April 29, 2017

3D Bioprinter Produces Skin for Tranplants

3D Bioprinter Prints Functional Human Skin Adequate for Transplant

3dprintedskin-frankmagliochetti-healthcareinnovationA team of researchers in Spain reports the development of a new three-dimensional (3D) printer capable of printing human skin suitable for transplant into patients. The printed skin is also suitable for testing drugs and cosmetics.

The team included several groups of researchers, including a group from the Universidad Carlos III de Madrid (UC3M) in Spain. The researchers describe their breakthrough in the scientific journal, Biofabrication.

3D Printing and Skin Production

3D printing has been around since the 1980s, when Charles (Chuck) Hull introduced the first stereolithography apparatus (SLA), but the 3D printing industry is now experience rapid growth with applications in many fields. In medicine, 3D printing holds great promise in someday giving clinicians the ability to produce personalized, complex human tissues and organs on demand. One woman has already received a 3D printed ear from one company, for example, while another frankmagliochettireport-3d-bioprintercompany provides 3D printed implants that the recipient’s body converts to bone.

Three-dimensional printing of human body parts is challenging in a number of ways. Replicating the complexity of anatomical structures is difficult. Ensuring the printed tissue survive transplantation in a living body is another problem.

The scientists in Spain have already engineered plasma-based, two-layered skin used successfully in the treatment of burns and other wounds in a large number of patients. The primary drawback to this method is that it takes 3 weeks to produce enough skin to cover an extensive burn or large wound. Another disadvantage is that the scientists must perform much of the process manually.

3D printing is similar to a desktop computer printer except that the nozzle on the 3D printer exudes biological components rather than ink. These biological components, or bio-inks, are essential to successful 3D printing of human organs and tissues.

To aid in the process, a computer controls the nozzles and flow of biological components so that the nozzles deposit the bio-inks on precise locations on the print bed.

Prints large area of skin in 35 minutes

The authors of the study describe how their 3D printing method generated a 100 x 100 centimeter area of skin in just under 35 minutes.

Like the scientists’ existing plasma-based manual method of producing skin, the 3D printing technology generates two layers of skin – the epidermis and the dermis. The printer starts by producing the epidermis, including the protective outermost layer of keratinized cells, known as the stratum corneum. Next, it prints the thicker, deeper dermis, complete with collagen-producing frank-magliochetti_bioprinter-skinfibroblasts.

The new 3D printing method is faster, but still complex. One of the authors of the report, Juan Francisco del Cañizo of the Hospital General Universitario Gregorio Marañón and Universidad Complutense de Madrid, notes:

“Knowing how to mix the biological components, in what conditions to work with them so that the cells don’t deteriorate, and how to correctly deposit the product is critical to the system.”

The research team tested the printed skin in test tubes and in immunodeficient mice. Transplantation of the printed skin into the mice helped the scientists test the long-term effects in a living animal. In both tests, the 3D printed skin was very similar to human skin and indistinguishable from the manually produced bi-layered skin from plasma.

There are two main potential uses for this 3D skin – to produce skin for research and laboratory testing of drugs and cosmetics, and to produce person-specific skin from the patient’s own cells to treat burns and other wounds. The research team is also investigating ways to use the technology to print other human tissues.

Source

http://iopscience.iop.org/article/10.1088/1758-5090/9/1/015006/meta

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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NSAIDs May Prevent Colorectal Cancer

NSAIDs May Prevent the Development of Colorectal Cancer after Polyp Removal

A recent study published in the British medical journal suggests that NSAIDs may help prevent colorectal cancer after polyp removal – This post goes into more detail on the study.

Frank Magliochetti

Taking non-steroidal anti-inflammatory drugs (NSAIDs) may prevent the recurrence of advanced neoplasia, a type of polyp that is the precursor of colorectal cancer, after the surgical removal of pre-existing polyps. Recurrence rates of benign polyps and advanced neoplasia are quite high, so clinicians are eager to find easy-to-follow treatments to reduce recurrence.frankmagliochettireport-healthcare-cancer-treatments

A team of scientists from across the United States recently collaborated with Mayo Clinic researchers to determine how well NSAIDs, aspirin and other supplements prevent the recurrence of precancerous or cancerous polyps. The results of the study, published in the British medical journal BMJ suggest NSAIDs may offer the greatest protection.

About Colorectal Cancer

Colorectal cancer is the third most common type of cancer in men and woman in the United States, according to the Centers for Disease Control and Prevention (CDC), and it is the second leading cause of cancer-related deaths among cancers affecting both men and women.

