Innovations in Genetic Testing

Genetic Testing Innovations

Genetic testing is quickly becoming a cornerstone of healthcare, with new medical technologies and innovations enhancing how scientists work with genetics. Gene therapy, simplified genetic tests, and analysis of fully sequenced genomes are just some of the genetic testing innovations improving healthcare today and tomorrow.

The global genetic testing market has consistently risen over the past few years. This rise is fueled by the increasing prevalence of genetic disorders and growing awareness about the benefits of genetic testing. In fact, the global genetic testing market will likely reach 22.834 billion USD in 2024, registering 11.50 percent CAGR throughout the assessment period (2019-2024), according to Market Research Future.

Genetic testing involves a set of laboratory tests that study the patient’s genetic makeup, and identify any gene mutations or alterations in the patient’s DNA that could potentially lead to the development of genetic disorders. Healthcare professionals can use genetic tests to confirm or rule out a suspected genetic disorder. Genetic testing can also help determine the probability that an individual will develop a genetic disorder or pass one down to the next generation.

Types of Genetic Testing and Innovations

As of August 2017, there were about 10,000 unique genetic test types, and approximately 75,000 genetic tests on the market including direct-to-consumer (DTC) genetic tests like 23andMe – more are under development every year. The general types of genetic tests include:

Newborn testing – used just after birth to detect genetic disorders early, when they are easiest to treat

Diagnostic testing – identifies or rules out a specific genetic condition

Carrier testing – identifies people who carry one copy of a gene mutation that, when coupled with another gene with the same mutation, causes a genetic disorder; this test can help couples determine their risk for having a child with a genetic disorder

Prenatal testing – offered during pregnancy if there is a chance that the baby will have a genetic disorder, prenatal testing detects changes in a fetus’s genes prior to birth

Pre-implantation testing – used to detect changes in embryos created through in-vitro fertilization or other assisted reproductive technology to reduce the risk of having a child with a specific genetic disorder

Predictive and presymptomatic testing – detect gene mutations associated with conditions that develop after birth or even later in life; helpful for people whose family member has a genetic condition, but who have no signs or symptoms of the condition at the time of testing

Forensic testing – uses DNA sequences to identify someone for legal purposes, such as identifying victims of a crime or catastrophe, rule out or implicate a suspect in a crime, or to establish paternity or other biological relationship

Genetic Testing Delivery Systems

Innovations in genetic testing involve new delivery systems, finding new genetic variants, and finding new uses for genetic therapies. Researchers from Fred Hutchinson Cancer Research Center recently started using gold nanoparticles as a scalable delivery vehicle for their CRISPR systems, for example, instead of the “old fashioned” approach of using electric shock or viral vectors to deliver genetic editing tools to DNA.

Another group of researchers analyzed coding genes from nearly 46,000 people to identify four genes that contained rare genetic deviations linked to type 2 diabetes. Pharmaceutical companies could use these genes and the proteins they encode as targets for new diabetes medications and treatments.

Doctors in the United States have begun using CRISPR gene-editing therapy to treat cancer patients for the first time. The University of Pennsylvania is following the first two patients in the country to undergo the new therapy – one with sarcoma and one with multiple myeloma, whose cancers did not respond to conventional treatment.

Genetic testing could even help scientists understand COVID-19; they currently use genetic testing known as RNA or PCR tests, to detect the disease.

genetic testing and innovations clinical trials

The tsunami of gene therapy clinical trials underway right now will create a flood of data, particularly in oncology. Oncology is an area that currently represents a quarter of Phase I and Phase II trials. Much of the push to expand genetic testing will come from the consumers themselves. Patients are currently pushing to expand genetic testing beyond its current confines of rare diseases to cover common conditions, such as Parkinson’s disease. In cases in which insurance does not cover the costs of these tests, patients may seek to enroll in clinical trials. When genetic testing is not affordable or accessible, consumers will turn to at-home genetic testing.

