RESEARCH UPDATE

The strongest risk factor for schizophrenia is the presence of an affected first-degree relative.1 One approach to investigate the effects of genetics on schizophrenia pathophysiology is the study of endophenotyes. Endophenotypes are measurable, heritable traits that are intermediate between genotypes and phenotypes, and they are more likely to be expressed in unaffected relatives of patients than in the general population.

The retina is embryologically related to and considered a window to the brain. There is evidence for retinal abnormalities in schizophrenia.2 Recently, the use of spectral-domain optical coherence tomography (OCT), a non-invasive imaging technique, has contributed to increased understanding of retinal abnormalities in schizophrenia.

OCT uses infrared light to create an optic ultrasound, providing information on the retinal nerve fiber layer (RNFL), ganglion cell layer (GCL), and inner plexiform layer (IPL) of the retina. Given the potential confounding of retinal imaging findings by metabolic dysfunction and antipsychotic medications in schizophrenia, the use of OCT in first-degree relatives represents an important new area of investigation.

Kurtulmus and colleagues3 performed a study of retinal layer thicknesses between patients with DSM-IV schizophrenia, their unaffected first-degree relatives, and healthy controls. The authors recruited 38 chronic, stable patients with schizophrenia; 38 unaffected first-degree relatives (parents [n=13], siblings [n=14], adult children [n=11]); and 38 controls without a family history of psychotic or bipolar disorder.

Exclusion criteria were history of systemic disease that may involve the eyes (including diabetes, hyperlipidemia, hypertension, and cardiovascular disease); pre-existing retinal or other ocular pathology; history of ocular surgery/trauma; any neurological condition affecting the visual pathway; severe refractive error; and alcohol or other substance use in the past year. In patients with schizophrenia, comorbid psychiatric diagnoses were excluded, and relatives and controls did not have a history of any psychiatric diagnoses.

OCT was performed without pupil dilation using a Spectralis OCT device, with all scans performed by the same operator. There were no significant differences in measurements between the right and left eyes, and so only the data from the right eye was analyzed. Between-group differences on OCT measurers were examined using analysis of variance, and significant findings were confirmed using linear regression models controlling for potential confounding factors.

Mean age in the study sample was 41; 55% were female; and the mean body mass index (BMI) was 27. In patients with schizophrenia, mean illness duration was 18 years and the mean total Positive and Negative Syndrome Scale (PANSS) score was 66. Of 38 patients, 26 were prescribed atypical antipsychotics, with a mean daily dose of 781 chlorpromazine units.

There was no significant difference between study groups in overall RNFL, GCL, and macular thickness. However, both patients and unaffected relatives had significantly lower IPL thickness compared with controls (the magnitude of this difference was about 5%). Increased BMI was associated with IPL thinning; however, the between-group differences remained significant after controlling for BMI and other potential confounding factors (eg, age, sex, smoking, medical comorbidity).

The IPL consists of the ganglion cell dendrites and synaptic connections in the retina, also termed the inner synaptic layer. This finding may reflect abnormal synaptic/dendritic organization in schizophrenia.

The authors note that limitations of the study include the relative small sample size, and differences in shared genetics across the various types of relatives included.

The bottom line

The authors performed what is believed to be the first study of OCT in unaffected relatives of patients with schizophrenia. Findings raise the possibility of IPL thinking as a potential endophenotype for schizophrenia.

Disclosures:

Dr Miller is Associate Professor, Department of Psychiatry and Health Behavior, Augusta University, Augusta, GA. He is the Schizophrenia Section Chief for Psychiatric Times. The author reports that he receives research support from Augusta University, the National Institute of Mental Health, the Brain and Behavior Research Foundation, and the Stanley Medical Research Institute.

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Are the Eyes a Window Into the Mind of Schizophrenia? - Psychiatric Times

Recommendation and review posted by Bethany Smith

The only white female giraffe and her calf reported to have been killed through poaching might have died four months ago, the Kenya Wildlife Service has said.

In a statement from KWS corporate communications officer Ngugi Gecaga, the agency said it is investigating the incident that led to the death of the two giraffes at Ishaqbini Hirola Conservancy in Garissa County.

Our teams on the ground have seen bones believed to be those of the two giraffes. The bones are estimated to be four months old."

He went on, "The management of the conservancy informed us of the missing giraffe and calf after failing to see them for a period of time."

The statement added that KWS personnel are working with community rangers and the conservancy management to establish the facts around the incident.

This comes after the Ishaqbini Hirola conservancy confirmed the deaths of the two giraffes in a statement on March 10.

The community conservancy said the giraffes were killed by poachers.

Mohammed Ahmednoor, Ishaqbini Hirola Conservancy manager, said This is a very sad day for the community of Ijara and Kenya as a whole. We are the only community in the world who are custodians of the white giraffe."

"Its killing is a blow to tremendous steps taken by the community to conserve rare and unique species, and a wakeup call for continued support for conservation efforts."

The white giraffe made headlines in 2017 after its discovery, with its unique white hide.

The giraffe had a rare condition known as leucism and did not suffer albinism.

Unlike albinism, animals with leucism produce dark pigment in their soft tissue, making their eyes dark in colour.

This is a long term loss given that genetics studies and research which were significant investment into the area by researchershas now gone down the drain. Further to this the white giraffe was a big boost to tourism, Ahmednoor added in a statement.

The announcement also comes in the wake of conflicting reports on social media platforms that the white giraffe and her calf were killed by a terror group for game meat. Other reports indicated that conflicting communities might have killed the animals.

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KWS: Dazzling white giraffes may have died four months ago - Standard Digital

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Researchers from the University of Maryland have created a new CRISPR gene-editing system that can successfully modify the DNA of plants to a greater extent than was ever possible before.

The new system, referred to as CRISPR-Cas12b, would allow scientists to effectively modify crops for various purposes, such as making them more resistant to diseases or pests. Previous gene-editing systems, such as CRISPR-Cas9 and CRISPR-Cas12a, have received plenty of attention in the scientific community, but aren't as well-suited to modifying plant DNA.

Image source: Getty Images.

"This type of technology helps increase crop yield and sustainably feed a growing population in a changing world. In the end, we are talking about broad impact andpublic outreach, because we need to bridge the gap between what researchers are doing and how those impacts affect the world," said Yiping Qi, assistant professor of plant science at the University of Maryland and the creator of the CRISPR-Cas12b system.

Ever since CRISPR technology first came onto the scene, researchers have considered using it to genetically modify crops. Scientists are already experimenting with CRISPR technology to make bananas that are more resistant to a strain of deadly fungus that is ravaging plantations in Latin America.

However, using CRISPR to treat conditions in humans remains its most compelling application. Many gene-editing biotech companies, among them CRISPR Therapeutics (NASDAQ:CRSP) and Editas Medicine, are alreadymaking use of CRISPR-Cas9 technology as they develop treatments for use in humans.

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Researchers Create New CRISPR Gene-Editing System for Plants - The Motley Fool

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The rapid and frightening spread of the coronavirus has sparked a battle thats drawing on a host of emerging technologies. Government, industry and academic researchers are scrambling to improve our ability to diagnose, treat and contain a virus thats threatening to reach pandemic status.

This isnt the first time researchers have faced off against a dangerous member of this family of viruses. But it is the first time theyve done it with a toolbox that includes the gene-editing tool CRISPR and the emerging field of synthetic biology.

Indeed, weve known about coronaviruses for nearly 60 years. But for several decades, they attracted little attention, causing symptoms similar to the common cold.

That changed in 2003, when a deadly member of the coronavirus family, SARS-COV, spread to 29 countries, killing 774 people. Suddenly, a coronavirus found previously in animals had managed to jump to humans, where it killed nearly 10 percent of those infected. The virus sparked fear across the globe, but was brought under control within a year. Only a small number of cases have been reported since 2004.

Then in 2012 came MERS-COV. The virus emerged in Saudi Arabia, jumping from camels to humans. The virus has never caused a sustained outbreak, but with a mortality rate of35 percent, it has killed 858 people so far. Infections have been reported in 27 countries, with most in the Middle East. The virus is considered by the World Health Organization to be a potential epidemic threat.

Interestingly, neither of these previous coronavirus threats were stopped by a cure or a vaccine. MERS still lurks in the background, while SARS was contained by what amounts to old-school practices, according to a 2007 article in Harvard Magazine:

Ironically, in this age of high-tech medicine, the virus was eventually brought under control by public-health measures typically associated with the nineteenth centuryisolation of SARS patients themselves and quarantine of all their known and suspected contactsrather than a vaccine.

There currently is no cure for this new wave of coronavirus infections (the resulting disease is called Covid-19), even though some antiviral therapies are being tested and one experimental vaccine is ready for testing in humans. The virus genome has been sequenced and its genetic code may shed light on how the disease starts and spreads, as well as inform on potential pharmaceutical targets for drug development. The Covid-19 virus similarity to the SARS-COV may mean that cures developed for one strain may prove effective for the other. The Canadian company AbCellera plans to test its antibody technology, already tried against MERS-COV, to neutralize the Covid-19 viral bodies.

What is really encouraging is the level of international collaboration aimed to fight this health emergency. Funding bodies, scientific societies and scientific journals have signed a joint statement, agreeing to openly share research findings with the global research community as soon as they are available. The very quick information dissemination gave scientists around the globe several RNA sequences of the virus genome. And these sequences can be used to better understand the epidemiology and origins of the virus. Moreover, the advancements in DNA technology let research groups in academia and industry synthesize the viral genetic material to use in the two areas of focus: detection of virus and vaccine development.

One of the trickiest things about the coronavirus is its speculated transmission by asymptomatic patients. This increases the number of infections and makes containment measures less effective, spreading fears that the virus may establish a permanent presence in some areas. There are also fears that many incidents lie undetected, spreading the virus under the radar. As of March 9, the virus has infected more than 110,000 people, killing nearly 4,000, in 97 countries.

Several biotech companies have scrambled to provide kits and resources for early and reliable detection of the new coronavirus. Mammoth Bioscience, a San Francisco-based startup, is already working on a detection assay using their CRISPR technology. The DNA technology companies IDT and Genscript already distribute PCR-based kits for detection for research purposes. The Chinese companies BGI and Liferiver Biotech use the same PCR technology for the kits they provide to their countries health authorities.

The French-British biotech Novacyt announced the launch of a diagnostic kit for clinical use in middle February. The kit will also use quantitative-PCR, developed by their sister company Primerdesign. Its high specificity will reduce the analysis time to less than two hours. The companys CEO Graham Mullis told Reuters that each kit will cost around $6.50, and that they have already received more than 33,000 orders.

The only way to effectively control and even eliminate the outbreak is to develop a vaccine. Unfortunately, the new outbreak hasnt attracted the attention of the lead vaccine manufacturers. Non-profit organizations, such as the Coalition for Epidemic Preparedness Innovations (CEPI), have jumped in to fill the gap. But despite the emergency, a vaccine may be several years away from being available

The University of Queensland in Brisbane, Australia, announced that theyre working on a coronavirus vaccine which they hope to have ready within the next few months. The molecular clamp approach the Australian researchers have developed allows is designed to boost the immune system response and work against several viral infections. GlaxoSmithKline has offered is adjuvant technology adjuvants are added to vaccines to boost their efficiency to speed up the process.

The Cambridge, MA-based Moderna uses a different approach to make vaccines. Their mRNA technology is modular and very adaptable to use for a new disease or when the epitope (the vaccines target) mutates. The company says its vaccine is ready for human trials.

The Covid-19 outbreak has rightly gained the attention of health authorities and the media. If the virus were to reach countries with weaker healthcare systems than Chinas, the number of deaths will rise significantly and containment will be even harder. Moreover, the long incubation time of the disease, combined with the asymptomatic spread, make quarantine and isolation measures less effective. The biggest risk is for the new coronavirus to become endemic in certain areas, where the disease is never truly extinct and displays seasonal outbreaks. We dont want the Covid-19 to become a new flu.

