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.

Spending Trends in Children’s Healthcare

Spending Trends 1996 – 2013: Health Care for Children

Spending on health care for children has risen in the past 20 years and a new article sheds light on where the money goes.

Frank Magliochetti

Personal health care spending for children skyrocketed 56 percent between 1996 and 2013, according to a new study published online by JAMA Pediatrics. Increased spending in health care for children reflects the increased spending for patients of all ages, according to the statistics presented by frankmaglochetti_healthcare-report-trendsthe Centers for Medicare & Medicaid Services (CMS). The United States spent about $3.2 trillion for health care in 2015, or $9,990 per person, up 5.8 percent from the year before.

Spending Trends for Children’s Personal Health Care in the U.S., 1996 – 2013

While health care spending on children continues to rise, there is very little data on differences in spending for specific conditions, age groups, gender, and type of care. There is also a paucity of information on how spending patterns have changed over the years. To shed light on these spending patterns, Joseph L. Dieleman, Ph.D., of the University of Washington, Seattle, and his team of researchers used 183 sources of data and 2.9 billion patient records gathered from the Institute for Health Metrics and Evaluation Disease Expenditure 2013 project database. They performed annual estimates for each year from 1996 through 2013 and used inflation-adjusted 2015 dollars to report estimates.

They found that spending for pediatric health care increased from $149.6 billion in 1996 to $233.5 billion in 2013. Spending per child rose from $1,915 in 1996 to $2,777 in 2013.

frankmagliochetti_report-trends-childrenhealthcareMost of the money went for well-newborn care in inpatient settings, attention deficit/hyperactivity disorder (ADHD) and well-dental care. Payers spent $27.9 billion for inpatient well-newborn care, which was the largest condition leading to health care spending.

ADHD and well-dental care services were the second and third largest conditions leading to health care spending in children, with $20.6 billion for ADHD care and $18.2 billion for well-dental care. At $9 billion, asthma care garnered the fourth highest level of spending.

The researchers found that, at $11,741, the greatest spending per child was for infants younger than 1 year in 2013. Spending per child increased over time, rising from $1915 in 1996 to $2777 in 2013. Ambulatory care among all types of care and inpatient well-newborn care, ADHD, and asthma showed the greatest growth.

Just over 30 percent of total children’s health care went for inpatient care, 38.6 percent went towards ambulatory care, and 7.8 percent was spent on retail pharmaceuticals in 2013. More was spent on males than on females.childrenhealthcarecosts-frank-magliochetti

The findings provide information about spending trends for child health care and serve as a guide for future spending. Payers can expect larger health care spending growth rates for inpatient well-newborn care and ADHD, for example, while health care professionals can gear up to provide an increased amount of care for these conditions.

“The next step should be analyzing the factors driving increased health care spending and determining whether changes in particular subcategories of spending have been associated with improvements in processes or outcomes. It is crucial to understand whether spending increases have been appropriate or misguided and how we might target spending increases and reductions now and in the future,” the authors conclude in a press release.

Source

http://jamanetwork.com/journals/jamapediatrics/fullarticle/2593700

https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/downloads/highlights.pdf

http://media.jamanetwork.com/news-item/how-much-money-is-spent-on-kids-health-care-where-does-it-go/

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.

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Teen Use of E-Cigarettes in the Rise-

Teen Use of E-Cigarettes on the Rise – Good or Bad News?

We review the pro’s and cons of this trend – given the information; what do you think about the rise in teen use of e-cigs?

Frank Magliochetti

Teen use of electronic cigarettes (e-cigarettes) has more than tripled since 2011, according to a frankmagliochetti-report-ecigs-teens_freerecent report by the U.S. Surgeon General, with 40 percent of high school students saying they had used the product at least once in their lives. In that report, 16 percent of students say they had used these products within the past 30 days.  E-cigarettes are a type of electronic nicotine delivery system that heats liquid containing nicotine, flavoring, and other ingredients into an aerosol. In a process known as “vaping,” users inhale the aerosol.

Regulation of Electronic Cigarettes

In 2016, the U.S. Food and Drug Administration (FDA) finalized their rule regulating all tobacco products, including e-cigarettes. The FDA prohibits the sale of electronic cigarettes and other tobacco products to individuals under the age of 18 years.

Some individual states also impose additional regulations on tobacco products, including electronic cigarettes, specifying who can smoke e-cigarettes and where the products may be used. California requires those purchasing e-cigarettes to be 21 years or over, for example, and it does not allow consumers to use electronic cigarettes in cars with minors present.

The 2016 FDA rule included other provisions to reduce access to e-cigarettes by teens by prohibiting the distribution of free samples and the use of vending machines, but the new regulations allowed flavored frankmagliochetti_teens-e-cigaretteselectronic cigarettes to remain on the market. Some anti-smoking groups were disappointed in this lack of regulation, in that flavors like gummy bear and bubble gum may entice younger people to start smoking tobacco. A study published in a December 2016 issue of Pediatrics supports this concern, finding that the use of flavored e-cigarettes among youth increases their risk of smoking tobacco.

