Wearable Medical Devices: Smart Tech

Smart Tech:  Wearable Medical Devices 2017 – 2020

Smart technologies will continue to drive the ever-growing medical wearable device market in 2017 and well into the future.
The global medical wearable devices market topped $3.2 billion in revenue in 2015, according to Mordor Intelligence, which expects the market to surpass $7.9 billion in 2020 as the industry continues to grow at a healthy CAGR of 19.8 percent during that period.
wearablemedicaldevices_frank-magliochetti-reportWearable medical devices, known simply as “wearables,” are small pieces of equipment featuring sensors that attach to the body. These sensors detect and monitor changes in specific body signatures produced by various body systems and organs. Early wearable technology allowed consumers to monitor vital signs. Today’s wearables allow users to monitor food intake, activity, and sleep levels. Tomorrow’s devices may provide continuous monitoring of glucose levels, smart clothing for infants, and smart EKG necklaces for those with heart problems.
Wearables have the potential to fill a number of applications in remote patient monitoring, sports and fitness monitoring, and home healthcare. Simplified usage of these devices, coupled with the ability to synchronize with smartphones and tables, assisted growth in this segment.
Global Wearable Devices Market- Market Dynamics

There are immense potential socio-economics of wearable medical devices for multiple sectors. Fitness devices that encourage the users to exercise can significantly reduce healthcare costs, for example.

Investors are focusing on a wide variety of projects, ranging from downloadable apps to improving the size, cost and sensitivity of sensors.wearablemedicaldevices_frankmagliochettireport

Several factors propel the growth of the global wearable market. Technological innovation is perhaps the most important factor, as these advancements lead to the introduction of new products.
Diabetes and other chronic diseases are rising at a seemingly uncontrollable rate. Wearable devices will play an increasingly important role in helping doctors and patients manage chronic diseases.

Developers make wearable devices easier to use and simplify interpretation of the data collected. Simplicity encourages use.
Market penetration of smartphones, smart watches and other wearable devices will promote the use of wearable medical technology. These devices have already penetrated the market deeply, with the worldwide smart watch shipments reaching about 25 million in 2015.

Some factors, such as reimbursement issues and high device cost, will restrain the medical wearables market somewhat but the effect should be minimal, as demand should remain high.
Several companies are already exploiting the growing interest in medical wearable technology by creating affordable products that offer high value to users and their healthcare partners.

Some of the key players already operating in the medical wearable device market include:
• Dräger
• Fitbit Inc.
• Intelesens Ltd.
• Lifewatch AG
• Omron Corporation
• Polar Electro
• Philips Electronics
• Withings SAS
These wearable manufacturers will likely improve hardware in existing products and create sturdier devices within the next few years. Hardware and device ifrankmagliochettireport_wearable-medical-devicesnnovations may include larger and easier to read displays, extended battery life, waterproof hardware, and compatibility with GPS and other sensors included in a standard smart phone. Software innovations may include advanced monitoring systems and improved patient care software, such as breathing exercises and on-demand nutrition counseling.
The wearable market is expanding because the devices are autonomous, which makes them easy to use, and non-invasive. It is also growing because of its ability to help prevent and manage chronic diseases.

Source
https://www.mordorintelligence.com/industry-reports/global-wearable-medical-device-market-industry

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.

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National Diabetes Trends by State

Frank Magliochetti Report – Diabetes Trends

The rates of diabetes across the United States have nearly doubled within the past 20 years, skyrocketing from 5.5 percent in 1994 to 9.3 percent in 2014. While diabetes prevalence is increasing, there is some good news on the horizon in regards to complication rates and access to preventive care.
Of the 12 states with the highest rates of diabetes, 10 are in the south, according to the CDC’s Diabetes Report Card. At 14.7 percent, Mississippi has the highest rate of diabetes. Colorado and Utah have the lowest rates of this metabolic disorder, with diabetes affecting only 7 percent of Utah residents and 6.8 percent of those living in Colorado. frankmagliochetti_diabetestrends-reportDiabetes rates vary between 8.1 and 10.4 in the Northeast. New Hampshire has the lowest rates in the region while Pennsylvania has the highest prevalence in the Northeast.
While the prevalence of diabetes is increasing, there has been a downturn in the percentage of diabetes complications over the past two decades. Deaths from hyperglycemic crisis have declined, for example, as have lower-limb amputations and end-stage renal disease. These declines may be, at least in part, the result of improvements in the rates of hypertension, high cholesterol, and smoking. Advancements in blood glucose control, early detection and management of complications, and strides in preventive care, treatment and management of diabetes.

