The United Nations has failed: Fixing the world is now up to all of us | TheHill – The Hill

As the United Nations General Assembly opens this week amidst the deadliest pandemic in a century, the worst climate change-induced disasters in millennia, and hundreds of millions of the worlds most vulnerable people falling back into abject poverty, one thing is clear: The United Nations ideal, as envisioned by its founders, has in many important ways failed.

Rather than blame the United Nations and other international organizations for this failure, we need to place blame where it is due on the U.N. member states that, for decades, have excessively defended their national sovereignty at the expense of our common good. Unless we find a way to collectively address our greatest global challenges from pandemics to climate change and ecosystem destruction, from systemic poverty and inequality to proliferating weapons of mass destruction our species will not just be at risk, we could even face extinction.

It was not coincidental that when the COVID-19 crisis began late last year, the World Health Organization (WHO) was caught flat-footed. We live in a world of sovereign states with only a thin overlay of international organizations working tirelessly, but too often in vain, to bring us all together. The WHO could not assessChinese government misinformationor send emergency teams to Wuhan, China, because our states have not given the WHO independent pandemic surveillance and emergency response capabilities for fear that this might compromise national sovereignty. The same basic story can be told for why we cant address so many other global issues.

Thats because, while our biggest problems are global, the ways we have organized to address them are predominantly national. Until we fix this fundamental mismatch, we will be in grave and growing danger. We cant do this by platitudes or by singing songs and waving our smartphones in the air.

In very short order, we humans have gone from being disparate bands of roving nomads to becoming a global species with the awesome power to remake almost every aspect of life on earth. But we have become a global species without developing a global consciousness or politics to match. To safeguard our future, we must change that. We needa new global operating system.

The foundation of this new approach must be a recognition of the mutual responsibilities of our deep global interdependence. Its manifestation must be an empowered and fully inclusive global movement of people of all backgrounds. Our national and international leaders have failed us, so regular people must divide upamong ourselvesthe jobs of buildinga better future or face the consequences of our inaction.

First, we must urgently ramp up the funding, staffing, authority, and global coordinating role of the World Health Organization. At a time when walls are going up around the world, we desperately need an empowered global health organization to operate above them. We dont now have the WHO we need but we can build it up, fast, if we put our collective minds to it.

Second, we must create a powerful new specialized agency within the U.N. focusing on common responses to shared, existential threats. Backed by and coordinating with states, but also operating with a high degree of depoliticized autonomy, this agency would be tasked with identifying and analyzing the greatest risks facing our species and our common home, developing, coordinating and implementing ongoing action plans for addressing them, compiling and sharing best practices from around the world, and leading efforts to build capacity everywhere, to prepare for and seek to prevent future global crises, and coordinating emergency responses when crises do occur.

Third,world leaders, particularly from the G-7 and G-20 counties, must commit to a specific, adequately funded plan to ensure safe drinking water, basic sanitation and essential protection from deadly pandemics to every person on Earth by 2030. This pandemic and its economic impact not only put the worlds most vulnerable populations at risk, it threatens all of us. If the virus grows and mutates anywhere, it poses an increased threat to people everywhere. In this context, calling for a massive, concerted global effort to address the emergency needs of the worlds most vulnerable population is not an act of charity but a pragmatic imperative.

Our world today exists at a crossroads. The pandemic, wildfires, poverty and despair we see around us are indicators of the even worse problems we will face if we dont dramatically change course.

The good news is that a hopeful future awaits us where our collective needs can be far better met. The question for the leaders meeting this week for the UN General Assembly and for all of us is whether we have the imagination and courage to together start building that world.

Jamie Metzlis a technology futurist, a member of the World Health Organizations international advisory committee on human genome editing andthe founder and chairman ofOneShared.World,a global social movement focusing on world collective-action policies.He is the author of five books, including Hacking Darwin: Genetic Engineering and the Future of Humanity (2019). He previously served on the National Security Council and State Department during the Clinton administration and with the United Nations. The views expressed are his own. Follow him on Twitter@jamiemetzl.

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The United Nations has failed: Fixing the world is now up to all of us | TheHill - The Hill

Global $4.88 Bn CRISPR & Cas Genes Market to 2027: Opportunities in the Expanding Gene & Cell Therapy Area & Government Fund In Genomic R&D – Yahoo…

Dublin, Sept. 21, 2020 (GLOBE NEWSWIRE) -- The "Global CRISPR & Cas Genes Market Size, Share & Trends Analysis by Product & Service (Vector-based Cas, DNA-free Cas, Cell Line Engineering), Application, End Use, and Segment Forecasts 2020-2027" report has been added to ResearchAndMarkets.com's offering.

The global clustered regularly interspaced short palindromic repeats (CRISPR) and CRISPR-associated (Cas) genes market size is expected to reach USD 4.88 billion by 2027, expanding at a CAGR of 16.6% from 2020 to 2027.

CRISPR & Cas Genes Market Report Highlights

The product segment is anticipated to dominate the market throughout the forecast period. This is attributed to the presence of enhanced individual products that can serve multiple purposes including genome engineering, specific genome cleavage using gRNAs, easy gene knockouts, along with reduced off-target cutting, and increased specificity

Cell line engineering services accounted for the largest market share in 2019. The development of this technology has simplified the genome engineering process to a large extent

In biomedical applications, genome engineering held the largest revenue share in 2019 as a result of an increase in the adoption of genome editing techniques for modifications in germline and therapeutics development

Recent advancements in CRISPR/Cas genome editing allow targeted modification in crops, thereby promising crop improvement and revenue generation in the market

A significant number of research studies carried out to develop disease-specific novel therapies and the presence of a huge clinical pipeline that integrates the application of this gene-editing technology are expected to boost revenue generation for the biotechnology and pharmaceutical companies segment

Asia Pacific is anticipated to witness the fastest growth over the forecast period. China holds a significant position in the CRISPR market and is increasingly exploring genome-editing for the development of medicines. The country has launched several CRISPER-based clinical trials, especially for cancer treatment.

Rise in the adoption of CRISPR technology in epigenetics, therapeutics, human germline editing, plant genome editing, and other fields of biotechnology is expected to drive the market.

Presence of a large number of service providers that provide knockout, knock-in, gene repression, gene activation, and other cell line engineering services propel the growth of cell line engineering services. In biomedical applications, genome engineering held the largest revenue share in 2019. Adoption of gene editing techniques for human- and non-human-based genomic engineering is one of the key factors that drive the segment.

The molecular scissor can facilitate the detection of viruses, allowing the development of cost-effective, robust, and rapid point-of-care diagnostics. It allows the detection of viruses at a level of molecular concentration that researchers rarely assess. Sherlock Bioscience estimated that a CRISPR-powered diagnostic test would be available in the future at a reasonable price. In recent times, the most important innovation has been the development of a test for COVID-19.

In March 2020, Mesa Biotech announced FDA authorization for its Accula device, a hand-held COVID-19 diagnostic test. Similarly, in April 2020, CSIR lab announced the development of a paper-strip test for Covid-19 that uses CRISPR-Cas9 to target and identifies the genomic sequences of the virus. Unlike the PCR tests, this test is available at a very low price, USD 6.59 (INR 1 = USD 0.013). Therefore, such initiatives are expected to encourage other players to leverage this crisis and launch novel products.

Key Topics Covered:

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Chapter 1 Research Methodology

Chapter 2 Executive Summary2.1 Market Snapshot, 2019 (USD Million)

Chapter 3 Crispr And Cas Genes Market Variables, Trends & Scope3.1 Market Trends & Outlook3.2 Market Segmentation & Scope3.3 Market Lineage Outlook3.3.1 Parent Market Outlook3.3.2 Related/Ancillary Market Outlook3.4 Crispr And Cas Genes: Patent Landscape3.4.1 By End - Use Settings3.4.2 By Variants Of Crispr Enzymes3.5 Penetration And Growth Prospect Mapping, By Biomedical Applications, 20193.6 Potential Threat Analysis To Crispr Technology3.6.1 Variations In The Crispr System3.7 Investors Perspective Analysis3.8 User Perspective Analysis3.9 Technology Mapping In Crispr Genome Editing Workflow3.10 Developments And Innovations For Analysis Of Off - Target Effects3.11 Crispr Technologies: Clinical Penetration3.11.1 Human Therapeutics3.11.2 Diagnostics3.11.3 Microbiome Research And Drug Resistance3.11.4 Animal Disease Models

Chapter 4 Industry Outlook4.1 Market Dynamics4.1.1 Market Driver Analysis4.1.1.1 Rising Adoption In Diverse Fields Of Biotechnology4.1.1.1.1 Epigenetics4.1.1.1.2 Medicine4.1.1.1.3 Human Germline Editing4.1.1.1.4 Tool For Qualitative And Quantitative Plant Genome Editing4.1.1.2 Technological Advancements In Crispr4.1.1.3 Introduction Of Anti - Crispr Protein4.1.1.4 Ongoing Competition For Crispr Commercialization4.1.2 Market Restraint Analysis4.1.2.1 Off - Target Effects Of Crispr Technology4.1.2.2 Intellectual Property Disputes Pertaining To Cas4.1.2.3 Ethical Concerns And Implications With Respect To Human Genome Editing4.1.3 Market Opportunity Analysis4.1.3.1 Expanding Gene & Cell Therapy Area4.1.3.2 Government Fund In Genomic R&D4.1.4 Market Challenge Analysis4.1.4.1 Risks Pertaining To The Usage Of Genetically Modified Food4.2 Policy Making & Regulation For Genetic Modification Using Crispr4.3 Porter's Five Forces Analysis4.4 SWOT Analysis, By Factor (Political & Legal, Economic, And Technological)

Chapter 5 Competitive Landscape5.1 Companies (Diagnostic & Drug Developers) Leveraging Gene Editing Technologies5.2 Major Deals & Strategic Alliances Analysis5.3 Market Entry Strategies5.3.1 Crispr Therapeutics: Business Translation5.3.2 Crispr Gene Editing Companies' Toolboxes5.4 Crispr And Cas Genes Market: Pipeline Analysis5.4.1 Editas Medicine5.4.2 Intellia Therapeutics, Inc.5.4.3 Crispr Therapeutics5.4.4 Caribou Biosciences, Inc.5.4.5 Egenesis5.4.6 Beam Therapeutics5.4.7 Ksq Therapeutics5.4.8 Cibus

Chapter 6 Product & Service Business Analysis6.1 Crispr And Cas Genes Market: Product & Service Movement Analysis6.2 By Product6.2.1 Global Crispr And Cas Genes Products Market, 2016 - 2027 (USD Million)6.2.2 Kits & Enzymes6.2.3 Global Crispr And Cas Genes Kits And Enzymes Market, 2016 - 2027 (USD Million)6.2.3.1 Vector - Based Cas96.2.3.2 Dna - Free Cas96.2.4 Libraries6.2.5 Design Tools6.2.6 Antibodies6.2.7 Others6.3 By Service6.3.1 Global Crispr And Cas Genes Service Market, 2016 - 2027 (USD Million)6.3.2 Cell Line Engineering6.3.3 Grna Design6.3.4 Microbial Gene Editing6.3.5 Dna Synthesis

Chapter 7 Application Business Analysis7.1 Crispr And Cas Genes Market: Application Movement Analysis7.2 Biomedical7.2.1 Global Crispr And Cas Genes Market For Biomedical, 2016 - 2027 (USD Million)7.2.2 Genome Engineering7.2.3 Disease Model Studies7.2.4 Functional Genomics7.2.5 Epigenetics7.2.6 Others7.3 Agriculture

Chapter 8 End - Use Business Analysis8.1 Crispr And Cas Genes Market: End - Use Movement Analysis8.1.1 Biotechnology & Pharmaceutical Companies8.1.2 Academics & Government Research Institutes8.1.3 Contract Research Organizations (Cros)

Chapter 9 Regional Business Analysis

Chapter 10 Company Profiles

Astrazeneca

Addgene

Caribou Biosciences, Inc.

Cellectis

Crispr Therapeutics

Editas Medicine, Inc.

Egenesis

F. Hoffmann - La Roche Ltd.

Horizon Discovery Group Plc

Genscript

Danaher Corporation

Intellia Therapeutics, Inc.

Lonza

Merck Kgaa

New England Biolabs

Takara Bio, Inc.

Thermo Fisher Scientific, Inc.

Synthego

Mammoth Biosciences

Inscripta, Inc.

Cibus

Beam Therapeutics

PlanteditVertex Pharmaceuticals Incorporated

Hera Biolabs

Origene Technologies, In
c.

Recombinetics, Inc.

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Global $4.88 Bn CRISPR & Cas Genes Market to 2027: Opportunities in the Expanding Gene & Cell Therapy Area & Government Fund In Genomic R&D - Yahoo...

Inherited blindness has a new cure, thanks to CRISPR – Genetic Literacy Project

In recent months, even as our attention has been focused on the coronavirus outbreak, there have been a slew of scientific breakthroughs in treating diseases that cause blindness.

Researchers at U.S.-based Editas Medicine and Ireland-based Allergan have administeredCRISPR for the first time to a person with a genetic disease. This landmark treatment uses the CRISPR approach to a specific mutation in a gene linked to childhood blindness. The mutation affects the functioning of the light-sensing compartment of the eye, called the retina, and leads to loss of the light-sensing cells.

According to the World Health Organization,at least 2.2 billion peoplein the world have some form of visual impairment. In the United States, approximately200,000 people suffer from inherited forms of retinal diseasefor which there is no cure. But things have started to change for good. We can now see light at the end of the tunnel.

I am an ophthalmology and visual sciences researcher, and am particularly interested in these advances becausemy laboratory is focusingon designing new and improved gene therapy approaches to treat inherited forms of blindness.

