March 29, 2024

Fall is Upon Us: What Does this Mean for Covid-19?

Fall is Upon Us – What does this Mean for Covid-19 in the US and Abroad?

Officials had hoped that the number of coronavirus cases would decline over the summer; since case numbers did not drop, many health professionals are worried that case numbers will spike across the United States and in other nations. In fact, the director of the Centers for Disease Control and Prevention (CDC) warned that country could be facing “the worst fall, from a public health perspective, we’ve ever had.”

There were more than 22,526,000 confirmed cases of COVID-19 worldwide as of August 20, 2020, according to Johns Hopkins University, and 5,567,955 of those cases were in the United States. With vaccine still months away, a number of factors could affect whether the number of cases will increase or decrease into autumn.

On August 13, 2020, the CDC predicted that the number of new cases could decrease into early September. The CDC used several models to make this prediction; many of the models base their assumptions on whether current interventions, such as social distancing, will continue into the fall. The CDC has not yet offered a prediction for the number of COVID-19 cases for autumn, but the federal agency does offer a reminder that the second and more deadly wave of the 1918 pandemic occurred in the fall.

Factors that could affect COVID-19 cases in the US and abroad

The rise or fall of COVID-19 cases in autumn will depend on a number of factors, including the onset of flu season, the use of social distancing and facemasks, the proportion of students returning to in-person classes rather than distance learning, the return to amateur, college and professional sports, and the development of a vaccine.

Unless cases drop dramatically in the next few weeks, the coronavirus outbreak will likely coincide with the flu season, which means the number of sick people could overwhelm an already-stressed healthcare system. Flu season typically starts in October and worsens through January and February. While flu vaccinations could help reduce the burden on healthcare systems, only about 45 percent of American adults received a flu vaccine during last year’s during the 2018–19 flu season, according to the CDC.

Mask wearing is common and culturally acceptable in many parts of the world, particularly in East Asia, but not so in the United States. About 63 percent of people in Japan wore masks during the pandemic, for example, but a July Gallup poll found that only 44 percent of American adults said they “always” wear a mask when outside their homes.

Opening Schools During Covid-19 Pandemic

Opening schools poses a challenge in the US and abroad – while education is essential, in-person learning could cause a spike in infection rates. During the first few months of the pandemic, children seemed to have a much lower infection rate than did adults, but a recent collaborative report by the American Academy of Pediatrics and the Children’s Hospital Association showed that there was a 24 percent increase in child cases between July 30th and August 13th.

Europe’s flattened curve and lower infections rates tempted officials to open schools, but it has not gone as planned. All of Germany’s northeastern state of Mecklenburg-Western Pomerania’s schools opened at the beginning of August, for example, but two schools shut down at the end of the first week infections; the use of masks in schools is preferred but not mandatory.

Schools never closed in Sweden and administrators never major adjustments to class size, lunch policies, or recess rules. This would have been a perfect opportunity to study schools’ role in the spread of the virus; unfortunately, officials never tracked infections among schoolchildren, even when outbreaks led to the closure of individual schools or when staff members died of coronavirus.

Fall Sports During The Covid-19 Pandemic

Fall sports provide ample opportunities for transmission, in that most sports involve close contact between players and the physical exertion associated with sports make mask-wearing difficult. To reduce the risk of transmission, many US high schools are canceling or rescheduling fall sports programs, but Florida and several other states intend to resume as planned. Guidance from the National Federation of State High School Associations (NFHS) may help inform decisions about reopening athletic activities in schools while keeping transmission rates low.

The NFL and a number of professional sports teams plan to start their regular seasons, but with some adjustments to lower risk of transmission, such as frequent testing and phased ramp-up to the regular season. The protocols put in place by the NFL, such as daily testing, banning fans at camp and canceling preseason games, seem to be holding for now – that may change as the season opens, however.

It will be difficult to predict the effects of reopening schools and resuming sports will have on the number of COVID-19 infections or deaths, especially in the absence of social distancing, masks, and a vaccine. In the next installment, we’ll take a look at how the number of COVID-19 cases changed over the fall season and predict what will happen with the approach of winter.

FRANK MAGLIOCHETTI

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Last year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment. Frank is also CEO of ClickStream, ClickStream’s business operations are focused on the development and implementation of WinQuik™, a free to play synchronized mobile app and digital gaming platform. The platform is designed to enable WinQuik™ users to have fun, interact and compete against each other in order to win real money and prizes. Twitter at @ClickstreamC and @WinQuikApp.