Preventive Care Usage Trends: Across the Nation and by State

Preventive care varies considerably between states.

The percentage of adults with diabetes who report receiving preventive care practices across the nation is as follows:
• Annual foot exam: 67.5 percentfrankmagliochettireport-diabetes
• Annual eye exam: 62.8 percent
• Checked A1c two or more times a year: 68.5 percent
• Daily self-monitoring of blood glucose: 63.6 percent
• Ever attended a diabetes self-management class: 57.4 percent
• Flu vaccine: 50.1 percent
Preventive care usage varies by state. At 85.8 percent, adults with diabetes in Maine report receiving the highest number of annual foot exams as compared with all other states, while residents of Nevada received the fewest. Adults with diabetes in New Hampshire and Vermont also received more annual food exams than the national average.
Adults with diabetes in Iowa received more eye exams than those in other states at 76.5 percent, while those in Oklahoma received the least number of eye exams. Vermont diabetics were more likely to check their A1c levels more than twice a year, affordablecareact_frankmagliochettireportwhile those in Nevada were the least to receive such preventative care. Diabetes patients in Colorado had the highest percentage of attendance rates in diabetes self-management classes, while those in New York had the lowest. People with diabetes in Minnesota had the highest flu vaccination rates, and those in Florida had the lowest.
The upturn is due, at least partially, to the Affordable Care Act because it supports diabetes prevention and control by expanding insurance coverage, access to care, and consumer protections. As the result, Medicare and other insurance providers now cover an increasing number screening tests for diabetes, pre-diabetes, and for complications associated with diabetes. Providers also offer an expanding list of preventive benefits that help support beneficiaries in self-care and in making lifestyle changes that prevent or minimize development of comorbidities and complications associated with diabetes. The expansion of coverage and preventive care will continue to affect diabetes trends across the nation and within each state.

Source:
http://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html

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.

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Trends in Pharma: 2017 – Biosimilars

Pharma Trends 2017:  Biosimilars

Frank Magliochetti Report

The FDA approved 56 new drugs in 2015 and, of these, 33 were specialty drugs and 23 were traditional. One was a biosimilar. Development, approval and acceptance of biosimilars may become an important trend in 2017.
The FDA is approving more specialty drugs than ever before and specialty medicines will likely face more competition in 2017. Increased FDA approval and frankmagliochetti-report-pharma-trends-biosimilarsdiscoveries of medications to treat orphan conditions and cancer will fuel competition. Biosimilars could overcome development hurdles and increase this competition even more.
Acceptance of biosimilars has been slow in the past. One of the reasons for the reluctance is that the development of biosimilars is different from that of generic drugs. Generic drugs for small molecules have a relative simple chemical structure that makes it easy to reproduce an identical chemical. It is more difficult to make a protein or peptide identical to the original biologic agent because of differences in the sugar residues attached to the protein, for example, or differences in the protein folding that make it unpredictable. This means that, even though a biosimilar has an identical peptide chain, it may not have an identical effect. These factors complicate the process of making biosimilars and increase the risk for problems.
Physician acceptance has been slow too but, as the cost of other medications rise, biosimilars will seem more attractive.
Approval of Biosimilars in 2015 and 2016
Biosimilars, which are products the FDA will approve with evidence that the medication up for approval is highly similar to an already-approved reference product, will probably continue to gain traction in 2017. The FDA has approved four biosimilars as of October 2016.
Zarxio is similar to Neupogen, according to an article published by Managed Healthcare Executive, except the biosimilar has a 15 percent lower list price. Both drugs treat low white blood cell counts associated with cancer and its treatment. The FDA approvedZarxio, made by Sandoz, in March 2015.
Inflectra is similar to Remicade to treat Crohn’s disease and ulcerative colitis. The FDA approved Inflectra in April 2016 but, due to litigation, the launch date is uncertain.
Erelzi, also made by Sandoz, is similar to Enbrel to treat arthritis. The FDA announced approval of Erelzi in August of 2016 and the expected launch date of biosimilar-frankmagliochetti-pharma-trends-2017February 2017 may be delayed.
Amjevita, by Amgen is similar to Humira and is for the treatment multiple inflammatory diseases. Amjevita became the fourth biosimilar drug to gain approval in September 2016. Launch date is set for March 2017 but may experience delays.
There are several biosimilars awaiting approval, including:
• Filgrastim by Grastofil, Apotex
• Pegfilgrastim by Apotex
• SB2 infliximab by Merck/Samsung Bioepis
• CHS‐1701 by Coherus Biosciences
• Epoetin alfa by Retacrit, Pfizer
The need for biosimilars will grow as the need for other drugs, especially cancer drugs and orphan drugs, increases. Doctors diagnose about 1.7 million cases of cancer each year, yet the death rate has fallen 23 percent since the early 1990s, partially due to new medications and treatments. The introduction of biosimilars could reduce cancer death rates even further.
Biosimilars may become one of the strongest trends in the pharmaceutical industry in upcoming years, as biosimilars have the potential to lower the cost for safe and effective treatments for a wider number of patients. Increased development of biosimilar cancer drugs is possible as some biopharmaceuticals lose patent protection.

