Why Do Some People Get Sick All the Time, While Others Stay in Freakishly Good Health? – Discover Magazine

This originally appeared in the July/August issue ofDiscovermagazine as "Titans of Immunity." Support our science journalism by becoming asubscriber.

For years, Melanie Mussons friends have marveled at her superpower: staying healthy no matter what germs are making the rounds. Colds and flu felled plenty of Mussons dormmates in college, but the viruses always seemed to pass her by. I never got sick once, she says. I got about five hours of sleep a night, I finished school in three years, and I worked 30 hours a week throughout. My best friends labeled me the machine.

Mussons ironclad immune system also set her apart at her first job. While she was working at an assisted living facility, her co-workers succumbed to a stomach virus that was running rampant. Undaunted, Musson offered to cover their shifts. There I was, the brand-new employee, getting as much overtime as I wanted. I wasnt worried that Id catch [the virus], because it just doesnt happen.

While the rest of us battle seasonal flu, chronic allergies and back-to-back wintertime colds, Musson and other immune masters glide through with scarcely a sniffle something University of Pittsburgh immunologist John Mellors sees all the time. People get exposed to the same virus, the same dose, even the same source. One gets very sick, and the other doesnt.

Its only natural to wonder: Why do some people always seem to fall on the right side of this equation? And could our own immune systems approach the same level with the right tuneup?

Doctors have noted natural variations in the immune response among people since Hippocrates time, but the reasons remained elusive for centuries. New research, however, is starting to illustrate just how your genes, habits and past disease exposures affect the character and strength of your immune response. These discoveries are helping to define the parameters of a race in which people like Musson have a head start and others have much more ground to cover.

The moment a virus, bacterium or other invader breaches your cells walls, your body rolls out a tightly choreographed defense strategy. The main architects of this process are a set of human leukocyte antigen (HLA) genes, which code for molecules that fine-tune the bodys immune response. So when a bacterium gets into one of your cells, your HLA genes churn out proteins that flag the cell as infected so that specialized immune cells will swarm in to destroy it. Other HLA genes activate cells that rein in the immune response, so it doesnt destroy more than necessary.

Like fingerprints, everyones HLA gene assortment is unique. Your HLA genes give you a broad repertoire of immune defense tactics, but that repertoire may be great for some microorganisms and lousy for others, Mellors says. Its not like theres one HLA type thats highly immune to everything. This genetic variation helps explain why you might catch every cold virus going around but havent gotten a stomach bug in decades. A Massachusetts General Hospital study found that some so-called HIV controllers immune stalwarts who dont develop AIDS from the virus HIV have HLA gene variants that prompt specialized cells to swarm in and attack proteins key to the virus function.

But your HLA genes arent the only ones that shape your immune resistance. The Human Genome Project has identified tens of thousands of gene variants that are more common in people who develop specific diseases and less common in people without these conditions.

Flagging these kinds of gene-disease links is a relatively simple matter, says immunologist Pandurangan Vijayanand of the La Jolla Institute for Immunology. After researchers identify a gene sequence thats linked to disease, however, they need to figure out what it is actually doing, says Vijayanand. How is this change in the sequence impacting the cell or causing the susceptibility [to disease]?

To answer this question, Vijayanand and his team are creating what they call an atlas, to catalog which proteins each gene produces and how these proteins change the function of different cell types. For example, he has identified a gene variant that makes people more prone to asthma a condition in which the body attacks its own healthy airway cells by driving high production of proteins that rev up the immune response. Other gene variants appear to help people fight lung tumors by prompting their tissues to produce more T lymphocytes, specialized immune shock troops that kill cancer cells.

While a dizzying number of genetic differences remain to be cataloged, immunologists agree that, in general, these differences help explain why resistance to some pathogens can seem to run in families. People like Melanie Musson probably get a genetic leg up to some degree Musson says her mother, father and siblings rarely get sick. Conversely (and unfairly), you might instead inherit a tendency to develop diabetes, recurrent strep infections or autoimmune diseases.

However anemic or hardy your innate immune arsenal, it supplies only the broad contours of your bodys resistance to threats. Environmental influences fill in the details, from where you live to your sleeping patterns to your history of previous infections.

In a 2015 Cell study, researchers studied more than 100 pairs of identical twins and how their immune systems responded to the flu shot. About three-quarters of the differences they saw were driven by environmental factors rather than genetic ones. The differences in twins immune systems also grew more pronounced the older they got, suggesting that outside influences continue to shape our immune potential over time.

Some of these influences show up in early childhood and may be hard to offset later on. Researchers have long known that children who live on farms are less likely to develop autoimmune diseases like asthma and allergies. An Ohio State University study from July 2019 hints at one reason why: Farm kids have a more diverse array of gut microbes than city kids, and the presence of some of these gut microbes predicts lower frequencies of immune cells that create allergic inflammation. Broad microbial exposure, in short, appears to train the immune system not to overreact to substances like animal dander.

But regardless of where you grew up, if youre unlucky enough to catch certain disease-causing bugs, they can throw your immunity off balance for years. Cytomegalovirus, a relative of the virus that causes chicken pox, stages its attack by reprogramming the human immune system. Some of the virus proteins latch onto certain immune cells, interfering with their ability to fight invaders. Other proteins, according to research from the University Medical Center Utrecht, interfere with the expression of key human HLA genes. And since cytomegalovirus infections are chronic, the resulting immune deficits can go on indefinitely.

Naturally, you cant control where youre raised or what random pathogens you acquire. But you can control your daily routine, what you put into your body and how you shield yourself against germs. In recent years, scientists have begun a full-fledged push to find out which lifestyle habits actually foster a robust immune system and which may be more hype than substance.

