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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

Healthcare: Precision Medicine Has Arrived

Will Precision Medicine Become Commonplace?

Will precision medicine become commonplace?

Precision medicine is a relatively new and powerful approach to medical care. Given its current growth rate and potential, precision medicine will likely be commonplace very soon.

Medicine is not always a one-size-fits-all solution – what works for one patient may not work at all for another. Individual differences in biology, environmental factors, and lifestyle may play a role in the risk of disease, affect symptoms, and even influence how well treatment works.

Treatments that shrink tumors or alleviate symptoms of arthritis in some patients, for example, are not always effective for other patients. Precision medicine aims to overcome the influences of biology, environment and lifestyle by matching the right treatments with the right patients.

Precision medicine involves the use of extensive medical testing that identifies unique differences in a patient’s condition, followed by the development of a treatment plan specific to that patient. In other words, doctors will run tests to identify unique characteristics that might make a patient more susceptible or resistant to certain diseases or treatments, and then create personalized treatment plans for each patient.

Precision medicine allows researchers and prescribers to predict which treatments and prevention strategies will work best to treat diseases in which groups of people. In contrast, the one-size-fits-all approach uses treatments and disease strategies designed for the average person.

Past, Present and Future of Precision Medicine

While the term “precision medicine” is relatively new, the concept of providing patient-specific treatment has been around for decades. For example, doctors perform blood tests to match patients with the right type of blood; they have been doing this since the early 1900s.

The advent of modern personalized medicine began about 20 years ago, when oncologists began using targeted therapy to treat HER-2 positive breast cancer. Precision medicine got a boost in 2015 with the introduction of the National Institutes of Health (NIH) Precision Medicine Initiative. NIH introduced the initiative in hopes of moving “the concept of precision medicine into clinical practice.” In other words, the initiative intends to make precision medicine commonplace.

The targeted, personalized approach already has a significant effect on many areas of medicine, including genomics that studies genes and their function, medical devices, and laboratory testing. Patients already benefit from precision medicine, especially patients with cancer. Doctors can use genetic testing to determine if a patient is at high risk for developing certain kinds of cancer, for example. When tests show that a person has a higher risk of cancer, a doctor can suggest ways to lower that risk. Cancerous tumors also provide genetic information that helps doctors develop more effective personalized treatment plans.  

The Precision Medicine Initiative has helped spur the commercial growth of precision medicine. The number of commercialized lab tests, known as predictive biomarker assays, is increasing dramatically. Predictive biomarker assays help doctors, pharmaceutical researchers and manufacturers predict the effectiveness of a treatment in any given patient group. These tests also help classify patients’ unique characteristics, which allow researchers and doctors to come up with the safest, most effective treatment for those specific patients.

Advancements in genome sequencing, an increase in consumer-focused healthcare, and innovations in healthcare information technology (IT) and connectivity have fueled explosive growth in the precision medicine market. Market Watch reports the value of the global precision medicine market at USD 47.43 billion in 2019, and projects the market will grow at a Compound Annual Growth Rate (CAGR) of 12.3 percent to reach a net market size of USD 119.90 billion in 2025.

Precision medicine will also stimulate further research exploring the genetic, environmental, and lifestyle factors that influence the development of disease and response to treatment. This research will likely bring about innovations that make precision medicine commonplace in clinical medicine.

SOURCES

Frank Magliochetti News

Frank Magliochetti News will be centered around reporting on trends, innovations, and news in the healthcare and bio/pharma industries.

Frank Magliochetti News is the latest in a growing network of online publications by Frank.

I’m please we have released Frank Magliochetti News, with so much going on it is my hope that Frank Magliochetti News will shed light on current, relevant, healthcare and pharma industry topics and innovations .  Please take time to head to my personal and corporate sites for news and information.
Earlier this year, Frank was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Earlier this year, Frank was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

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.frankmagliochettiNews.com


Vaccinated for Measles?

Even Vaccinated People Can Get the Measles

Measles are a serious infectious disease that can cause serious complications, such as ear infections, inflammation of the throat and lungs, pneumonia, swelling of the brain known as encephalitis, and pregnancy problems. Once very common, measles are now rare thanks to vaccinations, but people who have been vaccinated can still get the measles.

The measles vaccine became widely available in 1963. In the decade prior to the vaccine, measles infected 3 to 4 million people in the United States each year, according to the Centers for Disease Control and Prevention (CDC). Of the cases reported, 400 to 500 people died, 48,000 were hospitalized, and 1,000 suffered encephalitis from measles each year.

Widespread immunization drastically reduced measles rates right away, but the rate of measles began to creep up again in fully vaccinated communities. In 1989, health officials recommended receiving two doses, with the first at 12 to 15 months old and the second at 4 to 6 years old. One dose of the measles vaccine is about 93 percent effective at preventing measles, while two doses are about 97 percent effective. The immunity provided by the measles vaccination is long-term and probably lifelong.

