StemCell Therapy

2020 was the year of the pandemic. But the arrival of Covid-19 in January not only threw an Earth-sized wrench into our lives, it also dictated the course of scientific discovery. Never before have so much attention, investment, and passion been devoted to one scientific problem. Never before have pre-print servers exploded in popularity, allowing scientists to share discoveries at lightning speed. And never before have we managed to build an arsenal to beat back a life form entirely novel to us, massively accelerating vaccine development by months, if not yearsa true paradigm shift not just in vaccinology, but also in how science is done and communicated under fire.

Yet I dont want to focus solely on Covid-19. Were now in the end game. Last week, the FDA and its Canadian and British equivalents approved the Pfizer-BioNTech mRNA vaccine for emergency use. Modernas mRNA vaccine is hot on its heels, also boasting a success rate of over 90 percent. Front-line workers are receiving the jab all over the country. And dozens of other vaccines are still in the rat race.

Theres no escaping Covid-19 in an end-year retrospective. But theres good reason to look aheadthe biotech and camaraderie that created an entirely new type of vaccine in record pace isnt confined to the pandemic, vaccine research, or infectious diseases. They have the power to completely overhaul medicine.

You might have heard that mRNA vaccines have never previously been approved by the FDA. Yet the science behind them is decades long, courtesy of a young Hungarian-born biologist behind a key mRNA discoveryone so novel and groundbreaking it precipitated the death of her career.

Nearly all lifeforms are built by and run on proteins. But the instructions for building proteins are saved in our genetic material. Think of DNA as a library, and the cells protein-building factory as a far-off facility speaking a different language. mRNA, short for messenger RNA, is the translator that literally moves between our cells DNA library and the protein factory.

In other words, our bodies listen to mRNA to decide which proteins to build. If we could design and synthesize artificial mRNA and deliver them into cells, its possible in theory to hijack our cells own protein-building system to make any protein we wanteven those that are foreign, such as viral proteins.

Thats the reasoning behind both Pfizer-BioNTech and Modernas vaccines. By delivering the mRNA of a viral part into our cells, our bodies will make these proteins. Because these proteins are basically alien invaders, our immune system learns to recognize them and creates a memory of those foes. When it encounters a real infection, the entire immune military of trained antibodies and killer cells can then rapidly spur to life, nixing the invader before they have a chance to spread or reproduce.

Theres a reason mRNA vaccines are so desirable. Compared to traditional protein-based ones, such as those involving dead viruses that need to be grown in chicken embryos (not kidding), mRNA is incredibly easy to scale in production with low costs. This also makes it possible to screen through candidates at super-sonic speedand in a pandemic, speed is everything.

At least, thats the theory on paper. Thanks to recent advances in biotech and Covid-19 lighting sciences behind on fire, mRNA drugs have finally become a widely successful reality.

Broadly speaking, three main technologies have propelled mRNA vaccines to success in the Covid-19 race: whole-genome reading, mRNA design and packaging, and mRNA synthesis.

The first step to combating any viral foe is to know thy enemy. By January 11, Chinese scientists had deposited parts of the viruss genetic blueprint onto GenBank, a highly popular online database for genetic information. Whole-genome sequences soon followed, digitizing the virus and allowing comparisons between its genetic blueprint and other known viruses. Within a month, we knew that the virus belonged to the coronavirus family, allowing scientists to draw upon previous experience with similar virusesSARS, MERSto hone in on the newcomers surface spike proteins, named after their jagged shapes, as a potential vaccine target.

Genetic sequencing soon took the reins. As an offshoot of synthetic biology, a field that reshuffles the building blocks of life, the cost of making artificial genetic sequences has dropped dramaticallyso much so that its now simple to order these molecules through commercial companies at dollars a pop.

Its also made it possible to recreate an entire genome from scratch halfway across the world. A Swiss group, for example, used Chinas data to synthesize SARS-CoV-2s entire genome in the lab, essentially instantly teleporting it into their hands without having to wait for physical samples. Other teams reproduced only the spike protein to analyze for portions that are especially incendiary towards our immune system, which could spark a larger immune response. In early February, long before the world realized wed be in the midst of a pandemic, scientists had already nailed down the sequence and shape of the protein that eventually spurred the development of our newfangled mRNA vaccines.

The next step was finding a weapon against the virusand getting it inside a cell. Thanks to computational alignment tools, figuring out the genetic code for the spike protein was a piece of cake. The harder part was designing mRNA candidates, the instructions, to encode for the spike protein. One frustrating reason why mRNA vaccines have previously failed is because these molecules are extremely fragile. The body, with its relatively high heat and multitudes of molecular-digesting proteins, is a hostile place.

The hostility also goes the other way. Synthetic mRNAs are very foreign to our bodies. Without care, they can trigger the immune system to go into overdrivea dangerous condition that could result in serious problems.

Heres where new tech stood on the shoulders of age-old research. With hopes of making mRNA drugs a reality, scientists have long worked to change their basic componentsletters very similar to DNAs familiar quad squad of A, T, C, and Gwith slightly chemically-improved ones to increase their stability. Other swaps fine-tune the mRNAs efficacy so that it triggers a Goldilocks-like immune responsenot too much, not too little.

Finally, naked mRNA needs to get inside a cell to work. But once it does, its almost instantaneously chopped up. Without mRNA sticking around, our bodies cant make the viral spike protein, hence no immunity. To deliver it into cells, scientists relied on fatty bubblesalso known as lipid nanoparticlesto form a vessel around the mRNA strands. These cellular spaceships are also a gift from the past: back in 2018, the FDA approved their use for delivering another type of RNA molecules. Pfizer-BioNTech and Modernas results provide some of the strongest evidence that they also work well with mRNAs.

The success is indisputable: Moderna went from analyzing the viruss genetic sequence to an experimental jab in the arm in just 63 days. Pfizer-BioNTech broke lightspeed with its vaccine for emergency use in less than a year.

The biotechnologies that made Covid-19 mRNA vaccines are here to stay. So are the fountains of knowledge weve gained from this terrifying trial by fire. From the ins and outs of immune responses to what makes mRNA more stable, less toxic, and easier to deliver, to advances in synthetic biology and seamless global collaboration, the battle against Covid-19 highlights how a decade-long scientific dream just blossomed to fruition.

Covid-19 is only one foe. A similar strategy could now be used, with far more confidence, on our long-battled enemies such as HIV. Even novel vaccines are just a small slice of whats possible. mRNA is the bodys guidebook for building proteinany protein. A synthetic mRNA strand that recognizes certain types of cancer could lead to highly-specific cancer vaccines. BioNTech, for example, reported in 2017 that a vaccine against melanoma, tailor-made to each of its 13 participants unique cancer genetic profile, had higher immunity against their tumors and reduced the chance of spread. Synthetic mRNA could artificially produce missing or defective proteins in the body, such as those critical for normal eyesight or nerve function.

The dream of mRNA therapeutics has been alive since the 90s. One just came true. Keep your eyes peeled for others in 2021.

Image Credit: Felipe Esquivel Reed/Wikimedia Commons

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Fighting Covid-19 Brought These Lasting Breakthroughs to Science and Medicine - Singularity Hub

Dec. 28, 2020 13:04 UTC

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced its New Drug Submission for TRIKAFTA, Vertexs investigational triple combination medicine, has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in people ages 12 years and older.

We are pleased this submission has been accepted for Priority Review by Health Canada, and we anticipate this accelerated review process will enable access for patients as early as possible, said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex.

With Priority Review, the conventional review timeline of 300 days is reduced to 180 days. The expected approval target by Health Canada is in the first half of 2021.

About Cystic Fibrosis

Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes one from each parent to have CF. While there are many different types of CFTR mutations that can cause the disease, the vast majority of all people with CF have at least one F508del mutation. These mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working and/or too few CFTR proteins at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the early 30s.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create medicines for people with serious diseases. The company has multiple approved medicines that treat cystic fibrosis (CF) a rare, life- threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 11 consecutive years on Science magazine's Top Employers list and a best place to work for LGBTQ equality by the Human Rights Campaign. For company updates and to learn more about Vertexs history of innovation, visit http://www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Carmen Bozic in this press release, including expectations for patient access to our medicine, and statements regarding the anticipated timing of the expected approval target by Health Canada. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that the New Drug Submission to Health Canada may not be approved in the expected timeline, or at all, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, and other risks listed under the heading Risk Factors in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at http://www.sec.gov and available through the company's website at http://www.vrtx.com. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

View source version on businesswire.com: https://www.businesswire.com/news/home/20201228005171/en/

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Vertex Announces New Drug Submission for Investigational Triple Combination Medicine for the Treatment of Cystic Fibrosis Has Been Accepted for...

In August 2020, the FDA approved the first diagnostic test that combines next-generation sequencing and liquid biopsy. The test is intended to help guide treatment decisions for patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in metastatic nonsmall cell lung cancer (NSCLC), which is particularly deadly. The FDA called it a new era for mutation testing. The approval was granted to Guardant360CDx to provide information on multiple solid tumor biomarkers and to help identify EGFR mutations in patients who will benefit from treatment with osimertinib (Tagrisso), which is approved for a form of metastatic NSCLC.

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4. Dr Andre Goy Discusses What Weve Learned About CAR T Therapies and Cytokine Responses

In a video interview, Andre Goy, MD,chairman, director, and chief of the Division of Lymphoma at John Theurer Cancer Center in Hackensack, NJ,discussed what has been learned from existing chimeric antigen receptor T (CAR T)-cell therapies in managing cytokine responses.

Watch the interview here.

3. OneOncology, Foundation Medicine Create Partnership to Deliver Targeted Care

Also in August 2020, OneOncology, a network of nearly 170 community oncology care sites, and cancer genomic profiling firm Foundation Medicine announced a partnership to give patients and physicians access to genomic profiling tools as well as expanded research opportunities. In addition, OneOncology will help Foundation Medicine to create new assays for community oncology practices.

Read the full article here.

2. Broad Testing for Multiple Genes Benefits Patients With Cancer, Relatives

A study published in JAMA Oncology described how universalmultigene panel testingwas linked with increased detection of actionable, heritable variants beyond what one would expect to find using targeted genetic testing based on current cancer guidelines. The multicenter cohort study found that 1 in 8 patients had a pathogenic germline variant, half of which would not have been found if using guidelines alone. In addition, for the nearly 30% of patients with a high-penetrance variant, the findings led to a change in treatment.

Read the full article here.

1. How DNA Medicines Could Transform Treatment of Glioblastoma Multiforme

In an article appearing in the August 2020 edition of Evidence-Based Oncology, Jeffrey Skolnick, MD, the vice president of clinical development at biotech firm Inovio, discusses the companys proprietary technology that uses a computer algorithm to build DNA medicines that can target almost any antigen that can be presented to the human immune system through the major histocompatibility class I system. DNA medicines are built in the form of circular strands of synthetic DNA called plasmids, which can neither propagate nor integrate into the human genome. He also discusses their use in a potential application for glioblastoma, which is incurable.