Source
https://www.uspharmacist.com/article/record-number-of-fda-new-drug-approvals-in-2015
http://www.zarxio.com/index.jsp
http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-executive/news/five-specialty-pharmaceutical-trends-watch
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
http://www.erelzi.com/
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm
http://pi.amgen.com/united_states/AMJEVITA/AMJEVITA_mg.pdf
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm

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.

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CDC Warns Against Nasal Spray Vaccine

CDC: Don’t Not Using Nasal Flu Vaccine for 2016/2017 Season

Frank Magliochetti Report

The Centers for Disease Control and Prevention (CDC) has issued its 2016-2017 influenza vaccination recommendations, which includes the use of inactivated influenza vaccine (IIV) and the recombinant influenza vaccine (RIV). One of the most notable changes to the yearly recommendations is that the CDC is not recommending the use of nasal spray flu vaccinations using live attenuated frankmagliochetti-report_flu-shot-vaccineinfluenza vaccine (LAIV) during 2016-2017, as studies show it is not effective against preventing the flu.
The studies show LAIV had no protective benefit from children ages 2 to 17. In contrast, children who received an injection were 63 percent less likely to catch influenza than are those who received no vaccination at all.
While researchers have not yet determined the underlying cause of the loss of efficacy, but it could be due to changes in the dominant viral strains circulating in the nation during flu season. LAIV worked just as well as the shot at protecting children from H3N3 and the influenza B strain in recent flu seasons, according to a study published in the journal Pediatrics, but youngsters who received LAIV were three times more likely to suffer infection with H1N1 than were children who got the shot.
H1N1 has been the dominant strain for the past few years, according to a February 2016 CDC report, which means LAIVs can leave patients unprotected from the strains most likely to cause illness this flu season.

About Vaccinations, LAIVs, and Flu Season

Influenza vaccinations protect millions of people in the United States from developing influenza each year. Flu shots also reduce severity of influenza symptoms when it does develop, and prevents cdc-frankmagliochettireporthospitalizations relating to the flu. CDC recommends yearly flu shots for everyone 6 months and older. Antibodies typically take about two weeks to develop.
Many patients, and parents of pediatric patients, prefer LAIVs because of the perceived pain or trauma of an injection. LAIVs have been under development in the United States since the 1960s, according to the CDC, and the intranasal, trivalent, cold-adapted, live, LAIV received approval in 2003 as an option for among health patients aged 5 to 49 years. Because the nasal spray contains live, weakened influenza viruses, LAIV theoretically stimulates a stronger immune response than the shots, which contain killed viruses.
Influenza activity often begins to increase in October and peak sometime in late winter or early spring. The peak week of flu activity for the 2015-2016 season occurred on the last week of March 2016,

according to the CDC, which was one of the later season peaks on record. The CDC’s adjusted overall vaccine effectiveness (VE) against influenza A and B viruses for all ages was 47 percent, while the overall VE against A(H1N1)pdm09 was 41 percent and the overall VE against influenza B was 55 percent.

Vaccine manufacturers will provide an estimated 157 to 168 million doses of injectable influenza vaccine for the U.S. market. This is on par with last year’s vaccine distribution.

