StemCell Therapy

Coronavirus (COVID-19) is rapidly spreading across the U.S. and the world, and Americans are being advised by the Center for Disease Control (CDC) to remain vigilant and take precautions such as regular hand washing and hand sanitizing, avoiding unnecessary contact and gatherings, and for personal protection, maintaining a healthy diet and strong immune system.

Chiropractic care focuses on the central nervous system that regulates virtually every bodily function, including the immune system. The nervous system must communicate with the rest of the body, which is where coronavirus and chiropractic care cross paths as chiropractic comes in to remove nerve blockages via spinal misalignment.

Many chiropractors also specialize in nutrition, and while you may not be able to avoid contracting the coronavirus, the flu or a cold, you can control your own immune system and strengthening it against illness.

Sounds like the perfect opportunity to have a heart-to-heart with patients about their immune and nervous systems, says Bill Esteb, DC. Remember, if germs automatically caused disease, the human race wouldnt be around to debate the issue. Many forget that Louis Pasteur, the father of the germ theory, recanted his belief. On his deathbed he observed, Its the soil, not the seed. In other words, without the right environment, germs can do little harm.

Ryan Andrews, RD and principal nutritionist for Precision Nutrition, offers advice for what to eat to maximize your immune system, and what to eat and nutritional supplements if you contract the coronavirus or a flu.

Eating poorly can make you ill, and eating poorly while ill can extend your illness.

If your diet is lousy, youll get sick more often than someone who eats a healthier diet, Andrews says. Viruses and bacterial infections will hit you harder and keep you out for longer. Meanwhile, eating poorly while you are sick will only make you sicker. Good nutrition allows our bodies to respond to germy invaders quickly and efficiently, and in order to function well, the cells of our immune system need plenty of vitamins, minerals, amino acids, and essential fatty acids.

A healthy gut is essential to immunity, and prebiotics and probiotics in food and supplements help prevent illness.

The best whole food sources of prebiotics are vegetables like asparagus, garlic, Jerusalem artichokes, leeks, and onions, Andrews says. Carbs like barley, beans, oats, quinoa, rye, wheat, potatoes, and yams; fruit such as apples, bananas, berries, citrus, kiwi; and fats such as flax seeds and chia seeds.

Probiotics the bacteria themselves have been shown to help us recover faster, once we get sick. The best whole-food sources of probiotics are dairy such as yogurt, cheese, and kefir with live and active cultures; fermented vegetables like pickles, sauerkraut, kimchi; fermented soy such as miso and tempeh, and soy sauce and wine.

For supplementation of prebiotics, Andrews recommends 2-4 grams of prebiotics per day to help feed healthy gut bacteria and keep things balanced. You may actually feel worse before you feel better, he says, since bacteria release toxins.

Things to do to avoid getting sick according to Andrews include avoiding over- or under-exercising, avoiding over- or under-eating, maintaining a healthy body weight, washing your hands, getting enough sleep consistently, managing stress, eating plenty of nutrient-dense foods, and feeding your healthy bacteria.

Foods that can hasten recovery when you have a virus or infections are:

Garlic Acts as an antibiotic and lessens the severity of colds and other infections.Chicken soup Commonly touted as a food for colds, chicken soup (made from scratch, not a can) provides fluids and electrolytes, is warm and soothing, and may also contain anti-inflammatory properties that decrease cold symptoms. Green tea Boosts the production of B cell antibodies, helping us rid ourselves of invading pathogens.Honey Has antibacterial and antimicrobial properties and is an effective cough suppressant. In one study it was as effective as a cough-suppressing drug. A few teaspoons in a cup of green tea is all you need.Elderberries These have antiviral properties and are loaded with phytonutrients. A few small studies have found the elderberry extract reduces the duration of colds and other upper respiratory tract infections.

If youre already sick, says Andrews, drink lots of fluids (especially water and green tea), rest as much as possible to recover, focus on immune-boosting foods, supplement with pre- and probiotics, and use immune-boosting supplements.

Coronavirus and chiropractic are a pairing that remain vital, says Esteb, to maintain health and not handicap your immune system. Dont wait until you become ill, he says, as maintenance health care is key.

There is currently no vaccine to prevent coronavirus COVID-19, and the CDC recommends the basics such as avoiding close contact with people who are sick; avoiding touching your eyes, nose, and mouth; staying home when you are sick; covering your cough or sneeze with a tissue, then throwing the tissue in the trash; and cleaning and disinfecting frequently-touched objects and surfaces using a regular household cleaning spray or wipe.

For more recommendations or updates from the CDC go to cdc.gov/coronavirus/2019-ncov.

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Coronavirus and chiropractic: nutrition for avoiding, recovering - Chiropractic Economics

News Release

Monday, March 9, 2020

New strategy could be applied to other infectious diseases.

A new approach to direct the body to make a specific antibody against HIV led to sustained production of that antibody for more than a year among participants in a National Institutes of Health clinical trial. This drug-delivery technology uses a harmless virus to deliver an antibody gene into human cells, enabling the body to generate the antibody over an extended time. With further development, such a strategy could be applied to prevent and treat a wide variety of infectious diseases, according to the study investigators.

Researchers from NIHs National Institute of Allergy and Infectious Diseases (NIAID) reported the findings on March 9 in an oral presentation at the 2020 Conference on Retroviruses and Opportunistic Infections (CROI).

Antibodies are immune system proteins that help prevent or clear infections. Traditional vaccines induce the immune system to generate protective antibodies. Another approach to preventing infections is to deliver monoclonal antibodies preparations of a specific antibody designed to bind to a single target directly into people. Monoclonal antibodies also are used therapeutically, with many already approved for treating cancer, autoimmune diseases and other conditions and others being evaluated for treatment of infectious diseases, such as Ebola virus disease.

Administering proteins to people requires periodic injections or infusions to retain protective or therapeutic levels, which can be challenging, particularly in resource-limited settings. Delivery of antibody genes using a virus as a carrier, or vector, offers a potential alternative.

Monoclonal antibodies hold enormous promise for preventing and treating both established and emerging infectious diseases, said NIAID Director Anthony S. Fauci, M.D. Novel delivery platforms such as viral vectors could facilitate the future development and deployment of antibody-based prophylaxis and therapy, and these findings are a promising first step in that direction.

The drug-delivery system developed by scientists at NIAIDs Vaccine Research Center (VRC) uses adeno-associated virus serotype 8 (AAV8) to deliver an antibody gene. AAVs small viruses that do not cause disease in humans have proven to be safe, well-tolerated vectors for gene therapy. In a previous study in animal models, VRC researchers found that using AAV8 to deliver genes for antibodies against simian immunodeficiency virus (SIV), the monkey equivalent of HIV, led monkeys to safely produce high levels of anti-SIV antibodies and protected them from acquiring SIV.

Building on this preclinical work, researchers designed a Phase 1 clinical trial known as VRC 603. It aims to assess the safety and tolerability of an AAV8 vector carrying an anti-HIV antibody gene in adults living with well-controlled HIV, and to evaluate whether it could cause human cells to produce the antibody. The vector carries the gene for an anti-HIV monoclonal antibody called VRC07, which was originally isolated from the blood of a person with HIV.

VRC07 is a broadly neutralizing antibody (bNAb), meaning it can stop a wide range of HIV strains from infecting human cells in the laboratory. Other clinical studies are underway to determine whether bNAb infusionscan protecthumansfrom acquiring HIV. Scientists also are evaluating whether combinations of HIV bNAbs can suppress the virus in people living with HIV.

The CROI presentation by Joseph P. Casazza, M.D., Ph.D., principal investigator of VRC 603, described initial results from the first eight participants in the ongoing trial, which is being conducted at the NIH Clinical Center in Bethesda, Maryland. Each of these individuals, aged 30 to 60 years, received a single dose by intramuscular injection of one of three different dose levels of AAV8-VRC07. They continued taking daily antiretroviral therapy.

Following injection with AAV8-VRC07, all eight participants produced VRC07 at levels detectable in the blood. VRC07 production reached an early peak four to six weeks after injection, then decreased, and slowly began to increase again roughly 16 weeks after the injection. The researchers have monitored the five participants who received low or intermediate AAV8-VRC07 doses for one and a half to two years. For three of these five individuals, antibody levels one year after injection were higher than those observed at four to six weeks. The three volunteers who received the highest AAV8-VRC07 dose have so far been monitored for five months to one year. Two produced VRC07 at concentrations higher than those seen in the low and intermediate dose groups.

Study participants have not experienced any major side effects due to AAV8-VRC07. Some volunteers experienced transient mild tenderness at the injection site or mild muscle pain.

To the best of our knowledge, this marks the first time that an AAV-based technology to deliver an antibody gene has resulted in safe and sustained levels of that antibody in blood, said NIAID VRC Director John Mascola, M.D. We hope that further development of this technology will yield a drug-delivery strategy applicable to a broad range of infectious diseases.

Administration of monoclonal antibody-based therapies sometimes results in a persons immune system developing antibodies against the therapy. Only three of the eight VRC 603 participants developed antibodies against VRC07; it is not yet clear whether these anti-drug antibodies could reduce VRC07s ability to neutralize HIV. The VRC 603 participants HIV was kept under control with continued antiretroviral therapy during the trial.

The concentrations of VRC07 observed in the study participants were lower than the antibody concentrations observed in animal studies of the AAV8-based technology. The VRC researchers are analyzing data from VRC 603 to better understand the factors that determine how much bNAb is produced by human cells. They also are continuing to monitor the VRC 603 participants and to enroll new volunteers into the trial.