While the overall picture of how diet shapes immunity is still blurred, new studies do hint at the immune-strengthening effects of certain types of foods. Garlic, for instance, contains a sulfur compound called allicin, which spurs production of disease-fighting immune cells like macrophages and lymphocytes in response to threats.

(Credit: Lucky_Find/Shutterstock)

Researchers also report that specific bacteria-containing foods such as sauerkraut, kimchi and kefir produce an immunologically active substance called D-phenyllactic acid. This acid appears to signal immune cells, called monocytes, to report for duty by binding to a receptor protein on the cells surfaces. When people eat sauerkraut, very soon afterward, we see in the blood that theres an increase in the level of this substance, says Leipzig University biologist Claudia Stubert. In future studies, she hopes to clarify exactly how the acid affects monocytes activity in the body.

In addition to tweaking their diets, many titans of immunity embark on intense exercise regimens to keep their health robust. I swim and snorkel year-round in the ocean, up to a mile at a clip, from New England to Miami and a few secluded points in between, says Baron Christopher Hanson, a business consultant who claims he almost never gets sick. But so far, scientific proof that exercise improves immunity is limited. While a new study in rats shows that regular exercise changes the prevalence of different types of immune cells, it isnt clear whether these changes make you less likely to get sick.

Getting your daily quota of shut-eye, however, does seem to boost your immunity. Repeated studies show that sleep revs up your immune response, and a recent one from Germanys University of Tbingen reports that it does so in part by preparing disease-fighting T cells to do their jobs more effectively. Thats because your body churns out more integrins proteins that help T cells attach to germ-infected cells and destroy them while youre asleep.

But while getting more sleep could help snap your streak of winter colds, squirting your palms with hand sanitizer may not. In numerous studies, plain old soap and water was shown to kill germs better than sanitizer does. Hand sanitizer is great for alcohol-susceptible bugs, but not all bugs are susceptible, Mellors points out. Whats more, using sanitizer wont have any lasting effects on your immunity. The moment you touch another germy surface, your thin layer of protection will vanish.

Getting plenty of sleep is one way to boost your immune health: The body preps disease-fighting cells while youre asleep. (Credit: Realstock/Shutterstock)

Champions of immunity tend to credit their daily habits with keeping them healthy. But many have also lucked into an ideal balance between effector T cells, the frontline immune soldiers that fend off pathogens, and regulatory T cells, which keep the bodys immune arsenal in check so it wont over-respond to threats. An overactive immune system can be just as troublesome as an underactive one autoimmune conditions like rheumatoid arthritis, multiple sclerosis and allergies all stem from an immune response thats too forceful and sustained.

Last year, scientists at Kyoto University in Japan and elsewhere described one potential way to redress this kind of imbalance: turning effector T cells into regulatory T cells in the lab. Autoimmune episodes are triggered by antigens binding to [a] receptor on effector T cells, says molecular biologist Shuh Narumiya, one of the papers authors. When Narumiya and his colleagues used an inhibitor chemical to block an enzyme that controls cell development, cells that would normally develop into effector T cells turned into regulatory T cells instead a tweak that dialed down harmful autoimmune responses in mice.

While not everyone needs such immune fine-tuning, some people could potentially benefit from a treatment based on this technique, Narumiya says. Filling out the ranks of regulatory T cells could someday help keep a range of disabling autoimmune conditions under control.

Regardless of your T cell balance or your immune track record, theres a hefty dose of serendipity involved each time your immune system faces a threat. You might consider yourself forever prone to the flu or sniffles, but an X-factor a cross-country move, a dietary tweak, a new therapy can unexpectedly realign things and boost your immune potential.

By the same token, no matter how stalwart your HLA gene arsenal, how sound your sleep or how scrupulous your hygiene, you can end up knocked flat with a nasty bug when you least expect it. Immune health is like a gigantic roulette wheel. You throw the ball down and where it lands is a matter of chance, Mellors says. You have an encounter with a pathogen, and at the time you get exposed, your front line is not up to snuff. Even titans of immunity can have Achilles heels and even immune systems that seem licked at the beginning can pull off unlikely victories.

(Credit: Andrii Vodolazhskyi/Shutterstock)

Its a recurring theme of the COVID-19 crisis: Those infected with the virus develop vastly different symptoms. Some barely feel anything a scratchy throat, if that while others spend weeks in the ICU with ravaged lungs, unable to breathe on their own. This wide variation in how people respond to SARS-CoV-2 stems, in part, from each persons unique genetic and lifestyle factors that affect their immune function.

Genes: Scientists in Sydney and Hong Kong have found a particular gene variant tied to high rates of severe symptoms of SARS, a coronavirus related to the one that causes COVID-19. Because the novel coronavirus only recently appeared in humans, we dont know exactly which genetic quirks might make us more susceptible to it. Scientists are now investigating whether other specific genes might give some people higher or lower degrees of protection against the virus.

Age and Immune Health: In some older people, or in those who have underlying immune deficits from chronic conditions, regulatory T cells which usually keep immune responses under control do not function normally. When these people get COVID-19, so-called cytokine storms may cause excessive inflammation in the lungs, leading to life-threatening symptoms. A study conducted by researchers in China found that COVID-19 patients with severe illness had lower levels of regulatory T cells in their bloodstream. Children may be less prone to disabling symptoms because their immune systems are better regulated and they have fewer underlying conditions.

Smoking Habits: SARS-CoV-2 uses a cell surface receptor called ACE2 to enter the cells that line your respiratory tract. New research shows that in smokers, these receptors are more prevalent in the lungs, creating more potential access routes for the virus. If you smoke, says Boston Childrens Hospital immunologist Hani Harb, the virus will be able to enter more cells in higher numbers.