Source
https://www.cdc.gov/mmwr/volumes/65/rr/rr6505a1.htm?s_cid=rr6505a1_w

http://pediatrics.aappublications.org/content/early/2016/01/04/peds.2015-3279?sso=1&sso_redirect_count=1&nfstatus=401&nftoken=00000000-0000-0000-0000000000000000&nfstatusdescription=ERROR%3a+No+local+token

https://emergency.cdc.gov/han/han00387.asp

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5213a1.htm

http://www.cdc.gov/flu/about/season/flu-season-2015-2016.htm

https://www.cdc.gov/flu/professionals/vaccination/vaccinesupply.htm

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.

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Nobel Peace Prize for Medicine

Dr. Yochinori Ohsumi Wins Nobel Peace Prize for Medicine 

Frank Magliochetti Report

Yoshinori Ohsumi is the sole winner of the 2016 Nobel Prize in Physiology or Medicine. Dr. Ohsumi is a cell biologist who specializes in autophagy, which is the process cells use to destroy and recycle cellular components the cells no longer use. Ohsumi has worked tireless for decades to elucidate the processes behind autophagy. Because of Ohsumi’s work in the 1990s, scientists can now explore the importance of autophagy in frankmagliochettireport_yoshinori-ohsumia number of physiological processes, such as the body’s response to infection or adaptation to starvation.

Scientists of the 1950s observed a special cellular compartment, known as an organelle, which contained enzymes that digest carbohydrates, proteins, and fats. One type of specialized compartment, or lysosome, works somewhat like a furnace to break down unwanted cellular debris.

Researchers of the 1960s found large amounts of cellular content inside lysosomes, which suggests cells have a strategy for transporting large cargo to the lysosome. Further investigation revealed a new type of structure transporting cellular cargo to the lysosome. molecular level. Nobel laureate Christian de Duve coined the term autophagy, which means “self-eating,” in 1963 to describe this transport process.nobel-prize-medal-frank-magliochetti-report

In the 1970s and 1980s, researchers worked to understand another cellular system used to degrade proteins. This other system, known as the Proteasome, degrades proteins one at a time. The mechanism did not explain how the cell disposes of larger protein complexes.

In a series of experiments in the early 1990s, Dr. Ohsumi used baker’s yeast to identify the genes responsible for autophagy. Mutations in these genes can cause disease and the very process of autophagy contributes to the development of several medical conditions, including cancer and disease of the nervous system.

The scientist then went on to shed light on the underlying mechanisms in autophagy in yeast then showed that a similar mechanism occurs in human cells. His discoveries led to a new of understanding how cells recycle their content.

A Groundbreaking Experiment

Yoshinori Ohsumi worked in a number of research areas, but decided to focus on protein degradation in an organelle that corresponds to the lysosome in human cells, known as the vacuole. Researchers like Dr. Ohsumi frequently use yeast cells in research because these cells are easy to study. Yeast cells are particularly useful for indentifying genes important in complex cellular pathways.

While yeast cells are easy to study, they do present a challenge in that the cells are small, which makes their inner structures difficult to distinguish with a microscope. Because of this, Ohsumi was uncertain whether yeast cells even participate in the autophagy process. He reasoned that, if he could disrupt the degradation process while the autophagy process was active, he would be able to see cellular content slated for degradation building up within the vacuole with his microscope.autophagy_frankmagliochettireport

Ohsumi cultured mutated yeast lacking the ability to degrade cellular waste while stimulating autophagy by starving the cells. Within hours, the vacuole filled with cellular content that had not degraded. This experiment proved that autophagy exists in cells. More importantly, the discovery gave Ohsumi a way to identify and characterize key genes involved in the autophagy process. Dr. Ohsumi published his results in 1992.

Next, Dr. Ohsumi exposed yeast cells to a chemical that randomly caused mutations in genes then induced autophagy. This allowed Ohsumi to identify the genes necessary for autophagy. In subsequent studies, he was able to characterize and research the proteins encoded by these genes. Dr. Ohsumi was able to show that a cascade of proteins and protein complexes controlled the autophagy process.

Thanks to the work of Dr. Ohsumi and other scientists, we now understand how autophagy controls important physiological functions that involve the degradation and recycling of cellular components.

Source:

https://www.ncbi.nlm.nih.gov/pubmed/1400575

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.

