June 20, 2019

Medical 3D Printing Advancements

Advancements in Medical 3D Printing

Three-dimensional (3D) printing has been around since the 1980s, when Chuck Hull patented the mechanical process of printing successive layers of material to create objects. Known as stereolithography or additive manufacturing, the process quickly spread beyond industry into a number of sectors, including medicine.
3d-printing-and-health_frankmagliochettireportA 3D printer is similar to a standard computer printer except that, instead of ink, liquid plastic, metal, polyvinyl alcohol, and other materials flow through its print nozzles. 3D printers are unique in that the process can create three-dimensional solid-state objects made from a variety of materials. Printed objects can be as simple or as intricate as needed by the designer without requiring extra steps in the manufacturing process.
In 1999, surgeons grew a human bladder by layering human bladder cells onto 3D printed scaffold then later transplanted the bladder into the patient that donated the cells. In 2002, scientists used bio-ink replicating kidney tissue to print a functioning kidney.
There have been several major advancements since the earliest days of medical 3D printing. While it is still not possible to print out an entire organ suitable for transplant, it is possible to use three-dimensional printing to create scaffold for growing organs, grow tissues for laboratory testing, make skin grafts for burn victims, print sheets of cardiac tissue that beats like a heart, and more.
State of the Art Medical 3D Printing
Scientists from Harvard University recently made the first 3D printed organ-on-a-chip with integrated sensing, which allows researchers to collect reliable data during laboratory studies. These organs-on-chips, also known as medical-3d-printing_frankmagliochettireportmicrophysiological systems, closely match the properties of a specific disease or individual patient cells suitable for use in the laboratory. These chips simplify data acquisition and allow researchers to change and customize the study design system, opening new avenues for in vitro tissue engineering, toxicology and drug screening research.
Other researchers use direct laser writing to shape and form 3D printed undifferentiated stem cells to create complex 3D structures for various biomedical applications. Another company recently released a realistic-feeling 3D printed arm modelstudents can use to learn how to suture skin. The company, San Draw, had previously released a 3D printed arm model suitable for practicing injections. The 3D printed skin simulates the anatomy and feel of real human skin to improve student training.
3D printing presents nearly unlimited potential in the production of surgical instruments, including forceps, hemostats, scalpel handles, clamps, and even surgical smoke evacuators. 3D printed surgical tools come out of the 3d-printing_medical-frankmagliochettireportprinter completely sterile and ready to use, saving both time and money in sterilization, packaging and storage. Printed tools also cost one-tenth as much as stainless steel tools. 3D printing could therefore boost surgery access in low-income areas and reduce the risk of infection in areas with limited access to sterilizers.
Researchers can print out and expose various body tissues to chemicals and other substances to study the reaction of toxins on healthy tissue. Now scientists can print out cancer cells and other types of disease cells to study how tumors grow and develop, and to evaluate the effects of various treatments on those printed cells.
Research and development of medical 3D printing will likely accelerate as scientists find new uses for the additive manufacturing process and manufacturers learn new techniques for making medical and surgical products. 3D printers will certainly become more commonplace in the surgical suite and in laboratories in the coming years.

Source
https://3dprintingindustry.com/3d-printing-basics-free-beginners-guide/history/
http://www.nature.com/nmat/journal/vaop/ncurrent/full/nmat4782.html
https://www.researchgate.net/publication/309393081_3D_microfabrication_of_complex_structures_for_biomedical_applications_via_combination_of_subtractiveadditive_direct_laser_writing_and_3D_printing
https://3dprint.com/152558/san-draw-medical-suture-training/
https://3dprint.com/6652/3d-print-medical-tools/

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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Augmented Reality: A Disruptive Trend that is Changing 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 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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Tdap Lead to Increased Trend in HPV Vaccines

