StemCell Therapy

Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeting CAR T-cell therapy, yielded a response in73% of patients with heavily pretreated relapsed/refractory multiple myeloma, according to topline findings from the pivotal phase 2 KarMMA trial shared during the 2020 ASCO Virtual Scientific Program.

In the study, 33% of patients had a complete response with ide-cel. The median duration of response (DOR) was 10.7 months, and the median progression-free survival (PFS) was 8.8 months (95% CI, 5.6-11.6).

Ide-cel demonstrated frequent, deep, and durable responses in heavily pretreated, highly relapsed/refractory patients with myeloma, said Nikhil C. Munshi, MD, director of Basic and Correlative Science, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, professor of Medicine, Harvard Medical School. Overall, ide-cel provides an attractive option for the treatment of patients with triple-class exposed relapsed/refractory myeloma.

In March 2020, Bristol Myers Squibb and bluebird bio, Inc., the codevelopers of ide-cel, submitted a Biologics License Application (BLA) to the FDA for the use of the CAR T-cell therapy as a treatment for adult patients with multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

However, earlier this month, the FDA issued a Refusal to File letter to the companies regarding the BLA. In its initial review, the agency concluded that additional information was needed for the Chemistry, Manufacturing and Control module of the BLA. The FDA did not ask for any further clinical or nonclinical data according to the companies, which plan to resubmit the application by the end of July of this year.

The phase 2 KarMMA trial (NCT03361748) included 128 patients with relapsed/refractory multiple myeloma who received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

The median age was 61 months (range 33-78), 35% of patients had high-risk cytogenetics, 51% had high tumor burden, 39% had extramedullary disease, and 85% had 50% tumor BCMA expression. ECOG performance status was 0 (45%), 1 (53%), or 2 (2%). R-ISS disease stage was I (11%), 2 (70%), or III (16%). Patients had received a median of 6 (range, 3-16) prior antimyeloma regimens.

Ninety-four percent of patients had received 1 prior autologous stem cell transplant, and 34% had received more than 1. Eighty-eight percent of patients received bridging therapies during CAR T-cell manufacturing; however, only 4% of patients responded to the treatment. Regarding refractory status, 94% of patients were refractory to anti-CD38 antibodies and 84% were triple refractory.

Patients were treated at CAR+ T cell doses of 150 x 106 (n = 4), 300 x 106 (n = 70), or 450 x 106 (n = 54). The median follow-up was 18 months, 15.8 months, and 12.4 months, respectively. Across all patients, the median follow-up was 13.3 months. The primary end point was ORR, with secondary end points including CR, DOR, PFS, overall survival (OS), and quality of life.

Across all patients, the 73% ORR (95% CI, 65.8-81.1; P <.0001) included a 33% CR rate (95% CI, 24.7-40.9; P <.0001), a 20% very good partial response rate, and a 21% partial response rate. The overall CR rate comprised 26% of patients who achieved a CR/stringent CR (sCR) and were minimal residual disease (MRD)-negative, and 7% of patients who achieved a CR/sCR but who did not have MRD data. The median time to first response was 1 month (range, 0.5-8.8) and the median time to CR was 2.8 months (range, 1-11.8).

Durable responses were observed across all doses, said Munshi. At the dose of 450 x 106 CAR+ T cells, the ORR was 82% and the CR/sCR rate was 39%.

Clinically meaningful efficacy in terms of ORR was observed across subgroups, irrespective of age, risk categorization, tumor burden, BCMA expression level, extramedullary disease, triple-refractory status, penta-refractory status, and bridging therapy.

PFS increased as the target dose increased. At the 450 x 106 CAR+ T-cell dose, the median PFS was 12.1 months (95% CI, 8.8-12.3). The median PFS also increased by depth of response with a median of 20.2 months (95% CI, 12.3not evaluable) among patients who achieved a CR/sCR.

Munshi said the survival data are immature. At the time of the analysis, the median OS was 19.4 months (95% CI, 18.2not evaluable) and the 1-year OS rate was 78%.

Cytokine release syndrome (CRS) frequency increased with dose but was mostly low-grade, said Munshi. Overall, 84% of patients had 1 CRS event, with the majority (78%) being grade 1/2. There were 5 cases of grade 3 CRS, 1 case of grade 4, and 1 case of grade 5. The median time to onset of CRS was 1 day (range, 1-12), and the median duration of CRS was 5 days (range, 1-63). Fifty-two percent of patients received tocilizumab (Actemra) for CRS management, and 15% of patients received corticosteroids.

Neurotoxicity was mostly low grade and was similar across target doses, said Munshi. Overall, 18% of patients had 1 neurotoxicity event. There were 19 cases of grade 1/2 neurotoxicity and 4 cases of grade 3. There were no grade 4 or 5 incidents. The median time to onset of neurotoxicity was 2 days (range, 1-10), and the median duration was 3 days (range, 1-26). Two percent of patients received tocilizumab for neurotoxicity, and 8% of patients received corticosteroids.

The other significant adverse event, according to Munshi, was cytopenia91% of patients had any grade neutropenia (89% grade 3), and 63% (52% grade 3) had any grade thrombocytopenia. The median time to recovery of grade 3 neutropenia and thrombocytopenia was 2 months and 3 months, respectively, said Munshi.

There were 5 deaths within 8 weeks of ide-cel infusion2 following myeloma progression and 3 from AEs (CRS, aspergillus pneumonia, and GI hemorrhage). There was also 1 other AE-related death (CMV pneumonia) that occurred within 6 months, in the absence of myeloma progression.

Reference:

Munshi NC, Anderson Jr LD, Jagannath S, et al. Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T-cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): Initial KarMMa results. Presented at: 2020 ASCO Virtual Scientific Program; May 29-31, 2020. Abstract 8503.

Read the rest here:
Ide-cel Appears Active in Almost Three-Fourths of Heavily Pretreated Patients with Myeloma - Cancer Network

Have a question about coronavirus, also known as COVID-19?

We will ask the experts.

Send questions to tribdem@tribdem.com.

A reader of The Tribune-Democrat asked:

If you have been around someone with COVID-19 antibodies, do you have to quarantine?

The answer:

SARS-CoV-2 (COVID-19) antibodies include IgM and IgG. IgM is usually the first antibody produced by the immune system when a virus attacks. A positive IgM test indicates that you may have been infected and that your immune system has started responding to the virus.

IgM detection with COVID-19 is a median five days (range three to six days). IgG antibodies are detected in most patients 10 to 21 days (median 14 days) after symptoms of COVID-19 begin. IgG antibodies remain in the blood after the infection has passed.

IgG antibodies also indicate that you may have had COVID-19 in the past, and these antibodies may protect you from future infection. It is unknown at this time how much protection antibodies might provide against reinfection.

If the individual had a positive IgM antibody test, I recommend a molecular Polymerase Chain Reaction (PCR) swab test and quarantine until the PCR test result is available.

If the individual had a positive IgG antibody test and symptoms such as fever, cough and/or shortness of breath 10 to 21 days ago, I also recommend a PCR swab test and quarantine until the PCR result is available.

If the individual has positive IgG antibodies, no recent symptoms and no fever, then no further testing is indicated and quarantine is not necessary.

In summary, it depends on which antibody was detected and if the individual had recent COVID-19 symptoms and/or fever.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

If two relatives had coronavirus and are now negative, am I safe to be with them if I have not?

The answer:

A recent study from the Korean Centers for Disease Control and Prevention tracked 285 COVID-19 survivors who had tested positive for the coronavirus after their illness had apparently resolved, as indicated by a previous negative test result. The virus samples collected from them couldnt be grown in culture, indicating the patients were shedding non-infectious or dead virus particles.

So once you recover, and you have no symptoms or fever, its safe to go out in public. However, I would recommend continuing to follow CDC precautions, including social distancing, good hand-washing hygiene, and wearing a face mask.

Since the pandemic was just recently declared on March 11, there is no data on long-term immune response.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

After much concentration with social distancing and staying at home I inadvertently drank from a soda my granddaughter had been drinking from. She is from a family of four with no apparent symptoms. I am 70 years old with Type 2 diabetes. Is there testing we should have done following this incident or any additional measures? Im nervous that after all my efforts the past 2 1/2 months that I will contract the virus.

The answer:

I congratulate you on all your efforts and safe practices. In my opinion, no testing is indicated unless you develop any symptoms or fever, and no additional measures are needed.

I believe your risk is very low concerning the one incident which you described, and I would not worry. I do recommend that you continue social distancing, good hand washing hygiene, and wearing a face mask. Youre doing a great job!

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

My employer has required me to havetwo negative tests before returning to work. How long do I have to wait after my first negative test before I can get my second test?

The answer:

The CDC has placed guidelines concerning returning to work after recovery from COVID-19.

These guidelines state that an individual should havetwo consecutive negative results of an FDA-approved COVID-19 molecular assay for detection of SARS-CoV-2 RNA from at least two consecutive respiratory specimens collected greater than 24 hours apart.

Therefore, the least amount of time between testing that can occur is 25 hours.

It is important to point out that an individual must havetwo consecutive negative tests, and results for these tests can take several days to be returned to the individual.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

I am a personal trainer who has had an 89-year-old client request that I come to her home to train her. Besides being a trainer, I also have a part-time job at a regional airport near my home where I handle bagsand check in passengers, as well as cleaning the plane. I am very careful when I work about wearing a mask, gloves, using social distancing and washing my hands. Is it safe for my client if I train her?

The answer:

Im glad that you are using personal protective equipment (PPE) and practicing good hand-washing hygiene. The question of risk exposure for an 89-year-old individual is not insignificant, even though you are taking appropriate precautions.

In the United States, the highest incidence of severe outcomes with COVID-19 were in patients older than 85. Therefore, visitors other than caregivers are not recommended.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

I am 75 and have Post Polio Syndrome, chronic bronchitis and shingles. My husband is going back to work at an auto glass manufacturer. How can I isolate in my home? We also have three dogs. Could they carry the virus to me if he gets sick?

The answer:

Self-isolate in a private room and use a private bathroom, if possible. Wear a mask when you enter general living areas. Follow other Pennsylvania Department of Health and CDC recommendations and precautions including good hand-washing hygiene and frequently clean with a sanitizer common surfaces you may both touch.

CDC is aware of a small number of pets worldwide, including cats and dogs, reported to be infected with the virus that causes COVID-19, mostly after close contact with people with COVID-19. Based on the limited information available to date, the risk of animals spreading COVID-19 to people is considered to be low.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

I have symptoms of COVID-19 and am scheduled to do my test this morning. It will taketwo days to get results. Is it safe to use my inhaler and nasal spray? And if my test is positive, is it safe to use my inhaler and nasal spray?

The answer:

Im not aware of any inhaler and/or nasal spray contraindications with SARS-CoV-2 (COVID-19). I recommend that you follow-up with your primary care physician.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

If the virus has a very short life in/on non-living environments, why is it so important to deep clean spaces that have been vacated for several months?

Wouldnt routine cleaning suffice before the space is occupied again?

The answer:

Cleaning spaces that have been vacant for several months with a deep cleaning is a good idea in general. Many microbes could be present on these surfaces (Staphyloccous and Streptococcus species for example).

There have been news stories circulating that the CDC has changed their guidelines on how SARS CoV-2 spreads. This is untrue. The CDC merely placed the contaminated surfaces under a subcategory stating that the virus does not easily spread via contaminated surfaces. Both the old and new versions of the recommendations state that it is known that the virus can survive on contaminated surfaces for hours to days depending on the surface.

The best way to reduce risk of infection is to wash your hands regularly and clean surfaces with soap and water followed by a disinfectant.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

My husband had COVID-19 symptoms, a sore throat,and because he is 63 years old, we wanted to check to see if he is OK. His results came back positive and he is on a 14-day quarantine. We have now all been tested in the family. So far my youngest daughters results came back negative. Should she move out to be safe?

The answer:

I am assuming the test that all of you received was the genome test. If your husband was positive for the genome, that is indicative of an active infection. This means he is contagious. He needs to quarantine himself and limit the exposure to other family members. It is recommended that high-touch surfaces be cleaned multiple times a day as well.

It is prudent for your daughter (and any other family member who tested negative) to self-isolate in a separate part of the home. Since she is currently living in your home and your husband tested positive, there may have been exposure to SARS CoV-2 since the testing. Testing gives us a snapshot of what is occurring, and since you are all in the same household, there could have been exposure after testing.

If she has a place to go to for 14 days where she is not risking exposure to others, you may want to consider having her go there.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

If I pick up the virus from someone at noon, how soon do I start infecting others?

The answer:

A small number of studies suggest that some people can be contagious during the incubation period, the time between exposure to the virus and the onset of symptoms. The incubation period for SARS-CoV-2 (also known as the COVID-19 virus) is estimated to be between two and 14 days, with a median of five to seven days (possibly longer in children). Greater than 95% of patients develop symptoms within 10-12 days of infection.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

My ex and I have shared custody. She just called to say shes in quarantine waiting for COVID-19 test results. I have the children now, but she had them last week before her quarantine.

Do we need to quarantine now until we hear her results? From a concerned father.