Frank was appointed Chairman and Chief Executive Officer at Designer Genomics International, Inc. The Company has accumulated a growing body of evidence that highlights a link between alterations in the immune and inflammatory systems and the development of chronic human disease. The Company is visionary and has established itself as a leader in the field of inflammatory and immune genetic DNA and RNA biomarkers that play a causative role in debilitating conditions, such as atherosclerosis/heart disease, diabetes, arthritis, inflammatory bowel disease, post-traumatic stress disorders (PTSD) and cancer.
A proprietary state-of-the art data mining bioinformatics program, called ‘cluster analysis’ will be used to measure disease development susceptibility with potential for earlier diagnosis and intervention. The company is developing a healthcare program based on its proprietary genetic panels that will allow people to be their own healthcare advocate and take an active role in their health status as well as longevity.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

SOURCES:

https://www.webmd.com/coronavirus-in-context/video/robert-redfield

https://coronavirus.jhu.edu/

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/forecasts-cases.html

https://github.com/cdcepi/COVID-19-Forecasts/blob/master/COVID-19_Forecast_Model_Descriptions.md#JHU

https://www.cdc.gov/flu/pandemic-resources/1918-commemoration/three-waves.htm

https://www.cdc.gov/flu/fluvaxview/coverage-1819estimates.htm

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0237691

https://news.gallup.com/poll/315590/americans-face-mask-usage-varies-greatly-demographics.aspx

https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e3.htm

https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/

https://fortune.com/2020/08/10/covid-schools-reopening-class-children-coronavirus/

https://www.sciencemag.org/news/2020/05/how-sweden-wasted-rare-opportunity-study-coronavirus-schools

https://www.maxpreps.com/news/qiL5GOXkFkyfJ9jwZ8wb-g/where-the-start-of-high-school-sports-stands-in-all-50-states-amid-pandemic.htm

https://www.nfhs.org/media/3812287/2020-nfhs-guidance-for-opening-up-high-school-athletics-and-activities-nfhs-smac-may-15_2020-final.pdf

https://www.espn.com/nfl/story/_/id/29548681/2020-nfl-preseason-schedule-training-camp-other-key-dates

https://www.nfl.com/news/nfl-training-camp-amid-covid-19-pandemic-what-you-need-to-know

Covid-19: How Will It Affect Fall Sports

Covid-19 Pandemic Affecting Fall Sports

The coronavirus pandemic has changed how Americans do business – it has also affected how we play.

Many organized sports took a hiatus during the spring and summer as players, organizers, public health officials, and fans looked for ways to play safely, and are now trying to squeeze out a fall schedule. For example, soccer is a patchwork of canceled games, limited practices, and normal seasons… at least for now, as COVID-19 flare-ups may dash the dreams of players of all ages.

The decision to play has been especially difficult at the high school level. Most states have canceled high school basketball championships and spring seasons, for example, even before the start of school. Football was a different story, though. Football is a beloved fall tradition and, for pros and amateurs alike, marks the beginning of sports season. The decision whether to nix the fall season has been a controversial and often divisive one – nearly everyone wants football to return, but many wondered how to do it safely.

Twenty-five states had already kicked off their high school football season by September 17, and nine more planned to start their seasons in the fall. By then, a number of states and the District of Columbia said they would push their seasons back to 2021. Colorado had announced they would offer football in both fall and spring. Michigan had reversed their decision twice, moving football from fall to spring on August 14 then moving it back to fall on September 3,2020.

The pandemic has also tripped up recruiting efforts, particularly for high school seniors. High school sport seasons provide athletes with an opportunity to score scholarships that could change the course of their lives. In a typical year, young athletes have several chances to impress college scouts, but 2020 is anything but typical – the pandemic prevents coaches and prospects from traveling to meet in person, and it led to the cancelation of exposure camps normally held in late summer and early autumn.