Requiring Tdap May Increase HPV Vaccination in Adolescent Girls

About 9 in 10 people will get a human papillomavirus (HPV) infection at some point in their lives, according to the Centers for Disease Control and Prevention (CDC). HPV infections are associated with health problems, including several types of cancer in men and women, which means HPV infection is an urgent health problem. A new study shows that teenage girls were more likely to start the HPV vaccine series in states where schools required the meningococcal vaccine and/or the tetanus, diphtheria, and pertussis (Tdap) booster prior to admission.
frankmagliochetti_tdap-vaccineNationwide, 63 percent of girls have received at least one dose of the vaccine, and half of all boys have started the series. Low HPV vaccination coverage is an urgent public health problem and improving HPV vaccination rates will save lives. The nation’s high Tdap vaccination rate of 86 percent shows that high HPV vaccination coverage is possible.
Most cervical cancers, anal carcinomas, and oropharyngeal cancers are the result of infection with high-risk HPV strains. While vaccines capable of preventing HPV related cancers are available, low usage limits their utility.
Previous attempts at improving HPV vaccination included state laws requiring the vaccine, but many of these laws allowed for exemptions for any reason. Because parents could opt out for nearly any reason, these state laws have been largely ineffective at increasing HPV vaccination coverage.
Improving HPV Vaccination Coverage by Vaccinating Against Other Diseases
To identify policies that could improve suboptimal HPV vaccination rates, the authors of the study sought to evaluate the relationship between adolescent vaccination and states’ school entry requirements. In the study, published in the medical journal Pediatrics, researchers compared HPV vaccination coverage in teenage girls aged 13 to 17 years across states with different vaccination requirements for school entry.
The authors gathered information from published data regarding school entry requirements from the Immunization Action Coalition (2007-2012) and vaccination rates from the National Immunization Survey-Teen (NIS-Teen, 2008-2012). They analyzed Tdap booster and meningococcal vaccination rates and evaluated the possibility of increasing HPV vaccination rates by “spillover effect,” meaning schools that require vaccinations as a condition of attendance could have higher rates of HPV vaccination.

The Results

The researchers found that requiring vaccination for admission to school did indeed improve vaccination rates for HPV. Vaccination requirements also boostedfrankmagliochettireport__hpv_vaccine coverage for Tdap and meningococcal vaccinations.
Compared with other states, those states with Tdap booster and meningococcal vaccination had a 22 and 24 percentage point increases in coverage for these vaccines, respectively. States with HPV vaccination requirements had less than 1 percentage point increase in coverage. Requiring Tdap booster and meningococcal vaccinations caused an 8 and 4 percentage point spillover increases for HPV vaccination coverage.
The study was limited in that it failed to account for confounding variables, such as religion, ethnicity, and parental education. Furthermore, the study did not account for the types of school attended, as homeschooled adolescents and teens attending private schools may not be subject to the same vaccination requirements. Despite these limitations and considering the controversy surrounding HPV legislation, utilizing the spillover effect from meningococcal and Tdap vaccination may be an effective approach to improving HPV vaccination coverage.

SOURCE:

http://www.cdc.gov/vaccinesafety/vaccines/hpv-vaccine.html

http://pediatrics.aappublications.org/content/early/2016/11/05/peds.2016-1414?sso=1&sso_redirect_count=1&nfstatus=401&nftoken=00000000-0000-0000-0000-000000000000&nfstatusdescription=ERROR%3a+No+local+token

http://www.cdc.gov/hpv/infographics/vacc-coverage.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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Smart Tech: Wearable Medical Devices

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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2017 Trends in Cancer Care Drugs

2017 Trends in Cancer Care Drugs

Frank Magliochetti Report

Cancer drug development will continue to be a key focus area in 2017. While the number of new cancer frank-magliochettireport_2017_cancer-stopcases in the United States each year remains constant at about 1.7 million, the American Cancer Society says that the cancer death rate has plummeted 23 percent since the early 1990s. This is largely due to improved diagnostics, early detection, and new medications and treatments.
There has been extensive development of cancer medications in the past decade, and the development of oncology drugs will continue to be a key focus area in 2017. There are several important factors affecting cancer drug development in the upcoming year, including a large number of clinical trials already underway, the possibility of shortened regulatory approval time, and increases to consumer cost.

Cancer Drug Development

Extensive development of cancer medications is already underway, and much of this development will continue into 2017. New medicines, just launched within the past five years, now treat more than 20 types of tumors, according to a new report from IMS Institute for Healthcare Informatics. In fact, there were 70 new oncology treatments for more than 20 uses launched from 2011 to 2015. Further research of these new agents will likely result in approval for subsequent indications and provide therapeutic options to more patients.2017_cancertrends_frankmagliochetti
While there is substantial opportunity in the cancer drug industry, there will also be stiff competition in 2017. More than 500 companies are actively engaged in developing oncology drugs. Collectively, these companies are pursuing nearly 600 indications, primarily for non-small cell lung cancer, breast, prostate, ovarian and colorectal cancers.
This giant and diverse group of pharma companies has created a healthy pipeline of oncology drugs in clinical development. In fact, the pipeline of cancer drugs in clinical development has grown more than 60 percent over the past ten years.
Nearly 90 percent of these drugs are targeted agents, and the trend towards targeted agents will likely continue. There are more than 120 clinical development project underway for targeted agents to treat non-small cell lung cancer and melanoma, for example, and each features different mechanisms and combinations that promise new benefits.
It is taking less time for new cancer treatments to receive regulatory approval. The median time from patent filing to approval for cancer drugs in the U.S. dropped from 10.25 years in 2013 to 9.5 years in 2015. Initiatives such as the FDA Breakthrough Therapy designation expedite development and review of drugs that treat serious or life-threatening diseases or conditions.

