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Gene therapy innovations: Sarepta and Codiak partner on exosomes – Pharmaceutical Technology

July 9th, 2020 7:47 pm

Exosomes could be used to improve precision medicine approaches in various disease areas. Credit: Shutterstock.

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Genetic medicine-focused Sarepta Therapeutics has signed a two-year research agreement with Codiak Biosciences in which they will develop engineered exosome-derived therapeutics for neuromuscular diseases with few or no treatment options.

The collaboration will leverage Codiaks exosomeengineering and manufacturing capabilities with Sareptas expertise in precision genetic medicineto develop next generationtherapeutics, states Sarepta spokesperson Tracy Sorrentino.

According to the terms of the agreement, Sarepta has the exclusive option to license five targets of interest that are identified as a result of using Codiaks proprietary exosome-focused engEx platform. In return, Codiak is eligible for up to $72.5m in upfront and near-term license payments, plus research funding.

Exosomes are essential to the intercellular communication system that facilitates the transfer of many molecular payloads between cells. They have a few benefits linked to them being endogenous and inherently nonimmunogenic, as Codiak spokesperson Kate Niazi-Sai explains.

Founded five years ago, Codiaks mission is to make precision exosome therapeutics a reality by solving engineering and manufacturing challenges to enable exosomes to deliver precise therapeutics in a targeted way, notes Niazi-Sai. To this end, the company developed its engEx platform.

Using this platform, Codiak can design exosomes with precisely engineered properties, incorporate various types of biologically active molecules and direct them to specific cell types and tissues, says Niazi-Sai.

Sarepta and Codiak are hopeful that exosomes will help overcome some general issues facing adeno-associated virus (AAV)-based gene therapies. Sorrentino notes: The agreement with Codiak is part of our broader strategy to build an enduring model by exploring non-viral delivery options and next-generation genetic medicines.

Exosomes being a non-viral targeteddelivery approach that is inherently non-immunogenic means they might open up avenues for more targeted deliveryand potential re-dosing, Sorrentino notes. Niazi-Sai agrees with this sentiment.

AAVs have some limitations namely they are one-time therapies with current approaches, adds Sorrentino. They cannot be re-dosed due to the post-administration development of neutralising antibodies (NAbs) where the body identifies the virus as foreign and begins to mount an attack, which can diminish the effectiveness of a gene therapy or cause side effects.

There is a significant need to identify non-viral delivery vehicles for rare disease, specifically in neuromuscular conditions where therapeutic doses are high, explains Niazi-Sai.

To solve this problem, exosomes have a unique tropism compared to other delivery systems, and we can alter the tropism by engineering the exosome surface, with the goal of specifically reaching diseases of the muscle, says Niazi-Sai. Sorrentino explains that tropism is the ability to guide a specific cargo to the cell of interest.

Neuromuscular diseases also make particular sense for this partnership since this is an area of expertise for Sarepta. The company has focused on Duchenne muscular dystrophy (DMD) and other limb-girdle muscular dystrophies (LGMD) for a long time; both of Sareptas approved products Vyondys and Exondys are for DMD.

This research agreement with Codiak represents Sareptas third deal in 2020. One of the other agreements is a research partnership with Selecta Biosciences to leverage its immune tolerance platform in DMD and LGMD, which may allow re-dosing of patients on gene therapy.

The other is a collaboration to develop next-generation AAV vectors for muscle diseases with Dyno Therapeutic, a company that focuses on using artificial intelligence and machine learning to improve gene therapy vectors.

These deals all play into Sareptas broader strategy to collaborate with leaders in their respective fields in an effort to help advance the science, providethe greatest benefit to more patients, improve the utility and benefit of gene-based therapies, and ultimately deliver on our mission to use precision medicine to transform the lives of people with rare diseases, explains Sorrentino.

Sorrentino adds: We recognise helping patients is a team approach, and achieving our mission often means bringing together the science, people and advocates with a shared mission and specific expertise.

In fact, Sarepta has now signed a fourth deal with Hansa Biopharma, a leader in immunomodulatory enzyme technology in rare immunoglobulin G mediated disease, which has developed imlifidase. Under the terms of the agreement, Sarepta will develop and promote imlifidase as a pre-treatment to its gene therapy administration in DMD and LGMD to allow more patients to be eligible for this precision medicine approach.

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Gene therapy innovations: Sarepta and Codiak partner on exosomes - Pharmaceutical Technology

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Search for cure for common parasitic infection focus of $5.5 million NIH grant – Washington University School of Medicine in St. Louis

July 9th, 2020 7:47 pm

Visit the News Hub

Toxoplasma infection affects about 2 billion people globally

Parasitologist L. David Sibley, PhD (standing), the Alan A. and Edith L. Wolff Distinguished Professor of Molecular Microbiology at Washington University School of Medicine in St. Louis, talks with postdoctoral researcher Alex Rozenberg, PhD, (left) and staff scientist Joshua Radke, MD. The three are part of an international effort led by Sibley to find drugs to cure toxoplasmosis, a parasitic disease characterized by vision problems and brain complications.

L. David Sibley, PhD, the Alan A. and Edith L. Wolff Distinguished Professor of Molecular Microbiology at Washington University School of Medicine in St. Louis, has spent decades unraveling the secrets of Toxoplasma gondii, a parasite spread by cats and contaminated water and food. People infected with Toxoplasma can generally control the infection, but the parasite remains in their bodies for life and can reactivate to cause toxoplasmosis, a disease characterized by vision problems and life-threatening complications in the brain.

Sibleys discoveries have put him at the forefront of the field of parasite biology. A few years ago, he was busy fielding interview requests from journalists about his latest high-profile paper when he opened an email from a woman in Heidelberg, Germany.

I would like to ask you, wrote the woman, after explaining that her husband was dying of toxoplasmosis, how far (near?) is the possibility of human therapy based on your work?

To Sibley, the email was a wake-up call.

We always say that we do basic science so that one day there might be an improvement in human health, but we dont always push hard enough to convert our discoveries into benefits for patients, Sibley said. After thinking hard about this issue, my colleagues and I came up with the idea of trying to find chemical compounds that eliminate the chronic stages of the parasite, rather than just control it, like current drug therapies do. We know a lot about the biology of this parasite. My lab has spent 30 years figuring out all the tricks the parasite uses to block the immune system. We have developed sophisticated genetic tools and animal models to monitor infection. All this has led to a pile of high-profile papers, and recognition, but has not really had an impact on people who suffer from this infection. I thought, Why not see if we can identify small molecules that might lead to a curative drug?

That plaintive email eventually led Sibley and colleagues at the California Institute for Biomedical Research (Calibr) in La Jolla, Calif.; the Broad Institute in Cambridge, Mass.; and the International Centre for Genetic Engineering and Biotechnology in New Delhi, India to launch an effort to identify chemical compounds that eliminate the chronic stages of Toxoplasma and have the potential to be developed into drugs to eradicate the infection. As principal investigator, Sibley has received a $5.5 million grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH) to support the research.

Toxoplasma is a parasite that naturally cycles between mice and cats. An infected cat excretes millions of the parasite in its feces in a form known as oocysts, contaminating the soil and water. A mouse gets infected by eating food such as fruit or seeds contaminated with oocysts, and a cat eats the mouse, completing the cycle.

Humans and other animals are accidental participants in this process. Herbivorous animals like cows and sheep can become infected as they graze. People become infected by eating undercooked meat from such animals or unwashed vegetables, or by drinking contaminated water. Some people become infected by failing to wash their hands after cleaning cats litter boxes. Once inside a persons digestive tract, the parasite emerges from the cyst, burrows through the intestinal wall and spreads to the muscle, heart, brain and eyes. There, it develops into a cyst form and remains for the rest of the persons life.

About a quarter of the worlds population is thought to be infected with Toxoplasma. Most people do not have symptoms because a healthy immune system keeps the parasite in check. In people with compromised immune systems, though, the parasites do not stay in their cysts and instead begin to multiply, causing debilitating, sometimes fatal, damage to the brain, eyes and other organs. Women who become infected during pregnancy may pass the infection to their fetuses, resulting in severe birth defects.

Drugs for toxoplasmosis only target the parasite in the active phase, leaving cysts untouched. Since parasites may emerge from the cysts at unpredictable times, people must continue taking the drugs for prolonged periods, sometimes more than a year. Even so, the risk of relapse is high. Supplementing current therapies with a drug that eliminates the cysts not only would speed up treatment, it would cure the infection.

Nobodys ever really looked for drugs that target the latent, cyst phase, Sibley said. You cant just take drugs that work against other microbial infections and repurpose them. Thats been tried and it doesnt work very well. Its hard to kill the cyst form. Thats why they form cysts: to protect themselves when they are in an inhospitable environment. Were going to have to really dig into the biology and thats difficult and takes time. Since the potential monetary payoff will likely be small, big pharma just isnt interested. If potential drugs are going to be found, they will have to be started by academic labs.

The research project is already underway. A group led by Stuart Schreiber, PhD, a chemical biologist at the Broad Institute, screened some 80,000 small molecules for their ability to inhibit parasite growth and identified several promising leads. A group of structural biologists at the International Centre for Genetic Engineering and Biotechnology led by Amit Sharma, PhD, is analyzing how the initial leads interact with their target enzyme. A detailed understanding of the molecular structure will inform efforts to optimize the compounds. Medicinal chemist Arnab Kumar Chatterjee, PhD, leads a group at Calibr that is creating new molecules based on the promising leads but with improved potency, safety, bioavailability and other features. And Sibleys lab at the School of Medicine is responsible for the biological testing, making sure the team stays focused on compounds that actually have the capacity to treat the cyst stage.

The compounds weve started working on may not ultimately lead to a drug that works, Sibley said. There are no guarantees in this kind of work. But I think what we can do is establish a path forward. We can identify appropriate targets, establish the potency, and define the safety profile that youd need for an effective clinical candidate. Then, maybe more people will pick up on our leads and do the very difficult work that is necessary to get drug candidates evaluated in humans and get one of those candidates approved as a medicine, so people dont have to suffer and die from this devastating illness.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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Search for cure for common parasitic infection focus of $5.5 million NIH grant - Washington University School of Medicine in St. Louis

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Ziopharm Oncology Announces Initiation of Phase 1 Trial Evaluating Rapid Personalized Manufacturing CAR-T Technology in Patients with Relapsed CD19+…

July 9th, 2020 7:47 pm

BOSTON, July 09, 2020 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (Ziopharm or the Company) (Nasdaq:ZIOP), today announced the initiation of a phase 1 clinical trial to evaluate CD19-specific CAR-T, using its Rapid Personalized Manufacturing (RPM) technology, as an investigational treatment for patients with relapsed CD19+ leukemias and lymphomas. The trial is now open for enrollment at The University of Texas MD Anderson Cancer Center.

In this trial, the Company utilizes its non-viral Sleeping Beauty genetic engineering technology to infuse CAR-T the day after electroporation. Ziopharms RPM CD19-specific CAR-T therapy results from the stable, non-viral insertion of DNA into the genome of resting T cells to co-express the chimeric antigen receptor (CAR), membrane-bound IL-15 (mbIL15) and a safety switch.

We are pleased to expand the scope of our clinical development with MD Anderson, as we seek to evaluate our RPM technology using CD19-specific CAR-T cells, said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. RPM is a promising manufacturing solution, as T cells from the bloodstream are genetically reprogramed with DNA plasmids from the Sleeping Beauty system and then simply administered the next day.

Our CAR-T therapy can be administered at low cell doses, which may control cytokine release syndrome and is appealing for the treatment of patients including those with CD19-expressing malignancies that have relapsed after allogeneic bone marrow transplantation (BMT). There are limited effective treatment options for such patients as evidenced by the low rate of remission and poor long-term survival, Dr. Cooper added.

Up to 24 patients with advanced CD19+ leukemias and lymphomas who have relapsed after allogeneic BMT will be enrolled in this investigator-initiated trial (NCT03579888). The primary endpoint of the study is to determine the safety and maximum tolerated dose of donor-derived genetically modified CD19-specific T cells manufactured using the RPM process. An additional study is planned through Ziopharms joint venture with Eden BioCell to evaluate the RPM technology using patient-derived (autologous) CD19-specific CAR-T in Greater China.

Research reveals three-year survival for adults with CD19+ acute lymphoblastic leukemia after allogeneic BMT ranges from 30% to 65%.1 For patients with other CD19+ cancers, allogeneic BMT can provide three-year survival rates between 30% to 75%.1 Few patients experience a durable remission following allogeneic BMT, regardless of the treatment modality, with some having a median survival of only 2 to 3 months.2

About Ziopharm Oncology, Inc.Ziopharm is developing non-viral and cytokine-driven cell and gene therapies that weaponize the bodys immune system to treat the millions of people globally diagnosed with a solid tumor each year. With its multiplatform approach, Ziopharm is at the forefront of immuno-oncology with a goal to treat any type of solid tumor. Ziopharms pipeline is built for commercially scalable, cost effective T-cell receptor T-cell therapies based on its non-viral Sleeping Beauty gene transfer platform, a precisely controlled IL-12 gene therapy, and rapidly manufactured Sleeping Beauty-enabled CD19-specific CAR-T program. The Company has clinical and strategic collaborations with the National Cancer Institute, The University of Texas MD Anderson Cancer Center and Regeneron Pharmaceuticals. For more information, please visit http://www.ziopharm.com.