Fall Sports at the Collegiate Level

On September 22, 2020, the NCAA announced that a number of college sports would hold their 2020 fall championships in the spring of 2021. Sports included are men’s and women’s soccer, men’s and women’s cross-country, women’s volleyball, field hockey, and men’s water polo. They will cap bracket sizes at 75 percent of normal capacity, predetermine championship sites, and reduce the number of preliminary-round sites to support health and safety. While the NCAA has halted most college sports for the fall season, college football goes on. Mid-American Conference (MAC) announced their return on September 25, 2020, which means all 10 Football Bowl Subdivision (FBS) conferences are now competing in the fall. They committed to playing a 6-game conference-only schedule running from November 4th through December 18 or 19, with the MAC championship game. To keep players safe, MAC implemented COVID-19 testing protocols that call for four COVID tests per week, starting October 5. MAC is not allowing general public attendance or tailgating; Conference protocols will guide participation of any Marching Bands, Dance, Cheer and Spirit Squads at football games according to institutional discretion and public health guidance. MAC’s announcement cited the availability of COVID-19 tests and the quick turnaround time of test results across the Conference as leading to the decision to play.

Big Ten recently announced it would start its season on October 24, 2020, prompting 90 teams to attempt playing a full schedule this fall. The ACC, Big 12 and SEC as the Power 5 conferences will also try to play this fall, as will the American, Conference USA and Sun Belt.

Pro Sports During the Pandemic

Professional football is on in full force this fall, with the NFL planning to play a complete schedule. Just one year after celebrating the NFL’s 100th season in grand fashion, this year will feature mostly empty stadiums and canned cheers, officials and coaches in masks, the wearing of tracking devices for contact tracing, daily testing, socially distant meetings, and other protocols to keep fans and players safe. Players who test positive are placed on the reserve/COVID list. On September 26, Atlanta Falcons cornerback A.J. Terrell became the first player to be sidelined after a positive COVID-19 test.

It is hard to know how the pandemic will affect athletes and fans as we move from autumn to winter, but rest assured, the world of sports may never be the same.

FRANK MAGLIOCHETTI

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Last year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment. Frank is also CEO of ClickStream, ClickStream’s business operations are focused on the development and implementation of WinQuik™, a free to play synchronized mobile app and digital gaming platform. The platform is designed to enable WinQuik™ users to have fun, interact and compete against each other in order to win real money and prizes. Twitter at @ClickstreamC and @WinQuikApp.

Frank was appointed Chairman and Chief Executive Officer at Designer Genomics International, Inc. The Company has accumulated a growing body of evidence that highlights a link between alterations in the immune and inflammatory systems and the development of chronic human disease. The Company is visionary and has established itself as a leader in the field of inflammatory and immune genetic DNA and RNA biomarkers that play a causative role in debilitating conditions, such as atherosclerosis/heart disease, diabetes, arthritis, inflammatory bowel disease, post-traumatic stress disorders (PTSD) and cancer.
A proprietary state-of-the art data mining bioinformatics program, called ‘cluster analysis’ will be used to measure disease development susceptibility with potential for earlier diagnosis and intervention. The company is developing a healthcare program based on its proprietary genetic panels that will allow people to be their own healthcare advocate and take an active role in their health status as well as longevity.

This image has an empty alt attribute; its file name is frankmagliochetti_FrankMagliochettiNews.jpg
Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

Sources

https://www.maxpreps.com/news/qiL5GOXkFkyfJ9jwZ8wb-g/where-the-start-of-high-school-sports-stands-in-all-50-states-amid-pandemic.htm

https://www.maxpreps.com/news/ha3S_dWexUOaekUFjBMfkA/high-school-football-kickoff-dates-in-all-50-states.htm

https://www.ncaa.com/live-updates/ncaa/ncaa-sports-news-schedule-changes-coronavirus-updates-all-sports

https://getsomemaction.com/news/2020/9/25/football-maction-is-back.aspx

https://www.nfl.com/news/falcons-cb-a-j-terrell-tests-positive-for-covid-19-placed-on-reserve-list

Covid-19: The Race for a Vaccine Continues

Covid-19: The Race for a Vaccine

The race to save lives has begun. Scientists around the world are speeding to develop a vaccine for COVID-19, a disease that has claimed the lives of more than half a million lives worldwide, and sickened millions of others. Vaccine development usually takes 10 to 15 years, and the long, involved process takes a tremendous amount of public and private involvement. At the current rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections that cause COVID-19 disease, though, the world does not have 10 to 15 years to wait.

COVID-19 Race for a vaccine

On July 18, 2020, the World Health Organization (WHO) reviewed 23 candidate vaccines in clinical evaluation. Many were still in Phase 1 to establish their safety and dosage at the time of the WHO review, while others were in Phase 2 to establish their performance under ideal and controlled performance. As of that mid-July WHO review, three clinical trials had entered Phase 3 for testing on large numbers of people, although one vaccine trial had not yet recruited candidates.