Elizabeth Svoboda is a science writer in San Jose, California. Her most recent book is The Life Heroic: How To Unleash Your Most Amazing Self.

Originally posted here:
Why Do Some People Get Sick All the Time, While Others Stay in Freakishly Good Health? - Discover Magazine

Stem Cell Therapy Market Growth Trends, Key Players, Competitive Strategies and Forecasts to 2026 – Jewish Life News

Stem Cell Therapy Market Overview

The Stem Cell Therapy market report presents a detailed evaluation of the market. The report focuses on providing a holistic overview with a forecast period of the report extending from 2018 to 2026. The Stem Cell Therapy market report includes analysis in terms of both quantitative and qualitative data, taking into factors such as Product pricing, Product penetration, Country GDP, movement of parent market & child markets, End application industries, etc. The report is defined by bifurcating various parts of the market into segments which provide an understanding of different aspects of the market.

The overall report is divided into the following primary sections: segments, market outlook, competitive landscape and company profiles. The segments cover various aspects of the market, from the trends that are affecting the market to major market players, in turn providing a well-rounded assessment of the market. In terms of the market outlook section, the report provides a study of the major market dynamics that are playing a substantial role in the market. The market outlook section is further categorized into sections; drivers, restraints, opportunities and challenges. The drivers and restraints cover the internal factors of the market whereas opportunities and challenges are the external factors that are affecting the market. The market outlook section also comprises Porters Five Forces analysis (which explains buyers bargaining power, suppliers bargaining power, threat of new entrants, threat of substitutes, and degree of competition in the Stem Cell Therapy) in addition to the market dynamics.

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Leading Stem Cell Therapy manufacturers/companies operating at both regional and global levels:

Stem Cell Therapy Market Scope Of The Report

This report offers past, present as well as future analysis and estimates for the Stem Cell Therapy market. The market estimates that are provided in the report are calculated through an exhaustive research methodology. The research methodology that is adopted involves multiple channels of research, chiefly primary interviews, secondary research and subject matter expert advice. The market estimates are calculated on the basis of the degree of impact of the current market dynamics along with various economic, social and political factors on the Stem Cell Therapy market. Both positive as well as negative changes to the market are taken into consideration for the market estimates.

Stem Cell Therapy Market Competitive Landscape & Company Profiles

The competitive landscape and company profile chapters of the market report are dedicated to the major players in the Stem Cell Therapy market. An evaluation of these market players through their product benchmarking, key developments and financial statements sheds a light into the overall market evaluation. The company profile section also includes a SWOT analysis (top three companies) of these players. In addition, the companies that are provided in this section can be customized according to the clients requirements.

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Stem Cell Therapy Market Research Methodology

The research methodology adopted for the analysis of the market involves the consolidation of various research considerations such as subject matter expert advice, primary and secondary research. Primary research involves the extraction of information through various aspects such as numerous telephonic interviews, industry experts, questionnaires and in some cases face-to-face interactions. Primary interviews are usually carried out on a continuous basis with industry experts in order to acquire a topical understanding of the market as well as to be able to substantiate the existing analysis of the data.

Subject matter expertise involves the validation of the key research findings that were attained from primary and secondary research. The subject matter experts that are consulted have extensive experience in the market research industry and the specific requirements of the clients are reviewed by the experts to check for completion of the market study. Secondary research used for the Stem Cell Therapy market report includes sources such as press releases, company annual reports, and research papers that are related to the industry. Other sources can include government websites, industry magazines and associations for gathering more meticulous data. These multiple channels of research help to find as well as substantiate research findings.

Table of Content

1 Introduction of Stem Cell Therapy Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology of Verified Market Research

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Stem Cell Therapy Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Stem Cell Therapy Market, By Deployment Model

5.1 Overview

6 Stem Cell Therapy Market, By Solution

6.1 Overview

7 Stem Cell Therapy Market, By Vertical

7.1 Overview

8 Stem Cell Therapy Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Stem Cell Therapy Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

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Stem Cell Therapy Market Growth Trends, Key Players, Competitive Strategies and Forecasts to 2026 - Jewish Life News

Bit Bios enter button for the keyboard to the software of life nabs the company $41.5 million – TechCrunch

Bit Bio, the new startup which pitches itself as the enter button for the keyboard to the software of life only needed three weeks to raise its latest $41.5 million round of funding.

Originally known as Elpis Biotechnology and named for the Greek goddess of hope, the Cambridge, England-based company was founded by Mark Kotter in 2016 to commercialize technology that can reduce the cost and increase the production capacity for human cell lines. These cells can be used in targeted gene therapies and as a method to accelerate drug discovery at pharmaceutical companies.

The companys goal is to be able to reproduce every human cell type.

Were just at a very crucial time in biology and medicine and the bottleneck that has become really clear is a scalable source of robust human cells, said Kotter. For drug discovery this is important. When you look at failure rates in clinical trials theyre at an all time high thats in direct contradiction to the massive advancements in biotechnology in research and the field.

In the seventeen years since scientists completely mapped the human genome, and eight years since scientists began using the gene editing technology known as CRISPR to edit genetic material, theres been an explosion of treatments based on individual patients genetic material and new drugs developed to more precisely target the mechanisms that pathogens use to spread through organisms.

These treatments and the small molecule drugs being created to stop the spread of pathogens or reduce the effects of disease require significant testing before coming to market and Bit Bios founder thinks his company can both reduce the time to market and offer new treatments for patients.