Forward-Looking Statements DisclaimerThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the progress, design and timing of the Company's research and development programs, the potential benefits of the Companys therapies, and the Companys expectations regarding the number of patients in its clinical trials. Although Ziopharms management team believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Ziopharm, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, changes in our operating plans that may impact our cash expenditures, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Ziopharms product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies and for which indication; the strength and enforceability of Ziopharms intellectual property rights; competition from other pharmaceutical and biotechnology companies as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by Ziopharm, including those risks and uncertainties listed in Ziopharms Quarterly Report on Form 10-Q filed by Ziopharm with the Securities and Exchange Commission. We are providing this information as of the date of this press release, and Ziopharm does not undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

Investor Relations Contacts:Ziopharm Oncology:Chris TaylorVP, Investor Relations and Corporate CommunicationsT: 617.502.1881E: ctaylor@ziopharm.com

LifeSci Advisors:Mike MoyerManaging DirectorT: 617.308.4306E: mmoyer@lifesciadvisors.com

Media Relations Contact:LifeSci Communications:Patrick BurseyT: 646.876.4932E: pbursey@lifescicomms.com

1 D'Souza A, Fretham C. Current Uses and Outcomes of Hematopoietic Cell Transplantation (HCT): CIBMTR Summary Slides, 2018. Available at https://www.cibmtr.org

2 Keil F, Prinz E, Kalhs P, et al. Treatment of leukemic relapse after allogeneic stem cell transplantation with cytotoreductive chemotherapy and/or immunotherapy or second transplants. Leukemia 2001; 15:355-361.

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Ziopharm Oncology Announces Initiation of Phase 1 Trial Evaluating Rapid Personalized Manufacturing CAR-T Technology in Patients with Relapsed CD19+...

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Joy Adzovie: Genetically Modified Crops is the solution to global food insecurity – Myjoyonline.com

July 9th, 2020 7:47 pm

Genetically Modified Crops (GM crops) have generated a lot of controversies over the years. They have sparked debates among farmers and consumers alike with people always particularly paying attention to labeled GM and non-GM commodities on the market.

Some describe is as genetic modification. Some call it genetic engineering. Some call them genetically modified organisms (GMOs). Others describe them as biotechnology products, although biotechnology is a broader term. But all of them refer to the same thing.

A lot of ethical concerns have arisen about GM technology over the years. A very common claim made by some anti-GM activists is that you cannot play God which implies that scientists are defying the natural order of creation. Others are concerned about possible health risks associated with the consumption of GM foods although they have been proven scientifically to be safe, 20 years after their introduction.

In fact, in countries like USA, Brazil and South Africa, more than 80% of all soya beans, maize and cotton are GM crops. But there has been no single evidence of any of these crops negatively impacting the health of consumers in those countries. Before GM food is released for consumption, it is subjected to rigorous scrutiny which has zero tolerance for errors.

So, what exactly are GM crops?

In a bid to optimize yield, farmers have been breeding suitable varieties of crops through conventional selection for several centuries. This has made most wild ancestors of crops such as teosinte of maize go into extinction leaving the elite cultivars which look bigger and develop more desirable traits over the generations. This method of breeding is known as selective breeding or artificial selection which is globally accepted but currently inefficient to feed a fast-growing population anticipated to reach 9.6 billion in the next couple of decades. The exponential rise in population is inversely related to available land area hence the need for a more strategic approach to efficiently utilize the limited land resource to feed the growing global population. Also, pests and diseases, climate change, amidst other abiotic factors severely constrain crop production.

Biotechnology (which includes genetic modification) is an applied science that harnesses the natural biological capabilities of microbial, plants and animal cells for the benefit of mankind. It has changed the quality of life through improved medicine, diagnostics, agriculture and waste management, as well as offered opportunities for innovation and discoveries.

Genetic engineering is used to efficiently and precisely modify targeted plants using advanced biotechnological techniques. Advances in molecular biology have helped eliminate certain gaps in breeding such as reducing time to successfully introduce (introgress) a gene of interest into a commercial crop variety through a process called speed breeding and eradicating linkage drags associated with conventional breeding.

The principle is a simple one. To genetically improve or enhance a crop such as sweet potato which is susceptible to nematode attack, another crop such as tomato that is resistant to nematode attack is identified and the gene of interest is isolated. The gene isolated from the tomato is then introduced into the sweet potato. The host plant becomes a transgenic or genetically modified plant which expresses the desired trait (resistance to nematode) in subsequent generations.

Genetic engineering has had several uses such as in biofortification of crops to increase the concentration and availability of nutrients in crops hence solving hidden hunger problem faced by several African countries. The technology has also been used in the enhancement of plant architecture to optimize land usage and increase yield per area of land cultivated; and improved crops with heightened tolerance or resistance to both biotic and abiotic stresses including diseases and weather.

Benefits of GM crops

Some analysis shows that between 1996 and 2015,GM technology increased global production of corn by 357.7 million tons, soybean by 180.3 million tons, cotton fiber by 25.2 million, and canola by 10.6 million tons. GM crops also significantly reduced the use of agricultural land due to this higher productivity. In 2015 alone, they prevented almost 20 million hectares from being used for agricultural purposes, thus reducing the environmental impact of cultivating forests or wild lands. This is a great environmental benefit derived from higher agricultural yield.

Unfortunately, in Africa, only a few countries including South Africa and South Sudan have allowed for the growing of GM crops and are enjoying from these benefits. Ghana has not allowed for the local production of GM crops although parliament passed a law in 2011 to allow for their introduction.

Genetic engineering is a viable way to eradicate hunger and ensure food security in the coming decades hence is pivotal to achieving Sustainable Development Goal (SDG) 2 on eliminating hunger. Yield losses due to changing or fluctuating climate, pests, and diseases, drought, acidic or saline soils and, heat stress can all be remedied by growing genetically modified crops. GM technology is a blessing to mankind and promises a hunger-free future especially in such unsettling times with the COVID-19 pandemic. Lets embrace it.

The author is a Teaching Assistant at the University of Ghana, Graduate, Faculty of Agriculture.

Original post:
Joy Adzovie: Genetically Modified Crops is the solution to global food insecurity - Myjoyonline.com

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Genetically Modified Crops: The Solution To Global Food Insecurity – Modern Ghana

July 9th, 2020 7:47 pm

Genetically Modified Crops (GM crops) have generated a lot of controversies over the years. They have sparked debates among farmers and consumers alike with people always particularly paying attention to labeled GM and non-GM commodities on the market.

Some describe it as genetic modification. Some call it genetic engineering. Some call them genetically modified organisms (GMOs). Others describe them as biotechnology products, although biotechnology is a broader term. But all of them refer to the same thing.

A lot of ethical concerns have arisen about GM technology over the years. A very common claim made by some anti-GM activists is that you cannot play God which implies that scientists are defying the natural order of creation. Others are concerned about possible health risks associated with the consumption of GM foods although they have been proven scientifically to be safe, 20 years after their introduction.

In fact, in countries like the USA, Brazil, and South Africa, more than 80% of all soya beans, maize and cotton are GM crops. But there has been no single evidence of any of these crops negatively impacting the health of consumers in those countries. Before GM food is released for consumption, it is subjected to rigorous scrutiny which has zero tolerance for errors.

So, what exactly are GM crops?

In a bid to optimize yield, farmers have been breeding suitable varieties of crops through conventional selection for several centuries. This has made most wild ancestors of crops such as teosinte of maize go into extinction leaving the elite cultivars which look bigger and develop more desirable traits over the generations. This method of breeding is known as selective breeding or artificial selection which is globally accepted but currently inefficient to feed a fast-growing population anticipated to reach 9.6 billion in the next couple of decades. The exponential rise in population is inversely related to available land area hence the need for a more strategic approach to efficiently utilize the limited land resource to feed the growing global population. Also, pests and diseases, climate change, amidst other abiotic factors severely constrain crop production.

Biotechnology (which includes genetic modification) is an applied science that harnesses the natural biological capabilities of microbial, plants and animal cells for the benefit of mankind. It has changed the quality of life through improved medicine, diagnostics, agriculture and waste management, as well as offered opportunities for innovation and discoveries.

Genetic engineering is used to efficiently and precisely modify targeted plants using advanced biotechnological techniques. Advances in molecular biology have helped eliminate certain gaps in breeding such as reducing time to successfully introduce (introgress) a gene of interest into a commercial crop variety through a process called speed breeding and eradicating linkage drags associated with conventional breeding.

The principle is a simple one. To genetically improve or enhance a crop such as sweet potato which is susceptible to nematode attack, another crop such as tomato that is resistant to nematode attack is identified and the gene of interest is isolated. The gene isolated from the tomato is then introduced into the sweet potato. The host plant becomes a transgenic or genetically modified plant which expresses the desired trait (resistance to nematode) in subsequent generations.

Genetic engineering has had several uses such as in biofortification of crops to increase the concentration and availability of nutrients in crops hence solving hidden hunger problem faced by several African countries. The technology has also been used in the enhancement of plant architecture to optimize land usage and increase yield per area of land cultivated; and improved crops with heightened tolerance or resistance to both biotic and abiotic stresses including diseases and weather.

Benefits of GM crops

Some analysis shows that between 1996 and 2015, GM technology increased global production of corn by 357.7 million tons, soybean by 180.3 million tons, cotton fiber by 25.2 million, and canola by 10.6 million tons. GM crops also significantly reduced the use of agricultural land due to this higher productivity.

In 2015 alone, they prevented almost 20 million hectares from being used for agricultural purposes, thus reducing the environmental impact of cultivating forests or wildlands. This is a great environmental benefit derived from higher agricultural yield.

Unfortunately, in Africa, only a few countries including South Africa and South Sudan have allowed for the growth of GM crops and are enjoying these benefits. Ghana has not allowed for the local production of GM crops although parliament passed a law in 2011 to allow for their introduction.

Genetic engineering is a viable way to eradicate hunger and ensure food security in the coming decades hence is pivotal to achieving Sustainable Development Goal (SDG) 2 on eliminating hunger. Yield losses due to changing or fluctuating climate, pests, and diseases, drought, acidic or saline soils and, heat stress can all be remedied by growing genetically modified crops. GM technology is a blessing to mankind and promises a hunger-free future especially in such unsettling times with the COVID-19 pandemic. Lets embrace it.

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Genetically Modified Crops: The Solution To Global Food Insecurity - Modern Ghana

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LA’s ‘Wet Markets’ Could Be On The Chopping Block – LAist

July 9th, 2020 7:47 pm

A cashier at L.A. Fresh Poultry weighs some chicken. (Chava Sanchez/LAist)

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Zoila Isabel Sandoval sits on a hard, wooden chair in front of the spice rack at L.A. Fresh Poultry, waiting to place her order with a clerk. The basket of her rolling walker is piled with groceries. She's in a good mood. Today is her son's 40th birthday and they're going to celebrate with a big family lunch. She plans to make several Guatemalan-style dishes, including arroz con pollo chapina and pollo en jocon, a tomatillo-based stew. To do that, she needs six freshly slaughtered chickens.

Sandoval grew up in the farm town of San Rafael Las Flores in southern Guatemala, where she and her mother raised chickens and pigs at home.

"I liked seeing them grow, especially when they had little chicks or piglets," Sandoval says in Spanish.

After moving to Los Angeles two decades ago, she struggled to find a place where she could buy freshly slaughtered chickens.

"I have been eating like this ever since I was in my mother's womb," she says with a laugh.

When she discovered L.A. Fresh Poultry, a 2,000-square-foot market not far from her MacArthur Park apartment, she felt a sense of relief.

The store sells live chickens, turkeys, quails, ducks, squabs and rabbits, which its butchers will slaughter on site. In the eyes of the law, this will probably make L.A. Fresh Poultry a "wet market" a business that may soon be forbidden in the city of Los Angeles.

On June 10, the Los Angeles City Council passed a motion that could signal the beginning of the end for wet markets. The motion asks the L.A. Department of City Planning, the Department of Building and Safety and the City Attorney's office to come up with "a precise definition" of "wet market" and provide recommendations about which "establishments and practices should be prohibited."

Bob Blumenfield, one of the two city councilmembers who sponsored the motion, told us the information he's requesting is not an outright wet market ban yet. Rather, it's a "report on the feasibility of such an ordinance." But, he added, "It's the first step to prohibit the sale of living creatures for human consumption in the city of Los Angeles."

Although city officials haven't provided a definition for "wet market," the state of California defines "live animal market," an equivalent term, as "a retail food market where, in the regular course of business, animals are stored alive and sold to consumers for the purpose of human consumption." A further explanation, spelled out in California Penal Code PEN 597.3, says, "'Animal' means frogs, turtles, and birds sold for the purpose of human consumption, with the exception of poultry."

L.A. city officials are still in the process of working with L.A. City Attorney Mike Feuer to write the ordinance, according to Councilmember Paul Koretz, the motion's other sponsor. "The focus is primarily on animals that have unknown implications in terms of diseases they could spread," Koretz told us, although he acknowledges there is no guarantee the ordinance would be limited to animals that are commonly tied to illnesses.

Although no wet market or butcher shop has been the source of a COVID-19 outbreak in L.A., "There may be hygienic questions in terms of how they operate, and questions of animal cruelty in terms of how [animals] are kept and slaughtered," Koretz said. He told us he has no firsthand experience shopping at wet markets in L.A.

Ren Rowland, the chairwoman of animal rights organization PawPAC, supports the motion. She told us that whether wet market animals are wild (think bullfrogs or turtles) or domestic (think chickens, ducks, rabbits), "They also endure these terrible experiences of being transported and trafficked in these different containers in cages, in trucks and planes."

"We don't advocate for any markets to close for business," Rowland said. "We just believe that we need to stop the practice of the on-site slaughter."

The city of L.A., which has approximately 4 million residents, has maybe two dozen stores that slaughter and sell animals on their premises, according to a list provided by Blumenfield's staff. Blumenfield says the list isn't exhaustive and could potentially include businesses that are not wet markets. Regardless, these businesses make up a tiny fraction of L.A.'s nearly 1,200 markets and grocery stores.

Koretz told us he doesn't know of any major food-borne illness outbreaks that began at L.A. wet markets, "but there are some people that have become sick from eating some of the more exotic foods." He added that his knowledge of cruelty issues is secondhand.

So why the motion that could put an end to wet markets? And why do it now? One word: coronavirus.

"The fact that this virus potentially started in a wet market [in China] caused us to look at ourselves in Los Angeles, and do we have these kinds of wet markets that are cruel and potentially dangerous," Blumenfield said.

No one has conclusively determined the origins of COVID-19. Many scientists believe it originated in nature in one animal species (possibly bats) then jumped to another species (such as pangolins) before wreaking havoc on humans. In one theory, that transfer happened in a seafood and animal market near Wuhan, China.