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.

Genetic Industry

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.

Frank Magliochetti News is developing Genetic Innovation News.com the site is devoted to genetic innovations; we encourage contributors – the site wants to broadcast your news, discoveries,and innovations.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

SOURCES:

https://www.marketresearchfuture.com/reports/genetic-testing-market-2009

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5987210

https://www.genome.gov/dna-day/15-ways/direct-to-consumer-genomic-testing

https://www.23andme.com/

https://ghr.nlm.nih.gov/primer/testing/uses

https://www.nature.com/articles/s41563-019-0385-5

https://www.nature.com/articles/s41586-019-1231-2

https://www.the-scientist.com/news-opinion/sars-cov-2-spike-protein-shares-sequence-with-a-human-protein-67596

https://asm.org/Articles/2020/April/COVID-19-Testing-FAQs

https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/gene-therapy-coming-of-age-opportunities-and-challenges-to-getting-ahead

Covid -19: The Race for a Vaccine

The Race for a Vaccine: Covid-19

The race to save lives is underway. Scientists all over the world are speeding to develop a vaccine for COVID-19, a disease that has claimed more than half a million lives worldwide, and hs 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

Hereditary Cancer Testing: Prostate Cancer

Prostate cancer is the second leading cause of cancer death in men in the United States, behind only lung cancer, according to the American Cancer Society. Cancer of the prostate is a serious disease, but most men diagnosed with prostate cancer do not die from it – early detection and personalized treatment saves lives. Doctors currently use tests, such as prostate-specific antigen (PSA), to detect and diagnose prostate cancer, but hereditary cancer screening may hold the key to earlier diagnosis and more effective treatment.

Hereditary Cancer Testing

Some people inherit a genetic mutation from their mother or father. This damaged gene puts them at greater risk for developing certain forms of cancer, including prostate cancer. In fact, hereditary prostate cancer accounts for 5 to 10 percent of all prostate cancer. Having a brother or father with prostate cancer more than doubles a man’s risk for having the disease. Hereditary cancer testing helps men understand their inherited risk of developing cancer within their lifetime. This type of testing can also help reduce or eliminate unnecessary prostate biopsies completely in men suspected of having prostate cancer.

Hereditary cancer testing works by looking for specific changes, or mutations, in specific genes, chromosomes, and proteins. These mutations can change the way the gene works; in some cases, gene mutations can cause the uncontrolled growth of abnormal cells that characterize cancer.

Most commonly, hereditary cancer testing for prostate cancer looks for mutations in BRCA2 and BRCA1 genes, and in other genes associated with prostate cancer.

Hereditary Cancer Testing is Gaining Traction as a Way to Provide Earlier Diagnosis and More Effective Treatment for Prostate Cancer

While hereditary cancer testing can help inform treatment and management approaches to prostate cancer, genetic testing of men for prostate cancer is relatively uncommon, largely because of inconsistent guidelines covering the testing and challenges in implementing genetic counseling services. There is a lot of confusion regarding when men should undergo hereditary testing for prostate cancer, the genes that should be tested, understanding the impact genetic results will have on personalized treatment programs, and the effect hereditary testing for prostate cancer can have for men and their families.

Healthcare professionals and genetic testing companies are working hard to change that, though, and are making advances to bring hereditary cancer testing for prostate cancer to the men who need it. A group of healthcare professionals recently published key recommendations in Journal of Clinical Oncology, for example. The group, made of oncology, urology, genetic counseling, primary care, and Veterans Affairs experts along with patient stakeholders, strongly endorsed genetic testing in men with metastatic (spreading) prostate cancer to help guide treatment and to determine the patient’s eligibility in clinical trials. They also recommended this type of testing to screen men whose family history suggests an increased risk of prostate cancer and other types of cancer.  

 The researchers also addressed the impact hereditary cancer testing can have on the treatment of prostate cancer in its early stages. The group recommended BRCA-2 testing for screening and for helping men and their doctors make decisions about treating early-stage prostate cancer.