Gene therapy involves inserting the correct copy of a gene into cells that have a mistake in the genetic sequence of that gene, recovering the normal function of the protein in the cell. The eye is an ideal organ for testing new therapeutic approaches, including CRISPR. That is because the eye is the most exposed part of our brain and thus is easily accessible.

The second reason is that retinal tissue in the eye is shielded from the bodys defense mechanism, which would otherwise consider the injected material used in gene therapy as foreign and mount a defensive attack response. Such a response would destroy the benefits associated with the treatment.

In recent years, breakthrough gene therapy studies paved the way to thefirst ever Food and Drug Administration-approved gene therapy drug, Luxturna TM, for a devastating childhood blindness disease,Leber congenital amaurosisType 2.

This form of Leber congenital amaurosis is caused by mutations in a gene that codes for a protein called RPE65. The protein participates in chemical reactions that are needed to detect light. The mutations lessen or eliminate the function of RPE65, which leads to our inability to detect light blindness.

The treatment method developed simultaneously by groups at University of Pennsylvania and at University College London and Moorefields Eye Hospital involvedinserting a healthy copy of the mutated genedirectly into the space between the retina and the retinal pigmented epithelium, the tissue located behind the retina where the chemical reactions takes place. This gene helped the retinal pigmented epithelium cell produce the missing protein that is dysfunctional in patients.

Although the treated eyes showed vision improvement, as measured by the patients ability to navigate an obstacle course at differing light levels,it is not a permanent fix. This is due to the lack of technologies that can fix the mutated genetic code in the DNA of the cells of the patient.

Lately, scientists have been developing a powerful new tool that is shifting biology and genetic engineering into the next phase. This breakthroughgeneeditingtechnology, which is called CRISPR, enables researchers to directly edit the genetic code of cells in the eye and correct the mutation causing the disease.

Children suffering from the disease Leber congenital amaurosis Type 10 endure progressive vision loss beginning as early as one year old. This specific form of Leber congenital amaurosis is caused by a change to the DNA that affects the ability of the gene called CEP290 to make the complete protein. The loss of the CEP290 protein affects the survival and function of our light-sensing cells, called photoreceptors.

One treatment strategy is to deliver the full form of the CEP290 gene using a virus as the delivery vehicle. But the CEP290 gene is too big to be cargo for viruses. So another approach was needed. One strategy was to fix the mutation by using CRISPR.

The scientists at Editas Medicine first showed safety and proof of the concept of the CRISPR strategy in cells extracted from patient skin biopsy and in nonhuman primate animals.

These studies led to the formulation of thefirst ever in human CRISPR gene therapeutic clinical trial. This Phase 1 and Phase 2 trial will eventually assess the safety and efficacy of the CRISPR therapy in 18 Leber congenital amaurosis Type 10 patients. The patients receive a dose of the therapy while under anesthesia when the retina surgeon uses a scope, needle and syringe to inject the CRISPR enzyme and nucleic acids into the back of the eye near the photoreceptors.

To make sure that the experiment is working and safe for the patients, the clinical trial has recruited people with late-stage disease and no hope of recovering their vision. The doctors are also injecting the CRISPR editing tools into only one eye.

An ongoing project in my laboratory focuses on designing a gene therapy approach for the same gene CEP290. Contrary to the CRISPR approach, which can target only a specific mutation at one time, my team is developing an approach that would work for all CEP290 mutations in Leber congenital amaurosis Type 10.

This approach involves usingshorter yet functional forms of the CEP290 proteinthat can be delivered to the photoreceptors using the viruses approved for clinical use.

Gene therapy that involves CRISPR promises a permanent fix and a significantly reduced recovery period. A downside of the CRISPR approach is the possibility of an off-target effect in which another region of the cells DNA is edited, which could cause undesirable side effects, such as cancer. However, new and improved strategies have made such likelihood very low.

Although the CRISPR study is for a specific mutation in CEP290, I believe the use of CRISPR technology in the body to be exciting and a giant leap. I know this treatment is in an early phase, but it shows clear promise. In my mind, as well as the minds of many other scientists, CRISPR-mediated therapeutic innovation absolutely holds immense promise.

In another study just reported in the journal Science, German and Swiss scientists have developeda revolutionary technology, which enables mice and human retinas to detect infrared radiation. This ability could be useful for patients suffering from loss of photoreceptors and sight.

The researchers demonstrated this approach, inspired by the ability of snakes and bats to see heat, by endowing mice and postmortem human retinas with a protein that becomes active in response to heat. Infrared light is light emitted by warm objects that is beyond the visible spectrum.

The heat warms a specially engineered gold particle that the researchers introduced into the retina. This particle binds to the protein and helps it convert the heat signal into electrical signals that are then sent to the brain.

In the future, more research is needed to tweak the ability of the infrared sensitive proteins to different wave lengths of light that will also enhance the remaining vision.

This approach is still being tested in animals and in retinal tissue in the lab. But all approaches suggest that it might be possible to either restore, enhance or provide patients with forms of vision used by other species.

Hemant Khanna is an Associate Professor of Ophthalmology at the University of Massachusetts Medical School. His lab investigates molecular and cell biological bases of severe photoreceptor degenerative disorders, such as Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA). Find Hemant on Twitter @khannacilialab

A version of this article was originally published at the Conversation and has been republished here with permission. The Conversation can be found on Twitter @ConversationUS

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Inherited blindness has a new cure, thanks to CRISPR - Genetic Literacy Project

Human genetic enhancement – Wikipedia

Human genetic enhancement or human genetic engineering refers to human enhancement by means of a genetic modification. This could be done in order to cure diseases (gene therapy), prevent the possibility of getting a particular disease[1] (similarly to vaccines), to improve athlete performance in sporting events (gene doping), or to change physical appearance, metabolism, and even improve physical capabilities and mental faculties such as memory and intelligence.These genetic enhancements may or may not be done in such a way that the change is heritable (which has raised concerns within the scientific community).[2]

Genetic modification in order to cure genetic diseases is referred to as gene therapy. Many such gene therapies are available, made it through all phases of clinical research and are approved by the FDA. Between 1989 and December 2018, over 2,900 clinical trials were conducted, with more than half of them in phase I.[3] As of 2017, Spark Therapeutics' Luxturna (RPE65 mutation-induced blindness) and Novartis' Kymriah (Chimeric antigen receptor T cell therapy) are the FDA's first approved gene therapies to enter the market. Since that time, drugs such as Novartis' Zolgensma and Alnylam's Patisiran have also received FDA approval, in addition to other companies' gene therapy drugs. Most of these approaches utilize adeno-associated viruses (AAVs) and lentiviruses for performing gene insertions, in vivo and ex vivo, respectively. ASO / siRNA approaches such as those conducted by Alnylam and Ionis Pharmaceuticals require non-viral delivery systems, and utilize alternative mechanisms for trafficking to liver cells by way of GalNAc transporters.

Some people are immunocompromised and their bodies are hence much less capable of fending off and defeating diseases (i.e. influenza, ...). In some cases this is due to genetic flaws[clarification needed] or even genetic diseases such as SCID. Some gene therapies have already been developed or are being developed to correct these genetic flaws/diseases, hereby making these people less susceptible to catching additional diseases (i.e. influenza, ...).[4]

In November 2018, Lulu and Nana were created.[5] By using clustered regularly interspaced short palindromic repeat (CRISPR)-Cas9, a gene editing technique, they disabled a gene called CCR5 in the embryos, aiming to close the protein doorway that allows HIV to enter a cell and make the subjects immune to the HIV virus.

Athletes might adopt gene therapy technologies to improve their performance.[6] Gene doping is not known to occur, but multiple gene therapies may have such effects. Kayser et al. argue that gene doping could level the playing field if all athletes receive equal access. Critics claim that any therapeutic intervention for non-therapeutic/enhancement purposes compromises the ethical foundations of medicine and sports.[7]

Other hypothetical gene therapies could include changes to physical appearance, metabolism, mental faculties such as memory and intelligence.

Some congenital disorders (such as those affecting the muscoskeletal system) may affect physical appearance, and in some cases may also cause physical discomfort. Modifying the genes causing these congenital diseases (on those diagnosed to have mutations of the gene known to cause these diseases) may prevent this.

Also changes in the mystatin gene[8] may alter appearance.

Behavior may also be modified by genetic intervention.[9] Some people may be aggressive, selfish, ... and may not be able to function well in society.[clarification needed] There is currently research ongoing on genes that are or may be (in part) responsible for selfishness (i.e. ruthlessness gene, aggression (i.e. warrior gene), altruism (i.e. OXTR, CD38, COMT, DRD4, DRD5, IGF2, GABRB2[10])

There is some research going on on the hypothetical treatment of psychiatric disorders by means of gene therapy. It is assumed that, with gene-transfer techniques, it is possible (in experimental settings using animal models) to alter CNS gene expression and thereby the intrinsic generation of molecules involved in neural plasticity and neural regeneration, and thereby modifying ultimately behaviour.[11]

In recent years, it was possible to modify ethanol intake in animal models. Specifically, this was done by targeting the expression of the aldehyde dehydrogenase gene (ALDH2), lead to a significantly altered alcohol-drinking behaviour.[12] Reduction of p11, a serotonin receptor binding protein, in the nucleus accumbens led to depression-like behaviour in rodents, while restoration of the p11 gene expression in this anatomical area reversed this behaviour.[13]

Recently, it was also shown that the gene transfer of CBP (CREB (c-AMP response element binding protein) binding protein) improves cognitive deficits in an animal model of Alzheimers dementia via increasing the expression of BDNF (brain-derived neurotrophic factor).[14] The same authors were also able to show in this study that accumulation of amyloid- (A) interfered with CREB activity which is physiologically involved in memory formation.

In another study, it was shown that A deposition and plaque formation can be reduced by sustained expression of the neprilysin (an endopeptidase) gene which also led to improvements on the behavioural (i.e. cognitive) level.[15]

Similarly, the intracerebral gene transfer of ECE (endothelin-converting enzyme) via a virus vector stereotactically injected in the right anterior cortex and hippocampus, has also shown to reduce A deposits in a transgenic mouse model of Alzeimers dementia.[16]

There is also research going on on genoeconomics, a protoscience that is based on the idea that a person's financial behavior could be traced to their DNA and that genes are related to economic behavior. As of 2015, the results have been inconclusive. Some minor correlations have been identified.[17][18]

George Church has compiled a list of potential genetic modifications based on scientific studies for possibly advantageous traits such as less need for sleep, cognition-related changes that protect against Alzheimer's disease, disease resistances, higher lean muscle mass and enhanced learning abilities along with some of the associated studies and potential negative effects.[19][20]

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Human genetic enhancement - Wikipedia

Market trends and outlook coupled with factors driving and restraining the growth of the CRISPR Genome Editing market – The Daily Chronicle

With 75 percent of current S&P 500 companies expected to disappear until 2027, according to research by McKinsey. The only constant in our world is changing, the pace of change has been expediting significantly over the past years, fueled by huge investments in technology and science, easier access to truly global markets, and a general cultural shift towards innovation among other key drivers are helping to rise of CRISPR Genome Editing market.

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Moreover, this market report provides in-depth analyses of CRISPR Genome Editing market and display significant data regarding key companies, consumers, market developments, and the competitive landscape focusing Editas Medicine, CRISPR Therapeutics, Horizon Discovery, Sigma-Aldrich, Genscript, Sangamo Biosciences, Lonza Group, Integrated DNA Technologies, New England Biolabs, Origene Technologies, Transposagen Biopharmaceuticals, Thermo Fisher Scientific, Caribou Biosciences, Precision Biosciences, Cellectis, Intellia Therapeutics.

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Market trends and outlook coupled with factors driving and restraining the growth of the CRISPR Genome Editing market - The Daily Chronicle

Frankenfish or food of the future? The risks and rewards of Canadas genetically engineered salmon – The Narwhal

This is the second part of The Narwhals three-part series on the future of sustainable salmon.

On Prince Edward Island, anchored between Rollo Bay and a sea of potato fields, the first genetically engineered salmon raised in Canada for food are swimming in tanks.

Grown in a land-based containment system, they look like any other Atlantic salmon: silvery, pale-bellied and speckled on top. But hidden in their DNA is a growth hormone gene from chinook salmon spliced into genetic coding from ocean pout, an eel-like fish that allows them to grow to full size at twice the speed.

When the salmon are harvested early in the new year, they will be shipped to seafood distributors, finding their way to restaurants, hotels, hospitals and grocery stores. Yet Canadians munching on salmon tacos or salmon au gratin wont have a clue they are eating the worlds first genetically modified food animal. Unlike the European Union and the United States, Canada does not require GMO foods to be labelled and the fast-growing fish are no exception.

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AquaBounty Technologies, the U.S.-based biotechnology company pioneering the genetically engineered salmon, says it is combining the goodness of nature with the power of science and technology.

We believe savouring your favourite fish and helping save the planet should be one and the same, the companys website says. And thats why we believe in using science and technology to help solve global problems, like food scarcity and climate change.

AquaBounty markets the salmon as disease- and antibiotic-free, saying its product comes with a reduced carbon footprint and no risk of pollution of marine ecosystems compared to traditional sea-cage farming.

But others have a wildly different view of the AquaBounty salmon, grown with technology called AquAdvantage, a name that would be at home on the pages of a dystopian Margaret Atwood novel.

Its Frankenfish, says Charlie Sark, a member of the Mikmaq First Nations and professor in the school of climate change and adaptation at the University of P.E.I. Its science fiction. Just because weve created a machine that can splice genes together, does it mean we should do it?

Even if the engineered salmon are raised only in land-based containment systems, Sark and others say human error could lead to the genetic contamination of threatened wild salmon stocks, underscoring that the federal governments behind-closed-doors approval of AquAdvantage fish has far reaching consequences for Indigenous Rights and nature.