AAV8-VRC07 was developed by VRC scientists in collaboration with David Baltimore, Ph.D., of the California Institute of Technology and Alejandro Balazs, Ph.D., of the Ragon Institute of MGH, MIT and Harvard. AAV8-VRC07 was manufactured by the Clinical Vector Core of the Center for Cellular and Molecular Therapeutics at the Childrens Hospital of Philadelphia. More information about the VRC 603 trial is available on ClinicalTrials.gov using identifier NCT03374202.

NIAID conducts and supports research at NIH, throughout the United States, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

JP Casazzaet al. Durable HIV-1 antibody production in humans after AAV8-mediated gene transfer. Oral presentation at the 2020 Conference on Retroviruses and Opportunistic Infections (CROI). Presented March 9, 2020.

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Drug-delivery technology leads to sustained HIV antibody production in NIH study - National Institutes of Health

A SpaceX Dragon cargo spacecraft, currently on its way to the International Space Station (ISS) as part of the CRS-20 mission, is carrying a variety of scientific research projects as well as usual food and other supplies for the astronauts. The hardware going to the ISS this weekend includes a number of research projects in biotechnology that could improve the lives of patients here on Earth.

The payloads launching on SpaceX CRS-20 demonstrate that the ISS is not only an amazing multi-purpose, multi-user research facility in low Earth orbit but also a proof-of-concept incubator where industries can advance their applied research and technology development programs, ISS National Lab Chief Operating Officer Ken Shields said in a statement.

Moreover, the diversity of investigations supported by the private sector, government agencies, and academic institutions demonstrates the continued rising demand and interest in utilizing our orbiting laboratory to benefit life on Earth and build a thriving market economy in space.

One experiment by the startup Dover Lifesciences is an attempt to develop protein-based drugs to treat metabolic disorders and obesity. Proteins in the human body play a central role in health and disease and they can also be used as biological agents to treat disease, the ISS National Lab explained in a blog post.

By using protein crystallization to understand the structure of proteins alone and in complex with other molecules, scientists can better design therapeutics to prevent and treat disease. In microgravity, protein crystals can grow larger and with fewer imperfections than on Earth, revealing more detailed protein structures.

The research is looking for drugs that could inhibit the conversion of glucose to glycogen in the liver and muscles. If this were possible, it could be used as a treatment for obesity and some rare genetic disorders, and could even have applications in the treatment of cancer.

Other research includes the development of a small drug pump, shaped like a patch, which can deliver medicine in a controlled and continuous way. For people who have conditions that require regular injections, such as diabetes, this patch could offer an easier and safer way to get the medicine they need regularly.

Finally, the company 1Drop Diagnostics is aiming to develop a portable diagnostic device that can make diagnoses based on very small amounts of blood, which would be invaluable to patients and doctors in remote locations who have limited access to lab equipment.

The Dragon cargo spacecraft is set to arrive at the International Space Station at 4 a.m. PT on Monday, March 9.

Go here to read the rest:
SpaceX is carrying these biotechnology experiments to the ISS this weekend - Digital Trends

This story originally appeared onStockhead.

As with the early medical cannabis plays, a cluster of ASX-listed stocks has wasted little time attaching itself to the c word. Were talking of course about the coronavirus COVID-19 but sadly not another c word: cure.

Or not yet.

According to broker Morgans daily tally, the virulent bug has so far infected 95,332 people, with 38,564 current cases (6,883 of them critical).

Of the remaining 56,768 cases with an outcome, 53,483 recovered and 6,883 achieved a definitive performance indicator. They died.

Okay, a circa 7 per cent mortality rate or even a 1 or 2 per cent rate is nothing to sneeze at, so to speak. But we do wish breathless TV reporters would cease referring to it as the deadly virus, but that would be like asking them to stop referring to a horror smash rather than a sad everyday road accident.

While were on it, we also implore folk to stop hoarding toilet paper: after all, its the coronavirus, not the Caroma-virus.

Named after its crown-like shape but not the Royal Family per se, the common coronavirus is responsible for past pestilences including Severe Acute Respiratory Syndrome (SARS) and Middle Eastern Respiratory Syndrome (MERS).

The virus may indeed fizzle out, as the earlier SARS plague did.

But for the time being, we need the best and brightest minds in the labs to come up with a treatment or more likely a vaccine.

There are some promising developments overseas, which your columnist will return to if he hasnt succumbed as well (he did shake hands with someone who went to a Chinese restaurant a couple of weeks back).

Among the local biotechs and we use the term loosely theres been no lack of endeavour in linking their efforts to the virus.

But to be fair, in some cases investors did it for them.

Take Biotron (ASX:BIT), which was an obvious subject of attention given the company is focused on developing antiviral drugs for HIV and hepatitis.

Biotron also has a program for pan respiratory viruses and mentioned corona in a June 2019 presentation. Some punters latched on to the fact that it wasnt referring to a 1970s Toyota or Mexican beer and the Hot Copper pundits were off and running.

Biotron CEO Dr Michelle Miller has been more circumspect.

Yes, she says, the company has some good advanced compounds to work on, but the reality is that theres nothing that would be ready to fight the current outbreak.

Dr Miller says while the companys work on pan respiratory viruses continues, theres not much to add at this stage.

Uscom (ASX:UCM) shares went on a run after the company reported increased orders for its haemodynamic monitoring devices in China.

Uscom stands for Ultra-Sonic Cardiac Output Monitors.

The Uscom 1A device is a non-invasive diagnostic that monitors cardiovascular functions, using Doppler ultrasound to detect abnormalities.

Chinese health authorities have recommended Uscom 1A as a monitoring device for severe coronavirus cases, while international guidelines also suggest using the device for paediatric sepsis.

Uscom reported that in the first five weeks of 2019, Chinese sales orders rose 124 per cent, from 17 units to 38 units.

Uscom chief Professor Rob Phillips says the company is well positioned with the virus, but notes that Uscom is not a coronavirus story as such: fatalities from cardiovascular pulmonary failure result from conditions such as pneumonia.

Happily for Uscom, the outbreak comes as the company hones-in on the Chinese market with a new direct sales model.

The molecular diagnostics house has a suite of approved tests that cover gastro-enteric strains, flavivirus/alphavirus, sexually-transmitted diseases and drum roll respiratory pathogens.

Genetic Signatures (ASX:GSS) Easyscreen tests cover pan coronaviruses, which until now has not been able to distinguish COVID-19 from, say, SARS.

But thats all changed, with the company introducing a supplementary test that does just that. Management is fast-tracking a validation program to obtain the data required for international regulatory approvals as rapidly as possible.

However, Genetic Signatures cant be accused of beating up its prospects: management says while the bug presents significant opportunities, the outcome of the emerging pandemic is uncertain.

While the early-stage coronavirus is detected by a blood test, chest x-rays are then used to gauge the severity of the illness and assess fluid in the lungs.

Micro-X (ASX:MX1) is all about developing lightweight and portable x-ray machines for medical applications, as well as other purposes such as defence and airports.

The companys first product, Carestream DRX Revolution Nano is approved in the US and Europe.

In mid-February the company said it had procured orders for $780,000 of machines from governments of two Asian countries, in response to the coronavirus threat. This week, another $1m of orders, all marked for urgent delivery, flooded in.

While these are terrible circumstances with the coronavirus spreading so quickly, we are pleased that our equipment will soon be able to assist medical teams with their responses in affected countries, Micro-X CEO Peter Rowland says.

Why waste a crisis? No fewer than four ASX stocks are capitalising on demand for hand and surface sanitisers to halt the bug in the first place.

Antimicrobial solutions house Zoono Group (ASX:ZNO) proclaims that its impressively-monikered Z-71 Microbe Shield, as used in its hand sanitisers, kills COVID-19 99.99 percent of the time.

Zoono is selling into China via a tie up with Eagle Health (ASX:EHH), which manufactures and distributes product into 26 provinces.

Aeris Environmental (ASX:AEI) goes one step better, claiming its Aeris Active product kills influenza and noroviruses in 99.999 percent of cases.

For those remaining 0.001 percent, bad luck and dont buy a lottery ticket.

Interestingly, that announcement did not refer specifically to the coronavirus. But earlier, Aeris announced the Singapore National Environment Agency had listed Aeris Active as one of the general disinfectants effective against the virus.

Meanwhile, fruit juice maker Food Revolution Group (ASX:FOD) has turned from filling its bottles with squeezed oranges to stuffing them with alcohol-based hand sanitiser under the Sanicare brand.

Who would have thought? The swift repositioning results from a 1,260sqm upgrade at the companys plant at Mill Park in outer Melbourne, which enables all sorts of gels, powders, oils and cosmetics to be bottled.

Mainstream sanitiser products such as Dettol and Lysol (made by multinational Reckitt and Benckiser) are flying off the shelves.

But is a good scrub with soap and water just as effective? Australian National University microbiologist Professor Peter Collignon opines theres little difference between hand washing and the alcohol-based sanitisers.

One is just more convenient than the other and contains alcohol, he says. You can put it in your pocket and dont have to be near a sink or basin to use it.

So whos actually tackling the disease? Offshore, theres a conga line of developers having a crack at a vaccine.

In Israel, scientists at the Galilee Research Institute claim to be on the cusp of finalising a product that is capable of getting regulatory assent within 90 days.

Thats what you call fast-track approval.

According to the Jerusalem Post, the same team of scientists has been developing a prophylactic against infectious bronchitis virus, which affects poultry.

The effectiveness of the vaccine has been proven in pre-clinical trials carried out at the countrys Veterinary Institute.