The aggressive two-dose measles vaccination campaign eliminated measles from the U.S. in 2000. Now a measles outbreak is sweeping the nation and 2019 is shaping up to be one of the worst years for measles since its elimination nearly 20 years ago. This trend is worrisome for the very young, the very ill and other people who cannot receive a vaccination, as it puts them at risk of contracting measles. The increase of measles also increases the risk of infection among people who have received a measles vaccination but are still at risk of getting sick from the measles. Doctors refer to this group of people as “vaccine non-responders.”

About Measles Vaccines and Vaccine Non-responders

Immunization with the measles vaccine, known as the mumps-measles-rubella (MMR) vaccine, reduces the risk of infection with measles when exposed to the virus that causes the disease. Immunization with the MMR vaccine can also reduce the severity of symptoms if vaccinated individuals do get the measles.

Vaccinations work by “teaching” the immune system how to recognize and attach the measles virus. Vaccinations involve the introduction of live, attenuated measles virus. That means the vaccine contains a harmless version of the measles virus. The body responds to the presence of the vaccine by creating antibodies that will fight any measles virus they encounter in the future.

Some people have a strong response to immunizations with the measles vaccine, and develop a robust army of measles antibodies. These high-responders have a very low risk of contracting measles when exposed to the virus. Low-responders, whose bodies may have developed only a few antibodies to the measles virus, may contract measles but experience only mild to moderate symptoms.

Certain factors can influence a vaccine’s effectiveness. The viruses inside vaccines can die during the attenuation process to alter its effectiveness, for example. Administering vaccinations at the wrong time or incorrectly can also lower the effectiveness of the vaccine. Host-related factors, such as a person’s genetics, immune status, age, health, and even nutritional status can also affect how well a vaccine works.

While vaccinations may not provide 100 percent protection against the measles, it is still important that everyone who can receive vaccinations have the MMR. Widespread vaccination provides “herd immunity” that prevents serious viruses like measles from spread to those who either cannot receive the vaccine or who are low- or non-responders.

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

Pharmacogenomic Testing and Health Care Costs

Pharmacogenomic Testing: Could it Reduce Health Care Cost?

A relatively new type of drug testing could reduce health care costs. This type of testing is known as pharmacogenomic testing. It looks at how the genes a person inherits affects how medications works in his or her body.

Many things can affect how drugs work in the body. Someone’s size can be a factor, for example, as a large person needs more of a drug than does a small person. A person’s diet can also affect how well his or her body absorbs and uses medications.

Genes can also affect how a person’s body responds to drugs. Differences in genetic makeup between people influences what their bodies do to a drug and what a drug does to their bodies. A person’s genetic makeup may cause slow metabolism of medications, for example, and this can cause the drugs to accumulate to toxic levels in the body. Other people metabolize drugs so quickly that drug levels never get high enough to provide a therapeutic effect.

About Pharmacogenomics

In pharmacogenomics, scientists study the genetic differences that affect the response to drugs. The word “pharmacogenomics” is a combination of the word’s pharmacology and genomics; pharmacology is the study of the uses and effects of medications, while genomics is the study of genes and their functions. The aim of pharmacogenomics is to develop safe, effective medications and doses tailored to an individual’s genetic makeup.

Pharmacogenomic testing helps researchers get a better understanding of the relationship between genetics and drug response. This understanding ultimately leads to treatments that work better and cost less.

Most of the medications currently available are “one size fits all,” but these drugs do not work the same way for everybody due to genetic differences. These inherited differences can make it difficult to predict who will benefit from a drug, who will not respond at all, and who will suffer negative side effects. Incorrect predictions can lead to prescribing drugs that do not work, work poorly, or worst of all, cause adverse side effects.

The Food and Drug Administration (FDA) tracks adverse drug reactions and issues “black box warnings” for medications that have the potential for severe side effects associated with genetic predispositions and other causes. These warnings, which apply to more than 200 drugs, help doctors choose the right medications. In some cases, the black box warnings contain genomic information that alerts doctors to the potential risk of adverse reactions and provides dosing instructions according to pharmacogenomic testing results.

Pharmacogenomic testing can reduce health care costs by helping doctors prescribe medications that those patients who are genetically predisposed to benefiting from the drug. This testing can also reduces the risk of adverse events in patients with a certain genetic predisposition.

Negative side effects, also known as adverse drug reactions or adverse drug events, are a significant cause of hospitalizations and death. Adverse drug reactions lead to approximately 1.3 million emergency department (ED) visits and 350,000 hospitalizations every year, according to the Centers for Disease Control and Prevention (CDC). The FDA says that adverse drug events may be the fourth leading cause of death in the United States, causing more than 106,000 deaths annually.