Salmon are sacred, Sark says in an interview. You just cant change the genetics of an animal that Indigenous peoples have used for thousands of years without first consulting them.

An AquaBounty genetically engineered Atlantic farmed salmon photographed in July, 2020, at a fish farm facility on Prince Edward Island. Photo: AquaBounty

Genetically engineered salmon eggs were approved for land-based production in Canada in 2013, when Stephen Harpers Conservatives were in power.

The government only permitted one company, AquaBounty, to produce the eggs and only at a P.E.I. facility. Today, the Rollo Bay operation is also the sole supplier of genetically engineered Atlantic salmon eggs for the companys land-based salmon farm in Albany, Indiana, which planned to send salmon to market late this year or early in 2021.

The eggs had their genesis in a laboratory at Newfoundlands Memorial University, where scientist Garth Fletcher and his colleagues isolated the anti-freeze gene in ocean pout, which can survive year-round in near-freezing waters.

They replaced the coding region in the middle of the anti-freeze gene unlike in other fish, the gene doesnt turn off seasonally with the growth hormone gene from chinook salmon (the scientists used chinook because it was readily available at the time).

Then the team injected the new coding sequence into Atlantic salmon eggs. It took a while for us not to kill the eggs, Fletcher, head of the ocean sciences department, says in an interview.

After tweaking their technique, Fletcher and his colleagues were excited to discover the genetic trait was passed on through breeding. And then came another exciting finding for the team; the rapidly-growing salmon reached maturity in just under two years, compared to three.

Scientist Garth Fletcher is head of the ocean sciences department at Memorial University and worked with colleagues to develop the AquAdvantage technology now being used in AquaBounty salmon farms. Photo: David Howells / Memorial University

It was an enormous change in the rate of growth, Fletcher says, noting that cross-breeding has further enhanced growth speed. Its the same with any crop, if you can replant land or get another set of fish earlier than normal, you have increased productivity.

By comparison, regular Atlantic salmon grown in optimal conditions in Atlantic Sapphires land-based facility in Florida reach maturity in 22 to 24 months.

Fletcher doesnt consider the genetically modified salmon to be much different than new fruit and vegetable products created through cross-breeding, such as the Cosmic Crisp apple that has a longer shelf life or Depurple, a purple cauliflower sweeter than the typical white variety.

He says food companies are getting rid of everything that doesnt meet their standards in terms of a commercial product. Youre actually changing nature all these kinds of things are unnatural if you want to call it that.

There is a problem with food production in the world. I know some of it is political, but if I have an idea or a technique that might be able to help with food production then Im all for it, as a scientist.

The need for protein is growing in tandem with the worlds rising population, expected to top nine billion before 2025. Salmon, which have Omega-3 fatty acids and are a good source of minerals and vitamins, are increasingly in demand. But the on-going decline of wild stocks is constricting supply. And as tighter regulations make open net pen salmon farming more challenging, investors including AquaBounty are turning to land-based salmon farming.

AquaBounty farmed salmon grown in containment tanks. The company says the fish are reared without the need for antibiotics and are free from parasites. Photo: AquaBounty

Fletchers team, which was funded by the Natural Sciences and Engineering Research Council, partnered with a small company that morphed into AquaBounty, largely bankrolled by billionaire biotech entrepreneur Randall Kirk.

When AquaBounty set up its research and development facility on Prince Edward Island to produce the genetically modified eggs, the federal government did not permit the fish to be grown to adult size, so eggs were shipped to an AquaBounty research and development facility in Panama.

Once Health Canada approved the salmon for consumption in 2016, Ottawa allowed AquAdvantage salmon grown in the Panama facility to be sold to unwitting Canadian consumers.

The first batch of genetically modified Atlantic salmon from the Panama facility arrived at Montreals Pierre Elliot Trudeau airport in 2017, according to import documents obtained by the Quebec food watchdog group Vigilance OGM. More than 4.5 tonnes of AquAdvantage salmon subsequently flowed, unlabelled and untraceable, into Canadas food supply.

Peter Bowyer, AquaBounty farm manager, oversees containment systems where the salmon are grown. Photo: AquaBounty

There is no mandatory labelling for consumers in the grocery stores and theres very little transparency, and yet we find ourselves in the position of eating the worlds first genetically engineered animal, says Lucy Sharratt, coordinator of the Canadian Biotechnology Action Network, which represents 16 groups working on issues related to genetic engineering in food and farming.

Sharratt, who ha
s an extensive background working as a researcher and campaigner for groups involved in genetic engineering and global justice issues, says the lack of transparency extends to Ottawas decision-making process for approving the engineered salmon.

Starting in 2019, following a federal risk assessment, Ottawa allowed the salmon to be raised to maturity at the Rollo Bay facility, which also produces conventional salmon eggs, triggering concerns about a potential mix-up.

The biotechnology action network has tried to obtain information about the behind closed door approval process, Sharratt says, but information AquaBounty submitted to the government is confidential and the networks questions havent been satisfactorily answered.

The information thats used to decide the safety of genetically engineered food is submitted by the companies that want approval, she says. Very little of that information is publicly available. Very little is peer-reviewed.

The absence of information is all the more concerning, she says, because of the broad and also unknown implications of tampering with nature and the precedents it sets.

What we have here is potentially a very profound shift in the way we view food and where it comes from. Do fish come from the ocean, do they come from our rivers, do they come from an ecosystem? Or do they come from an on land factory? What decisions are we making that further threaten the future of wild salmon?

Lucy Sharratt, coordinator of the Canadian Biotechnology Action Network, is concerned about the consequences of genetically modified food. Photo: Lucy Sharratt

Nature Canada senior advisor Mark Butler says the federal government has opened a Pandoras box by approving the development and sale of genetically engineered salmon and eggs without a robust public discussion about the potential consequences.

You could say, whats wrong with pink blue jays or blue cardinals? We are now applying engineering to the genome to the very blueprint of life. It has big implications and this technology is racing along. I think it gets at the whole issue of whats wild and whats nature, and where do humans stop and where does nature start?

Do we have the right to edit the genome of a wild species from an Indigenous perspective? This raises some pretty fundamental questions and challenges.

Salmon are sacred to Indigenous peoples like the Mikmaq, and are part and parcel of food security and food sovereignty, Sark points out. They are also an integral part of cultures through ceremony, song, oral history and art. As wild stocks decline, it has a reverberating impact on the physical and spiritual health of Indigenous communities.

Sark says Indigenous peoples should have been properly consulted and Ottawa should have obtained their free, prior and informed consent before approving genetically engineered salmon.

As a Mikmaq I have a right to food, I have a right to fish lobster, I have an inherent right to access and harvest fish out of the ocean or out of the streams, the brooks, the rivers, the lakes. The Canadian government cannot extinguish that right.

He wonders what would happen if he caught an Atlantic salmon that somehow contained DNA owned by AquaBounty.

Im holding a salmon that Ive caught in my traditional waters, that my ancestors have used for thousands of years, but because its an escaped salmon or an inbred salmon from this genetically modified [organism], is it illegal for me to hold that fish and eat it without paying AquaBounty? Sark asks. Where does this end?

Kris Hunter of the Atlantic Salmon Federation, a science and advocacy organization dedicated to conserving and restoring wild Atlantic salmon, says genetically engineered salmon could be an ecological disaster for wild salmon, especially if rules change and they become the fish of choice for the farmed salmon industry.

if these animals were to get out what impact that would have on the wild fishery?

He points to the escape of hundreds of thousands of Atlantic salmon from fish farms in B.C. and Washington state. In December 2019, more than 20,000 salmon escaped from a Mowi fish farm near Port Hardy on northern Vancouver Island, while more than 160,000 Atlantic salmon escaped from a Cooke Aquaculture fish farm in Washington State in 2018, leading to a state ban on raising Atlantic salmon in open net pens.

Some escaped Atlantic salmon have been found in the salmon-bearing Fraser River, heightening worries that they will compete for food and habitat given evidence that the farmed fish can naturally reproduce.

Our concern would be if these animals were to get out and what impact that would have on the wild fishery? The wild fishery is not doing well right now.

Karen Wristen, executive director of Living Oceans Society, a non-profit organization dedicated to protecting Canadas oceans, is uneasy about how the fast-growing genetically modified salmon might behave in the wild, possibly mating with endangered salmon populations, preying on wild juvenile salmon and outcompeting wild salmon and other ocean creatures for food. You can picture it wanting to hoover up everything in its path.

And if the salmon farming industry transitions to land-based containment systems, Wristen and Butler say there will be pressure on companies from investors to embrace genetically engineered salmon, to keep costs in line with competitors.

A wild Atlantic salmon in the waters near Quebec. Canadas wild Atlantic salmon populations have dramatically declined in recent decades. Photo: Shutterstock

The U.S. Food and Drug Administration approved AquaBountys genetically engineered salmon in 2010, on the condition that the salmon be sterile. Sterility is achieved through a process that creates a condition called triploidy the salmon have three chromosome sets instead of two that is between 99.5 and 99.8 per cent effective.

Its an important barrier, but not a fool proof barrier, Butler notes. For every 10,000 salmon the company produces, between 20 and 50 fish will be fertile.

Hunter, director of programs for P.E.I. and Nova Scotia, says the Atlantic Salmon Federation has met with AquaBounty and the company appears to be doing due diligence to make sure the genetically engineered salmon dont escape.

Our concern is an accident. A truck goes off the road carrying these things as its crossing a salmon river, and the next thing you know these fish are out and theyre breeding amongst other fish populations and causing untold damage.

Genetically engineered salmon eggs could also get mixed up with the regular salmon eggs harvested at the same AquaBounty facility and end up at an open net pen farm, Hunter points out. The company isnt currently permitted to sell the eggs to open net pen operations in Canada, but Hunter says that could always change.

Systems fail and accidents happen. Once the genie is out of the bottle you cant put it back in We think this is a very risky enterprise. And we dont necessarily see the benefit.

In an emailed response to questions from The Narwhal, AquaBounty president and CEO Sylvia Wulf said the company does not plan to supply AquAdvantage salmon eggs to open net pen farms and will produce the genetically modified salmon in its own land-based facilities.

AquaBountys land-based farm in Albany, Indiana, plans to send its first salmon to market later this year or early next year, depending on demand, which has been dampened by the COVID-19 pandemic. The company also plans to build a much larger facility in Mayfield, Kentucky, that will produce 10,000 metric tonnes of salmon a year, about eight times more than its Indiana plant.

Wulf says all of the companys market production salmon are female and sterile, which means they cannot mate with each other or with other Atlantic salmon. In addition to the biological barrier, she says the companys land-based containment systems are equipped with physical barriers, including screens, grates, netting, pumps and chemical disinfection, to prevent escape of salmon at al
l life stages, from eggs to full size.

AquaBountys P.E.I. fish farm. The facility is located in farmland where potatoes and soybeans grow and is about one kilometre away from the Northumberland strait. The facilitys proximity to streams and ocean water is cause for concern among critics. Photo: Leo Broderick

And AquaBounty will address egg mix-up concerns by ensuring that eggs are from conventional salmon before sending them out to farms, says Wulf, who declined a telephone interview.

Sark calls the secretive federal approval process of AquAdvantage salmon a coup detat, noting that the Canadian Environmental Protection Act, which regulates genetically modified organisms, hasnt been updated for 20 years and doesnt have the bandwidth to consider genetically modified salmon.

The act, according to Butler, is a really complicated and obtuse piece of legislation, while Wristen says as challenging to decipher as the often maligned income tax act.

Our act is outdated, Sark says, and I would say extremely colonial in its essence that it cant consider genetic modification of animals that Indigenous people to a large extent still rely on, or use for ceremonial purposes, which is a matter of our sovereignty. Using the animals for sustenance is a matter of food security. The role it plays in ceremony and in culture and identity is a matter of our food sovereignty.

This is a first in the world. Youre approving it to go ahead. And your legislation is inadequate.

In the September Speech from the Throne, the Trudeau government pledged to update the environmental protection act. But Butler says senior officials in Environment Canada have indicated the changes will be minor, much to the dismay of those considering the impacts of genetically engineered salmon.

This is a first in the world, Sark says. Youre approving it to go ahead. And your legislation is inadequate and youre not considering making it adequate? Wait a second. Isnt that your job? Isnt that the role of government to make sure our health and security is looked after? Isnt that the ultimate number one goal when you sit there in Parliament to look after our interests, not the economic interests of one company?

In 2016, the Centre for Food Safety and the environmental law organization EarthJustice sued the U.S. Food and Drug Administration for approving genetically engineered salmon, acting on behalf of a broad coalition of environmental, consumer, commercial and recreational fishing organizations and the Quinault Indian Nation.

In early November, a U.S. federal court judge ruled the Food and Drug Administration failed to analyze the risks to endangered salmon from an escape and to take into account the full extent of plans to grow the genetically modified salmon in the U.S. and around the world.

The court also ruled that the Food and Drug Administrations conclusion that genetically engineered salmon could have no possible effect on endangered wild Atlantic salmon stocks was wrong, and violated the U.S. Endangered Species Act.

While Judge Vincent Chhabria found the current risk to wild salmon stocks is low, he said the possibility of exposure increases with each new facility built.

Understanding the harm that could result from that exposure and having an explanation of it on record will only become more important, the judge said, ordering the FDA to go back to the drawing board to sketch out a full explanation of potential environmental consequences.

The decision, watched closely by Nature Canada, the Atlantic Salmon Federation and other groups in Canada, was celebrated by Earthjustice and its clients. Our efforts should be focused on saving the wild salmon populations that we already have not manufacturing new species that pose yet another threat to their survival, Earthjustice managing attorney Steve Mashuda said in a media statement.