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Drug Breakthrough for HSDD

Sprout Pharmaceuticals

Frank Magliochetti Report

Sex, specifically women’s sexuality, is often considered a topic that the public and the media tip toe around. For some time now, there has been demand for a addyi-frank-magliochetti-reportmedication that will serve a similar function as Viagra but for the female population that requires a libido boost. Since there are pharmaceutical drugs created that aid men having trouble with sexual activity which are widely advertised and accepted as a legitimate prescription, advocates for female sexual health have been discussing this inequality in healthcare and the possible solutions. Male sexual health medicines have been around for a significant amount of time, however, the female alternative is still in the beginning stages.

Given the current political and societal atmosphere women’s sexual health is a frequently debated topic. There have been numerous doctors frankmagliochettireport_addyand advocates for the past several years that have spoken out on behalf of the need for a drug that can aid the female population that suffers from various medical issues that make participating in sexual activity difficult or altogether impossible. With the rising demand for such a product pharmaceutical companies have been working on creating the solution. In August of 2015, the FDA finally approved a pill that was developed for such a purpose. This drug called Flibanserin is made by Sprout Pharmaceuticals and is sold under the brand name Addyi; given the pink coloration of the pills they have come to be known as the “little pink pill.”

 

Sprout Pharmaceuticals has made a great breakthrough with Addyi; not enough attention has been given to finding potential solutions for those suffering with HSDD.

Frank Magliochetti

Addyi is intended for use in premenopausal women suffering from a disorder known as Hypoactive Sexual Desire Disorder (HSDD), this disorder decreases women’s libido for no known reason and negatively impacts the lives of women suffering from HSDD. HSDD can negatively impact the affected women’s relationships and generate unneeded difficulty and stress, Addyi is intended to alleviate these issues by boosting the libido in women suffering from HSDD. Addyi, unlike the potential alternatives that are in the research stages. manages to aid women in the increasing of their libido without the use of hormones. Flibanserin is designed to balance the neurotransmitters in women’s brains in order to increase their libido. The neurotransmitters that are impacted frankmagliochettireport-addyi-sproutpharmaby this drug are dopamine, serotonin, and norepinephrine.  Addyi has been available for prescription since October of 2016. According to Sprout Pharmaceuticals it should be available through insurance companies and will cost anywhere from $30 to $75 whether the patient has insurance or does not have insurance. Addyi has shown that it has a few side effects such as sleepiness, faintness (loss of consciousness) and, low blood pressure.

The pink pill was previously submitted to the FDA sixty times for approval and the continued to require additional testing to be positive that the drug was safe, effective, and could not be misused to sexually assault someone. however, the FDA now believes that by the end of the year the pink pill will be as prominent as Viagra. The strides this development is making for women’s health are phenomenal. Addyi becoming even half as popular as Viagra will demonstrate the significant changes that have been made in the way that society views women’s sexual health and will change the entire conversation  in regards to sex. Women’s pleasure is no longer a nonexistent aspect of the equation in mainstream conversations about sexual health, this development has the potential to be as groundbreaking as when the birth control pill was first developed in the 1960s.

Related Stories:

Snapshot of Sprout Pharmaceuticals

http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=182739307

Addyi general information

http://www.addyi.com/

What is HSDD?

http://www.everydayhealth.com/sexual-health/hypoactive-sexual-desire-disorder.aspx

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.

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Innovative Development in Medicine

Innovative Medicine:  Preventative Vaccines:  Bexsero & Trumenba

Frank Magliochetti Report

One of the biggest public health epidemics occurred back in 2014; Ebola and Meningococcal B were responsible. These two diseases took 10,000 people in Sierra Leone, Guinea and Liberia. These three countries have weak health systems, which is the reason why they were unable to treat their people.

In order to fight this disease, which made its first appearance in 1976,  WHO (World Health Organization) had been trying to find a cure for many years. On August 8, 2015, WHO declared that Ebola and Meningococcal B is a disease of international concern and thus began the search for its vaccine. By late October, 2015 WHO had finally come up with two vaccines that were guaranteed to prevent Meningococcal B. Sadly; the cure for Ebola has not yet been found however, its vaccines trials are currently being conducted in Sierra Leone.who_frankmagliochettireport

Meningococcal B is caused by bacteria called “Neisseria Meningitidis”. Neisseria Meningitidis has five serogroups: B, C, Y, W and A. The most common serogroups that affect people in the US is B, C and Y.