Proponents of electronic cigarettes can argue that tobacco smoking has actually declined among youth in the U.S., although there is not clear indication that e-cigarettes are responsible for the drop in teen smoking.

Dangers of Cigarettes, Electronic or Otherwise

Health officials are particularly worried about the use of electronics cigarettes and traditional tobacco products because of the negative effects nicotine has on the developing brain. Research shows that electronic cigarettes deliver only modest concentrations of nicotine to the inexperienced user but consumers can increase nicotine concentrations to levels similar to traditional tobacco cigarettes.

E-cigarettes also contain substances not found in tobacco products, such as heavy metals, volatile organic compounds, and ultrafine particles that consumers could inhale into their lungs. Some e-cigarette flavorings e-cig-teens-vaping-frank-maglichetti-reportcontain diacetyl, a chemical linked to serious lung disease. Still, the dangers from using electronic cigarettes may not be as lethal as the deadly effects of tobacco smoke, making e-cigarettes the safer choice for teenagers who insist on the habit.

“Kids are a kind of ‘third rail’ issue,” said Amy Fairchild, PhD, MPH, the associate dean of academic affairs at the Texas A&M School of Public Health in a press release. “On the one hand, they require extra protections. On the other, though, we also have to place their risks of harm into perspective. The consequences of combustible tobacco use are well known and serious, while e-cigarettes – while not risk free – represent a far lesser harm.”

Source:

https://e-cigarettes.surgeongeneral.gov/default.htm

https://www.federalregister.gov/documents/2016/05/10/2016-10685/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the

http://publichealthlawcenter.org/sites/default/files/E-Cigarette-Legal-Landscape-50-State-Review-November-2016.pdf

https://pediatrics.aappublications.org/content/pediatrics/early/2016/11/03/peds.2016-2513.full.pdf

https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3543069/

http://tobaccocontrol.bmj.com/content/23/suppl_2/ii30.full

https://vitalrecord.tamhsc.edu/teens-e-cigarettes/

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  – .  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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Augmented Reality in Healthcare

Augmented Reality: A Disruptive Trend that is Changing Healthcare

Google Glass and other types of augmented reality (AR) never really took hold in the consumer market but the advanced technology is now poised to be a disruptive trend that will forever change healthcare for patients and providers.frankmagliochettireport_medicalaugmentedreality
A Q4 2016 report by ABI Research suggests augmented reality will gain momentum as medical professionals seek out new tools and technologies to improve care and outcome for their patients. The research firm suggests regulatory activity will push the medical profession towards AR.

About Augmented Reality in Medicine

Augmented reality is a live view of a real-world environment supplemented with computer-generated sounds, graphics or other sensory input. Unlike virtual reality, which entirely replaces the real world with a simulated one, augmented reality replaces only certain elements.
AR can include “see what I see” applications, education and training. “See what I see” apps can transmit what EMTs see to emergency department physicians. In medical applications, augmented reality applications can simulate how it would feel to have certain medical conditions.
frankmagliochetti_augmentedrealityinmedicineAR applications (apps) can help patients check visual symptoms against a medical database or share information in real time with their doctors. Patients with hearing problems can use AR apps and their smart phones to convert auditory information, such as the screech of brakes or a loudspeaker announcement on an airplane, into text displayed on the smart phone. AR apps can highlight maps of wheelchair-friendly routes when an individual visits a city for the first time.
Augmented reality can provide medical training to a large number of students, even those living in remote or impoverished areas. Students use AR to practice surgical techniques, or even allow experienced surgeons to practice procedures on a three-dimensional AR rending of a patient before performing the procedure on the actual patient.

Augmented Reality Applications are Already in Use

Eye Decide by OrcaMD is an educational application that could potential improve patient compliance. This education tool simplifies complex eye conditions and treatments in a way that improves knowledge, understanding and retention. Users can view the eyeball from any angle, with and without skin. Eye Decide also demonstrates the effects of cataracts, age-related macular degeneration (AMD), and other eye conditions, so that patients can see what a particular disease will eventually do to their vision without proper treatment.
AccuVein displays a map of a patient’s vein to make placing needles easier and more accurate. The healthcare practitioner uses a handheld scanner that detects heat radiating from the veins, converts information gathered about that heat into a map of the veins, and then projects this map onto the patient’s skin. AccuVein enjoys a 40 percent annual growth rate. By the middle of 2015, this augmented reality app had already helped more frankmagliochetti_report-augment-reality-healthcarethan 10 million patients. Sales will likely continue at a robust pace as patients and nurses demand the technology to reduce the average number of “sticks” involved in placing an intravenous (IV) needle.
Many legally blind people still have some vision but cannot see well enough to recognize faces, drive, read, or avoid obstacles in their path. VA-ST is a visor that combines a 3D camera with a computer to enhance vision by improving contrast, and highlighting edges and features. Users can even pause or zoom video for a clearer view. This technology will become more popular as the population of the United States ages and suffers age-related vision loss.
Like other industries, medicine leverages new technology to improve efficiencies and performance. The move from a per-service reimbursement structure towards one that focuses on quality of care will spur growth of augmented reality in medical settings.