The answer:

Yes, self-isolate to your home while you wait for her results. Whoever else lives in your home should also stay at home. Close contacts are people who have been withinsix feet of you for a period of 10 minutes or more. If you or the children develop symptoms, notify your health-care provider for instructions and testing.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

How can I keep COVID-19 from spreading in my home once I turn on my whole-house air conditioning? My husband works and I am doing my best to isolate him in his room and a bathroom across the hall.

The answer:

There have been two studies that show the airborne droplets containing SARS-CoV2 can spread farther than six feet when the airflow in a room is increased (either from an air conditioner or a heating system). These systems often draw air in from a room and cool it, sending the cool air throughout the home and the heat outside. This type of system has the potential to circulate the virus in a home if someone is infected.

A study out of the University of Oregon together with the University of California-Davis says the best way to reduce the spread of the virus and still ventilate a room is to open a window. Opening a window in the home will reduce the possible virus concentration by increasing the concentration of air from the outside.

If you cant open the window (allergies, asthma, 95-degree heat) and there is concern that someone in the home is infected (showing symptoms, asymptomatic or exposed), you could block the intake vent in the room(s) that individual is isolating in.

Duct tape can cover the vent and help to reduce the spread of the virus through the home.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

Is there a COVID-19 test my 3-year-old grandson can take that would allow him to stay with us for a day or two if he tests negative? I am 71, and would do anything to see him again.

The answer:

Molecular (Polymerase Chain Reaction PCR) swab test detects RNA from SARS-CoV-2, also known as the COVID-19 virus. If the PCR is positive, the patient is considered infected with the COVID-19 virus and presumed to be contagious.

You mention testing your grandson, but also consider testing the grandparents as well. However, it is important to emphasize that a negative PCR does not exclude COVID-19.

Also, realize that the mean incubation period for COVID-19 is five days, and the range can be two to 14 days. This means that a negative result does not rule out infection.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

If a persons antibody IgGand IgM came back positive, are they able to spread the virus because of the IGM result?

The answer:

Testing shows us a snapshot of what is happening with a person andhis/her course of disease. The two types of antibody tests are looking for a particular type of immune response.

When we are exposed to a pathogenic microbe, our immune system has two ways to defeat it.

The first is called the innate response. This response is encoded in our DNA as a human.

Visit link:
Experts answer your COVID-19 questions: 'If two relatives had coronavirus and are now negative, am I safe to be with them if I have not?' -...

This summer, for the first time, genetically modified mosquitoes could be released in the U.S.

On May 1, 2020, the company Oxitec received an experimental use permit from the U.S. Environmental Protection Agency to release millions of GM mosquitoes (labeled by Oxitec as OX5034) every week over the next two years in Florida and Texas. Females of this mosquito species, Aedes aegypti, transmit dengue, chikungunya, yellow fever and Zika viruses. When these lab-bred GM males are released and mate with wild females, their female offspring die. Continual, large-scale releases of these OX5034 GM males should eventually cause the temporary collapse of a wild population.

However, as vector biologists, geneticists, policy experts and bioethicists, we are concerned that current government oversight and scientific evaluation of GM mosquitoes do not ensure their responsible deployment.

Coral reefs that can withstand rising sea temperatures, American chestnut trees that can survive blight and mosquitoes that cant spread disease are examples of how genetic engineering may transform the natural world.

Genetic engineering offers an unprecedented opportunity for humans to reshape the fundamental structure of the biological world. Yet, as new advances in genetic decoding and gene editing emerge with speed and enthusiasm, the ecological systems they could alter remain enormously complex and understudied.

Recently, no group of organisms has received more attention for genetic modification than mosquitoes to yield inviable offspring or make them unsuitable for disease transmission. These strategies hold considerable potential benefits for the hundreds of millions of people impacted by mosquito-borne diseases each year.

Although the EPA approved the permit for Oxitec, state approval is still required. A previously planned release in the Florida Keys of an earlier version of Oxitecs GM mosquito (OX513) was withdrawn in 2018 after a referendum in 2016 indicated significant opposition from local residents. Oxitec has field-trialed their GM mosquitoes in Brazil, the Cayman Islands, Malaysia and Panama.

The public forum on Oxitecs recent permit application garnered 31,174 comments opposing release and 56 in support. The EPA considered these during their review process.

However, it is difficult to assess how EPA regulators weighed and considered public comments and how much of the evidence used in final risk determinations was provided solely by the technology developers.

The closed nature of this risk assessment process is concerning to us.

There is a potential bias and conflict of interest when experimental trials and assessments of ecological risk lack political accountability and are performed by, or in close collaboration with, the technology developers.

This scenario becomes more troubling with a for-profit technology company when cost- and risk-benefit analyses comparing GM mosquitoes to other approaches arent being conducted.

Another concern is that risk assessments tend to focus on only a narrow set of biological parameters such as the potential for the GM mosquito to transmit disease or the potential of the mosquitoes new proteins to trigger an allergic response in people and neglect other important biological, ethical and social considerations.

To address these shortcomings, the Institute for Sustainability, Energy and Environment at University of Illinois Urbana-Champaign convened a Critical Conversation on GM mosquitoes. The discussion involved 35 participants from academic, government and nonprofit organizations from around the world with expertise in mosquito biology, community engagement and risk assessment.

A primary takeaway from this conversation was an urgent need to make regulatory procedures more transparent, comprehensive and protected from biases and conflicts of interest. In short, we believe it is time to reassess risk assessment for GM mosquitoes. Here are some of the key elements we recommend.

First, an official, government-funded registry for GM organisms specifically designed to reproduce in the wild and intended for release in the U.S. would make risk assessments more transparent and accountable. Similar to the U.S. database that lists all human clinical trials, this field trial registry would require all technology developers to disclose intentions to release, information on their GM strategy, scale and location of release and intentions for data collection.

This registry could be presented in a way that protects intellectual property rights, just as therapies entering clinical trials are patent-protected in their registry. The GM organism registry would be updated in real time and made fully available to the public.

Second, a broader set of risks needs to be assessed and an evidence base needs to be generated by third-party researchers. Because each GM mosquito is released into a unique environment, risk assessments and experiments prior to and during trial releases should address local effects on the ecosystem and food webs. They should also probe the disease transmission potential of the mosquitos wild counterparts and ecological competitors, examine evolutionary pressures on disease agents in the mosquito community and track the gene flow between GM and wild mosquitoes.

To identify and assess risks, a commitment of funding is necessary. The U.S. EPAs recent announcement that it would improve general risk assessment analysis for biotechnology products is a good start. But regulatory and funding support for an external advisory committee to review assessments for GM organisms released in the wild is also needed; diverse expertise and local community representation would secure a more fair and comprehensive assessment.

Furthermore, independent researchers and advisers could help guide what data are collected during trials to reduce uncertainty and inform future large-scale releases and risk assessments.

The objective to reduce or even eliminate mosquito-borne disease is laudable. GM mosquitoes could prove to be an important tool in alleviating global health burdens. However, to ensure their success, we believe that regulatory frameworks for open, comprehensive and participatory decision-making are urgently needed.

This article was updated to correct the date that Oxitec withdrew its OX513 trial application to 2018.

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Genetically modified mosquitoes could be released in Florida and Texas beginning this summer silver bullet or jumping the gun? - The Conversation US

We grew up in an era when the mainstream media reported the news straightforwardly, but now much of it is bought and paid for. In other words, it is propaganda defined as information, especially of a biased or misleading nature, used to promote or publicize a particular political cause or point of view.

The British Guardian newspaper is Exhibit A, or maybe, as members of the scientific community, we should say Public Enemy No. 1. The paper sought and received a grant$886,600from an advocacy group, the Open Philanthropy Project (OPP), to publish a series titled Animals farmed. The grant spurred a succession of articles that paint animal husbandry variously as inhumane, unhealthy, or dangerous to the environment:

To put it bluntly, the transactional arrangement between The Guardian and OPP has yielded propaganda, not news.

The Guardians hypocrisy is prominently on display in view of its stated commitments: We will inform our readers about threats to the environment based on scientific facts, not driven by commercial or political interests, and The Guardians editorial independence means we set our own agenda and voice our own opinions. Our journalism is free from commercial and political influence.

We can cite 886,600 rebuttals to those hollow promises.

What motivates the Open Philanthropy Project? It supports animal welfare, as do we, but the group has a conflict of interest from a financial interest in a competitor of animal husbandry. That is revealedhereby University of California Davis Professor of animal science Frank Mitloehner:

The Guardian was a likely candidate for such a shady arrangement, in any case. For decades, it has been a predictable source of disinformation and fear-mongering about molecular genetic engineering in agriculture, including asympathetic descriptionof Greenpeaces rationale for the wanton destruction of genetically engineered crop research, and stories supportingcritics of genetic engineering. The Guardian even had the audacity to run astoryclaiming that Father of the Green Revolution Dr. Norman Borlaug, killed millions, when in fact his research arguablysaveda billion people from starvation.

The reality is that four decades of research and development on genetically engineered food crops has confirmed what theory predicted from the outset, and what data have reinforced repeatedly that the use of the technology confers no incremental risk and is essentially an extension, or refinement, of earlier, less precise techniques for genetic improvement, and that it could yield monumental commercial and humanitarian successes.

The Guardian frequently propagates the myth that the terms genetic modification and the common shorthand GMO (for genetically modified organism) represent a meaningful grouping of things that is, a genuine category. In fact, organisms improved with the newest molecular genetic engineering techniques and the foods derived from them do not in any way constitute meaningful groupings, which makes any choice of what to include in them wholly arbitrary and misleading. Nor have they been shown to be lesssafeor, given the pedigree of the foods in our diet, in any way less natural than thousands of other common foods.

Genetic modification by means of selection and hybridization to say nothing of the natural movement of genes, as part of Darwinian natural selection has been with us for millennia, and the techniques employed along the way, including the newest ones, are part of a seamless continuum. For more than a century, plant breeders routinely have used radiation or chemical mutagens on seeds to scramble a plants DNA to generate new traits.

Since the 1930s, wide cross hybridizations, which involve the movement of genes from one species or one genus to another, have given rise to plants thatdo not exist in nature; they include the varieties of corn, oats, pumpkin, wheat, rice, tomatoes and potatoes we buy and consume routinely. (Yes, even heirloom varieties and the overpriced, often inferiororganicstuff at Whole Foods.) With the exception of wild berries, wild game, wild mushrooms and fish and shellfish, virtually everything in North American and European diets has been genetically improved in some way.

The erroneous assumption that genetic modification is a meaningful category has led to various kinds of mischief, including the vandalization of field trials and the destruction of laboratories; local bans or restrictions; and a spate of spurious lawsuits of various kinds.

The Guardian has published a few accurate news articles about genetic engineering, such asoneabout Nobel Laureatesstatingthere are no unique health risks from GE crops, andanotherthat reported positive attributes about GE crops. The paper also ran anarticleby a British farmer that paints an accurate picture of animal agriculture.

But fear sells far better and can be more persuasive than facts and it gets more prominent presentation; recall the old adage about media, If it bleeds, it leads. In any case, those few do not undo the litany of misrepresentation and bias. Responsible journalism is not served by a false equivalence between inaccurate, scurrilous, hit-pieces whether paid for or not and accurate news or opinion articles, especially when the former have predominated for decades. The Guardians fear-mongering is part of a calculated information cascade that has stigmatized andstymiedthe adoption of this safe effective technology in many parts of the world.

In democracies, freedom of the press includes the right to be biased and dishonest. The Guardian invokes that right repeatedly and, thereby, lets down its readers.

Rob Wager is a researcher in the department of biology at Vancouver Island University. Follow him on Twitter @RobertWager1. Henry Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was the founding director of the U.S. FDAs Office of Biotechnology. Follow him on Twitter @henryimiller

This article was originally published at the American Council on Science and Health (ACSH) and has been republished here with permission. Follow ACSH on Twitter @ACSHorg

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Viewpoint: News or propaganda? UK newspaper the Guardian paid over $800k to publish anti-farming 'investigation' - Genetic Literacy Project

This article originally appeared on The Conversation.

This summer, for the first time, genetically modified mosquitoes could be released in the U.S.

On May 1, 2020, the company Oxitec received an experimental use permit from the U.S. Environmental Protection Agency to release millions of GM mosquitoes (labeled by Oxitec as OX5034) every week over the next two years in Florida and Texas. Females of this mosquito species, Aedes aegypti, transmit dengue, chikungunya, yellow fever and Zika viruses. When these lab-bred GM males are released and mate with wild females, their female offspring die. Continual, large-scale releases of these OX5034 GM males should eventually cause the temporary collapse of a wild population.

However, as vector biologists, geneticists, policy experts and bioethicists, we are concerned that current government oversight and scientific evaluation of GM mosquitoes do not ensure their responsible deployment.

Coral reefs that can withstand rising sea temperatures, American chestnut trees that can survive blight and mosquitoes that cant spread disease are examples of how genetic engineering may transform the natural world.

Genetic engineering offers an unprecedented opportunity for humans to reshape the fundamental structure of the biological world. Yet, as new advances in genetic decoding and gene editing emerge with speed and enthusiasm, the ecological systems they could alter remain enormously complex and understudied.

Recently, no group of organisms has received more attention for genetic modification than mosquitoesto yield inviable offspring or make them unsuitable for disease transmission. These strategies hold considerable potential benefits for the hundreds of millions of people impacted by mosquito-borne diseases each year.