Meningococcal B disease is not caught through the air. In fact, it is a diseasewhich is transmitted from one person to another in close physical contact. The disease commonly spreads faster in the family due to the exchange of fluids from daily contact. The disease is found at the back of the throat and later causes sepsis. Sepsis is transferred to the blood that infects the blood stream, which causes damage to the brain and spinal column. Meningococcal B often results in liver failure, vision loss, amputation of limbs and death.

bexsero-frankmagliochettireportThe two vaccines Bexsero and Trumenba specifically treat Meningococcal B and were approved by the FDA in October 2015. The trials for Bexsero were conducted in UK, Chile, Australia and Canada amongst 2,600 young adults and adolescents. The results were that the three infectious strains that cause Meningococcal were destroyed.

Another 5,000 participants in the trials conducted in the USA experienced headache, muscle and joint pain, chills, fatigue and diarrhea after receiving the vaccine. Whereas, 15,000 participants experienced less side effects. All in all, the FDA approved the vaccines because the side effects were not viewed aslong term or fatal.

An accelerated approval was used by the FDA to make this vaccine go public claiming that Meningococcal B is a life-threatening disease. The effectiveness of Bexsero was approved two months prior to the trials being conducted.

FDA recommends that the vaccine should be given to infants, children from the ages of ten till twenty three and people who have a weak immune system. It is recommended that more than one dosage should be given to people having serogroup B Meningococcal.

Anna Jaques, a non-profit Hospital in Newburyport, Massachusetts has taken extra measures and brought more doctors and experts on anna_jaques_hospitaltheir team to prepare themselves if a patient with Ebola or Meningococcal B comes to their door.

https://www.ajh.org/

Anna Jaques is a remarkable medical facility housed with some of the top health care professionals North of Boston.

Frank Magliochetti

With 2016 being the year of medical innovations, the vaccine for Meningococcal B has come as a godsend that will save millions of lives in rural areas where this disease is commonly found. The vaccines are set to be released worldwide by the end of the year.

Other News and information on Trumenba and Bexsero

Trumenba Offical Website:

http://www.trumenba.com/

Important Safety Information

  • Trumenba should not be given to anyone with a history of a severe allergic reaction after a previous dose of Trumenba
  • Individuals with weakened immune systems may have a reduced immune response
  • The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills
  • Data is not available on the safety and effectiveness of using Trumenba and other meningococcal group B vaccines interchangeably to complete the vaccination series
  • Tell your healthcare provider prior to the vaccination if you are pregnant, or plan to become pregnant
  • Ask your healthcare provider about the risks and benefits of Trumenba. Only a healthcare provider can decide if Trumenba is right for you or your child

 

trumenba-frankmagliochettireportIndication

  • Trumenba is a vaccine indicated for individuals 10 through 25 years of age for active immunization to prevent invasive disease caused by Neisseria meningitidisgroup B
  • Trumenba is approved based upon demonstrated immune response against four group B strains representative of prevalent strains in the US. The effectiveness of Trumenba against diverse group B strains has not been confirmed

Bexsero

Official Site

https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/bexsero/pi/po.html?cc=3282D9F3E686&pid=

Important Safety Information

Indication

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.Bexsero_logo_4C_temp_norDNA_bigger

  • BEXSERO is contraindicated in cases of hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO
  • Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine
  • The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals
  • Syncope (fainting) can occur in association with administration of BEXSERO. Ensure procedures are in place to avoid injury from falling associated with syncope
  • The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%)
  • Vaccination with BEXSERO may not provide protection against all meningococcal serogroup B strains
  • Vaccination with BEXSERO may not result in protection in all vaccine recipients

AAP issues meningococcal B vaccine ( Trumenba & Bexsero)  guidelines for adolescents
Trumenba and Bexsero have both been approved for the prevention of serogroup B meningococcal disease in individuals aged 10 through 25 years by the American Academy of Pediatrics Committee on Infectious Diseases.