Adverse drug reactions are dangerous, but they are also costly. Adverse drug events cost the nation about $3.5 billion in excess medical costs every year. These drug reactions affect about 2 million hospitalizations each year and prolong these hospital stays by 1.7 to 4.6 days, which significantly adds to the cost of hospital care. Outside the hospital, adverse drug reactions result in more than 3.5 million visits to doctor offices, approximately a million emergency department visits and around 125,000 admissions to the hospital. More than 40 percent of the costs related to adverse drug reactions occurring outside the hospital may be preventable.

About Pharmacogenomic Testing and its Benefits

Researchers are using information from the Human Genome Project to investigate how genetics affects the body’s response to medications. The results help researchers to predict whether a drug will work effectively for a particular person, and to help prevent adverse drug events.

The test requires a small blood or saliva sample. Laboratory technicians perform tests that look for changes or variants in one or more genes, which can affect your body’s response to certain medications.

Pharmacogenomic testing evaluates the genetic factors that affect how your body metabolizes medications. The information gained from the test helps your doctor determine if a particular medication is right for you, calculate the correct dosage to adjust for your metabolism, and to help predict whether you could experience serious side effects from the drug. It can also save money.


Medical and finance expert Frank Magliochetti explains;

Healthcare spending in the United States reached $3.5 trillion in 2017, rising by 3.9% year-on-year and accounting for 17.9% of gross domestic product (GDP), according to data from the Centers for Medicare and Medicaid Services (CMS). Independent federal actuaries estimate that the amount climbed to $3.65 trillion in 2018, and the Organization for Economic Co-Operation and Development (OECD) ranks the United States as the country with the highest health expenditure per capita. According to CMS projections, US spending will continue to grow at an average rate of 5.5% annually through 2026, when it is expected to reach $5.7 trillion and account for 19.7% of GDP. These massive and steadily rising costs are a source of concern for the government, which is constantly exploring means of reining in healthcare expenses, including through preventive measures and investment in research projects. Among the most promising new developments is pharmacogenomic testing, which involves studying the impact of people’s genetic makeup on their response to drugs so that effective and efficient treatment regimens can be devised

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

Early Signs of Disease Identified with Wearable Sensors

Wearable Sensors May Help Identify Early Signs of Disease

Wearable technologies may be able to do much more than monitor a person’s blood pressure or total number of steps each day, according to a new study, which suggests wearable sensors can detect early signs of serious disease.

Wearable biosensors, otherwise known as wearables, are a low-cost technology capable of measuring physiological parameters continuously or frequently. Biosensor technology is a promising approach to monitoring physiological measurements, and these devices could potentially identify significant changes in health conditions. Capable of passive and routine recording, the technology can provide immediate real-time delivery of multiple measurements to the wearer or physician. Software simplifies the technology, so using wearable biosensors requires minimal training and attention from the wearer or the clinician.frank-magliochetti-biosensors-healthcare-report

In addition to physiological measurements, wearable devices can capture the wearer’s physical activities, such as walking, running, and biking, often in conjunction with a GPS to provide information about the location of the activity.

Wearables can Track Health and Provide Useful Health Information

The newest generation of portable biosensors can measure health-related physiology changes during various activities. The goal of the study, published in PLOS Biology in January 2017, was to investigate the use of portable biosensors in this capacity and their potential role in health management, specifically in the diagnosis and analysis of disease.

The researchers fitted participants with between one and seven commercially available activity monitors. Over the course of the study, the scientists recorded more than 250,000 daily measurements, including participants’ heart rate, skin temperature, blood oxygen, sleep and calories expended collected from up to 43 individuals. The scientists then combined biosensor information with medical measurements to develop a personalized, activity-based normalization framework, which they used to identify abnormal physiological signals and detect disease.

Several participants reported minor cold-like illnesses in the study’s first two years. At the onset of these illnesses, the sensors detected higher than normal readings for skin temperature and heart rate. Blood tests showed an increase in inflammation before symptoms occurred.

Biosensors-frankmagliochetti-reportThe devices could detect physiological differences, namely variations in heart rate patterns, between insulin-sensitive and insulin-resistant individuals. The researchers also found interesting physiological changes associated with alterations in environment. Participants’ blood oxygen levels decreased during high-altitude flight, for example, and this decrease in oxygen levels correlated with fatigue.

The wearables even detected physiological changes in one person – lead author of the study, Michael Snyder – who later turned out to have Lyme disease. The geneticist never developed the telltale bulls-eye rash that usually precedes the condition, but his smart watch and other sensors detected changes in his own oxygen levels and heart rate. Shortly afterwards, Snyder developed symptoms and received an official diagnosis of Lyme disease.