Although the EPA approved the permit for Oxitec, state approval is still required. A previously planned release in the Florida Keys of an earlier version of Oxitecs GM mosquito (OX513) was withdrawn in 2016 after a referendum indicated significant opposition from local residents. Oxitec has field-trialed their GM mosquitoes in Brazil, the Cayman Islands, Malaysia and Panama.

The public forum on Oxitecs recent permit application garnered 31,174 comments opposing release and 56 in support. The EPA considered these during their review process.

However, it is difficult to assess how EPA regulators weighed and considered public comments and how much of the evidence used in final risk determinations was provided solely by the technology developers.

The closed nature of this risk assessment process is concerning to us.

There is a potential bias and conflict of interest when experimental trials and assessments of ecological risk lack political accountability and are performed by, or in close collaboration with, the technology developers.

This scenario becomes more troubling with a for-profit technology company when cost- and risk-benefit analyses comparing GM mosquitoes to other approaches arent being conducted.

Another concern is that risk assessments tend to focus on only a narrow set of biological parameterssuch as the potential for the GM mosquito to transmit disease or the potential of the mosquitoes new proteins to trigger an allergic response in peopleand neglect other important biological, ethical and social considerations.

To address these shortcomings, the Institute for Sustainability, Energy and Environment at University of Illinois Urbana-Champaign convened a Critical Conversation on GM mosquitoes. The discussion involved 35 participants from academic, government and nonprofit organizations from around the world with expertise in mosquito biology, community engagement and risk assessment.

A primary takeaway from this conversation was an urgent need to make regulatory procedures more transparent, comprehensive and protected from biases and conflicts of interest. In short, we believe it is time to reassess risk assessment for GM mosquitoes. Here are some of the key elements we recommend.

First, an official, government-funded registry for GM organisms specifically designed to reproduce in the wild and intended for release in the U.S. would make risk assessments more transparent and accountable. Similar to the U.S. database that lists all human clinical trials, this field trial registry would require all technology developers to disclose intentions to release, information on their GM strategy, scale and location of release and intentions for data collection.

This registry could be presented in a way that protects intellectual property rights, just as therapies entering clinical trials are patent-protected in their registry. The GM organism registry would be updated in real time and made fully available to the public.

Second, a broader set of risks needs to be assessed and an evidence base needs to be generated by third-party researchers. Because each GM mosquito is released into a unique environment, risk assessments and experiments prior to and during trial releases should address local effects on the ecosystem and food webs. They should also probe the disease transmission potential of the mosquitos wild counterparts and ecological competitors, examine evolutionary pressures on disease agents in the mosquito community and track the gene flow between GM and wild mosquitoes.

To identify and assess risks, a commitment of funding is necessary. The U.S. EPAs recent announcement that it would improve general risk assessment analysis for biotechnology products is a good start. But regulatory and funding support for an external advisory committee to review assessments for GM organisms released in the wild is also needed; diverse expertise and local community representation would secure a more fair and comprehensive assessment.

Furthermore, independent researchers and advisers could help guide what data are collected during trials to reduce uncertainty and inform future large-scale releases and risk assessments.

The objective to reduce or even eliminate mosquito-borne disease is laudable. GM mosquitoes could prove to be an important tool in alleviating global health burdens. However, to ensure their success, we believe that regulatory frameworks for open, comprehensive and participatory decision-making are urgently needed.

Written by Brian Allan, Associate Professor of Entomology, University of Illinois at Urbana-Champaign; Chris Stone, Medical Entomologist, University of Illinois at Urbana-Champaign; Holly Tuten, Vector Ecologist, University of Illinois at Urbana-Champaign; Jennifer Kuzma, Goodnight-NCGSK Distinguished Professor, North Carolina State University; Natalie Kofler, Levenick Resident Scholar in Sustainability, University of Illinois at Urbana-Champaign.

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Genetically Modified Mosquitoes Could be Released in Florida and Texas This Summer - The Daily Beast

In May, federal regulators finalized a new biotechnology policy that will bring sweeping changes to the U.S. food system. Dubbed SECURE, the rule revises U.S. Department of Agriculture regulations over genetically engineered plants, automatically exempting many gene-edited crops from government oversight. Companies and labs will be allowed to self-determine whether or not a crop should undergo regulatory review or environmental risk assessment.

Initial responses to this new policy have followed familiar fault lines in the food community. Seed industry trade groups and biotech firms hailed the rule as important to support continuing innovation. Environmental and small farmer NGOs called the USDAs decision shameful and less attentive to public well-being than to agribusinesss bottom line.

But the gene-editing tool CRISPR was supposed to break the impasse in old GM wars by making biotechnology more widely affordable, accessible and thus democratic.

In my research, I study how biotechnology affects transitions to sustainable food systems. Its clear that since 2012 the swelling R&D pipeline of gene-edited grains, fruits and vegetables, fish and livestock has forced U.S. agencies to respond to the so-called CRISPR revolution.

Yet this rule change has a number of people in the food and scientific communities concerned. To me, it reflects the lack of accountability and trust between the public and government agencies setting policies.

The USDA Animal and Plant Health Inspection Service, or APHIS, serves as the dominant U.S. regulator for plant health. Since the mid-1990s, genetically modified crops have typically fallen under APHIS oversight because Agrobacterium, a plant pest, is commonly used as a tool to engineer GM products. Using a plant pest did not prevent many GM crops from being approved. But it did mean that if APHIS suspected a plant pest or noxious weed had been created through genetic engineering, the agency would regulate the biotech product, including its release into the environment, and its import, handling, and interstate movement.

Changes to APHIS regulations began during the Obama administration. In January 2017, the agency released new draft rules. However, the Trump administration withdrew these nine months later after pushback from industry and biotech developers which argued that the rules would stifle innovation.

Last summer, USDA released a revised rule for public comment, which it finalized on May 18, 2020. Most changes go into effect in April 2021.

Hints to how USDA intended to treat gene-edited crops came early on, when Penn States nonbrowning mushrooms and DuPonts waxy corn were approved by APHIS in 2015 and 2016, respectively.

Then in March 2018, USDA Secretary Perdue clarified the agencys stance. USDA does not currently regulate, or have any plans to regulate, plants that could otherwise have been developed through traditional breeding techniques as long as they are developed without the use of a plant pest as the donor or vector and they are not themselves plant pests.

The new SECURE rule establishes several ways for developers to qualify for deregulated status. Included are CRISPR modifications like deletions of sections of the genetic code, tiny substitutions, and introductions of DNA from related species. So, for example, a CRISPRd cauliflower would not be regulated if a chunk of DNA was deleted. But it would still be regulated if CRISPR introduced foreign DNA into cauliflower in a way that USDA believes could turn the product into a plant pest.

Another significant change is that companies and scientists will get to decide for themselves if a new product qualifies for exemption from oversight. APHIS says that developers may consult regulators if at any point they arent sure if a new crop is exempt. However, the agency has already expressed confidence that only about 1% of plants might not qualify for an exemption or for deregulation after an initial review.

Ironically, this policy has begun aligning communities typically at loggerheads in the polarized GM conversation. For example, the UC-based Innovative Genomics Institute, founded by CRISPR co-inventor Jennifer Doudna, wrote in its public comments to APHIS: While we recognize the agencys rationale behind self-determination and desire to provide regulatory relief in order to spur innovation, we are concerned that rather than stimulating innovation, such an undisclosed step may have the effect of dampening trust through the loss of transparency in the development and oversight process.

Meanwhile, GM-watchdog organizations including the National Family Farmers Coalition, Pesticide Action Network and Friends of the Earth issued a joint press statement criticizing a rule that allows industry to self-determine its regulatory status. The new framework, they said, has dealt a devastating blow to the security of farmers livelihoods, the health of their farms and communities, and their ability to build the biodiverse, climate-resilient, and economically robust farming systems that we so urgently need.

My research on democratizing biotechnology has helped me unpack the problematic ways in which democracy is being hitched to technological innovation. When it comes to CRISPR, the public has been told that being cheap, easy to use and free from regulation is a powerful cocktail that makes gene editing intrinsically more democratic.

Like many convenient narratives, there are certain truths to this story. But just as clearly, cheapness is not equivalent to democratic. According to USDA, some 6,150 comments were received on the draft rule during the three-month public feedback period, a window designed to give citizens a say in government policy.

The agency admitted that most letters expressed general opposition to GE products. Of the comments that specifically addressed provisions of the rule, approximately 25 expressed some support for the rule. This means a vast majority of the comments did not. Yet, the USDA disregarded this feedback. Such a lack of civic input can lead to environmental and health concerns being sidelined.

Thoughtful scientists, social movements and governments are now asking if there is an alternative way to regulate engineered food. For example, the Norwegian Biotechnology Advisory Board has set out an ethics-based regulatory framework aimed at advancing genetic technology, while protecting community and environmental health and promoting societal welfare.

In the academic sphere, colleagues in Europe have proposed a framework for responsible innovation. I have developed a set of principles and practices for governing CRISPR based on dialogue with front-line communities who are most affected by the technologies others usher in. Communities dont just have to adopt or refuse technology they can co-create it.

One way to move forward in the U.S. is to take advantage of common ground between sustainable agriculture movements and CRISPR scientists. The struggle over USDA rules suggests that few outside of industry believe self-regulation is fair, wise or scientific.

At present, companies dont even have to notify the USDA of biotech crops they will commercialize. The result, as Greg Jaffe of the Center for Science in the Public Interest told Science, is that government regulators and the public will have no idea what products will enter the market. Farmers and everyone else will pay the price,said Jim Goodman, dairy farmer and board president of the National Family Farm Coalition.

Reclaiming a baseline of accountability, then, is the first step in building public confidence in regulatory systems that work for people as well as science that the public believes in.

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How a new biotech rule will foster distrust with the public and impede progress in science - The Conversation US

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Perhaps it is difficult to find a moment in the history of humanity in which, in such a short time, such an enormous volume of information (and disinformation) has been generated about a problem that affects the entire human species, as what has happened with the COVID-19 pandemic. Nor has humanity faced such an uncertain near future.

In addition to the global health emergency, which has caused hundreds of thousands of deaths and more than 2 million infected people worldwide, this pandemic has put on the political table the unsustainability of the capitalist system worldwide, the paradigm of unlimited growth and the culture of growing consumer.

On Earth Day Coronavirus, a pollution hiccup?

Suddenly, the reality that we live on a limited planet, with increasingly scarce resources, and that in the biosphere all existence is interconnected, has unquestionably emerged. The zoonotic nature of the COVID-19 itself tells us of the direct transmission of the virus to humans, most likely due to the contact or consumption of wild species and even due to the natural boundaries being displaced and the loss of biodiversity. The fact that it expands globally also alerts us to the profound environmental changes caused by human action and its techno-industrial culture developed on the basis of fossil energy. We have to think about what can happen when, as a result of climate change, the thaws continue and the paleo viruses frozen thousands of years ago are released, in a period too fast for existing species, and especially humans, to adapt to that change. If we add to the above the unsustainability of production systems and value chains (think of stabled livestock, large extensions of monocultures, the application to these systems of agrochemicals, hormones, antivirals and genetic manipulation), we will have an approximate picture of the world that will emerge after the pandemic

This will be a challenge not only for science, which will have to rethink a series of paradigms, but also for world politics that has taken too long to have global agreements to slow down or minimize these processes; hence, one of the elements that should emerge from this experience at the global level is a more direct relationship between science and political decision-making at the country level.

After this pandemic, there will be no new normal, another world will have to be built and that construction will be carried out by all, with greater solidarity and conscious citizen participation, or it will be exercised through increasingly more authoritarian mechanisms of power; we can already see these trends in some governments.

The world as we have known it was structured from obtaining cheap fossil energy, which allowed a techno-industrial culture to develop in the last 200 years that led to the emergence of large human concentrations in megacities. The United Nations has predicted that the urban population will increase to 6.7 billion; that is, 68% of humanity by 2050. In that decade, if the current rhythm continues, there will be 43 megacities with more than 10 million inhabitants each, really something unsustainable for the planet. Current and future generations will be forced to rethink their lifestyles or be willing to live in a dystopian world of isolation, in which relationships must be mediated by technology.

The advances in technoscience in the last 20 years already present us with a new ethics, in which each human being is aware of their limits of all kinds.

Genetic engineering, with all its potential, implies the application of the precautionary principle for the introduction of each technological advance. We are still unaware of the many effects of new technologies on our health and the global environment, yet we continue to use them too frequently.

Over the past few months we have often seen on social media claims about the short-term recovery of natural spaces and wildlife activity in urban areas, dolphins swimming placidly in Venices canals, goats visiting Scottish historical sites, wild boars rummaging through the garbage in Paris and Barcelona. We have been glad that our brothers of other species recover their ancestral spaces even when it was our presence that expelled them; but this is all a fallacy. The processes of environmental deterioration at the planetary level continue, and their resilience, if they can start being reversed, will take years, but we have to start. Just think about these figures: in 2018, the burning of fossil fuels pumped 37.1 billion tons of carbon dioxide into the atmosphere. If we add to this the net carbon emissions caused by soil oxidation and the most vigorous forest fires, we can see why atmospheric concentrations of carbon dioxide reached an all-time high of 415 parts per million in early 2019.