The phrase "wet market" can mean a lot of things. Most of them merely sell fresh meat, fish and other perishable food. Others, like the one near Wuhan, also sell wild animals such as bats and civets. Although scientists may never be able to pinpoint the virus's origin, that hasn't stopped politicians or conspiracy theorists or racists from making "wet market" a pejorative term and blaming people or cultures commonly associated with them for the coronavirus pandemic.

President Donald Trump has repeatedly used the term "Chinese virus" to describe the COVID-19. As hate crimes against Asian Americans continue to rise, White House press secretary Kayleigh McEnany recently defended Trump's use of the term "kung flu," saying, "It's not a discussion about Asian Americans, who the president values and prizes as citizens of this great country. It is an indictment of China for letting this virus get here."

At the start of 2020, most Americans had never heard of wet markets. A few months later, they were Public Health Enemy #1. Even Canadian Lite Rocker Bryan Adams got in on the action.

By April, the Asian Pacific Policy & Planning Council's Hate Tracker had received more than 1,400 reports of verbal abuse, assault and shunning directed at Asian Americans, or people who look Asian.

Racism triggered by the so-called wet market-coronavirus connection even trickled down to the business sector. In late January, as the coronavirus became a growing global concern, Chinese restaurants started to see a major slump in customers.

The L.A. City Council's motion to ban wet markets which only applies within the city's boundaries and not in the San Gabriel Valley, where there are about a dozen such markets won't only impact Asian Americans. It will impact Muslims, Latinos, Armenians and anyone else who prefers meat from freshly slaughtered animals.

Koretz says he understands how the motion could be seen as discriminatory, but he views that interpretation as the result of a top-down leadership problem. "My only discomfort is with President Trump unnecessarily trying to utilize the hate against anybody different," he said, adding that Trump's divisive and racist language is an "unfortunate side element to this issue."

But Koretz maintains that there's a valid reason for the motion: "We're seeing how devastating this particular virus can be. And this practice, even though it is culturally associated with certain communities, the potential diseases will not be associated with any community. This is targeted towards health."

To Zoila Sandoval, the idea of buying meat that has been slaughtered elsewhere then frozen, swathed in plastic and shipped from hundreds of miles away is hard to accept.

Two times a week since L.A. Fresh Poultry opened 14 years ago, she has made the 20-minute walk from her home on Vermont Avenue to the store. The chance to buy freshly slaughtered animals is precisely why she comes here.

"It's killed here," she says. "It's not frozen and stored for I don't know how long. It's fresh and healthier."

She's not alone. Outside of wet markets, there's plenty of demand for freshly slaughtered, non-factory-farmed, humanely killed animals, whether it's the organic steaks of Belcampo Meat Co. or the organic, air-chilled thighs of Mary's Free-Range Chicken. Never mind the urban hipsters who home-raise chickens, sometimes for food.

Aside from a giant fiberglass rooster (and his small rabbit companion) perched on the roof, L.A. Fresh Poultry is an unassuming store next to the Virgil Avenue on-ramp of the 101. Behind the counter, bills from different countries have been stuck to the wall around a sign that reads, "I love Egypt."

Painted on another wall outside the store, a colorful parade of creatures including Daffy Duck and Bugs Bunny beckons potential customers. "Why buy frozen when you can buy fresh?" reads the mural. Indeed, in addition to the foodstuffs that any such store carries, L.A. Fresh Poultry has a live animal storage room, where chickens, rabbits and quails are kept in cages.

The market has been a neighborhood staple since opening in 2006. It serves customers seven days a week, from 8:30 a.m. until 6 p.m. This is owner Abdel Salam Elhawary's second such store. The first, Al Salam Pollera in East L.A., opened nearly 40 years ago, and is still thriving. He says approximately 80% to 85% of his customers are Mexican immigrants and the rest originally come from Guatemala or El Salvador. Elhawary also has a third store, Van Nuys Live & Fresh Poultry, which he opened in 2012.

A 68-year-old Egyptian immigrant who once taught French in his home country, Elhawary came to Los Angeles in 1980 and worked in a bank for nearly a decade before getting into the grocery game.

He started his business so Muslims could have more access to halal meats. For meat to be certified halal, whoever is doing the slaughtering must follow certain rules. The animal can't be unconscious. The butcher needs to use an extremely sharp instrument to prevent snags and the prolonging of any suffering. Allah's name must be said during the slaughter. Then, the animal must be hung upside down so the blood can drain. (By way of comparison, in industrial slaughterhouses, chickens might be shackled then electrocuted to death while sheep and pigs might be gassed into unconsciousness before they're slaughtered.)

"We have a Muslim community," Elhawary says, "it's about 40,000 to 50,000 Muslims around the [Koreatown] area. Mostly, the Bangladesh people come, and the Middle Eastern and others."

Hollywood resident Haji Ceesay, 53, is one of the market's many customers. Ceesay, a Muslim who comes from The Gambia, moved to Los Angeles in 1991. Ceesay prefers to consume freshly slaughtered animals for religious and cultural reasons.

"Back home that's what we do," Ceesay says. "We buy live chicken and it's different than the frozen ones here."

Ceesay left the store that day with six chickens.

These days, Elhawary says Muslims make up about 40% of his customers. He says the rest of his clients are Angelenos who originally came from Mexico, Central America, Armenia or Korea. He's as surprised as anyone by the diversity of his clientele, but he's happy to have the customers.

After 40 years in business, Elhawary isn't upset about the provision in the ordinance that would require him to stop selling live birds, such as quail and squab. Demand is low. The provision that would require him to stop slaughtering is another matter.

If that goes into effect, "I am gonna die," Elhawary says. "All my life is doing this. It's not only my shop. It's all over. Millions of people love to eat the fresh one."

"Millions" may be a bit of an exaggeration, but it's undeniable that live animal markets fill a need for thousands of residents, most of whom, by almost any account, are immigrants and/or people of color.

Sam Sammars, an L.A. Fresh Poultry customer who lives in East L.A., says he discovered the market in 2014 and has been coming once or twice a week since then. For him, it's worth the trip. The meat here is fresher than store-bought factory meat, and the prices are good $15 to $16 for a large, freshly slaughtered chicken.

"It tastes so natural, as if you're in the farm," he said while waiting in line to place his order.

Sammars grew up on a farm in Columbus, Ohio, where there weren't many supermarkets in the area, so he got used to the taste of fresh everything fresh fruits, fresh vegetables and fresh meat. Now 35, he says conventional farming and meat production, with their pesticides, genetic engineering, hormones and antibiotics, produce food that isn't as nutritious.

He said that if markets are prohibited from selling live and freshly slaughtered animals without the law making any distinction between chickens and ducks vs. frogs, exotic birds and wild animals, "It would be very strongly devastating."

At typical grocery stores and supermarkets, most meat comes from livestock that has been raised on "factory farms" (or what the USDA calls Concentrated Animal Feeding Operations), then slaughtered at industrial slaughterhouses and transported to markets by refrigerated trucks.

"Wet markets are selling a live animal or slaughtering it in front of you. That's very different," Blumenfield says. "When animals are just brought in and killed for human consumption, it completely avoids the regulatory system."

In fact, the state of California regulates how live animal markets, custom slaughterhouses and retail poultry plants can operate. The facilities are inspected by the California Department of Food and Agriculture to make sure they abide by health and safety regulations, which are designed to prevent the inhumane treatment of animals and the spread of diseases. The L.A. County Department of Public Health, for its part, regulates the retail portion of such businesses in accordance with the California Retail Food Code.

Regardless of the oversight process, Blumenfield also points out that the motion stems from a "cruelty issue."

"The idea is: Can we stop this cruel practice in Los Angeles?" he says, referring to slaughtering of rabbits, frogs and birds on site. "A wet market is the opposite of what you would find in a humane society."

Chef Wes Avila doesn't see wet markets that way. He says he used to buy 50 to 80 chickens per week from wet markets in Chinatown when he launched Guerrilla Tacos as a food truck, in 2014.To Avila, the complaints about wet markets aren't about ethics, they're about aesthetics. They just make some people uncomfortable.

"People want to pretend that meat comes from some magic pig tree or chicken tree. That's not the way it happens. It has to come from somewhere."

According to Elhawary, the chickens at his markets come from farms in Fresno or Ramona and he makes sure all the animals he sells are healthy.

"When they have bruises from the transportation, we trim it and throw the bad parts away. We use sharp knives, and we do the chicken fast and accurately. We don't let the chicken suffer," Elhawary says.

Nevertheless, activists who support the closure of wet markets prioritize another concern the transportation process. Rowland, of PawPAC, says people who want to maximize their profits will transport as many live animals as possible in trucks or planes, which is dangerous and inhumane.

Rowland says she doesn't believe slaughtering animals in industrial slaughterhouses then transporting the meat to grocery stores is necessarily more humane, safer or healthier.

But, she says, "There are no factory farms in the city of Los Angeles and so because of that, we don't have to address that issue."

The proposal to ban wet markets in L.A. is one part of Rowland's larger goal: putting a stop to any activities that cause animals suffering or torture. She says she's starting with California but wants that message to sweep the world.

Councilman Koretz, for his part, is waiting on the report so he can decide "whether it's a practical thing to pursue."

Although the report was supposed to come out by July 10 30 days after the motion was passed it has not yet been completed. A staffer at Councilman Koretz's office said the city expects to see the report in late July or early August.

If officials want to move forward with the proposal, the City Council will have to pass another motion directing City Attorney Feuer to draft the law.

While officials wait for the city's feasibility report, Elhawary worries. If the proposed measure moves forward, he says he may organize a demonstration with his customers. He fears that if he has to stop selling freshly slaughtered poultry, his three markets will go out of business.

In the meantime, Zoila Sandoval has been watching as the workers at L.A. Fresh Poultry process her order. After she's requested her six chickens at the counter, two licensed butchers grab them from the cages that are not visible to customers. They take the birds to the killing room, where they're slaughtered, drained and plucked. Then, two more workers remove the giblets, wash the chickens and pass them through an open doorway to a clerk.

One of the shop's two butchers, Merare Nataneal, has spent 12 years honing his craft. At 66, he worries the ordinance, if passed, will put him on the unemployment line.

"This is my work, and I don't want to lose it," Nataneal says in Spanish. "It's an uncomfortable position knowing that they might want to close this type of business down."

Behind the counter, a clerk weighs, wraps and bags the freshly killed birds. After paying at the register, Sandoval leaves L.A. Fresh Poultry under the gaze of Foghorn Leghorn, six still-warm birds piled in the basket of her walker as she rolls down Virgil Ave, heading home to make lunch for her son.

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LA's 'Wet Markets' Could Be On The Chopping Block - LAist

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Perspective on Pharma: Moving from academia to industry – EPM Magazine

July 9th, 2020 7:47 pm

In this Perspective on Pharma feature, Jung Doh, market development scientist at Beckman Coulter Life Sciences, explains how they entered the pharmaceutical industry after an unexpected opportunity arose.

As an early career scientist with a good number of years of graduate and post-doctoral training (two post-docs, actually), I made an unexpected leap: from academiawhere I thought I would spend my entire professional lifeto industry. And though it wasnt a move Id initially planned, Im the first to say that Im incredibly happy to have ended up here, since its afforded me research and personal growth opportunities I didnt even know I wanted.

After I received my doctorate in biology, I completed a post-doc in HIV research and a second, NASA-funded post-doc in the effects of microgravity on genomes. My dreamand a very concrete goal for many yearswas to become a professor at a research university, running my own lab in an area I was passionate about.

But then life intervened: my wife was offered a teaching position in Indianapolis that she couldnt pass up, so we relocated. After a few months of fruitless application to teaching and research positions at local universities, I started looking elsewhere. There are a lot of pharma and biotech companies in Indianapolis, so I started exploring some of them. In the interview process, (and much to my surprise), I discovered that they shared many of the same passions and goals I did: to benefit human health and life in fundamental and lasting ways.

The company where I ended up and still work, Beckman Coulter Life Sciences, was particularly interesting to me, since one of their key focuses was on next generation sequencing (NGS). Toward the end of my Ph.D. and in my post-doc training, NGS was becoming more routine, and I was fortunate to be able to learn and apply the techniques in my own research.

So I joined Beckman Coulter Life Sciences, which offers a range of scientific research instruments used to study complex biological problems and to advance scientific breakthroughs, first as a marketing application scientist, and then expanding into a dual role as application scientist and proof of principle scientist. In the latter, I worked with customers to develop modified protocols and tools to help research be done more efficiently. I then became product manager for our genomics product line, and as of this year, I have yet another new role, as market development scientist. In this role, I engage with the scientific community to learn from them, as well as support them to perform research better, faster, and with superior results and outcomes. I also bring the learnings and techniques gained from these collaborations to create collateral to offer other labs, or help our internal team develop product offerings for a specific need.

After making the leap into industry, I never looked back. There are, of course, benefits to both sectors. In academia, theres a certain degree of freedom and job securityonce youre tenured, that is. But it takes a lot to get tenured these daysthe funding and grants and a constant stream of publicationsparticularly in biology and related disciplines.

Though industry may seem more constrained at first glance, in many ways, theres as much or more opportunity, since there are a plethora of techniques to learn and apply in novel ways. And since technology evolves so rapidly, especially in genetic engineering and diagnostics, it seems like there are always new methods to master.

Related to this aspect, and alluded to earlier, is the strong sense that my and my colleagues work is genuinely translating into helping people across the globe. I got an inkling of that in the interview process, but its also been a palpable part of my work here. With the current pandemic, for instance, the company came together, and, within a matter of weeks, we were able to offer labs RNA extraction solutions for the virus, which are so critical right now. I felt honoured to be part of a company doing such great work, with flexibility and speed. It definitely speaks to the versatility of the industry.