The researchers also reviewed cancer screening strategies, such as the age men should begin screening for prostate cancer and which genes to test. The group recommended testing BRCA2 and another gene, HOXB13, for screening and early detection. Furthermore, the panel recommended that BRCA2 carriers begin PSA testing early; doctors may recommend early screenings beginning at age 40 or about 10 years prior to the youngest prostate cancer diagnosis in the patient’s family.

Because hereditary testing may uncover inherited cancer risk, the researchers also discussed genetic testing for both male and female relatives of those men who test positive for genetic mutations, depending on the patient’s family history of cancer and other factors.

Hereditary cancer testing for prostate cancer is growing increasingly common because of the important role it plays in the screening, diagnosis and treatment of prostate cancer.

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.

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.cancer.org/cancer/prostate-cancer/about/key-statistics.html#:~:text=Deaths%20from%20prostate%20cancer,do%20not%20die%20from%20it.

https://www.mskcc.org/cancer-care/risk-assessment-screening/hereditary-genetics/genetic-counseling/inherited-risk-prostate

https://www.cancer.org/cancer/prostate-cancer/causes-risks-prevention/risk-factors.html

https://ascopubs.org/doi/10.1200/JCO.20.00046

Autoimmune Disease, Inflammation & 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.
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 and the Pursuit of a Vaccine during the Covid-19 Outbreak

Vaccine Pursuit and Managing Lab Protocols during the Covid-19 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

The Pandemic (Almost) Nobody Saw coming – Covid19

Covid 19 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

Challenges in Healthcare 2020

Healthcare Challenges 2020

As we enter a new decade we are faced with many positive advances in healthcare, however, those forward steps are accompanied by a number of challenges. Here are the top three facing us in 2020. Frank Magliochetti will keep you informed on these challenges in the years ahead.

1. Cybersecurity

The medical and healthcare sector collects highly sensitive patient information, which puts the industry in the crosshairs of cybersecurity attacks. There were 2,546 healthcare data breaches involving more than 500 records in the United States between 2009 and 2018, resulting in the in the exposure and theft of 189,945,874 healthcare records – this equates to more than 59 percent of the nation’s population. In 2017 alone, the medical and healthcare sector experienced more than 350 data breaches that exposed 4.93 million patient records.

While experts are still finalizing the breach figures for 2019, it looks to be the worst year yet. Today, the healthcare industry accounts for four out of every five data breaches, according to HIPPA Journal. The cost of these breaches to the industry will likely reach $4 billion in 2020.

Black Book Market Research LLC recently surveyed 2,876 security professionals from 733 provider organizations to identify the reasons healthcare organizations continue to experience data breaches and cyber attacks. They found that budget constraints prevented the replacement of legacy software and devices, which left them more vulnerable to attack. “It is becoming increasingly difficult for hospitals to find the dollars to invest in an area that does not produce revenue,” said the founder of Black Book, Doug Brown, in a press release. Ninety percent of hospital representatives in the survey said that their IT security budgets have remained unchanged since 2016.

2. Transparency

Transparency has been a hot topic for several years, and will continue to be a burning issue into 2020 and beyond. A 2016 survey by Accenture found that 91 percent of consumers wanted to know their out-of-pocket costs before they received care.

Triggered by the Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First issued in June of 2019, the Centers for Medicare & Medicaid Services (CMS) issued new rules to increase price transparency.

The first rule, Calendar Year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Charges Public Final Rule, requires that hospitals provide patients with easily accessible information about standard charges for services and items offered. Standard charges must be available in a single data file that other computer systems can read. Hospital websites must display “shoppable services” information in a consumer-friendly format. This rule takes effect on January 1, 2021.

CMS’s second proposed rule, the Transparency in Coverage rule, would impose price transparency requirements on insurers.