The health authorities of 2020, the biotech industry, and the society in general are better prepared for a coronavirus outbreak than a few years ago. The situation is less risky than MERS and SARS, though the new virus is harder to contain. This outbreak offers a chance for everyone to become more aware of viral infections, the appropriate precautions and get vaccinated according to the official recommendations. And keep in mind that the best way to stay informed is through official sources, such as the WHO and the CDC.

As for the biotech industry, are they playing their part? The answer is a partial yes; there are several companies that immediately scrambled to help the situation. But the big players within the field could be doing more.

Kostas Vavitsas, PhD, is a Senior Research Associate at the University of Athens, Greece. He is also a steering committee member of EUSynBioS. Follow him on Twitter @konvavitsas

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Fighting the coronavirus outbreak with genetic sequencing, CRISPR and synthetic biology - Genetic Literacy Project

Recommendation and review posted by Bethany Smith

The recent performance of CRISPR Therapeutics AG (NASDAQ:CRSP) stock in the market spoke loud and clear to investors as CRSP saw more than 1.08M shares in trading volumes in the last trading session, way higher than the average trading volume of 1.08M shares by far recorded in the movement of CRISPR Therapeutics AG (CRSP). At the time the stock opened at the value of $52.64, making it a high for the given period, the value of the stock dropped by -4.77%. After the decrease, CRSP touched a low price of $49.1553, calling it a day with a closing price of $53.41, which means that the price of CRSP went 50.86 below the opening price on the mentioned day.

Given the most recent momentum in the market in the price movement of CRSP stock, some strong opinions on the matter of investing in the companys stock started to take shape, which is how analysts are predicting an estimated price of $74.46 for CRSP within consensus. The estimated price would demand a set of gains in total of -0.34%, which goes higher than the most recent closing price, indicating that the stock is in for bullish trends. Other indicators are hinting that the stock could reach an outstanding figure in the market share, which is currently set at 48.07M in the public float and 3.25B US dollars in market capitalization.

When it comes to the technical analysis of CRSP stock, there are more than several important indicators on the companys success in the market, one of those being the Relative Strength Indicator (RSI), which can show, just as Stochastic measures, what is going on with the value of the stock beneath the data. This value may also indicate that the stock will go sideways rather than up or down, also indicating that the price could stay where it is for quite some time. When it comes to Stochastic reading, CRSP stock are showing 42.28% in results, indicating that the stock is neither overbought or oversold at the moment, providing it with a neutral within Stochastic reading as well. Additionally, CRSP with the present state of 200 MA appear to be indicating bearish trends within the movement of the stock in the market. While other metrics within the technical analysis are due to provide an outline into the value of CRSP, the general sentiment in the market is inclined toward negative trends.

With the previous 100-day trading volume average of 780882 shares, Paycom Software (PAYC) recorded a trading volume of 758060 shares, as the stock started the trading session at the value of $282.26, in the end touching the price of $267.71 after dropping by -5.15%.

Paycom Software (PAYC) surprised the market during the previous quarter closure with the last reports recording $0.78, compared to the consensus estimation that went to $0.70. The records showing the total in revenues marked the cap of +28.65%, which means that the revenues increased by +44.51% since the previous quarterly report.

PAYC stock seem to be going ahead the lowest price in the last 52 weeks with the latest change of 58.35%.Then price of PAYC also went backward in oppose to its average movements recorded in the previous 20 days. The price volatility of PAYC stock during the period of the last months recorded 4.63%, whilst it changed for the week, now showing 6.09% of volatility in the last seven days. The trading distance for this period is set at -9.79% and is presently away from its moving average by -9.32% in the last 50 days. During the period of the last 5 days, PAYC stock lost around -5.29% of its value, now recording a sink by 8.54% reaching an average $246.92 in the period of the last 200 days.During the period of the last 12 months, Paycom Software (PAYC) jumped by 1.11%.

According to the Barcharts scale, the companys consensus rating was unchanged to 3.92 from 3.92, showing an overall improvement during the course of a single month.

PAYC shares recorded a trading volume of 1.03 million shares, compared to the volume of 881.54K shares before the last close, presented as its trading average. With the approaching 6.09% during the last seven days, the volatility of PAYC stock remained at 4.63%. During the last trading session, the lost value that PAYC stock recorded was set at the price of $267.71, while the lowest value in the last 52 weeks was set at $169.06. The recovery of the stock in the market has notably added 58.35% of gains since its low value, also recording -16.99% in the period of the last 1 month.

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This Is (Another) Opportunity To Buy CRISPR Therapeutics AG (CRSP), Paycom Software (PAYC) - US Post News

Recommendation and review posted by Bethany Smith

News Release

Monday, December 16, 2019

NEI-led study to test safety of treatment for a form of age-related macular degeneration that currently lacks treatment.

Researchers at the National Eye Institute (NEI) are launching a clinical trial to test the safety of a novel patient-specific stem cell-based therapy to treat geographic atrophy, the advanced dry form of age-related macular degeneration (AMD), a leading cause of vision loss among people age 65 and older. The geographic atrophy form of AMD currently has no treatment.

The protocol, which prevented blindness in animal models, is the first clinical trial in the U.S. to use replacement tissues from patient-derived induced pluripotent stem cells (iPSC), said Kapil Bharti, Ph.D., a senior investigator and head of the NEI Ocular and Stem Cell Translational Research Section. The NEI is part of the National Institutes of Health.

The therapy involves taking a patients blood cells and, in a lab, converting them into iPS cells, which have the potential to form any type of cell in the body. The iPS cells are programmed to become retinal pigment epithelial (RPE) cells, the type of cell that dies early in the geographic atrophy stage of macular degeneration. RPE cells nurture photoreceptors, the light-sensing cells in the retina. In geographic atrophy, once RPE cells die, photoreceptors eventually also die, resulting in blindness. The therapy is an attempt to shore up the health of remaining photoreceptors by replacing dying RPE with iPSC-derived RPE.

Before they are transplanted, the iPSC-derived RPE are grown in sheets one cell thick, replicating their natural structure within the eye. This monolayer of iPSC-derived RPE is grown on a biodegradable scaffold designed to promote the integration of the cells within the retina. Surgeons position the patch between the RPE and the photoreceptors using a surgical tool designed specifically for that purpose.

Under the phase I/IIa clinical trial protocol 12 patients with advanced-stage geographic atrophy will receive the iPSC-derived RPE implant in one of their eyes and be closely monitored for a period of at least one year to confirm safety.

A concern with any stem cell-based therapy is its oncogenic potential: the ability for cells to multiply uncontrollably and form tumors. In animal models, the researchers genetically analyzed the iPSC-derived RPE cells and found no mutations linked to potential tumor growth.

Furthermore, the use of an individuals autologous (own) blood cells is expected to minimize the risk of the body rejecting the implant.

Should early safety be confirmed, later study phases will include more patients to assess the efficacy of the implant to prevent blindness and restore vision in patients with geographic atrophy.

A Food and Drug Administration (FDA) requirement for moving forward with the clinical trial was the establishment of good manufacturing practice (GMP) protocols to ensure that the iPSC-derived RPE are a clinical-grade product. GMP protocols are key for making the therapy reproducible and for scaling up production should the therapy receive FDA approval.

The preclinical research for the trial was supported by the NEI Intramural Research Program and by an NIH Common Fund Therapeutic Challenge Award. The trial is being conducted at the NIH Clinical Center in Bethesda, MD.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

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

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NIH launches first U.S. clinical trial of patient-derived ...

Recommendation and review posted by Bethany Smith

In 2020, the National Eye Institute is launching a clinical trial to test the safety of a patient-specific stem cell therapy to treat geographic atrophy, the advanced dry form of age-related macular degeneration (AMD). The protocol is the first of its kind in the United States to replace a patients eye tissue with tissue derived from induced pluripotent stem (iPS) cells engineered from a patients own blood.

If successful, this new approach to AMD treatment could prevent millions of Americans from going blind. AMD is a leading cause of vision loss in people age 65 and older. By 2050, the estimated number of people with AMD is expected to more than double from 2.07 million to 5.44 million.

The first symptoms of age-related macular degeneration are dark spots in ones central vision, which is used for daily activities such as reading, seeing faces and driving. But as the disease progresses, the spots grow larger and increase in number, which can lead to significant loss of the central vision.

There are two kinds of AMD: the neovascular, or wet, form and the geographic atrophy, or dry form. Remarkable progress has been made in the ability to prevent vision loss from the neovascular form. In particular, anti-VEGF therapy has been shown to preserve vision required for driving among about half of patients who take it for five years.

By contrast, no therapies exist for treating geographic atrophy. Should this NEI-led study, and future studies, confirm the safety and efficacy of iPS cell-derived RPE-replacement therapy, it would likely be the first therapy approved for the treatment of geographic atrophy.

To produce the therapy, we isolate cells from a patients blood and, in a lab, convert them into iPS cells. These iPS cells are theoretically capable of becoming any cell type of the body.

The iPS cells are then programmed to become retinal pigment epithelium (RPE). RPE cells are crucial for eye health because they nourish and support photoreceptors, the light-sensing cells in the retina. In geographic atrophy, RPE cells die, leading to the death of photoreceptors and blindness. The goal of the iPS cell-based therapy is to protect the health of the remaining photoreceptors by replacing dying RPE tissue with healthy iPS cell-derived RPE tissue.

We grow a single-cell layer of iPS cell-derived RPE on a biodegradable scaffold. That patch is then surgically placed next to the photoreceptors where, as we have seen in animal models, it integrates with cells of the retina and protects the photoreceptors from dying.

This years clinical trial is a phase I/IIa study, which means it will focus solely on assessing the safety and feasibility of this RPE replacement therapy. The dozen participants will have one eye treated. Importantly, everyone will already have substantial vision loss from very advanced disease, such that the therapy is not expected to be capable of significant vision restoration. Once safety is established, later study phases will involve individuals with earlier stage disease, for which we are hopeful that therapy will restore vision.

A safety concern with any stem cell-based therapy is its oncogenic potential: the ability for cells to multiply uncontrollably and form tumours. On this point, animal model studies are reassuring. When we genetically analysed the iPSC-derived RPE cells, we found no mutations linked to potential tumour growth.

Likewise, the risk of implant rejection is minimised by the fact that the therapy is derived from patient blood.

Several noteworthy innovations have occurred along the way to launching the trial. Artificial intelligence has been applied to ensure that iPS cell-derived RPE cells function similar to native RPE cells. In addition, Good Manufacturing Practices, have been developed to ensure quality control, which will be crucial for scaling up production of the therapy should it receive approval from the U.S. Food and Drug Administration. Furthermore, the iPS cell-derived RPE patch is being leveraged to develop more complex RPE/photoreceptor replacement therapies.

Potential breakthroughs in treatment cannot move forward without the support of patients willing to participate in clinical trial research. Patients who volunteer for trials such as this are the real heroes of this work because theyre doing it for altruistic reasons. The patients in this first trial are not likely to benefit, so they are doing it to help move the field forward for future patients.

Editor's Recommended Articles

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Eye health: Testing the safety of stem cell therapy for age-related macular degeneration - Open Access Government

Recommendation and review posted by Bethany Smith

We are thrilled to share an excerpt form Dr. Q Schulte aufm Erley's article on Plant Stem Cells. Dr. Q is an entrepreneur, scientist and founder of one of our most loved partners: Shtrands. Shtrands is a beauty industry innovator. They provide a hair care concierge service that brings you curated products and expert advice to match your hair texture, scalp condition and styling needs.