Please Click the link below to read the entire post:

http://www.healio.com/internal-medicine/vaccination/news/online/%7B9d42e15b-0c08-477d-8b1e-f28a59c545ea%7D/aap-issues-meningococcal-b-vaccine-guidelines-for-adolescents

Pfizer heads back to school with Trumenba vaccination campaign

Please click the link below to read the entire post:

http://www.fiercepharma.com/marketing/pfizer-menb-vaccination-campaign-for-trumenba-gears-up-for-back-to-school

Teaching kids to share is usually a parental goal, but a new ad from Pfizer may have some parents rethinking the parameters.

The first campaign for meningococcal group B vaccine Trumenba highlights the dangers of MenB, which can be spread through habits common among teens–including kissing and sharing drinks and food.

The TV ad shows a mother in the hospital with her stricken son, asking “how did we get here?” The ad then goes back through events earlier in evening showing the son sharing food and drinks with several different friends at a party and kissing a girl.

“The campaign was designed to reach parents of teens and young adults during the summer and back-to-school season, when many parents are thinking about steps they can take to help protect their child’s health, including vaccination,” she said.

Trumenba is one of two vaccinations to protect against MenB, along with GlaxoSmithKline’s Bexsero. But last year, the CDC’s Advisory Committee for Immunization Practices (ACIP) stopped short of granting the pair universal recommendation. The vaccines are recommended for young adults ages 16 to 23, with a preferred age of 16 to 18, which means that doctors decide on an individual basis whether to vaccinate their patients against MenB.

watch the ad on iSpot.tv

https://www.ispot.tv/ad/ARCj/trumenba-meningitis-b

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.

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2017 Brings Equilibrium for Medical Costs  

Medical Costs in 2017 – Equilibrium

Frank Magliochetti Report

PwC calls 2017 the “year of equilibrium for medical costs” in its recent publication, Medical Cost Trend: Behind the Numbers 2017. Authors of the PwC report expect growth rate for 2017 to remain unchanged at apricewaterhousecoopers_frankmagliochettireport 6.5 percent.

Two main components of healthcare costs:

  • Unit price of services
  • Utilization, which is the volume and intensity of use of those services

Identifying trends in both unit price and utilization elucidates changes in overall spending. In other words, trends in unit prices and utilization provide a clear picture of whether costs are rising or falling, or if consumers are using more or fewer specific services and products.

Price, rather than utilization, had historically been the primary force behind medical cost trends. In the early 2000s, utilization grew to become on par with price as a major contributor to healthcare trend growth. Retail clinics and urgent care centers have made it more convenient for consumers to receive healthcare, and this convenience led to higher utilization. Greater utilization often results in reduced spending later down the road, especially if consumers use these clinics for preventive screening and for treatment of minor conditions before they become serious problems, but these savings may not reduce the short-term costs of higher utilization.

Recently, however, the price trend grew while the utilization trend declined. This decline in utilization shifts the focus back on the price trend, and does it in a frankmagliochettireport-health_costs-trends-2017way that may affect utilization.

Trends to watch in 2017

PwC predicts mainstream attention and regulatory recognition will cause behavioral health, once largely ignored as a necessary health treatment, to become a crucial part of employer health benefits. The organization also expects slower cost growth among specialty drugs for the first time in several years.

PwC expects employers to consider new benefit strategies, especially those that focus on leveraging high-performing networks with lower costs and higher quality.

At 30 percent from hospital inpatient and 19 percent from hospital outpatient, about half of employer health costs currently come from hospital spending, but costs for prescription drug care will probably see modest cost increases in 2017. Political pressure will likely suppress some of the largest drug cost increases. Furthermore, PwC predicts pharmacy benefit managers will adopt new and more aggressive strategies, which will likely contribute to deflation in the medical cost trend.

Business:  What do the Trends Represent

Always looking for new ways to reduce costs, employers will likely focus less on cost sharing and more on sharing new provider networks. They may realign cost sharing for ambulatory services, for example, evaluate current arrangements made by pharmacy benefit managers, or explore high-performance networkmedicalcoststrends_frankmagliochettireport arrangements.

Faced with competition from new sites of care, healthcare providers who want to grow their market share may consider consolidations or affiliations with other health systems. They may create new partnerships with insurers, provide a more convenient healthcare experience to consumers, or collaborate with pharmacy benefits managers.

Insurers may find it challenging to keep premiums low and control costs in 2017. Transforming business models and encouraging patients to visit lower-cost, high quality providers may help.