Read the full article here.

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The Top 5 Most-Read Precision Oncology Articles of 2020 - AJMC.com Managed Markets Network

In an in-depth study of how COVID-19 affects a patients brain, National Institutes of Health researchers consistently spotted hallmarks of damage caused by thinning and leaky brain blood vessels in tissue samples from patients who died shortly after contracting the disease. In addition, they saw no signs of SARS-CoV-2 in the tissue samples, suggesting the damage was not caused by a direct viral attack on the brain. The results were published as a correspondence in the New England Journal of Medicine.

We found that the brains of patients who contract infection from SARS-CoV-2 may be susceptible to microvascular blood vessel damage. Our results suggest that this may be caused by the bodys inflammatory response to the virus, said Avindra Nath, M.D., clinical director at the NIHs National Institute of Neurological Disorders and Stroke (NINDS) and the senior author of the study. We hope these results will help doctors understand the full spectrum of problems patients may suffer so that we can come up with better treatments.

Although COVID-19 is primarily a respiratory disease, patients often experience neurological problems including headaches, delirium, cognitive dysfunction, dizziness, fatigue, and loss of the sense of smell. The disease may also cause patients to suffer strokes and other neuropathologies.

Several studies have shown that the disease can cause inflammation and blood vessel damage. In one of these studies, the researchers found evidence of small amounts of SARS-CoV-2 in some patients brains. Nevertheless, scientists are still trying to understand how the disease affects the brain.

In this study, the researchers conducted an in-depth examination of brain tissue samples from 19 patients who had died after experiencing COVID-19 between March and July 2020. Samples from 16 of the patients were provided by the Office of the Chief Medical Examiner in New York City while the other 3 cases were provided by the department of pathology at the University of Iowa College of Medicine, Iowa City. The patients died at a wide range of ages, from 5 to 73 years old. They died within a few hours to two months after reporting symptoms. Many patients had one or more risk factors, including diabetes, obesity, and cardiovascular disease. Eight of the patients were found dead at home or in public settings. Another three patients collapsed and died suddenly.

Initially, the researchers used a special, high-powered magnetic resonance imaging (MRI) scanner that is 4 to 10 times more sensitive than most MRI scanners, to examine samples of the olfactory bulbs and brainstems from each patient. These regions are thought to be highly susceptible to COVID-19. Olfactory bulbs control our sense of smell while the brainstem controls our breathing and heart rate. The scans revealed that both regions had an abundance of bright spots, called hyperintensities, that often indicate inflammation, and dark spots, called hypointensities, that represent bleeding.

The researchers then used the scans as a guide to examine the spots more closely under a microscope. They found that the bright spots contained blood vessels that were thinner than normal and sometimes leaking blood proteins, like fibrinogen, into the brain. This appeared to trigger an immune reaction. The spots were surrounded by T cells from the blood and the brains own immune cells called microglia. In contrast, the dark spots contained both clotted and leaky blood vessels but no immune response.

We were completely surprised. Originally, we expected to see damage that is caused by a lack of oxygen. Instead, we saw multifocal areas of damage that is usually associated with strokes and neuroinflammatory diseases, said Dr. Nath.

Finally, the researchers saw no signs of infection in the brain tissue samples even though they used several methods for detecting genetic material or proteins from SARS-CoV-2.

So far, our results suggest that the damage we saw may not have been not caused by the SARS-CoV-2 virus directly infecting the brain, said Dr. Nath. In the future, we plan to study how COVID-19 harms the brains blood vessels and whether that produces some of the short- and long-term symptoms we see in patients.

This study was supported by NIH Intramural Research Program at the National Institute of Neurological Disorders and Stroke (NS003130) and an NIH grant (NS109284).

Reference: Lee, MH, et al. Microvascular Injury in the Brains of Patients with COVID-19. N Engl J Med. 2020. ePub 30 Dec. doi: 10.1056/NEJMc2033369.

About National Institute of Neurological Diseases and Stroke (NINDS): NINDS is the nations leading funder of research on the brain and nervous system. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.

About the National Institute on Aging (NIA): NIA leads the U.S. federal government effort to conduct and support research on aging and the health and well-being of older people. Learn more about age-related cognitive change and neurodegenerative diseases via NIAs Alzheimer's and related Dementias Education and Referral (ADEAR) Center website. For information about a broad range of aging topics, visit the main NIA website and stay connected.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit the NIH website.

NIH...Turning Discovery Into Health

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NIH study uncovers blood vessel damage and inflammation in COVID-19 patients' brains but no infection - National Institute on Aging

In 1987, when researchers first used the word genomics to describe the newly developing discipline of mapping DNA, Eric Green had just finished medical school. A few years later, he found himself working on the front lines of the young fields marquee moon shot: the Human Genome Project. To lead the nations participation in the global effort, Congress established the National Human Genomics Research Institute, or NHGRI, in 1989.

Sequencing the entire human genome began the following year, and it took 13 years to complete. Not long after, in 2009, Green took the helm of the research institute. By then, NHGRIs mission had evolved to include expanding the field of genomics into medicine. That meant funding and coordinating projects aimed at pinpointing the mutations responsible for genetic disorders, then developing tests to diagnose them and therapies to treat them. And even more broadly, it meant generating evidence that DNA data could effectively improve outcomes, even for people who dont suffer from rare diseases.

To help chart that course, one of Greens tasks is to periodically put together a strategic vision for the field. Aimed at celebrating progress, identifying technological gaps, and inspiring scientists to pursue the most impactful areas of research, his team published its latest projection in October. For the first time, Green and his colleagues outlined a set of 10 bold predictions about what might be realized in human genomics by the year 2030. Among them: High schoolers will show off genetic analyses at the science fair, and genomic testing at the doctors office will become as routine as basic blood work.

Three decades after that sequencing race began, weve perhaps reached the end of the early genomics era, a period of explosive technological growth that led to breakthroughs like the sequencing of the first dog, chicken, and cancer cells and the advent of cheap home DNA tests. The field has matured to the point that genomics is nearly ubiquitous in all of biologyfrom fighting invasive giant hornets to brewing better-tasting beer. Genomic medicine is no longer theoretical. But its also not widespread. Although scientists have mapped the human genome, they do not yet completely understand it. Green spoke to WIRED about what the next decade, and the next era in genomics, may have in store. This interview has been edited for length and clarity.

WIRED: October marked the 30th anniversary of the Human Genome Project. When you look around at where we are today, how does it live up to the expectations you had for the impacts the project would make in medicine?

Eric Green: I was inside the Human Genome Project from day one, and I cant stress enough how back then we didnt know what we were doing. We had this big audacious goal of reading out the 3 billion letters of the human instruction book, but we didnt have the technology to do it. We didnt have the methods. We didnt even have a functional internet. There was no playbook. So, as someone who got into this as a young physician, I could sort of imagine that one day genomics might be part of clinical care. But I truly did not think it would happen in my lifetime.

If we go back just 10 years, nobody was really using genomics in health care. We fantasized then about the idea of having a patient in front of us, where we did not know what was wrong with them, and being able to sequence their genome and figure it out. That was a hypothetical in 2011. Now it's routine. At least for people suspected of having a rare genetic disease.

Thats amazing. But also, its still a far cry from some of the hype around what the Human Genome Project was going to accomplish. In his remarks at the White House in 2000, then-NHGRI director Francis Collins said it would likely take 15 or 20 years to see a complete transformation in therapeutic medicine, promising personalized treatments for everything from cancer to mental illness. Obviously, that hasnt exactly come to pass. Why not?

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30 Years Since the Human Genome Project Began, Whats Next? - WIRED

rBIO launched last week with technology that can reduce the cost of insulin by 30 percent, making U.S. manufacturing cost-effective for insulin and several other drugs.

This new method is an enhancement of the recombinant DNA (rDNA) processes that have been used since the 1980s to produce insulin.

Forty years later, were taking it to the next level, Cameron Owen, rBIO co-founder and CEO, told BioSpace. It is akin to expediting billions of years of evolution.

The company genetically modified E. coli to cause it to hyper-produce peptide hormones initially, insulin thereby creating more product from the same quantity of material. Those bacteria will then manufacture the product at scale using standard vat fermentation processes.

The idea emerged when Owen was a graduate student at Johns Hopkins Universitys Carey Business School.

I had started another biotech company (Aevus Precision Diagnostics) that looked at the pharmacogenomics of diabetes medications, so I got to know the diabetes space really well, he said.

As he learned, Insulin is too expensive for many people who depend on it, and its supply chain is vulnerable because like most drugs used in the U.S. a large percentage of insulin is manufactured offshore. With 30 million diabetics in the U.S. now, and an expected 60 million by 2030, keeping up with demand is a significant challenge.

In 2016, the J. Craig Venter Institute determined the minimum number of genes bacteria needed to survive.

If you can take those minimal genes and add to them, youve eliminated a lot of processing waste, Owen said.

Therefore, rBIO is rewriting E.colis genetic code, eliminating the unnecessary genes and coding the genome so the bacteria hyper-expresses the maximum quantities of insulin but does not produce the products needed for the bacterias normal metabolic function.

rBIOs goal is to increase production to the cells theoretical limits. In this case, thats 100 molecules of insulin.

We havent achieved 100% theoretical maximum yield, he said, but production rates are approximately double that of todays generally accepted insulin production methods.

Whats different about this approach, beyond its high yield, is how the genetic code as devised. Were now at the point in genetics where the genetic code can be not only manipulated, but written, Owen said.

Rather than cut and paste genes in or out of organisms, rBIO actually designs the DNA, he said.

Were writing the DNA code from scratch, the way a computer programmer would, and translate it to biology, he said. Rather than use ones and zeros, we use ACGT the bases found in DNA molecules. We can manipulate those letters to write anything you want.

The rBIO team doesnt start entirely from scratch, of course. There are set sequences that we know work, so we are using those sequences, and designing others, Owen said. We wrote three different genetic codes for the bacteria during the past several months and put them into a lab setting to determine if they first and foremost grew and divided, and secondly whether they produced the product we wanted.

Two of the three bacteria strains were successful, and optimization is continuing.

Once rBIO determines the genetic code it wants, it outsources the actual gene assembly. rBIO has produced several milligrams of insulin this way in the lab.

The next stage, Owen said, is to scale up the company. That means bringing in management with the skills to take the organization to the next level and to help shape its direction.

This early in its existence, all the options are open.

My goal is to become a manufacturer, Owen said, but, realistically, this is more of an out-licensing opportunity to a company with the existing infrastructure for mass manufacturing already in place.

rBIO is still developing a platform technology, Owen pointed out. The company is focused on insulin, but also is considering eight other drugs for its pipeline, including erythropoietin and epinephrine. They each have a projected compound annual growth rate (CAGR) of 12 percent for the next decade, he said, so represent significant opportunities for the company.