Colorectal cancer, characterized by abnormal cell growth in the colon or rectum, is one of the few preventable types of cancers. Removing precancerous polyps during colonoscopy prevents those polyps from turning cancerous but it does not prevent recurrence of advanced neoplasia, also known as advanced adenomas or adenomatous polyps. A study published in PLOS showed a recurrence rate of 50.5 percent for polyps, and a 32.9 percent recurrence rate for neoplasia.

Research Suggests Non-Aspirin NSAIDs Reduces Risk of Recurrence of Precancerous Polyps

The results of the BMJ study showed that non-aspirin NSAIDs, particularly ibuprofen, work better than aspirin or many other nutritional supplements for most patients when it came to preventing the growth of advanced neoplasia. The researchers note that, because most colorectal cancers develop from neoplasia, frank-magliochetti-report-healthcare-cancer-preventionchemoprevention with NSAIDs has a favorable risk to benefit profile when it comes to reducing recurrence in those with a history of high-risk neoplasia.

  1. Hassan Murad, M.D., preventive medicine physician and clinical epidemiologist at Mayo Clinic, is the study’s senior author. “Approximately 85 percent of all colorectal cancers are thought to result from untreated adenomatous polyps,” says Murad, M.D., in a press release published by Mayo Clinic. “If we can find a way to stop their growth, we could prevent a majority of these cases.”

“We knew that aspirin and other NSAIDs have a protective effect, and that a number of other nutritional supplements have also been studied for their effectiveness in preventing cancer,” says Dr. Murad. “What we didn’t know is how they compared to each other.”

The research team conducted a meta-analysis from data obtained from 15 randomized control trials. The scientists reviewed information from 12,234 patients who were taking various supplements and medications. The researchers looked at low- and high-dose aspirin therapy, NSAIDs, vitamin D, calcium, and folic acid, and then compared each treatment alone and in different combinations.

Analysis of the information showed that non-aspirin NSAIDs worked better than all the other therapies for preventing adenomatous polyps recurrence within three to five years after removal through colonoscopy. Because these non-aspirin NSAIDs pose other health risks, this treatment may not be appropriate for all patients.

“It is important that patients and doctors have a discussion on the various risks and benefits of any medication or other therapy,” says Murad. “While a research publication may contain promising findings, it is generalized information, and each individual is different. So their care will be individualized, as well.”

Source

http://www.bmj.com/content/355/bmj.i6188

https://www.cdc.gov/cancer/colorectal/statistics/

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0050990

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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5 Trends in New Medical Economy

5 Trends in the New Medical Economy-

Frank Magliochetti Report

Five key trends will shape the new medical economy, according to a November 2016 briefing report by the cloud-based healthcare IT solutions provider CareCloud.frankmagliochettireport
The medical economy is shifting away from fee-for-service and towards value-based care. The industry faces a host of new economic realities as various forces shape the business of medicine. Five trends in particular will influence the new medical economy.

Five Trends Shaping the Business of Medicine

1. Patients as payers
Patients will continue to seize control over their own healthcare costs as a response to skyrocketing out-of-pocket expenses and deductibles. Insurance deductibles have increased by 255 percent since 2006, according to a survey by InstaMed, and the average health insurance premium for family coverage has gone up by 83 percent since 2005. Because they pay out of their own pockets, consumers want the best treatment bang for their buck, including information about services, options, and treatment costs.
Patients are also becoming increasingly proactive in managing their own healthcare by gathering information on diagnosis, billing and treatments digitally. Nearly two out of three consumers participating in the InstaMed survey expressed interest in using Apple Pay or other mobile payment systems for healthcare bills. More than three out of four consumers prefer to pay their household bills through online payment channels. The internet frankmagliochettireport_medicaleconomytrendswill continue to be a rich source of information, health apps, data, and medical devices for patients. CareCloud predicts a surge in retail urgent care clinics and concierge practices that cater to consumer-minded patients.
2. Doctors as digital innovators
An increasing number of healthcare providers are adopting EHR systems, and are shifting from server-based systems toward cloud technology to take advantage of improved usability, faster upgrade cycles and more innovation. Providers will likely use more specialized technologies across multiple EHR platforms. Application programming interfaces (APIs) will help medical groups enhance services without having to replace entire base systems.
3. Fiscal stewardship
Hospitals and health systems will try to reduce costs as they shift towards value-based care and away from fee-for-service care. Financial stewardship promotes health in the general population by increasing overall access to care.
4. Entrepreneurs in medicine
Exciting opportunities are ahead for “doctorpreneurs” and other medical professionals who either build new medical groups or acquire existing ones. Medical entrepreneurship offers the twin benefits of earning profits and social good.
While private equity investors traditionally invest in medical groups promising high reimbursement potential, such as dermatology and pain management, today’s medical entrepreneurs are looking at primary care groups.
5. Information retains its crown as king
The push to digitize medical records coupled with the rapid shift to value-based care has created a mountain of information. The information benefits population health management by making healthcare proactive rather medicaleconomytrends-frankmagliochettithan reactive, identifying at-risk patients and promoting early intervention. The plethora of data and new technologies now allows each patient to create a custom care plan tailored to their medical history. The development of intelligent apps that leverage data and analytics tools will help manage and disseminate this information.
Changing regulations, patient engagements and new economic realities are driving healthcare towards a value-based, consumer-centric model. Healthcare technology will evolve to focus more on adaptability and innovation.