The highly competitive cosmetics industry is always looking for the next best ingredient(s) that can fight the aging process and this led to a sizable increase in the number of anti-aging products on the market. With this is coming an increased number of active ingredients developed for this category; one of these ingredients is stem cell extract.This is an ingredient that must be assessed carefully, as marketing claims often push the limits of the available science.

The concept of stem cells originated at the end of the 19th century as a theoretical postulate to account for the ability of certain tissues (blood, skin, etc.) to renew themselves for the lifetime of organisms even though they are comprised of short-lived cells. Stem cells isolation and identification happened many years later though.

Stem cells have received a fair share of attention in the public debate mostly in connection with their potential for biomedical application and therapies. While the promise of organ regeneration have captured our imagination, it has gone almost unnoticed that plant stem cells represent the ultimate origin of much of the food we eat, the oxygen we breathe, as well the fuels we burn. Thus, plant stem cells may be ranked among the most important cells for human well-being.

A stem cell is a generic cell that can make exact copies of itself (daughters) indefinitely. These daughters can remain stem cells or further undergo differentiation (2). Such that a stem cell has the ability to make specialized cells for various tissues in the body, such as heart muscle, skin tissue, and liver tissue.

Because of their self-renewal functions, stem cells are the most important cells in the skin, as they are the source for continuous regeneration of the epidermis. Stem cell cosmetics are developed based on stem cell technology, which involves using extracts or culture media of stem cells. However, cosmetics containing human stem cells or their extracts have not been released into the market due to legal, ethical, and safety concerns. Meanwhile, plant stem cells, which circumvent these problems, are highly regarded in the cosmetics industry for improving culture technology.

The EUprohibits the use of cells, tissues, or products of human origin in cosmetics; stem cell therapy for anti-aging has not been approved or been deemed safe or effective in USA by the FDA. Furthermore, its use outside of a clinical research trial (which would be listed at http://www.clinicaltrials.gov) is prohibited. Whereas the Korea Food and Drug Association has allowed the use of sources originating from stem cell media in cosmetics since 2009 (3).

So, any cosmetics marketed as containing stem cells found on US market (should) contain stem cells extracted from plants.

A major difference between animal and plant stem cells is that plant stem cells provide cells for complete organs (branches, leaves, etc.), compared with the animal stem cells, which regenerate cells restricted to one tissue type.

Plants have nowhere to run when times get tough, so they must rely on an inner body plan to generate developmental responses to environmental changes.

Research by many labs in the last decades has uncovered a set of independent stem cell systems that fulfill the specialized needs of plant development and growth in four dimensions. In some long-lived plants, such as trees, plant stem cells remain active over hundreds or even thousands of years, revealing the exquisite precision in the underlying control of proliferation, self-renewal and differentiation.

There is some confusion around the term stem cell due to the marketing verbiage used by the cosmetic companies. In topical cosmetics the formulations dont contain stem cells straight out of the plants. They are actually a range ofplant stem cell extracts, which are manufactured using a cell culture technology.This technology consists of many and complicated methods that should ensure growth of plant cells, tissues or organs in the environment with a microbe-free nutrient. The plant cell technologyallows synthesis of the biologically active substances that exist in plants, but are not commonly available in natural environment or are difficult to obtain by chemical synthesis.

The extracts obtained through this technology from the plant stem cells are currently used for production of both common or professional care cosmetics (4).

The beneficial apple properties are known for centuries. Apples are cultivated today only for their taste, but earlier the main criterion of the type selection was the shelf life of the fruits.

One of such apple-tree types isUttwiler Spatlauberwhich is growing in Switzerland. This is a type cultivated solely due to a possible long-time storage of fruits, which remain fresh even for several months.Some trees come from the plant cutting sets planted during the 18th century!!!

The stem cell extracts are made in 2 main steps: first, the tissue material is obtained from apples (collected from a cut surfaces of the apples). Secondly, the material is going through a complicated biotechnological process to make the stem cell extracts that contains certain active ingredients. These are actually the ingredients used in formulations marketed as containing stem cells (5).

Swiss biotech company Mibelle Biochemistry created the product named PhytoCellTecTMMalus Domestica, that is a liposomal formulation (extract) derived from the stem cells of the Uttwiler Spatlauber apples. The company has published in vitro experiments done with hair follicles that showed the ability of theUttwiler Spatlauberstem cell extract to delaying of the tissue atrophy process (6); this ingredient delays hair aging.

At Teadora, we chose to includeMibelle'sPhytoCellTecTM Argan Plant Stem Cells in our ButterandBrazilian Glow Oiland here are the details from Mibelle that helped to convince us this ingredient was a must have companion to the huge list of active superfruits we crafted into our products, read on, it's pretty cool:

Deep-Seated Rejuvenation of the Skin:In order to maintain the skin in a healthy condition,cutaneous tissue is being continuously regenerated.This regenerative capacity relies on adult stem cells inthe skin. While considerable research has been done onepidermal stem cells, dermal stem cells were identifiedonly in 2009. The dermis is the middle layer of the skinand gives it tensile strength and elasticity, therefore it isalso the site where wrinkles originate.

PhytoCellTec Argan was developed to improvethe regenerative capacity of dermal stem cells therebyachieving deep-seated rejuvenation of the skin.

PhytoCellTec Argan is a powder based on stem cellsof the argan tree, one of the oldest tree species in theworld.In order to evaluate which active ingredient effectivelypromotes dermal stem cell activity, a stable humandermal papilla cell line was used as a new test system:stem cell activity is assessed based on the expression ofthe Sox2 gene, which is an established stem cell marker.Furthermore, the characteristic property of stem cells togrow in three-dimensional spherical colonies serves asa second observable indicator of stem cell viability inthis assay.

Clinical studies performed on healthy volunteers showedthat PhytoCellTec Argan:

effectively stimulates the regeneration of dermalconnective tissue, thereby increasing skin density

helps the skin to regain its firmness

significantly reduces wrinkle depth in crows feet area.

PhytoCellTec Argan is the very first active ingredientthat is capable of both protecting and vitalizing humandermal stem cells. This will not only help to acceleratethe skins natural repair process but also fights skin agingright at the root. Here are some of the amazing benefits:

Vitalizes and protects dermal stem cells Reduces wrinkles Tightens and tones skin tissues Increases skin firmness and density Deep-seated rejuvenation of the skinFirst cosmetic active with proven results forprotecting and vitalizing dermal stem cells

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Benefits of Plant Stem Cells for Skin & Hair | Teadora

Recommendation and review posted by Bethany Smith

Dublin, March 10, 2020 (GLOBE NEWSWIRE) -- The "Cell Therapy - Technologies, Markets and Companies" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

The cell-based markets was analyzed for 2018, and projected to 2028. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 309 of these are profiled in part II of the report along with tabulation of 302 alliances. Of these companies, 170 are involved in stem cells.

Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 67 Tables and 25 Figures. The bibliography contains 1,200 selected references, which are cited in the text.

This report contains information on the following:

The report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.

Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.

Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.

Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.

Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.

Key Topics Covered

Part I: Technologies, Ethics & RegulationsExecutive Summary 1. Introduction to Cell Therapy2. Cell Therapy Technologies3. Stem Cells4. Clinical Applications of Cell Therapy5. Cell Therapy for Cardiovascular Disorders6. Cell Therapy for Cancer7. Cell Therapy for Neurological Disorders8. Ethical, Legal and Political Aspects of Cell therapy9. Safety and Regulatory Aspects of Cell Therapy

Part II: Markets, Companies & Academic Institutions10. Markets and Future Prospects for Cell Therapy11. Companies Involved in Cell Therapy12. Academic Institutions13. References

For more information about this report visit https://www.researchandmarkets.com/r/bzimne

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Cell Therapy Insights Report, 2018-2028: Markets, Technologies, Ethics, Regulations, Companies & Academic Institutions - Benzinga

Recommendation and review posted by Bethany Smith

I feel like a sacrificial lamb, or an acceptable casualty. When a politician or scientist or couch expert says, Its only the old and ill that die, they are talking about me. The coronavirus threat has changed my identity from that of a father, husband, son, friend, pastor, alcoholic with two years sobriety and a slew of chips to prove it, to that of a comforting statistic. My new identity may soon be summed up on the news when they say, Its OK. He had underlying health problems.

Im not complaining about those who are young and healthy. When I consider my children and my wife, I, like many of you, thank God for their health. Three months ago, I would have said the same thing about my health. Unfortunately, that changed in January when I finally decided to go to the doctor and have the little red spots that had formed all over my skin, along with the new bruises that showed up daily, looked at. I found out that the blood platelets that keep all of us from bleeding to death had decided to take a vacation from my body. Most people have anywhere from 150,000 to 450,000 platelets per microliter of blood. Mine were at 4,000, and there was a danger of blood seeping into my brain, ending my life.

The first time I was in the hospital, I was there for eight days. They ran tests and stuck me with needles, capping it all off with a bone-marrow biopsy. I was diagnosed with a rare blood disorder called aplastic anemia. To put it simply, my stem cells are under siege, making it difficult for my body to produce platelets, as well as red and white blood cells. I have been hospitalized around 45 days since that diagnosis. Im actually writing this article from a hospital room. Theres a truly stunning view of the hospital roof outside my window. With no white blood cells, my immune system is completely compromised, and every little infection that normal people fight off without even noticing brings me back to the hospital again.

The only cure for me is to have a bone-marrow transplant. The problem is, even though there are several matches for my transplant, in order for the transplant to go as well as possible I have to be free of infections, viruses and other diseases. Only then can I be admitted to the University of Minnesotas Blood and Bone Marrow Transplant Center. Last month this didnt bother me. Now, though, the coronavirus is coming up behind me, daring me to wait longer.

If all goes well, Ill be discharged from the hospital and self-quarantined to my house with a bag full of antibiotics and other drugs. Sadly, Ive been told that the other things I need to stay healthy and get to my transplant are gone. The hand sanitizer, the antibacterial wipes, the masks that my family should be wearing, and the N95 respirators that I need to wear are nowhere to be found someone actually stole a box of masks from outside my hospital room. Many of these items have been snatched up by the same folks who thank God they are not me.

Again, dont get me wrong. I am grateful for those who are young and healthy. They should be thankful, for they are blessed. I just pray that when they give that thanks, they remember those of us who are terrified by what is coming. We are not simply a means to calm peoples fears; we are people who deserve compassion, mercy and dignity. I ask simply that you pray for the old and sick that they might get through this, that you leave a little hand sanitizer on the shelves for us, and for goodness sake, dont take the N95 respirators from my hospital room. I need them because my family, who knows that I am more than a comforting statistic, needs me. They need the man who loves them dearly and desperately wants to continue to be their father and husband.

Howard Baird lives in Maple Grove.

Visit link:
OPINION EXCHANGE | Amid the coronavirus threat: A plea on behalf of the old and sick - Minneapolis Star Tribune

Recommendation and review posted by Bethany Smith

derma aesthetics are proud to announce the launch of the Australasian Academy of Corneotherapy in Australia and New Zealand. The academy has been established to provide cutting edge Corneotherapy and skin education to all skin therapists, with the aim of advancing the level of in-depth skin health knowledge amongst the local industry.

Simone Vescio, Founder of the Australasian Academy of Corneotherapy says, Over the past eight years we have pioneered the awareness and education of corneotherapy across Australia and New Zealand, and were thrilled to be opening up our education to the aesthetics industry in Australasia!

Throughout 2020, the AAC will be holding series of Skin Extension Education Classes with the first classes having already opened their doors and been held in Sydney and Auckland in February.

From 2020 we are opening up our educational classes, training and access to the latest information on corneotherapy to all therapists, no matter what their brand of choice may currently be. There was a lack of non-product aligned education in our local industries, and were proud to be filling this gap, said Simone.