Owen said the companys technology also has the potential to make reshoring attractive for several drugs that currently are produced offshore.

The COVID-19 pandemic put the spotlight on the risks of off-shoring pharmaceutical products. According to the FDA, only 21% of the drugs on the World Health Organizations Essential Medicines List are manufactured in the U.S.

Medicine security shouldnt be allowed to be affected by the fluctuations of international trade policies, he said. Having the manufacture of life-saving medicines offshore is a major national security issue. Imagine what would happen if 30 million American diabetics couldnt access insulin. Wed be in a world of hurt.

Whether or not such drastic trade wars happen, rBIOs hyperproduction technology may offer significant benefits to therapeutic manufacturers and customers alike. He isnt overly concerned about competition. Instead, he sees potential allies.

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rBIO Launches with Technology to Hyper-Produce Insulin Cost-Effectively, at Scale - BioSpace

Peer victimization is recognized as a pressing public health issue, affecting 1 in 5 youth. Although extensive research demonstrates the negative effects of peer victimization on youth mental health, considerably less is known about if and how peer victimization adversely impacts physical health. Focusing on studies published in the past 5 years, this state-of-the-art review synthesizes recent research examining the relationship between peer victimization and physical health outcomes among children and adolescents. In addition to reviewing evidence for associations between peer victimization and global subjective health indices (eg, somatic symptoms), I highlight several biological sequelae of victimization (eg, cortisol dysregulation, inflammation) that may increase long-term risk for illness and disease. I conclude by considering strengths and limitations of existing work and suggesting several key directions for future research. I also discuss implications for practitioners and the role primary care providers can play in promoting health among peer victimized youth.

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Effects of Peer Victimization on Child and Adolescent Physical Health - American Academy of Pediatrics

AstraZeneca and MSDs Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers.

The three approvals authorise Lynparza for: maintenance treatment after 1st-line chemotherapy containing bevacizumab (genetical recombination) for patients with homologous recombination repair deficient (HRD) ovarian cancer; the treatment of patients with BRCA gene-mutated (BRCAm) castrate-resistant prostate cancer with distant metastasis (mCRPC); and as maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer.

The concurrent approvals by the Japanese Ministry of Health, Labour, and Welfare are based on positive results from the PAOLA-1, PROfound and POLO Phase III trials, which each were published in The New England Journal of Medicine.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: These three approvals allow patients in Japan to be treated with Lynparza, a targeted treatment personalised to their specific biomarkers. They further underline the critical importance of biomarker testing at diagnosis, which helps physicians determine a course of treatment tailored to individual patients to substantially delay disease progression.

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: For patients in Japan diagnosed with each of these types of cancer there are very few treatment options. Approvals for treatments such as Lynparza, the first PARP inhibitor to be approved in these specific types of metastatic castration-resistant prostate cancer and metastatic pancreatic cancer in Japan, enable us to advance this evolving era of personalised medicine and change how these cancers are treated.

Lynparza in ovarian cancerThe approval as 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced ovarian cancer is based on a biomarker subgroup analysis of the PAOLA-1 Phase III trial which showed Lynparza, in combination with bevacizumab maintenance treatment, demonstrated a substantial progression-free survival (PFS) improvement versus bevacizumab alone, for patients with HRD-positive advanced ovarian cancer.

In 2020, nearly 11,000 women in Japan were diagnosed with ovarian cancer, with more than 5,000 women dying of the disease.1 One in two women with advanced ovarian cancer has an HRD-positive tumour.2,3

Lynparza in prostate cancerThe approval for the treatment of BRCAm mCRPC is based on a subgroup analysis of the PROfound Phase III trial which showed Lynparza demonstrated a substantial improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus enzalutamide or abiraterone in men with BRCA1/2 mutations. Lynparza is the first and only PARP inhibitor approved in Japan in advanced prostate cancer.

Prostate cancer is the third most common type of cancer in Japan and in 2020, accounted for over 100,000 new cases.1 With limited treatment options, the average survival for men with mCRPC is only 9-13 months.8 Approximately 12% of men with mCRPC have a BRCA mutation,5 a subgroup of patients with a particularly poor prognosis.

Lynparza in pancreatic cancerThe approval for BRCAm metastatic pancreatic cancer is based on the results of the POLO Phase III trial which showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in PFS versus placebo in patients with germline BRCAm metastatic pancreatic cancer. Lynparza is the first and only PARP inhibitor approved in this disease.

Pancreatic cancer has one of the lowest survival rates of the most common cancers and in Japan was responsible for almost 40,000 deaths in 2020 the fourth most common cause of cancer death.1,5 Japan has the third-highest rate of pancreatic cancer in the world with 44,000 new cases diagnosed in 2020.1,6 Approximately 5-7% of patients with metastatic pancreatic cancer have a germline BRCA mutation.7

AstraZeneca and MSD are exploring additional trials in advanced prostate cancer including the ongoing PROpel Phase III trial testing Lynparza as a 1st-line treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021. AstraZeneca is exploring additional trials in advanced ovarian cancer, including the DUO-O Phase III trial testing Imfinzi (durvalumab) in combination with chemotherapy and bevacizumab, followed by maintenance treatment with Imfinzi, bevacizumab, and Lynparza in newly diagnosed advanced ovarian cancer patients.

PAOLA-1PAOLA-1 is a double-blinded Phase III trial testing the efficacy and safety ofLynparzaadded to standard-of-care bevacizumab versus bevacizumab alone, as a 1st-line maintenance treatment for newly diagnosed advanced FIGO Stage III-IV high-grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy and bevacizumab. AstraZeneca and MSD announced in August 2019 that the trial met its primary endpoint of PFS in the overall trial population.

The PAOLA-1 Phase III trial showed that Lynparza, in combination with bevacizumab maintenance treatment, reduced the risk of disease progression or death by 67% (based on a hazard ratio [HR] of 0.33, 95% confidence interval [CI] 0.25-0.45). The addition of Lynparza improved PFS to a median of 37.2 months versus 17.7 with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.

PROfoundPROfound is a prospective, multicentre, randomised, open-label, Phase III trial testing the efficacy and safety of Lynparza versus enzalutamide or abiraterone in patients with mCRPC who have progressed on prior treatment that included new hormonal agents (abiraterone or enzalutamide) and have a qualifying tumour mutation in BRCA1/2, ATM or one of 12 other genes involved in the homologous recombination repair (HRR) pathway.

The trial was designed to analyse patients with HRR gene mutations in two cohorts: the primary endpoint was rPFS in those with mutations in BRCA1/2 or ATM genes and then, if Lynparza showed clinical benefit, a formal analysis was performed of the overall trial population of patients with HRR gene mutations (BRCA1/2, ATM, CDK12 and 11 other HRR gene mutations). AstraZeneca and MSD announced in August 2019 that the trial met its primary endpoint of rPFS.

The subgroup analysis from the PROfound Phase III trial showed Lynparza reduced the risk of disease progression or death by 78% (based on a HR of 0.22, 95% CI, 0.15-0.32; nominal p<0.0001) and improved rPFS to a median of 9.8 months versus 3.0 with enzalutamide or abiraterone in men with mCRPC with BRCA1/2 mutations. Lynparza reduced the risk of death by 37% (based on a HR of 0.63, 95% CI 0.42-0.95) with median OS of 20.1 months versus 14.4 with enzalutamide or abiraterone.

POLOPOLO is a randomised, double-blinded, placebo-controlled, multi-centre Phase III trial of Lynparza tablets (300mg twice daily) as maintenance monotherapy versus placebo. The trial randomised 154 patients with germline BRCAm metastatic pancreatic cancer whose disease had not progressed on 1st-line platinum-based chemotherapy. Patients were randomised (3:2) to receive Lynparza or placebo until disease progression. The primary endpoint was PFS and key secondary endpoints included OS, time to second disease progression, overall response rate and health-related quality of life.

Data from the Phase III POLO trial showed Lynparza nearly doubled the time patients with germline BRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 on placebo and reduced the risk of disease progression or death by 47% (based on a HR of 0.53, 95% CI 0.35-0.82; p=0.004).

BRCABRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes are mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.8-11

HRDHRD, which defines a subgroup of ovarian cancer, encompasses a wide range of genetic abnormalities, including BRCA mutations and beyond. As with BRCA gene mutations, HRD interferes with normal cell DNA repair mechanisms and confers sensitivity to PARP inhibitors including Lynparza.12

LynparzaLynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in HRR, such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.

Lynparza is currently approved in a number of countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer. It is approved in the US, the EU, Japan, China, and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in the US and EU as a 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced ovarian cancer (BRCAm and/or genomic instability). Lynparza is approved in the US, Japan, and a number of other countries for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. It is also approved in the US, the EU and several other countries for the treatment of germline BRCAm metastatic pancreatic cancer. Lynparza is approved in the US for HRR gene-mutated metastatic castration-resistant prostate cancer (BRCAm and other HRR gene mutations) and in the EU for BRCAm metastatic castration-resistant prostate cancer. Regulatory reviews are underway in several countries for ovarian, breast, pancreatic and prostate cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 40,000 patients worldwide. Lynparza has the broadest and most advanced clinical trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZenecas industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and MSD strategic oncology collaborationIn July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the worlds first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.

AstraZeneca in oncologyAstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients lives and the Companys future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

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

See the rest here:
Lynparza approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers - India Education Diary

Through studies in mice, researchers find evidence that having a healthful balance of gut microorganisms is important for good health.

Researchers from the Institut Pasteur, French National Center for Scientific Research (CNRS), and Inserm have found evidence that gut microbiota also plays a role in mood regulation and brain function.

Gut microbiota is the community of bacteria, fungi, and viruses that live in the digestive tract.

These findings in mice suggest that changes to gut bacterial communities may lead or contribute to depression. If humans have a similar mechanism, doctors might be able to use bacteria strains to treat mood disorders, such as depression.

A group of 16 researchers from several prominent French research institutions conducted the study, which appears in Nature Communications.

Studies have found that some people with depression experience dysbiosis, which is an imbalance or change in their intestinal microbiota.

Research conducted on rodents also shows that gut dysbiosis has associations with neurological changes linked with depression, such as:

Animal studies also show that gut microbiota helps regulate anxiety. It may also influence the development of neurological conditions caused by circuit dysfunctions, such as Parkinsons disease, Alzheimers disease, depression, and obsessive-compulsive disorder.

Researchers think this is because gut bacteria release metabolites, tiny bits of food broken down by digestion that influence brain function. Metabolites may impact mood regulation by acting on the endocannabinoid system.

The endocannabinoid system is a complex cell-signaling system consisting of lipid (fat)-based neurotransmitters and their receptors.

It is found throughout the body and plays a role in important aspects of health, such as immune and nervous system function and cellular communication in the nervous system. It also regulates emotions, moods, and stress responses by activation of the systems main receptor, CB1.