Source
https://www.abiresearch.com/market-research/product/1025909-ar-in-telemedicine-training-and-first-resp/
https://itunes.apple.com/us/app/eye-decide-education-engagement/id454280553?mt=8
https://orcahealth.com/
http://www.accuvein.com/inf/
http://www.accuvein.com/2015/06/vein-visualization-emerges-as-premier-augmented-reality-application/
http://www.va-st.com/smart-specs/

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.  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

Top Prescription Drug Purchases / Trends 2016

Leading Prescription Drugs Purchases and Trends of 2016

Nearly half of all Americans take at least one prescription drug each day, according to the Centers for Disease Control and Prevention (CDC), and the cost of many of the most popular and most important medications is rising.
risingprescriptioncosts_frankmagliochettiThe Price for Prescription Drugs is Rising
Each of the past three years have seen double-digit price increases, including average rises of 12.6 percent in 2014 and over 10 percent in 2015. The average price for prescription drugs has increased an average of 10 percent in the past year. Despite pushback from insurers, scrutiny from lawmakers and outcry from consumers, many pharmaceutical companies plan to increase the price of prescription drugs.
Prescription drug spending in the United States totaled about $457 billion in 2015, according to the U.S. Department of Health and Human Services (HHS), accounting for 16.7 percent of all U.S. health care spending. In the 1990s, only about 7 percent of health care spending went towards prescription drugs.
A Wall Street Journal analysis found that prices for 30 prescription drugs increased at eight times the rate of inflation, with an average price hike of 76 percent from 2010 to 2014. Retail prices for some commonly used prescription drugs increased faster than general inflation each year from 2006 to 2013, according to AARP, which translates into an annual cost of therapy of more than $11,000 for a consumer who takes a prescription medication regularly. The total was nearly three-quarters of the average Social Security retirement benefit of $15,526, almost half the median income of a person on Medicare, and nearly one-fifth of the median U.S. household income.
Most Common Prescriptions and Average Cost by State
SearchRx compiled a list of the average costs of prescription drugs by state. At an average price of $12.82 per prescription, Mississippi tops the list as the US state with the lowest average per prescription cost. Arkansas was also low at $12.93, followed by Virginia at $13.90 and Louisiana at $13.10. Hawaii was the most expensive state to fill a prescription, at an average of $19.47, followed by North Dakota at $19.07, Alaska at $18.96 per prescription, and Delaware at $18.51.

The website also lists the most commonly prescribed medications last year:
1. Atorvastatin Calcium (generic for Lipitor) – lowers cholesterol and reduces risk of heart attack, stroke, and other complications in patients with type 2 diabetes, coronary heart disease, or other risk factors
2. Levothyroxine (generic for Synthroid) – primary use is for the treatment of hypothyroidism but it is also used to treat or prevent goiter
3. Lisinopril (generic for Prinivil) – for hypertension or congestive heart failure
4. Omeprazole (generic for Prilosec) – treats symptoms of GERD
5. Metformin (generic for Glucophage) – improves blood sugar in patients with type 2 diabetes
6. Amlodipine (generic for Norvasc) – for hypertension or anginafrank-magliochetti-report-drug-pricing
7. Simvastatin (generic for Zocor) – lowers cholesterol and triglycerides
8. Hydrocodone/Acetaminophen (generic for Lortab) – relieves moderate to moderately severe pain
9. Metoprolol ER (generic for Toprol XL) – treats angina and hypertension
10. Losartan (generic for Cozaar) – treats hypertension and reduces the risk of stroke in those with heart disease
SearchRx also ranked pharmacy chains in order of least expensive to most expensive. Walmart was the least expensive, followed by Target, “other,” Rite Aid, and CVS. Walgreens was the most expensive on the list.
If current trends continue, 2017 will see higher prescription prices, increased health premiums, and continued increases in the number of Americans who take prescription drugs every day.
Source
http://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm

https://www.washingtonpost.com/news/to-your-health/wp/2016/01/11/prescription-drug-prices-jumped-more-than-10-percent-in-2015/

http://time.com/money/4406167/prescription-drug-prices-increase-why/

https://aspe.hhs.gov/pdf-report/observations-trends-prescription-drug-spending

http://www.wsj.com/articles/for-prescription-drug-makers-price-increases-drive-revenue-1444096750

http://www.aarp.org/content/dam/aarp/ppi/2016-02/RX-Price-Watch-Trends-in-Retail-Prices-Prescription-Drugs-Widely-Used-by-Older-Americans.pdf

https://www.searchrx.com/blog/2016-prescription-prices-and-purchase-trends/

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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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.

frankmagliochetti_ParcaeCapital

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