In the US, Gilead Sciences plans to recruit 1,000 patients with coronavirus for a clinical trial to test its experimental anti-viral drug remdesivir (as used to tackle Ebola virus).

With the backing of the World Health Organisation, the drug is also being trialed in China.

Maryland-based, Nasdaq-listed Novavax says it is cloning the coronavirus to develop a vaccine, in the same way it developed one for MERS in 2013.

Novavax is looking at several vaccine candidates for animals and hopes to find one for human testing by the end of May.

Our previous experience working with other coronaviruses, including both MERS and SARS, allowed us to mobilise quickly, Novavax CEO Stanley Eck said.

Fellow Nasdaq minnow Moderna has shipped an experimental vaccine to the National Institute of Allergy and Infectious Diseases for testing.

Backed by billionaire hedge fund founder Jim Simons, Long Island-based private outfit Codagenix expects to have a vaccine ready for animal testing in four to six weeks, with one suitable for testing about six weeks later.

The Codagenix know-how is based on recoding the genomes of viruses to render them harmless. The technique is not exactly unknown, as its been used to eradicate polio and small pox.

And who can forget Australias very own Relenza anti-influenza Biota, which became Alpharetta Georgias Nabi, changed its name to Aviragen and then was subsumed as a sub-division of San Franciscos Vaxart, popping its head above the parapet to also claim an anti-viral program for COVID-19.

The South China Morning Post reports that a 65-year-old woman on her COVID-19 deathbed walked out of Chinas Kunming Hospital after being given a stiff shot of mesenchymal stem cells (MSCs).

Two trials are also underway to test the therapy against pneumonia, at a Beijing Military Hospital and Zhongnan Hospital of Wuhan University (yep, in the coronavirus capital).

Could the excitement rub-off on our ASX-listed plays Mesoblast (ASX:MSB), Cynata Therapeutics (ASX:CYP), Orthocell (ASX:OCC) and Regeneus (ASX:RGS)?

Cynatas Dr Ross Macdonald says the reports look authentic; and he believes that MSCs could be an effective adjunct in managing patients with serious issues pertaining to COVID-19.

This is not because MSCs are inherently anti-viral or can act as a vaccine, but more because they have shown benefit in major pathologies associated with infection, he says.

Cynata, we stress, has not mentioned coronavirus in its dispatches and nor has any of the other non-China MSC plays or not yet anyway.

But still, what decent CEO would not give his company a plug?

The clear advantage of (Cynatas) Cymerus technology (is) the ability to make large quantities of consistent, robust MSCs without having to find gazillions of donors, Dr Macdonald says.

Your columnist stresses that the coronavirus influence on the sector is not all positive, with some biotechs likely to be affected by supply or other disruptions.

In mid-February, Cochlear (ASX:COH) quickly stepped off the mark by announcing its earnings for the 2019-20 year were likely to come in at $270-290m, compared with the previously guided $290-300m.

The reason is that hospitals in China and Hong Kong have delayed cochlear implant procedures to avoid the risk of infection.

The aforementioned Uscom notes that with labs preoccupied with the virus, short-term revenues are less predictable. In other words, the coronavirus is a distraction as well as an opportunity.

IDT Australias (ASX:IDT) Dr David Sparling told Biotech Daily that his company had no direct supply chain exposure to China at all, and was doubtful that even the companys gowns and protective gear had much to do with the Middle Kingdom.

Editors note: Dr. Tim Boreham, who wrote this article for Stockhead, is one of Australias best-known small cap analysts and business journalists.

If you throw enough money and resources at tackling a disease you will get a result, right?

Er, not quite: cures for well-researched ailments such as Alzheimers disease, multiple sclerosis and an array of cancers remain elusive.

But when youve got an ailment that is crippling the global economy, the imperative to find a solution is somewhat more intensive.

Our best guess is that like SARS and MERS, COVID-19 will hang around for years to come, but the ill-effects will be made more tolerable with an effective vaccine and/or improved immunity over time.

In other words, it will become just another disease in the pantheon of maladies blighting humanity.

In the race for a cure, Gileads Remdesivir looks interesting, given it has been used before.

As for the opportunists in the sanitiser game, the surge in demand means tangible revenue gains and good on them.

But lets be clear: theyre hardly breaking new ground technology-wise and their gains will only be short term as other suppliers enter the market.

As for a cure, or lack of one, we suggest that investors hedge their bets with an exposure to the funeral stocks Invocare (ASX:IVC) and Propel Funeral Partners (ASX:PFP).

After all, theyre the last people to let you down.

Stockheadcovers emerging ASX companies and investment opportunities. Get daily stock updates atStockhead.

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The Aussie Biotech Companies Trying To Make A Buck From Coronavirus - D'Marge

New Jersey, United States,-The Nanoparticles in Biotechnology and Pharmaceuticals Market report was created with experience and knowledge by market analysts and researchers. It is a phenomenal compilation of important studies that examine the competitive landscape, segmentation, geographic expansion and sales growth, production and consumption of the Nanoparticles in Biotechnology and Pharmaceuticals market. Players can use the reports accurate market data and numbers, as well as statistical studies, to understand the current and future growth of the Nanoparticles in Biotechnology and Pharmaceuticals market. The report includes CAGR, market share, sales, gross margin, value, volume and other key market numbers that provide a clear picture of the growth of the Nanoparticles in Biotechnology and Pharmaceuticals market.

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Table of Content

1 Introduction of Nanoparticles in Biotechnology and Pharmaceuticals Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology of Verified Market Research

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Nanoparticles in Biotechnology and Pharmaceuticals Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Nanoparticles in Biotechnology and Pharmaceuticals Market, By Deployment Model

5.1 Overview

6 Nanoparticles in Biotechnology and Pharmaceuticals Market, By Solution

6.1 Overview

7 Nanoparticles in Biotechnology and Pharmaceuticals Market, By Vertical

7.1 Overview

8 Nanoparticles in Biotechnology and Pharmaceuticals Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Nanoparticles in Biotechnology and Pharmaceuticals Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

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Nanoparticles in Biotechnology and Pharmaceuticals Market 2020 Size, Shares, Key Players, Demand, Supply, Growth and Forecast to 2026 - 3rd Watch News

Macy Vollbrecht, a senior majoring in genetics, cell biology and development in the College of Biological Sciences at the University of Minnesota Twin Cities, has been named a Churchill Scholar by the Winston Churchill Foundation of the United States.

The scholarship, worth approximately 60,000 USD, will allow Vollbrecht to spend the 2020-21 academic year at Churchill College of the University of Cambridge. There, she plans to complete a masters of philosophy in plant sciences with an emphasis on plant development. Her research, conducted with Sainsbury Laboratory Director Prof. Ottoline Leyser, will focus on plant plasticity. Particularly, how alterations in cytokinin homeostasis and cytokinin-mediated regulation of hormones affect shoot branching in plants.

The daughter of Erik Vollbrecht and Susan Barry of Ames, Iowa, Vollbrecht began research in genetics with Prof. Maura McGrail at Iowa State University in a National Sciences Foundation program for young scientists and engineers in 2015. She was invited to continue that research the following summer, before she enrolled at the University of Minnesota Twin Cities.

At the U of M, she began working in Prof. Daniel Voytas lab in her freshman year. The Voytas Lab has been developing an innovative method to accelerate gene editing in plants using an expression of developmental regulator genes. At the Voytas Lab, Vollbrecht had the opportunity to design and carry out experiments that have been published in Nature Biotechnology.

In addition to her work at the U of M, Vollbrecht:

Volbrecht has been recognized by her department, the College of Biological Sciences and the larger-University with scholarships awarded to top students. These include: the Franklin Enfield Memorial Scholarship; Monica Tsang and James Weatherbee Scholarship; and the Genetics, Cell Biology and Development Scholarship. In addition, she was one of 52 students nationally to be awarded an Astronaut Scholarship in 2019.

The Churchill Scholarship is awarded to fifteen seniors majoring in the sciences, engineering and mathematics at colleges and universities across the United States, making it one of the most selective and prestigious postgraduate scholarships. Vollbrecht is the fifth U of M student in six years to be awarded a Churchill scholarship, following Max Shinn, math and neuroscience; Sammy Shaker, chemistry; Anthony Tabet, chemical engineering; and Merrick Pierson Smela, chemistry and biochemistry.

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The Winston Churchill Foundation of the United States was founded in 1959 to offer U.S. students of exceptional ability and achievement in the sciences, engineering and mathematics the opportunity to pursue graduate studies at the University of Cambridge. Nine graduates of the University of Minnesota have previously been named Churchill Scholars. Students at the University of Minnesota who are interested in the Churchill Scholarship or other major competitive awards to fund graduate or undergraduate study, in the United States or abroad, should contact Timothy Jones in the Office of National and International Scholarships at natschol@umn.edu.

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University of Minnesota Twin Cities senior awarded a Churchill Scholarship to study at the University of Cambridge - UMN News

As someone immersed in the biotechnology sector, Ive seen my share of startup stumbles. Giddy teams of brilliant scientists promising the next generation ofthisor sustainablethatoften fail to deliver, not because their core ideas are faulty but because they so often fail to get their arms around the true complexity of manufacturing.

Having a great idea for how biotechnology might improve lives is one thing think compostable plastics or alternative meats. But bringing those bold visions into reality is quite another.

Thats whereCulture Biosciencescomes in. Based in South San Francisco, the company has been stocking up on the type of expensive laboratory equipment bioreactors that most other biotechnology firms pour millions of dollars into. Culture then rents its physical lab equipment out to paying customers via an online portal. Think AWS, but for biology.

In this way, Culture is aiming to permanently reduce the complexity of biomanufacturing, allowing its customers to skip expensive investments in equipment and bring their goods to market sooner.