Previous research supports the idea that restoring gut microbial health may help treat depression. In animal studies, prebiotic treatment influenced emotional behavior. In human studies, prebiotic supplementation also improved mood in people with depression.

But despite educated theories, researchers still do not know precisely how gut bacteria impact brain function.

Researchers in the recent study set out to find the mechanisms linking gut microbiota and mood disorders. A team of researchers from some of these same French institutions published a report earlier this year, which found that stress-induced changes in gut microbiota reduced the efficacy of the antidepressant fluoxetine in mice.

In the study, researchers submitted genetically identical mice to unpredictable chronic mild stress (UCMS), a mouse model of stress-induced depression, for 8 weeks.

This treatment caused the mice to develop depressive-like behaviors, such as reduced eating, grooming, weight loss, and hippocampal neurogenesis. The hippocampus is responsible for learning and memory and is heavily affected by several psychiatric and neurological conditions.

Researchers then transplanted fecal samples containing gut microbiota from control and UCMS-exposed mice into healthy mice. To serve as a control, mice that received fecal transplants were germ-free mice or received treatment with antibiotics for 6 days.

After 8 weeks, mice that received transplants from UCMS mice developed depression-like symptoms. The mice also experienced a reduction in the number of new brain stem cells and neurons in their hippocampus.

These findings show that transferring gut microbiota from stress-induced depressive mice to healthy mice induced depression-like behaviors.

Surprisingly, simply transferring the microbiota from an animal with mood disorders to an animal in good health was enough to bring about biochemical changes and confer depressive-like behaviors in the latter.

Pierre-Marie Lledo, head of the Perception and Memory Unit at the Institut Pasteur (CNRS/Institut Pasteur), joint last author of the study

To figure out how this occurred, researchers explored the possibility that UCMS-exposed microbiota may trigger depression by altering metabolism. They found that mice with UCMS microbiota had significantly reduced levels of certain fatty acids in their blood and brain.

The reduced fatty acids included monoacylglycerols (MAG), diacylglycerols (DAG), polyunsaturated fatty acid (PUFA), and linoleic acid. monoacylglycerols (MAG), diacylglycerols (DAG), polyunsaturated fatty acid (PUFA), and linoleic acid. Variations of two of these fatty acids, DAD and PUFA, are converted into endocannabinoids (eCB).

The researchers speculate that gut dysbiosis may cause these changes in fatty acid levels. Studies link the dysregulation of the endocannabinoid system and its central receptor, CB1, with depression in both UCMS-model mice and humans.

In the study, the researchers found that mice with UCMS microbiota had greatly reduced levels of eCBs in their hippocampus and blood. They also found that mice with UCMS microbiota had reduced levels of Lactobacillus bacteria.

The researchers were able to reduce the depressive impact of the UCMS microbiota by enhancing CB1 levels and giving the mice a strain of Lactobacillus bacteria orally.

These findings suggest that chronic stress, diet, and the gut microbiota contribute to the development of depression-like behaviors via the endocannabinoid system.

This discovery shows the role played by the gut microbiota in normal brain function, says Grard Eberl, Head of the Microenvironment and Immunity Unit (Institut Pasteur/Inserm) and joint last author of the study.

More specifically, imbalances in the gut bacterial community that reduce fatty acid levels vital to the endocannabinoid system and brain function seem to encourage the development of depression-like behaviors.

These findings mean certain bacteria could act as a natural antidepressant, treating mood disorders by restoring gut microbial health. And this is promising news, considering the slew of potential adverse side effects and relatively low efficacy rate of most current antidepressants.

To confirm their results, the researchers will need to test their findings in humans. The researchers say that new research will also need to explore whether changes to the gut microbiota impact other brain targets of the endocannabinoid system in the same way.

See the article here:
Gut microbiota: How does it interact with the brain? - Medical News Today

Peoples health needs can change with age. But many wellness brands today focus mainly on young adults. Luckily, Vitality Beyond 50 is there to provide guidance specifically geared toward women in a different age group. Read more about the company below in this weeks Small Business Spotlight.

Provides nutritional guidance for women over 50.

Founder Kristine Bahr told Small Business Trends, I am an Integrative Functional Medicine nutritionist. I help women over 50 regain their energy and vitality with a personalized treatment plan including nutritional services and supplements.

Bringing scientific testing and experience to clients.

Bahr says, I have 20 years of experience as an Integrative Functional Medicine Nutritionist. I do scientific testing to determine the root cause of any illness.

By niching down another venture.

Bahr explains, Vitality Beyond 50 is an offshoot of my present business, Cutting Edge Wellness.

Seeing results with clients.

Bahr says, In my business history, I have helped thousands of clients, all ages achieve optimal health.

She adds, The best gifts I have received are women having babies after being they were infertile. It is a joy to my heart.

Setting up in a new area.

Bahr says, The biggest risk is when I moved from the Berkshires to Boston. I had to develop my business in a new location.

Exploring new areas and continuing to serve clients, just in new ways.

Bahr explains, I would travel more (excluding COVID restrictions) and write a book.

It is a time of Great Awakening. A time for waking up to who you are, not who others think you are. Abraham Hicks

* * * * *

Image: Vitality Beyond 50, Kristine Bahr

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Vitality Beyond 50 Targets a Specific Niche in the Wellness Industry - Small Business Trends

Researchers from Loyola College have found that herbal concoction Kabasura Kudineer, which has extracts from 15 medicinal plants, is vital in the prevention of COVID-19 and they have proved through a docking study that it can be used either to block the host cell receptor or to inactivate 3CLpro, the protease that controls the replication of the virus.

Dr Savariar Vincent, research supervisor and former Dean of Research at Loyola College and research scholar Dr Manoj Dhanraj teamed up with Dr Muthupandian Saravanan from Mekelle University in Ethiopia and Dr Selvaraj Arokiyaraj from Sejong University, South Korea for the research. Their paper was published in Frontiers Molecular Bioscience, a reputed journal in the field.

Another paper published in Journal of Ayurveda and Integrative Medicine stated that Kabasura Kudineer could be used for effective treatment of COVID-19 but the study only analysed 37 compounds while the Loyola College study worked on 145, Dr Vincent told Edex. "We analysed 145 compounds and 15 of them are extremely powerful and if we were to create medicine with it, it could prove to be a powerful medication against COVID-19. We have also used a different software for the study. Our paper has also been published in a Q1 journal which ensures worldwide reach," he added.

Tamil Nadu's recovery rate is quite high at 97 per cent and one of the reasons is that people here have been consuming Kabasura Kudineer, said Dr Vincent. "Even at times when antibiotics don't work, Kabasura Kudineer is shown to always work," he said. "We did a docking study using the gene structure of COVID and the various medicinal plants that are in Kabasura Kudineer. We have only been saying that it is a preventive measure. If we keep drinking it on a regular basis, then it will prevent COVID from spreading in the body. It is very effective when consumed for 14 days at a time," he added.

Kabasura Kudineer, an official Siddha Formulation, comprises of 15 medicinal plants Adhatoda vasica, Andrographis paniculata, Anacuclus pyrethrum, Coleus ambonicus Cypreus rotundus, Clerodendrum serratum, Hyfrophila auriculata, Saussurea lappa, Sida acuta, Syzgium aromaticum, Terminalia chebula, Tinospora cordifolia, Tragia involuerta, Zingiber officinale and Piper longum. "When we studied those 145 compounds in it, we found that all of them had the power to bind with the Coronavirus and stop it from propagating. It also ensures that the virus doesn't affect the receptors in the cells," added the professor. "Siddha, Ayurveda and Unani medicine should be brought into the mainstream and its power harnessed along with mainstream medicine. We need to do a lot more research into traditional medicine into it. Ministry of AYUSH has recommended it all across India and that has contributed to keeping the infection rate low. There are 29 Siddha COVID centres in Tamil Nadu," he said.

The researchers also said that this study is important because there was no scientific validation for Kabasura Kudineer before this. "Even Nilavembu Kudineer is very potent against dengue but there have been no scientific validations against it. That is why we decided to do this study. We have shared the findings with ICMR and they have acknowledged it. We will be submitting it to the TN government and the Siddha College soon," he said.

Read more from the original source:
Loyola College researchers find that Kabasura Kudineer's 145 compounds are extremely potent in controlling COVID-19 - EdexLive

Health Coaching Market research report is the new statistical data source added by A2Z Market Research.

Health Coaching Market is growing at a High CAGR during the forecast period 2021-2027. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market.

Health Coaching Market research is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share and contact information are shared in this report analysis.

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Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.

Top Key Players Profiled in this report are:

Aetna, National Consortium for Credentialing of Health & Wellness Coaches, Wellcoaches School of Coaching, National Society of Health Coaches, Duke Integrative Medicine, Humana.

The key questions answered in this report:

Various factors are responsible for the markets growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Health Coaching market. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market. The influence of the latest government guidelines is also analyzed in detail in the report. It studies the Health Coaching markets trajectory between forecast periods.

Global Health Coaching Market Segmentation:

Market Segmentation: By Type

Health EducatorsHealth CoachesWellness Coaches

Market Segmentation: By Application

Day spasCorporationsMedical centersNatural health food storesPhysician officesWellness centersSchools

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Regions Covered in the Global Health Coaching Market Report 2021: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

The cost analysis of the Global Health Coaching Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.

The report provides insights on the following pointers:

Market Penetration: Comprehensive information on the product portfolios of the top players in the Health Coaching market.

Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market.

Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market.

Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies.

Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Health Coaching market.

Table of Contents

Global Health Coaching Market Research Report 2021 2027

Chapter 1 Health Coaching Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6 Global Production, Revenue (Value), Price Trend by Type

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10 Marketing Strategy Analysis, Distributors/Traders

Chapter 11 Market Effect Factors Analysis

Chapter 12 Global Health Coaching Market Forecast

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Come winter and the hardest task is to get out of thewarmth of the blanket and go for that run.As soon as temperatures dip, even the most motivated and dedicated fitness enthusiasts start to press thesnooze icon on the mobile clock.If you are struggling to maintain theexercise schedule which you acedat during the summer months,you are not alone.

Dr Anjali Hooda Sanghwan, says, Winters are a great time to lose weight! The metabolic rate of the body is at its best, the calories we consume are utilised better in the winter.

She adds, The best way to stay fit and find motivationin the cold season is to remember that when summer approaches one can look forward to coming out of those heavy clothes to a super fit body that waskept under wraps for the time being. Its actually the best time to focus on fitness, the good part is youend up sweating less and yet can shed weight too.

We all would be kidding if we thought it was just as easy to get outside and run in the winter as it is in the summer. Sometimes, it can take more effort to actually get out of the bedthan it does to complete a run itself! But training outside will give you a boost mentally and physically.

As Luke Coutinho, Holistic Lifestyle Coach- Integrative Medicine,says, Daily exercise also gives us a regular dose of endorphins, ahappy hormone, which can go a long way in combating seasonal affective disorder, depression and anxiety, which is real and especially seen in areas where temperatures drop sub-zero. Exercise also helps keep immunity up so you can better fight off the flu, activates circulation which usually slows down and initiates a process of sweating, which is one of the most natural ways to throw toxins out of our body. And of course, it can avoid the winterweight gain, which most people fear about.