Earthjustice cited studies showing there is a high risk for genetically engineered organisms to escape into the natural environment, and that genetically engineered salmon can crossbreed with native fish. Genetically engineered crops commonly cross-pollinate or establish themselves in nearby fields or the wild a process known as transgenic contamination. The contamination episodes have cost American farmers billions of dollars over the past decade, Earthjustice noted.

In wild organisms like fish, it would be even more damaging.

Wulf says the company is disappointed with some of the judges conclusions but remains confident in the robust scientific studies and review that led to the 2015 FDA approval of AquaBounty salmon.

This case did not call into question FDAs approval regarding the health and safety of our AquAdvantage salmon, she wrote in her email. The focus of this decision was on the potential environmental impacts, and the judge confirmed the low threat to the environment of our salmon.

The decision will not impact operations at the Prince Edward Island or Indiana facilities, according to Wulf, who says the company will work with the FDA on next steps and will continue to evaluate the legal decision.

The future of our domestic and global food supply will depend on innovation and technology and AquaBounty remains steadfast in our commitment to leading that charge.

Butler, who supports land-based salmon farming operations, has a piece of advice for AquaBounty: Skip the genetically engineered salmon and just raise normal fish using the best techniques and the best genetic strains and we wont have a problem with your operation, he says.

Most Canadians, if they had to assess the risks and benefits, would just say, Give me a normal salmon.

Canadian farmed salmon are being genetically engineered to grow faster to feed more people. But some worry there isn't enough transparency and accountability when it comes to the impact of genetic engineering on the natural world and Indigenous rights. Illustration: Carol Linnitt / The Narwhal

And since youre here, we have a favour to ask. Our independent, ad-free journalism is made possible because the people who value our work also support it (weve made a conscious decision to keep our journalism free for all readers, regardless of whether or not they can afford to pay). Despite 2020 being the absolute worst, some really good things happened at The Narwhal, with more than two million readers and a record number of new monthly members. Will you be the next Narwhal to join our pod?

As a non-profit, reader-funded news organization, our goal isnt to sell advertising or to please corporate bigwigs its to bring evidence-based news and analysis to the surface for all Canadians. And at a time when most news organizations have been laying off reporters, weve hired eight journalists in less than a year.

Not only are we filling a void in environment coverage, but were telling stories differently by centring Indigenous voices, by building community and by doing it all as a people-powered, non-profit outlet supported by more than 2,200 members.

The truth is we wouldnt be here without you. Every single one of you who reads and shares our articles is a crucial part of building a new model for Canadian journalism that puts people before profit.

We know that these days the worlds problems can feel a *touch* overwhelming. Its easy to feel like what we do doesnt make any difference, but becoming a member of The Narwhal is one small way you truly can make a difference.

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Frankenfish or food of the future? The risks and rewards of Canadas genetically engineered salmon - The Narwhal

‘The Pattern Seekers’: What autism can tell us about the evolutionary tipping point that made us human – Genetic Literacy Project

[In The Pattern Seekers: How Autism Drives Human Invention, psychologist Simon] Baron-Cohen argues that humans split off from all other animals to become the scientific and technological masters of our planet because we evolved a unique piece of mental equipment that he calls the Systemizing Mechanism While everyone has a Systemizing Mechanism, its tuned especially high in people who are inventors and in those drawn to fields like science, engineering, music, competitive sports, high-level business and often, too, in people with autism.

Heres how the mechanism works: Humans alone observe the world and ask questions that demand why, how and what They use those patterns to build theories, which they then repeatedly test, looking always for systems to further employ and exploit.

As Baron-Cohen describes it, the Systemizing Mechanism is so all-powerful, it explains evolutionary change, historic progress and individual excellence including, for example, the ancient shift from simple to complex tool use, the invention of the light bulb and the late Kobe Bryants highly regimented training schedule. Its true, all these scenarios can be described as looping sequences of if-and-then reasoning. But its a much greater leap to show that this is the main engine of evolution, or that it demonstrates how human brains work in real time, or that the two things have much in common.

[Editors note: Find The Patter Seekers: How Autism Drives Human Invention here.]

Read the original post

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'The Pattern Seekers': What autism can tell us about the evolutionary tipping point that made us human - Genetic Literacy Project

Could We Populate Another Planet With Genetically Modified Organisms? – Gizmodo

Illustration: Benjamin Currie/Gizmodo

Earlier this year, a research team made waves by suggesting that we should disseminate Earths microbes on Mars in a preemptive effort to foster a climate hospitable to human life. To the anti-contamination school of celestial thought, this was heresy; to the most others, this was an obscure theoretical squabble over an issue theyd never heard about. Still, given that our descendants may well spend their most productive years on Mars, its worth trying to grasp these early, pre-colonial debates before they assume life-or-death urgency. To that end, for this weeks Giz Asks weve posed a two-parter to a number of relevant experts. First: Could we populate another planet with genetically modified organisms? Second: Should we?

Associate Professor, Anthropology, York University, whose research focuses on the social and ethical aspects of space exploration, among other things

We probably could; we probably shouldnt. But first, its worth asking: whos we?

Discussion of space and the future often involves a rhetorical we that encompasses all humanity or our species. But its time to think differently about space. There is no big we here. For the foreseeable future, only a very few human beings will have the capability to launch or act in spaceand only a very few human beings have the ability to genetically modify other organisms. And obviously, that tiny contingent of humans invents and develops these technologies with the general intention of using them.

That tiny contingent of humans does not include me. I have opinions. But I dont have a vote. And thats true for the vast majority of people reading this. That matters, because when a space agency, space advocacy group, Elon Musk, or Jeff Bezos, etc., says We should do X or Y in space theyre using traditional rhetoric that encourages audiences to think that we (the rest of humanity) are a part of what theyre doing. Clarity on this matters a lot now, as multilateralism is either faltering or collapsing, the capabilities of private actors are accelerating, and the likelihood of unilateral actions increases. There are a multitude of different interests in space, and a multitude of ideologies and capabilitiesnot one we.

Anyway, in theory, yes, some humans could introduce some genetically modified organisms onto another planet. (Full-on terraforming is much less feasible.) Not all planets would be suitable, but some might be. Human technology cannot yet physically reach the myriad planets outside our solar system, but miniscule interstellar probes carrying dormant microbial payloads and pointed at exoplanets are theoretically possible. But for the moment, the most likely targets would be the planets (and moons) in our own solar system. So:

Should some humans populate a world in our solar system with GM organisms? Nooooooooo. At the very least, not yet. Reason #1: many would regard this as a breach of the Outer Space Treaty. Reason #2: some of those worlds might have life already, and its much better to find it and study it thoroughly first. Reason #3: Perhaps other worlds have their own intrinsic value regardless of their liveliness. Worth considering, at least.

Further away: should some humans populate an exoplanet with GM organisms? A louder Noooooooooooooo. Louder because theres an unnerving asymmetry: it could be faster/easier to send a payload-laden micro-probe to an exoplanet than to study the exoplanet thoroughly first. Also, human beings are not going to exoplanets anytime soonif everwhich negates a main justification for doing this kind of bioengineering.

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Senior Scientist, SETI Institute

Take Mars, Europa, and Enceladuseach of which appear to have water tucked out of the way, below thick ice layers (although not always hiddenthere are plumes). We probably could modify an Earth organism, or suite of organisms, to live in such places for some limited period of time, but I couldnt guarantee you could populate one of those places with GMOs. Unless you were tremendously lucky, the Earth organisms might eat all of the minerals in reach, and then stage a massive die-off that would be tremendously yucky and pointless. And if you were that lucky, there might be native organisms that would just eat your GMO additions and yield a polite burp of methane and leave it at that. Right now we dont know enough to do something useful with GMOs at any alien place (and only a few on Earth).

There are lots of ways in which we are too ignorant to do anything useful with this scheme, and of course not knowing how ignorant we are is one of them. We do not need to give up on a search for life elsewhere in this solar system just because some microbiologists have a tool and no patience. And we dont need to take shortcuts in pursuing such a search so that we lose that scientific pursuit just because it is hard to do without inadvertent (let alone purposeful) contamination of the best sites.

Professor of Planetary Habitability and Astrobiology at Technical University Berlin, President of the German Astrobiology Society, and Co-author of The Cosmic Zoo: Complex Life on Many Worlds

I dont think were there yet, in two senses. We dont know the environmental conditions of other planets well enough, and we dont know how to optimally tune the genetic code of an organism to thrive in that extraterrestrial environment. The only planet where I see this as a possibility in the near future is Mars, which we know best of all the planets and moons in our Solar System.

But even if we can do it, I dont think we should. It would be a very human-centric approach. Instead, we should try to explore the diversity of life that may exist on other planetary targets. In regard to Mars, that would mean exploring whether indigenous (microbial) life exists, and if so, studying how it is different from life on Earth. (Even if there is a common origin, evolution in the different planetary environments would still have resulted in significant organismic changes.)

Mars (and any other planet or moon potentially harboring life) has many microenvironments that may contain life; to conclusively prove that there is no indigenous life at all, anywhere on the planet, may be close to impossible, at least for the foreseeable future (and especially given our current ignoranceafter all, we only know about one type of life). As long as the possibility of indigenous life cannot be excluded, populating Mars or any other planet with genetically modified organisms is out of the question.

If we encounter a habitable planetand one which we know for sure is uninhabitedthe question becomes harder to answer. We can come to that when the situation ariseswhich it wont for a very long time.

Professor and Principle Investigator of the Ohio Musculoskeletal & Neurological Institute and Emeritus Professor of Space Biology at Nottingham University

Indeed we could. We have the capability to land robots on other planets. Currently we sterilize these to prevent accidentally contaminating other planets with microscopic life forms. If we wanted to not sterilize or deliberately send microscopic life to other planets, this is fairly easy to do. Similarly, labs on Earth routinely make and use genetically modified microscopic life forms. Thus, it is also fairly easy to send GMO microscopic life forms to other planets.

Whether we should is the more difficult question. Who benefits from doing this, and who loses out? Do the benefits outweigh the losses? If this is done to allow human habitation of another planet, then potentially all of humanity gainswhereas those aspects of planetary science that want/need to study a natural planet lose out. If this is done to allow for the commercial/financial gain of a few, does that outweigh the loss to science?

Assistant Professor of Astronomy and Molecular and Cellular Biology at the University of Arizona

It depends on the planet. An exoplanet around a star system is probably out of reach with current technology.

If
the candidate planet is in our solar system, such as Marsperhaps. It becomes a question of: For how much, or how long, are you willing to provide technological assistance to create a habitable volume elsewhere? The engineered organisms will most likely be severely restricted in the range of places they can inhabit. So far as we know, no amount of genetic engineering will enable terrestrial organisms to survive under freezing temperature and extreme soil oxidation conditions, such as those found in the Martian environment.

Subsurface ocean worlds such as Enceladus or Europa might work, but we havent precisely characterized their habitability, and it is difficult to foresee how the organisms would be delivered there if the shell of ice is kilometers thick.

That being said, genetically engineering organisms and evolving them under various conditions may allow us to understand the limits of life here on Earth.

Do you have a burning question for Giz Asks? Email us at tipbox@gizmodo.com.

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Could We Populate Another Planet With Genetically Modified Organisms? - Gizmodo

Gene Drives Could Kill Mosquitoes and Suppress Herpesvirus Infections – American Council on Science and Health

Several years ago, a brand new method of genetic engineering called CRISPR was invented, and it was based on discoveries made about the rudimentary "immune system" possessed by bacteria. Essentially, bacteria have a way of "remembering" which viruses had infected them previously, and they possess a molecular system that destroys viral DNA that matches that of a prior infection.

The molecular system consists of a DNA-cutting protein called Cas9. (See infographic from Business Insider below.) When equipped with a special guide RNA, Cas9 can be used to cut specific DNA sequences, for instance, a mutated gene that is causing a health problem. Because a broken DNA molecule is dangerous, the cell will attempt to repair it. If a DNA segment is snuck into the cell before the repair occurs, the cell can insert the new (and usually improved) DNA piece, providing a method to "edit" DNA.

The implications for such a technology are obvious. Such a method could be used, for example, to cure a person of a genetic disease or more easily produce genetically enhanced crops for farmers. But there are even cleverer uses. Because the CRISPR-Cas9 system can be designed to be self-propagating, it can be used to force a gene into a population of animals, such as mosquitoes. If this system targets genes that are important for survival or reproduction, then once released, this "gene drive" would rapidly spread through the population, killing off mosquitoes. (See infographic from The Economist.)

Now, a team of researchers writing in the journal Nature Communications has shown that a gene drive can be used to suppress infection with cytomegalovirus, a type of herpesvirus. The underlying molecular mechanism of the gene drive is similar to others before it: A self-propagating chunk of DNA inserts itself into a gene that is important to the virus. In this case, the gene is UL23, which is needed for cytomegalovirus to avoid the human immune response.

The researchers showed that when a cell is infected by both the normal virus (called "wildtype" or "WT") and the modified virus carrying a gene drive ("GD"), the gene drive was able to quickly and efficiently spread through the entire population, representing up to 95% of the final proportion of viruses. The end result is the suppression of viral infection (in cell culture, not in an animal model) because the gene drive virus lacks the important UL23 gene, which is needed for the virus to avoid a potent immune molecule known as interferon gamma(IFN-), which the authors added to the cell culture.

Could such a system work to treat viral infections in humans? Possibly. The authors note that a different gene (other than UL23) might need to be targeted, since lack of this gene is only fatal to the virus if IFN- is added to the cell culture. There are also concerns that a gene drive system could cause the viruses to mutate in various ways and may have unforeseen consequences.