Culture today announced that it plans to triple its bioreactor capacity thanks to a new $15 million Series A, led byCultivian Sandbox Ventureswith participation fromThe Production Boardand existing investors. For full disclosure, Im also an investor in this company through my role as an Operating Partner atDCVC.

Bioreactors are used to grow cells, which in turn can grow almost anything. Recent breakthroughs in synthetic biology now mean that scientists can program living cells more precisely than ever. Synthetic biology and biofabrication hold the answers to so many of the challenges we face today, says Will Patrick, Cultures co-founder and CEO.

We spent time talking to scientists working in industrial biotechnology, learning about their work in detail. There were so many companies working on potentially game-changing products, ranging from alternative food proteins to bio-based chemicals to life-saving medicines. Yet, they all faced formidable challenges in taking their lab-scale discoveries and turning them into commercially viable products at scale. We heard time and time again that the process of scaling-up from the bench to production was time-consuming, risky, and expensive. There were also so many stories about potentially promising products failing to be scaled-up to production successfully.

Culture already services some notable customers, includingZymergen, which is breeding microbes that produce value-added molecules for a number of industries, andClara Foods, which is working to fast-track new sources of animal-free protein. Other new customers includeNektar Therapeutics,C16 Biosciences, andBoost Biomes.

Its a business model built on trust. As Culture expands, its stockpile of bioreactors which could soon exceed 300 must keep up with customers demands. By offering a reliable cloud service that can quickly be scaled up or down according to need, Culture hopes to save its customers lots of money in the long run.

Our mission is to build an end-to-end platform where bioprocess scientists can manage their entire workflow in our software application, said Patrick. In our conversations with scientists, we identified the bench-scale bioreactor lab as a key bottleneck in the scale-up process. Running bench-scale bioreactors to screen strains and develop bioprocesses is critical for developing new products, but it is also time-consuming, labor-intensive, and expensive.

At the moment, Patrick tells me that his customer base is roughly 60 percent biopharma and 40 percent industrial biotechnology. But I think it will flip. Im really big on the industrial biology sector. These spaces are massive, and the opportunity is so huge.

Platforms that broadly enable scientists, engineers, and innovators to do more for less could add fuel to the already hot synthetic biology sector. I recently wrote about howinnovations in bio-nylon could soon unlock a $10 billion sector, how investments into synthetic biology made here on Earth couldaid in 21st-century efforts to explore and inhabit space, and how synthetic biology companies arenow racing to stop coronavirus.

Disruptors like Culture Biosciences renew my hope that this biological revolution is here to stay.

Follow me on twitter at@johncumbersand@synbiobeta. Subscribe to my weekly newsletters insynthetic biologyandspace settlement.

Thank you toIan Haydonfor additional research and reporting in this article. Im the founder ofSynBioBeta, and some of the companies that I write aboutincludingCulture Biosciencesare sponsors of theSynBioBeta conferenceandweekly digestheres the full list of SynBioBeta sponsors. Im an operating partner atDCVC, which is an investor in Culture Bioscience.

Originally published on Forbes https://www.forbes.com/sites/johncumbers/2020/03/04/with-15m-series-a-culture-biosciences-is-growing-cells-in-the-cloud/

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With $15M Series A, Culture Biosciences Is Growing Cells In The Cloud - SynBioBeta

NEW YORK, March 09, 2020 (GLOBE NEWSWIRE) -- Daxor Corporation(NYSE MKT: DXR), an investment company with innovative medical instrumentation and biotechnology operations focused on blood volume measurement, today announced that the U.S. Air Force (USAF) has awarded Daxor a contract to define specifications to adapt blood volume analysis technology to meet the needs of USAF.

The selection was made under the USAFs Small Business Innovative Research (SBIR) program. The contract award will be to validate the product-market fit between Daxors blood volume analyzer and USAF stakeholders and define technological enhancements desirable to facilitate adoption of the device by USAF and other defense stakeholders.

Daxor looks forward to adapting its technology to provide time sensitive, mission critical care information and decision support to the specially trained personnel within the Air Force, said Michael Feldschuh, CEO of Daxor Corporation.

"This opportunity enables us to continue to push our research and development program forward, opening new applications for our technology says Jonathan Feldschuh, Chief Scientific Officer. We are focused on making blood volume measurement simpler and quicker to perform, whether in an aircraft, a field hospital, or at the patient bedside.

This is the second award for Daxor with the Department of Defense (DoD). SBIR contracts are designed to stimulate innovation by companies to develop technologies and solutions that meet critical Army needs. SBIR programs benefit the DoD and the private sector and support the nations economic growth.

About Daxor Corporation

Daxor Corporation (NYSE: DXR) is an innovative medical instrumentation and biotechnology company focused on blood volume measurement. We developed and market the BVA-100 (Blood Volume Analyzer), the first diagnostic blood test cleared by the FDA to provide safe, accurate, objective quantification of blood volume status and composition compared to patient-specific norms. The BVA technology has the potential to improve hospital performance metrics in a broad range of surgical and medical conditions including heart failure and critical care by better informing treatment strategies, resulting in significantly better patient outcomes. Our mission is to partner with clinicians to incorporate BVA technology into standard clinical practice and improve the quality of life for patients. For more information please visit our website at https://www.daxor.com

Forward-Looking Statements

Certain statements in this release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the impact of hiring sales staff and expansion of our distribution channels. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risk associated with our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, FDA regulatory actions, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and additional other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Daxor does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations Contact

Bret ShapiroSr. Managing Partner, CORE IR516-222 -2560brets@coreir.com

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Daxor Corporation Contracted to Adapt Its Blood Volume Analyzer Technology for US Air Force Needs - BioSpace

ANKARA

Turkey's progress in the health sector is strategically critical beyond its economic significance, the Turkish president said on Saturday.

Congratulating the award recipients of the international biotechnology congress BIO Turkey in Istanbul, Recep Tayyip Erdogan in a letter stressed the importance of the pharmaceutical industry for Turkey

Erdogan underlined that the sector was the most important after the defense industry, emphasizing that during difficult times Turkey could only rely on its own production and infrastructure to survive.

"However, we have unfortunately faced veiled resistance in our steps to develop our domestic and national pharmaceutical industry and strengthen our medical device sector, just as we once had in the defense industry," he said.

Attending the ceremony, Vice President Fuat Oktay said that Turkey would act against "approaches" that sought to compel domestic ventures to move abroad even as the government attempted to bring research and development, design and production facilities into the country.

Inviting scientists, non-governmental organizations and universities to support Turkey's biotechnology initiatives, Oktay said investments in the defense, health and food industries would "not only save us from dependency but also turn Turkey into a global exporter."

Health Minister Fahrettin Koca also spoke at the ceremony, underscoring the role of partnerships between academia, industry and individual projects in training a qualified labor force.

After his speech, Koca presented a plaque of appreciation to the representatives of the congress's sponsors.

*Writing by Davut Demircan

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Turkey eager to invest in biotech - Anadolu Agency

New York, March 09, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Precision Medicine Software Market 2020-2024" - https://www.reportlinker.com/p05873485/?utm_source=GNW Our reports on global precision medicine software market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors. The report offers an up-to-date analysis regarding the current global market scenario, latest trends and drivers, and the overall market environment. The market is driven by benefits of precision medicine.In addition, digitization of healthcare is anticipated to boost the growth of the global precision medicine software market as well.

Market Segmentation The global precision medicine software market is segmented as below: Delivery Mode: On-premise

Cloud-based

Geographic Segmentation: Asia

Europe

North America

ROW

Key Trends for global precision medicine software market growth This study identifies digitization of healthcare as the prime reasons driving the global precision medicine software market growth during the next few years.

Prominent vendors in global precision medicine software market We provide a detailed analysis of around 25 vendors operating in the global precision medicine software market , including some of the vendors such as F. Hoffmann-La Roche Ltd., Fabric Genomics Inc., Gene42 Inc., Human Longevity Inc., International Business Machines Corp., Koninklijke Philips NV, NantHealth Inc., Roper Technologies Inc., SOPHiA GENETICS SA and Syapse Inc. . The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to an analysis of the key vendors.Read the full report: https://www.reportlinker.com/p05873485/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The Global Precision Medicine Software Market is expected to grow by USD 882.65 mn during 2020-2024, progressing at a CAGR of 11% during the forecast...

New York, March 09, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cloud Computing in Cell Biology, Genomics and Drug Development" - https://www.reportlinker.com/p05873501/?utm_source=GNW The report analyzes trends and dynamics including drivers, limitations, challenges and opportunities.

The report discusses strategies adopted by emerging market players with recommendations for new market entrants.This research study discusses historical, current and potential market size.

The report will help market players and new entrants to make informed decisions about the production and export of goods and services, as well as providing organizations, distributors and exporters information about market development and trends.The study segments the market on the basis of applications and end uses.

A geographical market analysis is provided for all major segments.

Report Includes: - 43 data tables and 18 additional tables - An overview of the global market for cloud computing applications in cell biology, genomics and drug development - Analyses of global and regional market trends, with data from 2018 to 2019, and projections of compound annual growth rates (CAGRs) through 2024 - Assessment of market trends and opportunities, key developments and the impact of cloud computing technology on the biotechnology, pharmaceutical and healthcare industry verticals - Insight into recent developments in cloud infrastructure and information pertaining to key partnerships between cloud service providers and pharma/biotech companies and investment in pharmaceutical R&D sector - Discussion of the suppliers' landscape, as well as the market positioning and strategies of key manufacturers and suppliers for cloud computing applications - Review of patent applications filed regarding cloud computing technology in the U.S. healthcare sector - Company profiles of the leading market players, including Amazon Web Services (AWS) Inc., Cisco Systems Inc., DXC Technology, Google LLC, Salesforce.com Inc., and SAP SE

Summary The global market for cloud computing in cell biology, genomics and drug development is estimated to grow at a CAGR of REDACTED during the forecast period.The market was valued at REDACTED in 2018 and is expected to reach REDACTED in 2024.