Swapneel Hazare, Strength and Conditioning Coach,Founder - Shield Fitness, says, Unfortunately, during winters people feel it is necessary to spendmost of their time indoors to avoid the cold. On the contrary activities like jogging, walking,running or cycling outside is vital to get you the much-required dose of Vitamin D. This willbuild your immunity and will protect you against any illness caused by the change inweather.

Though its cold, but its time to embrace a strict workout schedule. We are sure these tips would help you.

1. Get the right kit

Though sounds the most banal advice but itwould make a big difference. Gloves and a headband to cover your ears will reduce the risk of catching a cold.

2. Set a goal

Focusing on a goal is the key to keep yourselfmotivated. Create your fitness goals and remember just how you will feel when you complete your kilometers.

3. Find a workout buddy

With friends, everything becomes easier. Even if itmeans running or jogging in the morning. Apart from accountability, you could chatand then enjoy a hot cup of chai after the workout.

4. Make it interesting

Keep in mind to make your workouts diversified, include body weight/strength training orgrounding practices like Hatha Yoga. You can complement your exercise routine withmassage therapies to balance Vata Dosha, says Namita Piparaiya, Yoga, and Ayurveda Lifestyle Specialist, Founder - Yoganama

Link:
Dont let the winters eat up your fitness regime - Hindustan Times

CLARKSBURG, W.Va. (WV News) With New Years Day right around the corner, many people are contemplating and committing to resolutions that help promote healthier lifestyles while they put 2020 behind them.

Getting in shape and weight loss remain among the most popular resolutions, and Dr. Elizabeth H. Hess, MD, United Hospital Center Family Medicine Residency Associate Program director and Integrative Medicine director, said its important to take some things into account in order to be successful.

I think its important when you think about a New Year/New You theme that its not limited to resolutions about a specific weight loss goal. We often focus on numbers on the scale but a new you should start with a mindset and emphasize how you accept yourself and choose to take steps that will help you feel better and stronger and more empowered as you reduce your risk of many chronic diseases like hypertension, diabetes and heart disease, she said.

When setting goals, its important to be realistic and not set them too out of reach in the beginning. Smaller goals can help people stick to their plans, she said.

I recommend starting with small steps, but at the same time celebrate milestones along the way. This strategy is proven to be successful, yet simple, as it focuses on small, practical changes that add up to a healthy lifestyle over time, she said.

Hess said regular physical activity is essential for good health. Incorporating it into a new routine early can aid in weight loss, and in the future, can help keep it off.

Regular physical activity is an essential part of this wellness journey, and, yes, it can aid with weight loss and more specifically help maintain weight loss but the benefits of physical activity go way beyond the waist line. Specifically, regular physical activity helps elevate your mood and has shown to be an effective treatment or add-on treatment for anxiety and depression. It also plays a role in healthy sleep patterns. Finally, it gives our immune system a natural boost, which is so essential during the COVID-19 pandemic, she said.

For adults, Hess said its recommended they get at least 150 minutes of moderate-intensity aerobic exercise a week, like fast walking, casual biking or light yard work, or 75 minutes of vigorous-intensity aerobic activity a week, like jogging or swimming. Adults should also add two days of resistance training to their routine, as well as explore activities that improve flexibility, she said.

To get in those minutes, North Central West Virginia is home to several area gyms and facilities for people to pursue their resolutions, such as the Harrison County YMCA, which aside from the exercise equipment, offers several classes to keep members engaged and healthy.

Healthy eating habits, Hess said, are another important aspect when losing weight.

Most of us have developed habits of how, when and why we eat. When we want to make changes in our diet and nutrition, I think its very important to also reflect on our attitudes toward food and our relationship with food. How, when and why we eat can often have deep-seated emotional triggers and if these issues are not addressed, it can be difficult to make lasting changes to how we see and use food to nourish ourselves. A lot of patients often want to adopt a radical change or a so-called fad diet and hope to see rapid changes in weight.

Weight loss management experts often dont recommend just one way of eating or prescribed diet plan. Its important that all the nutrients and micronutrients our body requires are included or supplemented in our eating pattern, but for a starting point, I would suggest starting with a mindfulness-based eating program, she said.

Mindful eating is about using mindfulness or our full attention to learn to recognize the difference between true hunger and non-hunger triggers and to really pay attention to our experience of eating, she said.

Mindful eating involves eating slowly without distraction, learning to distinguish between true hunger or emotional or habit-eating cues and only eating until full, she said.

It also stresses engaging all the senses in the act of eating and noticing how food affects your feelings. It makes eating intentional and not automatic. This mindful act of eating will lend to any nutrition program you adopt for weight management but most importantly it will build a healthy relationship and appreciation for the food you eat, she said.

Permanently improving eating habits requires a person to reflect on their habits, replacing unhealthy habits on healthier ones and reinforcing those habits.

For those trying to improve their overall wallet health, Edward Jones financial adviser Larry Cann offered several pointers.

Sit down and create a budget, and more importantly follow it. For most folks, actually seeing, paying attention to what they are spending on a more regular basis often times helps curve some of that frivolous spending, he said.

With 2020 being a trying year for everyone, filled with job losses, cut hours and parents teaching children at home while working on their own careers, Cann said being prepared is an important focus heading into the new year.

As part of that budget, work towards having an emergency fund. Id define an emergency fund as having somewhere in the neighborhood of approximately six months worth of living expenses. That gives you that cushion for the unexpected, including the loss of a job, cutting of hours, losing overtime pay, (etc.). Having that emergency fund gives you a cushion and time to react when something bad does happen, he said.

For those paying down debt, Cann said putting focus on paying the highest interest debts is impactful, and for folks who have already started planning financially in any way, remember to establish goals, create a plan to follow and dont overreact.

For those curious, unsure or even frightened about finances, seeking the help of a financial adviser can be very beneficial, as they can help you create a plan, lay out the goals an individual would like to accomplish and help achieve them.

You dont have to have a million dollars to talk to us. Thats simply not the case. ... If you are in a position where you are confused, worried and not quite sure, if you have a goal and you dont have a plan in place to help achieve that goal, reach out to somebody. Let somebody help you create that plan, he said.

{span}Staff writer Steven Baublitz can be reached at (304)626-1404 or sbaublitz@theet.com.{/span}

Link:
North Central West Virginia experts give tips on sticking to popular New Year's resolutions - WV News

There is a certain type of tea (not the kind you drink) made from manure that was once stuffed inside a cow horn, buried on a farm for a season or two, dug up, and diluted with water. That tea is stirred in a bucket until a vortex, which absorbs the energy of the environment around it, forms. Every few minutes, the vortexs direction is switched. After the mixture absorbs its share of environmental energy, it is sprayed, arbitrarily, over grape vines in a vineyard.

The spraying takes place according to a calendar that follows the phases of the moon and alignment of the stars to determine four types of daysroot, leaf, flower, fruitand the plants you should be cultivating on these days. It also dictates the types of wine you should be drinking on these days. Wines shine brightest on fruit days, although you can get away with a lighter white wine on flower days, too. If youre drinking a Pinot Noir on a root day, you have made a huge mistake.

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The label "biodynamic" is often attached to this intensive practice of winemaking, but its a type of farming in generalpart practice, part philosophy. Biodynamics were first theorized a century ago by Rudolf Steiner, an Austrian philosopher and beekeeper who hosted a series of lectures in the 1920s decrying the creep of synthetic fertilizers and chemicals into farming. To this day, the biodynamic protocol refuses conventional additives, follows specific preparations for composting, and plans by that biodynamic calendar.

"We people tend to think we can control things," says Rex Farr, co-owner of Farrm Wine, a biodynamic vineyard on Long Island, New York. "But we cant control anything. Biodynamic farming is about giving up control. Its the PhD of organics. It includes energies that are not just in the soil but aboveground, too: how the moon affects the tides, how the stars and planets all play a part in the energy cycle that we here on terra firma are part of."

Biodynamic wines arent new, but as the reality of climate change sets in and younger generations look to spend money on brands paying attention to it, they have been newly attended to, whether wine drinkers understand them or not.

The big idea in biodynamics is self-sustaining agriculture: The biodynamic farm is symbiotic with its plants, soil, animals, and process. It does not take away from the earth, and it does little to disrupt the natural environment of the, albeit manmade, farm with human intervention and destruction. It predates the organic movement by about 15 years. But because biodynamic farming also follows the energy of the cosmos, an idea that has no basis in fact, the decision to drink biodynamic wine becomes a question not of taste or quality but one of integrity. Its not about what kind of wine we like, but what our values are when we go to buy a bottle.

"A lot of consumers walk into the store and want a natural or biodynamic wine because theyve heard the word around," says Jane Arbogast, assistant wine buyer at Eastside Cellars in New York City. "But when I push them, they usually dont know exactly what it means. What theyre usually looking for is something with morals that match their own."

If you are seeking the biodynamic label, youll likely find it at your local wine store and definitely at the closest Whole Foods, in the non-conventional wine aisle full of other green-sounding words like natural, sustainable, and regenerative, nestled among low-intervention wines and dry-farmed wines. These seemingly eco-friendly words are not bound by any USDA (or even colloquial) definition and can easily misrepresent environmental responsibility to the wine-drinking masses. Natural might appeal to the psyche, but it has no real claim to health, despite the health food industrys insistent usage. Natural is not inherently good. Arsenic is natural. It can also kill you.

"We call it 'greenwashing,'" says Ed Field, co-owner of Natural Merchants, an importer of organic and biodynamic wine for places like Whole Foods. "Natural, sustainablethose are like nails on a chalkboard. If you throw in terms that are undefined, it [all] becomes a marketing gimmick."

Part of the draw toward biodynamics is the sense that natural, sustainable, even organic, are not enough. "On a scale from the most green to the least green, biodynamic is the most extreme," says Arbogast. "Its the most dedicated to preserving the earth's resources."

Biodynamic practices havent been updated since Steiners first call to them in 1924, and although any product with a biodynamic label is certified as such from an international governing body called Demeter, in the U.S., the USDA stamp of organic approval is the closest thing we have to a legally bound manifestation of the idea. But where organics focus on what we dont addchemicals, synthetics, and the likebiodynamics also emphasize not taking anything away.

"Say a plant is sick," says Farr. "The Western approach would be: Lets go treat it with Roundup. We ask, 'Why is the plant sick?' Im not just going to eliminate the problem but look at the sourcethe plant, the roots, the soil."

In this way, biodynamic winemaking sounds a lot like integrative medicine: If a person has a chronic skin rash, you dont just prescribe a topical antibiotic and move along. You look at their stress levels, their food intake, their bloodwork. But biodynamics get real hippie, real quick. Some farmers believe in it like a religion. Steiner, for example, doesnt just have modern-day students of the practice, but zealots. They live and breathe the idea that we as people and as an earth are all interconnected with the soil and stars, and we must limit the damage we do to the natural order of things. Wine is not just good or bad based on taste, but right or wrong, ethical or unethical.