Still, the technology is powerful and should be researched further. The coronavirus pandemic reminds us that we want to have multiple weapons in the public health arsenal should we be confronted with another life-threatening microbe.

Source: Walter, M., Verdin, E. Viral gene drive in herpesviruses. Nat Commun 11, 4884 (2020). Published: 28-Sept-2020. DOI: 10.1038/s41467-020-18678-0

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Gene Drives Could Kill Mosquitoes and Suppress Herpesvirus Infections - American Council on Science and Health

Was the MERS virus a model for the creation of COVID-19? – WION

First reported in 2012 in Saudi Arabia, Middle East Respiratory Syndrome (MERS) is a respiratory illness caused by a coronavirus with symptoms similar to the COVID-19 coronavirus, namely, fever, cough and shortness of breath with a range from none, to mild, to severe.

As of January 2020, about 2,500 cases of MERS have been reported worldwide. Human-to-human transmission typically requires close contact with an infected person, the spread being uncommon outside of hospitals.

In contrast to COVID-19, the death rate from MERS is about 35%.

MERS is believed to have originated in bats, was transmitted to camels as an intermediate host, then infecting humans, who had contact with the infected animals.

Although the COVID-19 virus has structural similarities to bat coronaviruses, its precise origin has yet to be identified.

The most distinguishing and unique structural feature of the COVID-19 virus is the furin polybasic cleavage site, a sequence of amino acids that interacts with human cell enzymes, which cut or cleave parts of the viral structure, thus contributing to the life cycle of the virus.

In the case of COVID-19, that sequence of amino acids is usually identified as proline-arginine-arginine-alanine or, in scientific notation, PRRA, which precedes an arginine-serine cleavage point, R-S.

It is unknown from where the PRRA sequence originated because it does not exist in any of the bat coronaviruses identified as close relatives of the COVID-19 virus.

A model for such a structure, however, does exist in the MERS coronavirus, which has a proline-arginine-serine-valine or PRSV sequence preceding the R-S cleavage point and having the following alignment:

COVID-19 PRRAR-S

MERS PRSVR-S

Both sequences begin with proline (P), both are polybasic having more than one arginine (R) and both have a non-polar amino acid in the fourth position, alanine (A) and valine (V), respectively, prior to the cleavage point, R-S.

It is important to note that COVID-19 and MERS are from two completely different families of coronaviruses, so one could not have evolved from the other.

According to the scientific article Structures and dynamics of the novel S1/S2 protease cleavage site loop of the SARS-CoV-2 spike glycoprotein," the presence of proline (P) is highly unusual.

Unlike other amino acids, proline produces structural rigidity in proteins and is found in only 5 out of 132 identified furin cleavage site sequences.

Likewise, alanine (A) located just prior to the R-S cleavage point exists in only 5 out of 132 furin cleavage site sequences.

In an early June scientific article, A novel bat coronavirus closely related to SARS-CoV-2 contains natural insertions at the S1/S2 cleavage site of the spike protein, the authors claimed to have identified a bat coronavirus, called RmYN02, that appears to have a precursor of the COVID-19 furin polybasic cleavage site.

RmYN02 has a proline-alanine-alanine (PAA) insertion roughly in a similar position to the COVID-19 virus, but PAA is chemically neutral, lacks any basic amino acids and has no R-S point to be cleaved.

RmYN02's PAA sequence, therefore, cannot be considered a precursor of the COVID-19 furin polybasic cleavage site.

So, the question remains, if no yet identified close relative of COVID-19 has a similar furin polybasic cleavage site, from where did such a unique structural feature with amino acids in unusual positions arise?

Furin polybasic cleavage sites are known to increase viral infectivity and pathogenicity. Genetic engineering techniques for inserting such cleavage sites have existed for at least fifteen years.

At present, no natural evolutionary pathway has been identified to explain the presence of COVID-19s furin polybasic cleavage site.

Those who may have manufactured the COVID-19 virus, could have been trying to mimic the cleavage site found in MERS.

Furthermore, the high rate of human-to-human transmission found for COVID-19, may have resulted from "pre-adapting" the virus for human infection by serial infection or passaging of the virus using animal models genetically-engineered to express the human coronavirus receptor.

There is now a preponderance of evidence that the COVID-19 virus was the product of laboratory experimentation rather than a natural infectious "jump" from bats to humans.

China still has a lot of explaining to do.

(Lawrence Sellin, Ph.D. is a retired U.S. Army Reserve colonel, who previously worked at the U.S. Army Medical Research Institute of Infectious Diseases and conducted basic and clinical research in the pharmaceutical industry. His email address is lawrence.sellin@gmail.com)

(Disclaimer: The opinions expressed above are the personal views of the author and do not reflect the views of ZMCL.)

Link:
Was the MERS virus a model for the creation of COVID-19? - WION

Maze Therapeutics and Alloy Therapeutics Form Broadwing Bio to Develop Antibody Therapies for Genetically Validated Targets in Ophthalmic Diseases -…

SOUTH SAN FRANCISCO, Calif. & LEXINGTON, Mass.--(BUSINESS WIRE)--Maze Therapeutics, a company focused on translating genetic insights into new medicines, and Alloy Therapeutics, a company developing platforms and services to enable drug discovery, today announced the formation of Broadwing Bio to develop targeted antibody therapies for the treatment of ophthalmic diseases. Broadwing Bio will advance programs directed to genetically validated ophthalmology targets identified using Mazes human genetics and functional genomics platform, the COMPASS platform. Alloy Discovery Services will generate therapeutic candidates using Alloys broad suite of antibody discovery technologies, including the ATX-Gx mouse platform.

Under the terms of the agreement, Maze and Alloy will fund Broadwing Bio to rapidly advance its programs through preclinical and clinical development with the opportunity for independent financing and partnering. Maze and Alloy will retain certain rights to participate in the development and commercialization of products originating from Broadwing Bio. The company will be led by Andrew Peterson, Ph.D., founder and chief executive officer of Broadwing Bio.

We are very excited to partner with Alloy on the formation of Broadwing Bio, with a mission to advance therapeutics for ophthalmology indications, said Jason Coloma, Ph.D., chief executive officer of Maze. Maze is advancing a pipeline of programs based on genetic insights of disease, without restrictions on modality or therapeutic area. This joint venture will allow us to pursue compelling Maze-identified targets through a dedicated organization with the experience and focus to develop highly differentiated therapies addressing unmet needs in ophthalmology, while retaining significant financial participation and product rights.

Broadwing Bio is a great example of the high impact partnerships Alloy Discovery Services will conduct on a very select basis, where we can invest heavily in the success of the partnership, said Errik Anderson, chief executive officer and founder of Alloy Therapeutics. We are honored to be working with an incredible scientist-entrepreneur like Andy, in partnership with Mazes team, to advance these exciting drug targets designated by Maze.

Broadwing Bio has established a team of experienced leaders and scientific advisors, including

There are a number of ophthalmic diseases for which effective therapeutic options are limited, but recent genetic insights provide avenues to change this situation, said Dr. Peterson. Broadwing Bio has the very unique opportunity to bring together the capabilities of two exceptional companies in order to develop novel treatments targeted at these diseases. Im thrilled to join the company as CEO and look forward to building the Broadwing Bio team, while leveraging Maze and Alloys insights and experience in drug discovery in order to bring medicines to patients in need.

About Maze Therapeutics

Maze Therapeutics is a biopharmaceutical company developing a broad portfolio of therapeutic candidates for a number of genetically defined diseases. Maze is focused on translating genetic insights into new medicines by utilizing an approach that combines the analysis of large-scale human genetics data, cutting-edge functional genomics and an array of drug discovery approaches. The Maze COMPASS platform reveals modifier genes that confer protection and provides deeper understanding of the target biology and how these targets can be best targeted with drug therapies. Maze was launched in 2019 by Third Rock Ventures, with funding from ARCH Venture Partners, GV, Foresite Capital, Casdin Capital, Alexandria Venture Investments, City Hill and other undisclosed investors. Maze is based in South San Francisco. For more information please visit mazetx.com.

About Alloy Therapeutics

Alloy Therapeutics is a biotechnology company dedicated to empowering scientists in the relentless pursuit of making better medicines for all. To this end, Alloy seeks to democratize access to foundational drug discovery platforms and services to scientists worldwide. Alloys first platform, the ATX-Gx mouse platform, is a suite of transgenic mice designed for best-in-class in vivo discovery of fully human monoclonal antibodies. Alloys partners include academic scientists, small and medium biotech, and Fortune 50 biopharma. Founded in 2018 and privately funded by visionary investors, Alloy Therapeutics is headquartered in Boston, Massachusetts with European labs in Cambridge, UK. As a reflection of our irrational commitment to the scientific community, 100% of our revenue from platforms and services is reinvested in innovation and supporting access to innovation. To join the revolution, visit alloytx.com or schedule a 15-minute chat with our Founder and CEO at alloytx.com/ceo.

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Maze Therapeutics and Alloy Therapeutics Form Broadwing Bio to Develop Antibody Therapies for Genetically Validated Targets in Ophthalmic Diseases -...

The virus causing COVID-19 most likely evolved in natural wildlife populations before spreading to humans – Health Feedback

CLAIM

[G]enetic evidence within the Spike gene of SARS-Cov-2 genome [] does exist and suggest that the SARS-CoV-2 genome should be a product of genetic manipulation; The characteristics and pathogenic effects of SARS-CoV-2 are unprecedented

DETAILS

Incorrect: The genetic features of SARS-CoV-2 are common in other coronaviruses that occur in nature and have animal reservoirs. Therefore, these features do not prove in any way that the virus was constructed in a laboratory or genetically modified.Unsupported: The author does not provide evidence to support her claim that the virus causing COVID-19 was created in a lab. The pre-print cherry-picks data and overlooks alternative hypotheses about the virus evolving in nature. Contrary to the claim, the most likely scenario is that the SARS-CoV-2 virus was transferred to humans from bats or other animal reservoirs, similar to how other viruses were transferred to humans like the SARS-CoV-1 virus (a coronavirus closely related to SARS-CoV-2) and Ebola.

KEY TAKE AWAY

Although the exact origin of the SARS-CoV-2 virus remains unknown, previous claims that the virus contained artificial elements or that it had been patented were debunked. The virus most likely originated in nature, probably in bats, according to the genetic similarity between SARS-CoV-2 and other animal coronaviruses. Dr. Yan claims to prove that the SARS-COV-2 virus originated in a lab, but a careful analysis of her pre-print actually shows this claim is unsubstantiated.

REVIEW On 14 September 2020, the Chinese virologist Li-Meng Yan published a a pre-print (an unpublished draft of a science paper) on the website Zenodo claiming to provide evidence that SARS-CoV-2, the virus that causes COVID-19, was created in a laboratory and is not of natural origin. Many outlets promoted the pre-print and Fox News aired an interview with Yan and Tucker Carlson on 16 September 2020. Hundreds of posts shared the unsupported claim, receiving millions of interactions, according to the social media analytics tool CrowdTangle.

This pre-print resurrected the baseless claim that SARS-CoV-2 is man-made, a claim that has been repeated since the beginning of the COVID-19 pandemic and Health Feedback previously covered here, here, here, and here. Yans pre-print, which was not peer-reviewed by other experts in the field, claims that some unique characteristics in the SARS-CoV-2 genome prove that the virus is man-made. However, experts disputed Yans pre-print for being flawed and containing unsubstantiated claims. Gkikas Magiorkinis, Assistant Professor of Hygiene and Epidemiology and Scientific Coordinator of the National Reference Centre for Retroviruses at the National and Kapodistrian University of Athens, said:

[C]losely related coronaviruses have been retrieved from animals such as bats and pangolins, which makes the scenario of naturally occurring evolution far more likely than any scenario of laboratory manipulation. In fact, we have [a] clear history of zoonotic origin of lethal coronavirus outbreaks such as SARS-CoV and MERS-CoV. The paper by Li-Meng et al. does not provide any robust evidence of artificial manipulation, no statistical test of alternative hypotheses (natural evolution vs artificial manipulation) and is highly speculative.

Specifically, Yan focuses on three features of the viral genome to claim that SARS-CoV-2 is man-made. The first feature is an allegedly high similarity between the genetic sequence of SARS-CoV-2 and the previously known bat coronavirus ZC45. According to Yan, this similarity indicates that this bat coronavirus served as a template to construct SARS-CoV-2 in the laboratory. However, the bat coronavirus is only 89% related to SARS-CoV-2. In virology terms, that is very distant, said Stanley Perlman, a professor of immunology and microbiology at the University of Iowa, in an explanation to FactCheck.org.

According to Yan, the second genetic feature of SARS-CoV-2 that suggests it is man-made is the spike (S) protein that resembles that of SARS-CoV-1 from the 2003 epidemic in a suspicious manner. S protein allows the SARS-CoV-2 virus to bind to and infect animal cells. SARS-CoV-2 lacks a set of key amino acids within the S protein that conferred SARS-CoV-1 its super-affinity for human cells[1,2], however it can bind to human cells with a greater affinity than SARS-CoV-1. If scientists wanted to engineer improved binding for the S protein in SARS-CoV-2, they would most likely use the already-known and efficient amino acid sequences in SARS-CoV-1 instead of engineering a new amino acid sequence. The differences in S protein between the two viruses strongly suggest that the SARS-CoV-2 evolved independently of human intervention and instead resulted from natural evolutionary processes, undermining the claim that the virus was engineered[3].

The third genetic feature highlighted in Yans pre-print is the presence of unique restriction sites within the S protein of SARS-CoV-2, which she claims contribute to the increased virulence and pathogenicity of the virus. Restriction sites are specific recognition sequences in the genome that researchers use to cut and manipulate genes. Experts who reviewed the pre-print consider this evidence to be incorrect, as these restriction sites frequently appear in nature. Virologist and assistant research professor at Rutgers University Jason Kaelber explained in a point-by-point response to Yans pre-print in Twitter, that these types of restriction sites easily emerge in nature, as it has been documented for flu[4].