In biomedical research, cloud computing has resolved big data concerns and improves data, analytics, collaboration and sharing. Increasing biomedical research based on human, animal, plants, and microbes has increased the dependency on proper storage and network infrastructure as well as secure and scalable computing.

With growing big data concerns, researchers are inclined towards cloud computing platforms.These platforms provide flexibility to users to pay according to their usage of cloud services including software, hardware infrastructure and platforms to solve biomedical computation concerns.

The cloud offers ondemand storage and an analysis facility to users which makes it an emerging computing platform to address big data concerns.Owing to the flexibility and cost-effectiveness, cloud services are gaining significant importance in life science research for data storage, communication and collaboration with stakeholders.

On cloud platforms, large datasets and applications for gene sequencing, image analysis, protein folding and data mining can be shared for collaborative research between facilities.

The major pivotal factors contributing to the growth of the market include rising genomics and proteomics research and the increasing number of clinical trials performed across various countries.Considerable public and private investment in genomics and proteomics research is providing support to biotechnology start-ups and research institutes.

This helps healthcare providers to develop and commercialize genomics technologies and personalized medicines. Increasing U.S. FDA approvals for personalized medicines are supporting the growth in genomics research. For example, according to the Personalized Medicine Coalition, in 2018, approximately REDACTED of the REDACTED new molecular entities (NMEs) approved by the FDA are personalized medicines which constitute REDACTED of all new drug approvals. The Coalition classified REDACTED of NMEs as personalized medicines in 2017, REDACTED in 2015 and REDACTED in 2016. The U.S. FDA is making efforts to facilitate access to genomic testing and integration of real-world evidence into its regulatory framework. As a result, the FDA has begun to authorize the marketing of cancer-related genetic tests, and pharmacogenetics were allowed to be sold directly to the consumers. This has resulted in the development of personalized medicine as an emerging practice of medicine that utilizes the genetic profile of an individual to make appropriate decisions regarding prevention, diagnosis and treatment of the condition. Gaining complete knowledge about the patient's genetic profile helps doctors to choose proper therapy or medication and to administer it with the proper regimen or dose. Significant data is generated by sequencing a single human genome which necessitates the adoption of cloud services. The 1000 Genomes Project is an effort to sequence genomes of at least a thousand people from across the globe to develop the most comprehensive and medically relevant picture of human genetic variation. This initiative intends to make genomic data easily accessible from international research institutions. Major support for the project is offered by the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH), Wellcome Trust Sanger Institute in Hinxton, England and the Beijing Genomics Institute, Shenzhen (BGI Shenzhen) in China.Read the full report: https://www.reportlinker.com/p05873501/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Cloud Computing in Cell Biology, Genomics and Drug Development - Benzinga

OAKLAND, Calif.and SAN DIEGO, March 9, 2020 /PRNewswire/ --Blue Shield of California has become the first health plan in the United States to cover rapid and ultra-rapid Whole Genome Sequencing to help critically ill babies and children in intensive care with unexplained medical conditions receive precision care.

Rady Children's Institute for Genomic Medicine researchers have pioneered the fastest use of this advanced diagnostic technology to rapidly identify and decode the root causes of rare genetic disorders for some of the sickest infants and children hospitalized in intensive care across the country.

The Rady Children's Institute team offers the quickest turnaround of genomic test results available nationwide, delivering a preliminary diagnosis in less than three days for medically urgent cases. The blood samples can be taken at any hospital and sent to Rady Children's Institute for sequencing and analysis.

"Our system is optimized to identify or rule out most genetic diseases in a single test, and provide the medical team at the bedside with child-specific, disease-specific information so they can make better, faster medical decisions," said Stephen Kingsmore, M.D., DSc, president and CEO of the Institute.

Whole genome sequencing scans a child's entire genetic makeup for thousands of anomalies from a blood sample. Rady Children's specialists also provide consultation to the medical team caring for the patient to offer targeted guidance that can enable timely and precise personalized care.

"We know that uncertainty and long testing wait times can create tremendous risks for children in intensive care, and anxiety for their families, all the while creating more challenges for physicians and specialists," said Terry Gilliland, M.D., executive vice president of Healthcare Quality and Affordability at Blue Shield of California. "By providing our members with access to Rady Children's Institute for Genomic Medicine's pioneering work in rapid whole genome sequencing, we're supporting them in what is often the most difficult time in their lives."

Blue Shield members with Individual and Family Plans or employer-sponsored health plans who have a critically ill child, up to age 18, hospitalized in neonatal or pediatric intensive care at any location with an undiagnosed condition may be eligible.

This is the latest example of Blue Shield's leadership in making the newest evidence-based medical technologies and services available to its members.

The nonprofit health plan also was the first insurer to cover confirmatory testing for members who received a positive Ashkenazi Jewish BRCA finding from consumer genetic-testing companies such as 23andMe, as well as prostate gene expression assays for patients with low risk prostate cancer, helping them to avoid unnecessary radiation treatment and surgical intervention.

Without medical insurance coverage, access to rapid Whole Genome Sequencing is often not readily available for many hospitalized children who could potentially benefit from this service. Families in need of this care have often had to rely upon funding provided by private philanthropy and research grants to gain access to rapid Whole Genome Sequencing and associated precision care.

"Genetic disease is a leading cause of infant death in the U.S. and Blue Shield is paving the way in providing coverage for this rapid, molecular diagnosis that can result in life-saving treatments," Dr. Kingsmore said.

Located on the campus of Rady Children's Hospital-San Diego, the Institute houses a state-of-the-art genome sequencing lab and employs a multi-disciplinary team of experts who specialize in providing timely and accurate guidance to physicians caring for children with rare genetic disease.

About Blue Shield of CaliforniaBlue Shield of California strives to create a healthcare system worthy of our family and friends that is sustainably affordable. Blue Shield of California is a tax paying, nonprofit, independent member of the Blue Cross Blue Shield Association with over 4 million members, 6,800 employees and more than $20 billion in annual revenue. Founded in 1939 in San Francisco and now headquartered in Oakland, Blue Shield of California and its affiliates providehealth, dental, vision, Medicaid and Medicare healthcare service plans in California. The company has contributed more than $500 million to Blue Shield of California Foundation since 2002 to have an impact on California communities.

For more news about Blue Shield of California, please visitnews.blueshieldca.com. Or follow us on LinkedIn, Twitter, or Facebook.

About Rady Children's Institute for Genomic MedicineThe Institute is leading the way in advancing precision healthcare for infants and children through genomic and systems medicine research. Discoveries at the Institute are enabling rapid diagnosis and targeted treatment of critically ill newborns and pediatric patients at Rady Children's Hospital-San Diego and partner hospitals. The vision is to expand delivery of this life-saving technology to enable the practice of precision pediatric medicine at children's hospitals across California, the nation and the world. RCIGM is a subsidiary of Rady Children's Hospital and Health Center. Learn more at http://www.RadyGenomics.org. Follow us on Twitterand LinkedIn.

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Blue Shield of California Becomes First Health Plan in U.S. to Cover Cost of Rapid Whole Genome Sequencing for Critically Ill Children - P&T Community

BOSTON--(BUSINESS WIRE)--Invicro LLC, a Konica Minolta Company announced it has entered into a strategic research partnership with industry leading pathologist, Dr. David Rimm, MD, PhD, at The Yale University School of Medicine to advance the development of Quanticell, Konica Minoltas proprietary tissue biomarker detection technology.

Invicro is a global provider of imaging biomarkers, core lab services, CAP-CLIA pathology services, advanced analytics and software solutions for drug discovery and development. Dr. Rimm is the Professor of Pathology and Medicine; Director of Pathology Tissue Services; and Director of Translational Pathology at Yale University.

Quanticell is an ultra-sensitive, quantitative, amplification-free technology that detects proteins at the cellular and subcellular level using photostable, highly bright phosphor-integrated dots (PIDs). This nanoparticle-based detection technology circumvents the limitations observed with traditional multiplex chromogenic and fluorescent-based assays, such as signal saturation, non-linearity and high background.

With his unmatched knowledge and experience in anatomical pathology, product commercialization, and late-stage clinical trials, Dr. Rimm is a leading pioneer in the quantitative pathology space, said Dr. Ken Bloom, Chief Medical Officer for Advance Pathology Solutions for Invicro. We could not be happier to have him as a scientific research partner. I am highly confident that his efforts will support the advancement of Quanticell for specific drug development initiatives.

Chromogenic-based Immunohistochemistry (IHC) is ubiquitously used in research and clinical practice, including companion diagnostics (CDx). Despite IHCs wide use, underperforming assays often require additional molecular testing due to narrow detection range. With expertise in quantitative and digital pathology and having invented the AQUA technology for predicting response to therapies or recurrence in a myriad of disease indications, Dr. Rimm and his research team will evaluate a multitude of assay conditions to assess Quanticells technology performance for quantifying HER-2 expression across a much wider dynamic range.

I am thrilled to be working on this cutting-edge technology that has the potential to revolutionize molecular drug target testing that will in turn maximize therapeutic efficacy and reduce undesired toxicity, said Dr. Rimm. In previous studies performed in my laboratory, we have found that HER-2 protein expression spanned three logs of dynamic range and discovered DAB-based methods typically only show a linear range of one log, which we hypothesize can be addressed with Konica Minoltas novel detection technology.