Its a thesis that had investors like the famous serial biotech entrepreneur, Richard Klausner, who served as the former director of the National Cancer Institute and founder of revolutionary biotech companies like Lyell Immunopharma, Juno, and Grail, leaping at the chance to invest in Bit Bios business, according to Kotter.

Joining Klausner are the famous biotech investment firms Foresite Capital, Blueyard Capital and Arch Venture Partners.

Bit Bio is based on beautiful science. The companys technology has the potential to bring the long-awaited precision and reliability of engineering to the application of stem cells, said Klausner in a statement. Bit Bios approach represents a paradigm shift in biology that will enable a new generation of cell therapies, improving the lives of millions.

Photo: Andrew Brookes/Getty Images

Kotters own path to develop the technology which lies at the heart of Bit Bios business began a decade ago in a laboratory in Cambridge University. It was there that he began research building on the revolutionary discoveries of Shinya Yamanaka, which enabled scientists to transform human adult cells into embryonic stem cells.

What we did is what Yamanaka did. We turned everything upside down. We want to know how each cell is defined and once we know that we can flip the switch, said Kotter. We find out which transcription factors code for a single cell and we turn it on.

Kotter said the technology is like uploading a new program into the embryonic stem cell.

Although the company is still in its early days, it has managed to attract a few key customers and launch a sister company based on the technology. That company, Meatable, is using the same process to make lab-grown pork.

Meatable is the earliest claimant to a commercially viable, patented process for manufacturing meat cells without the need to kill an animal as a prerequisite for cell differentiation and growth.

Other companies have relied on fetal bovine serum or Chinese hamster ovaries to stimulate cell division and production, but Meatablesays it has developed a processwhere it can sample tissue from an animal, revert that tissue to a pluripotent stem cell, then culture that cell sample into muscle and fat to produce the pork products that palates around the world crave.

We know which DNA sequence is responsible for moving an early-stage cell to a muscle cell, says Meatable chief executive Krijn De Nood.

If that sounds similar to Bit Bio, thats because its the same tech just used to make animal instead of human cells.

Image: PASIEKA/SCIENCE PHOTO LIBRARY/Getty Images

If Meatable is one way to commercialize the cell differentiation technology, Bit Bios partnership with the drug development company Charles River Laboratories is another.

We actually do have a revenue generating business side using human cells for research and drug discovery. We have a partnership with Charles River Laboratories the large preclinical contract research organization, Kotter said. That partnership is where we have given early access to our technology to Charles River They have their own usual business clients who want them to help with their drug discovery. The big bottleneck at the moment is access to human cells.

Drug trials fail because the treatments developed either are toxic or dont work in humans. The difference is that most experiments to prove how effective the treatments are rely on animal testing before making the leap to human trials, Kotter said.

The company is also preparing to develop its own cell therapies, according to Kotter. There, the biggest selling point is the increased precision that Bit Bio can bring to precision medicine, said Kotter. If you look at these cell therapies at the moment you get mixed bags of cells. There are some that work and some that have dangerous side effects. We think we can be precise [and] safety is the biggest thing at this point.

The company claims that it can produce cell lines in less than a week with 100 percent purity, versus the mixed bags from other companies cell cultures.

Our moonshot goal is to develop a platform capable of producing every human cell type. This is possible once we understand the genes governing human cell behaviour, which ultimately form the operating system of life, Kotter said in a statement. This will unlock a new generation of cell and tissue therapies for tackling cancer, neurodegenerative disorders and autoimmune diseases and accelerate the development of effective drugs for a range of conditions. The support of leading deep tech and biotech investors will catalyse this unique convergence of biology and engineering.

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Bit Bios enter button for the keyboard to the software of life nabs the company $41.5 million - TechCrunch

Could pressure for COVID-19 drugs lead the FDA to lower its standards? – The Conversation US

Given the death, suffering, social disruption and economic devastation caused by COVID-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus.

But the Food and Drug Administration, charged with the task of evaluating and deciding whether to approve new drugs and other products, has a problem. The FDAs standards appear to be dropping at a time when rigorous regulatory review and robust oversight are crucial.

For example, on March 28, the FDA granted emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate, despite the drugs having known safety concerns and negligible evidence of efficacy in treating COVID-19.

As a specialist in bioethics and public health, I see troubling signs that suggest the FDAs new program for expediting reviews of potential therapies for COVID-19 is not working as it should. Instead, its regulatory oversight has been weakened. In its place, I see signs of political interference, inappropriate pressure to authorize products for emergency use, and an overwhelming surge of clinical studies that challenges the FDAs capacity to carefully scrutinize them before deciding whether they should proceed.

Even with numerous special approval programs in existence, it typically takes about eight years for new drugs to proceed from initial authorization of clinical trials to FDA approval. Because the process of testing drugs and other potential therapies can be so lengthy, the pandemic poses a challenge to the FDAs usual review and approval processes.

In response to COVID-19, the FDA established the Coronavirus Treatment Acceleration Program (CTAP) to expedite the regulatory review process and help facilitate the speedy development of treatments and preventive measures.

The FDA has redeployed many staff members to serve on CTAP review teams. In public statements about CTAP, the FDA has not disclosed how many staff members serve on these teams. And its not certain if all reassigned staff members have the background and training required to review COVID-19 studies and individual patient requests for expanded access to investigational new drugs. There is little publicly available information concerning how CTAP is staffed, how review teams have been organized, and what kinds of expertise particular teams of reviewers possess.

If FDA employees are being assigned unfamiliar responsibilities, or are reviewing applications for products beyond their expertise, theres a risk those reviews will not be sufficiently thorough.