Based on these three genomic features, Yans pre-print concludes that SARS-CoV-2 does not derive from natural viral evolution, but from genetic engineering to eventually become a highly-transmissible, onset-hidden, lethal, sequelae-unclear, and massively disruptive pathogen. Cat coronaviruses, which are unlikely to be genetically engineered, also cause a wide spectrum of disease outcomes similar to COVID-19 in humans[5]. Angela Rasmussen, a virologist at Columbia University, also discussed these three lines of evidence in a Twitter thread stating that these genetic features also appear in nature and do not prove that the virus was created in a laboratory.

According to an 11 July 2020 statement from the University of Hong Kong (HKU) where Yan worked as a post-doctoral fellow, Yan never conducted any research on human-to-human transmission of the novel coronavirus at HKU during December 2019 and January 2020, and what she might have emphasised in the reported interview has no scientific basis but resembles hearsay.

In addition to insufficient support for the claim that the virus is man-made, the authors of the pre-print are not affiliated with a research institution, but rather the Rule of Law Society & Rule of Law Foundation, two related organizations with no prior record of scientific publications. The authors do not disclose any potential conflict of interests, even though these entities have connections to the former chief White House strategist Stephen Bannon and the exiled political activist Guo Wengui. Bannon and Wengui published misinformation about COVID-19 in the past.

Scientists and public health authorities repeatedly refuted similar claims about the origin of SARS-CoV-2. On 19 February 2020, 27 eminent public health scientists stated in The Lancet that numerous international studies analyzing the genome of the SARS-CoV-2 virus overwhelmingly conclude that this coronavirus originated in wildlife as have so many other emerging pathogens. On 30 April 2020, the U.S. Office of the Director of National Intelligence concurred with the scientific consensus. Indeed, the transmission of pathogens from animals to humans is a common process called zoonosis, which is responsible for about 60% of the emerging infectious diseases globally, according to the World Health Organization.

The pre-print ignores all recent data from coronaviruses in pangolins and bats, which demonstrate that genetically similar coronaviruses occur in nature and have animal re
servoirs. A 17 March 2020 study published in Nature Medicine concluded that SARS-CoV-2 likely originated in pangolins or bats and later developed the ability to infect humans[3]. Accordingly, a recent publication in Science Advances suggests that recombination of SARS-CoV-2 with pangolin coronaviruses was possibly a critical step in the evolution of SARS-CoV-2s ability to infect humans[6]. This process of recombination occurs naturally when two viruses infect simultaneously the same host and exchange pieces of genetic material, resulting in a novel virus with different characteristics to the viruses it comes from.

In summary, the genetic features of SARS-CoV-2 used to support the claim that the virus is man-made are not unique and occur naturally in other coronaviruses. The pre-print does not provide any evidence that the virus has been created in a laboratory setting, and thus the hypothesis that SARS-CoV-2 is man-made remains unsupported by available scientific evidence. Although the possibility of a laboratory leak cannot be completely excluded until the origin of SARS-CoV-2 is precisely determined, evidence from genetic analyses of the virus indicates that it likely originated in bats and later made the jump into humans, probably involving other intermediary animals[7].

Several competing hypotheses have been proposed to explain where the novel coronavirus actually came from. Health Feedback investigated the three most widespread origin stories for the novel coronavirus (engineered, lab leak or natural infection), and examined the evidence for or against each proposed hypothesis in this Insight article.

This article in Medium, comprehensively summarizes the scientific flaws in Yans arguments.This review by National Geographic provides additional comments from scientists.

This fact check is available at IFCNs 2020 US Elections FactChat #Chatbot on WhatsApp. Clickhere, for more.

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The virus causing COVID-19 most likely evolved in natural wildlife populations before spreading to humans - Health Feedback

Commission charts narrow path for editing human embryos – Science Magazine

He Jiankui shocked the world when he described the implantation of edited embryos that led to the birth of twin girls, Lulu and Nana.

By Jon CohenSep. 3, 2020 , 10:00 AM

No recent biomedical experiment has caused more consternation than He Jiankuis creation of the first gene-edited babies, in 2018, which was widely seen as dangerous, unethical, and prematureand which led to his incarceration by China. Now, an international committee has concluded that gene-editing methods, despite substantial improvements, are still far from mature enough to safely introduce heritable DNA modifications into human embryos.

But they might be one day, in rare circumstances, adds the panel, calling for the formation of a global scientific body that would review proposals for what it calls heritable human genome editing (HHGE) and try to influence whether countries decide to allow its use. The group, which today released one of the mostin-depth reportson the topic yet, spells out in great detail genetic situations that HHGE could address and the strict oversight that clinicians in the future must meet before again creating humans with modified DNA that they can pass on to offspring.

For more than 1 year,the International Commission on the Clinical Use of Human Germline Genome Editingreviewed the scientific literature on CRISPR and other ways to modify DNA, held public meetings and webinars, and consulted scientists, physicians, ethicists, and patient groups. The 18 members of the commissionwho come from 10 countries and, as the report notes, include experts in science, medicine, genetics, ethics, psychology, regulation, and lawagreed with earlier groups that concluded no one should follow in Hes footsteps anytime soon. CRISPRthe genome editor He used, and refined versions of itthey concluded, still cannot efficiently and reliably make precise changes without causing undesired changes in human embryos.

The report stresses that it focuses on initial clinical use of HHGE, and says the field needs to be closely monitored and frequently reevaluated. There are a lot of gaps in our knowledge and further research is needed, Kay Davies, a geneticist at the University of Oxford who co-chaired the commission, said at a briefing today.

Organized by the U.K.s Royal Society and the science and medicine branches of the U.S. National Academies of Sciences, Engineering, and Medicine, the commission aimed to describe a responsible clinical translational pathway that could move genome editing from the lab to assisted-reproduction interventions for human diseases. The report largely steers clear of the complex social and ethical implications of creating gene-edited babies. But it does delve into the governance of the issue, notably calling for creating an International Scientific Advisory Panel to assess proposed uses of HHGE, provide regular updates about related technologies, and review clinical outcomes if an edited embryo implanted into a mother is born. It also recommends the creation of an international mechanism by which a clinician or researcher could report plans for or uses of HHGE that they find concerningin essence, a hotline for whistleblowers.

The commissions foray into such issues has perturbed some. The report strays beyond its scientific remit, Sarah Norcross, director of the Progress Educational Trust, a charity focused on helping people with infertility or genetic conditions, said in a statement released by the U.K. Science Media Centre. The World Health Organization (WHO) is still deliberating on the governance of genome editing, and should not feel constrained by this report's governance recommendations if it sees fit to deviate from them.

The genome editing commission categorized potential uses of HHGE, creating a six-level hierarchy that ranges from the most to least compelling rationales to take the risk. The use of HHGE that is easiest to justify, they said, would be helping those rare couples who, even with in vitro fertilization (IVF) and screening of embryos, have little or no chance of having a baby that does not inherit a genetic conditionfor example, Huntington disease, cystic fibrosis, beta thalassemiathat will cause severe morbidity or premature death. The report stresses that these situations are few and far between. People have two copies of most genes, one inherited from the mother and the other from the father. For a so-called recessive disorder such as cystic fibrosis, there are maybe one or two couples in the United States who both are homozygous for this mutationmeaning in their inherited pair of the geneand would produce an affected child. In dominant disorders, like Huntington, a child needs to inherit only one mutated gene to develop the disease, so one homozygous parent, also a rarity, inevitably would pass on the disease to all embryos.

If HHGE is allowed, the panel said, any embryo edit should only specifically change one DNA sequence into a specific desired sequence that is common in the relevant population. This means the simplest, most frequently used form of CRISPR, which can cripple genes but does not fix them, should not ever be used in embryos; in Hes controversial experiment, for example, he attempted to knock out a gene and make the childrens cells resistant to HIV infection.

I welcome the commissions report, which continues to add depth to the ongoing global conversation about the science of germline editing, says Alta Charo, a bioethicist at the University of Wisconsin, Madison, who is part of a committee organized by WHO that is examining how to best govern this controversial arena.

Harvard University chemist David Liu, who has pioneered improved genome editing technologies that borrow from CRISPRs toolkit, describes the report as thoughtful, balanced, and well-bounded. But he still has misgivings about whether HHGE should ever be allowed. I continue to struggle to imagine plausible situations in which clinical germline editing provides a path forward to address an unmet medical need that cannot be provided by other options, Liu says. He and others stress that preimplantation genetic testing (PGT), which IVF clinics routinely use, could avoid the need for most human embryo editing. In all but the rarest circumstances, it would allow couples to select and then implant embryos that did not have the disease-causing mutations borne by parents.

There are some couples, however, who have a high likelihood of PGT failing to give them an unaffected child, and this is the one exception to the second-tiered category in the report. The third category of HHGE uses is for genetic diseases that have less serious effects and may also be corrected or treated, like deafness, for which there are now cochlear implants.

In the wake of Hes 2018 revelation, Denis Rebrikov, a DNA sequencing specialist at the Pirogov Russian National Research Medical University, has pursued a project to correct a deafness mutation in couples who each have the aberrant gene. Rebrikov, who is not yet satisfied he can safely edit a human embryo and so has not sought Russias approval to move forward, says the cases for which the commission would allow HHGE are so rare that the panels endorsement is meaningless. In this formulation, it is a ban on editing the genome of the embryo in principle, Rebrikov says.

Norcross echoes that criticism, calling the reports criteria for human embryo editing far too narrow.

Diseases caused by several genes represent the fourth category of HHGE uses. The fifth, and most taboo in the eyes of the panel, would involve genetic enhancements of children, making make them resistant to HIV, better at sports, taller, smarter, or even able to withstand radiation exposures encountered during extended spaceflight.

A key danger of editing human embryos is that unintended off-target DNA changes will occur and not be detected before embryo implantation. The panel explores in detail a possible solution: editing the stem cells that produce human sperm or eggs before using those gametes for IVF. This would have significa
nt safety implications since the issues of on-target editing fidelity and avoidance of off-target events could be largely settled before any gamete is considered for use in the creation of an embryo, the report notes.

Fyodor Urnov, a CRISPR researcher at the University of California, Berkley, says the report confirms the widespread consensus that, at best, theres only a niche justification for editing human embryos. The careful guidelines laid out in this report show that the list of problems that could be addressed by such editing is, in fact, quite small, Urnov says. It is an open secret in the gene-editing community that human reproductive editing is a solution in search of a problem.

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Commission charts narrow path for editing human embryos - Science Magazine

Are we mapping a path to CRISPR babies? | TheHill – The Hill

In November 2018, at a gene-editing summit hosted by scientific societies from the U.S., the U.K., and Hong Kong, a Chinese researcherannouncedthat he had created the worlds first genetically modified babies.He Jiankuifully expected to be celebrated for a scientific breakthrough; hementionedthe Nobel Prize. Instead, he was almost universally condemned.

Key figures associated with theU.S. National AcademiesandU.K. Royal Societyjoined in thecriticismbut did not reject heritable genome editing. Instead, they objected to the Chinese researchers timing. It was too soon, they said. It hadnt been done as they thought it should have been. But according to the researcher now being called a rogue, it was theNational Academies 2017 reportthat had given him the green light for his experiments.

In the aftermath of this headline-grabbing debacle, the scientific societies decided on a do-over. They declared it time to define a rigorous, responsible translational pathway toward clinical use of heritable genome editing. Theyset upa carefully selectedinternational commissionwith themandateto map the scientific details ofhowdesigner-baby technology could be brought to the fertility clinic.

This mandate was flawed from the start. The idea that now is the time to set aside the deeply controversial question ofwhetherheritable genome editing should be done at all so that a small group of experts can settle the nitty-gritty details ofhowit should take place is entirely backward. It flies in the face of the widely shared acknowledgment that scientists alone cannot make this decision; that we must have wide-ranging and inclusive public discussions aimed at buildingbroad societal consensus. It undermines policies in some70 countriesaround the world that prohibit heritable genome editing. And its a slap in the face to the manyscientists,biotech executives,human rights and social justice advocates, and others who support a moratorium or ban on altering the human germline.

The commissions 225-pagereport, released on Sept. 3, does have some strong points. It is more cautious than the previous report, recommending that heritable genome editing should initially be allowed only in the exceedingly rare cases where embryo screening for severe genetic conditions would not be an option. And it paints a vivid picture of the significant technical hurdles facing those eager to pursue heritable human genome editing: shortfalls in the editing tools, in the technologies necessary to test safety and efficacy, even in our understanding of the genetics underlying most heritable diseases.

These findings ought tolay to restthe unfounded assumption that engineering the genomes of human embryos will soon be safe and effective. But even the most cautious considerations of technical safety cant stand-in for the fundamental point that the decision about whether to allow heritable genome editing should be driven by our values, not settled by the science.

The commission claims they are not endorsing heritable genome editing, merely constructing maps of the technological path in case a country should wish to use them. At best, this puts the cart before the horse and sends both horse and cart down a one-way road.

Heritable genome editing cant be separated from its real-world consequences. There are already clear signs that legalizingit would lead to reproductive tourism, jurisdiction shopping, andmission creep. As an example, the U.K.sapprovalof so-called mitochondrial donation for a small number of women with certain mitochondrial DNA diseases wasquickly followedby fertility clinics inUkraine,Spain, and Greeceoffering this high-risk technique, with no evidence of effectiveness, for general and age-related infertility.