AAC Skin Extension Education 2020 - Class Schedule:Tuesday, 17 March 2020 PerthMonday, 30 March 2020 MelbourneMonday, 18 May 2020 AlburyMonday, 27 July 2020 BrisbaneMonday, 2 November 2020 Christchurch

The AAC Skin Extension Education classes have been designed to deliver comprehensive education on some of the most important and complex subjects and skin conditions. Plus, there will also be time for Q&A and further learning from your peers and educator during the day, said Simone.

Topics covered in each class include:

See the article here:
Press Release: Introducing the Australasian Academy of Corneotherapy - PRWire

Recommendation and review posted by Bethany Smith

There are only two northern white rhinos left on the planet, and theyre both female. Unless scientists can make a dramatic breakthrough, the entire species will die with those two individuals.

In a nondescript building just north of San Diego, California, the fight to save the northern white rhino is coming down to the wire. However, the battleground here looks less like a scene from a wildlife documentary and more akin to something out of a science fiction novel.

At the San Diego Zoo Institute for Conservation Research, an army of scientists armed with liquid nitrogen, microscopes, and ultrasound machines is working around the clock to create an unprecedented first in the conservation world: they are looking to turn frozen rhino skin cells into baby rhinos.

Its not just the science that is groundbreaking, but also the team looking to save this species. Composed mostly of women, the lab is a rarity in a field traditionally dominated by men.

Find out more about Call to Earth and the extraordinary people working for a more sustainable future

The first step in this conservation effort began more than four and a half decades ago in 1975 when scientists established the institutes Frozen Zoo. In a small room measuring no more than 36 square meters the skin cells of more than 10,000 individuals across 1,100 species sit in giant steel tanks suspended in time, frozen in liquid nitrogen.

Among the collection are the skin samples of 12 northern white rhinos. These are vital to the groups efforts because there is such a small gene pool of living northern whites.

The population has been decimated by poachers, who target rhinos because of the belief in parts of Asia that their horns can cure various ailments. The two surviving females both live under guard at the Ol Pejeta Conservancy in Kenya. Even thoughembryos have been producedin an Italian lab using eggs extracted from the pair, any future descendants from this kind of embryo would carry the genes of those two females.

That may not be enough genetic diversity to maintain a stable population. The hope is that the skin samples of those 12 individuals at the Frozen Zoo contain enough diversity to sustain the northern white species long-term.

The arduous task for these scientists is to create a rhino population from those samples.

Marlys Houck is curator of the Frozen Zoo. She graduated high school in 1979, the same year the Frozen Zoo froze its very first northern white rhino skin cell. She later joined the institute to work on the rhino project.

I was hired specifically to try to make the cells of the rhinos grow better because they were one of the most difficult to grow cell lines, she told CNN.

Since then, shes figured out how to successfully grow and freeze the skin cells of the northern white.

The impact of this work is not lost on her. Were losing species so rapidly, she said. One of the things we can do is save the living cells of these animals before its too late.

Were at the forefront of science today, she added. If we do everything right these cells should be here 50 years from now being used for purposes that we cant even imagine today.

Marisa Korody is one of the four scientists tasked with turning these frozen cells into new life. They have to reprogram the frozen skin cells into pluripotent stem cells. In laymans terms, Korody explains that stem cells can become any cell type in the body if theyre given the right signals.

The aim is to ultimately turn the stem cells into sperm and eggs. The ambitious feat has only been achieved in animals by Japanese scientists. While Korody and her team have looked to that research as a road map, she admits that doing the same with rhinos is uncharted territory. We dont really know what twists and turns we need to take in order to get from A to B, she said.

They havent even figured out how to do this in humans, she added. We have as much information as we possibly can about humans. We have a fraction of that for rhinos.

Korody says being at the forefront of this kind of science has been a dream job. This was really the first project thats trying to apply this type of science to conservation as a whole, she said.

She may spend most of her time at work looking through the lens of a microscope, but her mind is always on the final goal for the rhinos: We want to be able to put them back into the wild one day and have them living free.

Because the remaining two female northern white rhinos cant carry a pregnancy, even if the team can create embryos, the last obstacle is finding rhinos who can carry them to term.

The woman tasked with that job is Barbara Durrant. As the director of reproductive sciences, shes spent four years studying the reproductive systems of six female southern white rhinos at the institutes sister facility, the Nikita Kahn Rhino Rescue Center.

Though the rhinos at the center are a different species, Durrant says they are the closest relative to the northern white. The aim is to eventually have them be surrogates for northern white embryos.

On any given day, Durrant can be found conducting ultrasounds to help her understand each rhinos distinct reproductive cycle. In 2019, two of the centers females gave birth to southern white babies. Both were conceived via artificial insemination, giving Durrant and the teams working on the rhino project hope for the future.

Durrant believes one reason the project works so well is because there are so many women involved. Women are naturally collaborative with each other, she said. Because we have so many obstacles along the way and challenges and setbacks, we support each other and we have sympathy for each other.

Read: Rare bird brought back from extinction in the wild

Houck says women tend to be naturally nurturing. The cells are living little organisms that were growing and tending almost every day, and I think women are drawn to taking care of something and growing it into something more.

Its wonderful leading a team of women, and I really think theyre changing the world, she added. People are going to look back and see it was this amazing group of women who quietly, unrecognized, work at this and just get better and better.

Read the rest here:
Meet the women racing to save the northern white rhino from extinction in San Diego - KTLA

Recommendation and review posted by Bethany Smith

NanoSurface Biomedical announced today that it has executed an exclusive IP license agreement related to innovative heart-on-chip technology developed by researchers at the University of Washington (UW). An experimental system built from the same heart-on-chip technology was launched into space on Friday, March 6, 2020 at 11:50 PM EST aboard SpaceX's 20th resupply mission to the International Space Station (ISS) as part of the Tissue Chips in Space initiative conducted in partnership between the National Center for Advancing Translational Sciences (NCATS) and the ISS U.S. National Laboratory (ISS National Lab). NanoSurface will commercialize the heart-on-chip platform for use by pharmaceutical companies in preclinical drug development.

The heart-on-chip system will spend 30 days aboard the ISS as part of a series of experiments intended to study the effects of microgravity on human cells and tissues. "In space we are using the heart-on-chip system in microgravity conditions to help improve our understanding of the aging process and cardiac biology, but this heart-on-chip system also has enormous potential for accelerating the discovery of new medicines back here on Earth," said Deok-Ho Kim, an Associate Professor of biomedical engineering and medicine at Johns Hopkins University, the principal investigator for the heart-on-chip experiment aboard the ISS, and the scientific founder of NanoSurface Bio.

The heart-on-chip platform uses three-dimensional engineered cardiac tissues (3D ECTs) grown from human cardiomyocytes, or beating heart cells, derived from induced pluripotent stem cells (iPSCs). As the 3D ECTs beat, researchers can measure the amount of force generated by each contraction, and then evaluate how that force changes after treating the tissues with candidate drugs. 3D ECTs can be made from cells from either healthy individuals or individuals with diseases, offering great promise in predictive preclinical testing of candidate drugs for safety and efficacy.

"I am incredibly excited that the talented team at NanoSurface will be carrying this technology forward for use in the drug development industry," said Nathan Sniadecki, one of the inventors of the heart-on-chip technology and a professor of mechanical engineering at UW. Last year, Professor Sniadecki joined NanoSurfaces board of scientific advisors to guide the commercial development of the technology.

NanoSurface Bios execution of this exclusive license adds significant value to the portfolio of IP it has already licensed from researchers at UW. "It is well recognized that the drug development process is extremely slow and expensive. At NanoSurface we are eager to develop technologies that enable the use of human iPSC-derived cells and tissues in preclinical drug development, ultimately leading to better prediction of how drugs will affect patients in the clinic, lowering costs, and speeding life-saving medicines to market," said NanoSurface CEO Michael Cho.

About NanoSurface Biomedical

NanoSurface Biomedical is a biotechnology company based in Seattle, WA that develops stem cell-based assay technologies to accelerate drug development. NanoSurfaces structurally matured cardiac tissue models, assay instruments, and discovery services leverage human stem cell technology to help pharmaceutical companies predictively assess the safety and efficacy of candidate drugs early during preclinical development. NanoSurfaces mission is to help bring life-saving medicines to market in less time and at lower cost. To learn more, visit http://www.nanosurfacebio.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200309005703/en/

Contacts

NanoSurface BiomedicalDirector of Sales & Marketing: Heejoon Choi, 800-913-4403 x702heejoon@nanosurfacebio.com

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NanoSurface Bio Executes Exclusive License of Heart-on-Chip Technology Launched Into Space - Yahoo Finance

Recommendation and review posted by Bethany Smith

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.

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

Recommendation and review posted by Bethany Smith

NATIONAL HARBOR, Maryland Long-term opioid use in men is linked to a significantly increased risk for hypogonadism, new research suggests.

Findings from a retrospective case-control study show that men who used long-acting opioids on a long-term basis had close to a 1.5-fold increased risk of developing the condition. Moreover, for every increase in 100 maximum morphine equivalent daily dose (MEDD), there was a 44% increase in risk.

Dr Natalie Hanks

Hypogonadism, a condition in which little or no testosterone is produced by the testes, puts men at risk for infertility and osteoporosis, but such adverse endocrine effects of long-term opioid use are frequently unrecognized, study investigator Natalie Hanks, MD, Ochsner Clinical School, University of Queensland University Medical Center, New Orleans, Louisiana, told Medscape Medical News.

The findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.

The investigators note that opioid-induced androgen deficiency (OPIAD) can be detrimental to patients' quality of life as well as to the healthcare system.

The investigators examined the dose-response relationship between opioids and hypogonadism to shed more light on future diagnosis and management of OPIAD.

The researchers analyzed data from 357 men aged 1880 years with long-term opioid use, defined as using opioids continuously for longer than 3 months.

Exclusion criteria included the following: a diagnosis of hypogonadism prior to initiation of long-term opioid use; a history of Klinefelter syndrome, a rare genetic condition in which a male is born with an extra copy of the X chromosome; other chromosomal abnormalities; cryptorchidism; varicocele; myotonic dystrophy; mumps; radiotherapy to the testes; testicular torsion; long-term corticosteroid use; prostate cancer; or an endocrine disorder.

In total, 95 long-term opioid users had hypogonadism and served as case patients; 263 long-term opioid users did not have hypogonadism and served as control patients.

Case patients were matched to control patients by age, race, and body mass index in a 1:4 ratio. MEDD data were collected from electronic health records.

The prevalence of hypogonadism varied with MEDD dose. It was 15.6% for MEDD <100; 27.1% for MEDD 100199; 41.5% for MEDD 200299, 35.7% for MEDD 300499; and 50% for MEDD 500800.

Interestingly, for 14 patients, the estimated probability of hypogonadism plateaued in the MEDD 500800 range.

The results also showed a significant linear association between maximum MEDD and the odds of developing hypogonadism with long-term use of long-acting opioids (odds ratio, 1.44; 95% confidence interval, 1.16 1.78) by 100 units' difference in maximum MEDD.

"I feel as if hypogonadism is often overlooked or forgotten among all of the other side effects that go along with opioid use," Hanks said. "Our findings require replication in other clinical settings, but our results do suggest that we should start to look for signs of hypogonadism and opioid-induced androgen deficiency in this population and try to diagnose and treat it promptly."

Commenting on the findings for Medscape Medical News, Robert Bolash, MD, Cleveland Clinic, in Ohio, said the study provides important information about an often ignored side effect of long-term opioid use.

Dr Robert Bolash

This "well-matched control trial was conducted in a sizeable cohort and shows a thought-provoking dose-response curve," said Bolash.