About Invicro

Headquartered in Boston, MA, Invicro was founded in 2008 with offices, laboratories and clinics around the world, from coast-to-coast within the United States, to Europe and Asia that support leading pharmaceutical and biotechnology and top research universities. Invicros multi-disciplinary team provides solutions to help enhance the discovery and development of life-changing drugs across all stages of the drug development pipeline (Phase 0-IV), leveraging all modalities within a broad scope of therapeutic areas, including neurology, oncology, cardiology, and immunology. Invicros quantitative biomarker services, advanced analytics tools, and clinical operational services are backed by their industry-leading software informatics platforms, VivoQuant and iPACS.

Invicro is a Konica Minolta company and part of their precision medicine initiative, which aims to accelerate personalized medicine, discover novel therapeutic targets and develop innovative therapeutic technologies for unmet medical needs. Along with their sister company, Ambry Genetics, Invicro develops and leverages the latest approaches in quantitative biomarkers including imaging, quantitative pathology and genomics. Visit http://www.invicro.com for more information.

About Konica Minolta

Konica Minolta, Inc. (Konica Minolta) is a global digital technology company with core strengths in imaging and data analysis, optics, materials, and nanofabrication. Through innovation, Konica Minolta creates products and digital solutions for the betterment of business and societytoday and for generations to come. Across its Business Technologies, Healthcare, and Industrial-facing businesses, the company aspires to be an Integral Value Provider that applies the full range of its expertise to offer comprehensive solutions to the customers most pressing problems, works with the partners to ensure the solutions are sustainable, anticipates and addresses tomorrows issues, and tailors each solution to meet the unique and specific needs of its valued customers. Leveraging these capabilities, Konica Minolta contributes to productivity improvement and workflow change for its customers and provides leading-edge service solutions in the IoT era. Headquartered in Tokyo and with operations in more than 50 countries, Konica Minolta has more than 43,000 employees serving approximately two million customers in over 150 countries. Konica Minolta is listed on the Tokyo Stock Exchange, (TSE4902). For further information, visit: https://www.konicaminolta.com/

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Invicro Collaborates with Yale's Dr. David Rimm to Expand the Utility of Quanticell for Clinical Pathology Applications - Business Wire

(CNN) Whether youre inclined to choose coffee or green tea for your morning boost could be determined by your genes, a recent study found.

To examine genetic associations with food preferences, researchers from the Riken Center for Integrative Medical Sciences (IMS) and Osaka University in Japan studied the genetic data and food preferences of more than 160,000 people in Japan.

The research, published in the journal Nature Human Behavior, found genetic links for 13 dietary habits including consumption of alcohol, other beverages and foods, and also complex human diseases such as cancer and diabetes.

We know that what we eat defines what we are, but we found that what we are also defines what we eat, said Yukinori Okada, Senior Visiting Scientist at Riken IMS and professor at Osaka University, in a press release.

Genome studies are typically conducted to associate specific genetic variations with particular diseases, according to the National Human Genome Research Institute, part of the US National Institutes of Health.

This involves grouping thousands of people together depending on whether they have a disease and looking at DNA markers called single nucleotide polymorphisms, or SNPs, which can be used to predict the presence of that disease. If researchers find a SNP that is repeatedly associated with the disease group, they can assume that people with that genetic variation might be at risk for the disease.

Rather than looking at diseases, the Riken team examined dietary habits to find out if there were any markers that made people at risk for typically eating certain foods.

The researchers used data of more than 160,000 Japanese people from the BioBank Japan Project, launched in 2003 with a goal to provide evidence for the implementation of personalized medicine. The project collects DNA and clinical information, including items related to participants lifestyles such as dietary habits, which were recorded through interviews and questionnaires.

They found nine genetic locations that were associated with consuming coffee, tea, alcohol, yogurt, cheese, natto (fermented soybeans), tofu, fish, vegetables and meat.

Variants responsible for the ability to taste bitter flavors were also observed. This association was found among people who liked to eat tofu; while those without the variant consumed less alcohol or none at all.

Those who ate more fish, natto, tofu and vegetables had a genetic variant that made them more sensitive to umami tastes, best described as savory or meaty flavors.

The main ingredients of the foods mattered, too for example, there were positive genetic correlations between eating yogurt and eating cheese, both milk-based foods.

In order to find whether any of these genetic markers associated with food were also linked with disease, the researchers conducted a phenome study.

The phenome comprises all the possible observable traits of DNA, known as phenotypes. Six of the genetic markers associated with food were also related to at least one disease phenotype, including several types of cancer as well as type 2 diabetes.

Since the research studied only people native to Japan, the same genetic variations associated with food preferences are likely not applicable to populations across the globe. However, similar links have been discovered in different groups.

A 2014 study presented at the European Journal of Human Genetics meeting in Milan identified a genetic variant that affects preferences for butter or oil on bread. A separate European study from the same year found genetic variants related to the perception of saltiness of a food.

A form of a bitter receptor gene was found, in a 2014 study, to contribute to differences in the enjoyment of coffee: People who perceived stronger bitterness liked coffee more; those with a lower bitterness perception liked coffee less.

The study authored by Okada also didnt measure environmental factors. Our environment, demographics, socioeconomic status and culture such as whether we eat food from work or home; our age; how much money we make; and what our families eat are some of the biggest drivers of our food choices.

These factors would weigh more than the genetics in some cases, said Dr. Jos Ordovs, director of Nutrition and Genomics at Tufts University in Massachusetts, who was not involved in the study.

Given all the findings that genetic differences influence not only responses to foods but preferences as well, experts think considering them can help nutritionists personalize diets to each persons needs and tastes while still hitting nutritional requirements.

Something that sometimes we have felt is that the nutrition field has been focusing too much on nutrients rather than on foods, Ordovs said.

Previous studies have been looking at genes that were associating with higher protein intake or higher fat intake or higher carbohydrate intake, Ordovs said. But this study is more aligned with the fact that people eat foods. They dont just eat proteins, carbohydrates and fats. People tend to eat within a specific pattern.

Further research is needed to explain an exact balance between genetic predisposition and volition when it comes to food choices in different groups of people, but Okada suggests that by estimating individual differences in dietary habits from genetics, especially the risk of being an alcohol drinker, we can help create a healthier society.

The-CNN-Wire & 2020 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.

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Prefer Tea Over Coffee? It Could Be Your Genes, Study Finds - CBS Baltimore

It has been one year since Alex Trebek announced his stage IV pancreatic cancer diagnosis.

The Pancreatic Cancer Action Network (PanCAN), a leading patient advocacy organization dedicated to fighting the worlds toughest cancer, is extremely grateful to him for his continued openness about his treatment journey and more importantly, his strength and resolve to fight for all who look to him for inspiration.

Throughout the past year, Trebek has transformed the conversation around pancreatic cancer and provided hope to people impacted by this disease.

In his latest health update, Trebek mentioned that he is one of the 18.4% of patients with stage IV pancreatic cancer to hit the one-year survival mark. This is a significant milestone for someone with this diagnosis.

PanCAN is hopeful that others will have similar outcomes.

The good news is that today we know that some patients are living beyond this milestone as a result of progress happening in the field.

Earlier this week, PanCAN announced new research that revealed pancreatic cancer patients who receive precision medicine live an average of one year longer than those who do not. This is the first study to demonstrate an overall survival benefit from precision medicine in pancreatic cancer patients.

PanCAN recommends that all pancreatic cancer patients undergo testing of both their tumor tissue (molecular profiling) and blood or saliva for genetic (germline) changes to determine if they have an actionable alteration and to identify treatment options for that patient.

PanCAN offers a free Know Your Tumor precision medicine service as well as free, in-depth, and personalized resources and information on the disease. Patients can contact our Patient Central today by calling 877-2-PANCAN (877-272-6226) M F, 7 a.m. 5 p.m. PT or emailingpatientcentral@pancan.org

We continue to work tirelessly for Trebek and the thousands of patients that are diagnosed every year with pancreatic cancer. And we are pleased to report that there has been other tremendous progress in just the last three months that offers patients much hope.

Every pancreatic cancer patient and every tumor is unique. We will continue to work hard to make sure all patients have access to free, personalized information and resources to increase their likelihood of a positive outcome. And we hope that Trebek continues to do well.

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Statement from The Pancreatic Cancer Action Network (Pancan) In Response to Alex Trebek's Health Update - Pancreatic Cancer Action Network -...

Dr Jane Cooke Wright whether youve heard of her or not, her research changed the path of oncology, paving the way for cancer treatment as we know it.In a time when medicine and research were predominantly white and male, Jane and her family had challenged the preconceptions of what a scientist should be. Jane and her sister, Barbara, represented the third generation of Wright family medics; the tradition began with their grandfather, who, after being born into slavery, later graduated from Meharry Medical College as valedictorian of his class. Their father, Dr. Louis Tompkins Wright, was one of the first African-American graduates of Harvard Medical School and founded the Harlem Hospital Cancer Research Foundation (HHCRF).

After briefly considering the idea of pursuing an art degree, Wright graduated with honors from New York Medical College and in 1949 began working with her father at the HHCRF.

Chemotherapy wasnt always one of the go-to approaches for cancer treatment. In the early to mid-20th century, using drugs to treat cancer was considered somewhat experimental, only to be used if other treatment avenues had been exhausted. Despite the hesitant attitudes towards chemotherapeutic agents, Wright and her colleagues made many strides towards establishing chemotherapy as a viable treatment for cancer.