Why Must We Wait So Long?

Most vaccines in development never make it to licensing – in fact, many vaccine candidates never make to clinical evaluation on real humans because they fail to produce the desired immune response in the pre-clinical stages of testing in cell cultures and lab animals.

Regulators set a high bar for vaccination approval and often require years’ worth of safety data because, unlike medicines that treat diseases, vaccines are administered to healthy people to prevent illness. Releasing a vaccine could potentially do more harm than good, so many regulatory bodies set stiff guidelines for approval.

covid-19-race for A CURE

It is not yet clear what data federal regulators would accept as proof that a vaccine is safe and successful in the middle of the pandemic. On June 30, 2020, the U.S. Food and Drug Administration (FDA) said a vaccine must prevent COVID-19 or decrease the severity of illness in at least 50 percent of people who receive the vaccine. The FDA may consider some vaccine candidates for its Accelerated Approval pathway, but that the vaccine candidate must demonstrate an identifiable immune response or other measure that shows it is reasonably likely that the vaccine would provide clinical benefit. Regulators in other nations have not yet announced what they would consider acceptable criteria for approval, which creates a challenge for vaccine makers trying to gain approval.

More Challenges for Vaccine Makers

Vaccine makers also face challenges determining the best way to trigger the immune response. Vaccines typically work by exposing the body to the antigens of a particular pathogen to activate the immune system without causing disease. Made with weakened or inactivated form of the pathogen, these vaccines are often difficult to develop and produce quickly. Because of the urgent nature of the pandemic, researchers are looking for innovating ways to introduce antigens and otherwise activate an immune response to SARS-CoV-2. Four of the 23 vaccine candidates in clinical testing use an approach that involves engineering messenger RNA (mRNA) that tells human cells how to create the antigens themselves.

RACE FOR A VACCINE COVID-19

Moderna is one of those four companies. On July 15, 2020, the biotech company published data from an early-stage trial that shows its vaccine caused patients to generate an immune response by developing antibodies, although it caused some side effects. Supported by the National Institutes of Health, the study showed volunteers who receive the vaccine produced substantially more neutralizing antibodies than do most patients who have recovered from COVID-19. A second injection administered four weeks after the initial vaccination was necessary to produce a dramatic immune response. Vaccine experts were not impressed, however, concerned that the data was long on text and short on proof.

Other research teams, such as University of Oxford/AstraZeneca are using viral vector vaccines to speed up the process. Viral vector vaccines use a harmless virus as a kind of Trojan horse that carries the pathogen’s genetic material into cells in order to trigger an immune response. The team released more information about its coronavirus vaccine candidate, AZD1222, on July 20, 2020.

Developing a COVID-19 vaccine will be one of the most exciting and important events in human history, with the potential to save millions of lives around the world. Join us next month when we review the next leg of the race for a COVID-19 vaccine.

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Last year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment. Most recently; Frank was appointed Chairman and Chief Executive Officer at Designer Genomics International, Inc. The Company has accumulated a growing body of evidence that highlights a link between alterations in the immune and inflammatory systems and the development of chronic human disease. The Company is visionary and has established itself as a leader in the field of inflammatory and immune genetic DNA and RNA biomarkers that play a causative role in debilitating conditions, such as atherosclerosis/heart disease, diabetes, arthritis, inflammatory bowel disease, post-traumatic stress disorders (PTSD) and cancer.
A proprietary state-of-the art data mining bioinformatics program, called ‘cluster analysis’ will be used to measure disease development susceptibility with potential for earlier diagnosis and intervention. The company is developing a healthcare program based on its proprietary genetic panels that will allow people to be their own healthcare advocate and take an active role in their health status as well as longevity.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

Sources

https://coronavirus.jhu.edu/map.html

https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-facilitate-timely-development-safe-effective-covid

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval

https://www.nejm.org/doi/full/10.1056/NEJMoa2022483

https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-and-oxford-university-announce-landmark-agreement-for-covid-19-vaccine.html

Inflammation: Autoimmune Disease and COVID-19

People with autoimmune disease face a number of challenges – their condition can cause pain, skin problems, digestive issues, weakness, muscle aches, stiff joints, and more. Autoimmune diseases and their treatments can weaken immune systems to leave patients vulnerable to infections. These conditions can also cause inflammation around the body, and even in vital organs, such as the lungs. In patients with COVID-19, an unhealthy immune response can damage the lungs to cause serious complications, including severe breathing problems.