That intangible, philosophical way of behaving might be what draws both farmers and wine drinkers to a century-old hypothesis. Its a poetic ideal, which makes it impossible to study, impossible to quantify. If, ultimately, you want to know if biodynamic wine is quantifiably better than other green-sounding wines, youre out of luck. Maybe thats the point.

"Science compiles proof through controlled experiments," says Anna Katharine Mansfield, associate professor of enology at Cornell Universitys College of Agriculture and Life Sciences. "But biodynamics wouldnt fit that frame. They believe you cant replicate a system." You cant test biodynamic wine in a lab, because it matters what day of the week and month and year you drink it on. It matters who you are with and how it is shared and why it is experienced at all. In Mansfield's opinion, if a farmer takes care of the overall, holistic health of a vineyard system, that's good. "But that also happens in organic growing. When you move to relying on the tides of the moon and all that, it probably isn't better than organic."

Wine is not just good or bad based on taste, but right or wrong, ethical or unethical.

Viticulture and enology, the studies of winemaking, are built inside the scientific framework of falsifiability: We test ideas that have the capacity to be proven wrong. In this way, biodynamics seem more like religion than science. We cant prove that the hypothesis is true, but we also cant prove that its not true.

"I have no degree in agriculture, but I have 30 years of farming experience," says Farr. "We are just caretakers of what we do out here. We are not trying to control nature. Theres certainly more spirituality in biodynamics than organics. You can just feel something different. You really can."

Belief in holistic farming aside, some are driven to the biodynamic label by the perception that non-conventional wines are "healthier." It is probably more accurate to say that certain types of wine are less damaging or have fewer additivesthat some wines are less bad than others.

"I have to laugh when people ask for wine without chemicals," says Mansfield. "Everything that makes wine taste good are chemicals. Wine is chemicals. Humans are chemicals. The most toxic thing in any bottle of wine is the alcohol. Let's just agree that we are ingesting a toxin because we like it."

For the record, a casual wine consumer cannot usually tell the difference between a biodynamic wine and other winesnatural, organic, and sometimes even straight-up conventional. Just tastes like good ole fermented grape juice. And no winenot biodynamic, organic, nor naturalis a health food. But what you think, your perception of the wine, is really what ends up defining how good it is. If you think that the wine you bought is a moral investment, that youre supporting sustainable farming, that you are a healthy person who buys healthy things, then youll probably have a better experience drinking that wine.

We have stories about wines because it has never been compelling to reduce the earth and our time on it into data in a lab. Thats why philosophies of farming and cosmic calendars and belief in something beyond what is here right now exist. Science can only arm us with so much.

Biodynamic wine is about those stories. Wine is not just wine. One thing is never, can never be, just one thing. Everything is connected. To some, it is impossible to separate wine from its former life as a grape, the grape from the tea-sprayed vine, or the tea on the vine from its energy in the vortex of space. The wine can't be stripped from its context, just as we cant strip ourselves from the earth and our space in the stars, our morals from our wines.

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What Are Biodynamic Wines? - Why Biodynamic Wines Are the Most Green - Esquire.com

Globa Health Coaching Market Research Report uses definitions, classifications, and market scopes to give a detailed estimate of the current status of the Health Coaching industry. Basics of the Health Coaching industry are being studied, such as the competitive landscape structure, prominent players in the industry, and the size and value of the Health Coaching market. Health Coaching Market growth trends, development plans, dynamic market drivers, and risk assessments are implemented. All Health Coaching Industry traders, dealers, and distributors are being investigated globally. This study describes the strategies and business plans implemented by the main players in the Health Coaching market.

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AetnaAmerican Association for Health EducationAmerican Council of Exercise (ACE)CignaCleveland ClinicDr. Dears Wellness InstituteDuke Integrative MedicineHealth Coach InstituteHumanaInternational Coach Federation

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Type IType II

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Global Health Coaching Market Research Report focuses on key applications and growth rates and outlooks till 2026 - Factory Gate

The pandemic-interrupted racing season produced several exceptional candidates for the Richard Petty Driver of the Year award, conferred by vote of the National Motorsports Press Association. Kevin Harvick led NASCARs premier division with nine victories. Chase Elliott claimed his first Cup Series title.

Scott Dixon won the first three races on the IndyCar Series on the way to his sixth championship. Denny Hamlin led the Joe Gibbs Racing, Toyotas flagship team, with seven triumphs and 18 top-five finishes in NASCARs top series. Kyle Larson won 46 of the 92 dirt races he entered, taking checkered flags in four different types of race cars.

Ultimately, it was Kevin Harvick who was named Richard Petty Driver of the Year with 45 percent of the vote from the NMPA membership. In a season interrupted for 10 weeks by the coronavirus pandemic, Harvick won the first race after the resumption of competitionMay 17 at Darlingtonand went on to claim eight more trophies for a career-best nine victories.

Harvick finished fifth in the final standings after narrowly failing to qualify for the Championship 4 race, which Elliott won to secure his maiden championship. But the NMPA rewarded Harvick for his body of work, which elevated his career total to 58 wins, most among active drivers now that Jimmie Johnson has left the Cup Series to race IndyCars next year.

It was the fourth such award for Harvick, who earned the distinction for the first time in 2001 when he was thrust into the limelight as Dale Earnhardts successor at Richard Childress Racing after Earnhardt died in a last-lap crash in the season-opening Daytona 500. Harvick also was the top vote-getter in his 2014 championship season and in 2018.

Buoyed by victories in the final two races of the season, Elliott was second in the balloting with 30 percent of the vote. Dixon and Larson, the latter of whom will return to the Cup Series with Hendrick Motorsports in 2021, also were selected on multiple ballots.

One by-product of the coronavirus pandemic has been the strengthening of the charitable instincts among top NASCAR stars. The Checkered Flag Foundation, founded by 2012 NASCAR Cup champion Brad Keselowski, celebrated its 10th anniversary by providing business suits to returning veterans of the United States Armed Services to aid them in securing work after their service.

Keselowski said:

Weve been celebrating the 10th year of the Checkered Flag Foundation in 2020, and this feels like such a fitting way to end the season and spread some joy around the holidays. Im grateful that we could come together to recognize veterans during this important transition for them.

On November 5, Martin Truex Jr. and his long-time girlfriend, Sherry Pollex, celebrated the opening of the Sherry Strong Integrative Medicine Oncology Clinic at the Weisinger Cancer Institute in Charlotte, N.C. Pollex has been waging a recurring battle with cervical cancer; she and Truex, through his Martin Truex Jr. Foundation, have committed their time and resources to the benefit of cancer patients throughout the United States.

Bristol Motor Speedway, a property of Speedway Motorsports Inc. (SMI), is exploring an agreement with Nashville Fairgrounds Speedway that could return NASCAR racing to the historic short track, the second-oldest operating motorsports speedway in the United States, dating to 1904.

Until a potential agreement, Bristol would assume operation of the .596-mile track and take on financial responsibility for the renovation and maintenance of the facility. Nashville Fairgrounds Speedway is deeply rooted in NASCARs past. The Cup Series last raced there in 1984.

President, and CEO of SMI and Bristol Motor Speedway, Marcus Smith, Said:

We can work together to transform Nashville Fairgrounds Speedway into an amazing multipurpose entertainment destination. Were ready to roll up our sleeves and go to work to fully restore the speedway, recruit national events and breathe new life into a venue that has a legendary status in auto racing history.

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Kevin Harvick Earns Driver of the Year Honors for Fourth Time - World Sports Network

DALLAS--(BUSINESS WIRE)--Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today announced new additions to its leadership team with the appointments of Greg Gara as Senior Vice President of Manufacturing and Kimberly Lee, D.O., as Senior Vice President of Corporate Communications and Investor Relations.

We are excited to welcome Greg and Kim to Tayshas leadership team, said RA Session II, President, Founder and CEO of Taysha. They each bring significant domain experience and their contributions will be invaluable as we continue our mission of eradicating monogenic CNS diseases. Gregs technical expertise in AAV gene therapy manufacturing along with his proven success in constructing several cGMP gene therapy facilities and Kims deep experience across capital markets and corporate communications will add tremendous value to the team. Importantly, both share our unrelenting, patient-first focus and passion for bringing new cures to life.

Mr. Gara has over 25 years of experience in designing, constructing, and starting up large- and small-scale manufacturing facilities for biotechnology companies globally. Prior to joining Taysha, he served as Vice President of Pharmaceutical Engineering at Sarepta, where he led and managed manufacturing operations for all gene therapy products. Before Sarepta, he served as Vice President of Technical Operations and Engineering at AveXis, a Novartis company, where he led the design, construction, and startup of the Libertyville facility and the new facilities in Research Triangle Park and Colorado. Mr. Gara also led the team for the facility expansion in North Carolina and the renovation of the Colorado site. Prior to AveXis, he led the facilities and engineering organization at Hospira prior to the companys acquisition by Pfizer. Before joining Hospira, he spent 15 years at Amgen, holding positions of increasing responsibility, and was part of the Cork, Ireland, construction project. Mr. Gara received a B.A. in Biology and Environmental Science from Augustana College.

Tayshas dedication to the development and commercialization of potentially transformative gene therapy treatments and its innovative and pioneering spirit is truly inspiring and I am excited to contribute in a meaningful way, said Mr. Gara. I look forward to playing an instrumental role in the companys growth and expansion of its manufacturing capabilities.

Dr. Lee joins Taysha with over 20 years of capital markets, strategic corporate finance, and communications experience from prior roles as a biotech equity research analyst on Wall Street and corporate strategy, communications, and investor relations professional. She most recently served as Head of Corporate Strategy and Investor Relations at Lexicon Pharmaceuticals and previously as Vice President of Corporate Strategy, Corporate Communications and Investor Relations at Raptor Pharmaceuticals until its acquisition by Horizon Pharma. Prior to joining Raptor, Dr. Lee was a biotechnology sell-side analyst at investment banks, including Jefferies and Wedbush Securities, covering biotechnology companies across all market capitalizations, multiple therapeutic areas, and modalities. Dr. Lee received a B.S. in Biological Sciences from Stanford University and a D.O. from Kirksville College of Osteopathic Medicine.

In less than one year, Taysha has made extraordinary progress in developing and funding its elegant platform and rapidly advancing its product candidates for the betterment of patients and I am thrilled and grateful to be a part of this journey, said Dr. Lee. I am eager to learn from and work alongside this team of gene therapy experts at this exciting stage of our companys lifecycle and I look forward to making lasting contributions.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available at http://www.tayshagtx.com.

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Taysha Gene Therapies Expands Leadership Team to Deepen Manufacturing and Communications Capabilities - Business Wire

As we prepare to enter a new decade, we look back on the major milestones and blunders within European biotech over the last 10 years.