Cubas challenges

Cuba has a different but contradictory panorama. A poor country, blocked for 60 years by the worlds greatest power and with a frankly deteriorating open economy (it is estimated that its GDP will decrease between 4 and 7% in 2020), with a large debt, without external financing, with a high rate of illiquidity, with a country risk like never before, perhaps it is the deepest point of the systemic crisis of its economy. This really places it in a very critical situation, above all due to the enormous supply crisis that threatens to become a food crisis as acute as that of the early 1990s. From the economic point of view, the only alternative is unblocking the mechanisms and to rapidly start applying the agreements contained in the Guidelines discussed massively 10 years ago and which inexplicably have not been applied.

I think that all Cubans could agree on the urgency of doing away with obstacles to agricultural production, the inefficiency of this sector and the dreadful methods of administration and management, which contrast with the statistics that show that most of the national food production is generated by small producers, then the assessment still has blank questions. Advancing towards an agriculture with low energy inputs, sustainable management of the soil and crops, rational use of water, that is, organic agriculture will benefit everyone, there are examples and very successful at that.

Cuba has potentialities that must be taken into account from an environmental point of view and that have been gradually implemented. Its energy dependence constitutes an Achilles heel for its economy and attempts are being made, with a very successful intensive policy, to decrease it with an accelerated increase in clean energy; the Cuban aquifer stock is limited, but the country has a very intelligent and well-structured water policy.

The development of the Cuban health policy with the pandemic has been successful so far and there is no indication that wont continue like this; the Cuban experience in the detection and control of epidemics has made it possible to establish mechanisms of local control and primary care that other countries have not been able to implement, just remember that Cuban doctors have participated in the control and treatment of epidemics such as Ebola in Africa and cholera in Haiti, in addition to the epidemics that for decades have been introduced in Cuba by foreign aggressions (swine fever, dengue, etc.). It is possible to think, unlike other countries, that the island will emerge from the pandemic in a relatively short period of time and with minimal impact on its population. For this reason, the greatest complexity will not be precisely the epidemic, but rather the food supply, and in this direction all the nations efforts must be applied; I say the nation, and not only the state. For its part, the government must open the floodgates to diverse productive forces, the effort is everyones.

On June 2, in commemoration of World Environment Day, the director general of the Environment Agency of the Cuban Ministry of Science, Technology and Environment (CITMA) expressed in a television appearance in Holgun a principle that will have to be present in the next designs of Cuban domestic policies, the interconnection of the natural world with society, or what is the same as the eco-social relationship of all the elements that make up and determine our environment. The relationship of science and politics must recognize that the Cuban territory is limited and all relationship we establish on it has a finite character and has a load capacity that cannot be exceeded. The celebration of June 5 this year is curious, because as always, it is a date in which the environmental work carried out for twelve months by each province and municipality is recognized, but now, in 2020 it will have to be done almost virtually due to the epidemic.

Thinking of Pinar del Ro, a province that this year was the best in its environmental work (the parameters established for the evaluation cover all the activities in the province of the different sectors that tend towards environmental sustainability), brings to mind the need to transfer the financing dedicated to the expansion of tourism to the reactivation and development of agriculture. Tourism is recognized in the world as the smokeless industry, but it is still an industry, it requires the import of all kinds of inputs, as well as being an eminently extractive activity. Today Cuba has a capacity per rooms that is far from the market demand for the island, the existing statistics do not exceed more than 30% of linear occupancy in the various destinations of the archipelago. If we add to this the globalized nature of tourism (it arises precisely with the development of capitalism in its last phase) and the physical interconnections that are established with visitors, even immunologically, we approach a portrait of an activity that is very profitable but that creates links of dependency on a specific and very fragile world market.

According to the activitys development plans in the near future, if the developmentalist vision continues to be applied in the tourism sector, Pinar del Ro will have a huge megaproject called Punta Colorada, which will cost billions of dollars and will have an impact, undoubtedly, on the marine-coastal ecosystems of the northwest of the province and in the Guanahacabibes and Viales biosphere reserves.

The COVID-19 epidemic in the world has put the neoliberal capitalist system in check. It will remain to be seen if it is able to resist this onslaught.

For Cuba it means the need and the urgency to consolidate what exists and works well and transform the inefficient, because for Cuba once again the possibility of creating an eco-socialist alternative with citizen participation is opening.

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The pandemic, the environment and Cuba - OnCubaNews

By Melissa Healy

Los Angeles Times

To capture the speed and audacity of its plan to field a coronavirus vaccine, the Trump administration reached into science fictions vault for an inspiring moniker: Operation Warp Speed.

The vaccine initiatives name challenges a mantra penned by an actual science fiction writer, Arthur C. Clarke: Science demands patience.

Patience is essential for those who ply the science of vaccines. But in that field, challenging economic conditions and a forbidding regulatory system converge with the immune systems complexity and the resilience of microscopic pathogens. Add in drug companies preference for big profits and the result is a trash heap of failed and abandoned efforts.

In the last 25 years, the U.S. Food and Drug Administration has approved new vaccines for only seven diseases. A vaccine to protect against the Ebola virus won approval just last year, three years after the epidemic in West Africa ended.

But in the midst of a COVID-19 pandemic that has killed more than 100,000 Americans and cratered the U.S. economy, Trump has shown little tolerance for sciences deliberate pace. And scientists, with fingers crossed, are falling in line.

The president declared that he wants 300 million doses enough to protect as many as 90% of Americans developed, manufactured and delivered by January 2021. He has ordered academics, government officials, private companies and the U.S. military to work together to make it so.

That means big and it means fast, Trump said. A massive scientific, industrial and logistical endeavor unlike anything our country has seen since the Manhattan Project.

The new effort will demand the support, development, testing and assessment of several promising vaccine candidates by scientists at the National Institutes of Health, the FDA and companies and academic institutions across the world.

It will require the manufacture, procurement and storage of complex biologic medicines, as well as the vials, needles, syringes and storage equipment needed to deliver them. All will be needed on a massive scale.

And all that materiel will need to be transported, distributed and possibly administered by an army of logistics specialists.

Wherever possible, Operation Warp Speed envisions that many steps that have always followed each other in strict sequence clinical trials and production, for instance, or government approval and supply-chain development be done in parallel.

The program has awarded a total of $2.16 billion so far to five companies with vaccine candidates at different stages of development.

To lead the effort, Trump tapped immunologist Moncef Slaoui, a pharmaceutical venture capitalist and former chairman of vaccines at the drug giant GlaxoSmithKline. The U.S. Armys most senior logistics and procurement specialist, Gen. Gustave Perna, will be the operations chief operating officer. Both expressed confidence in the operations success.

Pena called the project herculean. Slaoui, who has been criticized for holding a major stake in at least one of the vaccine makers that stands to benefit from Operation Warp Speed, told Trump we will do the best we can.

The time is short and the stakes are high. Just over four months after the coronavirus announced its presence inside the United States, President Trump is determined to send the country back to work.

With no effective treatment in sight, and no indication that the coronavirus would magically disappear, as Trump has frequently predicted, a vaccine will be the ultimate game changer in the pandemic, according Dr. Anthony Fauci, the nations leading expert on the outbreak.

Theres never a guarantee of success, Fauci said. But he added that he was cautiously optimistic that by winter, at least one of nearly a dozen promising vaccine candidates would have shown itself to be safe and effective in inducing immunity in humans.

Vaccine scientists are similarly cautious, especially of a testing schedule that will compress both the size and duration of safety and effectiveness trials and even overlap them in a bid to save time.

Its fine for politicians to say were going to have a vaccine next month, said Mayo Clinic immunologist Dr. Gregory Poland. But the literature is littered with false starts and unanticipated safety effects in vaccines.

Poland noted that a vaccines rarer side effects are often not recognized until its put into broad use. To ferret out an adverse outcome that only occurs in one person in 100,000, for instance, a company would need to test it in 384,250 people from broad backgrounds and with a variety of medical conditions, he said.

Such large trials are unlikely in the rush to field a vaccine, Poland said, and he fears the result could be a dangerous erosion of public trust. The yearly flu shot carries a risk of less than 1 in 1 million cases of the neurological complication Guillain-Barre syndrome, he said. And even with that low a risk, close to half of Americans refuse to get it.

You have a whole spectrum of people out there who wont be reassured by any amount of information, Poland said. If we dont pay strict attention to safety, this is going to backfire.

Money may help. Congress approved $8.3 billion in early March to fund federal agencies pandemic response. And scientists across the world have been scrambling to design vaccines to protect a population with no immunity to the deadly new pathogen.

Scientists in China, Kazakhstan, India, Russia, Germany, Sweden and the United States have brought 10 potential COVID-19 vaccines to the point where they are being evaluated in humans in some form. Another 115 are considered by the World Health Organization to be in the preclinical stage of development.

In some cases, these preclinical vaccine candidates are scarcely off the drawing board. In others, they are still being tweaked or tested in cells. Some are being tried in lab animals.

The prospective vaccines range widely in their design and novelty. There are those that challenge a persons immune system with a killed or attenuated virus, the traditional approach used by the polio vaccine and other immunizations. Others are products of genetic engineering and have never been tried in a vaccine before.

The vaccine candidates also vary in their ease of manufacture, the number of doses a patient needs to gain lasting immunity, and the way they are administered.

FDA Commissioner Dr. Stephen Hahn has said his agency evaluated about 10 vaccine candidates in early studies. By late May, it had narrowed its focus to five candidates that will begin a rapid and sometimes overlapping progression through human studies of safety and effectiveness.

Meanwhile, the groundwork for large-scale production is already being laid. Trump has said that the U.S. military may aid in the manufacture, and companies with the capability to produce vaccines will be recruited to do so.

Given the pressing urgency of the administrations deadline, vaccine candidates that can be produced fastest, transported most easily and administered to patients most efficiently will likely win the most and earliest support, experts said.

The redundancy built into Operation Warp Speed may also prove a vital safeguard against failure.

If the coronavirus shows signs that it is mutating in ways that could make one vaccine candidate ineffective, the scientific judges could swiftly shift their preferences toward a competitor that can be adapted more readily to changes in the virus. If rare but untoward effects show up with broader use, back-up vaccines could be brought on line. Some vaccines will be found to work better or worse in specific populations, and can be used accordingly.

The result will be an evolving panoply of vaccine choices, not only because some will be ready earlier than others, but because some will be more effective than others in certain populations.

There will be of necessity multiple types of vaccines, Poland said.

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Can Operation Warp Speed deliver a COVID-19 vaccine by the end of the year? - The Daily World

The UK grains sector faces enormous change after almost five decades operating under the European Unions Common Agricultural Policy. It also faces enormous potential disruption following the UK exit from the EU on Jan. 31, unless a new trade deal with the EU can be made by the end of the year. At the same time, the sector is coping with the problems caused by the coronavirus (COVID-19) pandemic, with supply chains disrupted and new challenges from the need to feed a population in lockdown.

The International Grains Council (IGC) projects the UKs 2020-21 grains production at a total of 19.7 million tonnes, down from 25.7 million the year before. The countrys wheat production is put at 10 million tonnes, down from 16.3 million in 2019-20. Barley production is forecast to rise to 8.4 million tonnes, up from 8.2 million.

The UKs rapeseed crop is forecast at 1.3 million tonnes in 2020-21, compared with 1.8 million in 2019-20.

The Agriculture and Horticulture Development Board (AHDB) on Feb. 27 published a forecast putting 2019-20 wheat imports at 1.050 million tonnes, down 808,000 on the year before because of greater supply.

It is worth noting that the fall in imported demand is expected to be driven by the animal feed and bioethanol sectors, the AHDB commented. Imported wheat usage by flour millers is expected to be marginally higher year on year.

The AHDB forecast barley imports at 52,000 tonnes, down 18,000 on larger domestic supply. Maize imports in 2019-20 are put at 2.3 million tonnes. While the pace of maize imports is expected to slow somewhat over the next few months, imports may begin to increase again at the end of this season and into the 2020-21 season, due to its relative price compared with domestic grains.

Trade sources put likely imports of wheat at 2.6 million tonnes in 2020-21, with barley imports at 60,000 tonnes. Imports of rapeseed are forecast at 600,000 tonnes.

According to the National Association of British and Irish Millers (nabim), there are 32 companies, with a total of 51 milling sites in the countrys flour milling sector. Thirty-one are members of nabim, with 50 sites between them accounting for 99% of UK flour production. The association puts the industrys annual consumption of wheat to produce flour at 5 million tonnes, with some 1.3 million to 1.5 million tonnes used by starch and bioethanol producers.

The COVID-19 pandemic and the lockdown that has accompanied it has forced the industry to change. Following representations from nabim, the government decided to relax working time rules to help ensure deliveries. It also recognized food industry workers as key, giving them access to childcare and education support, the association said in an April 3 statement. British schools are closed but remain open to care for children of key workers.

An early warning system also has been set up by nabim to give notice of problems before they become critical.

The grain supply and delivery sector, including nabim members, has agreed small changes in working practice that will help the flow of goods and accompanying documentation while respecting social distancing and the difficulty of distributing documentation while so many administrative staff are working from home, nabim said. The government has allowed extra time for some tests to be undertaken and, wherever possible, auditing is being conducted remotely.