Autoimmune Diseases and Inflammation

The immune system protects the body from disease and infection. In people with autoimmune disorders, though, the immune system can attack healthy body cells by mistake. There are more than 80 types of autoimmune diseases, according to the National Library of Medicine. Autoimmune diseases include rheumatoid arthritis, psoriasis, inflammatory bowel disease, lupus, Sjogren’s disease, multiple sclerosis, Hashimoto’s disease, Celiac disease and type 1 diabetes.
Some autoimmune diseases target just one organ, such the pancreas; other autoimmune conditions affect the entire body. Many of autoimmune diseases share similar symptoms. A large number of autoimmune conditions cause inflammation, characterized by redness, heat, pain and swelling. In fact, inflammation is the classic sign of an autoimmune disease.

COVID-19 and Inflammation

The virus, known as SARS-CoV-2 or simply “coronavirus,” causes a wide variety of symptoms associated with COVID-19 disease. Most notably, the virus causes cough, fever, and shortness of breath. Coronavirus is highly contagious, already infecting at least 2 million people in the United States by the middle of June 2020, and claiming the lives of 113,000. While people with autoimmune disorders are not more likely to contract coronavirus than are the rest of the general population, they are more likely to develop severe complications if they do contract COVID-19 if they have a suppressed immune system due to their autoimmune disease or treatment for their autoimmune disorder. One of the most serious complications of COVID-19 is severe inflammation throughout the body, including the lungs, heart and brain. The body reacts to the presence of the SARS-CoV-2 virus with a robust inflammatory response; health professionals now regard this excessive inflammatory response as a hallmark symptom of COVID-19.
The excessive immune response triggered by SARS-CoV-2 can cause hyper-inflammation of the lungs and of other organs. Severe inflammation of the lungs can prevent the proper exchange of oxygen and carbon dioxide, which makes it difficult for patients to get the oxygen they need.

How Autoimmune Diseases Cause Inflammation

Special receptors cover the exterior surface of body cells. Proteins bind to these receptors to change the way the cell works. A specific type of protein, known as cytokines, binds to certain receptors to regulate the body’s immune response. Cytokines are mediators, which mean they trigger and control a body response. Specifically, cytokines mediate the inflammation response to tissue injury or infection. In other words, cytokines promote inflammation as a response to tissue injury or infection. There are several types of cytokines, and each type can work alone, work together, or work against each other to regulate the immune response. A special type of cytokine, known as interleukin or IL, may play an important role in the immune response in COVID-19 patients. There are 40 interleukins, IL-1 through IL-40, and each performs a function. Interleukins normally help the immune system fight off viruses and bacteria in the body, but an overactive immune system can cause interleukins to attack the body instead. This can lead to chronic inflammatory conditions.
In a significant physiological event, known as a cytokine storm, can cause the release of a flood of interleukin that leads to widespread and dangerous inflammation. Research shows that COVID-19 can cause a cytokine storm that releases IL-6, IL-1, IL-12, and IL-18. The excessive number of cytokines can damage tissue and could lead to the breakdown of the protective lining in the lungs and blood vessels. The breakdown and weakening of this protective lining can allow fluid and proteins to leak from blood vessels and into the tiny air sacs of the lungs. This fluid displaces air, which prevents the air sacs from filling with oxygen. The resulting lack of oxygen causes the patient to experience shortness of breath, and puts the patient at a higher risk for complications and a more severe case of COVID-19. Inflammation related to autoimmune disease can have serious consequences for patients. This is especially true for those who contract COVID-19. To View Frank Magliochetti Press Releases Please CLICK HERE Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment. Most recently; Frank was appointed Chairman and Chief Executive Officer at Designer Genomics International, Inc. The Company has accumulated a growing body of evidence that highlights a link between alterations in the immune and inflammatory systems and the development of chronic human disease. The Company is visionary and has established itself as a leader in the field of inflammatory and immune genetic DNA and RNA biomarkers that play a causative role in debilitating conditions, such as atherosclerosis/heart disease, diabetes, arthritis, inflammatory bowel disease, post-traumatic stress disorders (PTSD) and cancer.
A proprietary state-of-the art data mining bioinformatics program, called ‘cluster analysis’ will be used to measure disease development susceptibility with potential for earlier diagnosis and intervention. The company is developing a healthcare program based on its proprietary genetic panels that will allow people to be their own healthcare advocate and take an active role in their health status as well as longevity.
This image has an empty alt attribute; its file name is GRACE-HEALTH-TECHNOLOGY_Frank-MAgliochetti.jpg
Mr. Frank Magliochetti MBA Managing Partner Parcae Capital www.parcaecapitalcorp.com www.frankmagliochetti.com