Over the last decade, we have seen many biotech breakthroughs to come from Europe, including first-in-class therapies for cancer, the first approved in vivo gene therapy, as well as notable efforts to combat Covid-19. Some other areas have proven to fall behind expectations, such as Alzheimers or microbiome research, and will need a push over the next decade. Lets have a look back at what the biotech industry has accomplished in the decade were now leaving behind.

Few would disagree that this has been a game-changing decade within oncology. Weve seen the arrival of checkpoint inhibitor drugs, the first oncolytic viral therapy, and the approval of the first CAR-T cell therapies.

For Alexandra Bause, who leads a venture creation program at the investment firm Apollo Health Ventures, immuno-oncology was one of the most exciting things to happen during the last decade. Its not just one cancer and one drug for that specific cancer anymore, we can now activate, reactivate or replenish the bodys own immune response and we can potentially target malignant cells throughout the whole body.

This decade has witnessed the advent and establishment of checkpoint inhibitor drugs. These immunotherapies consist of therapeutic antibodies that block immune checkpoints proteins on the surface of immune cells that tumors use to evade the immune system.

The first checkpoint inhibitor, ipilimumab, was approved in 2011. Since then, six other checkpoint inhibitor drugs belonging to a new generation that blocks the PD-1/PD-L1 immune checkpoint have been approved. These drugs have made a big difference for a certain percentage of patients with difficult-to-treat forms of cancer.

Many good things came to cancer patients in the last decade, said Martin Bonde, CEO of Inthera Biosciences in Switzerland. For instance, we are now much better at treating multiple myeloma and malignant melanoma than we were 10 years ago. At the start of the decade, malignant melanoma had a 5% 5-year survival rate, now its over 50 % thanks to drugs like Opdivo (nivolumab) and Keytruda (pembrolizumab).

Since the initial approval of Opdivo and Keytruda as treatments for advanced melanoma in 2015, their indications have been expanded to include a range of blood and solid cancers. They are also used in combination with other checkpoint inhibitors as well as conventional chemotherapeutic agents. Sales-wise, Keytruda takes the lead as one of the worlds best-selling drugs.

The year 2015 also brought the approval of Imlygic, the first viral therapy for cancer in the Western world. The treatment acts by injecting melanoma tumors with a virus that infects and destroys cancerous cells. While Imlygic hasnt proved to be a blockbuster, viral therapies for cancer going forward could find a niche when combined with other cancer treatments such as checkpoint inhibitors.

In 2017, we saw the US approval of Kymriah, the worlds first CAR-T cell therapy. This treatment consists of engineering the patients own immune cells to make them better at identifying and attacking cancer cells. That same year, a second CAR-T therapy, Yescarta, was approved and a third one, Tecartus, received approval this year.

Despite concerns regarding severe side effects and prohibitive pricing, CAR-T cell therapy has made a big difference for patients with blood cancer that had not responded to other treatments, with remission rates above 90% in some cases. There are now over 1,000 clinical trials testing different forms of CAR-T technology aiming to improve its efficacy and safety and to extend its use to other forms of cancer, such as solid tumors.

The future of cancer treatment seems to be going in the direction of combining different approaches and selecting the most suitable for each patient. According to Bonde, combination therapy will continue to be refined with genomics technology.

I think its difficult to see combination therapy going away anytime soon because cancer is so complex and still difficult to treat, so we need to attack it from multiple angles. I think we will continue to see the search for new mechanisms of action, and research will help us to understand how we can best tackle a particular cancer in relation to its genetic makeup.

The last decade brought gene therapy to the market, offering a one-off treatment for patients suffering from genetic disorders. In Europe, the first gene therapy, Glybera, was approved in 2012. Although the treatment was withdrawn after a commercial failure, it set a precedent; there are now a total of 11 cell and gene therapies approved in the EU.

In 2018, the EMA approved Luxturna, a gene therapy developed by Novartis to treat blindness caused by a genetic mutation. This made Europe the first to approve an in vivo gene therapy, in which the genetic modification happens directly within the body rather than in cells extracted from the patient.

Despite these breakthroughs, the number of approved gene therapies in Europe is very modest compared to the over 1,200 gene therapy trials taking place across Europe. Meaning there is still a lot of space to grow.

Today we can get the entire human genome sequence in 24 hours for $500. This has opened up the possibility to design drugs using genetic information this is just starting and will be important in the next decade in gene therapy for cancer and elsewhere, said Bonde.

The gene therapies approved to date have mostly consisted of replacing a faulty gene with a functional copy delivered on viruses. Rapid technical advances within gene-editing technologies such as CRISPR-Cas9 are now making it possible to make precise edits to the genome, and many such therapies have entered clinical trials in Europe.

The orphan disease space has become much more crowded in recent years, with companies trying to target specific gene mutations behind a given rare disease, many of which incorporate gene therapy or gene-editing technologies, while others target downstream pathways with small molecules, said Bause.

The last decade has primarily been about tool-building within the gene therapy area and with the advent of CRISPR-Cas9 and related technologies, we are really only at the beginning of this era.

A therapeutic area that has seen huge investment, particularly in the second half of the last decade, is aging. Companies in this field seek to tackle aging-related diseases.

Why is this so important? According to Alexandra Bause, a wide range of diseases can be attributed to aging. In our 20s, 30s, and 40s, most of us are healthy, and then disease may creep up from the age of 50 years. The underlying aging process is causing the majority of known diseases that make up the major markets, such as Alzheimers, cancer, heart disease, chronic kidney disease, type 2 diabetes, metabolic disorders, and more.

Right now, much of the focus is on reverting age-related physiological damage. As research sheds light on the mechanisms underlying aging, many strategies to combat aging are being explored. Senolytics are a prominent example. These are small molecules that can simultaneously eliminate aged cells and promote tissue rejuvenation.

In recent years weve seen the creation of companies developing senolytics, including Senolytx in Barcelona and Velabs Therapeutics in Helsinki. However, a senolytic candidate developed by the US company Unity Biotechnology failed a key phase II trial in osteoarthritis earlier this year and the company is still suffering the fallout. Evidently, a lot more progress is still needed in the senolytics field before it can produce any marketed drugs.

Other strategies include drug repurposing, stem cells, and genomics. A major study called TAME is looking at whether the drug metformin can extend longevity and delay the onset of age-related chronic diseases such as heart disease, cancer, and dementia.

Metformin is widely used to treat type 2 diabetes but it also seems to have properties that may reduce Alzheimers and cancer risk. The TAME study will evaluate whether metformin doesnt just increase healthy lifespan by diminishing the risk of Alzheimers and cancer, but actually affects cellular pathways of aging as well. This is an important drug and an important study because it demonstrates how drugs can be repurposed to directly impact aging, said Greg Bailey, CEO of anti-aging company Juvenescence.

The organizers of the TAME trial also plan to launch a study into what biomarkers can best assess biological age, since its currently hard to measure how much a drug has slowed the aging process. Going forward, these trials will be a huge help to those working within aging, which is not currently seen as an official disease by the EMA or FDA. This means that companies are limited to targeting a specific age-related disease each time they want to test new treatments in clinical trials.

I think genetic modification of cellular pathways and epigenetics will play an enormous role. There is incredible ongoing work with Yamanaka factors; those transcription factors and gene modifications can reset cells to embryonic stage, potentially erasing the epigenetic changes of aging. Clearly the control of these factors and genes would be hugely transformational, said Bailey.

The field is coming fast and furious. We have the opportunity and ability to turn science fiction into science. In the last 10 years, scientists have truly begun to understand the cellular pathways involved with aging. And when we understand a cellular pathway, we can manipulate it. This was made possible by unlocking the human genome with computational biology, and advances in machine learning have literally opened the floodgates.

Although Covid-19 only appeared at the end of the decade, it has already made a huge impact on the biotech industry. If there is a positive in this crisis, the speed at which the biotech, pharma and research communities have come together in the face of Covid-19 is truly remarkable. It has probably accelerated scientific knowledge by years, said Bailey.

Covid-19 has focused the attention on biotech and healthcare and I believe that biotech is the ultimate superhero. It is the Modernas and the BioNTechs of this world that will kill Covid, said Antoine Papiernik, Managing Partner at life sciences VC firm Sofinnova Partners.

There are currently over 50 Covid-19 vaccines in clinical trials, with 12 of these in late-stage testing. One area in particular that has seen a big push because of the pandemic has been RNA therapeutics. In partnership with Pfizer, BioNTech in Germany has obtained approval in the UK and US for a Covid-19 vaccine, making it the first medicine using messenger RNA technology.

Although European diagnostics and vaccine development have seen a boost in funding this year thanks to Covid-19, funding for infectious diseases in general will still be an uphill battle. Its almost impossible to get funding for infectious diseases nowadays. Why? Because there are few patients in need, and a lot of drugs already out there, and treatment lasts a maximum of 2 weeks. How much can you charge for that compared to a cancer treatment? said Bonde.

There have been some efforts to boost the development of new antibiotics, such as the launch of the Antimicrobial Resistance Action Fund this year. Additionally, the UK began trialling a new payment policy to incentivize antibiotics development in 2019. However, this may still not be enough.

Its a broken business model, and its going to hurt us because an estimated 10 million people will die over the next 10 years or so, from multi-resistant bacteria. But theres no incentive in the market for companies to go after it. I think this should and will end as a state matter. The state will make sure that we have enough options to deal with deadly bacteria.

The last decade saw hundreds of clinical trials for Alzheimers disease, yet not a single drug is able to stop or slow down its progression. Clinical trials are failing one after the other, in most cases because of a lack of convincing therapeutic efficacy when tested in large groups of patients.

For the last decade, research and clinical strategies within the Alzheimers field have largely focused on the beta amyloid protein, which accumulates in the brains of Alzheimers patients years before they experience cognitive symptoms. These findings led to the hypothesis that these beta amyloid plaques were responsible for cognitive decline, but the failure of clinical trials targeting beta amyloid seems to indicate the solution may lay elsewhere. The biggest challenge is that no consensus exists on the underlying mechanisms of the disease, which is now the 6th leading cause of death worldwide.

Poor disease models and an incomplete understanding of the mechanisms of disease are a big part of the problem. Beta amyloid might be more of a biomarker or a symptom, than the mechanism, said Bause.

Companies dont talk to each other enough to share knowledge about what doesnt work. How many amyloid drugs do you have to put into trials before you realize that this isnt working? This is one of the biggest blunders of the last decade from my perspective, added Bailey.

Even for companies following other approaches, the results have been mixed so far. One example is an antibody drug developed by the Swiss company AC Immune and US partner Genentech to tackle Alzheimers disease by blocking a protein called tau. However, this drug proved a dud on a debut phase II trial this year.

However, the French company AB Science provided a glimmer of hope at the end of the decade. Its drug designed to reduce inflammation in the brain reportedly reduced the number of mild Alzheimers cases that progressed to being severe cases in a phase IIb/III trial this month.