One feature of the lockdown has been increased demand from consumers for bagged flour for home baking. A website has been set up by nabim to let consumers know where they can buy the size of bags normally only sold to catering outlets, which are now closed.

The UK left the EU on Jan.31. The country is currently in a transition phase, in which trade continues under the same terms as before, while a future relationship between the two is negotiated. The advent of the COVID-19 crisis means that the transition period, due to last until the end of 2020, is widely expected to be extended, although the British government, which would have to ask for an extension, is still, at the time of writing, insisting that it will stick to the planned timetable.

One aspect of the future that is causing particular concern for the milling industry is the arrangements for trade between the islands of Britain and Ireland. Although the northern part of Ireland is part of the UK, under the 1998 Good Friday Agreement, which brought piece to Northern Ireland after many years of turmoil, there must be no hard border between the UK and the Republic of Ireland on the island of Ireland. That means that a customs barrier is planned, within the UK. The government of Prime Minister Boris Johnson is pretending that the problem does not exist, and no checks will be necessary, ignoring an explicit reference in the UKs Withdrawal Agreement with the EU. The high level of integration between the food sectors in the two countries, particularly in milling, means controls, with a potential need for sanitary and phytosanitary checks, could be highly onerous.

Leaving the EU takes British agriculture out of the EUs Common Agricultural Policy, with its system of direct payments to support farming. Instead, in a bill introduced to parliament on Jan. 16, the government plans to create a system under which farmers are rewarded for providing public goods such as improved air and water quality, higher animal welfare standards, improved access to the countryside or measures to reduce flooding.

In England, direct payments will be phased out over a seven-year period, starting in 2021.

BIOFUELS and GMOs

The UK is currently using E5 gasoline, but the government has announced a move to E10, beginning in 2021. The country has two large ethanol plants, Ensus and Vivergo, both in the northeast. Only Ensus is currently operating, using wheat and maize.

In an April 9 report, the USDA attach in London explained how the British government appears to want to expand the use of GM crops in the country, but the continuing close trading relationship between the UK and the remaining EU countries makes a big change unlikely.

The report cites the July 2019 inaugural speech of Prime Minister Johnson who said: Lets liberate the UKs extraordinary bioscience sector from anti-genetic modification rules.

Under any scenario, the UKs departure from the EU will not change policy or trade in genetically engineered plants or animals in the short to medium term, the attach commented. The EU is the UKs largest trading partner and the UK will retain much EU food law for many years to come.

For most of the British public, genetic engineering in food is irrelevant. There are very few mainstream grocery products that contain GE as an outright ingredient and, with this invisibility, UK consumers consider the GM problem to have gone away.

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Focus on the United Kingdom | 2020-06-01 - World Grain

Mish brings extensive global executive leadership experience in the development, manufacturing and commercialization of active pharmaceutical ingredients, including cannabinoids, and related consumer products

Franzino brings extensive strategic financial leadership experience in tobacco and alcoholic beverage industries

WILLIAMSVILLE, N.Y., June 03, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII) (22nd Century or the Company), a leading plant biotechnology company primarily focused on reduced nicotine tobacco and also hemp/cannabis plant genetics research and development, announced today that James A. Mish has been appointed Chief Executive Officer, effective June 22, 2020. The Company also announced that John Franzino has been appointed Chief Financial Officer, effective immediately.

Mish brings extensive global executive leadership experience in science-driven organizations with a recent focus on the development, manufacturing and commercialization of active pharmaceutical ingredients (API), including cannabinoids, and related consumer products. He has an outstanding track record of delivering profitable growth at both privately held and publicly traded companies. Prior to joining 22nd Century, Mish served as Chief Executive Officer of Noramco, a global leader in the production of controlled substances for the pharmaceutical industry, and Purisys, a synthetic cannabinoid API, ingredients and solutions provider to pharmaceutical and consumer products companies. Mish led the creation and spinoff of Purisys from Noramco during his tenure.

We are very pleased to welcome Jim as our new Chief Executive Officer at this critical juncture in our Companys history, said Nora B. Sullivan, Chairperson of the Board of Directors of 22nd Century. Jims extensive and proven executive leadership capabilities, substantial science-based industry background and deep experience with pharmaceutical and consumer products make him an outstanding candidate to successfully execute on the Companys initiatives and strategic plan going forward. We are confident that under Jims demonstrated leadership capabilities, 22nd Century will continue to build its portfolio of assets and create value for the benefit of our shareholders. We expect that with Jims direction and guidance, 22nd Century will achieve meaningful growth as the Company looks towards the anticipated authorization of our MRTP application for our proprietary, reduced nicotine cigarettes, and as we work to develop new hemp/cannabis intellectual property and proprietary plants with valuable cannabinoid profiles.

I am delighted to join 22nd Century Group at this pivotal time in the Companys growth as it looks to deliver on its primary mission to reduce smoking-related harm and also bring new and valuable hemp-derived cannabinoid products to market, said Mish. 22nd Century is an innovative, plant-based biotech company with an extensive and growing intellectual property portfolio that is poised to disrupt both the tobacco and hemp/cannabis industries. I look forward to partnering with 22nd Centurys Board and management team to drive the business forward to deliver value to our customers and shareholders.

Sullivan continued, We are also pleased to welcome John Franzino into the role of Chief Financial Officer. John is an accomplished strategic financial executive with a track record of successful leadership in high-growth, highly regulated, consumer-facing industries including tobacco and alcoholic beverages. We are excited to have a CFO of his caliber on the executive management team to help lead the Company through the next chapter of its growth.

Prior to joining 22nd Century Group, Franzino served as Chief Financial Officer of the West Point Association of Graduates. Additionally, he has extensive strategic financial leadership experience serving as Vice President of Finance and Controller at Bard College; as Chief Financial Officer of Santa Fe Natural Tobacco Company, a subsidiary of Reynolds American, Inc.; and as Chief Financial Officer of Labatt USA. Franzino is a Certified Public Accountant (CPA) and holds a Master of Business Administration degree from Farleigh Dickinson University.

Also, on behalf of the Companys Board of Directors, I would like to thank Andrea Jentsch, who has resigned as Chief Financial Officer due to personal reasons, for her service and significant contributions to the Company. Despite the challenges presented by COVID-19, Andrea has built a very strong team critical to advancing the Companys accounting, finance, information technology and human resources activities, and she has made a number of significant improvements to the Companys processes, internal reporting and IT resources that will be important enablers for the commercialization of the Companys proprietary plants and products. We wish Andrea the best in her future endeavors, Sullivan added.

About 22nd Century Group, Inc.22nd Century Group, Inc. (NYSE American: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing and modern plant breeding. The Companys primary mission in tobacco is to reduce the harm caused by smoking by bringing its proprietary reduced nicotine content tobacco cigarettes containing 95% less nicotine than conventional cigarettes to adult smokers in the U.S. and international markets. The Companys primary mission in hemp/cannabis is to develop proprietary hemp/cannabis plants with valuable cannabinoid profiles and agronomic traits and to commercialize those plants through a synergistic portfolio of strategic partnerships in the hemp/cannabis industry.

Learn more atxxiicentury.com, on Twitter@_xxiicenturyand onLinkedIn.

Cautionary Note Regarding Forward Looking StatementsThis press release contains forward-looking statements concerning our business, operations and financial performance and condition as well as our plans, objectives and expectations for our business operations and financial performance and condition that are subject to risks and uncertainties. All statements other than statements of historical fact included in this press release are forward-looking statements. You can identify these statements by words such as aim, anticipate, assume, believe, could, due, estimate, expect, goal, intend, may, objective, plan, potential, positioned, predict, should, target, will, would and other similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management's beliefs and assumptions. These statements are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. All forward-looking statements are subject to risks and uncertainties and others that could cause actual results to differ materially from those contained in our forward-looking statements. Please refer to the Risk Factors in our Annual Report on Form 10-K filed on March 11, 2020 and in our subsequently filed Quarterly Report on Form 10-Q. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.

Contacts:Mei Kuo22nd Century Group, Inc.(716) 300-1221mkuo@xxiicentury.com

Cory ZiskindICR(646) 277-1232cory.ziskind@icrinc.com

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22nd Century Group Appoints James A. Mish as Chief Executive Officer and John Franzino as Chief Financial Officer - GlobeNewswire

OKLAHOMA CITY, June 3, 2020 /PRNewswire/ --Progentec, a leader in next-gen diagnostics and digital technologies for the management of autoimmune diseases, announced today that Hakan Sakul, Ph.D., Vice President and Head of Diagnostics at Pfizer, has joined the Progentec Board of Directors. Dr. Sakul has a distinguished track record in the development and commercialization of companion diagnostics, precision medicine, and pharmacogenomics. His wealth of experience and knowledge will support Progentec in its mission to improve health outcomes for people living with autoimmune diseases.

"Lupus is a difficult disease to diagnose and a lab-based testing is sorely needed to confirm its diagnosis," said Dr. Sakul. "I am delighted to join Progentec's Board in this important phase of the company's diagnostics development journey."

In addition to his R&D, clinical, and product expertise, Dr. Sakul has deep experience in regulatory policy. He is currently a member of California Gov. Newsom's Precision Medicine Advisory Council, and was previously an Advisory Board member for California Gov. Brown's Precision Medicine Advisory Committee. Dr. Sakul is also on the board of directors for the Personalized Medicine Coalition and serves on Luminex Corporation's Oncology Advisory Committee.

About Progentec Diagnostics, Inc.

Progentec is committed to improving access and health outcomes for patients in therapeutic areas with a high level of unmet need by combining clinically-validated diagnostic interventions with state-of-the-art digital technologies. Through collaborations with research institutions and health practitioners around the world, Progentec is working to reduce mortality and morbidity while improving care management and service delivery for chronic health conditions.

Forward-Looking Statements:

Statements contained herein that are not historical facts are forward-looking statements that represent management's beliefs and assumptions as of the date of this news release based on currently available information. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it cannot assure that these expectations will prove to be correct. Such statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in any forward-looking statements.

Contact:

Mohan Purushothaman

(973) 885-5242

mpurushothaman@progentec.com

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SOURCE Progentec Diagnostics, Inc.

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Precision Medicine and Diagnostics Expert Hakan Sakul, Ph.D., of Pfizer Joins the Progentec Board of Directors - BioSpace

Precision medicine (PM) is an approach to patient care that allows doctors to select treatments that are most likely to help patients based on a genetic understanding of their disease. Personalized nanomedicine involving individualized drug selection and dosage profiling in combination with clinical and molecular biomarkers can ensure the maximal efficacy and safety of the treatment. The major hindrance toward the development of such therapies is the handling of the Big Data, to keep the databases updated. Robust automated data mining tools are being developed to extract information regarding genes, variations, and their association with diseases. Phenotyping, an integral part of PM, is aimed at translating the data generated at cellular and molecular levels into clinically relevant information.Precision Medicine Moves Care from Population-Based Protocols to Truly Individualized Medicine as President of the US announced the Precision Medicine Initiative in his 2015 State of the Union address. Under the initiative, medical care would transition from a one-size-fits-all approach to an individualized approach, in which data on each patients genomic makeup, environment, and lifestyle (the exposome) helps medical professionals tailor treatment and prevention strategies. To achieve the Precision Medicine Initiative mission statement, to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care, researchers and clinicians need vast and varied amounts of data and the technology to ensure that data is widely accessible and usable.

Browse Complete Report with TOC https://univdatos.com/report/precision-medicine-market-current-analysis-and-forecast-2020-2026

Insights Presented in the Report

Based on technology type, the market is fragmented into big data analytics, bioinformatics, gene sequencing, drug discovery, companion diagnostics, and others.Recent technological and analytical advances in genomics, have now made it possible to rapidly identify and interpret the genetic variation underlying a single patients disease, thereby providing a window into patient-specific mechanisms that cause or contribute to disease, which could ultimately enable the precise targeting of these mechanisms

Based on the market segment by application type, the market is segmented into oncology, respiratory diseases, central nervous system disorders, immunology, genetic diseases and others. With the advent of precision medicine, cancer treatment is moving from a paradigm in which treatment decision isprimarily based on tumor location and histology followed by molecular information to a new paradigm whereby treatment decisions will be primarily based on molecular information followed by histology and tumor location

Based on the market segment by end-user, the market is fragmented into hospitals & clinics, pharmaceuticals, diagnostic companies, Healthcare-IT firms and others. The precision medicine suppliers that understand technology and the goals of value-based healthcare can create value in the precision medicine value-chain by offering value-based solutions and platforms to interpret and connect data points. There are a number of technology companies who work in the field of precision medicine and more will be founded in the years to come

For better understanding on the market dynamics of Precision Medicine market, detailed analysis was conducted for different countries in the region including North America (United States, Canada, Mexico and Rest of North America), Europe (Germany, UK, France, Italy, Spain and Rest of Europe), Asia-Pacific (China, Japan, Australia, India and Rest of APAC), and Rest of World

Some of the major players operating in the market includeHoffmann-La Roche, Medtronic, Qiagen, Illumina, Abbott Laboratories, GE Healthcare, NanoString Technologies, bioMrieux SA, Danaher Corporation, and AstraZeneca

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Detailed examination of drivers, restraints, key trends and opportunities prevailing in the industry.