Beyond the scientific, Ive learned about areas seemingly outside of science, but that are actually integral parts of the business. When I was product manager, for instance, I learned how to manage people, run meetings, build financial models, approach marketing and sales, and many other facets of the business. I had no formal business training going in, but you learn by doing, from your manager and peers. I ended up really loving all these other parts of the business of sciencetheyre challenging, but incredibly rewarding, because they push you beyond your comfort zone into uncharted areas. For that, industry has opened up areas that I didnt even know would be important, let alone fun and rewarding.

Finally, Ive been surprised and heartened by the strong sense of family that exists within a company. Part of this is felt through the opportunities for development, which is evident in all the stages I went through and all the roles Ive had. Theres a sense that staff are supported to grow as scientists and as people, which has made my accidental leap into industry all the more fulfilling.

For young scientists, theres a lot to think about when making decisions about what to study and what track to follow. I would encourage people to not get too hung up on tracks, but to stay open to the possibilitiesin other words, dont get too stuck on academia as the only option just because its where youve done your training. What really matters is having a passion for what you do, and following your interests. Genetic engineering is an area thats exploded in recent years, and will likely grow in the coming years. Ive been lucky that my own work has translated so tangibly into helping people, and at a large scalebut the same is true for many other areas in medical science. So carry onyou may end up in a totally different place from where you started, and thats not a bad thing at all.

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Perspective on Pharma: Moving from academia to industry - EPM Magazine

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Yeast Market Trend, CAGR Status, Growth, Analysis and Forecast to 2028 – 3rd Watch News

July 9th, 2020 7:47 pm

Brewing or beer making represents a massive and highly lucrative sector. According to a study, global alcohol consumption has constantly been on the rise, and the consumption of beer accounts for the highest volume share. Yeast, being the cardinal ingredient used in the production of beer, provides the right proportion of texture and flavor to beer during its production. As a result, increasing demand and consumption of beer has been elevating the globalyeast market, which is anticipated to grow at a CAGR of 5.4% during the forecast period 2018-2026. The market valuation has been estimated to be over US$ 10,200 Mn by 2026 end.

Yeast Innovation: The Future of Brewery

The brewing industry has overcome a slew of challenges and moved beyond times when technological breakthroughs were not applied to the beer crafting process. According to a research, one small, low-capital innovation, within the reach of all beer makers is enhancing and improvising the yeast they use in their beer. Even though yeast is partially responsible for imparting the flavor and aroma to beer, brewers often compare yeast to hops. This leaves yeasts dynamic nature untapped, which can be used for product enhancements.

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Research has shown that non-GMO development techniques such as selective breeding can be used to optimize the brewing strains. Ultimately, brewers can enhance the quality of beer by innovative yeast that can be fully customized pertaining to the brewery and its beer with the specific desired parameters in fermentation performance, processing, storage, flavor, and aroma, without compromising quality or brand identity.

Alternatives to Traditional Straining to Drive Innovation in Yeast Market

Studies on the beer and yeast market have pointed at various possibilities that would drive the use of yeast in beer making. For instance, to develop brewers yeast, market players could use hop-accentuating enzymes in high volume which will change the aroma and flavor profiles of the different hop varieties used in beer. Additionally, brewers can add a trait to increase fermentation temperature ranges which would produce desired flavor profiles at lower temperatures, eliminating the problem of off odors that occur at higher temperatures.

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Genetically Engineered Yeast to Offer Excellent Taste to Beer

From great-tasting to cloudy and off-taste beers, yeast accounts for up to a third of a brews final flavor. Brewing yeast has its own genetic limitations. For researchers across the globe, brewing yeast is at the forefront of genetic research and synthetic biology, which is pushing the boundaries of genetic engineering. Geneticists can now tweak the genetic code of brewing yeast to suppress or express certain beer characteristics. From taking out the gene responsible for the butter-flavored molecule diacetyl to using specific gene for banana and clove flavors made by hefeweizen yeast brewers would now be able to use this ability of genetically modified (GM) yeast for the production of beer.

Whether it is straining of yeast or making use of genetically engineered yeast, increased consumption of alcoholic beverages in the world, with beer leading the consumption segment, has witnessed several yeast innovations in recent years, favoring the market growth. For more insights, speak to our expert food analysts at Persistence Market Research to know more about the yeasts market and its impact on the end-user industry.

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Yeast Market Trend, CAGR Status, Growth, Analysis and Forecast to 2028 - 3rd Watch News

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COVID-19 Research: Women Are Changing the Face of the Pandemic – Genetic Engineering & Biotechnology News

July 9th, 2020 7:47 pm

The pristine X-ray crystallography data gathered by Rosalind Franklin played a crucial role in the discovery of DNAs structure. Yet when the discovery was recognized by the Nobel Committee in 1962, the winners of the Nobel Prize did not include Franklin, who had died in 1958. Only recently has Franklin received some of the recognition that she deserves for her essential contribution to one of the biggest discoveries of the past century.

We still have a lot of work to do, unfortunately, notes Akiko Iwasaki, PhD, an immunologist at Yale School of Medicine and a fierce advocate for women in science. Things have definitely gotten better since [Franklins] days she tells GEN. But we still have a huge disparity in women representationespecially at the senior level. Iwasaki adds that we have to address what she thinks is the root cause of the problemthe academic culture and the unconscious (or conscious) bias against women and people of color that prevents these brilliant people from moving up the academic ladder.

To mark the centenary of Franklins birth, GEN sought to highlight scientists at the forefront of COVID-19 researchsome of the most influential research currently being conductedwho are women. In this article, GEN speaks with researchers who are leading efforts to track SARS-CoV-2 genomes, to uncover host factors influencing COVID-19 progression, to develop saliva-based COVID-19 tests, and more.

Working as a pediatrician in China, Qian Zhang, MD, wanted to understand why some children are more susceptible to infections than others. Children are exposed to hundreds of pathogens every day, Zhang tells GEN, but only a very small proportion get really severe infections. Zhang has been researching differences in susceptibility for the past decade. Notably, she performed postdoctoral work at the National Institute of Allergy and Infectious Diseases (NIAID) with Helen Su, MD, PhD. Afterward, Zhang became a postdoctoral fellow at the Rockefeller University, in the laboratory of Jean-Laurent Casanova, MD, PhD.

Working with patient samples, researchers in the Casanova laboratory look for rare, deleterious mutations that might govern susceptibility to infection. In particular, they look for monogenic variants, where a single defect makes an individual far more susceptible to infection. Zhangs hypothesis for COVID-19 is that patients who are susceptible to less virulent respiratory pathogens will also be susceptible to COVID-19. By taking an unbiased approach, Zhang and colleagues may find genetic factors that have never been identified before.

Normally, Zhang analyzes children because it is in childhood that people usually experience infection for the first time. But COVID-19 is different, she notes, because this infection is the first time for everyone.

Zhang previously led the influenza team in the Casanova laboratory. So, taking on COVID-19 is a natural shift. She adds that many commonalities between the two lung infections have been established, and that many tools developed for flu research can be used in COVID-19 work. Besides, there simply arent any more flu patients coming in.

Zhang asserts that her group, like others, has adapted its work to the pandemic. Investigators normally work on well-defined infections. COVID-19, however, isnt so well defined. Too little about it is known. For example, without key pieces of data such as a fatality rate, investigators who look for genetic lesions may be unaware of the lesions prevalence. We have to change our analysis while the data are coming in, Zhang explains.

How much hesitation did Akiko Iwasaki, PhD, have in moving into COVID-19 research? None, she says. I knew the importance of speed and urgency. She notes that she had learned the value of these attributes from her experience jumping into Zika.

Iwasaki, a professor of immunobiology and molecular, cellular, and developmental biology at the Yale School of Medicine and an investigator at the Howard Hughes Medical Institute, has spent the past few months trying to understand the immune response of COVID-19 patients. Iwasakis laboratory is working to develop real-time analyses of immune markers and cytokines that could sharpen patient assessments and even inform treatmentdecisions.

The biggest surprise, so far, has been the role of interferon (IFN) in this disease, asserts Iwasaki. For other viruses, such as influenza and rhinovirus, type 1 IFN has a protective role for the host. But SARS-CoV-2 seems different. Studies in a mouse model have shown that IFN contributes to the inflammatory response without shutting down viral replication. According to Iwasaki, this is unusual. In other viral infections, IFN can shut down the virus. But Iwasaki thinks that the IFN here is being induced a little bit too late or in too small of an amount.

Iwasakis main goal is to understand what type of immune response confers protective immunity versus the types that lead to disease. Because patients have diverse responses to SARS-CoV-2, the researchers are working to build disease trajectories that reflect patient-specific aspects of the immune responsecytokine or antibody production, T-cell response, viral load, etc. By conducting longitudinal sampling and following patients trajectories, the researchers hope to predict how patients will fare when they are admitted to the hospital. Ideally, she envisions a panel that could be ordered by a physician that would allow patients to be treated with a more personalized medicine approach, based on their immune profiles.

This analysis has never been done so extensively for an infectious disease, Iwasaki asserts, because we never had the urgency to do this for other viral pathogens. In 2020, thankfully, the technology exists to do this type of analysis in real time.

Another area Iwasaki has recently explored is sex differences in SARS-CoV-2 infection. By studying male and female immune responses, her group found one clue as to why males are reportedly more susceptible to COVID-19. In a preprint posted in medRxiv, Iwasaki and colleagues described how they investigated sex differences in viral loads, antibody titers, and cytokines in COVID-19 patients, and how they found that T-cell activation was significantly more robust in women than in men. Men who dont develop a good T-cell response have worse disease outcomes.

Emma B. Hodcroft, PhD, a postdoctoral researcher at the University of Basel, recalls agreeing to keep her supervisors project going while he traveled. She was to take charge in early February. Continuity was important because they had just started uploading sequences of SARS-CoV-2 into the online genomics engine Nextstraina collaboration started in 2014 to track flu virus diversity and help predict the next flu strain.

Because Nextstrain has hubs in Europe and the United States, the absence of data uploads at the University of Basel would hamper runs during the European daytime. She has, in her own words, never looked back.

The pipeline analysis that Nextstrain runs makes phylogeny from viral genome mutations. Phylogenetics is a field full of limitations, Hodcroft notes. She adds that the field is particularly troublesome because its beautifully dangerousthe picture that is drawn is always less certain than it looks. While it is tempting to start telling stories about these sequences, she says, one must be cautious. The roughly 40,000 cases currently in the system is a drop in the bucket compared to the number of COVID-19 cases. There is much more likelihood that we havent sampled someone than we have, she admits.

As borders reopen and travel resumes, continued genomic analysis, Hodcroft tells GEN, could uncover details about virus transmission, including transmission routes. She will be keeping a close watch while cautiously communicating new findings. These data are of interest to a large and growing audience, and members of this audience may misinterpret (intentionally or not) what they hear. Deciphering the uncertainty that surrounds the field of phylogenetics requires expertisesomething not all scientists who have ventured into the world of COVID-19 phylogenetics possess.

Hodcroft gets upset when misinterpreted data spark a storyline that needs to be debunked. I dont think that telling these false stories that panic the public helps anybody, she declares. There is plenty to be worried about with this virus.

COVID-19 is the second SARS epidemic Rachel Graham, PhD, has worked on since she started her graduate work in a coronavirus lab in 2002. Currently working in a large coronavirus laboratory at University of North Carolina (UNC) led by Ralph S. Baric, PhD, she says that Barics group has scaled up from what was a busy program to an extremely busy program.

Graham uses large sequence sets to study how the virus transcriptional program contributes to replication and virulence. As the virus mutates, its subgenomic RNAs are produced in different ways, indicating that the transcription itself may be a virulence factor. She says that as the population acquires more herd immunity, researchers may see a lot of transcriptional differences in the virus, and these differences could result in changes in virulence. SARS-CoV-2 will be the first virus where this relatively new idea in virology will be examined in detail.

Lisa Gralinski, PhD, assistant professor of epidemiology at UNC, has been studying coronaviruses for 12 years. Her current work centers around virus host interactions, specifically in animal models such as the humanized ACE2 transgenic mouse. The mouse was developed at UNC in the mid-2000s after the first SARS outbreak. Researchers had even started the paperwork to cryopreserve the mouse just before COVID-19 struck. Quickly adjusting to COVID-19, they changed course and started as many breeding pairs as possible.

Graham and Gralinski may be new to the UNC faculty, but they are veterans in a rapidly growing field. Gralinski notes that six months ago, few people worked in coronavirus. Unlike SARS, SARS-CoV-2 is not currently a select agentwhich means that more people are free to work on it. Both Graham and Gralinski welcome more hands on deck, but theyve been alarmed by some of the ways that people are working with SARS-CoV-2 in their Biological Safety Level 3 (BSL3) labs. SARS-CoV-2 requires special precautions and security due to the high titers used in experiments.

In early March, Anne L. Wyllie, PhD, an associate research scientist in epidemiology at Yale, was chatting with her colleague, Nathan D. Grubaugh, PhD, an assistant professor of epidemiology. He was lamenting the level of SARS-CoV-2 RNA detection in patient samples. Wyllie drew his attention to a method she had been using to detect Streptococcus pneumoniae from saliva samples of asymptomatic carriers.

Her method, which used Thermo Fishers MagMAX Kit for Nucleic Acid Extraction, had worked so well for Wyllie that she suggested that Grubaugh use it to test for SARS-CoV-2. Wyllie recalls that when Grubaugh and colleagues compared the methods, Wyllies method blew the other one out of the water. Ultimately, the MagMAX Kit and the King Fisher platform (which happens to be named Frankie in the lab, in honor of Rosalind Franklin) became the Grubaugh laboratorys method of choice. Wyllie is now co-lead on the COVID-19 project with Grubaugh.

Wyllie was the lead author on a preprint uploaded to medRxiv showing that saliva samples offer a more sensitive and consistent alternative to nasopharyngeal swabs for COVID-19 testing. Saliva samples, the paper argued, should be considered a viable alternative to nasopharyngeal swabs to alleviate COVID-19 testing demands. This could be key to meeting public testing demands.