CTAP is essentially an opaque regulatory initiative. Decisions emerge from CTAP but we dont know who made them, why they were made, or what information was provided to FDA. While some details have been shared, I believe that, in general, CTAP would benefit from greater transparency.

The FDA, claiming to cut red tape, says its now reviewing many clinical study protocols for COVID-19 within 24 hours. But what specific bureaucratic impediments did the FDA eliminate to fast-track the process? That we dont know. In public statements about CTAP, the FDA hasnt identified what bureaucratic impediments it removed. The agency has yet to disclose this important information.

What we do know: The FDA has enabled COVID-19 studies to proceed at a far more rapid pace than trials that are testing interventions for other diseases. By doing so, the FDA needs to respond to scientists, physicians, bioethicists, regulatory specialists and other critics concerned that the FDA is failing to maintain its regulatory standards.

Mounting evidence indicates CTAPs oversight may be inadequate. One example: The FDA has cleared an application for a clinical study to test a stem cell product to see if its safe and if it works. The stem cells, researchers hope, will provide enough immune support to reduce symptoms and hospitals stays for COVID-19. But the study has no control group that can be used to compare the stem cell intervention against a placebo or sham procedure.

Without such a control group, the study will not generate usable data concerning whether or not the administered stem cells are effective.

Because of how little information has been disclosed about CTAPs operation, the inner workings of CTAP seem beyond public scrutiny. No information is available on why some trials were cleared to proceed despite what many researchers would consider glaring shortcomings. This includes poor study design, small sample size, substantial overlap with other studies, or as in case of the stem cell study, a lack of a control group.

That specific problematic trials are being allowed to proceed within a wider climate of disrespect for evidence-based clinical research adds to the concern. Many scientists fear that President Trumps boosterism for drugs he believes prevent or treat COVID-19 has helped to undermine the independence and integrity of FDA decision-making. The FDAs emergency use authorization for hydroxychloroquine sulfate and chloroquine phosphate only heightened the concern. The independence of the FDA is also in question amid efforts to develop safe and effective vaccines for COVID-19.

The agency has indicated that summary statistics about CTAP will be forthcoming. So far, however, the FDA has only disclosed limited information about the programs operations. Meanwhile, the number of trials allowed to proceed and need for oversight has grown.

When the creation of CTAP was announced on March 31, the FDA said clinical trials had begun for 10 therapeutic agents to treat COVID-19, with 15 more in planning stages. The FDA now reports that by mid-April, it had received 950 inquiries and proposals concerning COVID-19 related drug development. By May 11, 144 active trials of therapeutic agents were in progress, or cleared to proceed. Another 457 development programs for therapeutic agents were in planning stages.

It is good to have such information in the public domain. However, I believe the public deserves to know much more about how CTAP is functioning. Along with providing regular updates on the number of COVID-19 applications it has received, and the number cleared to proceed, the FDA needs to report the number of proposed studies it has declined to review; the number of times the FDA has not cleared studies to proceed and has instead imposed holds due to safety issues; and the duration between when investigational new drug applications were submitted and when the studies were allowed to proceed or placed on hold.

Most importantly, the public needs to know more about how decisions are being made within CTAP. Public understanding of CTAP would increase if the FDA identified the clinical studies it reviews and clears, and provided links to listings on ClinicalTrials.gov.

The FDAs commissioner has defended the agencys practices during the pandemic, including the use of less robust datasets. But the FDAs review process needs to result in the development of safe and effective COVID-19 treatments. Speed of product development, while crucial in a pandemic, must never be prioritized over all other considerations. Political pressure cannot influence regulatory decision-making; the agency must release more information about CTAPs review standards and decision-making processes. First and foremost, the FDAs rigorous oversight rather than a race to satisfy an aggressive and perhaps political agenda is imperative during this pandemic.

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Could pressure for COVID-19 drugs lead the FDA to lower its standards? - The Conversation US

Vancouver Island father dies of leukemia after battle to find mixed-race stem cell donor – Lake Country Calendar

A Saanich father who fought to grow the data bank of mixed-race stem cell donors has died of leukemia.

Jeremy Chow was diagnosed with acute myeloid leukemia in November 2018. While chemotherapy treatment worked and Jeremy entered remission, doctors advised that stem cell therapy would be the best possible treatment to eradicate the risk of returning cancer cells.

But when Jeremy and his wife Evelyn Chow began their quest to find a match, they learned there were virtually no donors in the national or worldwide registry who matched Jeremys genetic makeup a requirement for a successful stem cell transplant.

READ ALSO: In a fight against cancer, Victoria mans only stem cell match was his own donation

Ironically, Jeremy had applied to become a stem cell donor years earlier. When doctors searched the database they found one unusable match: his own donation. Shocked and saddened by the lack of options, the family spearheaded the Match4Jeremy campaign, organizing stem cell drives and raising awareness of the dire need for mixed race and Asian donors.

On Aug. 8, 2019, the family learned that Jeremys cancer had returned. But the Chows battle to find a match didnt slow down. They worked with the Otherhalf-Chinese Stem Cell Initiative to host an emergency stem cell drive in Vancouver that month.

Despite their tireless efforts, Jeremy did not recover from the second round of cancer. The father of two died on May 30 with his wife at his side.

On a GoFundMe page aimed at raising money for his daughters educations, family friend Jenny Leung says Jeremy fought hard and did it with grace, humour and a positive attitude.

READ ALSO: Stem cell donor with rare genetic makeup needed to save Saanich man after cancer returns

Jeremys priority was always being able to provide and take care of his family, Leung writes. He was so involved with his girls lives, from driving them to their extracurricular activities to attending school fairs, to braiding their hair and explaining to them the importance of a good education.