One of the most significant came in 1951; Wright led a seminal piece of research that laid the foundations for treating solid tumors chemotherapeutically.1 The study primarily established the efficacy of methotrexate, a folic acid antagonist, in treating breast cancer, which was a major result in itself. However, it also demonstrated the long-term efficacy of combination therapy and adjustment of treatment regimens according to the individual patients symptoms of toxicity. Methotrexate continues to be used to this day, alone or in combination, to treat a range of cancers from head and neck to non-Hodgkins lymphoma.

Adjusting treatment according the individual was an idea forming the basis of much of Wrights research, representing some of the early steps towards personalized medicine. Whilst previous researchers had used mice tumors as a model for predicting response to different chemotherapeutics, Wright and her colleagues cultured tumor tissue taken from patients. Once grown, the primary cultures were treated with a variety of chemotherapeutic agents and their response was assessed. In doing so, Wright helped to develop a method for testing and selecting the most effective course of chemotherapy for a particular tumor in an individual patient.2

The solution came in 1964, in the form of the American Society of Clinical Oncology (ASCO), of which Wright was a founding member and notably, the only woman of the founding group. In a 2010 interview, Wright explained why the society was created:

Our goals were to bring about a set of standards for a clinical oncology specialty, to enlarge the area of knowledge in the field and to ensure that vital information was readily available and disseminated.3Wright set out to achieve these goals during her tenure as associate dean and professor of surgery at her alma mater, New York Medical College, developing cancer treatment guidelines and a program teaching doctors how to use chemotherapy. Her appointment to the position was also a significant social feat at the time; upon taking office in 1967, Wright became the highest ranked African American woman at a nationally recognized medical institution. This was only one of a number of high-ranking positions held by Wright over the next 20 years.

In a 2011 interview, Wrights daughter, Alison W. Jones, PhD, gave an insight into how her mother achieved so much in a time and society which often had preconceptions of what a womans life should be. She never looked at things as obstacles, Jones explained. She looked at them as challenges and I think that she was a very ambitious person and I think that she never let anything stand in the way of her doing what she wanted to do.

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Jane C. Wright: The Woman Who Changed the Landscape of Oncology - Technology Networks

Drug testing and screening for cancer drug discovery can take years and the 2D cell cultures and animal models used to estimate their efficacy before reaching human trials are often not representative of the human body, which is why researchers are turning to bioprinting technologies to increase the success rate during human trials by providing human-specific preclinical data. In 2018 there were 17 million new cases of cancer worldwide, and the disease is expected to affect 27.5 million people each year by 2040, this high incidence level makes tackling the disease enough of a reason for researchers to consider new technologies that could accelerate drug discoveries and screenings. Although still in its lab phase, a new development that uses immersion bioprinting of human organoids could change 3D drug screening.

Researchers from Cornell University, Wake Forest School of Medicine, Virginia Polytechnic Institute and State University and The Ohio State University have published an article in Micromachines, demonstrating an immersion printing technique to bioprint tissue organoids in 96-well plates to increase the throughput of 3D drug screening. Using a hydrogel bioink comprised of hyaluronic acid (HA) and collagen they were able to bioprint it into a viscous gelatin bath, which blocks the bioink from interacting with the well walls and provides support to maintain a spherical form.

According to the article, the use of bioengineered human cell-based organoids may not only increase the probability of success during human trials, but they could also be deployed for personalized medicine diagnostics to optimize therapies in diseases such as cancer. However, they suggest that one limitation in employing organoids in drug screening has been the difficulty in creating large numbers of homogeneous organoids in form factors compatible with high throughput screening, so bioprinting can be used to scale up the deposition of such organoids and tissue constructs.

The team of scientists employed two commercially available bioprinters to evaluate the compatibility of the collagen-HA hydrogel and the HyStem-HP hydrogel: Cellinks INKREDIBLE bioprinter and Allevis Allevi2 bioprinter. This method was validated using several cancerous cell lines and then applied to patient-derived glioblastoma (GBM) a fast-growing brain tumor and sarcoma (or malignant tumor) biospecimens for drug screening.

For the initial analysis of hydrogel biocompatibility, researchers used two common cell lines: human liver cancer and human colorectal cancer.

While carrying out patient-derived tumor biospecimen processing, they obtained two glioblastomas and one sarcoma biospecimen from three surgically treated patients in adherence to the guidelines of the Wake Forest Baptist Medical Center IRB protocols. These biospecimens were processed into cell suspensions, successfully yielding millions of viable cells from each sample. The cells were then combined with the collagenHA bioink for deployment in immersion bioprinting. After bioprinting, the GBM and sarcoma patient-derived tumor organoids (PTOs) were maintained for seven days in the incubator, after which a chemotherapy screening study was initiated.

Schematic of the printing process using 2 bioinks in two commercially available bioprinters: Cellink Inkredible and Allevi 2 (Image: Cornell University/Wake Forest)

The researchers claim that while their PTOs have been useful for disease modeling, mechanistic study, and drug development, they have also used these models in a diagnostic sense to influence therapy, which might just be the ultimate goal of their work.

This 3D bioprinting approach called immersion bioprinting is an efficient way to surpass the limitations that have plagued tumor organoid systems. The experts, in this case, suggest that there have been few advances in regard to approaches to the printing process itself, or generation of novel, more user-friendly bioinks. Indicating that unfortunately, many bioprinting studies are somewhat repetitive, falling back on traditional biomaterials and their crosslinking approaches, which were never developed to be bioprinted or to accurately represent the complexities of the native ECM (extracellular matrix).

Results of the published study suggests that the realization of this technology that can fabricate PTOs in a consistent and high-throughput fashion will provide a valuable ex vivo/ in vitro tool that can be deployed for many subsequent studies, including target discovery, mechanistic investigation of tumor biology, drug development, and personalized drug screens to aid in treatment selection in the clinic.

Clinical oncology is faced with some critical challenges during this decade, from inefficient trial design to integrating new technologies in diagnostics and drug trails. However, advances in new methodologies, from hardware design to improved bioinks developed specifically for bioprinting, are opening up new opportunities for bioprinting-based applications. This new study, in particular, suggests that with advances in bioprinting hardware, software, functional ECM-derived bioinks, and modifications to printing protocols, bioprinting can be harnessed not only to print larger tissue constructs, but also large numbers of micro-scaled tissue and tumor models for applications such as drug development, diagnostics, and personalized medicine.

Employing bioprinted patient-derived tumor organoids in a clinical precision medicine setting (Image: Cornell University/Wake Forest)

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New Method: Immersion Bioprinting of Tumor Organoids Will Increase the Throughput of 3D Drug Screening - 3DPrint.com

Lee Carmen, Associate VP for Information Systems and CIO, University of Iowa Health Care

Lee Carmen, Associate VP for Information Systems and CIO, University of Iowa Health Care

Lee Carmen was appointed associate vice president for information systems in July 2007. Carmen oversees information technology services, including technical support, applications development, and clinical applications across the University of Iowa Health Care enterprise

As a CIO, what are some of the recent trends that you see in the healthcare space?

As the CIO of a large Midwestern quaternary care medical center, I have expertise in varied domains from electronic medical records (EMRs) and clinical systems to security, networking, data management, and analytics. As far as the recent trends are concerned, with the advent of technologies like artificial intelligence, healthcare organizations are highly interested in partnering with companies that have experience in managing and analyzing large data sets.

How do you keep abreast of the innovative technologies entering the healthcare space?

Fortunately, the information architecture at Iowa is quite similar to the architectures at peer institutions. They not only have the same EMR solution but also analytics tools, nurse call systems, clinical monitoring systems, allowing us to collaborate, inform and advise each other on new technology advances and implementations. To leverage more from this professional networking, we interface with our key vendor partners for EMRs,or clinical equipment and our ERP partners. We engage the early adopters of emerging technologies to reap the benefits of the services today as well as in the future. Being an academic medical center, we have many nationally recognized researchers, who share new technologies of interest or value with us. To gain more insight into the ever-evolving technology landscape, we keep an eye on the new patents being released, the venture capitalists funding, and the IPOs from a business angle.

What is your checklist for choosing technology vendors?

Many IT companies today have limited experience in healthcare operations, so one of the first things we check is the vendors experience in the space based on the customers they are currently working with. Since we operate with 850 beds, generating yearly revenue of $2.5 billion, a vendor for a 100-bed community hospital might not be a match. However, we further look at their viability, operational tenure, and funding model. Our team of security, data architecture, data networking, and user design experts works closely with the vendor, to ensure they both are on the same page of design, scalability, and architecture.

As we expand our technology footprint in a healthcare setting, we also need to train our workforce for implementing and supporting the technicalities

Elaborate on some of the current projects that you are currently overseeing, and what impacts do you hope to get out of them?

With provider productivity, efficiency, and burnout being the hot issues today, the introduction of additional technology into clinical settings can often have a negative effect on the healthcare providers. To ensure that the technology we bring in is a net benefit instead of a net detriment to the providers, we focus on designing, configuring, and implementing systems in a way that supports their everyday workflows.

While many new players are making their way into the healthcare communication space, there are established vendors refreshing their product lines on-the-move. Looking at the communication between clinicians and patients during treatment, we evaluate whether the tools in place are adequate to meet the care delivery needs, or do they need modernization. We provide patients with self-service tools, enabling them to schedule appointments and ask questions of their providers. We are configuring our existing enterprise systems to allow them to take inpatient data from network-enabled devices such as Apple watches or glucose monitors. Further, the next step is to augment this collected data in a safe, scalable, secure way that is relatively easy for our patient population to access.