We knew a pandemic would come and we knew we would have to be ready, says Viviana Simon, MD, PhD, professor of microbiology at Mount Sinai School of Medicine. A decade after starting her virology laboratory in 2006, Simon and her colleagues built the Virology Initiative in 2017, which allowed real-time access to samples from patients with viral infections. The goal, she explains, was to study emerging viruses in New York Cityviruses such as Zika, chikungunya, and dengue. Having the initiative established allowed the laboratory to spring into action when the pandemic hit. Simon notes that a virology infrastructure capable of such responsiveness would not be easy to build in the middle of a pandemic.

Simon remarks that there was never any doubt that there would be a pandemic: We thought that it would be a respiratory virus and figured that it would be an avian influenza strain. Any pandemic would almost certainly come through New York City, which serves as a gateway not just for people, but for viruses from all over, she says.

Simon tells GEN that her team heard rumors about a new virus in December and began preparing. The moment the first sequences were released in mid-January, she recalls, We ordered primers. And then? Simon and colleagues waited and waited, she says, for the first case to show up. The first COVID-19 case was diagnosed at Mount Sinai on February 29. Only then could the Simon team grow the virus and sequence it.

Simons team has analyzed the genetic diversity of SARS-CoV-2 circulation in New York City and how the virus was introduced. The team is also interested in assessing the durability of antibodies and determining the degree to which antibodies are protective.

The size of Simons laboratory has doubled, primarily due to a temporary influx of postdoctoral researchers and technicians, volunteers that come from laboratories shut down by COVID-19. This COVID task force jumped in to support the COVID-19 research being done at Mount Sinai. Simon remarks that when temporary personnel start returning to their own laboratories, she will be busy hiring more people.

The dedicated researchers highlighted in this article have been working almost nonstop for months, motivated by a shared passion to beat back a virus that has taken over the world. These researchers represent different scientific backgrounds, and they are tackling different facets of the virus. But they would no doubt recognize common elements in their professional development. For example, the challenges that come with being women in male-dominated fields. Hopefully, it will not take decades to recognize and celebrate the contributions of some of these outstanding scientists.

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COVID-19 Research: Women Are Changing the Face of the Pandemic - Genetic Engineering & Biotechnology News

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How Pharmaceutical and biotechnology Segment to be the Most Lucrative in Chromatography Systems Market – 3rd Watch News

July 9th, 2020 7:45 pm

There is an unexpected shift in the world, and many sectors are experiencing thoughts triggered by the COVID-19 pandemic. The outbreak of COVID-19 has had a positive impact on the demand for chromatography. In the pharmaceutical industry, chromatography technology is commonly used for the detection of cancer cells. It is also used for drinking water and air processing, plasma fractionation, enzyme purification, and purification. The Environmental Authority, for example, listed chromatography as safe for the measurement of drinking water purity as a means of easy propagation of the coronavirus through polluted water. During this coronavirus crisis, we are helping our clients in understanding the impact of COVID-19 on the chromatography system market.

Our report includes:

A new report by Research Dive states that the global chromatography system market is set to grow at a CAGR of 6.9% and is projected to garner a revenue of $16,304.0 million during the period of forecast from 2019 to 2026. The report delivers in-depth insights into opportunities, vital segments, restraints, drivers, and prominent players of the global market. Based on the type, end-use, and region of the global market segmentation. The report offers insights on drivers, opportunities, restraints, analysis of segment, and competitive market players. Increasing the use of chromatography methods in the pharmaceutical industry is a significant factor for market growth, according to our analysts. Nonetheless, due to the existence of capillaries for the oxygen, hydrogen, and methane separation, a requirement of qualified professionals and high construction costs and maintenance costs is anticipated to impede the growth of the market for the chromatography device. The global market is segmented on the basis of type, end-use industry, and region.

Check out How COVID-19 impact on the Chromatography Systems Market. Click here to Connect with Analyst @ https://www.researchdive.com/covid-19-insights/207/chromatography-system-market#myQueryForm

Pharmaceutical and biotechnology Segment to be the Most Lucrative

The chromatography device market is categorized on the basis of end-use application into hospitals and medical, pharmaceutical, and biotechnology industries and the food and agriculture industry. The demand for pharmaceuticals and biotechnology is projected to rise by 7.3% CAGR, with $5,651.4 million anticipated by 2026. The need for highly sensitive product information in terms of quality and purity, increased use of biopharmaceuticals, especially bio-similar medicines, and monoclonal antibodies that are expected to drive the need for chromatography system are all contributing to the size of the market in the prediction time frame.

The world market share for Asia-Pacific is prominent and is projected to hit $3,283.9 million by 2026 @ https://www.researchdive.com/covid-19-insights/207/chromatography-system-market

Asia-Pacific Region to Expand Business at a Considerable Growth Rate

The world market share for Asia-Pacific is prominent and is projected to hit $3,283.9 million by 2026. The rise in research activities in different fields, such asbiological innovation and pharmaceutical purpose, has contributed to this dominance. A substantial increase is expected to result in sales of $3,283.9 million by 2026, with a 7.5% CAGR in demand for Asia-Pacific RO water treatment system components. In Asia-Pacific, this anticipated rise is mainly due to the existence, of several biopharmaceutical research and development centres, in various major companies such as Merck, Eli Lilly, and Pfizers. These factors are anticipated to fuel the growth of the market over time.

Prominent Players of the Market

Some of the key players of the global chromatography system market include Agilent Technologies (NYSE: A), Perkin Elmer, APIX, Thermo Fisher Scientific Inc., Xylem (OI Analytical), CDS Analytical, Shimadzu Corporation, Waters Corporation, Jasco Inc, Bio-Rad Laboratories and others. These players are adopting several strategies such as mergers & acquisitions and novel product developments to improve their company position in the global industry.

About Us:Research Dive is a market research firm based in Pune, India. Maintaining the integrity and authenticity of the services, the firm provides the services that are solely based on its exclusive data model, compelled by the 360-degree research methodology, which guarantees comprehensive and accurate analysis. With unprecedented access to several paid data resources, team of expert researchers, and strict work ethic, the firm offers insights that are extremely precise and reliable. Scrutinizing relevant news releases, government publications, decades of trade data, and technical & white papers, Research dive deliver the required services to its clients well within the required timeframe. Its expertise is focused on examining niche markets, targeting its major driving factors, and spotting threatening hindrances. Complementarily, it also has a seamless collaboration with the major industry aficionado that further offers its research an edge.

Contact us:Mr. Abhishek PaliwalResearch Dive30 Wall St. 8th Floor, New YorkNY 10005 (P)+ 91 (788) 802-9103 (India)+1 (917) 444-1262 (US)Toll Free: +1-888-961-4454E-mail: [emailprotected]LinkedIn:https://www.linkedin.com/company/research-dive/Twitter:https://twitter.com/ResearchDiveFacebook:https://www.facebook.com/Research-Dive-1385542314927521Blog:https://www.researchdive.com/blogFollow us:https://marketinsightinformation.blogspot.com/

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B.R.A.I.N. Biotechnology Research And Information Network AG: Change in the Management Board of BRAI – PharmiWeb.com

July 9th, 2020 7:45 pm

DGAP-News: B.R.A.I.N. Biotechnology Research And Information Network AG / Key word(s): Personnel07.07.2020 / 08:30 The issuer is solely responsible for the content of this announcement.

Change in the Management Board of BRAIN AG

Chief Business Officer Ludger Roedder is leaving the executive board with immediate effect

Zwingenberg, Germany07 July 2020

The biotechnology company B.R.A.I.N. Biotechnology Research and Information Network AG announces that Chief Business Officer Ludger Roedder will leave the executive board by mutual agreement with immediate effect on July 7th, 2020 due to different strategic visions. Mr. Roedder will leave the BRAIN AG at the end of the calendar year.

Dr Georg Kellinghusen, Chairman of the Supervisory Board, states: "We like to thank Ludger Roedder for his contribution and commitment to the development of the BRAIN AG since 2018 and wish him the most success for his next ventures. We feel very comfortable with the future setup of a two person's board consisting of Adriaan Moelker, CEO, and Lukas Linnig, CFO. Currently we are not planning a succession for Ludger Roedder".

About BRAIN

B.R.A.I.N. Biotechnology Research and Information Network AG (BRAIN AG; ISIN DE0005203947 / WKN 520394) is one of Europe's leading technology companies in the field of industrial biotechnology, the core discipline of Bioeconomy. As such, BRAIN identifies previously untapped, efficient enzymes, microbial producer organisms or natural substances from complex biological systems that can be put to industrial use. The innovative solutions and products developed by help of this "Toolbox of Nature" are successfully applied in the chemistry, the cosmetics and the food industries. BRAIN's business model is based on two pillars. The BioScience segment comprises mainly of the research and development business with industrial partners (the "Tailor-Made Solutions" cooperation business), and the company's own research and development. The BioIndustrial segment consists mainly of the industrially scalable products business. Further information is available at http://www.brain-biotech.com.

B.R.A.I.NBiotechnology ResearchAnd Information Network AGDarmstdter Str. 34-3664673 ZwingenbergGermanywww.brain-biotech.com

Contact Investor RelationsMichael SchneidersHead of Investor RelationsPhone: +49-6251-9331-86E-Mail IR: mis@brain-biotech.com

Media ContactDr. Stephanie KonleManaging AssociateCorporate CommunicationsPhone +49-6251-9331-70Email: stk@brain-biotech.com

DisclaimerThis press release contains forward-looking statements. These statements reflect the current views, expectations, and assumptions of the management of BRAIN AG and are based on information currently available to the management. Forward-looking statements are no guarantees of future performance and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. There are numerous factors which could influence the future performance by and future developments at BRAIN AG and the BRAIN group of companies. Such factors include, but are not limited to, changes in the general economic and competitive environment, risks associated with capital markets, currency exchange rate fluctuations, changes in international and national laws and regulations, in particular with respect to tax laws and regulations, and other factors. BRAIN AG does not undertake any obligation to update or revise any forward-looking statements.

Follow BRAIN AG on Twitter (Twitter@BRAINbiotech) and LinkedIn (@BRAIN AG)

07.07.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at http://www.dgap.de

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Should You Buy Nektar Therapeutics (NKTR) in Biotechnology Industry? – InvestorsObserver

July 9th, 2020 7:45 pm

Nektar Therapeutics (NKTR) is near the bottom in its industry group according to InvestorsObserver. NKTR gets an overall rating of 32. That means it scores higher than 32 percent of stocks. Nektar Therapeutics gets a 15 rank in the Biotechnology industry. Biotechnology is number 11 out of 148 industries.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 32 would rank higher than 32 percent of all stocks.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Nektar Therapeutics (NKTR) stock is trading at $24.83 as of 3:27 PM on Wednesday, Jul 8, a rise of $0.69, or 2.84% from the previous closing price of $24.14. The stock has traded between $23.86 and $24.88 so far today. Volume today is less active than usual. So far 561,924 shares have traded compared to average volume of 1,185,195 shares.

To see InvestorsObserver's Sentiment Score for Nektar Therapeutics click here.

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Chromatography in Biotechnology Market Bolstered by Emerging New Advancements, Says QYR | Bio-Rad Laboratories Inc., Danaher Corp., MilliporeSigma,…

July 9th, 2020 7:45 pm

LOS ANGELES, United States: The report is an all-inclusive research study of the global Chromatography in Biotechnology market taking into account the growth factors, recent trends, developments, opportunities, and competitive landscape. The market analysts and researchers have done extensive analysis of the global Chromatography in Biotechnology market with the help of research methodologies such as PESTLE and Porters Five Forces analysis. They have provided accurate and reliable market data and useful recommendations with an aim to help the players gain an insight into the overall present and future market scenario. The Chromatography in Biotechnology report comprises in-depth study of the potential segments including product type, application, and end user and their contribution to the overall market size.

Get Full PDF Sample Copy of Report: (Including Full TOC, List of Tables & Figures, Chart) https://www.qyresearch.com/sample-form/form/1809781/covid-19-impact-on-global-chromatography-in-biotechnology-market

In addition, market revenues based on region and country are provided in the Chromatography in Biotechnology report. The authors of the report have also shed light on the common business tactics adopted by players. The leading players of the global Chromatography in Biotechnology market and their complete profiles are included in the report. Besides that, investment opportunities, recommendations, and trends that are trending at present in the global Chromatography in Biotechnology market are mapped by the report. With the help of this report, the key players of the global Chromatography in Biotechnology market will be able to make sound decisions and plan their strategies accordingly to stay ahead of the curve.

Competitive landscape is a critical aspect every key player needs to be familiar with. The report throws light on the competitive scenario of the global Chromatography in Biotechnology market to know the competition at both the domestic and global levels. Market experts have also offered the outline of every leading player of the global Chromatography in Biotechnology market, considering the key aspects such as areas of operation, production, and product portfolio. Additionally, companies in the report are studied based on the key factors such as company size, market share, market growth, revenue, production volume, and profits.

Key Players Mentioned in the Global Chromatography in Biotechnology Market Research Report: Bio-Rad Laboratories Inc., Danaher Corp., MilliporeSigma, Qiagen, Scion Instruments, Thermo Fisher Scientific Inc., Perkinelmer, Ge Healthcare Life Sciences, Antec Scientific, Asynt Ltd.

Global Chromatography in Biotechnology Market Segmentation by Product: Gas Chromatography, Thin Layer Chromatography, Supercritical Fluid Chromatography, Liquid Chromatography, HPLC/UHPLC, Affinity Chromatography

Global Chromatography in Biotechnology Market Segmentation by Application: Cancer Research Centers, Cancer Hospital, Pharmaceutical, Pathological Sectors, Companies and Academic Institutions, Others

The Chromatography in Biotechnology Market report has been segregated based on distinct categories, such as product type, application, end user, and region. Each and every segment is evaluated on the basis of CAGR, share, and growth potential. In the regional analysis, the report highlights the prospective region, which is estimated to generate opportunities in the global Chromatography in Biotechnology market in the forthcoming years. This segmental analysis will surely turn out to be a useful tool for the readers, stakeholders, and market participants to get a complete picture of the global Chromatography in Biotechnology market and its potential to grow in the years to come.