3. Patient-friendly Payment Models

Patient financial responsibility for outpatient, and emergency department care is on the rise, with out-of-pocket costs increasing by 12 percent in 2018, according to TransUnion.

This shift towards patient financial responsibility could bog down invoice and payment processing, particularly for practices that do not have an in-house invoicing and payment processing system geared towards accepting payments from patients. These practices will need to build patient portals, secure payment processing, and other infrastructure to handle such payments and fund administrative costs of maintaining these technologies. Furthermore, they will need to ensure their payment portals and processing systems are compliant with guidelines that protect patient information.

Unfortunately, 90 percent of healthcare providers still use paper and manual payment processes, according to a 2018 InstaMed survey. To make matters worse, 70 percent of consumers said they were confused by medical bills. Not surprisingly, 77 percent of providers said it takes more than a month to collect a payment. To be paid on time, providers must overcome the obstacles of upgrading their payment processing systems and clarify billing.

With a little planning – and a bit of luck – those in the healthcare industry can overcome these challenges and put themselves in a great position for the rest of the decade.

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.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

SOURCES:

https://www.beckershospitalreview.com/cybersecurity/11-of-the-biggest-healthcare-cyberattacks-of-2017.html

https://blackbookmarketresearch.com/health-data-security-and-privacy

https://www.prnewswire.com/news-releases/healthcare-data-breaches-costs-industry-4-billion-by-years-end-2020-will-be-worse-reports-new-black-book-survey-300950388.html

https://www.whitehouse.gov/presidential-actions/executive-order-improving-price-quality-transparency-american-healthcare-put-patients-first/

https://www.cms.gov/newsroom/fact-sheets/cy-2020-hospital-outpatient-prospective-payment-system-opps-policy-changes-hospital-price

https://www.hhs.gov/sites/default/files/cms-9915-p.pdf

https://newsroom.transunion.com/out-of-pocket-costs-rising-even-as-patients-transition-to-lower-cost-settings-of-care/

https://www.businesswire.com/news/home/20190415005538/en/

Changes in Healthcare Expected in 2020 – 2021

The healthcare industry hit the ground running in 2020, and it doesn’t look like it will slow down anytime soon. In fact, healthcare is changing on so many different fronts, it might be tough to keep up this year. Here are 8 top changes in healthcare for 2020 – 2021. Frank Magliochetti will keep you up to date with the progress of all eight of these expected changes throughout the years ahead.

Top 8 Changes in Healthcare Expected for 2020 – 2021

1. Digitization

Like many other industries, healthcare is digitizing at a swift pace. Digitization of records had been the focal point for many in the healthcare industry, but that changeover is nearly complete. In fact, a 2019 report shows that 84 percent of healthcare professionals had already switched their practices over to digital health records. The report also shows that those who had digitized health records delivered better patient care, provided better individual outcomes for patients, improved workplace experience for healthcare workers, and could offer cost-effective healthcare services in comparison to those organizations that did not digitized.

2. Smart devices

 Now many in the healthcare industry are hoping to gain these benefits and more by expanding their digital transformation into other areas of their internal and external operations. The emergence of several new technologies, such as blockchain, cloud and edge capabilities, and 5G connectivity will fuel these changes in 2020 – 2021 and beyond.

Some healthcare organizations have adopted remote and self-monitoring medical chatbots, for example, in which patients use a messenger program to interact with a computer that simulates human conversation. Others are investigating the use of smart pills, which are medications equipped with electronic sensors that, once ingested, send wireless messages to devices outside the body. Personalized medicine will become increasingly common, as more life sciences and healthcare organizations begin to create smarter, more specific and more custom-tailored products and services for each patient interaction. Other advances, such as bioprinting of prosthetics, will take shape with the realization of new materials and build processes; these advances will help reduce invasiveness and increase safety of medical implants.

3. Big data and AI

2020 – 2021 will likely see greater adoption of artificial intelligence (AI) – only a third of U.S. healthcare organizations have adopted AI technology, using it to overhaul triage and streamline administration, diagnostics, and more.

