mexico.

These Mexican assets are the Guanajuato mine complex - consisting of two mines Guanajuato and San Ignacio, and the Topia mine.

The company also owns the Coricancha mine in Peru where last year it executed a successful bulk sample mining program in accordance with a 2018 preliminary economic assessment (PEA). Great Panther is establishing the conditions, under which a restart at the mine could be implemented.

To sum up, Great Panther owns an operating gold mine in Brazil and two operating primary silver mines in Mexico. It also owns two mines on care and maintenance -one in Mexico and one in Peru.

A majority of companies are affected in some way or other by the global coronavirus pandemic and on April 3 this year, Great Panther said it was temporarily suspending mining and processing at its Mexican operations to mitigate its spread.

It said activity at the Guanajuato Mine Complex (GMC) and the Topia mine would cease until April 30, in line with the directive of the Mexican government announced on March 31.

The group pointed out that monthly output for the firm from Mexico accounts for only around 2% of annual group output on a gold equivalent ounce basis.

Reporting its 2019 financial results on March 31, Great Panthersaid the aim for 2020 was to ramp up exploration, expand its resources and improve its finances.

Its purchase of Tucano led to increased production (on a gold equivalent basis) and revenue by 182% and 234%, respectively, when compared to 2018.

For the 12 months to December 31, 2019, Great Panther's revenue came in at C$198.7 million, up from C$139.2 million in 2018, reflecting the acquisition of Tucano.

The net loss was C$91.0 million, as mine operating earnings were offset by an impairment of Tucano goodwill of C$38.7 million.

Cash and short term deposits at the end of the year were C$36.9 million compared to C$50.5 million the year before - down 27%. The firm's net working capital was C$12.8 million.

For Tucano this year, 2020 planned production is between 120,000 and 130,000 gold ounces - up around between 13% and 23% compared to the 106,000 gold ounces of production in 2019.

Following the 2019 financials, Noble Capital repeated an 'outperform' rating on Great Panther, saying that along with the potential for the Guanajuato mine to return to production in 2020, the company was taking the 'necessary steps' to improve the long-term growth profile of Tucano through near mine and regional exploration programs.

"We project 2020 EPS and EBITDA of $0.03 and $62.2 million, respectively. While EPS is unchanged, EBITDA is down modestly from our prior estimate of $63.8 million," the broker's analysts said.

"While Great Panther has had its share of operating challenges, we believe 2020 could be a transition year to improved financial performance," theyadded.

Noble expects all-in sustaining costs (AISC) at Tucano to be in the range of US$1,150 to US$1,250 per gold ounce for 2020, compared to US$1,406 in 2019.

Capital expenditures of $7 million are associated with a new primary crusher to be installed at the plant mid-year and the expansion of Tucano's tailings storage capacity, it said.

Exploration expenditures are expected to be US$7 million and focused on near-mine drilling activities, said analysts.

At the time of the full-year results, Jeffrey Mason, Great Panther's interim president and CEO and chairman, told investors: "The company's focus for 2020 is to continue the current program of implementing operational improvements, ramp up exploration programs to replace and expand mineral resources, and improve our financial position, all with the objective of creating shareholder value and regaining the confidence of our various stakeholders."

"Importantly, we are investing a minimum of $11 million to realize the significant exploration potential at our assets, focusing on mine life extension at Tucano and a possible re-start of the Guanajuato mine later this year," he added.

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Great Panther Mining has big plans for 2020 with aims to ramp up exploration, resources and strengthen finances - Proactive Investors USA & Canada

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