Key questions answered in the report:

Request for customization in Report: https://www.qyresearch.com/customize-request/form/1809781/covid-19-impact-on-global-chromatography-in-biotechnology-market

About Us:

QY Research established in 2007, focus on custom research, management consulting, IPO consulting, industry chain research, data base and seminar services. The company owned a large basic data base (such as National Bureau of statistics database, Customs import and export database, Industry Association Database etc), experts resources (included energy automotive chemical medical ICT consumer goods etc.

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Exciting Treatment Harnesses the Immune System – Curetoday.com

July 9th, 2020 7:43 pm

Immunotherapy is a wonderfultestament to the benefits that arise from our growing understanding of the incredibly intricate human immune system.

BY Debu Tripathy, M.D.

Scientists have known for decades that the presence of these immune cells in cancerous tumors is associated with better health outcomes, but not until more recently did they understand why. Compounding the challenge to learn more was the fact that, for a long time, tumor immunology was considered a soft science, with these approaches dismissed as alternative medicine.As we learned that cancer can affect the bodys immune responses and realized rare victories with early immune stimulators such as interferon and interleukin-2, the field of immunotherapy was revived. Newer tools emerged, including drugs known as monoclonal antibodies that target specific proteins to stimulate the immune system. In addition, genetic analysis enabled scientists to identify separate classes of T cells and learn about their unique cancer-fighting abilities.

The location of certain T cells also attracted attention: Why would lymphocytes swarm specifically around tumor cells? This observation, along with new knowledge about the different types of immune cells and the cancer-driving proteins they fight, shed light on why TIL-infiltrated tumors were linked with a better prognosis. Armed with that understanding, scientists created an immunotherapy technique that harnessed the power of TILs to treat numerous cancer types, an experimental strategy discussed in an article in this special issue of CURE.

With this strategy, scientists remove TILs from a patients tumor and select the ones best able to fight the disease those that naturally bind to antigens created by cancer-driving genes. Then the scientists multiply the TILs in a lab through exposure to interleukin-2, which stimulates the cells growth, finally reinfusing them into the patient.

There is still a hit-or-miss element to TIL-based therapy not everyone has a good response, and many techniques are being tried and refined. The work is laborious and requires time to isolate and grow the TILs, which can be too long a wait for some patients with rapidly growing cancers. To address that problem, companies are trying to move this effort from small-bandwidth academic laboratories to scaled-up commercial facilities. As these processes become standardized, it is our hope that the time needed to create ready-to-use cells, along with the cost of the technology, will drop as the success rate rises.

With many of the nations top academic and communithy centers conducting clinical trials in this area, TIL therapy seems poised to make strides in the next couple of years. It will be exciting to watch this strategy move toward wider availability.

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New Study Shows Therapy May Improve Your Immune System – The Mighty

July 9th, 2020 7:43 pm

What happened: Autoimmune conditions affect millions of Americans. A new study from the University of California, Los Angeles published in JAMA Psychiatry analyzed 56 studies about autoimmune disease and concluded that psychosocial intervention (essentially therapy) was associated with enhanced immune system functioning.

In particular, the study found that cognitive behavioral therapy (CBT) created the same amount of immune system improvement as drugs that are typically used to treat inflammatory diseases of the immune system. The study also noted that 10 weeks of CBT costs about $1,500, while one years worth of a drug for autoimmune inflammation can cost $25,000 per year.

Psychosocial interventions are reliably associated with enhanced immune system function and may therefore represent a viable strategy for improving immune-related health.

The Frontlines: The immune system usually works to attack germs and viruses that endanger our health. People with autoimmune diseases have an immune system that mistakenly attacks their own body, destroying organs, joints or skin. Autoimmune diseases are on the rise and are connected with genetic factors, stress, environmental factors and diet.

Get more on mental health: Sign up for our weekly mental health newsletter.

A Mighty Voice: Our community member, Samantha Reid, who has Crohns disease, already knows how interconnected her body and mind are. She shared, If youre physically sick, its exceedingly normal to develop mental illness symptoms as well. You are not alone, and you are not to blame. But just because its normal doesnt mean you cant treat it and try to create a life with more peaks and fewer valleys. You can submit your first person story, too.

Also keep in mind: Often patients with invisible symptoms are told its all in their head and referred for mental health treatment instead of further work to diagnosis a chronic illness. Its important to note that while therapy traditionally associated with mental health can help you manage chronic illness symptoms, its likely only one strategy in a larger treatment plan.

From Our Community:

What takes up the most time in your day-to-day life?

Add your voice:

Other things to know: Autoimmune disease is a physical condition but it also has a psychological impact. Read more about this connection:

Where to learn more: Get information about autoimmune conditions from the American Autoimmune Related Diseases Association.

Header image via microgen/Getty Images

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A ‘Pan-Viral’ Vaccine Designed to Protect the Elderly from Known, and Unknown, Viruses – BioSpace

July 9th, 2020 7:43 pm

The immune response against the AlloPrime vaccine can influence the response to a virus (like the coronavirus that causes COVID-19).

What if you could get one vaccine that protects you against a wide spectrum of viruses, even viruses we havent discovered yet? That might sound impossible and futuristic, but this is just what Immunovative Therapies and its sister company Mirror Biologics, Inc. are aiming to achieve. Their new pan-viral vaccine called AlloPrime is slated to begin a Phase I/II trial next month.

Our pan-viral vaccine harnesses the same protection mechanism that naturally protects us from viral diseases a healthy immune system, Michael Har-Noy, MD, Ph.D., Founder and CEO of Immunovative Therapies, told BioSpace. By remodeling the elderly immune system with a vaccine, we can arm the system to rapidly respond to a viral encounter in the same manner that a young immune system responds to a novel viral encounter.

Just as our body slows down with age, so does our immune system. AlloPrime focuses on remodeling the weakened older immune system by a mechanism known as heterologous immunity. Heterologous immunity occurs when the immune response to one pathogen causes an enhanced response to a later unrelated pathogen. This means that the immune response against the AlloPrime vaccine can influence the response to a virus (like the coronavirus that causes COVID-19).

Im sure the timeliness of strengthening the elderly immune system isnt lost on you COVID-19 heavily impacts older adults. In fact, 80 percent of COVID-19 deaths in the United States have been in people 65 years and older.

As the majority of younger individuals exposed to the virus that causes COVID-19 are either asymptomatic or have mild symptoms, protecting the vulnerable elderly population would enable opening of the economy and building of herd immunity without an increase in hospitalizations and deaths, commented Dr. Har-Noy.

Older adults usually have a weaker response to vaccines, so even if an effective COVID-19 vaccine is created, it could be less protective in older adults, the population that needs protection the most. Thats what is unique about this pan-viral vaccine it focuses specifically on modulating the elderly immune system. AlloPrime could be given as an immune modulator to the elderly on its own or it could be administered as an adjuvant with other vaccines to boost their effectiveness.

In respiratory viral infections that can be transmitted person-to-person, it is especially important to protect the vulnerable elderly population, Dr. Har-Noy said. There is no guarantee that current vaccine technologies, which focus on eliciting neutralizing antibodies, will work to develop a COVID-19 vaccine that is why having a plan B that focuses on a cellular anti-viral immune response is so important, specifically one that targets the most vulnerable.

Immune system basics

Before we get into the nitty gritty details, lets go over the basics of the immune system. Your immune system is the collection of specialized cells and molecules that fight invading pathogens, like viruses and bacteria.

There are two main branches: innate immunity is the quick, non-specific first line of defense, and adaptive immunity is the slower, pathogen-specific response. There are also two types of adaptive immunity: responses that involve cells that destroy pathogens or infected cells (cell-mediated immunity), and responses that involve making antibodies to tag the pathogen for destruction (humoral immunity).

If the pathogen hides inside cells, like viruses do, then creating antibodies against the virus may not provide the most comprehensive protection as they tend to recognize things outside the cell. Generating a cell-based immune response against a virus could provide more robust, longer-lasting protection.

Knowing the optimal immune response to a virus is especially important now. Understanding how COVID-19 affects cell-mediated and antibody-based immunity will be crucial to determining immunity and developing an effective COVID-19 vaccine.

How is this pan-viral vaccine different than other vaccines?

Current vaccine development usually focuses on stimulating the production of antibodies against the virus of interest. This relies not only on knowing what virus you are targeting, but also on having a deep understanding of the virus molecular structure. Most vaccines directly use viral information (such as viral genetic material, viral pieces, or even whole, weakened virus) to attempt to train the persons immune system to recognize and destroy the virus.

Although this method has generated the multitude of efficient vaccines currently available, it has come up short for creating vaccines against certain viruses, such as HIV, Zika, and other pandemic coronavirus strains (such as those that caused SARS and MERS).

Even if a vaccine can successfully generate antibodies against a virus, the vaccine may be rendered less effective or useless if the virus mutates; the antibodies wouldnt recognize the viral mutant as well (if at all). This happens with the various strains and mutations of the flu virus, which is why you need to get an annual flu shot to stay protected.

Immunovatives vaccine, however, isnt reliant on the virus it focuses on the cell-mediated immune response rather than virus-specific antibodies. The vaccine supplements a persons immune system by providing living bioengineered foreign immune cells, called AlloStim, that arent virus-specific. Instead, these foreign cells elicit a powerful immune response that creates a swarm of immune cells ready to sound the alarm and fight future viral invaders.

Rather than trying to figure out which viral peptides are immunogenic or could display on MHC molecules, our approach focuses on the natural immune response, which starts with the cellular innate immune response, Dr. Har-Noy said. Our vaccine would provide pan-viral protection to the most vulnerable population without needing to know the viral structure, including protection against COVID-19 viral mutants and the next viral pandemic that might emerge.

What are AlloStim cells and how are they made?

Immunovatives pan-viral AlloPrime vaccine consists of specialized, engineered living immune cells called AlloStim. To create AlloStim cells, blood from healthy donors is collected and a subset of the white blood cells, called CD4+ T-cells, are isolated from the blood. In the laboratory, the donor T-cells are converted into a patented immune cell that is activated with antibody-coated microbeads to create AlloStim cells.

AlloStim cells possess properties from multiple types of immune cells. They have cytolytic T-cell/natural killer (NK) cell-like properties because they contain sacs (called granules) of certain digestive enzymes (perforin and granzyme B) that can destroy virally-infected cells. AlloStim cells also have the ability to promote anti-viral effects by steering the immune response to elicit Th1 helper T-cells by producing critical signaling molecules, such as CD40L, interferon-gamma (IFN-gamma), and TNF-alpha. These molecules activate macrophages, which educate the immune system to develop memory immune cells that can elicit a response upon encountering any virus.

AlloStim cells are also currently being tested in separate studies as a cancer vaccine for various chemotherapy-refractory metastatic cancers.

Weve seen that AlloStim cells provided protective effects in cancer patients with viral infections, such as lower viral counts in cancer patients with hepatitis B and lowered viral burden in HIV patients, Dr. Har-Noy said. We also have animal data demonstrating that this approach could protect mice from lethal challenge with cancer cells and malaria. These observations, in light of the current pandemic, made us think about using this technology as a preventative vaccine against viral infections.

(image above depicts AlloStim cells. Credit: Immunovative Therapeutics)

How can AlloStim cells be used as a pan-viral vaccine?

The rationale for creating this AlloStim cell-based vaccine was recently published in the Journal of Translational Medicine. Dr. Har-Noy suggests that giving older adults AlloStim cells can repopulate their exhausted immune cells, creating an army of new, refreshed memory immune cells that are ready and waiting for an invader.

Because AlloStim cells are intentionally mismatched to the person, their immune system will be alerted and create an immune response against the cells. After injecting the angry living AlloStim cells under the skin, the cells produce high levels of inflammatory molecules (such as IFN-gamma and TNF-alpha) and express CD40L on their surface. These inflammatory molecules, in addition to danger signals released by the persons own cells, cause an immune response known to be effective against most viral infections.

The elderly have missing or senescent interferon-producing cells, and many modern viruses, such as the virus that causes COVID-19, actively suppresses interferon production as an immune evasion strategy, Dr. Har-Noy said. The goal of this pan-viral vaccine is to provide this missing part of the elderly immune system to overcome the viral evasion mechanism and provide an immediate source of interferon.

Having a stronger, quicker anti-viral immune response the next time they encounter an invading virus provides heterologous immunity, tamping down the early viral infection before it can get out of hand.

Allopriming with AlloStim cells is a more refined and modern method to elicit heterologous immunity, explained Dr. Har-Noy. Heterologous immunity can broaden the protective outcomes of vaccinations, so it could potentially be used to enhance a future COVID-19 vaccine to be more effective in the elderly.

The AlloPrime vaccine wouldnt just be for healthy people either. At the onset of a viral illness, such as COVID-19, a person who previously got this vaccine could get another dose of AlloStim cells. This would prompt a stronger and faster anti-viral immune response that could help the body fight off the virus quicker.

AlloStim cells have already been shown to prompt an immune response in heavily immunocompromised cancer patients, whose immune systems are not too far off from the weakened older immune system. Although it is not known how long the AlloStim-induced immunity lasts, Dr. Har-Noy said it lasted for years in many of the cancer patients they assessed.

AlloStim cells have the benefits of having lots of human safety data and these cells are already being manufactured under good manufacturing processes (GMP), so we are able to quickly pivot into COVID-19 clinical trials, commented Dr. Har-Noy. In addition, since the AlloStim cells are off-the-shelf, where one donor can produce enough doses for potentially thousands of patients, the vaccine has the benefit of economy of scale to make it more affordable.

FDA clearance of Phase I/II study

The FDA recently cleared Immunovative and Mirror Biologics to begin a Phase I/II trial of their pan-viral AlloPrime vaccine in healthy older adults. For the study, the company aims to recruit a total of 40 healthy adults divided between two age cohorts: ages 65-74 and ages 75+.

Participants will receive five doses of the vaccine intradermally (under the skin) within a 14-day period, each dose being a few days apart. They will be monitored for adverse events for 30 days after receiving their initial dose. Blood samples will be taken before, 30 days after, 6 months after, and 1 year after initial dosing to monitor immune response durability.