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The study comprehensively covers the market across different segments

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Precision MedicineMarket can further be customized as per the requirement or any other market segment. Besides this, UMI understands that you may have your own business needs, hence feel free to connect with us to get a report that completely suits your requirements.

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Precision Medicine Market Industry Analysis, Size, Share, Growth, Trends, and Forecast 2020-2026 - 3rd Watch News

Like so many people across the United States and around the world, my colleagues and I at Celmatix feel deeply outraged by the brutal and senseless murders of Breonna Taylor, Ahmaud Arbery, and George Floyd. We stand in solidarity with the millions of people lifting their voices in protest and also join countless more in reflecting on what we can do to make this a turning point for racial inequality.

Inequality comes in many forms for People of Color, both here and abroad, but race-related health disparities are among the starkest and most resistant to progress. Being a Black female further amplifies these inequities, which is particularly troubling and ironic given the fact that Women of Color make up the majority of healthcare workers. Over the last few months, the COVID-19 pandemic has brought this unfortunate reality into even more clear focus.

An often-cited quote in the business world is you cant manage what you cant measure. At Celmatix, we have been working for over a decade to address critical gaps in data collection for womens health. This has included thinking outside of the bubble of traditional research metropolises like Boston and San Francisco, and expanding our research partnerships to reproductive health centers of excellence across the US and to biological repositories that allow us to reach women at community health centers and urban hospitals which serve women who may not have access to reproductive specialist care. In addition to investing in diversified data for our scientific and clinical research studies, weve also made significant investments in our Next Gen Womens Project, an ambitious two-year consumer research effort that interviewed or surveyed more than 4K millennial women to understand how their healthcare needs differ from earlier generations of women and to discern their attitudes concerning their reproductive health and fertility. As part of this research, we had the privilege of collaborating withthe Black Womens Health Imperative, Womens Health Magazine, and Oprah Magazineto better understand why Black women are facing higher infertility rates, greater stigma around reproductive challenges, and larger barriers to accessing fertility care.

Taken together, the picture is clear: the disparities we see in womens health funding, research, delivery, innovation, data collection, and outcomes are consistently amplifiedmultifoldfor women of color.As we reflect on policy changes that could have an outsized impact on addressing centuries of racial inequality in the US, we can think of no better place to start than with improving the health of black women.

Black Womens Health ImperativeThe countrys first nonprofit organization created by Black women to help protect and advance the health and wellness of Black women and girls

Black Mamas Matter AllianceThe alliance helps advocate for better legislation to reduce black maternal mortality, highlights necessary areas of research and spreads information about the social determinants of health that influence outcomes like traumatic birth or maternal and infant mortality.

Sister SongSisterSong is a Southern-based, national membership organization; its purpose is to build an effective network of individuals and organizations to improve institutional policies and systems that impact the reproductive lives of marginalized communities

Fertility for Colored GirlsProvides services for underserved Black women and couples. This includes educational programming about treatment options, resources to connect with counselors, financial grants, and monthly support group meetings hosted by seven different chapters across the country,

Linda Villarosa:Journalist

Patrice Peck:Journalist

Laurie Zephyrin, MD:Obgyn, VP Health Care Delivery System Reform at Commonwealth Fund

Reproductive Injustice: Racism, Pregnancy, and Preterm Birth.Davis DA.NY: NYU Press:

Black Lives Matter: Claiming a Space for Evidence-Based Outrage in Obstetrics and Gynecology.Eichelberger KY, Doll K, Ekpo GE, Zerden ML. Am J Public Health. 2016 Oct;106(10):17712. doi: 10.2105/AJPH.2016.303313.

Key Facts on Health and Health Care by Race and Ethnicity,Samantha Artiga and Kendal Orgera. KFF, Published: Nov 12, 2019

When Maternity Wards in Black Neighborhoods Disappear:NYT, Kelly Glass, May 4, 2020

A Preventable Cancer is on the Rise in Alabama:The New Yorker, Eyal Press, March 30, 2020

This article originally appeared on Celmatix, where Dr.Piraye Yurttas Beim, who is also an EndoFound Board Member, is the founder. If you have additional data to share or organizations you would like us to highlight here, please reach out to atinfo@celmatix.comor info@endofound.org. Please also check back as we plan to expand on this list in the coming weeks. And finally, we urge you to help us raise awareness about this important issue by sharing this in your networks.

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The Disparities In Healthcare For Black Women | EndoFound - Endometriosis Foundation of America - The Blossom

New York, June 05, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Digital Genome Market Forecast to 2027 - COVID-19 Impact and Global Analysis by Product ; Application ; End User, and Geography" - https://www.reportlinker.com/p05908643/?utm_source=GNW However, dearth of skilled professionals is likely to restraint the growth of the market during the forecast years.

Digital genome is a complete digital set of genetic material that present in an organism or a cell.Digital genome technology deals with genes and their functions to find the causes behind the chronic diseases and also to fix them.

The technology is associated with the advancements that help to make healthcare more personal and more effective for the treatment.Digital genome facilitates instant access to trait sequences to resolve unending custom queries.

Genomic sequencing is rapidly transitioning into clinical practice, and implementation into healthcare systems has been supported by substantial government investment, accounting for US$ 4 billion in at least 14 countries. These national genomic medicine initiatives are driving transformative change under real-life conditions while simultaneously addressing barriers to implement and gather evidence for broader adoption.

The UK has announced the worlds largest genome project as part of 200 million public-private collaboration between charities and pharmaceutical.The UK has already developed the largest genome database in the world through the 100,000 Genomes Project.

Led by Innovate UK as part of UK Research and Innovation, the project will fund researchers and industry to combine data and real-world evidence from UK health services and create new products and services that diagnose diseases efficiently. Moreover, in August 2018, Boston, a Massachusetts-based company, announced that it landed US$ 4.3 million in seed funding and that it would be partnering with Veritas Genetics, a genome sequencing company. The funds will support the companys mission to usher in the era of personal genome sequencing by creating a trusted, secure, and decentralized marketplace for genomic data.

Cardiovascular diseases (CVDs) such as atherosclerosis, angina pectoris, and acute myocardial infarction are a significant cause for mortality in the world owing to the present day hectic lifestyle. As per the data provided by WHO, CVDs are the number 1 cause of death globally, taking an estimated 17.9 million lives each year. Diabetes is one of the life-threatening chronic diseases with no functional cure. Diabetes of all types can lead to various complications in different parts of the body and can increase the overall risk of premature death. Heart attack, stroke, kidney failure, leg amputation, vision loss, and nerve damage are the major complications associated with diabetes. As there is a significant increase in diabetes cases across the world, it results in life-changing complications among the population. According to the International Diabetes Federation (IDF), in 2017, 46 million diabetic patients were reported in North America, which is expected to reach 62 million in 2045. As chronic diseases are increasing at a faster pace, the research on genomics for life-threatening illnesses has progressed rapidly over the last five years, thereby driving the market growth during the forecast period.

Based on product, the digital genome market is segmented into DNA/RNA analysis, sequencing chips, sequencing and analyzer instruments, sample prep instruments, and sequencing and analysis software. The sequencing and analyzer instruments segment held the largest share of the market in 2019; whereas, the sequencing chips segment is estimated to register the highest CAGR in the market during the forecast period.

Based on application, the digital genome market is segmented into diagnostics, agricultural, academic research, drug discovery, personalized medicine, and other applications. The diagnostics segment held the largest share of the market in 2019; however, personalized medicine segment is estimated to register the highest CAGR in the market during the forecast period.

Based on end user, the global digital genome market is segmented into diagnostics and forensic labs, academic research institutes, hospitals, and others. The diagnostics and forensic labs segment held the highest share of the market in 2019; whereas, the academic research institutes segment is estimated to register the highest CAGR in the market during the forecast period.

The World Health Organization (WHO), Food and Drug Administration (FDA), NHS (National Health Service), and Centers for Disease Control and Prevention are some of the major primary and secondary sources referred for preparing this report.Read the full report: https://www.reportlinker.com/p05908643/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

__________________________

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Digital Genome Market Forecast to 2027 - COVID-19 Impact and Global Analysis by Product ; Application ; End User, and Geography - GlobeNewswire

This Patch article is sponsored by Summit Physical Therapy Inc.

Summit Physical Therapy, founded in 1988, is an independent, physical therapist-owned, private practice with a convenient location serving Union, Essex and Morris counties. In a world of medicine dictated by corporations, Summit Physical Therapy stays true to its roots with treatment provided only by licensed physical therapists.

In this environment, it is able to provide the personalized treatment that every patient deserves, as well as develop relationships that last longer than treatment. From exercising to stretching, the practice teaches you exactly how to manage your condition so you can live a happy and pain-free life.

John V. Scioscia, president of Summit Physical Therapy, let Patch in on the secrets to his 30-plus years of success in the business, as well as how the practice is providing virtual treatment throughout the COVID-19 pandemic.

Patch: How long have you been doing business in town?

Scioscia: Summit Physical Therapy has been operating since 1988. My wife and I have lived in Summit now for the past 35 years. We raised our children here and have stuck around even after they left. The whole family has been very involved in the community, between sports, my involvement in various boards and organizations, and my wife previously working at Lincoln-Hubbard Elementary School.

Patch: What attracted you to the line of work you're in, and how did you get started?

Scioscia: I have always had a passion for science and fixing things. As a child, this led me in the direction of medicine. I eventually wound up being recruited to Boston University for wrestling with the intention to become a physician. Over the course of my athletic career at Boston, I became involved with physical therapy and athletic training. After college, I started my career in professional sports, but I soon realized I wanted a life that allowed for more time at home with my family. I founded Summit Physical Therapy, and the rest has been amazing.

Patch: If you had to sum up your business mission in five words to a stranger, what would those words be?

Scioscia: Honest. Independent. Experienced. Skilled. Community.

Patch: What's the most satisfying part of your job?

Scioscia: In general, the most satisfying part of my job is helping people. There are some instances when a patient is dealing with a more difficult or complex case and confides that we have made a breakthrough. That is a special moment. As a physical therapist, I get a lot of time to truly invest in a patient's well-being. Making that personal connection and building trust with someone who needs it most is particularly satisfying.

Patch: How would you say your business or organization distinguishes itself from the others?

Scioscia: The physical therapy industry as a whole has changed in recent years. Most have adopted a "team" model, where your care is delivered by numerous aides, technicians and assistants, putting the therapist in more of a supervisory role. At Summit Physical Therapy, your care is delivered entirely by physical therapists. We pride ourselves in being involved in every part of the rehab process. We even take care of sanitizing surfaces ourselves. Nothing is outsourced. Neighbors caring for neighbors. We have also maintained the same staff. Aside from bringing on a new therapist two years ago, our entire staff has worked here for over 20 years. It is hard to say that about any company, let alone a PT clinic. You definitely know someone who has been treated by our therapists.

Patch: What's the best piece of advice you've ever been given when it comes to success?

Scioscia: "You are either moving forward or moving backward." This has applied to how we manage the business but is also applicable to our patients and athletes.

Patch: Are there any new projects or endeavors you're working on that you're extra excited about?

Scioscia: Interestingly enough, we had been planning to start offering telehealth services starting the summer of 2020 prior to this COVID-19 outbreak. Our goals were to provide an easier way for patients to receive care when they could only make it to the clinic on a less-than-optimal basis, provide PT for our patients who travel for business or vacation, provide a more-efficient method to monitor patients as they phase back into normal life after rehab, and to provide athletic program monitoring from a far with our Performance Therapy service.

Obviously, this pandemic moved our rollout date up by a few months, and we have now been practicing telehealth for over three months! Maintaining our theme of honesty, telehealth is not adequate to replace all in-clinic treatment, but is phenomenal for many treatments. We have seen great success with getting patients in for isolated treatments, if in acute or recent-onset pain, progressing to telehealth when symptoms are less irritable. For patients who are in lesser levels of pain, telehealth can be a great option even to start. We are currently offering free telehealth consultations to answer any questions and to help you find what treatment option is best for you.

Patch: Do you have any events coming up in your community?

Scioscia: In November 2019, we started hosting a lecture series at our clinic as well at a few local businesses. Since March, we have converted the series to webinars, which is not only awesome to maintain social distance but allows many more people to access the information from their home. Keep an eye on our Facebook and Instagram for the next webinar we host.

Patch: How can Patch readers learn more about your work and business?

Scioscia: Our website was designed less as a marketing tool and more as a source of information for our patients and the public. We have information on specific conditions, what to expect with PT page, therapist bios, and even a request for an appointment function. We are also on Facebook and Instagram.

Phone: 908-598-9009Email: physicaltherapysummit@gmail.com

More:
Summit Physical Therapy Offers Personalized Treatment To Patients - Patch.com

Market Scenario

Global in Vitro Fertilization market is expected to reach USD 847.8 Bn by 2026 at a CAGR of 10.5 % during the forecast period.

The Global in Vitro Fertilization market is segmented based on product, type of cycle, end-user, and region.

Request for Report Sample: https://www.trendsmarketresearch.com/report/sample/10296

By Product type Reagents, Equipment.By Type of Cycle Fresh Non-Donor IVF Cycles, Frozen Non-Donor IVF Cycles, Frozen Donor IVF Cycles, Fresh Donor IVF Cycles, By End User Hospitals & Research Laboratories, Cryobanks. By region North America & South America, Europe, Asia-Pacific and, Middle East & Africa

In vitro fertilization is a procedure in which egg from women ovary are removed and after that, the egg is fertilized with a sperm in a laboratory procedure, and then the fertilized egg is transferred into the women uterus. In vitro fertilization is used in the management of female infertility.