"The relationship appears to be nonlinear, with particular hazard at low and moderate doses, then a plateau at high-dose therapy ranges. It would be interesting to see if duration of therapy was similarly hazardous or if dose was the primary driver of this endocrine dysfunction," he added.

Bolash also said the study is an important reminder about this important side effect of long-term opioid used.

"Contemporary pain physicians often consider the respiratory depressant and gastrointestinal side effects of this class of therapy, and may need to revisit the notable challenges that opioids can impart on the endocrine side effects as well," he noted.

Hanks and Bolash report no relevant financial relationships.

American Academy of Pain Medicine (AAPM) 2020 Annual Meeting: Abstract LB015. Presented February 27, 2020.

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Long-term Opioid Use in Men Linked to Hypogonadism - Medscape

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Latest Report on Hormone Replacement Therapeutics Market size | Segment by Applications (Menopause, Hypothyroidism, Growth Hormone Deficiency, Male Hypogonadism and Other Diseases), by Type (Estrogen Hormone, Growth Hormone, Thyroid Hormone and Testosterone Hormone), Regional Outlook Opportunity, Market Demand, New Latest Trends, Hormone Replacement Therapeutics Market Share & Revenue by Manufacturers, Leading Companies Profiles, 2026. Analyzes current market size and upcoming Few years growth of this industry.

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This report is highly informative document with inclusion of comprehensive market data associated with the significant elements and subdivision of the Global Hormone Replacement Therapeutics Market that may impact the growth scenarios of the industry. The report may commendably help trades and decision makers to address the challenges and to gain benefits from highly competitive Global Hormone Replacement Therapeutics Market.

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A former chef living in the UK has become the second person in the world to be 'cured' of HIV, according to scientists.

Adam Castillejo has remained free of HIV for two-and-a-half years since he was given ground-breaking therapy at Hammersmith Hospital in west London.

The 40-year-old, who was born in Venezuela but lives in England, received a transplant of bone marrow stem cells that rid him of the AIDS-causing virus.

The donor's DNA carries a gene mutation that makes blood highly resistant to the virus.

His doctor Professor Ravindra Kumar Gupta, of the University of Cambridge, said: "We propose these results represent the second ever case of a patient to be cured of HIV."

American Timothy Ray Brown, now 54, became the first person to be cured of HIV/AIDS in 2011.

He was dubbed "The Berlin Patient" because he lived in the city at the time - and was treated there.

Prof Gupta said: "Our findings show the success of stem cell transplantation as a cure for HIV, first reported nine years ago in the Berlin patient, can be replicated."

Mr Castillejo has received bone marrow stem cells for the past three years from a donor who carries a rare gene called CCR5 that stops HIV in its tracks.

He has also spent 18 months without taking anti-retroviral drugs - the medication that controls the virus and stops it progressing.

Mr Castillejo told the New York Times he was in a "unique and very humbling position."

He said: "I want to be an ambassador of hope."

As a young man, he made his way first to Copenhagen and then to London in 2002 he was found to be HIV positive in 2003.

Reporting his case in The Lancet HIV, Prof Gupta says long-term follow-up "suggests no detectable active HIV virus remains in the patient."

He added: "Although the treatment is high-risk and only suitable for certain patients, the results provide evidence this patient is the second to be cured of the virus - replicating the finding that HIV cure is possible through stem cell transplantation."

Prof Gupta pointed out Mr Castillejo and Mr Ray Brown were given stem cells to treat cancer, not HIV.

Stem cell and bone marrow transplants are life-threatening operations. Dangers lie in the patient suffering a fatal reaction if substitute immune cells don't take.

Medication that lowers the virus to an undetectable level is a safer option for those living with HIV.

Prof Gupta said: "It is important to note this curative treatment is high-risk, and only used as a last resort for patients with HIV who also have life-threatening haematological malignancies.

"Therefore, this is not a treatment that would be offered widely to patients with HIV who are on successful anti-retroviral treatment."

But the successes shed light on how a more widely applicable cure might be developed in the future, say the team.

Mr Castillejo has a healthy number of immune cells, suggesting he has recovered well.

What's more, 99 percent are derived from the donor's stem cells, indicating the transplant had been successful. This suggests a "99 percent probability of cure," said the researchers.

But Mr Castillejo will need continued, but much less frequent, monitoring for re-emergence of the virus.

Co-author Dr Dimitra Peppa, of the University of Oxford, said: "Gene editing using the CCR5 has received a lot of attention recently.

"The London and Berlin patient are examples of using the CCR5 gene in curative therapies outside of gene editing.

"There are still many ethical and technical barriers - for example gene editing, efficiency and robust safety data - to overcome before any approach using CCR5 gene editing can be considered as a scalable cure strategy for HIV."

Some 37 million people worldwide are currently infected with HIV and the AIDS pandemic has killed around 35 million people worldwide since it began in the 1980s.

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Former UK-based chef is second person in the world to be 'cured' of HIV - Mirror Online

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The second person ever to be cleared of HIV has revealed his identity, saying he wants to be an ambassador of hope to others with the condition.

Adam Castillejo, the so-called London patient, was declared free of HIV last year, 18 months after stopping antiretroviral therapy following a stem cell or bone marrow transplant to treat blood cancer.

Castillejo, 40, went public on Monday in an interview with the New York Times and revealed he had been living with HIV since 2003.

In 2012 he was diagnosed with Hodgkin lymphoma and subsequently underwent a stem cell transplant. Crucially, the medical team picked a donor whose stem cells had two copies of a mutation that meant the white blood cells they developed into were resistant to HIV.

Timothy Brown, known as the Berlin patient and the first person to be cleared of the virus, underwent a similar treatment. However, while Brown and Castillejo had chemotherapy, only Brown had radiotherapy as part of his cancer treatment.

Last year it emerged the procedure had not only successfully treated the cancer, but that Castillejo was in remission for HIV as well. However, he chose to remain anonymous at the time.

I was watching TV and its like, OK, theyre talking about me, he told the New York Times. It was very strange, a very weird place to be.

Now Castillejo has decided to reveal his identity because he wants his case to be a cause for optimism. This is a unique position to be in, a unique and very humbling position, Castillejo said. I want to be an ambassador of hope.

Stem cell transplants are not suitable for most people with HIV because they involve a serious and invasive procedure that carries risks.

However, drug advances mean people who are HIV positive can take a pill every day to reduce their levels of the virus, preventing transmission and helping them to live a long and active life.

Prof Ravindra Gupta, the first author of the new study from Cambridge University, said Castillejos case was important: It is a second case of cure,. It means the first one wasnt an anomaly or a fluke.

This article was amended on 10 March 2020. An earlier version was wrong to say that Adam Castillejo had acute myelogenous leukaemia. This has been corrected to say he was diagnosed with Hodgkin lymphoma.

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Second person ever to be cleared of HIV reveals identity - The Guardian

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NEW YORK, March 10, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited(Nasdaq: MESO; ASX:MSB) today announced that it plans to evaluate its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the United States, Australia, China and Europe. The Company is in active discussions with various government and regulatory authorities, medical institutions and pharmaceutical companies to implement these activities.

Mortality in COVID-19 infected patients with the inflammatory lung condition acute respiratory distress syndrome (ARDS) is reported to approach 50%, and is associated with older age, co-morbidities such as diabetes, higher disease severity, and elevated markers of inflammation.1 Current therapeutic interventions do not appear to be improving in-hospital survival.1

Remestemcel-L has potential for use in the treatment of ARDS, which is the principal cause of death in COVID-19 infection.1 This is supported by recently published results from an investigator-initiated clinical study conducted in China which reported that allogeneic MSCs cured or significantly improved functional outcomes in all seven treated patients with severe COVID-19 pneumonia.2

Additionally, in post-hoc analyses of a 60-patient randomized controlled study in chronic obstructive pulmonary disease (COPD), remestemcel-L infusions were well tolerated, significantly reduced inflammatory biomarkers, and significantly improved pulmonary function in those patients with elevated inflammatory biomarkers. Since the same inflammatory biomarkers are also elevated in COVID-19, these data suggest that remestemcel-L could be useful in the treatment of patients with ARDS due to COVID-19.The COPD study results have been submitted for presentation at an international conference, with full results to be submitted for publication shortly.

Remestemcel-L is being studied in numerous clinical trials across several inflammatory conditions, including in elderly patients with lung disease and adults and children with steroid-refractory acute graft versus host disease (aGVHD).3-5 This product candidate is currently being reviewed by the United States Food and Drug Administration (FDA) for potential approval in the treatment of children with steroid-refractory aGVHD.

Remestemcel-L Remestemcel-L is being developed for rare pediatric and adult inflammatory conditions. It is an investigational therapy comprising culture-expanded MSCs derived from the bone marrow of an unrelated donor and is administered in a series of intravenous infusions. Remestemcel-L is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in several diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

Intellectual PropertyMesoblasts intellectual property (IP) portfolio encompasses over 1,000 patents or patent applications in all major markets and includes the use of MSCs obtained from any source for patients with acute respiratory distress syndrome (ARDS),and for inflammatory lung disease due to coronavirus (COVID-19), influenza and other viruses. Additionally, these patents cover Mesoblasts manufacturing processes that yield industrial-scale cellular medicines.This IP position is expected to provide Mesoblast with substantial commercial advantages as it develops its product candidates for these conditions.

References1. Liu Y et al. Clinical features and progression of acute respiratory distress syndrome in coronavirus disease 2019. Medrxiv 2020; https://doi.org/10.1101/2020.02.17.200241662. Leng Z, et al. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia[J]. Aging and Disease, 10.14336/AD.2020.02283. Kurtzberg J et al. Annual Meeting of the American Society for Transplantation Cell Therapy, 2020.4. Chaudhury S et al. A Phase 3 Single-Arm, Prospective Study of Remestemcel-L, Ex-Vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Steroid Refractory Acute GVHD in Pediatric Patients. Biol Blood Marrow Transplant 2018; 24:S119S290.5. Kurtzberg J et al. Allogeneic human mesenchymal stem cell therapy (remestemcel-L, Prochymal) as a rescue agent for severe refractory acute graft-versus-host disease in pediatric patients. Biol Blood Marrow Transplant. 2014 Feb;20(2):229-35.

About MesoblastMesoblast Limited (Nasdaq: MESO; ASX: MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblasts proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has filed a Biologics License Application to the United States Food and Drug Administration (FDA) to seek approval of its product candidate RYONCIL (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward- looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblasts expenses, future revenues, capital requirements and its needs for additional financing; Mesoblasts financial performance; developments relating to Mesoblasts competitors and industry; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For further information, please contact:

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Mesoblast To Evaluate Anti-Inflammatory Cell Therapy Remestemcel-L For Treatment Of COVID-19 Lung Disease - BioSpace

Recommendation and review posted by Bethany Smith

For Mr. Castillejo, the experience was surreal. He watched as millions of people reacted to the news of his cure and speculated about his identity. I was watching TV, and its, like, OK, theyre talking about me, he said. It was very strange, a very weird place to be. But he remained resolute in his decision to remain private until a few weeks ago.

For one, his doctors are more certain now that he is virus-free. We think this is a cure now, because its been another year and weve done a few more tests, said his virologist, Dr. Ravindra Gupta of the University of Cambridge.

Mr. Castillejo also tested his own readiness in small ways. He set up a separate email address and telephone number for his life as LP, as he refers to himself, and opened a Twitter account. He began talking weekly with Mr. Brown, the only other person who could truly understand what he had been through. In December, Mr. Castillejo prepared a statement to be read aloud by a producer on BBC Radio 4.

After talking through his decision with his doctors, friends and mother, he decided the time was right to tell his story.

I dont want people to think, Oh, youve been chosen, he said. No, it just happened. I was in the right place, probably at the right time, when it happened.