The blood samples will be used to monitor participants immune response to the vaccine, including if they make memory T-cells against the AlloStim cells, if those memory T-cells can be activated after exposure to virus components, and if the activated memory T-cells can trigger an anti-viral state (if they produce IFN-gamma) and suppress viral growth in virally-infected human respiratory tract cells. The vaccine-induced cytotoxic T-cells ability to kill virally-infected cells will also be assessed.

This is a good way to show efficacy because it produces a definitive response, Dr. Har-Noy said. The production of neutralizing antibodies against the virus of interest doesnt necessarily determine a vaccines efficacy. Especially for new viral infections like COVID-19, we dont know if the antibodies recovered from patients are protective or, if they are protective, for how long they provide protection.

The Phase I/II study is expected to begin next month.

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How Ayurveda and Naturotherapy can help to boost your immune system? – PINKVILLA

July 9th, 2020 7:43 pm

Dr Manoj Kutteri, Wellness Director Atmantan Wellness Centre, has shared some Ayurvedic and Naturotherapy based tips for the better immune system. Read on to know more.

Every human body has an ingrained doctor that we call the immune system. The science today has conveniently forgotten this inherent capacity of the human body to heal by itself. Ayurveda, Naturopathy and Yoga systems are built to fit into this wholesome health model proposed by evolutionary biologists globally these days. The understanding is that human physiology is a self-correcting system that does not tolerate outside interventions in minor illness syndromes.

Ayurvedic treatments are a natural cure for viral infections. The traditional Ayurvedic Panchakarma retreat with its deeply nourishing, enriching, and purifying practice is one of the best Ayurvedic treatments to treat viral infections like the coronavirus. Through Yogic Kriyas like Neti, Dhouti, etc the Ayurvedic Panchakarma is performed in various forms like Shirodara, Januvasti, Kativasti, etc. and water therapies to cleanse, and cure the body from within. The cleansing therapy helps detoxify the body, and boost immunity to fight through viral infections.

Ayurveda is full of medicines and herbs potent to improve immunity and cure cough and cold. Tulsi is the herb of all reasons with Vitamin C, antioxidants, antiseptic and antiviral properties. For Viral infections like cold, flu, etc or something as severe as the coronavirus, Tulsi leaves can be a perfect solution to fight through the viral infections, increase immunity and recover from infections. Chewing on one fresh Tulsi leaf daily is recommended to fight through viral infections. Alternatively, Tulsi tea or adding the leaves in soup, food, etc. can help boost your immunity and provide some relief.

Ayurvedic practices can help you stay healthy through seasonal viral infections. Be it cough, cold or flu, the Ayurvedic lifestyle can help you improve your body functioning, boost immunity and fight through infections.

Some tips include:

Turmeric Paste Turmeric is a healing Ayurvedic herb known for healing properties. Making a paste of turmeric or adding raw turmeric with honey can bring in relief from coughing and sneezing.

Neem Neem has antiseptic and antiviral properties. Neem concoctions, when taken daily, can fight through viral infections.

Fruits and Vegetables Adding a lot of fruits, green leafy vegetables, nuts, and seeds, etc can enrich your diet and bring in nutrients for optimum body functioning.

Oil Pulling and other therapies Traditional Ayurvedic Therapies are a great cleanse, entailing improved stamina, immunity and energy to fight through diseases.

In addition to Naturopathic practices, here are small steps that you can take which reap astoundingly positive results:

Eat clean: The clich is true; your body is a temple and you have to be careful of what youre feeding it. While a once in a blue moon cheat day wont hurt, unmindful eating habits are the core reason for stunting the growth of your immune system. Nourish your body with vitamin-rich foods and give it a sufficient amount of fibre, remember your immune system has nothing to do with the way your body looks. For a healthy liver, cruciferous vegetables like Kale, Broccoli and Cabbage should be included in daily diet. A healthy liver ensures the bodys natural detoxification process.

Sleep well: Getting your sleep cycle in sync is one of the biggest gifts you can give your body. The body requires bout 8 hours of sound sleep to rejuvenate and reboot its systems. It has to be kept in mind that its not only 8 hours of sleep, but the timely hours of sleep that matter too. Often, we stress ourselves by staying up till 3 am and sleeping only at sun up thereby disrupting the normal functioning of our body that leads to obesity, stress, emotional imbalance and other illnesses.

Work-out: Working out on a regular basis has been scientifically proven to boost the immune system. Regular exercise mobilizes the T cells, a type of white blood cell which guards the body against infection. However, continuous rigorous workout weakens the immune system, leaving you prone to flu and viral infections. The low level of Vitamin D in the body has been termed as one of the major reasons for respiratory problems. A brisk walk in the sunlight for 1015 minutes will ensure that enough Vitamin D is produced in the body. These are simple but highly effective tweaks in your daily routine. The key is listening carefully to your body and conscious living, consistently.

Dr Manoj Kutteri, Wellness Director Atmantan Wellness Centre.

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Meet the Researcher Leading NIH’s COVID-19 Vaccine Development Efforts – GovExec.com

July 9th, 2020 7:43 pm

A safe, effective vaccine is the ultimate tool needed to end the coronavirus disease 2019 (COVID-19) pandemic. Biomedical researchers are making progress every day towards such a vaccine, whether its devising innovative technologies or figuring out ways to speed human testing. In fact, just this week, NIHs National Institute of Allergy and Infectious Diseases (NIAID) established anew clinical trials networkthat will enroll tens of thousands of volunteers in large-scale clinical trials testing a variety of investigational COVID-19 vaccines.

Among the vaccines moving rapidly through the development pipeline is one developed by NIAIDs Dale and Betty Bumpers Vaccine Research Center (VRC), in partnership with Moderna, Inc., Cambridge, MA. So, I couldnt think of a better person to give us a quick overview of the COVID-19 vaccine research landscape than NIHs Dr. John Mascola, who is Director of the VRC. Our recent conversation took place via videoconference, with John linking in from his home in Rockville, MD, and me from my place in nearby Chevy Chase. Heres a condensed transcript of our chat:

Collins: Vaccines have been around since Edward Jenner and smallpox in the late 1700s. But how does a vaccine actually work to protect someone from infection?

Mascola: The immune system works by seeing something thats foreign and then responding to it. Vaccines depend on the fact that if the immune system has seen a foreign protein or entity once, the second time the immune response will be much brisker. So, with these principles in mind, we vaccinate using part of a viral protein that the immune system will recognize as foreign. The response to this viral protein, or antigen, calls in specialized T and B cells, the so-called memory cells, and they remember the encounter. When you get exposed to the real thing, the immune system is already prepared. Its response is so rapid that you clear the virus before you get sick.

Collins: What are the steps involved in developing a vaccine?

Mascola: One cant make a vaccine, generally speaking, without knowing something about the virus. We need to understand its surface proteins. We need to understand how the immune system sees the virus. Once that knowledge exists, we can make a candidate vaccine in the laboratory pretty quickly. We then transfer the vaccine to a manufacturing facility, called a pilot plant, that makes clinical grade material for testing. When enough testable material is available, we do a first-in-human study, often at our vaccine clinic at the NIH Clinical Center.

If those tests look promising, the next big step is finding a pharmaceutical partner to make the vaccine at large scale, seek regulatory approval, and distribute it commercially. That usually takes a while. So, from start to finish, the process often takes five or more years.

Collins: With this global crisis, we obviously dont have five years to wait. Tell us about what the VRC started to do as soon as you learned about the outbreak in Wuhan, China.

Mascola: Sure. Its a fascinating story. We had been talking with NIAID Director Dr. Anthony Fauci and our colleagues about how to prepare for the next pandemic. Pretty high on our list were coronaviruses, having already worked on past outbreaks of SARS and MERS [other respiratory diseases caused by coronaviruses]. So, we studied coronaviruses and focused on the unique spike protein crowning their surfaces. We designed a vaccine that presented thespike proteinto the immune system.

Collins: Knowing that the spike protein was likely your antigen, what was your approach to designing the vaccine?

Mascola: Our approach was a nucleic acid-based vaccine. Im referring to vaccines that are based on genetic material, either DNA or RNA. Its this type of vaccine that can be moved most rapidly into the clinic for initial testing.

When we learned of the outbreak in Wuhan, we simply accessed the nucleic acid sequence of SARS-CoV-2, the novel coronavirus that causes COVID-19. Most of the sequence was on a server from Chinese investigators. We looked at the spike sequence and built that into an RNA vaccine. This is calledin silicovaccine design. Because of our experience with the original SARS back in the 2000s, we knew its sequence and we knew this approach worked. We simply modified the vaccine design to the sequence of the spike protein of SARS-CoV-2. Literally within days, we started making the vaccine in the lab.

At the same time, we worked with a biotechnology company called Moderna that creates personalized cancer vaccines. From the time the sequence was made available in early January to the start of the first in-human study, it was about 65 days.

Collins: Wow! Has there ever been a vaccine developed in 65 days?

Mascola: I dont think so. There are a lot of firsts with COVID, and vaccine development is one of them.

Collins: For the volunteers who enrolled in the phase 1 study, what was actually in the syringe?

Mascola: The syringe included messenger RNA (mRNA), the encoded instructions for making a specific protein, in this case the spike protein. The mRNA is formulated in a lipid nanoparticle shell. The reason is mRNA is less stable than DNA, and it doesnt like to hang around in a test tube where enzymes can break it down. But if one formulates it just right into a nanoparticle, the mRNA is protected. Furthermore, that protective particle allows one to inject it into muscle and facilitates the uptake of the mRNA into the muscle cells. The cells translate the mRNA into spike proteins, and the immune system sees them and mounts a response.

Collins: Do muscle cells know how to take that protein and put it on their cell surfaces, where the immune system can see it?

Mascola: They do if the mRNA is engineered just the right way. Weve been doing this with DNA for a long time. With mRNA, the advantage is that it just has to get into the cell [not into the nucleus of the cell as it does for DNA]. But it took about a decade of work to figure out how to do nucleotide silencing, which allows the cell to see the mRNA, not destroy it, and actually treat it as a normal piece of mRNA to translate into protein. Once that was figured out, it becomes pretty easy to make any specific vaccine.

Collins: Thats really an amazing part of the science. While it seems like this all happened in a blink of an eye, 65 days, it was built on years of basic science work to understand how cells treat mRNA. Whats the status of the vaccine right now?

Mascola: Early data from the phase 1 study are very encouraging. Theres a manuscript in preparation that should be out shortly showing that the vaccine was safe. It induced a very robust immune response to that spike protein. In particular, we looked for neutralizing antibodies, which are the ones that attach to the spike, blocking the virus from binding to a cell. Theres a general principle in vaccine development: if the immune system generates neutralizing antibodies, thats a very good sign.

Collins: Youd be the first to say that youre not done yet. Even though those are good signs, that doesnt prove that this vaccine will work. What else do you need to know?

Mascola: The only real way to learn if a vaccine works is to test it in people. We break clinical studies into phases 1, 2, and 3. Phase 1 has already been done to evaluate safety. Phase 2 is a larger evaluation of safety and immune response. Thats ongoing and has enrolled 500 or 600 people, which is good. The plan for the phase 3 study will be to start in July. Again, thats incredibly fast, considering that we didnt even know this virus existed until January.

Collins: How many people do you need to study in a phase 3 trial?

Mascola: Were thinking 20,000 or 30,000.

Collins: And half get the vaccine and half get a placebo?

Mascola: Sometimes it can be done differently, but the classic approach is half placebo, half vaccine.

Collins: Weve been talking about the VRC-Moderna nucleic acid vaccine. But there are others that are coming along pretty quickly. What other strategies are being employed, and what are their timetables?

Mascola: There are many dozens of vaccines under development. The response has been extraordinary by academic groups, biotech companies, pharmaceutical companies, and NIHsAccelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership. I dont think Ive ever seen so much activity in a vaccine space moving ahead at such a rapid clip.

As far as being ready for advanced clinical trials, there are a just handful and they involve different types of vaccines. At least three nucleic acid vaccines are in clinical trials. There are also two vaccines that use proteins, which is a more classic approach.

In addition, there are several vaccines based on a viral vector. To make these, one puts the genes for the spike protein inside an adenovirus, which is an innocuous cold virus, and injects it into muscle. In regard to phase 3 trials, there are maybe three or four vaccines that could be formally in such tests by the fall.

Collins: How is it possible to do this so much more rapidly than in the past, without imposing risks?

Mascola: Its a really important question, Francis. A number of things are being done in parallel, and that wouldnt usually be the case. We can get a vaccine into a first-in-human study much more quickly because of time-saving technologies.

But the real important point is that for the phase 3 trial, there are no timesavers. One must enroll 30,000 people and watch them over months in a very rigorous, placebo-controlled environment. The NIH has stood up whats called a Data Safety Monitoring Board for all the trials. Thats an independent group of investigators that will review all vaccine trial data periodically. They can see what the data are showing: Should the trial be stopped early because the vaccine is working? Is there a safety signal that raises concern?

While the phase 3 trial is going on, the U.S. government also will be funding large-scale manufacture of the vaccine. Traditionally, you would do the vaccine trial, wait until its all done, and analyze the data. If it worked, youd build a vaccine plant to make enough material, which takes two or three years, and then go to the Food and Drug Administration (FDA) for regulatory approval.

Everything here is being done in parallel. So, if the vaccine works, its already in supply. And we have been engaging the FDA to get real-time feedback. That does save a lot of time.

Collins: Is it possible that well manufacture a whole lot of doses that may have to be thrown out if the vaccine doesnt work?

Mascola: It certainly is possible. One would like to think that for coronaviruses, vaccines are likely to work, in part because the natural immune response clears them. People get quite sick, but eventually the immune system clears the virus. So, if we can prime it with a vaccine, there is reason to believe vaccines should work.

Collins: If the vaccine does work, will this be for lifelong prevention of COVID-19? Or will this be like the flu, where the virus keeps changing and new versions of the vaccine are needed every year?