Bigger, better data leads to more powerful AI, but big data and artificial intelligence leave many patients and healthcare institutions feeling vulnerable. Data privacy and accountability for insider threats will be major concerns for healthcare institutions in the upcoming years.

4. Renewed support for nurses

Advances in technology, advanced algorithms, and AI have taken some of the burden off the shoulders of nurses, especially when it comes to the monitoring and decision support of patients. No matter how sophisticated medical technology becomes, however, it will never replace the human touch and compassion that nurses bring to the bedside. Nurses bring experience, judgment and the capacity to know what patients need, even when technology suggests otherwise. In fact, the World Health Organization (WHO) has named 2020 the Year of Nurse and Midwife to highlight the need for more nurses and to advocate for increased investments in the nursing workforce.

5. Patient safety

Patient safety has been a pressing healthcare issue for decades, yet WHO reports that one in 10 patients in harmed while receiving hospital care. The Joint Commission has issued their National Patient Safety Goals Effective January 2020, in which they outline ways to improve patient safety. Safety goals include indentifying patients correctly, improving staff communication, storing and administrating medicines correctly, using alarms safely, infection prevention, identifying patient safety risks, and preventing surgical errors.

6. 5G communication technology

The implementation of 5G communication technology will allow clinicians to connect with voice, video, and data. Telehealth and remote home monitoring systems have allowed patients to receive care at home, which is especially helpful for those in rural areas, and helped doctors interface with patients or share information with specialists for years. Slow network speeds and congestion from a growing Internet of Things (IoT) can delay patient care and can even hurt outcomes; 5G technology can speed connections and resolve congestion to keep information flowing freely.

7. Human centered design

Human-centered design relies on the human perspective to solve problems; it focuses on what users, not designers, think. Unlike other approaches to healthcare in which providers assume what the patient wants, human-centered design starts by understanding the perspective of the person experiencing the problem.

8. Natural language processing

Doctors spend about half their patient time staring at computer screens, according to research. Natural language processing (NLP) can help doctors spend more time with patients. NLP products capture conversations between clinicians and patients, transcribe that discussion into a word-for-word transcript, and populate the electronic health record with information from that conversation.

The healthcare industry is at a significant turning point, with next-gen technology taking medicine into uncharted territories. While AI, 5G and other technologies will hyper-connect patients and caregivers, NLP, improved software design, and the human touch of nurses and doctors will change the face of medicine as we move through the decade.

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.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

SOURCES:

https://www.usa.philips.com/c-dam/corporate/newscenter/global/future-health-index/fhi2019/fhi-2019-report-united-states.pdf

https://www.who.int/news-room/campaigns/year-of-the-nurse-and-the-midwife-2020

https://www.who.int/features/factfiles/patient_safety/en/

https://www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/npsg_chapter_hap_jan2020.pdf

https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2016.0811

Laboratory Management Systems – Level of Importance

Importance of Laboratory Management Systems

The need for more elaborate and accurate laboratory management systems is becoming more and more important as the scale of research and development continues to escalate.   Laboratories have been among the heaviest users of information technology since its inception more than 30 years ago. As places where questions are answered and breakthroughs begin, labs have played a defining role in defining and developing information management systems along the way.

The global laboratory information management systems (LIMS) market is growing rapidly. In fact, the research and consulting group, Acumen, anticipates the LIMS market size will around USD 2.4 billion by 2026, with 9.3% CAGR during the forecast time period. Technical advancements in pharmaceutical labs and the increasing need for laboratory automation will likely be the primary drivers behind this growth.

Biotechnological and pharma organizations are investing in research and development, which rely on sophisticated and scalable laboratory management systems for effective management and security, tracking data, patient demographics, billing, and more. To support the explosive growth of research and development, today’s laboratory management systems will need to evolve and grow.