Mr. Castillejo grew up in Caracas, Venezuela. His father was of Spanish and Dutch descent which later turned out to be crucial and served as a pilot for an ecotourism company. Mr. Castillejo speaks reverently of his father, who died 20 years ago, and bears a strong resemblance to him. But his parents divorced when he was young, so he was primarily raised by his industrious mother, who now lives in London with him. She taught me to be the best I could be, no matter what, he said.

As a young man, Mr. Castillejo made his way first to Copenhagen and then to London in 2002. He was found to have H.I.V., the virus that causes AIDS, in 2003.

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The London Patient, Cured of H.I.V., Reveals His Identity - The New York Times

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Credit: Online Marketing on Unsplash.

When it comes to applying genomic sequencing in diagnostic medicine, increasing evidence is demonstrating that whole exome sequencing (WES) can sometimes fall short. This is a particular issue when analyzing large segments of DNA from patients and can adversely impact a physician's diagnosis.An alternative to WES is the utilization of a smaller, more targeted genetic test that analyzes a specific panel of genes known to be associated with a certain pathology. These tests are less of a financial burden on healthcare systems and patients and can offer highly accurate results. Targeted NGS is enabling this testing approach, and we're seeing increased adoption of NGS in the clinical diagnostics space.

But what barriers still exist to the full implementation of NGS, and how can we remove them? Technology Networks recently spoke with Luca Quagliata, Ph.D., Global Director of Medical Affairs for Thermo Fisher Scientific, to learn more.Molly Campbell (MC): How is genome sequencing currently utilized in the oncology diagnostics space? What are its limitations?Luca Quagliata (LQ): Sequencing of DNA and RNA is currently used in routine molecular testing for two purposes. Firstly, they are used with the aim of supporting a diagnostic decision, i.e. differential diagnosis (such as PIDGFA mutation status in gastrointestinal stromal cancer. More commonly, they are adopted to complement a pathology report by adding information related to a clinically relevant genomic variant (e.g. mutations in the EGFR gene) that are directly associated with any specific approved drug treatment (for example, BRAF inhibitors for V600E BRAF mutated melanoma patients).Some of the major limitations of genomic testing are related to quality of the starting material for testing (generally known as pre-analytic issues, e.g. tissue fixation), the ability of a given sequencing method to generate usable results (not every sequencing approach is born equal), the capability of interpreting the results (e.g. is the observed genomic variant a pathogenic alteration or is simply benign?) and finally the economic aspect. Who should pay for the test?MC: Why does WES commonly fail to adequately analyze large segments of DNA?LQ: As above mentioned, not all sequencing methods are born equal, WES can be performed using a variety of library preparation kits, possibly leading to substantially different results.1 Unfortunately, no universally accepted standard has been established for WES, especially for oncology applications.Generally, one of the most common issue is related to the sequencing depth, also known as coverage. High coverage allows to gain higher confidence in the generated results, as the genomic examined regions are analyzed multiple times, thus increasing the robustness of the data. However, high coverage comes at the cost of increasing sequencing price. Plus, even in the absence of any financial constraints, increasing coverage indefinitely is simply not possible due to technical limitations, i.e. the input material will define the maximal reachable coverage.

Furthermore, it is well established that, in certain situations, even pushing the coverage a 100-fold higher does not generate any tangible benefit in terms of data analysis output. Finally, a variety of alignment and calling algorithms can be deployed to identify large DNA segments rearrangements. Once again, no standard is strictly defined, thus the varying ability of different algorithms will greatly impact the final result. To conclude, while robust approaches are in place for single nucleotide variants (SNV) or multiple nucleotide variants (MNP), as well as insertions and deletions (INDEL), this is not the case when applying WES to study large DNA segments. Nowadays, microarray-based investigations are very popular for assessment of large genomic rearrangements.MC: Why is a targeted test more suitable in the diagnostics space?LQ: Targeted NGS is most commonly used for routine diagnostics because:

MC: NGS is becoming increasingly easier for patients to access and costs are rapidly declining. In your opinion, will we reach a stage where a genetic test is as common as, say, having a blood test when you visit your healthcare provider?LQ: While the price of NGS, meaning reagents related costs to perform the test, is undoubtedly going down, one should not forget that the largest fraction of NGS cost is generated by the human labor necessary to carry out the analysis. Thus, any technological approach that will reduce human intervention in the process will be the most effective in compressing the overall sequencing cost to enable true democratization of NGS.At Thermo Fisher Scientific, we recently made a significant step in this direction with the launch of the Ion Torrent Genexus System, the first research NGS solution that automates the entire specimen to report workflow in a single day with only two touch points.Having said that, there is no doubt that sequencing will eventually become as common as performing a classical blood check. The question is, rather, when will it happen?

In my opinion, that will largely depend not exclusively on the reduction of the overall NGS cost, but rather our ability to expand our understanding of the genomic variants clinical implications. As for now, only a limited fraction of variants can be clearly classified and associated with either a clinical condition or a drug treatment benefit. In my view, it is rather a matter of knowledge than merely a problem of costs. We use blood testing not only because it is easy and cheap, but because we can generate valuable and meaningful information through it.MC: The number of individuals undergoing direct-to-consumer genetic testing at home is on the rise. In your opinion, what impact is this having on the use of genetic testing in the clinical spaceLQ: Direct-to-consumer (DTC) genetic testing is an interesting recent phenomenon that in my view poses several questions, mainly regarding the quality of the results it provides. Several regulatory agencies have expressed concerns and are now acting with the aim of monitoring this market. In this initial and still immature phase of DTC, I strongly advocate for the implementation of a regulatory framework that should be considered not a barrier to wide genomic testing access but rather a safeguard.Should that framework be implemented, then DTC market expansion will have a positive effect on the use of genetic testing in the clinical space, as an audience of genetic-educated patients will also inevitably push physicians toward the adoption of genomics in medicine.

Should the DTC genetic market be given complete freedom, I am concerned that it would negatively impact genetic testing in the clinical space, as people might be easily convinced that managing this kind of data is simplistic, and thus the value of a controlled and professionally regulated testing approach will lose value. I think of this in relation to the "Dr Google self-medication" phenomenon.MC: What challenges still exist in the use of NGS in diagnostics?LQ: Overall NGS data generation and interpretation is still perceived as being extremely complex. Furthermore, while we are witnessing an increase in policy coverage for NGS testing, reimbursement remains a practical issue as well as NGS results being restricted to very specific indications. Finally, limited medical education and awareness regarding the value of genetic testing remains high in the healthcare community, with a substantial knowledge gap between physicians working at large academic centres and those working in the community setting. It will take a shared collective effort to remove the above-mentioned barriers to allow broad adoption of NGS in routine diagnostics. No single company, as large as it could be, can achieve such results.

We at Thermo Fisher Scientific are on the front-line supporting precision medicine through partnering with a variety of major stakeholders in the field, from patient advocacy groups to medical associations and Pharma.

Luca Quagliata, Ph.D., Global Director of Medical Affairs for Thermo Fisher Scientific, was speaking to Molly Campbell, Science Writer, Technology Networks.References:

1. Clinical Exome Studies Have Inconsistent Coverage, Clinical Chemistry, Volume 66, Issue 1, January 2020, Pages 199206.

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Removing the Barriers to Broad Adoption of NGS in Diagnostics - Technology Networks

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SAN FRANCISCO, March 10, 2020 /PRNewswire/ --The global hereditary testing marketsize is expected to reach USD 8.9 billion by 2026, expanding at a CAGR of 6.3% over the forecast period, according to a new report by Grand View Research, Inc. Key factors driving the market are declining cost of sequencing and availability of genetic tests at a lower price. Furthermore, the availability of niche and fragmented point-solutions across genomics value chain, namely sequencing, analytics, interpretation, aggregation, and marketplace, is anticipated to propel the market growth over the forecast period.

Key suggestions from the report:

Read 276 page research report with ToC on "Hereditary Testing Market Size, Share & Trends Analysis Report By Disease Type (Hereditary Cancer Testing, Hereditary Non-cancer Testing), By Region (North America, Europe, APAC, LATAM, MEA), And Segment Forecasts, 2020 - 2026" at: https://www.grandviewresearch.com/industry-analysis/hereditary-testing-market

The advent of direct-to-consumer genetics is anticipated to play a major role in the genetic testing market by enabling individuals to carry out self-testing. This expands the role of genetic counselors, which further aids in understanding the importance of genetic tests and helps in the selection of appropriate tests. A growing number of registered genetic counselors is anticipated to boost the adoption of hereditary genetic tests in the coming years.

Technology developers are introducing advanced products to enhance the efficiency of genetic tests by diagnostic companies. For example, in June 2019, QIAGEN launched a new QIAseq Expanded Carrier Screening Panel, a novel Next-generation Sequencing (NGS) panel integrated with advanced bioinformatics solutions for rare and inherited diseases testing. Such ongoing developments in the market space are expected to boost revenue growth to a large extent in the coming years.

Grand View Research has segmented the global hereditary testing market on the basis of disease type and region:

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About Grand View Research

Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

Contact:Sherry JamesCorporate Sales Specialist, USAGrand View Research, Inc.Phone: +1-415-349-0058Toll Free: 1-888-202-9519Email: sales@grandviewresearch.comWeb: https://www.grandviewresearch.comFollow Us: LinkedIn| Twitter

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Hereditary Testing Market Size Worth $8.9 Billion by 2026 | CAGR: 6.3%: Grand View Research, Inc. - Benzinga

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Maverick Coltin seemed like any other newborn when he first came home from the hospital, wearing his beanie cap with bear ears and blue-and-gray onesie and following the typical around-the-clock cycle of sleeping and breastfeeding. But within a couple of days, his parents noticed something was off. At 6 days old, Maverick completely stopped feeding. His arms and legs would stiffen and then release, the spasms punctuated by his cries.

His parents rushed him to Rady Childrens Hospital in San Diego, where EEG monitors recorded that he was having as many as 30 seizures an hour. Doctors scrambled to find the cause. Anti-seizure medicines didnt work, so he was sedated to stop the damage to his brain. His organs started to fail, and his skin turned a dusky blue. His mother, Kara Coltin, walked into his empty nursery at home and cried.

So when doctors from Radys Institute for Genomic Medicine asked for permission to sequence Mavericks genome as part of a clinical trial of ultra-rapid sequencing for newborns who are critically ill from an unknown cause, Mavericks parents didnt hesitate. The doctors cautioned that they couldnt guarantee that they would pinpoint a genetic disorder or, if they did, that it could be treated. They gave the standard caveat about genetic testingthat identifying a genetic disorder could affect Mavericks eligibility for life insurance someday. But even if the sequencing didnt help him, his participation would contribute to a study that could benefit other babies. Obviously, the pros outweighed the cons manyfold, his mother says. We just wanted his pain to stop.

Within 36 hours, the Coltins had an answer: Maverick has pyridoxine-dependent epilepsy, caused by a rare mutation of the ALDH7A1 gene, which codes for the enzyme antiquitin. By giving him high doses of vitamin B6 and controlling a couple of amino acids in his diet, doctors stopped the seizures. Maverick, now 2 years old, runs around like a normal, rambunctious toddler. He has hit all his developmental milestones, although they have been somewhat delayed. He hasnt had a seizure since his treatment began. Every once in a while, I think back on him being dusky blue and super skinny and hooked up to all these tubes, says Kara Coltin. I look at him and its hard to believe that happened to him. People who see him on a normal basis would never know he was ever sick.

The technology that saved Mavericks life stretched the limits of bioinformatics, returning results far sooner than is typical for genetic testing. Rapid sequencing typically takes about seven days for a preliminary diagnosis, while Rady completes ultra-rapid sequencing in three days or less. (In 2018, Rady set a Guinness World Record by sequencing a babys genome in 20 hours and 10 minutes.)