Mascola: From what we know about coronaviruses, we think its likely COVID-19 is not like the flu. Coronaviruses do have some mutation rate, but the data suggest its not as rapid as influenza. If were fortunate, the vaccine wont need to be changed. Still, theres the matter of whether the immunity lasts for a year, five years, or 10 years. That we dont know without more data.

Collins: Do we know for sure that somebody who has had COVID-19 cant get it again a few months later?

Mascola: We dont know yet. To get the answer, we must do natural history studies, where we follow people whove been infected and see if their risk of getting the infection is much lower. Although classically in virology, if your immune system shows neutralizing antibodies to a virus, its very likely you have some level of immunity.

Whats a bit tricky is there are people who get very mild symptoms of COVID-19. Does that mean their immune system only saw a little bit of the viral antigen and didnt respond very robustly? Were not sure that everyone who gets an infection is equally protected. Thats going to require a natural history study, which will take about a year of follow-up to get the answers.

Collins: Lets go back to trials that need to happen this summer. You talked about 20,000 to 30,000 people needing to volunteer just for one vaccine. Whom do you want to volunteer?

Mascola: The idea with a phase 3 trial is to have a broad spectrum of participation. To conduct a trial of 30,000 people is an enormous logistical operation, but it has been done for the rotavirus and HPV vaccines. When you get to phase 3, you dont want to enroll just healthy adults. You want to enroll people who are representative of the diverse population that you want to protect.

Collins: Do you want to enrich for high-risk populations? Theyre the ones for whom we hope the vaccine will provide greatest benefit: for example, older people with chronic illnesses, African Americans, and Hispanics.

Mascola: Absolutely. We want to make sure that we can feel comfortable to recommend the vaccine to at-risk populations.

Collins: Some people have floated another possibility. They ask why do we need expensive, long-term clinical trials with tens of thousands of people? Couldnt we do a human challenge trial in which we give the vaccine to some healthy, young volunteers, wait a couple of weeks, and then intentionally expose them to SARS-CoV-2. If they dont get sick, were done. Are challenge studies a good idea for COVID-19?

Mascola: Not right now. First, one has to make a challenge stock of the SARS-CoV-2 thats not too pathogenic. We dont want to make something in the lab that causes people to get severe pneumonia. Also, for challenge studies, it would be preferable to have a very effective small drug or antibody treatment on hand. If someone were to get sick, you could take care of the infection pretty readily with the treatments. We dont have curative treatments, so the current thinking is were not there yet for COVID-19 challenge studies [1]. If you look at our accelerated timeline, formal vaccine trials still may be the fastest and safest way to get the answers.

Collins: Im glad youre doing it the other way, John. Its going to take a lot of effort. Youre going to have to go somewhere where there is still ongoing spread, otherwise you wont know if the vaccine works or not. Thats going to be tricky.

Mascola: Yes. How do we know where to test the vaccine? We are using predictive analytics, which is just a fancy way of saying that we are trying to predict where in the country there will be ongoing transmission. If we can get really good at it, well have real-time data to say transmission is ongoing in a certain area. We can vaccinate in that community, while also possibly protecting people most at risk.

Collins: John, this conversation has been really informative. Whats your most optimistic view about when we might have a COVID-19 vaccine thats safe and effective enough to distribute to the public?

Mascola: An optimistic scenario would be that we get an answer in the phase 3 trial towards the end of this year. We have scaled up the production in parallel, so the vaccine should be available in great supply. We still must allow for the FDA to review the data and be comfortable with licensing the vaccine. Then we must factor in a little time for distributing and recommending that people get the vaccine.

Collins: Well, its wonderful to have someone with your skills, experience, and vision taking such a leading role, along with your many colleagues at the Vaccine Research Center. People like Kizzmekia Corbett, Barney Graham, and all the others who are a part of this amazing team that youve put together, overseen by Dr. Fauci.

While there is still a ways to go, we can take pride in how far we have come since this virus emerged just about six months ago. In my 27 years at NIH, Ive never seen anything quite like this. Theres been a willingness among people to set aside all kinds of other concerns. Theyve gathered around the same table, worked on vaccine design and implementation, and gotten out there in the real world to launch clinical trials.

John, thank you for what you are doing 24/7 to make this kind of progress possible. Were all watching, hoping, and praying that this will turn out to be the answer that people desperately need after such a terribly difficult time so far in 2020. I believe 2021 will be a very different kind of experience, largely because of the vaccine science that weve been talking about today.

Mascola: Thank you so much, Francis. And thanks for recognizing all the people behind the scenes who are making this happen. Theyre working really hard!

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Meet the Researcher Leading NIH's COVID-19 Vaccine Development Efforts - GovExec.com

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Cell-like decoys could mop up viruses in humans including the one that causes COVID-19 – The Conversation US

July 9th, 2020 7:43 pm

The Research Brief is a short take about interesting academic work.

Researchers around the world are working frantically to develop COVID-19 vaccines meant to target and attack the SARS-CoV-2 virus. Researchers in my nanoengineering lab are taking a different approach toward stopping SARS-CoV-2. Instead of playing offense and stimulating the immune system to attack the SARS-CoV-2 virus, were playing defense. Were working to shield the healthy human cells the virus invades.

Conceptually, the strategy is simple. We create decoys that look like the human cells the SARS-CoV-2 virus invades. So far, weve made lung-cell decoys and immune-cell decoys. These cell decoys attract and neutralize the SARS-CoV-2 virus, leaving the real lung or immune cells healthy.

To make the decoys, we collect the outer membranes of the lung or immune cells and wrap them around a core made of biodegradable nanoparticles. From the outside the decoys look the same as the human cells they are impersonating. Our decoys are hundreds of times smaller in diameter than an actual lung or immune cell, but they have all the same cellular hardware sticking out of them.

We call them nanosponges because they soak up harmful pathogens and toxins that attack the cells they impersonate. My team and I first developed the concept 10 years ago, and since then weve shown the nanosponges offer a new approach to fighting viral infections like HIV; bacterial infections like methicillin-resistant Staphylococcus aureus, or MRSA, E. coli and sepsis; and inflammatory diseases like rheumatoid arthritis.

We recently published results showing that the SARS-CoV-2 coronavirus binds to these decoy nanosponges, which were more than 90% effective in causing the virus to lose its ability to infect cells in petri dishes. Once the virus is locked into the decoy, it cant invade any real cells, and is cleared by the bodys immune system.

Vaccines are critical for protecting against viral infections, but as viruses mutate they can render vaccines and treatments ineffective. This is why new flu vaccines are developed each year. Fortunately, SARS-CoV-2 doesnt appear to mutate as quickly as influenza viruses, but this highlights the need for alternatives that are unaffected by mutations.

Im hopeful that other teams of researchers come up with safe and effective treatments for COVID-19 as soon as possible. But for now, my team is working and planning as if the world is counting on us.

The different types of nanosponges weve developed are in various stages of pre-clinical development. So far, the results look promising, but there is more work to do to ensure theyre safe and effective.

Cellular nanosponges are a new kind of drug. We made the first nanosponges using human red blood cell membranes, and these are the furthest along in the regulatory process, having undergone all stages of pre-clinical testing.

Cellics Therapeutics, a startup company I co-founded, is in the process of submitting an investigational new drug application to the FDA for the red blood cell nanosponges to treat bacterial pneumonia. If these red blood cell nanosponges get FDA approval and if the pre-clinical data for the COVID-19 nanosponges keep looking good, the COVID-19 nanosponges could have a clearer path to clinical trials in the years ahead.

We are currently testing the nanosponges for SARS-CoV-2 in animals. If the nanosponges do reach the clinical trial stage, there are several ways of delivering the therapy, including direct delivery into the lung for intubated patients via an inhaler like those used by asthmatic patients or through an intravenous injection.

There is also the possibility that our immune-cell nanosponges could soak up the inflammatory cytokine proteins that are triggering the dangerous immune system overreactions in some people suffering from COVID-19.

[You need to understand the coronavirus pandemic, and we can help. Read The Conversations newsletter.]

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Medical care for very ill COVID-19 patients is getting better – USA TODAY

July 9th, 2020 7:43 pm

The U.S. is currently facing a shortage of ventilators. Here's how they work and why they are so important in fighting COVID-19. USA TODAY

When Dr. Carl June first heard about symptoms in seriously ill COVID-19 patients, his thoughts jumped to Emily Whitehead.Emily, 7, had endured the same kind of immune systemoverreaction when June treated her in 2012 with an experimental therapy against her leukemia.

Her immune system went into life-threatening overdrive, just like many of those with COVID-19.

In a last-ditch effort to save Emily's life, he had given her a drug,tocilizumab, that kept his own daughter's rheumatoid arthritis under control. To everyone's surprise, the drug worked. Emily is now a normal teenager.

Tocilizumab is one of hundreds of therapies being tested against COVID-19.

Four months ago when COVID-19 arrived in the USA, there were no therapies shown to treat it. Doctors relied solely on what's called supportive care, including intravenous fluids, fever reducersand ventilators, the bulky machines that allow people to breathe when they can't do it on their own.

There are two approved therapies shown to make a difference in COVID-19, and 150 treatments and more than 50 antivirals are being tested in people.

A treatment that kept people from falling seriously ill or even needing hospitalization could strip the fear from the coronavirus andallow people to resume their pre-COVID-19 lives.

Once somebody develops a treatment for the virus, everything will go away, said Daniel Batlle, a kidney expert from Northwestern Medicine and professor of medicine at Northwestern University in Chicago.

Even after a vaccine is developed, treatments that save lives and prevent hospitalization will be crucial.Vaccines might not work for everyone, and doses may initially be limited.

The majority of people diagnosed with COVID-19 more than 80% will recover without the need for hospitalization or significant treatment.

For those who do require care, treatments haveevolved as researchers learn more about the coronavirus and the infection it causes, as well as the damage it can do tovarious parts of the body.

Potential therapies being tested, experts said, fall into four major categories that are best used at different times:

Even as these different approaches are tested, many unanswered questions and challenges remain. One is how to treat patients who might have different responses to the virus, said Dr. John Wherry, director of the institute for immunology at the Perlman School of Medicine at the University of Pennsylvania.

At Penn, he and his colleagues have seen three types of patients: a large group whose immune system is overreacting, a small group whose immune system is underreacting, and others whose immune system is more balanced in the response.

Drugs are tested on all patients without making any distinction, Wherry said. That means ones that tamp down the immune system might help patients with an overactive immune systembut hurt those whose immune systems arent working hard enough, and do nothing for those with a balanced immune response.

Drugs that might be useful for patients with too little immune response might be seen as ineffectivebecause they don't help the larger number of people with immune overreactions, he said.

Wherry said researchers are getting closer to identifying which patients are likely to do better with which kind of therapy. We still need to be pushing very hard and thinking very creatively about how to match treatments to the right patient, he said.

Doctors learn other approaches simply by treating patients.

Batlle, the kidney expert, said that although COVID-19 has been considered a lung disease, as many as half of patients hospitalized with severe cases also suffer acute kidney injury. Its notclear how many patients will be left with long-term kidney problems after recovering from severe cases of COVID-19.

We dont want to scare anybody, but kidney damage was initially underreported, and now several studies have shown that it is extremely frequent in hospitalized patients," he said.

Treatment for acute kidney injury usually involves dialysis, which removes toxins from the blood that the kidneys can no longer address. Batlle hopes treatments that address COVID-19-related inflammation and formation of blood clots will eventually reduce such injuries.

We should be better prepared to help these patients and not rely (only)on supportive care, he said.

As coronavirus cases in some states start to rise again, make sure to remember these safety tips. USA TODAY

Since mid-May, dexamethasone and remdesivir have been shown useful for certain COVID-19 patients. Both are recommended by the National Institutes of Health and the Infectious Disease Society of America.

For hospitalized patients, these drugs are beginning to show an effect, said Dr. Rajesh Gandhi, an infectious disease specialist at Massachusetts General Hospital who sits on both panels.

Placing patients on their stomachs rather than their back when they have breathing problems may help, according to some experts.

Gandhi and other doctors said they are much more comfortable treating COVID-19s many symptoms, which can include blood clots, immune problems and organ failure, in addition to lung issues.

Get daily coronavirus updates in your inbox:Sign up for our newsletter

Some said COVID-19 is a multi-system disease, targeting at times the lining of blood vessels. This would explain how it damages so many of the body's organs, all of which are fed by blood vessels.

A study by theRecovery Collaborative Group, still not fully vetted, showed that dexamethasone, at a dose of 6 mg per day for up to 10 days, can be lifesaving for patients with COVID-19 who are on ventilators. The evidence was weaker for patients who are hospitalized and receiving oxygen. The study found no support for giving the steroid to less seriously ill COVID-19 patients, but more research is underway.

According to a study in May in the New England Journal of Medicine,the drug remdesivir, developed to treat Ebola, shortened the recovery time of patients hospitalized with COVID-19 and lower respiratory tract infections.

Scientists said remdesivir might be even more effective in people who are notsick enough to require hospitalization, but because it can be delivered only intravenously, it has not been tested on outpatients. Its manufacturer, Gilead, is rushing to ramp up production and to develop an inhaled version of the drug.

Although remdesivir is helpful, it doesnt cure COVID-19 and is far from a home run, said Dr. Mark Rupp, an infectious disease expert at the University of Nebraska.

Its kind of like getting on base with a single, he said. Weve got a long way to go.

Although its tempting tothrow everything in the medicine cabinet at COVID-19, Rupp said he learned while fighting Ebola in 2014-2015 that its much more important to conduct high-quality clinical research during an outbreak.

Without such research, you throw the kitchen sink at everybody, and you dont know what helps and what hurts and thats a dangerous place to be, he said.

He cited the example of hydroxychloroquine,which was used early on to treat COVID-19 before research showed it was ineffective in very sick patients.

Everybody wants to do good, we want to help our patients, Rupp said. But sometimes well-meaning efforts really dont result in beneficial effects.

Its only by testing drugs and other therapies through clinical trials that doctors learn what works and what doesnt, he said. The more data and information we can gather, the better off were going to be.

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Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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