The Evolution of Laboratory Management Systems
Information technology is the glue that holds the laboratory – and modern medicine – together. IT can compress the time and distance separating the lab from the patients and physicians. Laboratory information systems move information from place to place, seamlessly and instantaneously, to put information in the hands of doctors, patients, and interoperating businesses participating in the care, when they need it the most.

Most clinical labs once used laboratory information systems (LIS) to simplify administration and instrumentation tasks, and use laboratory information management systems to make collection, storage, and distribution of patient test results and other data easier. Many labs are now using full-service integrated systems that combine LIS and LIMS functions.

Simply combining several small lab management programs together will not be enough. Today’s LIMS must have advanced features that reduce or eliminate human error, improve real time tracking and time saving, increased revenue, and reduced workload and stress within the lab.

Tomorrow’s lab management systems will build upon today’s technologies, such as the ability to track samples in real time and unique auto-authorization feature that automatically approves reports with normal values. Modern lab solutions allow labs to manage logistics efficiently; assigning barcodes to samples at the collection station and notifying the processing center of the sample collection allows the lab to allocate resources, reagents and material even before the samples reach the processing center.

The next generation of laboratory management systems must be powerful and flexible enough to keep up with the evolving sophistication and specialization of clinical labs and their demands for advanced IT capabilities. Labs are increasing their use of molecular diagnostics, such as next-generation sequencing (NGS) systems that can create terabytes of patient data and analyses in the blink of an eye and other processes, which require a new approach to IT. Labs are also ratcheting up their ability to handle other emerging technologies, such as digital pathology, which present their own heavy-duty imaging storage and analytical processing challenges. Finally, lab management systems must evolve to handle the oncoming tsunami of data resulting from the push towards personalized medicine.

The rapid evolution of IT in healthcare creates an unparalleled opportunity to develop new, advanced laboratory management systems that can handle more data, save more money, and serve even more laboratory clients. The new systems will evolve to handle assay data management, data mining, data analysis, electronic laboratory notebook (ELN) and more.  Lab management systems that do not evolve may become outdated in their prime.

From introducing groundbreaking products to reducing waste and improving sustainability, laboratories are changing the face of research and clinical medicine. Innovations in laboratory management helps labs maintain their forward momentum in the ever-changing world of medical technology.

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.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

Source: https://www.acumenresearchandconsulting.com/laboratory-information-management-system-market

Top 5 Healthcare Trends to Watch for in 2020

Top 5 Trends to Watch for in 2020

Healthcare is changing at the speed of light as researchers discover new treatments and as developers create new technologies that improve the health and well-being of the public. A dizzying array of new healthcare products will hit the market in the next year. Here are five of the most important healthcare trends to watch in 2020.

5 Must-Watch Healthcare Trends for 2020

1. AI and Machine Learning

Artificial intelligence (AI) and machine learning use computers that study algorithms and statistical models – and learn from them – without guidance from humans. Machine language systems can solve problems just as a clinician might – by weighing evidence. Unlike a single clinician, though, these systems can simultaneously observe and process a nearly limitless number of inputs.

Using insights from past data to make informed clinical decisions is the essence of evidence-based medicine. Researchers have traditionally used mathematical equations, such as linear regression, to identify and characterize patterns within data. AI uses machine learning to uncover complex associations that fit easily into mathematical equations. Using sophisticated machine learning and very large data sets allows AI to predict outcomes and estimate patient risk faster – and sometimes better – than clinicians and medical researchers.

2. Laboratory Informatics

A rising need for laboratory automation, development of integrated lab informatics solutions, growing demand for biobanks/biorepositories to store millions of biological samples used in research, and the ongoing struggle to comply with regulatory standards is fueling growth for laboratory informatics.

Laboratory informatics (LI) is information technology that uses instruments, software, and data management tools to capture, migrate, process, and interpret scientific data for immediate and future use.