He was always looking for a way to care for those around him whether it meant sharing knowledge, offering a helping hand, or just being there in any way he could, she added. Jeremy was truly someone to look up to and although he was always supporting others, he rarely asked for anything in return.

While the Chow family fought for a match for Jeremy, their crusade for stem cell donors gained momentum when they realized just how dire the situation was for mixed-race and Asian Canadians. Only three per cent of the Canadian Blood Services stem cell registry is mixed race.

In March 2019, Jeremy spoke with Black Press Media.

If all of this goes well [and] I stay in remission, and the awareness is out there and other people sign up to be donors and other people are getting the help they need, then thats a win, he said.

Donations are being accepted via GoFundMe to support Jeremys family and his daughters future education.

READ ALSO: Victoria couple continues fight for increased diversity in Canadian stem cell registry

Do you have something to add to this story, or something else we should report on? Email:nina.grossman@blackpress.ca

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Vancouver Island father dies of leukemia after battle to find mixed-race stem cell donor - Lake Country Calendar

Royalty Pharma Acquires Partial Royalty Interest on Prevymis From AiCuris Anti-Infective Cures GmbH – Citybizlist Real Estate

NEW YORK and WUPPERTAL, Germany, (GLOBE NEWSWIRE) -- Royalty Pharma and AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious diseases, announced today that they have entered into an agreement whereby Royalty Pharma has acquired a partial royalty interest on Prevymis (letermovir) from AiCuris for a one-time payment of $220 million. Prevymis is licensed by MSD, the tradename of Merck & Co. Inc., Kenilworth, NJ, USA.

The product was approved by the US Food & Drug Administration (FDA) in 2017 and by the European Medicines Agency (EMA) and Japans Pharmaceuticals and Medical Devices Agency (PMDA) in 2018 for prophylaxis (prevention) of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) who are at high risk for CMV reactivation. CMV infection is a complication in these patients, and early CMV reactivation after transplant is associated with increased mortality.

The agreement with Royalty Pharma reflects the major medical need for innovative anti-infective drugs and their commercial potential, and enables us to further advance our proprietary pipeline of novel treatments against infectious diseases without losing the possibility to participate on future revenues from Prevymis, said Dr. Holger Zimmermann, CEO of AiCuris Anti-infective Cures GmbH.

We are excited to add a royalty interest in this important therapy to our portfolio, said Pablo Legorreta, Founder and CEO of Royalty Pharma.

About Royalty PharmaFounded in 1996, Royalty Pharma is the industry leader in acquiring pharmaceutical royalties. Royalty Pharma funds innovation in life sciences both directly and indirectly: directly when it partners with life sciences companies to co-develop and co-fund products in late-stage clinical trials, and indirectly when it acquires existing royalty interests from the original innovators (academic institutions, research hospitals, foundations and inventors). The companys portfolio includes royalty interests in over 45 products including AbbVie and J&Js Imbruvica, Astellas and Pfizers Xtandi, Biogens Tysabri, Gileads HIV franchise, Mercks Januvia, Novartis Promacta, and Vertexs Kalydeco, Symdeko and Trikafta. Royalty Pharma is also a leading investor in pre-approval royalties, having since 2011 invested over $5.6 billion in royalties on pre-approval products and committed over $1.2 billion to direct R&D funding in exchange for royalties. For more information, visitwww.royaltypharma.com

About AiCuris Anti-infective Cures GmbH

AiCuris was founded in 2006 as a spin-off from Bayer and focuses on the discovery and development of drugs targeting infectious diseases. SANTO Holding is the Companys majority investor. PREVYMIS (Letermovir), a first-in-class non-nucleoside cytomegalovirus (CMV) inhibitor acting via a novel mechanism of action, was licensed to MSD in 2012 and is approved in the EU, the USA, Japan and other parts of the world for use in bone marrow transplants for the prevention of HCMV infections in adults who receive an allogeneic hematopoietic stem cell transplant. The Company is developing drugs for the treatment of viruses such as human CMV, herpes simplex virus (HSV), hepatitis B virus (HBV), and adenoviruses. In the field of antibacterials, AiCuris seeks to develop innovative treatment options for life-threatening, multidrug-resistant, hospital-treated pathogens.

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Royalty Pharma Acquires Partial Royalty Interest on Prevymis From AiCuris Anti-Infective Cures GmbH - Citybizlist Real Estate

OncoImmune, Inc. Reports Progress on its Phase III Clinical Trial testing CD24Fc for Severe and Critical COVID-19 – Business Wire

ROCKVILLE, Md.--(BUSINESS WIRE)--OncoImmune, Inc. reached an important milestone in its Phase III clinical trial testing the safety and clinical efficacy of CD24Fc for severe and critical COVID-19 patients (SAC-COVID) on June 9, 2020. The first 70 patients have been randomized and received either CD24Fc or placebo as the treatment for severe COVID-19. After reviewing the safety data, the Institutional Review Board has approved continuing enrollment while interim analysis occurs.

Current therapeutic strategies for COVID-19 include use of anti-viral therapies that block viral replication and non-anti-viral therapeutics that target host responses responsible for the destruction of host organs. Since many hospitalized patients have either largely cleared the SARS-CoV-2 virus or may have developed immunity to it, non-antiviral strategies have emerged as an important approach in treating severe and critical COVID-19 patients.