But now ultra-rapid sequencing is moving from an investigational tool to a standard of care. Blue Shield of California is the first insurer to cover rapid and ultra-rapid sequencing of babies and children who have life-threatening and unexplained medical conditions. Since the new policy began in July 2019, 28 babies or children in California have received the testing through Blue Shield, which is just beginning to promote the new coverage.

Blue Shield expects that 250 to 500 newborns will be eligible for the whole genome sequencing each year, which represents about 10 percent of their insured babies treated in neonatal intensive care units in California. Company executive vice president Terry Gilliland said he will encourage other Blue Cross and Blue Shield plans around the country to adopt a similar policy. When you think about all the pain and suffering families go through with sick babies, this is going to be an enormous benefit, he says.

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Ultra-Fast Genome Sequencing Could Save the Lives of Newborns - WIRED

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Dr. Zsofia Stadler, a co-director of the CCFs annual EAOCRC Summit, discussed hereditary risks for colorectal cancer, and how primary care physicians play a role in documenting family history.

BY Kristie L. Kahl and Zsofia Stadler

Transcript:

Kristie L. Kahl: What are family risks associated with colorectal cancer, including Lynch syndrome?

Zsofia Stadler: For colon cancer, we know that in the United States, every individual has about a 5% lifetime risk of developing colon cancer. If you have a family history of one first-degree family relative, so that would be a parent or sibling with colon cancer, that risk increases two-fold, or a 10% lifetime risk of colon cancer. Certainly, family history is an important risk factor. In Lynch syndrome, which is the most common hereditary colon cancer predisposition syndrome, the lifetime risk for colon cancer is up to 70%.

So, its a very high risk of colon cancer. In addition to colorectal cancer, these patients are also at risk for a variety of other cancers, including women for endometrial cancer, ovarian cancer; men and women for gastric cancer, urothelial cancer, pancreas cancer. Its really a pan-cancer syndrome.

Kristie L. Kahl: Why do you think we dont talk about Lynch syndrome as much?

Zsofia Stadler: We are certainly trying to get the word out there. There are many organizations, like the Colon Cancer Foundation, that are trying to get the word out about Lynch syndrome. Interestingly, Lynch syndrome is quite common.

Its estimated that approximately 1 in 300 individuals have a Lynch syndrome, but its not as well tested for as BRCA1 and BRCA2, probably because we have known about BRCA1 and BRCA2 genes for a little bit longer and we have just started to appreciate how common Lynch syndrome really is in the population. So, I think its time to get the word out there about colon cancer risk and Lynch syndrome.

Kristie L. Kahl: How can we help to raise more awareness around this?

Zsofia Stadler: There are many different organizations that are raising more awareness. AliveNKicking is one of them. Weve worked a lot with the Romeo Milio Lynch Syndrome Foundation as well, the Colon Cancer Foundation. I think that it is extremely important.

Its also important for medical geneticists to get the word to primary care physicians. By the time the patients present to the colorectal surgeon or the medical oncologists, or even to the gastroenterologist, during their colon cancer diagnosis, its too late. And usually in the setting of Lynch syndrome, there is some family history of colorectal cancer or endometrial cancer. So, if we could engage the primary care physicians to recognize Lynch syndrome as a warning sign that maybe these patients need to be referred to for genetic testing, that would be wonderful.

Kristie L. Kahl: What role does the genetic counselor play with all of this?

Zsofia Stadler: Genetic counselors are specifically trained to talk to patients about genetic testing for genetic predisposition syndromes, and they provide counseling in the pre-genetic test appointment. Then they provide the genetic testing and give recommendations after genetic testing, including what kind of surveillance or risk-reducing surgeries a patient should undergo.

Moreover, they also help to identify at risk family members who also need genetic testing. So, they are able to provide the counseling and interpret the test results and engage other family members as well.

Kristie L. Kahl: Who should go to a genetic counselor?

Zsofia Stadler: Right now, we recommend that all patients who have a diagnosis of colorectal cancer have at least their tumor tested for markers of Lynch syndrome. This can be done with two different tests an immunohistochemical stain or a microsatellite instability tumor testing. If either one of those is positive or abnormal, then those patients automatically need genetic testing.

In addition, patients who have very early onset colon cancer should be evaluated, or those with a personal or family history of polyps that lead to very high risk of colorectal cancer.

Kristie L. Kahl: How can we help families to have these conversations?

Zsofia Stadler: Its very interesting because in the medical genetics field, especially in older generations, talking about cancer is a little bit taboo. No one wants to talk about it. Oftentimes, patients and families dont know what types of cancer grandma had, and thats especially true with the gynecologic malignancies.

They would say, she had a female cancer, but that could be ovarian, uterine or cervix, and whichever it is, that implicates different potential etiologies. Its very important that families talk about not just the fact that someone had cancer in the family, but what kind of cancer they had. At what age were they diagnosed? Because colon cancer at age 85 or 40 are very different in terms of genetic risks.

Kristie L. Kahl: If we start these conversations earlier, how can that reflect on diagnosing earlier?

Zsofia Stadler: If everyone realizes that even having one first-degree relative with colon cancer at age 60 or under, all of those individuals need colonoscopies starting at age 40. So, sometimes what happens is the primary care physicians dont even start to talk about colon cancer risk until age 50, at which time they usually start colonoscopy screening. But in some individuals, if the primary care physician was aware of the family history then they may have initiated colonoscopies sooner, or if they were aware of the polyp history.

Kristie L. Kahl: How can we help to educate primary care physicians?

Zsofia Stadler: One of the most important parts that a primary care physician can play is to take an accurate family history questionnaire. This is a relatively accurate and easy tool to implement and there have been efforts to use a tool that goes into the EMR and estimates the risk, which would be wonderful. The data shows that primary care physicians are pretty good at asking about parents. Where the primary care physicians get a little bit less exact is second-degree family history, including grandparents, aunts, uncles and even siblings, they dont ask about that.

Also, family histories are dynamic. So, if you take a family history to the initial appointment with your primary care physician, it needs to be updated over time. So, patients need to know if there is a new diagnosis in the family, they have to inform their primary care physicians. But at the same time, the primary care physicians should be asking the patient once in a while, Is there anything new going on in your family? Has anyone been diagnosed with cancer? Because sometimes, these family histories change, and you could uncover a genetic predisposition syndrome.

Kristie L. Kahl: What is your biggest piece of advice for someone who thinks theyre at risk for colorectal cancer?

Zsofia Stadler: Talking first to your primary care physician, see if you need to see a genetic counselor for genetic testing. I think thats the first step. If you dont have a primary care physician, you can also reach out to a genetic counselor and see if you meet guidelines or criteria for genetic testing.

Transcription edited for clarity.

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Cambridge Analytica has become a household name, synonymous with invasion of privacy. Its controversial entanglement with Facebook was a wake-up call about how we share information online. Of course, Cambridge Analytica is gone now, and Mark Zuckerberg has survived so far. But the fallout for Facebook feels never-ending: the initial stock drop, the congressional testimony, a record-breaking $5 billion fine from the Federal Trade Commission, a class-action suit approved by a federal judge,1 and another uncomfortable grilling in Congress.

The Facebook scandal is a cautionary tale for executives and consumers alike. But the lesson is much bigger than one about so-called fake news. The hasty reconstruction of value chains around new technologies is introducing and exacerbating ethical concerns across industries. Its a free-for-all race as companies compete to impress users with new capabilities, and whats at stake isnt just which ones survive but whether we are able to sustain a civilized society or end up in a high-tech Wild West.

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Facebook ushered in a new era of publishing by building the worlds largest content creation and distribution network, amassing billions of users. It invited content makers and advertisers to subsidize those users on a platform that many people feel they cant live without. No longer was the media value chain being orchestrated by a few large organizations; Facebook was opening up markets by enabling anyone with a keyboard and an internet connection to effortlessly plug into the worlds largest distribution system. In effect, Facebook broke apart the media value chain and simultaneously re-created it around the companys application programming interfaces (APIs).

But as Facebook helped transform an industry ecosystem, it didnt concern itself with editorial ethics. It sold access to its user base to companies like Cambridge Analytica while maintaining distance from anything posted on its own platform. Content creators could tap into end-user data to precisely target their messaging, whether the information they were putting out was false, misleading, or true. Driven by demand from billions of users, Facebook focused only on ensuring that the content on its network amassed clicks.

In this new world of publishing where authors, editors, and distributors are separate entities pursuing their own interests the scandalous consequences may seem predictable. After all, accountability also splinters with the rest of the value chain. But when no one steps up to maintain ethical standards across the system, we all suffer in the end.

Facebook is just one example of the evolving and murky world of self-defining ethics in technology. In this article, we argue that as technological systems rapidly restructure, ethical dilemmas will become more common and that well-understood theories can help us predict when and where problems may arise. Executives across industries find it enticing to democratize access to cumbersome markets like health care, lending, and publishing. But if youre the executive who happens to decouple consumer protection from mortgage lending, all the positive intentions in the world wont protect you from the unavoidable backlash.

Bottom line: Predicting where your industry will stumble within this new world can make the difference in ensuring your business flourishes with its reputation intact.

To be clear, this is not about a few software bugs resulting from a move fast and break things mentality. This is about leaders, acting in the best interest of markets and consumers, enabled by the ubiquity of the internet, who unintentionally sidestep the ethical protections that underpin society as we know it. To understand the imminent ethical crisis and why current circumstances are so different, we need to understand how value chains emerge and why even responsible technology companies may overlook their ethical obligations.

In 2001, Clayton Christensen, Michael Raynor, and Matthew Verlinden published a lauded article in Harvard Business Review, Skate to Where the Money Will Be.2 It explained what they called the Theory of Interdependence and Modularity. The theory holds that when new technologies emerge, they tend to be tightly integrated in their design because dependence among components exists across the entire system. To combat this fragility, one entity must take tight control of the systems overall design to ensure performance.

Consider the early iPhone. Apple controlled the software, hardware, and even the network to give users the best experience. There was one size, one browser, and one carrier. Features were eliminated to support battery life, capacitive touch, and call quality. In Christensens language, the designs interdependence was critical, as the phone itself struggled with basic performance issues related to its core function of voice communication. Only Apples unequivocal control made the product reasonably competitive.

Christensen and coauthors argued that, over time, the connections among different parts of complex systems become well understood. Each elements role is defined. Standards are developed. To use Christensens term, the industry becomes modular, and an array of companies can optimize and commercialize small, specific components with no meaningful impact on overall system performance. Todays iPhone consumers can choose their screen size and phone thickness, the app store is filled with tools and games from millions of different developers, and phones are available on any network. An entire smartphone industry now exists whereby consumers can pick and choose practically everything about their phones, and the software on them, to meet their individual needs.

For any new technology industry, modularization is the end state; it benefits consumers and grows the pie. Since one company no longer needs to take responsibility for the entire system, every company is free to focus on whichever elements they deem to be strategically advantageous. Christensen, Raynor, and Verlinden counseled companies to anticipate how their markets would become modular and to compete in the places most difficult to master. In the smartphone arena, chipset makers and mobile app companies gobble up all the profit in the system as they tackle the most differentiated parts of it. Playing off a famous hockey tip from Wayne Gretzky in their HBR article title, the authors coached strategists to head to where the money will be, not where it is today.

But modularization is a double-edged sword: The disaggregation of development responsibility also means the diffusion of responsibility for ethical outcomes.

And todays reality is that modularization is accelerating across industries. The internet standardized communication, architecture, and information exchange in every function, allowing new businesses to turn a profit by perfecting ever-more-narrow slices of a value chain.