Major Market Drivers:

Rising rate of infertility Increasing in delayed pregnancies and raising awareness of personalized medicine. Surge in IVF success rate Unfavourable Reimbursement Scenario. Rise in disposable income worldwide.Restraint: High cost of treatment which is restraining this market. Less awareness level for IVF in developing countries which is another restraint of this market.

Request for Report Discount: https://www.trendsmarketresearch.com/report/discount/10296

Global In Vitro Fertilization Market

Strategic Developments in the Global In Vitro Fertilization Market:

In July 2018, Merck launched new products QBOX IVF. This product useful in data transfer between lab instrument and electronic medical record provider. It provides support healthcare professionals in fertility.

In February 2016, Adelaide biotech company, a reproductive health science company expanded IVF expertise into other DNA testing area by the launch of new product. This screening kits count the number of chromosomes in embryo to transfer in an IVFcycle.

Product Insights:Reagents and electrodes segment are expected to reveal exponential CAGR throughout the forecast period due to innovative product launches, and surge in IVF success rate unfavorable reimbursement scenario and rise in disposable income worldwide across the globe.

The North American region is playing the principal role in the global in vitro fertilization market due to the presence of several leading players. Though, Asia-Pacific will be the second major market in the proximate future. The presence of innovative medical advanced technology, a rising rate of infertility, increasing in delayed pregnancies and rising awareness on personalized medicine in the region.Scope of the Global In Vitro Fertilization Market Report

Global In Vitro Fertilization Market, by Product

Reagents EquipmentGlobal In Vitro Fertilization Market, by Type of Cycle

Fresh Non-donor IVF Cycles Fresh donor IVF cyclesGlobal In Vitro Fertilization Market, by End Users

Hospitals & Research Laboratories Cryobanks OthersGlobal In Vitro Fertilization Market, by Instrument

Incubators Cryosystem Cabinet Ovum Aspiration Pump Sperm Aspiration Pump Micromanipulator OthersGlobal In Vitro Fertilization Market, by Technology

Intra-cytoplasmic Sperm Injection (ICSI) Preimplantation Genetic Diagnosis (PGD)Global In Vitro Fertilization Market, by Region

North America Europe Asia Pacific Middle East & Africa South AmericaGlobal In Vitro Fertilization Market Key Players

Groupe Clinique Ambroise Par amedes MVZ Cologne GmbH AMP Center St Roch, AVA International Clinic Scanfert Bangkok IVF center Betamedics Biofertility Center Bloom Healthcare Bourn Hall Fertility Center Cardone & Associates Reproductive Medicine & Infertility Cook Medical Inc. Coopersurgical Inc. Hamilton Thorne, Inc. Irvine Scientific Laboratoire CCD Merck KGaA Nidacon International AB Nikon Corporation Thermo Fisher Scientific Inc. Vitrolife AB

Full View of Report Description: https://www.trendsmarketresearch.com/report/analysis/MMR/global-in-vitro-fertilization-market

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In Vitro Fertilization Market Industry Insights, Trends and Forecast up size 2026 - Cole of Duty

BioSpectrum Asia spoke to Francis Van Parys, Vice-President Commercial, Asia-Pacific, Cytiva (Formerly GE Life Sciences), Seoul, South Korea

The UK headquartered Cytiva is a $3.3 billion global life sciences leader with nearly 7000 associates operating in 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture and delivery of transformative medicines to patients. Cytiva announced the collaboration with Takara Bio to develop DNA vaccine to confront the virus in Japan, on May 21. BioSpectrum Asia spoke to Francis Van Parys, Vice-President Commercial, Asia-Pacific, Cytiva (Formerly GE Life Sciences), Seoul, South Korea, who is responsible for providing transformational technologies in biopharmaceutical research, manufacturing and diagnostics to Cytiva customers and partners in the life sciences industry in China, India, Japan, Korea, ASEAN and Australia & New Zealand, for his major plans in store and his plans to enhance growth within the APAC region for the company.

Edited excerpts-

What are the major plans in store for Cytiva? Any new segments to be explored?

Cytiva offers the same high-quality services as we did when we were part of GE Healthcare Life Sciences. It shouldnt be overlooked that we are already a life sciences global leader and we expect our significant growth of recent years to continue. We have been at the forefront of innovation and development of areas such as protein purification, single-use technology and cell and gene therapies.

Cytiva will benefit from being a newly-created organization that is already a global life sciences leader. We have market leading brands such as KTA, Amersham, HyClone and Whatman, among others. We also have more than 100,000 systems in use globally. We will continue innovating from within and working with our customers to develop next generation solutions.

One area where we want to and must do better is sustainability. This is a challenge and opportunity for any organization operating today and one that Cytiva takes very seriously. We dont want to be just compliant in sustainability terms, we want to lead the industry. We will be focusing on areas such as GHG emission, use of plastics, packaging, water management and societal impact among other areas.

How do you plan to enhance your growth within the APAC region?

Asias Economies are seeing rapid growth in past decades meanwhile it suffers for the increases in cardiac disease, cancer and diabetes are subsequently anticipated, driven by increased life expectancy and lifestyle changes. Biotherapeutics are, and will remain, in the forefront of curing many of these diseases and improving the quality of lives across Asia.

Cytiva is well positioned to support the growth in protein-based therapeutics and future treatments, such as cell and gene therapies. Additionally, as the global healthcare system rapidly moves toward more personalized medicine, Cytiva will work with our customers to ensure we are developing the right tools and technologies to ensure efficient manufacturing of novel therapeutics.

How is Cytiva contributing to this fight against COVID-19?

The COVID-19 crisis has brought together the scientific community like never before. Our global team is helping to accelerate the work of researchers, developers, and manufacturers of diagnostics and vaccines, to bring access to much-needed solutions for COVID-19.

In Asia, we just announced the collaboration with Takara Bio to develop DNA vaccine to confront the virus in Japan, on May 21. Genedrive: PCR assay to detect SARS-CoV-2; Sona Nanotech: rapid response lateral flow test; Avacta: Affimer-based point-of-care rapid screening test and University of Queensland: vaccine

What will be the impact of this pandemic on the global economy? How is Cytiva preparing itself?

Cytivas number one priority is the health and safety of our employees and our customers. We are working closely with local governments, and world health authorities to actively monitor the outbreak and take all necessary precautions. We are prepared to walk alongside our customers to help ensure continuity of business, stay connected virtually for support, and provide solutions in this time of need.

The pandemic should not derail us from our key mission, which is to support the worlds development of new technologies and the manufacturing of existing drugs, which are so much important to the diabetes patient, or the cancer patient, or the young child that needs a vaccine. To achieve this mission, you have to shuffle, because suddenly you have to prioritize particular initiatives that you didn't have in mind at all two months ago. We have a task force with special focus on the COVID-19 coronavirus, like we did when Ebola and SARS were global pandemics. This allows us to rapidly respond to the needs of our customers.

Cytiva has comprehensive crisis management andsecurity of supplyprograms in place. We are committed to fulfilling customer orders and regularly adjust our manufacturing output to respond to market demands, while ensuring our operations and service capabilities continue safely. We are also in regular contact with our suppliers regarding their business continuity plans to help minimize disruption of the flow of materials into our manufacturing facilities.

Ankit Kankar

ankit.kankar@mmactiv.com

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The COVID-19 crisis has brought together the scientific community like never before - BSA bureau

QY Research has published a new report on the global Targeted Biomarker market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, The analysts have clarified every part of the market exhaustive fastidious research and full focus to each point. This report gives additional information on statistical data to assist readers with understanding the entire market. This report offers a clear understanding of the present as well as future scenario of the global Targeted Biomarker industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Targeted Biomarker production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.

Key companies operating in the global Targeted Biomarker market include _ bioMerieux, IntegraGen, Myriad Genetics, Protagen, Qiagen, PerkinElmer, Merck Millipore, Bio-Rad Laboratories, Enzo Biochem, EKF Diagnostics, Meso Scale Diagnostics, LLC. Targeted Biomarker Breakdown Data by Type

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Segmental Analysis

The report has classified the global Targeted Biomarker industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Targeted Biomarker manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Targeted Biomarker industry.

Global Targeted Biomarker Market Segment By Type:

, Safety biomarker, Efficacy biomarker, Validation biomarker Targeted Biomarker Breakdown Data by Application,

Global Targeted Biomarker Market Segment By Application:

Diagnostics development, Drug discovery & development, Personalized medicine, Disease risk assessment, Others

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Targeted Biomarker industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key companies operating in the global Targeted Biomarker market include _ bioMerieux, IntegraGen, Myriad Genetics, Protagen, Qiagen, PerkinElmer, Merck Millipore, Bio-Rad Laboratories, Enzo Biochem, EKF Diagnostics, Meso Scale Diagnostics, LLC. Targeted Biomarker Breakdown Data by Type

Key questions answered in the report:

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TOC

Table of Contents 1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Targeted Biomarker Revenue1.4 Market Analysis by Type1.4.1 Global Targeted Biomarker Market Size Growth Rate by Type: 2020 VS 20261.4.2 Safety biomarker1.4.3 Efficacy biomarker1.4.4 Validation biomarker1.5 Market by Application1.5.1 Global Targeted Biomarker Market Share by Application: 2020 VS 20261.5.2 Diagnostics development1.5.3 Drug discovery & development1.5.4 Personalized medicine1.5.5 Disease risk assessment1.5.6 Others 1.6 Study Objectives 1.7 Years Considered 2 Global Growth Trends by Regions2.1 Targeted Biomarker Market Perspective (2015-2026)2.2 Targeted Biomarker Growth Trends by Regions2.2.1 Targeted Biomarker Market Size by Regions: 2015 VS 2020 VS 20262.2.2 Targeted Biomarker Historic Market Share by Regions (2015-2020)2.2.3 Targeted Biomarker Forecasted Market Size by Regions (2021-2026) 2.3 Industry Trends and Growth Strategy 2.3.1 Market Top Trends 2.3.2 Market Drivers2.3.3 Market Challenges2.3.4 Porters Five Forces Analysis2.3.5 Targeted Biomarker Market Growth Strategy2.3.6 Primary Interviews with Key Targeted Biomarker Players (Opinion Leaders) 3 Competition Landscape by Key Players3.1 Global Top Targeted Biomarker Players by Market Size3.1.1 Global Top Targeted Biomarker Players by Revenue (2015-2020)3.1.2 Global Targeted Biomarker Revenue Market Share by Players (2015-2020)3.1.3 Global Targeted Biomarker Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Targeted Biomarker Market Concentration Ratio3.2.1 Global Targeted Biomarker Market Concentration Ratio (CR5 and HHI)3.2.2 Global Top 10 and Top 5 Companies by Targeted Biomarker Revenue in 20193.3 Targeted Biomarker Key Players Head office and Area Served3.4 Key Players Targeted Biomarker Product Solution and Service3.5 Date of Enter into Targeted Biomarker Market3.6 Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026)4.1 Global Targeted Biomarker Historic Market Size by Type (2015-2020)4.2 Global Targeted Biomarker Forecasted Market Size by Type (2021-2026) 5 Targeted Biomarker Breakdown Data by Application (2015-2026)5.1 Global Targeted Biomarker Market Size by Application (2015-2020)5.2 Global Targeted Biomarker Forecasted Market Size by Application (2021-2026) 6 North America6.1 North America Targeted Biomarker Market Size (2015-2020)6.2 Targeted Biomarker Key Players in North America (2019-2020)6.3 North America Targeted Biomarker Market Size by Type (2015-2020)6.4 North America Targeted Biomarker Market Size by Application (2015-2020) 7 Europe7.1 Europe Targeted Biomarker Market Size (2015-2020)7.2 Targeted Biomarker Key Players in Europe (2019-2020)7.3 Europe Targeted Biomarker Market Size by Type (2015-2020)7.4 Europe Targeted Biomarker Market Size by Application (2015-2020) 8 China8.1 China Targeted Biomarker Market Size (2015-2020)8.2 Targeted Biomarker Key Players in China (2019-2020)8.3 China Targeted Biomarker Market Size by Type (2015-2020)8.4 China Targeted Biomarker Market Size by Application (2015-2020) 9 Japan9.1 Japan Targeted Biomarker Market Size (2015-2020)9.2 Targeted Biomarker Key Players in Japan (2019-2020)9.3 Japan Targeted Biomarker Market Size by Type (2015-2020)9.4 Japan Targeted Biomarker Market Size by Application (2015-2020) 10 Southeast Asia10.1 Southeast Asia Targeted Biomarker Market Size (2015-2020)10.2 Targeted Biomarker Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Targeted Biomarker Market Size by Type (2015-2020)10.4 Southeast Asia Targeted Biomarker Market Size by Application (2015-2020) 11 India11.1 India Targeted Biomarker Market Size (2015-2020)11.2 Targeted Biomarker Key Players in India (2019-2020)11.3 India Targeted Biomarker Market Size by Type (2015-2020)11.4 India Targeted Biomarker Market Size by Application (2015-2020) 12 Central & South America12.1 Central & South America Targeted Biomarker Market Size (2015-2020)12.2 Targeted Biomarker Key Players in Central & South America (2019-2020)12.3 Central & South America Targeted Biomarker Market Size by Type (2015-2020)12.4 Central & South America Targeted Biomarker Market Size by Application (2015-2020) 13Key Players Profiles13.1 bioMerieux13.1.1 bioMerieux Company Details13.1.2 bioMerieux Business Overview and Its Total Revenue13.1.3 bioMerieux Targeted Biomarker Introduction13.1.4 bioMerieux Revenue in Targeted Biomarker Business (2015-2020))13.1.5 bioMerieux Recent Development13.2 IntegraGen13.2.1 IntegraGen Company Details13.2.2 IntegraGen Business Overview and Its Total Revenue13.2.3 IntegraGen Targeted Biomarker Introduction13.2.4 IntegraGen Revenue in Targeted Biomarker Business (2015-2020)13.2.5 IntegraGen Recent Development13.3 Myriad Genetics13.3.1 Myriad Genetics Company Details13.3.2 Myriad Genetics Business Overview and Its Total Revenue13.3.3 Myriad Genetics Targeted Biomarker Introduction13.3.4 Myriad Genetics Revenue in Targeted Biomarker Business (2015-2020)13.3.5 Myriad Genetics Recent Development13.4 Protagen13.4.1 Protagen Company Details13.4.2 Protagen Business Overview and Its Total Revenue13.4.3 Protagen Targeted Biomarker Introduction13.4.4 Protagen Revenue in Targeted Biomarker Business (2015-2020)13.4.5 Protagen Recent Development13.5 Qiagen13.5.1 Qiagen Company Details13.5.2 Qiagen Business Overview and Its Total Revenue13.5.3 Qiagen Targeted Biomarker Introduction13.5.4 Qiagen Revenue in Targeted Biomarker Business (2015-2020)13.5.5 Qiagen Recent Development13.6 PerkinElmer13.6.1 PerkinElmer Company Details13.6.2 PerkinElmer Business Overview and Its Total Revenue13.6.3 PerkinElmer Targeted Biomarker Introduction13.6.4 PerkinElmer Revenue in Targeted Biomarker Business (2015-2020)13.6.5 PerkinElmer Recent Development13.7 Merck Millipore13.7.1 Merck Millipore Company Details13.7.2 Merck Millipore Business Overview and Its Total Revenue13.7.3 Merck Millipore Targeted Biomarker Introduction13.7.4 Merck Millipore Revenue in Targeted Biomarker Business (2015-2020)13.7.5 Merck Millipore Recent Development13.8 Bio-Rad Laboratories13.8.1 Bio-Rad Laboratories Company Details13.8.2 Bio-Rad Laboratories Business Overview and Its Total Revenue13.8.3 Bio-Rad Laboratories Targeted Biomarker Introduction13.8.4 Bio-Rad Laboratories Revenue in Targeted Biomarker Business (2015-2020)13.8.5 Bio-Rad Laboratories Recent Development13.9 Enzo Biochem13.9.1 Enzo Biochem Company Details13.9.2 Enzo Biochem Business Overview and Its Total Revenue13.9.3 Enzo Biochem Targeted Biomarker Introduction13.9.4 Enzo Biochem Revenue in Targeted Biomarker Business (2015-2020)13.9.5 Enzo Biochem Recent Development13.10 EKF Diagnostics13.10.1 EKF Diagnostics Company Details13.10.2 EKF Diagnostics Business Overview and Its Total Revenue13.10.3 EKF Diagnostics Targeted Biomarker Introduction13.10.4 EKF Diagnostics Revenue in Targeted Biomarker Business (2015-2020)13.10.5 EKF Diagnostics Recent Development13.11 Meso Scale Diagnostics, LLC.10.11.1 Meso Scale Diagnostics, LLC. Company Details10.11.2 Meso Scale Diagnostics, LLC. Business Overview and Its Total Revenue10.11.3 Meso Scale Diagnostics, LLC. Targeted Biomarker Introduction10.11.4 Meso Scale Diagnostics, LLC. Revenue in Targeted Biomarker Business (2015-2020)10.11.5 Meso Scale Diagnostics, LLC. Recent Development 14Analysts Viewpoints/Conclusions 15Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source15.2 Disclaimer15.3 Author Details

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Targeted Biomarker Market 2020- Analysis And In-Depth Research On Market Size, Trends, Emerging Growth Factors And Forecast To 2026 - Cole of Duty

New York The way the COVID-19 crisis ends is with vaccines not a vaccine. More than one horse can win this race. Some of us might end up getting a shot of a more traditional vaccine, which uses parts of an inactivated virus to stimulate immunity. Others might get vaccines based on emerging technologies that use synthetic versions of the viruss genetic code.

One such novel candidate, based on RNA the single-stranded cousin of DNA and made by Moderna, showed promising results in early human trials, though critics warned the evidence is preliminary. Meanwhile, a different prototype based on DNA made headlines for an experiment that showed it worked in monkeys.

In the end, some vaccines might be extremely effective but harder to scale; others the opposite. Even a less-effective vaccine might work well enough to provide herd immunity in a wider population. Other vaccines might be more appropriate for health care workers, who have to risk exposure on the job, and need protection as soon as possible.

Scientists have created more than 70 vaccine candidates so far. If we end up with two, three, or four vaccines, thats good, since we have seven billion people, says Harvard vaccine researcher Dan Barouch, who led the development of one of the vaccines featured in recent news. His group began working on a vaccine in January, after the virus started spreading in China.

There are good reasons for him and other scientists to be optimistic.

For COVID-19, its clear most humans who get infected recover that alone shows the human immune system can eliminate the virus, he says. That makes it a much easier target than HIV, which he calls unprecedented in the history of vaccinology for its ability to evade the immune system. And the SARS-Cov2 virus doesnt have the fast mutation rate that makes flu viruses a moving target.

Art Krieg, a physician and founder of Checkmate Pharmaceuticals, says hes very optimistic that because the human immune system can successfully battle the virus, so will one or more of the many experimental vaccines.

All vaccines have to provide a danger signal to prime the immune system into acting against an invader. In 1995, Krieg reported the discovery one of these danger signals called CpG DNA which has been used in several vaccines, including one for hepatitis B, and is in some of the experimental candidates fighting against the virus that causes COVID-19.

Next, the vaccine has to mimic the invader in order to get the immune system to create specific antibodies that target the intended enemy. Vaccine designers using genetic material (DNA or RNA) have to stimulate the immune system enough to generate those antibodies, but not so much that the immune system destroys the vaccine before it can complete its mission.

The biggest driver of recent headlines (and stock market drama) was a vaccine produced by the Massachusetts-based company Moderna, which is based on synthetic genetic material identical to parts of the code carried by the coronavirus. The genetic material is RNA. (Other RNA vaccines are being studied by BionTech, Translate Bio, and Curevac.) The RNA tricks human cells into making proteins identical to the spike proteins the virus uses to penetrate human cells. And that, in turn, stimulates the immune system to make antibodies that will be ready to block that protein if the real coronavirus invades.

The excitement about Modernas vaccine followed the release of data from a trial that involved 45 volunteers, though the company only described results for eight of them. Of the eight, all produced antibodies with the desired neutralizing property needed to attack the virus in the future. What happened to the other 37 people? Since this vaccine requires two doses, they probably just didnt have that data yet, says Krieg.

A similar concept is behind DNA vaccines. The one developed by Harvards Barouch made the news for a successful experiment in monkeys. Other DNA vaccines are already in early human trials, including candidates developed by Oxford University, Johnson & Johnson and the Chinese company CanSino Biologics.

These DNA vaccines use synthetic strings of code for making the spike protein carried by the virus. In some of these, the synthetic DNA is injected alone, while in others, it rides into human cells inside a deactivated cold virus (called an adenovirus). The human cells transcribe the DNA to RNA, and then into the decoy spike protein used to create immunity to the real thing. While the prototype developed by Barouchs group at Harvard can be given in two shots, the Oxford DNA vaccine and several others that use cold viruses confer immunity with just one shot, says Krieg.

DNA and RNA arent our only options. Yet another vaccine concept, made by Dynavax, uses the spike protein itself and stimulates the immune system using a synthetic DNA danger signal the CpG DNA. These protein-based vaccines would have to be produced in bulk in fermentation vats, which Krieg says is something the biotech industry is equipped to do.

Krieg says all the novel vaccines work through the same well-established scientific principles, and are very likely to be safe. Still, he says, its well known that vaccines dont work as well in the elderly and immunocompromised. Imperfect vaccines could still eradicate the virus through herd immunity but only if the bulk of the population gets vaccinated. Once the technical hurdles are overcome, there will be social hurdles already, there are movements among anti-vaxxers to resist but its not too soon to plan to surmount them.

Barouch says the ordinarily competitive nature of science has changed, as everyone understands how much is at stake in terms of lives and economic damage. In retrospect, critics might be able to criticize approaches that didnt work, but right now, we need all the ideas we can get.

Science writer Faye Flam is a Bloomberg Opinion columnist.

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The more COVID-19 vaccines, the merrier - The Japan Times

Last year, University neuroscientists Alban Gaultier and Dorian Rosen found that antidepressant drug Fluvoxamine may help control inflammation in the immune response system. In May, that discovery sparked a clinical trial at Washington University in St. Louis to determine if the drug could help treat COVID-19 patients, as reducing inflammation in the body has become a key way to fight the virus.

Fluvoxamine, also known as Luvox, is most commonly used to treat Obsessive Compulsive Disorder. The drug functions as a selective serotonin reuptake inhibitor by increasing levels of serotonin a chemical in the brain associated with feelings of well-being and happiness in the body. Since 1983, Fluvoxamine has been used by more than ten million patients around the world.

SSRIs are commonly prescribed because of their safety and tolerability, and many SSRIs, including Fluvoxamine, have been used to treat a variety of other conditions such as migraine headaches, fibromyalgia and anxiety.

In their initial experiment, Gaultier and Rosen determined that the drug reduced the production of cytokines small proteins secreted by the immune system that regulate immunity and inflammation. The drug also proved effective in reducing damage in the inflammatory response during sepsis a life threatening complication of infection in which the immune system spirals out of control and protected mice from lethal shock.

New research has found that many seriously ill coronavirus patients have a large number of cytokines in their blood. These high levels of cytokines likely result from cytokine storms, a severe immune response that releases a large number of cytokines in reaction to a disease or infection. During a cytokine storm, the body begins to attack its own cells rather than use all its resources to fight off the virus.

The information we have so far suggests that the second phase of the illness can involve a life-threatening inflammatory reaction what we call a cytokine storm, said Caline Mattar, assistant professor of medicine in the Washington University infectious diseases division, in a press release from Washington University. We want to learn whether fluvoxamine might help prevent that second phase of the illness.

The trial is being led by Mattar and Washington University psychology professor Eric J. Lenze. It is expected to test whether or not fluvoxamine can prevent cytokine storms in patients with COVID-19, which could help keep the immune system in check and help fight the virus without destroying organs, according to Gaultier.

For some patients, blocking the production of cytokine may be life saving, as the cytokine storms accelerate the breakdown of the immune system, which often results in hospitalization. High fevers, lung damage and respiratory distress symptoms currently experienced by thousands of COVID-19 patients are signs of overworked immune systems.

The trial will test Fluvoxamine in 152 patients with COVID-19 in Illinois and Missouri, as the team's physicians are only licensed to treat people in those states. The patients will either receive the drug or a placebo while quarantined at home. The hope is to target patients who are not sick enough to go to the hospital and hopefully prevent them from getting sicker and being hospitalized. The patients will administer the medication themselves, as the study has been designed to be contactless, and then will use thermometers, fingertip oxygen sensors and automatic blood pressure monitors to monitor their own condition.

Washington Universitys website offers information about who is eligible and how the trial will specifically interact with its patients virtually.

While it may sound unusual to administer a drug typically used to treat OCD as a COVID-19 treatment, Lenze believes it is in line with other alternative treatments being tested at the moment.

Using a psychiatric drug to treat COVID-19 may sound counterintuitive, but its no more counterintuitive than using a malaria drug, Lenze said in the press release.

Similar to Fluvoxamine, the malaria drugsremdesivir and hydroxychloroquine are being tested in off-label ways as COVID-19 treatments. Off-label testing of drugs by health care officials is not uncommon once a drug has been approved by the Food and Drug Administration.

Fluvoxamine received approval in 1994 when the FDA agreed that the benefits of the drug would outweigh its possible side effects like headache and nausea.

Gauliter notes the benefits that come from fluvoxamine already being FDA-approved.

The clinical trial is a smart move to push forward, and since the drug is already approved, it will be easier for people to access it, Gaultier said to The Cavalier Daily.

Even if the drug proves ineffective in fighting COVID-19, patients in the trial will still benefit from the supervision of the doctors and professional recommendations for further treatment.

Gaultier who works closely with the Washington University team believes the clinical trial is set to have its results by the end of June and hopes that fluvoxamine will improve COVID-19 outcomes.

Hopefully the clinical trial will have a positive outcome, which everybody needs, Gaultier said.

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University research sparks clinical trial to test antidepressant that could treat COVID-19 - University of Virginia The Cavalier Daily