Source
http://on.carecloud.com/thenewmedicaleconomy.html
http://www.instamed.com/blog/trends-impacting-the-healthcare-payments-mar

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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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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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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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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Medication Adherence in the United States  

United States:  Medication Adherence Check Up

Non-adherence includes stopping, not starting, or taking less than the prescribed amount of a medication. More than half of all adults in the United States with a chronic illness report at least one episode of non-adherence to their prescription medication, according to the first National Report Card on Adherence. This report card, developed bymedical-adherance_frankmagliochettireport the National Community Pharmacists Association (NCPA), gives Americans a weak score when it comes to takingmedications as prescribed.

The Centers for Disease Control and Prevention (CDC) says that 80 percent of all medical treatments involve medication. The CDC also estimates that 20 to 30 percent of prescriptions go unfilled.

There is some good news in medication adherence trends, however. A study published in September 2016 shows that low adherence for anti-hypertensive medications decreased among Medicare beneficiaries from 37.4 percent in 2007 to 31.7 percent in 2012.

medication-adherance-appsTechnology is helping to improve adherence rates. Smartphone apps and other technologies have created a new medication adherence market, which offers computerized solutions that remind patients to take medications and take other measures to improve adherence. The global medication adherence market is growing at a significant rate, according to a P&S Market Researchpress release, boasting a 17.5 percent CAGR during 2016-2022.

 

Reasons for Poor Adherence

There are many reasons patients do not take prescriptions as directed. Forgetfulness, concerns about side effects, poor understanding of the need to take medications, affordability, and difficulty getting to the pharmacy are common reasons for poor adherence.

Pharmacy connectedness, which is a feeling of familiarity with a pharmacy provider, is an important factor when it comes to medication adherence. Only 36 percent of those who get their prescriptions by mail report pharmacy connectedness in the report card, while 67 percent of those who visit a chain pharmacy and 89 of those who go to a neighborhood pharmacy report a personal connection with their pharmacists. Patients living in the Northeast and Midwest are slightly more likely to report pharmacy connectedness; those living in urban areas are less likely to

Affordability is another primary predictor in whether a patient will take a medication as prescribed. Whether or not insurance pays for the drug, overall health and income often factor into the affordability of a medication.

Improving Medication Adherence

Healthcare providers can help patients improve medication adherence. Pharmacists are at the front line of addressing non-adherence. Establishing pharmacy connectedness with new patients and improving person connections with existing customers can help these healthcare professionals engage with clients, provide better information about the importance of taking medications as prescribed, and encourage them to better comply with medication regimens. Because of their greater personal connection with patients, independent pharmacists may be in particularly good position to optimize adherence.

Practitioners also play a vital role in stressing medication compliance, monitoring adherence, and helping patients manage side effects and other complicating factors that might prevent patients from taking medication as prescribed. Keeping patients well informed about health conditions can also improve compliance. Both prescribers and pharmacists can help reduce non-adherence by helping economically vulnerable patients find the most affordable medications.

Information, communication, and patient support help patients become engaged and involved in their own health care; they also improve patient satisfaction and loyalty. The results of the scorecard survey suggest patient engagement can reduce the currently high levels of prescription medication in the United States, and address the associated costs and health risks of non-adherence.

Source

http://www.ncpa.co/adherence/AdherenceReportCard_Full.pdf

https://www.cdc.gov/cdcgrandrounds/pdf/gr-pharmacists-10-21-2014.pdf

https://www.ncbi.nlm.nih.gov/pubmed/27432867

http://www.prnewswire.com/news-releases/global-medication-adherence-market-expected-to-grow-with-175-cagr-during-2016-2022-ps-market-research-574469501.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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Nobel Peace Prize Winner for Medicine – Yoshinori Ohsumi

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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