A similar trajectory is all too easy to foresee if heritable genome editing is approved, even for limited circumstances. Especially where fertility services are offered on a for-profit basis, its unlikely that any boundaries would hold. We could soon see fertility clinics marketing genetically upgraded embryos, tempting parents-to-be with ads about giving their child the best start in life. From there, a normalized system of market-based eugenics could emerge, exacerbating already existing discrimination, inequality, and conflict.

Amid our multiple ongoing crises, it would be easy to overlook another report on still speculative biotechnology. But this one represents a profoundly consequential step, one that tries to settle in advance the coming decision about whether to engineer genes and traits passed on to future children and generations. Its another attempt to focus discussion on the science, while minimizingthe complex social realities in which scientific and technological developments unfold.

KatieHassonis program director on genetic justice andMarcyDarnovskyis executive director of theCenter for Genetics and Society,a non-profit organization based in Berkeley, California that works to encourage responsible uses and effective governance of human genetic and assisted reproductive technologies.

Excerpt from:
Are we mapping a path to CRISPR babies? | TheHill - The Hill

Japan CRISPR/Cas9 Market size and Key Trends in terms of volume and value 2019-2026 – The Daily Chronicle

The research study presented in this report offers complete and intelligent analysis of the competition, segmentation, dynamics, and geographical advancement of the Global Japan CRISPR/Cas9 Market. The research study has been prepared with the use of in-depth qualitative and quantitative analyses of the global Japan CRISPR/Cas9 market. We have also provided absolute dollar opportunity and other types of market analysis on the global Japan CRISPR/Cas9 market.

It takes into account the CAGR, value, volume, revenue, production, consumption, sales, manufacturing cost, prices, and other key factors related to the global Japan CRISPR/Cas9 market. All findings and data on the global Japan CRISPR/Cas9 market provided in the report are calculated, gathered, and verified using advanced and reliable primary and secondary research sources. The regional analysis offered in the report will help you to identify key opportunities of the global Japan CRISPR/Cas9 market available in different regions and countries.

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The authors of the report have segmented the global Japan CRISPR/Cas9 market as per product, application, and region. Segments of the global Japan CRISPR/Cas9 market are analyzed on the basis of market share, production, consumption, revenue, CAGR, market size, and more factors. The analysts have profiled leading players of the global Japan CRISPR/Cas9 market, keeping in view their recent developments, market share, sales, revenue, areas covered, product portfolios, and other aspects.

segment by Type, the product can be split intoGenome EditingGenetic engineeringgRNA Database/Gene LibrarCRISPR PlasmidHuman Stem CellsGenetically Modified Organisms/CropsCell Line Engineering

Market segment by Application, split intoBiotechnology CompaniesPharmaceutical CompaniesAcademic InstitutesResearch and Development Institutes

Based on regional and country-level analysis, the CRISPR/Cas9 market has been segmented as follows:North AmericaUnited StatesCanadaEuropeGermanyFranceU.K.ItalyRussiaNordicRest of EuropeAsia-PacificChinaJapanSouth KoreaSoutheast AsiaIndiaAustraliaRest of Asia-PacificLatin AmericaMexicoBrazilMiddle East & AfricaTurkeySaudi ArabiaUAERest of Middle East & Africa

In the competitive analysis section of the report, leading as well as prominent players of the global CRISPR/Cas9 market are broadly studied on the basis of key factors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on price and revenue (global level) by player for the period 2015-2020.The key players covered in this studyCaribou BiosciencesIntegrated DNA Technologies (IDT)CRISPR TherapeuticsMerckMirus BioEditas MedicineTakara BioThermo Fisher ScientificHorizon Discovery GroupIntellia TherapeuticsAgilent TechnologiesCellectaGenScriptGeneCopoeiaSynthego

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Japan CRISPR/Cas9 Market Size and Forecast

In terms of region, this research report covers almost all the major regions across the globe such as North America, Europe, South America, the Middle East, and Africa and the Asia Pacific. Europe and North America regions are anticipated to show an upward growth in the years to come. While Japan CRISPR/Cas9 Market in Asia Pacific regions is likely to show remarkable growth during the forecasted period. Cutting edge technology and innovations are the most important traits of the North America region and thats the reason most of the time the US dominates the global markets. Japan CRISPR/Cas9 Market in South, America region is also expected to grow in near future.

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Japan CRISPR/Cas9 Market size and Key Trends in terms of volume and value 2019-2026 - The Daily Chronicle

Toxicity of dorsal root ganglia is widely associated with CNS AAV gene therapy – Science Codex

New Rochelle, NY, September 2, 2020A meta-analysis of non-human primate (NHP) studies showed that adeno-associated virus (AAV) gene therapy often caused dorsal root ganglion (DRG) pathology. There were no clinical effects. The study is reported in the peer-reviewed journal Human Gene Therapy.Click here to read the full-text article free on the Human Gene Therapy website through October 2, 2020.

The dorsal root ganglion is a cluster of neurons in the dorsal root of a spinal nerve. DRG pathology was present in 83% of NHP given AAV through the cerebrospinal fluid and 32% of NHP that received an intravenous injection.

The data suggest that DRG pathology is almost universal after AAV vectors are delivered into the cerebral spinal fluid of nonhuman primates. However, none of the animals receiving a vector expressing a therapeutic transgene displayed any clinical signs, stated James M. Wilson, MD, PhD, a professor of Medicine and director of the Gene Therapy Program and the Orphan Disease Center, and coauthors from the Perelman School of Medicine at the University of Pennsylvania.

The DRG pathology associated with AAV has triggered an increase in the intensity of preclinical evaluation of AAV vectors prior to initiation of clinical trials of new vectors, according to Editor-in-Chief of Human Gene Therapy Terence R. Flotte, MD, Celia and Isaac Haidak Professor of Medical Education and Dean, Provost, and Executive Deputy Chancellor, University of Massachusetts Medical School. The insights offered by Dr. Wilsons paper provide an excellent summary perspective on this phenomenon, which could potentially eliminate the need for a number of redundant preclinical safety studies and thus shorten the path to the clinic for new vectors.

Individual studies utilized for data extraction were supported by REGENXBIO (all studies previously published), Biogen (some studies previously published), Passage Bio, Amicus Therapeutics, ODC MPS I pilot grant MPS-18-D010-01 and MPS-19-001-0, Janssen, Cure FA, Rett Syndrome Research Trust and Elaaj Bio. These entities funded the original studies whose samples were later run through the comparative meta-analysis covered in the manuscript. The studies, company sponsor, and transgenes representing each data point are not disclosed.

About the JournalHuman Gene Therapy ,the Official Journal of the European Society of Gene and Cell Therapy and eight other international gene therapy societies, was the first peer-reviewed journal in the field and provides all-inclusive access to the critical pillars of human gene therapy: research, methods, and clinical applications. The Journal is led by Editor-in-Chief Terence R. Flotte, MD, Celia and Isaac Haidak Professor of Medical Education and Dean, Provost, and Executive Deputy Chancellor, University of Massachusetts Medical School, and an esteemed international editorial board. Human Gene Therapy is available in print and online. Complete tables of contents and a sample issue are available on the Human Gene Therapy website.

About the PublisherMary Ann Liebert, Inc., publishers is known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research. Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industrys most widely read publication worldwide. A complete list of the firms 90 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.

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Toxicity of dorsal root ganglia is widely associated with CNS AAV gene therapy - Science Codex

The Brain Implants That Could Change Humanity – The New York Times

When I asked Facebook about concerns around the ethics of big tech entering the brain-computer interface space, Mr. Chevillet, of Facebook Reality Labs, highlighted the transparency of its brain-reading project. This is why weve talked openly about our B.C.I. research so it can be discussed throughout the neuroethics community as we collectively explore what responsible innovation looks like in this field, he said in an email.

Ed Cutrell, a senior principal researcher at Microsoft, which also has a B.C.I. program, emphasized the importance of treating user data carefully. There needs to be clear sense of where that information goes, he told me. As we are sensing more and more about people, to what extent is that information Im collecting about you yours?

Some find all this talk of ethics and rights, if not irrelevant, then at least premature.

Medical scientists working to help paralyzed patients, for example, are already governed by HIPAA laws, which protect patient privacy. Any new medical technology has to go through the Food and Drug Administration approval process, which includes ethical considerations.

(Ethical quandaries still arise, though, notes Dr. Kirsch. Lets say you want to implant a sensor array in a patient suffering from locked-in syndrome. How do you get consent to conduct surgery that might change the persons life for the better from someone who cant communicate?)

Leigh Hochberg, a professor of engineering at Brown University and part of the BrainGate initiative, sees the companies now piling into the brain-machine space as a boon. The field needs these companies dynamism and their deep pockets, he told me. Discussions about ethics are important, but those discussions should not at any point derail the imperative to provide restorative neurotechnologies to people who could benefit from them, he added.

Ethicists, Dr. Jepsen told me, must also see this: The alternative would be deciding we arent interested in a deeper understanding of how our minds work, curing mental disease, really understanding depression, peering inside people in comas or with Alzheimers, and enhancing our abilities in finding new ways to communicate.

Theres even arguably a national security imperative to plow forward. China has its own version of BrainGate. If American companies dont pioneer this technology, some think, Chinese companies will. People have described this as a brain arms race, Dr. Yuste said.

Not even Dr. Gallant, who first succeeded in translating neural activity into a moving image of what another person was seeing and who was both elated and horrified by the exercise thinks the Luddite approach is an option. The only way out of the technology-driven hole were in is more technology and science, he told me. Thats just a cool fact of life.

Moises Velasquez-Manoff, the author of An Epidemic of Absence: A New Way of Understanding Allergies and Autoimmune Diseases, is a contributing opinion writer.

The Times is committed to publishing a diversity of letters to the editor. Wed like to hear what you think about this or any of our articles. Here are some tips. And heres our email: letters@nytimes.com.

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The Brain Implants That Could Change Humanity - The New York Times

Sanford Health is first in nation to dose patient with promising novel therapeutic candidate for COVID-19, SAB-185 – PRNewswire

SIOUX FALLS, S.D., Sept. 2, 2020 /PRNewswire/ -- Sanford Health, the largest provider of rural healthcare in the country, today announced it has initiated a Phase 1b trial of SAB-185, a first-of-its-kindhuman polyclonal antibodytherapeutic candidate developed by SAB Biotherapeutics (SAB), that would be used to treat patients with mild to moderate COVID-19 at an early stage of the disease. The trial will enroll a total of 21 adult patients across several clinical sites. Sanford Health is the first site in the country to open the study to patients.

"Today's milestone underscores our relentless commitment to advancing the science of medicine to ensure our patients benefit from new discoveries as quickly as possible," said David A. Pearce, PhD, president of innovation and research at Sanford Health. "Working with SAB Biotherapeutics on this clinical trial gives us an opportunity to deliver on our promise to patients."

"We are eager to participate in this clinical trial to investigate the safety of SAB-185, a human polyclonal antibody therapeutic candidate for COVID-19," said Dr. Susan Hoover, principal investigator and an infectious disease physician at Sanford Health. "Our goal is to advance the science around COVID-19 so physicians can be better prepared to treat this novel coronavirus in the future, especially for our populations most at-risk."

SAB's novel platform, which leverages genetically engineered cattle to produce fully human antibodies, enables scalable and reliable production of specifically targeted, high potency neutralizing antibody products. This approach has expedited the rapid development of this novel immunotherapy for COVID-19, deploying the same natural immune response to fight the disease as recovered patients, but with a much higher concentration of antibodies.

"SAB is pleased to advance SAB-185, one of the leading novel therapeutics for COVID-19, into human trials and leverage the rapid response capabilities of our first-of-its-kind technology during this pandemic, when its needed most," said Eddie Sullivan, founder, president and CEO of SAB Biotherapeutics.

SAB is a Sioux Falls-based biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies.Sanford Health is committed to taking research from the bench and bringing promising new treatments to our patients' bedside.New medical discoveries come out of hard work, innovation and research. SAB and Sanford Health are committed to developing and delivering novel solutions to overcome this global pandemic and improve people's lives.

About Sanford HealthSanford Health, one of the largest health systems inthe United States, is dedicated to the integrated delivery of health care, genomic medicine, senior care and services, global clinics, research and affordable insurance. Headquartered inSioux Falls, South Dakota, the organization includes 46 hospitals, 1,400 physicians and more than 200 Good Samaritan Society senior care locations in 26 states and 10 countries. Learn more about Sanford Health's transformative work to improve the human condition atsanfordhealth.orgorSanford Health News.

About SAB BiotherapeuticsSAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. Utilizing some of the most complex genetic engineering and antibody science in the world, SAB has developed the only platform that can rapidly produce natural, highly-targeted, high-potency, human polyclonal immunotherapies at commercial scale. The company is advancing programs in autoimmunity, infectious diseases, inflammation and oncology. SAB is rapidly progressing on a new therapeutic for COVID-19, SAB-185, fully human polyclonal antibodies targeted to SARS-CoV-2 without using human donors. For more information visitsabbiotherapeutics.comor follow @SABBantibody on Twitter.

Media Contacts:

Angela Dejene[emailprotected](218) 280-0148

Melissa Ullerich[emailprotected](605) 695-8350

SOURCE Sanford Health

http://www.sanfordhealth.org

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Sanford Health is first in nation to dose patient with promising novel therapeutic candidate for COVID-19, SAB-185 - PRNewswire

Is Lab-Grown Meat Healthy and Safe to Consume? – One Green Planet

It goes by many names: cultured, in vitro, cell-based, cultivated, lab-grown meat, etc. As the names imply, it is a meat alternative made in a lab via animal cells and a cultured medium, like fetal bovine serum or a proprietary mix of sugars and salts. Several companies around the world are promoting this new technique as a way to cultivate a meat alternative that is supposedly cleaner and safer than traditional meat.