CD24Fc is a first-in-class biologic that fortifies an innate immune checkpoint against excessive inflammation caused by tissue-injuries. The Phase III trial has been opened at 10 medical centers nationwide and enrolls severe and critical COVID-19 patients that either require supplemental oxygen support, or high flow oxygen non-invasive ventilation. The patients receive a single infusion of CD24Fc or placebo at the beginning of the trial and are followed for up for 28 days thereafter to determine the time to clinical improvement. Because the drug works through a novel mechanism that does not duplicate that of other experimental therapeutics, patients enrolled in other trials need not be excluded. The Phase III trial will enroll a total of 230 patients randomized into blinded CD24Fc or placebo arms, with time to clinical improvement from severe or critical to mild symptoms as the primary endpoint (ClinicalTrials.gov Identifier: NCT04317040).

We have seen neither infusion reactions nor other drug-related adverse events associated with the trial in first 70 patients. The mortality rate so far is 5%, which is considered low among severe and critical COVID-19 patients. The preliminary results show that the safety of the drug is outstanding for this indication, said Dr. Pan Zheng, MD., PhD, Chief Medical Officer of OncoImmune.

About OncoImmune, Inc.

OncoImmune (www.oncoimmune.com) is a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel immunotherapies for cancer, inflammation and autoimmune diseases. OncoImmune is based in Rockville, Maryland.

OncoImmunes lead product, CD24Fc, is a novel therapeutic that regulates host inflammatory response to tissue injuries and which has broad implications in the pathogenesis of cancer, autoimmune disease, metabolic syndrome and graft-versus-host disease (GvHD). CD24Fc has completed a Phase IIa trial for the prophylactic treatment of acute Graft versus Host Disease (aGvHD) in leukemia patients undergoing hematopoietic stem cell transplantation (HSCT) and resulted in a significant improvement in 180 Day Grade III-IV acute GVHD Free Survival, the Phase III primary endpoint. CD24Fc prophylaxis also resulted in reduced relapse and, compared to match controls, CD24Fc demonstrated improvement in Overall Survival, Non-Relapse Mortality and Relapse-Free Survival. A dose-dependent reduction in severe (Grade > 3) mucositis was also observed. A 20 patient open label dose expansion cohort at the recommended clinical dose is fully enrolled and the drug continues to perform very well. In addition to the Phase III COVID-19 trial, a Phase III study for the prevention of aGVHD is being opened nationwide.

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OncoImmune, Inc. Reports Progress on its Phase III Clinical Trial testing CD24Fc for Severe and Critical COVID-19 - Business Wire

T-Cell Lymphoma Treatment Market 2020-2026: Analysis by Growth Factors, Key Trends and Competitive Strategies – Cole of Duty

The research study T-Cell Lymphoma Treatment market 2020 launched by ABRReports.com provides the detailed analysis of the current market status, investment plans, production and consumption, price trends, and analysis by the market player, by region, by type, by application and etc, and custom research can be added according to specific requirements

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The prime objective of this report is to help the user understand the market in terms of its definition, segmentation, market potential, influential trends, and the challenges that the market is facing with 10 major regions and 50 major countries. Deep researches and analysis were done during the preparation of the report. The readers will find this report very helpful in understanding the market in depth.

The key players covered in the T-Cell Lymphoma Treatment Market research report are:By Market Players:BioCryst PharmaceuticalsSpectrum PharmaceuticalsMerckJohnson & JohnsonShionogiNovartisShenzhen ChipScreen Biosciences, Ltd.Genmab ASBristol-Myers SquibbSeattle GeneticsMedivir ABSorrento TherapeuticsAmgenEisai Co., Ltd.

By TypeChemotherapyRadiation TherapySurgical TherapyStem Cell Transplantation TherapyOthers

By ApplicationHospitalsClinicsAmbulatory Surgical CentersOthers

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The data and the information regarding the market are taken from reliable sources such as websites, annual reports of the companies, journals, and others and were checked and validated by the industry experts. The facts and data are represented in the report using diagrams, graphs, pie charts, and other pictorial representations. This enhances the visual representation and also helps in understanding the facts much better.

Key pointers of the Table of Contents:

Chapter 1 Industry OverviewChapter 2 Global T-Cell Lymphoma Treatment Competition by Types, Applications, and Top Regions and CountriesChapter 3 Production Market AnalysisChapter 4 Global T-Cell Lymphoma Treatment Sales, Consumption, Export, Import by Regions (2015-2020)Chapter 5 North America T-Cell Lymphoma Treatment Market AnalysisChapter 6 East Asia T-Cell Lymphoma Treatment Market AnalysisChapter 7 Europe T-Cell Lymphoma Treatment Market AnalysisChapter 8 South Asia T-Cell Lymphoma Treatment Market AnalysisChapter 9 Southeast Asia T-Cell Lymphoma Treatment Market AnalysisChapter 10 Middle East T-Cell Lymphoma Treatment Market AnalysisChapter 11 Africa T-Cell Lymphoma Treatment Market AnalysisChapter 12 Oceania T-Cell Lymphoma Treatment Market AnalysisChapter 13 South America T-Cell Lymphoma Treatment Market AnalysisChapter 14 Company Profiles and Key Figures in T-Cell Lymphoma Treatment BusinessChapter 15 Global T-Cell Lymphoma Treatment Market Forecast (2021-2026)Chapter 16 Conclusions

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T-Cell Lymphoma Treatment Market 2020-2026: Analysis by Growth Factors, Key Trends and Competitive Strategies - Cole of Duty

Stem Cell Therapy Designed To Treat Severely Ill Coronavirus Patients Being Tested In Maryland – msnNOW

Provided by CBS Baltimore

BALTIMORE (WJZ) A stem cell therapy trial for the most critically ill coronavirus patients is underway in Maryland.