SOURCES:

https://medlineplus.gov/autoimmunediseases.htmlhttps://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.htmlhttps://www.ncbi.nlm.nih.gov/books/NBK499840/https://www.medscape.com/answers/2500114-197455/what-is-the-role-of-interleukin-il-inhibitors-in-the-treatment-of-coronavirus-disease-2019-covid-19

Managing Lab Protocols During the Pursuit of a Covid-19 Vaccine

Pursuit of Vaccine and Managing Lab Protocols during the Covid19 Pandemic

On April 22, 2020, the Director-General of the World Health Organization (WHO) said, “To be clear, WHO’s advice is to find and test every suspected case, not every person in a population.”

While testing every person is not essential to controlling COVID-19, finding and testing every suspected case is. As the COVID-19 outbreak sweeps across the globe, the world turns to laboratories for answers. Laboratory scientists are responding by providing doctors with ways to diagnose COVID-19 and by pursuing the development of a vaccine that could someday stop the pandemic in its tracks. Until a vaccine is found, social distancing and testing are the best ways to control the spread of the disease.

The 2019 novel coronavirus, now named SARS-CoV-2, has sickened millions of people with COVID-19. By the end of April 2020, the United States had by far the highest number of confirmed cases and deaths in the world, according to Johns Hopkins University.

Testing is the only way to determine the case fatality rate (CFR), which is the ratio between confirmed deaths and confirmed cases. Testing is also the best way to assess the overall effectiveness of preventive measures and vaccines. Determining the CFR requires time and reliable data to confirm cases and deaths based on trusted laboratory testing. Strict adherence to proven and accepted laboratory protocols provides the most accurate data possible.

Managing Laboratory Protocols during the COVID-19 Outbreak

Managing laboratory protocols during the SARS-CoV-2 outbreak is challenging because, as with the outbreak of any novel virus, researchers are entering uncharted territories. Virologists had a limited understanding of transmission patterns, clinical features, severity, and risk factors for COVID-19 infection at the start of the pandemic. To address those unknowns, WHO established Four Early Investigation Protocols, which are now known as the WHO Unity Studies.

The protocols rapidly and systematically collect and store data that will be critical in refining recommendations for case definition and surveillance, and for characterizing the key epidemiological features of COVID-19. The protocols will also help the medical community gain a greater understanding of the spread, severity and spectrum of the disease, as well as its impact on the community. Information gained from the data will help guide countermeasures, such as case isolation and contact tracing.

Rapid detection of COVID-19 cases is essential for controlling the emergence of this rapidly spreading illness and for understanding the key epidemiological features of the disease, but rapid detection requires wide availability of diagnostic testing.

Within a month of the first outbreak in China, the Centers for Disease Control and Prevention (CDC) developed a real time Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) test that can diagnose COVID-19. The CDC provides instructions for the use of real-time rT-PCR assays for the in vitro qualitative detection of coronavirus in sera and respiratory specimens. FIND also maintains a list of SARS-CoV-2 tests in development or commercially available for COVID-19, and WHO maintains a list of COVID-19 in-house PCR protocols assays.

Challenges of managing laboratory protocols

Even with reliable assays, managing laboratory protocols during COVID-19 is challenging. The pandemic has disrupted the supply chain for many laboratories, for example. Personal protection equipment (PPE) is scarce, for example, and there have been shortages of SARS-CoV-2 PCR reagents.

Biosafety is also a major concern, as keeping lab workers safe is a high priority. The CDC has released biosafety guidelines for labs working with Coronavirus: Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). These guidelines include essential information on virus isolation, waste management, and decontamination. The EPA also released an expanded COVID-19 disinfectant list on March 13, 2020, but social distancing is far more effective than disinfection for controlling viral transmission. Unfortunately, social distancing is much more difficult than disinfection in a typical laboratory, where technicians work side by side and in close proximity to specimens.

While the protocols are far from perfect, and disruptions in the supply chain can slow testing, laboratory protocols will continue to play an important role in preventing the spread of COVID-19 until a vaccine is found.