In all PwC predicts medical costs will continue to rise in 2017 at the same rate as they did in 2016. The authors of the study predict larger increases in the future.

Source

http://www.pwc.com/us/en/health-industries/health-research-institute/behind-the-numbers.html

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.

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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.

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Healthcare: Smartphone Apps Connecting Patients with Dr’s

Handheld Medicine: Doctors Connecting with Patients using Smartphones

Frank Magliochetti Report

Some fantastic news and what is an absolute healthcare trend; technology is making it easier for communication between DR’s and patients!

Doctors are connecting with patients in an entirely new way – through smartphones.Mobile payments, apps, and digital advertising changed the way retailers work by providing new opportunities to attract new customers, build loyalty and improve sales. Now these same technologies that altered retail are revolutionizing the world of medicine. The use of smartphones and apps helps drive down costs, increases access to information, and fulfills the public’s desire for “anytime, anywhere” diagnosis, treatment and monitoring.

frankmagliochetti_doctormobilevideocallUntil now, the healthcare industry has underutilized smartphones, apps and even connected medical accessories. This is changing, as connectivity allows consumers to take control of their own care. The adoption of mobile health apps has doubled in only two years. The percentage of consumers with at least one medical, health or fitness app increased from 16 percent in 2013 to 32 percent in 2015, according to PWC.

Primary care practitioners and chronic disease managers are leading the way towards a new generation of telemedicine, and patients are eager to follow. Doctors in India set up patients with smart home monitoring kits that connect wireless to the company’s online platform. From there, patients can connect with a wide range of specialists, including dermatologists, cardiologists and fertility doctors who can conduct virtual examinations and prescribe medicine from remote locations.

Clinicians in the United States can now use their smartphones as digital otoscopes. A growing number of clinicians now send patients with chronic conditions home with connected pacemakers, glucose trackers, ECG monitors and other types of remote monitoring devices. Patients can turn their phones into precision digital scales for weighing out food or connect their bathroom scales to mobile app on their phones to track their weight. Symptom checkers, activity trackers, and on-demand e-visits are now available directly to consumers.

The Future of Smartphone Medicine

Moving towards mobile care will cause a dramatic shift in the needs of the healthcare community. Organizations will need assistance managing utilization, connecting healthcare providers working in remote locations, and overseeing the massive amount of data transferred and stored. There will be an increasing need to evaluate the security, privacy and risk associated with using these new tools.frankmagliochetti-report

Connected tools will create fresh links between healthcare and industries with which it rarely interacts, such as retail, hospitality and financial services. Connectivity will also generate more opportunities for healthcare providers and patients to plug in.

Healthcare providers can look forward to engaging in virtual medicine as more facilities build that technology into their long-term strategic plans. Virtual medicine allows health systems to move away from centralized brick-and-mortar locations towards decentralized partnerships and joint ventures to create “bedless” hospitals. Even with the limited smartphone medicine in use today, a growing share of clinicians can already deliver care remotely.

Patients are Eager to Participate

About 68 percent of adults in the United States have smartphones, according to Pew Research Center, which is up from just 35 percent in 2011. Tablet ownership is up to 45 percent.

aha_frankmagliochettiConsumer interest in telemedicine is growing as quickly as interest in smartphones. According to survey results provided by the American Hospital Association, 74 percent of U.S. consumers would be willing to use telehealth services and 30 percent already use computers or mobile devices to check for medical information. Seventy percent are comfortable communicating with their doctors via email, text or video rather than seeing them in person. More than three out of four patients believe that access to care is more important than human interaction with their healthcare providers.

Advanced hardware technology, the introduction of new apps and wireless links facilitates the move towards handheld medicine.

Sources:

http://www.pwc.com/us/en/health-industries/top-health-industry-issues/care-in-palm-of-hand.html

https://www.doctorkepaas.com/

http://www.medicalpracticeinsider.com/news/oto-converting-iphone-digital-otoscope

https://play.google.com/store/apps/details?id=rascsoft.precisionbalance&hl=en

http://weightgurus.com/http://www.pewinternet.org/2015/10/29/technology-device-ownership-2015/

http://www.aha.org/research/reports/tw/15jan-tw-telehealth.pdf

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry – Frank is releasing a comprehensive site which will cover the Healthcare – Bio and Pharna industries- titled the Frank Magliochetti report.  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.

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