Do you have any additional highlights on the challenges persistent in the healthcare arena?

There is a never-ending challenge to recruit talented technology professionals in the healthcare space. As we expand our technology footprint in a healthcare setting, we also need to train our workforce for implementing and supporting the Technology.

What are some of the leadership principles that you abide by to influence your peers and subordinates?

I believe I am here to work for my staff, rather than having them work for me. My role is to communicate between other leaders in the organization and my team about the strategic direction and operational needs of the company and accentuate areas of focus. Understanding my teams requirements in terms of direction and resources to further meet the organizational needs, I act as a buffer between these two parties. I also attempt to remove the barriers for my technology teams, allowing them to bring out the best of their abilities and get solutions into production, as timely as possible. In addition, my responsibilities include working with and advising our executive leadership team on what we could develop or implement to support the growth of the organization.

How do you think the future of healthcare would turn out to be?

With healthcare in rural settings being a big issue for us, projecting forward, the focus will be on the telemedicine space and on the ability to deliver and receive care from providers at any geographic location convenient for the patient. Besides the advances in automation, we will be witnessing the rise of technology-enhanced alternate care delivery models, which will be different from visiting a physical clinic or an emergency room. At our organization, one of our physician-researchers has developed the first FDA approved AI device that screens patients for diabetic retinopathy by taking images of their eye and running it through an AI engine for a clinical interpretation. This device cuts down the physician's need to diagnose, freeing up their time to focus on more complex areas. Besides the development of tools like EMRs to accept different types of data inputs, advancements are occurring in the personalized medicine space and the ability to find diagnosis and treatment strategies for patients based on their unique requirements, all driven by data.

What is your advice to an aspiring CIO of a healthcare establishment?

Healthcare organizations are unique places to work in as you are surrounded by some of the smartest, most dedicated, and hard-working members of our society, such as doctors, nurses, pharmacists, and others. My advice to the junior staff is to take advantage of the environment they are working in, and understand how every different person and team interacts with a patient. Be it an outpatient world, an inpatient one, an emergency room, an intensive care unit, or an operating roomall come with different requirements; you need to be exposed to different health care delivery areas to understand its nuances. Aspiring healthcare IT professionals need to listen and absorb everything from the various clinical settings as it will have a significant impact on the services that they can ultimately deliver back to the organization.

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Keeping Up with the Change in Healthcare - CIOReview

Most development-stage biopharmaceutical companies pin their hopes on a single clinical hypothesis evaluated with a handful of drug candidates at best. Fate Therapeutics(NASDAQ:FATE) is not most early stage companies.

The cellular therapy pioneer is developing 13 unique pipeline programs. That may give the impression that Fate Therapeutics is throwing everything at the wall and seeing what sticks, but a closer look shows there's been a rational build-out of the pipeline. That doesn't necessarily mean all of the hypotheses will work -- development-stage biopharmas are inherently risky investments -- but if the lead clinical programs report promising data in 2020 from the next wave of major trials, investors might begin to see the value of the company's vision.

Here's why this pharma stock is my top buy in March.

Image source: Getty Images.

Fate Therapeutics has staked its future on the general idea that first-generation immunotherapies leave much room for improvement. It's not wrong. The successful development of chimeric antigen receptor (CAR) T cells put cellular therapy on the map a few years ago, but there are inherent limitations to their production and use.

Take Yescarta as an example. In the second half of 2017, it became the second CAR-T drug to earn approval from the U.S. Food and Drug Administration (FDA). It's a personalized medicine used to treat certain cancers of white blood cells. To make a dose, immune cells are harvested from a patient, isolated, genetically engineered to attack the patient's cancer, multiplied in the lab, and then administered back into the patient.

The immunotherapy is highly effective. In a large post-approval study involving 533 individuals, Yescarta achieved an overall response rate of 84% and a complete response rate of 66%. That means 84% of individuals responded to treatment and 66% of individuals had no evidence of disease after six months. The study proved why Gilead Sciences was wise to acquire Kite Pharma, which developed Yescarta and pioneered CAR-T therapies.

But first-generation immunotherapies such as Yescarta have limitations. Using donor- or patient-derived cells increases the complexity of treatment, which increases costs and the potential for errors. Manufacturing a dose of a patient-derived CAR-T therapy can take two to three weeks and cost $425,000. Hospitals administering CAR-T therapies can charge as much as $1.5 million to ensure they aren't losing money while adhering to stringent protocols.

CAR-T therapies can also cause severe side effects including cytokine release syndrome (CRS) and neurotoxicities (Yescarta comes with a boxed warning for these side effects). They can only be dosed once. And engineering them with first-generation gene editing tools such as CRISPR/Cas9 has been found to be error-prone. Fate Therapeutics thinks there's a better way.

Image source: Getty Images.

Fate Therapeutics is developing cellular therapies that address most of the concerns of first-generation CAR-T therapies.

Rather than rely on cells derived from each individual patient, the company engineers cells from a master clonal cell line. That allows for an off-the-shelf drug product that can be easily reproduced, confidently characterized for quality control, and efficiently manufactured in batches. The company estimates its manufacturing cost is less than $2,500 per dose. Individuals can also receive treatment in an outpatient setting and avoid racking up massive hospital bills.

The development-stage biopharma is also relying mostly on natural killer (NK) cells, which have several advantages compared to CAR-T cells.NK cells shouldn't be accompanied by severe side effects such as CRS or neurotoxicities, can rally the rest of an individual's immune system to attack tumors, and can be dosed multiple times to extend the duration of response. It's also possible to combine NK cells with other drugs, especially monoclonal antibodies, which could provide unique synergies to improve patient outcomes.

Fate Therapeutics has also tapped Inscripta's novel CRISPR gene-editing tool, which uses a novel cutting enzyme that has been shown to be more efficient than Cas9. That's important for ensuring all cells used for a drug product are homogeneous, rather than a distribution of cells with varying genetic profiles and levels of activity.

On paper, the company's approach stacks up favorably against a general first-generation cellular therapy.

Metric

First-Generation Cellular Therapy

Fate Therapeutics

Starting material

Cells derived from patient

Cells derived from master clonal cell line (nine of 13 clinical programs)

Manufacturing process

Complex process required to make a single dose

Manufactured in batches (many doses from one production run)

Manufacturing time and cost

2-3 weeks and $450,000

Available off the shelf and less than $2,500

Engineering tools

Error-prone first-generation CRISPR/Cas9 tools

Next-generation CRISPR tool using MAD7 enzyme is more efficient than Cas9 (first drug candidate could begin trials in 2020)

Cell type and dosing

CAR-T cells that can be dosed only once

Mostly NK cells that can be dosed multiple times (eight of 13 clinical programs)

Side effects

CRS and neurotoxicities

No cases of CRS reported in early studies of NK cells

Data source: Fate Therapeutics.

The benefits on paper are nice, but investors will be more concerned with how the approach stacks up in the real world -- and 2020 might be the year they get an answer.

Fate Therapeutics is developing cellular therapies against a range of solid tumor cancers and blood cancers. The company made six presentations at the American Society of Hematology (ASH) annual meeting in December, which provided investors with the first real glimpse of the pipeline's potential.

The takeaways were mostly positive and certainly raised the level of intrigue on Wall Street, as evidenced by a rising stock price. Fate Therapeutics notched several industry firsts (such as with FT500, which became the first off-the-shelf derived NK cell therapy to begin a clinical trial) while setting the stage for more important data readouts in 2020.

Drug Candidate, Cell Type

Indication

Last Update

FT516 (monotherapy), NK cell

Acute myeloid leukemia (AML)

First patient received one cycle of three once-weekly doses, had no evidence of disease in bone marrow at Day 42.

FT516 (combination therapy), NK cell + monoclonal antibody

B-cell lymphoma

First patient received one cycle of three once-weekly doses, no data reported.

FT500 (monotherapy or combination), NK cell or NK cell + checkpoint inhibitor

Advanced solid tumors in individuals who failed prior checkpoint inhibitor therapy

12 patients total, six of 11 evaluable patients achieved stable disease after first cycle, no cases of CRS or neurotoxicity in 62 total doses.

Data source: Fate Therapeutics Press releases.

Fate Therapeutics also plans to initiate new studies in 2020. A combination therapy comprising a FT596 (an NK cell drug candidate) and rituximab (a monoclonal antibody) is expected to begin a phase 1 study in lymphoma in early 2020. Meanwhile, the company expects to submit investigational new drug (IND) applications for its first off-the-shelf CAR-T cell product, FT819, and first CRISPR-edited product, FT538, in the second quarter of this year.

Fate Therapeutics began the year with $261 million in cash, which means investors and Wall Street analysts will be solely focused on clinical results and the continued buildout of the pipeline in 2020.

While all development-stage biopharma stocks are inherently risky, the number of shots on goal insulates investors from a single failure. In fact, each drug candidate is genetically engineered against unique molecular targets, or used in specific combinations, which means any single clinical failure can't be extrapolated across the entire pipeline.

Fate Therapeutics still needs to generate clinical results demonstrating its next-generation approach to cellular therapy can lead to robust clinical benefits for patients, but Wall Street and deep-pocketed industry leaders might coalesce around the development-stage company if early and mid-stage studies continue to impress. That could make its current $2.3 billion market valuation a bargain for investors with a long-term mindset -- and with an appetite for above-average risk.

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Here's My Top Stock to Buy in March - Motley Fool

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Global Personalized Medicine Market 2020 Industry Analysis, Trends, Size, Growth, Share, Strategies And Forecast To 2025 - NJ MMA News