Pursuit of a COVID-19 Vaccine

The best way to defeat COVID-19 is to develop a vaccine, of course, but vaccine development can often take 10 to 15 years. Vaccines for respiratory viruses are also elusive. Two toddlers died in 1966 from respiratory syncytial virus (RSV), for example, and vaccines for the parainfluenza viruses (PIVs) and metapneumovirus (MPVs) are still not available.

There are 120 projects working towards a vaccine; only five have received approval for clinical trials in humans. University of Oxford researchers began Phase I human trials of ChAdOx1 nCoV-19 in late April. In this trial, half of the roughly 1100 participants receive ChAdOx1 nCoV-19 vaccine, while the control group receives the common meningitis vaccine, MenACWY. The first two volunteers, one from the test group and one from the control, received their inoculations on April 23, 2020.

Fast tracking the development of this vaccine or others could potentially save thousands or millions of lives, providing the vaccine undergoes sufficient testing to ensure its safety and efficacy. It is possible to get a licensed vaccine in one and a half to two years, and even possible to get a vaccine into use much sooner. Reliable laboratory testing will help researchers determine if their vaccines are working.

Many of the battles against the COVID-19 outbreak will be fought in laboratories in the United States and around the world. Widespread testing will play an important role in reducing deaths associated with coronavirus and improving the health and well-being of people across the globe.

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

This image has an empty alt attribute; its file name is GRACE-HEALTH-TECHNOLOGY_Frank-MAgliochetti.jpg

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

SOURCES:

https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19–22-april-2020

https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19–22-april-2020

https://coronavirus.jhu.edu/map.htmlhttps://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/early-investigations

https://www.cdc.gov/coronavirus/2019-ncov/lab/index.htmlhttps://www.finddx.org/covid-19-2/pipeline/

https://www.who.int/docs/default-source/coronaviruse/whoinhouseassays.pdf?sfvrsn=de3a76aa_2

https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Fhealthcare-supply-ppe.html

https://asm.org/Articles/Policy/2020/March/ASM-Expresses-Concern-about-Test-Reagent-Shortageshttps://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.htmlhttps://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2

https://www.labconscious.com/blog/2020/3/17/laboratory-sustainablity-in-the-coronavirus-crisishttps://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

https://cvi.asm.org/content/23/3/189https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4547785

https://www.cbsnews.com/news/coronavirus-vaccine-covid-19-human-clinical-trial-oxford-england/

http://www.ox.ac.uk/news/2020-04-23-oxford-covid-19-vaccine-begins-human-trial-stagehttps://www.drugbank.ca/drugs/DB15656

Covid19 The Pandemic (Almost) Nobody Saw Coming

Of all the changes 2020 had brought, almost nobody saw coronavirus disease 2019 (COVID-19) coming.

First reported in late December 2019 in Wuhan, China, the newly discovered coronavirus (2019-nCoV) quickly made its way around the globe, killing thousands and sickening hundreds of thousands more. There is quite a bit of information out there to disseminate we felt it time to give an overview and a few thoughts on Covid-19; as this situation is fluid we do expect to add more information in future posts.

On March 12, 2020, the World Health Organization declared COVID-19 a pandemic, meaning the disease had spread to multiple continents around the globe. Like other pandemics, COVID-19 seemed to move swiftly, taking governments, healthcare providers and citizens by surprise. 

Not everyone was blindsided, though – a handful of experts in global health, the biosciences, national security, emergency response and economics got together in October 2019 to talk about what would happen if a global pandemic suddenly hit the world’s population. The experts discussed how Americans and others around the world would fare if a novel and highly transmissible coronavirus outbreak reached pandemic proportions.

Just as its real-life counterpart did, the fictional coronavirus jumped between countries and continents via international air travel. In both accounts, the virus caused problems for health care systems, economies, and political leaders. The fictional scenario assumed governments would first try closing borders and banning travel, but by the time authorities enacted border closures and travel bans, carriers would have unknowingly transmitted the disease to others before developing symptoms. The experts also projected the travel bans would disrupt trade and worsen international cooperation.

The simulation provided a shocking glimpse into the near future, but in today’s rapid-fire news cycle, very few people took notice. When the predictions began to come true in the form of COVID-19, many people regarded the threat somebody else’s problem because it was occurring in another country and could never reach the shores of our nation. Others thought COVID-19 was nothing more than a seasonal influenza. They were wrong on both counts.