Researchers at the University of Maryland School of Medicine are trying to save the maximum number of patients who are significantly sickened by the virus and reduce the mortality rate.

Thanks to a sponsorship by Australian regenerative medicine company Mesoblast, the stem cell therapy trial is underway at several sites across the U.S., including in Maryland.

The therapy involves 300 people hospitalized with COVID-19 with moderate to severe acute respiratory distress syndrome.

These are patients that are intubated, requiring great support for their lung function, Dr. Sunjay Kaushal with the University of Maryland said.

CORONAVIRUS RESOURCES:

COVID-19 patients often become very ill from an escalated immune response referred to as a cytokine storm, which creates high levels of inflammation that can be fatal. The experimental stem cell therapy called remestemcel-L, which has been developed for various inflammatory conditions like what is being seen with the coronavirus, aims to block or mitigate that response, Kaushal said.

Were trying to extrapolate from what they have been shown to be efficacious in trying to treat before and trying to use that type of therapy now for COVID-19 patients, he said.

Once the final results from the trial are available, which could take between six and eight months, researchers hope to reach even more patients.

Were excited, weve seen some early signs that these cells may be efficacious, Kaushal said.

Ultimately, their hope is to provide a new treatment for those suffering from the worst cases of COVID-19.

Were hoping we can save a lot of patients lives, Kaushal said.

For the latest information on coronavirus go to the Maryland Health Departments website or call 211. You can find all of WJZs coverage on coronavirus in Maryland here.

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Stem Cell Therapy Designed To Treat Severely Ill Coronavirus Patients Being Tested In Maryland - msnNOW

Stem Cell Alopecia Treatment Market Growth Trends, Key Players, Competitive Strategies and Forecasts to 2026 – Jewish Life News

Stem Cell Alopecia Treatment Market Overview

The Stem Cell Alopecia Treatment market report presents a detailed evaluation of the market. The report focuses on providing a holistic overview with a forecast period of the report extending from 2018 to 2026. The Stem Cell Alopecia Treatment market report includes analysis in terms of both quantitative and qualitative data, taking into factors such as Product pricing, Product penetration, Country GDP, movement of parent market & child markets, End application industries, etc. The report is defined by bifurcating various parts of the market into segments which provide an understanding of different aspects of the market.

The overall report is divided into the following primary sections: segments, market outlook, competitive landscape and company profiles. The segments cover various aspects of the market, from the trends that are affecting the market to major market players, in turn providing a well-rounded assessment of the market. In terms of the market outlook section, the report provides a study of the major market dynamics that are playing a substantial role in the market. The market outlook section is further categorized into sections; drivers, restraints, opportunities and challenges. The drivers and restraints cover the internal factors of the market whereas opportunities and challenges are the external factors that are affecting the market. The market outlook section also comprises Porters Five Forces analysis (which explains buyers bargaining power, suppliers bargaining power, threat of new entrants, threat of substitutes, and degree of competition in the Stem Cell Alopecia Treatment) in addition to the market dynamics.

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Leading Stem Cell Alopecia Treatment manufacturers/companies operating at both regional and global levels:

Stem Cell Alopecia Treatment Market Scope Of The Report

This report offers past, present as well as future analysis and estimates for the Stem Cell Alopecia Treatment market. The market estimates that are provided in the report are calculated through an exhaustive research methodology. The research methodology that is adopted involves multiple channels of research, chiefly primary interviews, secondary research and subject matter expert advice. The market estimates are calculated on the basis of the degree of impact of the current market dynamics along with various economic, social and political factors on the Stem Cell Alopecia Treatment market. Both positive as well as negative changes to the market are taken into consideration for the market estimates.

Stem Cell Alopecia Treatment Market Competitive Landscape & Company Profiles

The competitive landscape and company profile chapters of the market report are dedicated to the major players in the Stem Cell Alopecia Treatment market. An evaluation of these market players through their product benchmarking, key developments and financial statements sheds a light into the overall market evaluation. The company profile section also includes a SWOT analysis (top three companies) of these players. In addition, the companies that are provided in this section can be customized according to the clients requirements.

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Stem Cell Alopecia Treatment Market Research Methodology

The research methodology adopted for the analysis of the market involves the consolidation of various research considerations such as subject matter expert advice, primary and secondary research. Primary research involves the extraction of information through various aspects such as numerous telephonic interviews, industry experts, questionnaires and in some cases face-to-face interactions. Primary interviews are usually carried out on a continuous basis with industry experts in order to acquire a topical understanding of the market as well as to be able to substantiate the existing analysis of the data.

Subject matter expertise involves the validation of the key research findings that were attained from primary and secondary research. The subject matter experts that are consulted have extensive experience in the market research industry and the specific requirements of the clients are reviewed by the experts to check for completion of the market study. Secondary research used for the Stem Cell Alopecia Treatment market report includes sources such as press releases, company annual reports, and research papers that are related to the industry. Other sources can include government websites, industry magazines and associations for gathering more meticulous data. These multiple channels of research help to find as well as substantiate research findings.

Table of Content

1 Introduction of Stem Cell Alopecia Treatment Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology of Verified Market Research

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Stem Cell Alopecia Treatment Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Stem Cell Alopecia Treatment Market, By Deployment Model

5.1 Overview

6 Stem Cell Alopecia Treatment Market, By Solution

6.1 Overview

7 Stem Cell Alopecia Treatment Market, By Vertical

7.1 Overview

8 Stem Cell Alopecia Treatment Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Stem Cell Alopecia Treatment Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

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Stem Cell Alopecia Treatment Market Growth Trends, Key Players, Competitive Strategies and Forecasts to 2026 - Jewish Life News