Alzheimers isnt the only field to suffer from inadequate animal models. Other notable disease areas that lack translatable animal models include infectious diseases, bacterial sepsis, psychiatric disorders and immunological disorders.

Alexandra Bause points out that the problem with animal studies is not only due to an incomplete understanding of the underlying mechanisms of disease, but also to the fact that there are intrinsic problems with the way animals are tested. Most companies or most research programs are looking at young animals, and theyre artificially making these young animals sick. Then they are giving them the drug to target whatever made them sick, and they recover. But that doesnt mean that an old animal can recover equally.

Other factors that limit the predictive power of animal models are assumptions that animals and humans use the same or highly similar cellular pathways in response to specific diseases, as well as gender-biases and the use of germ-free animals that dont reflect the potential impact of our microbiome on health and disease.

For the next decade, the biotech industry will have to face the challenge of improving animal models or even replacing them with alternatives such as organs on chips or tissue bioprinting.

In the last decade, the study of the microbiome has gained a lot of attention. The human microbiome, which comprises the collection of microorganisms that live in and on our bodies has been linked to almost every disease imaginable. There are currently more than 1,000 clinical trials listed worldwide testing microbiome-related therapies.

This created huge expectations that are taking longer than expected to pan out. Technological advances have resulted in the generation of mountains of data that is often extremely complex and difficult to interpret. We still dont really understand the dynamic complexity of the microbiome or how to manipulate it for therapeutic benefit.

I think theres a long way to go, said Bonde. Im not sure were ever going to fully understand it.

We aggressively looked at a number of microbiome companies and its fascinating but chaotic. We know what we can do with lactobacilli, but what do we do with everything else? You can change one factor, but what does it do to the other billion or trillion entities that constitute the microbiome? said Bailey.

Overall, the biotech industry in Europe has matured over the last decade and strengthened its position in the global market. If the biotech market in Europe was born around 25 years ago, then by now we have learned from the best during our childhood as well as our adolescent years. Today, as an industry, we are now young adults in our prime, ready to forge our own paths, said Antoine Papiernik, Managing Partner at the French life sciences investment firm Sofinnova Partners.

During this pandemic, Europe has demonstrated its strength, resilience, and scientific prowess, he added. Europe has strong scientific and technological output, it has cultivated talent and built highly experienced management teams, and more than ever before, we are capable of funding young biotechs and medtech to success.

The last decade has brought incredible levels of progress to the biotech industry, while also opening up new challenges to tackle in the coming years. Stay tuned for part two next week, where well look in more detail into what the next decade has in store.

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A Look Back at the Past Decade of European... - Labiotech.eu

Even in the midst of the COVID-19 pandemic, the medical community made advances throughout 2020. Here are 5 of the years most impactful innovations.

Overall, 2020 has been a tumultuous year. From a health perspective, its been one turned upside down with a deadly global pandemic reorienting how we live our lives and relate to others.

The COVID-19 pandemic has justifiably dominated headlines and attention from media, policymakers, and health officials alike.

While its clearly the defining public health, cultural, economic even political event of the year, the pandemic shouldnt obscure the fact that 2020 was also a time of great medical innovation.

From breakthroughs in oncology, gene therapies, and heart health, to the development of COVID-19 vaccines that are now being administered domestically and around the world, theres a lot that the medical community can be proud of in 2020.

Healthline touched base with leading experts about some of the most impactful medical advances of the year and how they hint at a more hopeful tomorrow.

Almost every expert Healthline interviewed agreed that gene editing was one of the big stories of the year.

In October, Emmanuelle Charpentier and Jennifer A. Doudna were awarded the Nobel Prize in Chemistry for discovering the CRISPR/Cas9 genetic scissors. (Just five other women have won this prize before).

This gene scissor tool is what it sounds like enzymes snip out pieces of DNA to restore them to their normal function, Dr. William Morris, executive medical director of Cleveland Clinic Innovations, told Healthline.

Charpentier and Doudna showed that these genetic tools could be controlled to cut any kind of DNA molecule at a designated location not just distinguish DNA from viruses, as these scissors exist in their natural form.

Essentially, it means we can rewrite the code of life, according to the Nobel Prizes official announcement.

Morris said that this innovation has wide-ranging ramifications for people who have a wide range of genetic conditions.

He cited sickle cell disease, a condition where malformed sickle-shaped red blood cells cause blockages in blood flow, preventing the protein hemoglobin from effectively ferrying needed oxygen through the body.

Morris said these microscopic tools can cut out these genetic errors.

There have only been a handful of drugs to treat these kinds of conditions in the past.

Now, this kind of development allows you to remove the error and replace the [genetic] code, kind of like in your computer or your iPhone if you downloaded a patch for new software to repair an app that always crashes thats what this is, Morris explained.

Its so earth-shatteringly amazing to tell these patients who otherwise faced an entire lifetime of pain and suffering. You can now use the word cure, which is unbelievable to think about, he said.

Olivier Elemento, PhD, director of the Englander Institute for Precision Medicine at Weill Cornell Medicine in New York City, told Healthline that 2020 is the year of the genetic code.

Were really able to use the genetic code in humans and viruses to help humanity in ways we were not equipped to before, in ways we couldnt do before, Elemento said.

He added that gene therapy in general, along with this CRISPR technology, is pretty extraordinary.

This more comprehensive understanding of genetics extends beyond the Nobel Prize.

For instance, Elemento said Weill Cornell Medicine, where he currently works, along with New York-Presbyterian Hospital and Illumina Inc. recently announced an initiative to sequence the genome of thousands of patients.

The more we understand about genetics and gene therapies, the more improved our precision medicine capacity will be opening up the possibilities of creating targeted therapies for all kinds of conditions.

Recently, the American Heart Association released its own list of innovations in medical treatments.

The spotlight includes a new phase 3 study that could change the way hypertrophic cardiomyopathy (when the heart muscle thickens and can stiffen) is treated.

It also highlights new treatments that might change up the first-line treatment for atrial fibrillation (AFib) a new minimally invasive surgery to prevent stroke and a new trial that reveals more treatment might not necessarily mean better treatment for coronary heart disease.

American Heart Association President Dr. Mitchell S.V. Elkind, MS, FAAN, FAHA, wrote in an email to Healthline that all of these advances over the past year reflect connections between seemingly disparate areas of medicine and the fact that we are most successful when we break down the barriers between fields.

In order to tackle an issue as wide ranging as heart disease, for instance, it takes an interdisciplinary, comprehensive approach.

For example, we learned more this year about the unexpected ways in which medicines designed to treat diabetes, the sodium glucose transporter 2 inhibitors, or SGLT2 inhibitors, help patients with heart failure, even those without diabetes, he added.

Elkind also cited our growing understanding of how connections between infectious diseases like the flu and COVID-19 are tied to greater risk for heart disease and stroke.

Often, the most important advances occur when experts from different areas work together in creative ways to solve a difficult problem, he wrote.

When asked if there was one particular heart health innovation that stood out the most to him, Elkind said that what resonated with him was something not tied to fancy medications or groundbreaking research.

An analysis of people from across the U.S. showed that rates of blood pressure control have begun to decline in the U.S., after almost two decades of better control. High blood pressure is one of the most important and easily treated risk factors for stroke and heart disease, and so this backsliding is especially alarming, he added.

He stressed that the study also pointed to the impact that having health insurance has on controlling ones blood pressure.

Those with some form of health insurance had blood pressure control rates of 4354 percent, while for those without insurance, it was only 24 percent, Elkind explained.

Improving access to quality care is one of the best ways we have to improve health, and that is where we at the American Heart Association will be placing our efforts in the coming years, he said.

Benjamin Neel, MD, PhD, director of the Perlmutter Cancer Center at NYU Langone Health, said 2020 has been a year thats seen cancer research push forward on multiple fronts.

He said technologies are in development for early detection of cancer by way of blood tests.

Its been known for quite some time that tumors release DNA into the blood stream, we have technology developing from the standpoint of monitoring tumors, conducting sensitive tests for tumors, for tests for recurrence of cancers and protein-based tests, Neel told Healthline, outlining current research.

He also cited technology that modulates the regulatory DNA sequence patterns which refers to the part of the DNA molecule that can change the way a gene expresses itself in a living thing to pinpoint when methylation patterns might point to the development of cancer.

Among other research highlights over the past year, Neel said researchers have been developing new ways of drugging genetic mutations.

He mentioned work being done in developing a compound to degrade the androgen receptor for prostate cancer cells what allows these cancer cells to grow.

One of the biggest changes this year came in the form of how our new normal work-from-home lifestyle has impacted medicine.

As more and more people stay away from offices and public spaces, theyre turning to telemedicine. The Zoom screen is the new doctors office.

Morris said that, while this isnt a medical discovery per se, its a crucial in some ways life-saving development for how we relate to healthcare in our lives.

Out of this whole pandemic, one of the things weve discovered as clinicians is that we need to see patients where they are and not force them to cross state lines, Morris said. While we had telemedicine, we had some patients over Skype and video visits, there were clear disincentives and policies in place against people easily crossing state lines to seek medical care, of receiving care remotely.

He said the pandemic facilitated a push at the government level and with state and federal regulators to reduce barriers to these tools that are critical lifelines for patients.

Even when healthcare professionals couldnt always see patients in person this year, the embrace of telemedicine has resulted in unprecedented increases in the adoption and use of these tools and seeking care, Morris added.

This pandemic has challenged us to question old perceptions and policies, so that was a very positive thing, he stressed.

Innovation doesnt necessarily have to be an aha moment in a lab or something right in front of us, he said. Its unfortunate we needed a pandemic or a challenge to sometimes see a barrier, and sometimes that barrier is us.

This year, a possible breakthrough in Alzheimers disease research and treatment came in the form of a blood test that can diagnose this progressive form of dementia.

While the news is huge, the test is still in the trial phase.

If ultimately approved, a simple test for the condition would be a game changer.

There are as many as 5 million people living with Alzheimers in the United States, a number that will likely triple by 2060, according to the Centers for Disease Control and Prevention (CDC).

While this test has yet to go through all the proper approvals, a company distributed the first publicly available Alzheimers blood test this fall.

As 2020 comes to a close, experts are looking to a more hopeful new year.

For its part, Cleveland Clinic, which enters its centennial next year, released a list of the predicted top 10 innovations of 2021.

Morris said that while many think of this year as fraught and divisive full of tragedy and setbacks looking back at these innovations shows theres always something to be grateful for and look forward to.

Elemento said that he expects a biotech and pharma boom in the next few years.

Citing the breakthroughs in gene therapies and genetic manipulation indicate what will be a continual embrace of this kind of medical technology.

All these technologies, now everyone knows they exist and that they can be used for good, it will be a big boom for these technologies, Elemento added.

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5 Medical Innovations You Probably Didn't Notice Happened in 2020 - Healthline