Patient Costs may Rise

In campaign speeches, the new President-elect of the United States has promised changes to the Affordable Care Act, and these changes may increase patient costs. Average treatment costs for a year of cancer care for patients with commercial insurance plans rose 19 percent to $58,097 in 2014.  Cost increases in 2017 may depend on where the patient receives care. Outpatient services account for more than half of the total costs, according to the IMS report, and the average combined total cost of all  drugs used by the patient accounts for 28 percent of the total cost of care.
Average costs for administering cancer drugs are usually twice as high when patients receive treatment in hospital outpatient settings than when they receive care in physician offices. Higher costs for outpatient care increases patient cost responsibility. Coupons and other forms of assistance may offset the cost to consumers.

Source

http://onlinelibrary.wiley.com/doi/10.3322/caac.21332/abstract
https://morningconsult.com/wp-content/uploads/2016/06/IMS-Institute-Global-Oncology-Report-05.31.16.pdf

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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Pharmaceutical Trends for 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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Genome Editing – Progressing Trend

The Rush for Genome Editing

Frank Magliochetti Report

The Rush for Genome Editing

Gene-editing technology has sparked a frenzy of competitors fueled to develop the first of what may be thousands of treatments for genetic disorders.

From science fiction of movies like Jurassic Park to the reality of GMO foods, the concept of customizing plants, animals and even human genomes has mesmerized our imagination and culture for decades. This obsession is not surprising considering the remarkable impact of genetic engineering on our lives, and the promise it may hold for our future.crispr-genome-editing-franlmagliochetti-report_northandoverma

Modifying the genes of an organism is no easy task. It’s not as simple as removing the parts you do not like with an eraser. It involves making changes at a molecular level that are both complex and challenging.

One concern among scientists is the modifications made in human germline cells – i.e. the sperm or the egg. These are genetic changes that would actually be passed on through generations and the fear is that there could be unexpected side effects. Couple that with the ethical concerns of people misusing this technology to intentionally modify the genome to make “designer babies” with enhanced characteristics. These are some real concerns that are causing scientists to pause and weigh the pros and cons of use of this technology.

More and more companies are racing to stay ahead of the trend and become the leaders in the field.

In Cambridge MA, Intellia Therapeutics Inc. has a 65,000 square foot build out underway, however, it is still planning to functioning while under construction.

Intellia is one of a trio of startups in the Cambridge area working locally in the biotech niche known as CRISPR-Cas9. The gene-editing technology was frank-magliochetti-report_intelliadiscovered just four years ago.

Drug development historically has been a slow process – it often takes more than a decade to bring a medicine from lab to marketplace. But that’s changing, thanks to new machines that can screen drug targets faster and an entrepreneurial environment that’s more akin to high-tech than Big Pharma.frankmagliochettireport_genome_editing

Intellia has high-profile collaboration deals with Swiss drug giant Novartis AG and Regeneron Pharmaceuticals Inc. of Tarrytown, N.Y. It raised $108 million in an initial public offering in May. Their scientists are working on gene-editing treatments for everything including the hepatitis B virus to a rare form of blindness. If all goes well, it could move its earliest drug candidates into clinical trials within 18 to 24 months.

Competitors for Intellia include Editas Medicine and Crispr Therapeutics Inc. both completed their own IPOs this year. There are more to come: all with the heightened interest of investors. These companies are in a race to develop the first treatment based on gene editing.

Genome editing is going to be a hot trend to watch in 2017 and for many years to come.

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 Using Nasal Spray Flu Vaccine

CDC Recommends Not Using Nasal Spray 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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Diabetes Trends: National and 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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2017 – Year of Equilibrium for Medical Costs  

Medical Costs

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.

There are 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 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.

What the Trends Mean for Businesses

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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