(We are only looking at those products that culture cells taken from animals into a new meat-like formulation. There are many other products that culture plant, fungi, or algal cells into a meat substitute, but we are not reviewing them here.)

29 companies are planning to bring lab-cultured meat to market in the form of chicken, beef, pork, seafood, pet food, and beyond. These companies include Memphis Meats, Aleph Farms, Mosa Meat, Meatable, SuperMeat, and Finless Foods. These companies are backed by huge investments from meat industry corporations (Cargill and Tyson), venture capitalist firms (Blue Yard Capital, Union Square Ventures, S2G Ventures, and Emerald Technology Ventures), and billionaires (such as Bill Gates and Richard Branson).

While the hype is certainly there, is lab-cultured meat actually better? Its proponents tout it as an environmentally responsible, cruelty-free, and antibiotic-free alternative to current meat production. While the goal of producing sustainable meat without killing animals is admirable, lab-cultured meat is in its infancy and the science behind the production methods requires more scrutiny.

Of particular concern is the genetic engineering of cells and their potential cancer-promoting properties. To be able to better assess whether the products are being produced by methods that involve genetic engineering and use genetic constructs (called onco-genes, typically used to make stem cells keep growing; this is not a problem for lab experiments, but could be for food products) that might encourage cancer cells, we need more information on how the cells are engineered and kept growing. Many of the companies are claiming this information is confidential and a business secret. These companies are not yet patenting their production processes wherein this information would be more fully disclosed. Some suggest that the production will follow the FDA cell culture guidelines, but theFDAs cell culture guidelines do not apply to this because theyre not designed for food.

To produce lab-cultured meat, many producers extract animal cells from living animals. This is typically done via biopsy, a painful and uncomfortable procedure that uses large needles. If a company could scale up with this method, it would require a consistent supply of animals from which to acquire cells and innumerable painful extractions. To make the cell-based product more consistent, the producer may biopsy the same animal many times for the cells that growing meat requires.

Growing animal cells (typically muscle cells) also requires a growth medium. When lab-cultured meat production first began, companies depended on fetal bovine serum (FBS) as a growth medium. Producing FBS involves extracting blood from the fetus of a pregnant cow when the cow is slaughtered.

Given its high cost, it appears that FBS is usually only used during small-scale lab trials. Additionally, increasing production capacity using FBS comes with its own set of concerns. Even disregarding the high cost of FBS, non-genetically engineered animal muscle cells only proliferate or increase to a certain degree. In order to overcome this limitation, large companies such as Mosa Meats and Memphis Meats claim theyve found an FBS alternative that does not involve animals along with an effective way to expand production. For Memphis Meats, this process involves the utilization of abioreactor and the creation of immortal cell lines.

Curious about how we make our Memphis Meat? See below! #sogood pic.twitter.com/co5d7OY0bI

Memphis Meats (@MemphisMeats) May 8, 2018

These companies are using a bioreactor essentially a very large vessel for containing biological reactions and processes to implement a scaffold-based system to grow meat, which uses a specific structure for cells to grow on and around. The scaffolding helps the cells differentiate into a specific meat-like formation. Researchers cite using cornstarch fibers, plant skeletons, fungi, and gelatin as common scaffold materials. Instead of animal muscle cell precursors (otherwise known as myosatellites), researchers have been using cultured stem cells. This distinction is important because extracted muscle cells will only proliferate to a certain extent. Companies are trying cultured stem cells as an alternative type of cell(s) that could proliferate exponentially so that they could scale up production, and later differentiate the cells into the various cell types that make up animal meat (muscle, fat, and blood cells) in a bioreactor.

In this process, the stem cells still come from animals or animal embryos, but what differentiates the two methods is that in the scaffold-based system, the cells can be genetically engineered to proliferate indefinitely. These cells are otherwise known as pluripotent (which make many kinds of cells, like stem cells) or totipotent (which make every kind of cell, as do embryos). This would greatly expand a companys capacity to make lab-cultured meat, but the methods by which companies make these cells proliferate come with human health and food safety ramifications.

While the FDA has previously reviewed enzymes, oils, algal, fungal, and bacterial products grown in microorganisms, these new animal cell-cultured products are much more complicated in structure and require a more thorough review. The scale required for making lab-cultured meat feasible for mass consumption will be the largest form of tissue engineering to exist and could introduce new kinds of genetically engineered cells into our diets. Further research will also be needed to conrm or dispel uncertainties over various potential safety issues. Candidate topics for research include the safety of ingesting rapidly growing genetically-modied cell lines, as these lines exhibit the characteristics of a cancerous cell which include overgrowth of cells not attributed to the original characteristics of a population of cultured primary cells. If lab-cultured meat enters the market, there are several human health concerns associated with this new production method, specifically that these genetically-modified cell lines could exhibit the characteristics of a cancerous cell.

While these companies dont disclose much to the public about their processing methods, their public patents reveal the creation of oncogenic, or cancer-causing, cells.A Memphis Meats patent on the creation of modified pluripotent cell lines involves the activation or inactivation of various proteins responsible for tumor suppression. Another patent from JUST Inc. describes the utilization of growth factors as part of its growth medium. This process could promote the development of cancer-like cells in lab-cultured meat products. Additionally, it is possible certain growth factors can be absorbed in the bloodstream after digestion.

If they are using stem cells, cell-based meat companies need to pay attention to the risk of cancer cells emerging in their cultures. A research team from the Harvard Stem Cell Institute (HSCI), Harvard Medical School (HMS), and the Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard has found that as stem cell lines grow in a lab environment, they often acquire mutations in the TP53 (p53) gene, an important tumor suppressor responsible for controlling cell growth and division. Their research suggests that inexpensive genetic sequencing technologies should be used by cell-based meat companies to screen for mutated cells in stem cell cultures so that these cultures can be excluded.

Cancer-causing additives are prohibited in our food supply under the Delaney Clauses in the 19
58 Food Additive Amendments and the 1960 Color Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA). These new rapidly growing cell lines might be considered color additives if they are being used to produce the color in the meat. The federal statutes regulating meat also prohibit the selling of animals with symptoms of illness, such as cancerous cells in meat. Regardless, all of these new ways of making cells that continue to grow or differentiate should require a safety assessment to determine if they contain cancerous cells before they can be sold.

In describing the scaffolding and growth media being used, lab-cultured meat companies need to be fully transparent about what ingredients theyre using. During the above-mentioned industry nonprofits presentation, the presenter suggested the growth media could be composed of a variety of different ingredients like proteins, amino acids, vitamins, and inorganic salts classified under the GRAS (Generally Recognized As Safe) process that allows companies to do their own testing and not submit to a new FDA food additive review. Since companies are not required to fully disclose the composition of their scaffolding or growth media, potentially exposing consumers to novel proteins and allergens, the new mixture of ingredients should be reviewed under a full FDA supervised food additive review, not GRAS.

Another major issue associated with processing methods using cell lines and/or culture medium is contamination. Unlike animals, cells do not have a fully functioning immune system, so there is a high likelihood of bacterial or fungal growth, mycoplasma, and other human pathogens growing in vats of cells. While lab-cultured meat companies emphasize that this type of meat production would be more sterile than traditional animal agriculture, its unknown how that is true without the use of antibiotics or some other pharmaceutical means of pathogenic control.

Based on commentary from various companies, antibiotic usage across the industry is still very unclear. While the industrys promoters have outlined many uses for antibiotics in lab-grown meat production in preventing contamination, they have not disclosed the amount of antibiotics being used in the various processes. Instead, they suggest that because mass production of lab-grown meat will be done in an industrial rather than lab setting, with bioreactors and tanks, there will be higher safety oversight than in medical labs. It is suggested that the many preventative measures in the industry will maintain a sterile boundary and deter antibiotic use in production. It remains a question of how a food production plant would be more sterile than a medical lab.

Some companies, such as Memphis Meats claim they are genetically engineering cell lines to be antibiotic-resistant, which would suggest they plan on using antibiotics, but dont want their meat cells to be affected. Problems with bacterial and viral contamination plague medical cell culture, so they generally use antimicrobials. Still, any large-scale production that requires antibiotic use even if just for a short-term duration should require such lab-cultured meat undergo even stricter USDA drug residue testing, pathogen testing, and FDA tolerance requirements than conventionally-produced meat. Many other companies claim they dont plan to use antibiotics in expanded production which begs the question, in addition to supposed sterile bioreactors, are they using other undisclosed processes to prevent contamination? For example, Future Meat Technologies describes the use of a special resin to remove toxins.

The companies have also not disclosed plans for how they will dispose of the toxins from bioreactors, scaffolding, and culture media like growth factors/hormones, differentiation factors, often including fetal calf serum or horse serum, and antimicrobials (commonly added to cultured cells to prevent bacterial and fungal contamination, particularly in long-term cultures). In conventionally-produced meat, animals dispose of these toxins in their urine and feces. If companies cant find a way for this meat to dispose of these toxins, they could potentially build up within the meat itself. Given the lack of clarity of these companies and their processes, there must be continuous monitoring of the cell lines and growth media/bioreactor for contaminants and some sort of standardization established across the industry to ensure safety.

The industry is new and the exact production process and inputs needed for large-scale, lab-cultured meat production are unknown (or not being disclosed by the companies). It is the responsibility of both FDA and USDA to ensure that all inputs used in production and the final product are safe for human and animal consumption. These agencies must ensure that lab-cultured meat is labeled appropriately, including if any of the product ingredients are genetically modified or if the ingredients are produced using unmodified cells from animals. These agencies must also ensure that this product doesnt introduce new allergens into the food supply, that any hormones or antibiotics used are not found at unsafe levels in the final product, and that the product doesnt contain any compounds or oncogenic (cancer-causing) cells that have not been approved for use in food.

Lab-cultured meat should not be allowed to use the Generally Recognized As Safe (GRAS) regulatory loophole wherein companies can hire their own experts to evaluate their products, often in secret without any notice to the public or FDA. GRAS is an inappropriate designation because the consensus among knowledgeable experts regarding the safety of lab-cultured meat does not yet exist. Instead, FDA should require that lab-cultured meat products be regulated more thoroughly as food additives. Meat companies should submit complete food additive petitions for each of the novel ingredients used to produce these meats as well as a final food approval petition for the entire product. The production facilities, like all meat processing plants, should then have USDA inspectors on-site monitoring the process and inspecting the meat. The USDA announced in August that it will start the process of developing regulations for these new kinds of meat. Adequate regulation will be necessary to address the concerns raised in this blog.

Overall, due to the novel nature of lab-cultured meat, the lack of transparency from the companies involved, and the myriad potential health risks to consumers, rigorous regulation of this product is vitally important. Join Center for Food Safetys mailing list to protect your right to safe food HERE >>

For those of you interested in eating more plant-based, we highly recommend downloading theFood Monster App with over 15,000 delicious recipes it is the largest plant-based recipe resource to help reduce your environmental footprint, save animals and get healthy! And, while you are at it, we encourage you to also learn about theenvironmentalandhealth benefitsof aplant-based diet.

Here are some great resources to get you started:

For more Animal, Earth, Life, Vegan Food, Health, and Recipe content published daily, subscribe to theOne Green Planet Newsletter! Lastly, being publicly-funded gives us a greater chance to continue providing you with high-quality content. Please considersupporting usby donating!

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Is Lab-Grown Meat Healthy and Safe to Consume? - One Green Planet

Cats point the way to potential COVID-19 remedies – FierceBiotech

Last week, Gilead Sciences said it would test its COVID-19 drug remdesivir against a related compound in its library called GS-441524 in animal trials, after facing scrutiny over the latter drug, which has been used for years to treat feline infectious peritonitis (FIP) despite not being licensed for that use.

Now, another California biotech, Anivive Lifesciences, is working on a COVID-19 antiviral drug thats inspired by cats, and it has new preclinical research findings to back up the project.

Scientists led by the University of Alberta reported that a drug developed to treat a coronavirus that can cause FIP inhibited the main protease of both SARS-CoV and SARS-CoV-2. That prevented the human coronaviruses from replicating in cell cultures, they reported in the journal Nature Communications.

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Anivive originally licensed the drug, called GC376, from Kansas State University in 2018 and has been working since then to develop it as an antiviral to treat FIP, a progressive disease in cats thats often caused by a coronavirus and is fatal if left untreated. Last month, Anivive said it had started two preclinical studies to determine whether GC376 could also treat COVID-19.

RELATED: COVID-19: New animal data back up Gilead's remdesivir as other treatment candidates emerge

GC376 was designed to inhibit a protease called 3C, which promotes the replication of several coronaviruses that infect animals and people. They include feline coronavirus (FCoV), which usually causes mild symptoms in cats but can lead to FIP.

Two pilot studies of GC376 in pet cats infected with FIP showed that the drug was effective against the disease within two weeks and was well tolerated. Anivive is currently scaling up production of the drug for larger studies in cats.

For the new study, the University of Alberta team tested both GC376 and its parent drug, GC373, for their ability to inhibit the 3C protease. Both drugs blocked viral replication, they reported.

The authors acknowledged that vaccines against COVID-19 are advancing rapidly, but they suggested antiviral drugs are still necessary in the short term. SARS-CoV-2 is a virus with a significant mutation rate. Also, in some patients the virus has persisted longer than 2 months with some possibility of re-infection, they wrote in the study.

M. Joanne Lemieux, Ph.D., professor of structural biology at the University of Alberta, pointed out in an interview with Genetic Engineering & Biotechnology News that GC376 could be advanced rapidly into human trials, given its track record in veterinary medicine.

Because this drug has already been used to treat cats with coronavirus, and its effective with little to no toxicity, its already passed [preclinical] stages, and this allows us to move forward, Lemieux said.

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Cats point the way to potential COVID-19 remedies - FierceBiotech