Laboratory informatics will grow from USD 2.6 billion in 2019 to USD 3.8 billion by 2024, according to MarketsandMarkets, and boast a 7.5 percent compound annual growth rate (CAGR) during the forecast period. High accuracy and efficiency of laboratory informatics results, rising burden certain diseases, and increasing applications of LI solutions are driving this market.

3. Silver Technology

In 2018, the number of people over the age of 65 surpassed the number of children younger than 5 years for the first time in history, according to Our World in Data. “Silver technology” provides healthcare solutions that support that aging population.

Technology has historically helped improve the health of older adults through diagnostics, communications, imaging, and health informatics. Silver technology in 2020 will help reframe the delivery of healthcare, and facilitate communication between older adults, their family caregivers, and service providers.

Technology can help older adults live independently longer, manage medications, monitor changes in cognition, stay connected with friends and family members, drive a car, and access healthcare. Some technologies, such as health information technology (HIT), remote monitoring and telehealth, technologies that allow adults to age safely in place, mobile health technologies and workforce-training technologies, will have a profoundly positive effect for older adults in 2020.

4. Wearable Fitness Technology

Fueled by consumer appetite for sophisticated gadgets, rising popularity of wearable fitness and medical devices, growing popularity of the IoT, expanding awareness about the importance of fitness, and the increase in disposable incomes in developing economies, wearable fitness technology will likely trend upwards in 2020. MarketsandMarkets says that the wearable fitness technology market earned USD 5.77 billion in 2016 and predicts it will take in USD 12.44 billion by 2022, growing at a CAGR of 13.7 percent.

Major trends in wearable fitness technology include smartphone apps featuring advanced data analysis, advanced sensors capable of tracking athletic performance and other qualitative attributes, purpose-specific wearables, and even the integration and implantation of technology with and in the human body.

Wearable technology products, such as smart watches and wristbands, spurred an evolution in fitness technology. The wearable fitness technology of 2020 will include a wide variety of smart apparels and other innovative products, such as smart shoesheadbands, and more.

5. 5G Mobile Healthcare Technology

5G will become widely available starting in 2020. In fact, Verizon CEO Hans Vestberg says that half of the United States will have the technology by then.

The transition from 4G to 5G will open new cloud applications for the healthcare industry. 5G provides mobile data speeds that are up to 10 times faster than 4G and up to 100 times faster than other existing networks. Faster speeds will support real-time, high-quality video for telemedicine that allows patients to interact with their care teams, remote patient monitoring, virtual and augmented reality for use in clinician training, and other emerging medical technologies that test the limits of existing network speeds. 5G will also alleviate concerns about internet of things (IoT) and potentially allow billions of monitoring devices and wearables that provide essential information about patients’ well-being.

Spurred by advances in computer technology and research, the medical world will continue to change in 2020 and beyond. These changes will likely help older adults live independently longer and help the next generation be healthier.

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.

My 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.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

https://twitter.com/F_Magliochetti1
www.parcaecapitalcorp.com
www.frankmagliochetti.info 

SOURCES

https://www.facs.org/media/press-releases/2019/carrano102919

https://www.marketsandmarkets.com/Market-Reports/lab-informatic-market-203037633.html?gclid=Cj0KCQiAtf_tBRDtARIsAIbAKe1NAHHnFhIGLrwW1avAsxlVwwOrsLY0wjIxMikZeJcNPY_4njamWTsaAu-IEALw_wcB

https://ourworldindata.org/population-aged-65-outnumber-children

https://www.marketsandmarkets.com/Market-Reports/wearable-fitness-technology-market-139869705.html

https://www.wearable-technologies.com/tag/smart-shoes/

https://www.usa.philips.com/c-e/smartsleep/deep-sleep-headband.html

https://www.advisory.com/research/health-care-it-advisor/it-forefront/2019/04/5g-transformation

https://www.cnbc.com/2019/08/01/verizon-ceo-sees-functioning-5g-wireless-in-half-the-us-next-year.html?__twitter_impression=true