Consider Lyft. When the company went public in March 2019, its filings recognized the riskthat it relied on critical third parties for payments, financing, web infrastructure, background checks, and other significant technology components.It isa massively successfulbusiness, but many of its core processes are delivered through the combined servicesof other vendors. Wed expect similar risks to be identified in the filings of almost every outgoing IPO.

The rise of companies focused on simple components of complex systems has created a virtual la carte menu from which would-be disrupters can tailor new, complex products according to customer demands. The result: a virtuous cycle that has caused a whirlwind reconstruction of value chains in every industry.

In our increasingly modular world, companies can quickly tailor products to user demands; innovation and opportunity flourish, but so do the potential risks not just to a companys bottom line and reputation but also to society at large. Innovation might be able to move with lightning speed, but our user protections do not.

The danger of trusting the pull of user demand to shape an industry is that users short-term desires dont always account for long-term societal needs. Think of the personal choice of smoking versus its secondhand effects on other people, or the short-term savings of not carrying personal health insurance versus the long-term impact on public health, or the convenience of driving your own car to work versus the societal benefit of public transportation. In many situations, a user makes a choice and society bears the burden of it.

Now lets expand this dilemma to a uniquely modern one. Imagine youre a parent who wants to educate your child about technology, given the increasing need for young people to understand engineering concepts and have some familiarity with design. You purchase a cheap 3D printer and use it to impart lessons around technology, software, and manufacturing processes. Youve brought into your home an amazing tool but also a potentially dangerous one.

For context, 3D printing (or additive manufacturing) is the process whereby a physical object is constructed using a 3D computer model and a standard machine that extrudes material to build the object, often layer by layer. These machines are extremely affordable for small-batch productions relative to the manufacturing equipment weve relied on until now. Most 3D printers cant yet create objects at the speed required for commercial scale, but flexibility was designed into their architectures from the beginning. Whereas the injection-mold manufacturing used in the last paradigm required specialized configuration, 3D printers are designed to enable someone to make almost any design a reality.

Today, 3D-printable items already range from the mundane, like plastic trinkets, to life-changing, like affordable housing. The first airplane with a 3D-printed part took flight in 2014. And the worlds first 3D-printed heart was announced in April 2019. Simply put, 3D printing will democratize the production of anything.

On its face, this is amazing. Imagine completely eliminating the organ-transplant waiting list or not having to run to a hardware store when you need a nail. Its no wonder that hundreds of thousands of households have already invested in 3D printers. The world of home-printing critical goods is imminent.

Unfortunately, putting a modular manufacturing device in every household drives the same type of value-chain disruption that Facebook enabled with its publishing API. Customers are no longer beholden to the large companies that also were responsible for producing and distributing products. Instead, any amateur designer can use inexpensive computer design software to create models for production and then distribute their designs to millions of eager consumers by leveraging distribution networks of 3D-printer makers. With a simple download, end users can now fire them off to 3D printers.

Such modularization in manufacturing allows us to bypass the controls that have existed for generations in supply chains, regulated industries, and intellectual property. Relatively benign examples abound: Your child wants a new action figure do you pay for it or just print an illegal replica? Much more serious, what if your driving-age teen puts a faulty home-printed part in your car? Even worse, consider firearms. Gun regulations vary across countries and U.S. states, but they do exist and many are enforced at the point of sale: What types of arms and ammunition can be sold and to whom? If anyone can download a model from the internet and print a weapon at home, much of our approach to gun control will be rendered moot.

Of course, most consumers bringing desktop 3D printers into their homes simply wish to take advantage of the flexibility of the new systems, not to forecast every potential use and failure of them. Users pull technology into their lives to scratch an itch: Facebook to entertain themselves and socialize, Lyft to get from point A to point B, 3D printers to educate their kids or get simple tasks done faster. Consumers dont (and shouldnt) be responsible for thinking about the implications of introducing new systems on the back of modular innovations.

As executives, if we rely on users to guide our ethical responsibilities, we are destined to be at best reactive and, at worst, too late to chart the right course.

Luckily, if you believe that the internet will continue to enable rapid modularization in every industry, there are clear ways to navigate this compelling future.

Around the time the news feeds debuted, Anne Wojcickis 23andMe began offering direct-to-consumer DNA testing: Simply spit in a vial, and 23andMe would analyze more than 600,000 genetic markers to send you information about your health risks and ancestry. Time named it the Best Invention of 2008 for pioneering retail genomics. And it was possible only because of the modularization in intellectual property related to genomics and gains in cloud computing that enabled high-volume storage, search, and processing. Of course, this modularization also created ethical gray areas.

Beyond empowering individuals with easy access to their health indicators, Wojcicki maintained a vision to accelerate and simplify medical research. The cost and time required to bring new treatments to market could be slashed with access to a sufficiently large, diverse database of consenting participants. Its easy to get caught up in the extraordinary possibilities. Its harder to consider tough questions about things like test validity, unexpected parentage discoveries, and the role of primary care providers in understanding results. Its tougher still to imagine all the new ways that access to this information might upend our existing social systems: What are your obligations to report a genetic marker for a disease to your health insurer? Can health insurers buy access to this information? What access should law enforcement have? What if you choose not to participate but your information can be easily inferred from that of a relative? And whos responsible for considering all of these questions and others?

Ownership and accountability are messy in the age of modularity.

Considering all possible societal implications is a big ask for people merely curious about their ancestry. And consumer genetic testing falls somewhere between the Centers for Medicare and Medicaid Services regulations of clinical research (consumer DNA testing is not a clinical trial) and the Food and Drug Administrations regulations of drugs, biological products, and medical devices (the FDA now lumps consumer genetic tests in with medical devices).

Wojcicki spoke about this topic for four consecutive years at Stanfords Graduate School of Business. Her take is that, despite its challenges, trust is still crucial to keeping the health care system functioning. Therefore, if individuals couldnt contemplate the wide-ranging effects, and if regulators couldnt keep up with the breadth and pace of change, Wojcicki had to take responsibility to deliver that trust. Borrowing a proven concept from the existing health industry, she engaged an independent institutional review board to serve as ethical adviser on all of 23andMes activities.

The fact is, 23andMes data can be used for earth-changing research and, at the same time, have unexpected destructive effects. Skipping the middlemen of primary care providers in ordering genetic tests or of clinical research organizations in collecting data is not a question of morality but of how we as a society maximize the benefits while controlling costs. Pertinent applications of 23andMes data will be debated, probably for years, before something like public consensus develops.

Weve already seen that modularity enables businesses to quickly scale to entire populations, after discovering and delivering what users want and that this speed shortcuts our long-standing approaches to public scrutiny. By seeking out third-party advisers to review the use of their data, Wojcicki has created a countervailing power to represent the societal viewpoint, just as any traditional research institution would maintain.

In redefining the way we access medical information and participate in research, direct-to-consumer genetic testing is another area where modular innovations could fail us without thoughtful action. The FDA, and certainly an individual consumer, cannot possibly consider all the positive and negative implications of merely spitting in a cup. The companies that find enormous value in this act must take on some of the ethical onus, as 23andMe has set out to do.

Christensen et al.s Theory of Interdependence and Modularity is a powerful explanation of how value chains evolve and of the influence of consumer demand. As value chains split apart, innovators can reassemble them in response to customers desires, in ways that take advantage of new technological options. Executives who embrace these changes should also seek to conscientiously address the often less-than-obvious ethical issues that arise. We suggest three courses of action:

1. Assume you become the standard bearer. Most innovators are comfortable playing on the margin. As disrupters who embrace modularity come up from below, its easy for them to point to traditional businesses and refer to their ability to fulfill complex needs in the market. But success as a disrupter should come with a sense of obligation to change the paradigm, particularly when the upstart turns into the dominant platform. So instead of focusing only on the outcomes of your initial attack, work backward. Assume you become dominant. Then ask what is most likely to break, what can be done to prevent breaks, and how to handle them when they occur.

2. Document the safeguards that would have prevented such failure in the current system. Borrow a page from lean process improvement and start by mapping the complete value chain for the service youre providing as it existed before your company arrived. Next, chart out the future state in which youre dominant. Chances are, youve created an efficiency by removing or reducing the scope of some step. Learn the history of how this step evolved, and consider the safeguards ingrained within it: Are they regulatory? Are they related to standards? Are they social constructs? Consider the protections inherent in restricted access: What education or training did those with access have? If it helps, imagine how a horde of naive teenagers might misuse or misunderstand your service. Definitely contemplate how it may be used by malicious actors. Safeguards have protected consumers as well as the market. Know them, and plan for how they will be addressed in the future state.

3. Identify who is responsible for delivering these capabilities. In some cases, it will be crystal clear: Ride-share services could not survive without trust in drivers, so Lyft and Uber must ensure background checks are done, even if they dont conduct them directly. In other cases, it wont be obvious: Are 3D printers just a platform facilitating exchange between model designers and consumers? Leaders need to anticipate that theyll be held accountable for the failures of the changes they usher in.

To put these recommendations into practice, its important to assume success, understand the gaps, and take responsibility for the future that will be created. The particulars of implementation will vary by industry and company, of course. But we believe strongly that these three actions are key to recognizing where ethical uncertainties may arise from modularity and how to responsibly navigate that change.

The model for the Liberator, a 3D-printable plastic gun, was downloaded more than 100,000 times before a federal judge blocked the posting of 3D gun blueprints online.3 Lucky for us all, not every household has a 3D printer; the printed parts have to be meticulously assembled; and, even when built correctly, the gun produced is unreliable (its just as likely to misfire on its owner as on the intended target). In time, these complications will be worked out. But that also means theres time for regulators to plan for the obvious threat.

In other arenas, we should be more concerned. Industries such as lending, media, employment, and health care as we know them have evolved over the course of decades; their protections were sometimes hard-won and sometimes inherent in the very nature of the previous operators or target audiences. Faster than ever, disrupters and large corporations alike are reforming these value chains to take advantage of blazing-fast transfer of information, the application of artificial intelligence, and the creation of marketplaces and networks that distribute low-margin work. Its optimistic and reckless to assume that the existing protections will automatically port over to the newly modular systems.

Strict compliance with the laws, while crucial, is also insufficient to avoid the ethical pitfalls. In a piece for CNN Business, the former COO of Cambridge Analytica, Julian Wheatland, reflected on the scandal: Cambridge Analytica made many mistakes on the path to notoriety. But its biggest mistake was believing that complying with government regulations was enough and thereby ignoring broader questions of data ethics and public perception.4

Lesson: The only rational solution is to embrace new ethical paradigms in a thoughtful way. Every executive should imagine the future that is bound to arrive and consider both the path toward consumer delight and the systemic protections that will be required.

Max Wessel (@maxwellelliot) is chief innovation officer at SAP, responsible for technology research and product incubation efforts. Nicole Helmer (@nikkihelmer) is a decision scientist at SAP, working at the intersection of customer experience, emerging technologies, and new product development.

1. J. Stempel, Judge Lets Facebook Privacy Class Action Proceed, Calls Companys Views So Wrong, Reuters, Sept. 9, 2019, http://www.reuters.com.

2. Building on a theory popularized by Kim B. Clark: C.M. Christensen, M.E. Raynor, and M. Verlinden, Skate to Where the Money Will Be, Harvard Business Review 79, no. 10 (November 2001): 72-83.

3. C. Domonoske, Federal Judge Extends Order Blocking 3D Gun Blueprints From Internet, NPR, Aug. 27, 2018, http://www.npr.org.

4. J. Wheatland, I Was a Top Executive at Cambridge Analytica. It Taught Me a Tough Lesson About Public Trust, Perspectives, CNN Business, Aug. 19, 2019, http://www.cnn.com.

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A Crisis of Ethics in Technology Innovation - MIT Sloan

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