COVID-19 is Here, and it is More than Just a Flu

The first patient with COVID-19 walked into a U.S. emergency department on January 19, 2020. Today, thousands of Americans have tested positive for novel coronavirus.

COVID-19 is similar to the flu in many ways, and is significantly different in other ways. Both are infectious illnesses, for example, and both cause a dry cough and fever. Influenza causes aches, chills, fatigue, and headache and chills; these symptoms are less common with COVID-19. Flu symptoms come on suddenly, getting worse over a day or two. Symptoms of COVID-19 develop gradually, worsening over the course of several days.

COVID-19 is different from the flu in other ways:

  • Difficulty breathing and shortness of breath are the hallmarks of COVID-19 – they are also signs to seek immediate medical attention; flu does not cause shortness of breath and difficulty breathing
  • COVID-19 is more likely to kill than the flu – about 3.4 percent of people with COVID-19 have died and seasonal flu generally kills far fewer than 1 percent of those infected
  • Unlike the flu, there is no vaccine for COVID-19, and it will probably take a year to develop one
  • There is no treatment for COVID-19
  • Children, who are typically at high risk of contracting flu, are at lower risk for COVID-19 than are older adults

With a higher basic reproduction number, which is the number of infections one infected person can cause COVID-19, is more infectious than the flu. COVID-19 seems to have a basic reproduction number somewhere between 2 and 2.5, so the average person infected with the coronavirus spreads the disease to 2 to 3 other people. The basic reproduction number of seasonal influenza varies from year to year, but is often about 1.28.

COVID-19 is wreaking havoc on nearly every segment of the population, but it presents special danger to some. Director of the National Alliance on Mental Illness (NAMI) HelpLine Dawn Brown reported an increase in calls to the NAMI hotline. Callers expressed a wide variety of concerns, including feelings of depression and loneliness from social isolation, worries about job stability and income, fears of getting sick, grief over the death of a loved one, and homelessness. “Right now, the bigger concerns are around anxieties about the unknowns, you don’t know what you don’t know, and the people we serve tend to be a little more vulnerable to anxiety and panic.”

What Happens in the Future Depends Largely on What We Do Today

Arguably late to the situation, the U.S. government issued The President’s Coronavirus Guidelines for America, which directs citizens to listen to state and local authorities, stay home when sick, self-isolation measures, and good hygiene. States have issued a variety of public health emergency declarations, including the activation of National Guards, school and business closures, and limits on event sizes.

The medical community geared up quickly in response to the pandemic. Hospitals began enacting preparedness plans, clinicians developed treatment plans for critically ill patients, and researchers immediately turned their attention to developing a vaccine. Mayo Clinic announced the development of a new test that provides results in 24 hours.

The actions of individuals, families, businesses and communities will have the greatest influence in how the pandemic ends – they will also bear the brunt of its consequences. In even the best case scenario, hundreds or thousands of people in the United States could perish; new research suggests the number of deaths in the nation could exceed 2 million.

While nobody knows exactly how COVID-19 will change our lives, almost everyone can agree that the changes will be profound.

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

This image has an empty alt attribute; its file name is GRACE-HEALTH-TECHNOLOGY_Frank-MAgliochetti.jpg

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

SOURCES:

http://www.euro.who.int/en/health-topics/health-emergencies/coronavirus-covid-19/news/news/2020/3/who-announces-covid-19-outbreak-a-pandemic

https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19—3-march-2020

https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200306-sitrep-46-covid-19.pdf?sfvrsn=96b04adf_2

https://www.researchgate.net/publication/265345236_Estimates_of_the_reproduction_number_for_seasonal_pandemic_and_zoonotic_influenza_A_systematic_review_of_the_literature

https://www.whitehouse.gov/wp-content/uploads/2020/03/03.16.20_coronavirus-guidance_8.5x11_315PM.pdf

https://www.nga.org/coronavirus/#stateshttps://www.phe.gov/Preparedness/COVID19/Documents/COVID-19%20Healthcare%20Planning%20Checklist.pdf

https://jamanetwork.com/journals/jama/fullarticle/2762996

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins

https://www.mprnews.org/story/2020/03/12/new-mayo-clinic-test-could-speed-detection-of-covid19

https://www.imperial.ac.uk/media/imperial-college/medicine/sph/ide/gida-fellowships/Imperial-College-COVID19-NPI-modelling-16-03-2020.pdf