The researchers concluded by saying the portable biosensors can provide information useful for the monitoring of personal activities and physiology. These devices will likely play an important role in health management and access to care by those traditionally limited by geography or socioeconomic class.

Lead author of the study, Michael Snyder, said in a press release that today’s wearables are “the equivalent of oral thermometers but you’re measuring yourself all the time.” He added wearables might someday act as a “check engine” light that tells the wearer when it is time to see a doctor.

Source

http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.2001402

http://www.biosciencetechnology.com/news/2017/01/testing-wearable-sensors-check-engine-light-health-0

Frank Magliochetti is Managing Partner for Parcae Capital

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release new sites dedicated to the industry. Frank currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

Genome Editing – CRISPR

CRISPR- Genome Editing:

Frank Magliochetti Report:   CRISPR

CRISPR trials just may be one the most important healthcare industry breakthroughs of this generation.  How these breakthroughs affect the overall picture of bio/pharma will be interesting to stay focused on.

Frank Magliochetti

Almost every year, a new disease is introduced in the world which affects the population of our country. It would be wrong to say that people living in rural areas may be more prone to catch diseases than those who are living in the city. The fact is that no matter where you live or how Frank-Magliochetti_crisprhard you try to protect yourself from the outside world, there are some in-house diseases that may catch up to you.

Once such disease that can strike anyone at any time is cancer which arises through our genetics.   A disease that in some cases runs down from generation to generation which may strike no matter what we may do to help prevent it.  It is something we all dread.

A study conducted on genetic based cancer diseases was conducted in the US and finally was granted access for testing on humans on June 21st.   The NIH (National Institute of Health) gave the green light to start testing the CRISPR-Cas9 trial on humans so that help from T Cells could be enlisted to protect the body.

To understand the trial, first, one needs to understand what exactly CRISPR-Cas9 is. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a drug derived from Streptococcus pyogenes, which enabled the researchers to make permanent mutations. This introduces double stranded healing breaks in cells to activate the repair pathways in a human body. They adapt immunity in certain archaea and bacteria, which allow organisms to invade and eliminate genetic material.

This disease was discovered in 1989 but until 2007 its symptoms were unknown. 2016 has brought new hope for people to live a healthy life. The trial will be funded by Sean Parker, a tech entrepreneur who has a $250 million dollar cancer treatment center; The Parker Institute for Cancer Immunotherapy.

There have been other trials conducted but the problem with them was that the T Cells, which were reintroduced to a person’s body were not that effective, however, they did kill the NY-ESO-1, the T Cells stopped proliferating and became less effective. crispr-magliochetti

There are many hospitals all over the world that are holding CRISPR trails. Some trials were started at the beginning of August while others are set to start in September.

Hospitals such as Massachusetts General Hospital located in Boston have been conducting tests on genome editing since 2013. This is one of the oldest hospitals in Boston and gets close to 100,000 patient visits per year. There are even chances that MGH affiliated laboratories will also conduct genome editing trials.

Many more hospitals based in Boston have announced that with proper funding, they will start genome editing trials in 2017. Since the trials are so expensive, scientists will pick patients who are immune to Cas9 enzyme.

The discovery and trials of CRISPR is one of the best advancements in medical history. Though the patients for the trial will be chosen in small numbers, people living in fear that their life may end after four or five years due to a genetic illness like Leukemia may now have new hope of living a healthy and happy life.

The content below was aggregated from a Boston Globe opinion piece by Jim Kozubek please click the link to head to the official site to read the rest of the post.

https://www.bostonglobe.com/ideas/2016/09/03/crispr-and-capitalists/uX8NuPsva5L2iNI2DCBArJ/story.html

CRISPR and the capitalists

CRISPER-CAS9 IS A method of manipulating DNA that is transforming medicine and science. It is both popular (“molecule of the year!”) and dangerous (researchers have received threats from GMO activists). It is also wildly lucrative.

The first clinical trial of these tiny molecular scissors may begin by the end of the year. Meanwhile, two camps, the Broad Institute — where I held affiliation for nearly three years — and University of California at Berkeley and researcher Emmanuelle Charpentier, are locked in a patent showdown that will play out in early 2017 with perhaps a billion dollars at stake.
Society treats science as a public trust by funding it through taxes, but perhaps it shouldn’t do so indefinitely. One of the subliminal things that the CRISPR-Cas9 legal showdown tells us is that academic-industry partnerships may one day be mature enough that science may begin to forgo its tax base.

In 1943, President Franklin D. Roosevelt directed his wartime chief of research, Vannevar Bush, to find a way to extend funding after the war. In a document with soaring language entitled “Science the Endless Frontier,” Bush laid out the argument for robust federal funding engines through the National Institutes of Health, the creation of the National Science Foundation, and what would become a briskly expanding network of research scientists throughout the United States.
Read More – CLICK HERE

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital