Category Archives: Genetic Engineering

New York, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Microbiome Therapeutics: Global Markets" - https://www.reportlinker.com/p05976892/?utm_source=GNW The report analyzes the market by segmenting it into the various types of microbiome therapeutics, based on the strategies used for treatment: additive (fecal matter transplants or FMTs, live biotherapeutic products or LBPs), modulatory (postbiotics, prebiotics) and subtractive microbiome therapeutics (phages and antimicrobials).

This study surveys the microbiome therapeutics market by application or disease segments: infectious diseases, metabolic diseases, cancer, gut-brain axis and others.The market is also assessed in the following geographic regions: North America, Europe and emerging markets.

Emerging markets include countries like India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada and Latin America.

The report features leading clinical trials indicating the status and phase of development. New developments and patents are boosting the growth of this market in the global context.

The new report provides comprehensive profiles of market players in the industry.The industry structure chapter focuses on the changing market trends, market players and their leading pipeline candidates.

This chapter also covers the mergers and acquisitions and any other collaborations or partnerships that happened during the evaluation period of this report that are expected to shape the industry.

Factors such as strengths, weaknesses, threats and opportunities that are expected to play a role in the microbiome therapeutics market are evaluated in detail.

Excluded from this report are the markets for prebiotics and probiotics labeled as nutritional or dietary supplements. Prebiotics and probiotics, if included, only pertain to when used in the context of microbiome therapy.

Report Includes: - 32 data tables and 47 additional tables - An in-depth overview of the global microbiome therapeutics market - Analyses of the global market trends, with data corresponding to market size for 2021-2025, and projections of compound annual growth rates (CAGRs) through 2026 - Latest information on market drivers and opportunities, challenges and restraints, technological developments, and regulatory updates, along with their impact on the stakeholders in this market - Evaluation of market potential for microbiome therapeutics market, their market share analysis on the basis of product types, applications, and regions - Highlights of this innovation driven microbiome therapeutics market covering current trends, disease areas of application, clinical trials and their stages, and new developments - Impact of COVID-19 pandemic on the global economy and delay in the clinical trial activity and financial effects on the overall growth of this market - Competitive landscape of this market featuring leading biopharmaceutical companies, their products pipeline and company share analysis - Key merger and acquisition deals, collaborations and partnerships, licensing and manufacturing agreements, and other notable investment strategies within this market - Patent review and deep-dive of the issued patents on the basis of categories such as type, year, disease type, company, country, and assignee - Profile description of the major market participants, including Azitra Inc., Evelo Biosciences, LNC Therapeutics, Second Genome and Vedanta Biosciences Inc.

Summary: The microbiome has become a buzz word and attracted millions of dollars in federal grants, awards and funding from venture capitalists. Technological advances in next-generation sequencing and data analytics clubbed with modern approaches of systems biology and genetic engineering have greatly expanded the knowledge of commensal microbial populations and their interactions with the human hosts.

The Human Microbiome Project (HMP), MetaHIT and other independent efforts fueling the exploration of microbiome and its association with human health have led to a research explosion in this area in the last decade.Myriad of studies abound that show that microbiome has a role in mediating many physiological processes such as metabolism, nutrition and immunity.

It has been observed in many clinical studies that alterations in the microbial populations or microbial dysbiosis can lead to diseases. As such, modulations of the microbiome such that its normal condition is restored or pathogenic bacteria is eliminated have become potential strategies to address many unmet medical needs. Diseases that still do not have any definitive cure, or available treatments are either not satisfactory or costprohibitive, are being actively targeted as treatment indications by microbiome therapeutics.

There are many active players in the field of microbiome therapeutics, ranging from discovery and clinical-stage to late-stage companies that are exploiting different approaches to modulate the microbiome.Although fecal microbial transplants (FMTs) have been in practice for some time, the use of live biotherapeutic products (LBPs) in the form of single strains or microbial consortia is becoming a widely popular strategy due to targeted mechanisms and controlled production processes.

The development of small molecule drugs (postbiotics) and use of phages are also being actively explored.

Currently, no microbiome therapeutic has been approved in the U.S. or in any other market. There are some candidates in Phase 3 trials, such as Seres Therapeutics SER109 and Rebiotixs RBX2660 that are being evaluated for the treatment of recurrent Clostridium difficile infection. Despite an expansive patent portfolio and a large number of clinical trials in the field of microbiome therapeutics, the market is facing some challenges. The absence of any regulatory framework has created an uncertain situation for many developers in this novel market. The complexity of the human microbiome and variations among different individuals add to the difficulties in the design of clinical trials. Additionally, hurdles are expected during the scaling-up of processes and proving the functional aspects of these drugs.

For the microbiome therapeutics market to grow, a strong collaborative effort is needed from all stakeholders, including the regulatory agencies. Statistically relevant results and proof-of-concept studies driven by technological advances in biomarkers, functional assays, and computational biology are required that will eventually pave the way for product approvals.Read the full report: https://www.reportlinker.com/p05976892/?utm_source=GNW

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

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Microbiome Therapeutics: Global Markets - GlobeNewswire

Oct 8th 2020

OCTOBERS FIRST week is a nervous time for scientists with serious accomplishments under their beltsfor this is when the phone might ring from Stockholm. Those who give out the Nobel science prizes (the Karolinska Institute for the physiology or medicine award, and Swedens Royal Academy of Science for the awards in physics and chemistry) are known neither for offering the winners more than an hour or twos notice of the public announcement of their success, nor for respecting time zones. New laureates in North America receive the news in the dead of night. That, though, is normally reckoned a small price to pay for what is still seen as sciences most prestigious honour.

Britain being in a more convenient time zone from the Swedish point of view, Sir Roger Penrose, of Oxford University, was not actually asleep when his own phone rang. But he was, he says, in the shower. He was one of three winners of the physics prize, the others being Andrea Ghez and Reinhard Genzel, of the University of Californias Los Angeles and Berkeley campuses respectively. Their prize was for the theoretical explanation and subsequent discovery of some of the strangest objects in the universe: black holes.

Black holes are, famously, so dense that nothing, not even light, can escape their immense gravitational pull. A black holes centre is thought to be a point of infinite density, called a singularity, where the known laws of physics break down. Though the possibility that they existed was hypothesised a century ago, as a consequence of Einsteins general theory of relativity (which is actually a theory of how gravity shapes the structure and contents of the universe), early work suggested that they could form only from the collapse of perfectly symmetrical stars or gas clouds. That is hardly realistic, and Einstein himself doubted that they actually existed.

They therefore remained a theoretical curiosity until 1965, when an as-yet-unknighted Dr Penrose worked out the specifics of how real matter could collapse in a way that would form one. He showed, using a mathematical concept which he called a trapped surface, that even asymmetric, clumpy stars and dust clouds could become black holes. This work provided the tools needed by observational astronomers to go out hunting for them.

By definition, it is impossible to see a black hole directly. Instead, physicists glean insights into them by studying the effect of their gravity on the motion of their stellar neighbours. Dr Ghez and Dr Genzel used this idea to gather evidence that Sagittarius A*a bright source of radio waves at the centre of the Milky Way, Earths home galaxyis actually a supermassive black hole around which all the stars in the galaxy, the Sun included, orbit.

Dr Ghez and her team employed the Keck Observatory telescope, in Hawaii, with its ten-metre-wide primary mirror, to make their observations. Dr Genzels group used a series of eight-metre-wide telescopes high in the mountains of the Atacama desert, in Chile, for theirs. These instruments were all sensitive enough to peer through the clouds of dust that otherwise obscure the heart of the Milky Way.

Over three decades both sets of researchers, working independently, tracked around 30 of the brightest stars at the galactic centre (see chart). A star called S2, for example, takes 16 years to complete an orbit of Sagittarius A*, and, at its closest approach, comes within 17 light-hours of it. These measurements have permitted astronomers to piece together a picture of Sagittarius A* as a black hole of around 4m solar masses, packed into a region of space that is about the size of the solar system.

April 2019 saw the release of the first-ever image of a black hole (Sagittarius A*s local equivalent at the centre of a galaxy called M87, 53m light-years from Earth). This was taken, in radio frequencies, using the Event Horizon Telescope, a collaboration that links eight existing radio telescopes all around Earth and thus permits far higher resolution than any single instrument could manage. As technology improves, the Event Horizon Telescope could also one day provide a more detailed image of the region around Sagittarius A*.

As is often the way, the chemistry prize went for a discovery that might equally well have been handed out for medicineCRISPR-Cas9 gene editing. The winners were Emmanuelle Charpentier of the Max Planck unit for the science of pathogens, in Berlin, and Jennifer Doudna of the University of California, Berkeley.

CRISPR-Cas9 is derived from a bacterial defence mechanism that snips small sequences of DNA from viral interlopers and copies them into a bacteriums own genome, thus creating a scrapbook by which to recognise such aggressors, should they come again. The laureates prize is not, though, for the mere discovery of a novel bacterial immune system. It is for the adaptation of that discovery into the most important gene-editing tool yet inventedone that is already helping to design disease-resistant crops and new therapies for cancer, and which may, perhaps, end hereditary disease in human beings.

If an organisms collective DNA can be thought of as the book of its life, CRISPR-Cas9 allows for any specific sequence of words within that book to be identified, selected, removed and replaced. This is done by creating a molecule called a guide RNA, which matches a target DNA sequence, and pairing it with an enzyme, Cas9, that is capable of snipping the DNA helix at this point. Then, if so desired, a new piece of DNA can be inserted.

The laureates path to Stockholm began at a caf in Puerto Rico in 2011. That was when Dr Charpentier, who had discovered intriguing and unexplained RNA fragments in a bacterium, engineered a meeting with Dr Doudna, an expert in the DNA-snipping capability of Cas proteins. Since this collaboration bore fruit in 2012, progress has been rapid. By February 2013 Feng Zhang of the Broad Institute in Cambridge, Massachusetts and George Church of Harvard Medical School had independently demonstrated the techniques effectiveness in mouse and human genomes, paving the way for the treatment of human diseases. Clinical trials are now under way to test its power against sickle-cell anaemia and certain cancers, with animal experiments showing promising results in the treatment of muscular dystrophy.

There has also been controversy. In 2018 He Jiankui of the Southern University of Science and Technology, in Shenzhen, China, announced the birth of twin girls whose embryos he had edited with the help of CRISPR-Cas9. Dr Hes stated goal was to induce immunity to HIV, by disabling the gene for a protein which that virus uses to gain admission to cells. This was too much for the authorities. Even ignoring the issues of consent involved when a procedure is carried out on an embryo, making genetic edits so early in life means that they will be incorporated into germ cells, and thus passed down the generations. That raises serious ethical questions, and what Dr He did was declared illegal by the Chinese government. Dr He is now in prison.

Nor is germ-line editing the only controversy surrounding CRISPR-Cas9. A further complication concerns who gets the patents that will monetise it. The University of California and the Broad have been involved for years in a legal battle over the matter. By giving the prize to Dr Doudna and Dr Charpentier the Royal Academy of Science may have put its thumb on the scales. In picking them it has also, for the first time, awarded a Nobel science prize to an all-female group. Dr Charpentier, via a phone link to the room where the announcement was made, said I hope this provides a positive message to young girls. Women in science can also be awarded prizes. But more importantly, women in science can also have an impact.

Regardless of which category it truly fits into, the creation of CRISPR-Cas9 was a high-end piece of technowizardy. The actual prize for medicine, however, went for a piece of old-fashioned medical detective workthe identification of hepatitis C, a virus that causes life-threatening liver infections and is passed on by exposure to contaminated blood. Though other widespread diseases, such as malaria and HIV/AIDS, gain more attention, the World Health Organisation (WHO) reckons that around 70m people are infected with hep C and that it kills 400,000 people a year. Hep C has also, in the past, turned the business of blood transfusion into a lottery, since there was no way to tell whether a particular batch of blood harboured it. That this is no longer the case is, in no small measure, thanks to the work of this years laureatesHarvey Alter, Michael Houghton and Charles Rice.

Dr Alters work came first. In the 1960s he was a colleague of Baruch Blumberg, who discovered the hepatitis B virus (for which he won a Nobel prize in 1976). Hepatitis viruses are labelled, in order of discovery, by letters of the alphabet. A, a waterborne pathogen, causes an acute infection that passes after a few weeks and induces subsequent immunity. The effects of B and C, though, are chronic and may result eventually in cirrhosis and cancer. Blumbergs discovery led him to a vaccine for hep B, and also meant that blood intended for transfusion could be screened. But it became apparent that such screened blood still sometimes caused hepatitis, albeit at lower rates. Since hep A was also being screened for by this time, that suggested a third virus awaited discovery.

In 1978 Dr Alter, then working at Americas National Institutes of Health, proved this was true by injecting into chimpanzees blood from recipients of transfusions screened for the known viruses who had nevertheless developed hepatitis. These animals sometimes then went on to develop the illness. It took until 1989 to clone the new virus. That was done by Dr Houghton, who was then working at Chiron, a Californian biotechnology firm subsequently bought by Novartis, a Swiss pharmaceutical giant.

Dr Houghton amplified viral genetic material drawn randomly from chimpanzees infected with the as-yet-unidentified virus and tested this against antibodies from infected humans. Antibodies are proteins crafted by the immune system to stick specifically to parts of particular pathogens. By looking at which chimpanzee-derived material the antibodies in question attached themselves to, Dr Houghton was able to isolate the virus and identify it as a type of flavivirus, a group that also includes yellow fever and dengue. He also thus provided a way of screening blood intended for transfusion.

Dr Rice, working at Washington University, in St Louis, Missouri, eliminated lingering uncertainties about whether the flavivirus Dr Houghton had identified was the sole cause of hep C. Attempts to use cloned, purified versions of it to infect chimpanzees had not worked, leading to doubts about whether it was acting alone. Dr Rice identified part of the viral genome which looked crucial to the process of infection, but was highly mutable. He suspected that this mutability was hindering successful infection in the laboratory, and was able to eliminate it by genetic engineering. The stabilised virus was, indeed, infectious to chimps.

The consequence of all this is that blood for transfusion can now be screened routinely for hep C, and drugs to treat it have now been developed. Unfortunately, this has not stopped the march of the illness. Those in rich countries have benefited. Deaths in Britain, for example, fell by 16% between 2015 and 2017. But the wider picture is grim. Some countries, such as Egypt, have recently done well. Others, less so.

One reason is that, besides transfusion, hep C is spread by drug users sharing needles. It can also be spread sexually. This stigmatises it in the eyes of some. And unlike HIV/AIDS, which spreads in similar ways but quickly developed a political lobby to find a treatment once it was discovered, no one spoke up at the beginning for those suffering from the effects of hep C.

That is starting to change. In 2016 the WHO published a strategy for the elimination of all forms of hepatitis. The tools are there to do this. Whether the will to use them also exists remains to be seen.

This article appeared in the Science & technology section of the print edition under the headline "They walked in looking like dynamite"

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Who won this years Nobel science prizes? - The Economist

The Global Marketers provides you regional research analysis on Genetic Engineering Drug Market and forecast to 2026. The global Genetic Engineering Drug Market report comprises a valuable bunch of information that enlightens the most imperative sectors of the Genetic Engineering Drug market. The global Genetic Engineering Drug market report provides information regarding all the aspects associated with the market, which includes reviews of the final product, and the key factors influencing or hampering the market growth.

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Main players in the Genetic Engineering Drug Market:

GeneScience Pharmaceuticals Co., LtdBeijing SL Pharmaceutical Co., LtdBiotech Pharmaceutical Co., LtdShenzhen Neptunus Interlong Bio-Technique Co., LtdJiangsu Sihuan Bioengineering Co., LtdTonghua Dongbao Pharmaceutical Co., LtdAnhui Anke Biotechnology (Group) Co., Ltd3SBio Inc.Shanghai Lansheng Guojian Pharmaceutical Co., Ltd

Some of the geographic regions examined in the overall Genetic Engineering Drug Market are:

In addition, the global Genetic Engineering Drug market report delivers brief information about federal regulations and policies that may ultimately affect market growth as well as the financial state. The situation of the global market at the global and regional levels is also described in the global Genetic Engineering Drug market report through geographical segmentation. The Genetic Engineering Drug report introduces speculation attainability evaluation, a task SWOT investigation, and venture yield evaluation.

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Global Genetic Engineering Drug Market Segmentation:

On the Basis of The Application:

30 Years Old30 Years Old-60 Years Old60 Years Old

On the Basis of Type:

Monoclonal AntibodyRecombinant Human ErythropoietinRecombinant Human InterferonRecombinant Human Growth HormoneRecombinant Human Insulin

Moreover, the report comprises the main developments made in the Genetic Engineering Drug market. Porters five force analysis is used to conclude the competition in the Genetic Engineering Drug market along with new entrants and their strategies & tactics. The report involves the value chain analysis which denotes workflow in the Genetic Engineering Drug market. Also, the market has been classified on the basis of category, processes, end-use industry, and region. On the basis of geography, the report Genetic Engineering Drug the market.

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The Genetic Engineering Drug Market research report presents a comprehensive analysis of the market and contains attentive insights, facts, past data, and statistical support, and industry-validated market data. It furthermore contains projections applying a suitable set of assumptions and methodologies. The research Genetic Engineering Drug report provides examination and information according to market segments such as geographies, applications, and industry by considering major players.

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Genetic Engineering Drug Market 2020 | What Is The Estimated Market Size In The Upcoming Years? - The Daily Chronicle

The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a revolutionary development in medicine.

This technology is rapidly advancing, and several CRISPR/Cas-based drugs have entered clinical trials over the past several years. One kind of product in clinical trials is CRISPR-modified cells, such as CTX001 (CRISPR-Cas9-modified autologous hematopoietic stem cells), currently under study for the treatment of b-thalassemia and severe sickle cell anemia. Another CRISPR-based product, AGN-151587, is injected into the eye with the goal of eliminating a genetic mutation in patients with Leber congenital amaurosis 10, a leading cause of childhood blindness. In parallel, others are working to harness the CRISPR/Cas system to develop drugs for rare diseases, including bespoke therapies tailored to an individual patients needs.

Given CRISPR/Cas-based drugs potential to treat rare diseases, issues relating to orphan drug exclusivity will arise as these products are developed. In May 2020, for example, CTX001 received an orphan drug designation for transfusion-dependent b-thalassemia.

In January 2020, the FDA provided draft guidance regarding orphan drug exclusivity for gene therapy products, which includes CRISPR/Cas gene editing (Draft Guidance). This guidance focuses on the analysis of whether two gene therapy products are the same under the Orphan Drug Act. Although informative, the limited scope of the Draft Guidance invites more questions than it answers.

Same Drugs Under the Orphan Drug Act

Obtaining orphan drug exclusivity involves a two-step process. First, a sponsor requests designation of a drug for a particular rare disease or condition. See 21 C.F.R. 316.20. If this drug is the same drug as a drug already approved to treat the same rare disease or condition, the sponsor must provide a plausible hypothesis that the new drug is clinically superior to the previously-approved drug. Id. Whether two drugs are the same depends on consideration of structural features relevant to that type of drug. See id. 316.3(b)(14).

If the new drug later obtains marketing approval for a use or indication within the rare disease or condition for which it received orphan drug designation, the FDA will determine if the drug is eligible for orphan drug exclusivity. See 21 C.F.R. 316.31(a). In this situation, to receive exclusivity, the sponsor of the new drug must show that its drug is clinically superior to the same previously-approved drug for the same rare disease or condition. See id. 316.34(c). A clinical superiority determination is based on the new drugs greater efficacy, greater safety, or a major contribution to patient care. See id. 316.3(b)(3).

Highlights from Draft FDA Guidance

To determine whether one gene therapy product is the same as another, per 316.3(b)(14)(ii), the FDA will evaluate the principal molecular structural features of the two products, particularly transgenes (e.g., transgenes that encode different enzymes for treatment of the same rare disease) and vectors. For example:

Additionally, [w]hen applicable, the FDA generally intends to consider additional features of the final gene therapy product, such as regulatory elements or, in the case of genetically-modified cells, the type of cell that is transduced. It generally intends to consider requests for designation and exclusivity of gene therapy products to evaluate whether such additional features may also be considered to be principal molecular structural features.

Implications for CRISPR/Cas Therapy Exclusivity

The Draft Guidance helps answer certain high-level questions relating to whether two gene therapy products would be considered the same under the Orphan Drug Act. As various stakeholders have recognized, however, it is short on the details that meaningfully aid the process of drug research and development.

It is clear from the Draft Guidance that a new product can be considered the same as a previously-approved product even if the two products are not perfectly identical, but the guidance does not explain what would constitute a minor difference between such products, or what the scope of additional features would be.

For example, the Draft Guidance does not clarify what makes two transgenes the same. Nor does it cite to prior guidance or regulations that may answer this question. The question is significant because Cas nucleases and other parts of the CRISPR/Cas system may be modified in various ways. To address whether these modifications bar a finding of same-ness, the FDA could potentially import the kinds of considerations that govern same-ness of other kinds of large-molecule products, such as polynucleotide drugs or closely related, complex partly definable drugs with similar therapeutic intent (e.g., viral vaccines). See 21 C.F.R. 316.3(b)(14)(ii)(C), (D). However, this is not clear from the Draft Guidance.

The Draft Guidance also does not explain what will factor into the case-by-case basis assessment of whether viral vectors from the same viral class are the same. In the case of AAV2 and AAV5the two viruses identified in the guidanceresearchers have found that these viruses differ with respect to sequence analysis, tissue tropism, and heparin sensitivity. It is not clear from the guidance, however, whether a plausible hypothesis of clinical superiority will be required to seek orphan drug designation for a drug based on AAV2 if the previously-approved drug expresses the same transgene(s) but is based on AAV5.

It would be beneficial to sponsors and other stakeholders if these aspects of gene therapy drugs sameness are clarified further before they invest significant resources into the design and development of these therapeutics.

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Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics - JD Supra

STEAMBOAT SPRINGS You can hear the love in Mariah Gillaspies voice as she talks about her daughters Emma and Abby, who suffer from a rare genetic disease that causes seizures and development issues.

Emma, shes our oldest, and shell be 4 in October, Mariah said. Shes our calm, sweet little child. She has these little coos that sound like a dove. She really enjoys music, and she loves being around other kiddos her age.

Abby is our younger daughter, and shell be 2 in October, and she is our feisty little thing, Mariah continued. So, she lets you know when shes happy; she lets you know when shes not happy.

There is no question the two girls, the only two people in the world believed to have this disease, are surrounded by the love they get from Mariah and their dad Mark.

Mark grew up in Steamboat Springs and graduated from high school here in 2001. The couple now live in Centennial, but Marks parents, Jeanne and Joe Gillaspie, still live in Steamboat as does Marks older brother.

Four years ago, Mark and Mariah were overwhelmed with joy as they welcomed their first child Emma to the world, but when she was three months old, the couple started to notice she was having some strange movements, and when she started having episodes where she would hold her breath until she would turn pale, the couple took her to the doctor.

The doctor initially thought it was reflux, but when Emma stopped breathing in the doctors office, she was rushed to Childrens Hospital of Colorado for more evaluation and tests.

Throughout all this, I was convinced everything was going to be OK, Mariah said. It never crossed my mind that something was seriously wrong, and I had never considered that these were seizures.

Eventually, Emma was diagnosed with infantile spasms, which Mariah said didnt look serious on the outside but were damaging Emmas brain and impacting her development from the inside. Emma started treatment immediately, and the family was encouraged with the results. But then there was a relapse and a new medication, and then another relapse and another new medication.

Mariah said each new medicine came with a longer list of side effects, and Emmas immune system suffered. She had a bout with pneumonia that left her in the hospital for two months.

Through it all, the Gillaspies continued to search for answers.

We did a whole slew of genetic testing, and it came back inconclusive, Mariah said. They found absolutely nothing that could be the cause of her disease, and they told us this is probably some completely random condition that was caused by something that happened in utero.

They also told the Gillaspies that Emmas condition was rare, and there was less than a 3% chance of it happening again. So after extensive genetic testing, they decided to have a second child.

When Abby arrived two years later, they were thrilled, but at about six weeks, they noticed their youngest daughter was displaying the same movements that Emma had shown prior to her diagnosis. So it was back to the doctors, and it was confirmed through genetic testing that Abby and Emma shared the same mutated gene THAP12.

After discovering their daughters were suffering from the same condition, the family embarked on a grassroots effort to drive research about the rare genetic disease, which led to the creation of a foundation, Lightning and Love, a name that was chosen because the family believes lightning struck their family twice in the form of two daughters with the same rare disease.

The doctors would say, Im sorry, theres nothing we can do. We have to wait for science to catch up,' Mariah said. Every doctor that weve encountered has really been amazing and done their very best for us. Its just unfortunate science hasnt caught up to the girls, yet. Thats kind of, whereas parents, were passionate enough to move science along a little faster.

The nonprofit organization is supported by a GoFundMePage, and tax-deductible donations can be made through the Lightning and Love website.

The latest research funded by the foundation involved genetically engineering a zebrafish model to see if it showed symptoms of disease, specifically seizures. The zebrafish did have seizures, which Mariah said was a major breakthrough toward the ultimate goal of finding a gene replacement cure for her daughters.

But the journey for Mark and Mariah has proven to be more than just research and discovery.

What were realizing is the more we talk about it, and the more we do to get our story out there, the more were realizing that theres a lot of other parents that are going through tough times with their kids, too, Mark said. In an odd twist, or an ironic twist, this tough hand that weve been dealt has actually been a very positive light to a lot of other people out there. For me, that is just as important as the research.

The familys story was recently featured on the podcast, Go Shout Love.

The couples positive message is guiding them along the road they hope will lead to a better life for their family. But in the meantime, Mark and Mariah will continue to put smiles ontheir daughters faces the same way most other parents do by offering their love, support and opportunities to find happiness.

For Emma, that means being tossed into the air and caught by her daddy, and for Abby, it is time in her sensory room and being around her dad and her family.

Emma loves very big movements. Shes not mobile, and she cant walk, so when we kind of throw her around in the air or fly her around the room, she absolutely loves it, Mariah said. Abby loves her daddy. She gives big old smiles when he walks into the room.

To reach John F. Russell, call 970-871-4209, email jrussell@SteamboatPilot.com or follow him on Twitter @Framp1966.

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Family seeks answers, finds hope after daughters diagnosed with rare genetic condition - Steamboat Pilot and Today

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At the intersection of emerging technologies and international affairs, one of the most provocative areas is the applications of advancedgenetic engineering. The COVID-19 global pandemic and uncertainty about the origin of the causative virus illustrates both immediacy and the potential geopolitical implications of such technologies. These new gene editing techniques include one which has garnered a great deal of attention, the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) systems, as well as other, less well-known ones. CRISPR is not the first type of gene editing technology, but it is the most well-known within national and international security debates. Such advancements now allow for easier and more tunable manipulation of the genetic code of life with implications for governance of science and technology and with international security significance in the context of proliferation, deterrence, and unconventional weapons. Biosecurity and other emerging technologies require new models, not simpleextrapolationsof Cold War or more recent deterrence (or nonproliferation) paradigms.

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Emerging Life Sciences and Possible Threats to International Security - Foreign Policy Research Institute

Back in the halcyon days, when I somehow got paid for messing with the minds of the impressionable youth of UAF, I liked to ask said minds to project themselves back in time 400 years, to take a look around and report back what, if anything, they noticed different between those times (counting back from now, for example, to the Lords Year 1620. (James I was King, if that helps) and our own times: changes in musical tastes, ethics, physics, theology or attitudes regarding leprosy, for instance.

1620 CE was earlier than heart transplants, genetic engineering and baseball. It was before George Washington and water-seal toilets. Oxygen wouldnt be invented until the mid-1700s (Really: no Periodic Table of Elements, no radioactivity). The Holy Inquisition was in practice: pious religious officials were still torturing heretics and burning witches. It was before abortion rights. Autochthonous peoples in many parts of the world had not been introduced to the blessings of European economics, religion and warfare. It was before Facebook.

Things had changed in the last 400 years. Bigly. My students always got that answer right.

Then Id ask them to project themselves 400 years into the future, to the early 25th Century, say, to look around, to report back. I asked them to pay particular attention to the way our descendants in 2420 look back on our (presumably long-obsolete) ways of doing things: our medicine, say, or our governmental systems, or our responses to global hunger, overpopulation, pollution.

This was a harder task. The problem with prognostication is that we normal people are not particularly good at it, being annoyingly set in our ways. This is not to say that we cant make predictions, but even deeply considered and finely calibrated events such as space launches, brain surgery, or steering an oil tanker around Bligh Reef occasionally go awry. Some events, like nuclear meltdowns or worldwide pandemics, can present unanticipated difficulties.

I asked my students to avoid fantasies like self-aware computers, two-way wrist radios or honest politicians. I was hoping for revolutionary ways of perceiving the world, something on the order of the atalatl, General Relativity or Akira Kurosawa. I was angling for new stuff: examples of true scientific, artistic or musical invention.

My students always protested. Were on to you, old man, you you English teacher! Youve been harping all semester about how we mortals really cant see into the future, that we make up the future with our words. Now you want us to think something no one has ever thought before!

Thats exactly what I wanted them to do, of course. To be fair, really new ideas are not particularly common. It took humans millennia to come up with the atlatl (c.20,000 BCE), even longer to invent the calculus (c.1665 CE) or germ theory (c.1840). But without inventive ways of looking at the world, humanity might still believe that malaria is caused by bad air, that light travels across a medium called luminiferous ether, or that things burn because they contain phlogiston.

Theres been much talk lately of returning to normal, but I wonder if thats really what we want. I wonder if normal isnt what got us into our present public health and economic crises. I think for a lot of people in our community normal is worrying about buying groceries, paying the rent, health care, personal safety.

In this Year of Our Trump and the Corona pandemic (known also to certain elderly cynics as the beer virus or the sniffles) the question for my students would be, Given that we really cant see into the future and given that our current pandemic is unlikely to be our last, whats our best strategy for the survival of Our People (defined however you like) for the next seven generations or so?

Id hope for some inventive thinking along the lines of how to take care of every person on Earth in honest and practical ways. Emphasizing that we have plenty to be humble be about when predicting the future, Id ask them to come up with ideas never tried before. Id suggest that food, shelter and health care need never to be money-dependent, for example. Id ask our youth for creative ways of feeding people, sheltering people, caring for people all people on this, our planetary spaceship.

Id invite them to approach the task with an honest and generous spirit.

Lynn Basham lives in Fairbanks. He taught atthe University of Alaska Fairbanks as an instructor, mostly in the English Department, for about 20 years and retired about10 years ago.

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Inventing the future for humankind | Community Perspectives - Fairbanks Daily News-Miner

LONDON, Sept. 24, 2020 (GLOBE NEWSWIRE) -- (Companies Included: Crispr Therapeutics, Thermo Fisher Scientific, Intellia Therapeutics, Horizon Discovery, and Synthego Corporation)

In another instance, in early May, the US Food and Drug Administration (FDA) granted Sherlock Biosciences an emergency use authorization (EUA) for its COVID-19 diagnostic assay, beating out other companies and academic groups trying to use the powerful gene-editing technology to figure out who is infected with the novel coronavirus. Sherlocks test is the first FDA-authorized use of CRISPR technology for anything. Sherlocks test is a molecular diagnostic, intended to identify people who have acute SARS-CoV-2 infection. It capitalizes on a CRISPR-based technology developed in the lab of Feng Zhang, a scientist at Broad Institute of MIT and Harvard and a cofounder of Sherlock.

The Business Research Companys report titled CRISPR Technology Global Market Report 2020-30: Covid 19 Growth And Change covers the CRISPR market 2020, CRISPR technology market share by company, global CRISPR technology market analysis, global CRISPR technology market size, and CRISPR technology market forecasts. The report also covers the global CRISPR technology market and its segments. The CRISPR technology market share is segmented by product type into Cas9 and gRNA, design tool, plasmid and vector, and other delivery system products. The CRISPR technology market share is segmented by end-user into biopharmaceutical companies, agricultural biotechnology companies, academic research organizations, and contract research organizations (CROs). By application, it is segmented into biomedical, agriculture, diagnostics, and others.

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The global CRISPR technology market value is expected to grow from $685.5 million in 2019 to $1,654.2 million in 2023 at a compound annual growth rate (CAGR) of 24.6%. The application of CRISPR technology as a diagnostic tool is expected to boost CRISPR technology market growth during the period. The Sherlock CRISPR SARS-CoV-2 kit is the first diagnostic kit based on CRISPR technology for infectious diseases caused due to COVID-19. In May 2020, the US FDA (Food and Drug Administration) announced emergency use authorization of Sherlock BioSciences Inc.s Sherlock CRISPR SARS-CoV-2 kit, which is a CRISPR-based SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) diagnostic test.

This test helps in specifically targeting RNA or DNA sequences of the SARS-CoV-2 virus from specimens or samples such as nasal swabs from the upper respiratory tract, and fluid in the lungs from bronchoalveolar lavage specimens. This diagnostic kit has high specificity and sensitivity, and does not provide false negative or positive results. Widening the application of CRISPR technology for the diagnosis of infectious diseases will further increase the demand for CRISPR technology products and services and drive the CRISPR market 2020.

Several advancements in CRISPR technology are trending in the market. Advancements in technology will help in reducing errors, limiting unintended effects, improving the accuracy of the tool, widening its applications, developing gene therapies, and more. Scientists, researchers and companies are increasingly developing advanced CRISPR technologies for more precise editing and to get access to difficult to reach areas of human genome. For instance, in March 2020, scientists at University of Toronto developed CHyMErA, a CRISPR-based tool for more versatile genome editing. Similarly, in March 2020, researchers at New York genome center developed a new CRISPR screening technology to target RNA, including RNA of novel viruses like COVID.

In November 2019, researchers at ETH Zurich, Switzerland, swapped CAS9 enzyme for Cas 12a, that allowed the researchers to edit genes in 25 target sites. It is also estimated that hundreds of target sites can be modified using the above method. In October 2019, a team from MIT and Harvard developed new CRISPR genome editing approach called prime editing by combining CRISPR-Cas9 and reverse transcriptase into a single protein. The prime editing has the potential to directly edit human cells with high precision and efficiency.

The CRISPR technology market share consists of sales of CRISPR technology products and services, which is a gene-editing technology that allows researchers to alter DNA sequences and modify gene function. The revenue generated by the market includes the sales of products such as design tools, plasmid & vector, Cas9 & gRNA, and libraries & delivery system products and services that include design & vector construction, screening and cell line engineering. These products and services are used in genome editing/genetic engineering, genetically modifying organisms, agricultural biotechnology and others, which include gRNA database/gene library, CRISPR plasmid, and human stem cell & cell line engineering.

CRISPR Technology Global Market Report 2020-30: Covid 19 Growth And Change is one of a series of new reports from The Business Research Company that provide market overviews, analyze and forecast market size and growth for the whole market, CRISPR technology market segments and geographies, CRISPR technology market trends, CRISPR technology market drivers, CRISPR technology marketrestraints, CRISPR technology market leading competitors revenues, profiles and market shares in over 1,000 industry reports, covering over 2,500 market segments and 60 geographies. The report also gives in-depth analysis of the impact of COVID-19 on the market. The reports draw on 150,000 datasets, extensive secondary research, and exclusive insights from interviews with industry leaders. A highly experienced and expert team of analysts and modellers provides market analysis and forecasts. The reports identify top countries and segments for opportunities and strategies based on market trends and leading competitors approaches.

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The Global CRISPR Technology Market Size Is Seeing Exponential Growth Due To The Application Of CRISPR Technology In Treating COVID-19 - GlobeNewswire

GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), in partnership with the UK Governments Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.

With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal Phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373s efficacy, said Gregory M. Glenn, M.D., President, Research and Development at Novavax. The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries. We are grateful for the support of the UK Government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research.

NVX-CoV2373 is a stable, prefusion protein made using Novavax recombinant protein nanoparticle technology that includes Novavax proprietary MatrixM adjuvant. The vaccine has a favorable product profile that will allow handling in an unfrozen, liquid formulation that can be stored at 2C to 8C, allowing for distribution using standard vaccine channels.

Novavax has continued to scale-up its manufacturing capacity, currently at up to 2 billion annualized doses, once all capacity has been brought online by mid-2021.

About the Phase 3 Study

Consistent with its long-standing commitment to transparency and in order to enhance information-sharing during the worldwide pandemic, Novavax will be publishing its UK study protocol in the coming days.

The UK Phase 3 clinical trial is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 10,000 subjects aged 18 to 84 years. Half the participants will receive two intramuscular injections of vaccine comprising 5 g of protein antigen with 50 g MatrixM adjuvant, administered 21 days apart, while half of the trial participants will receive placebo.

The trial is designed to enroll at least 25 percent of participants over the age of 65 as well as to prioritize groups that are most affected by COVID-19, including racial and ethnic minorities. Additionally, up to 400 participants will also receive a licensed seasonal influenza vaccine as part of a co-administration sub-study.

The trial has two primary endpoints. The first primary endpoint is first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least 7 days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The second primary endpoint is first occurrence of PCR-confirmed symptomatic moderate or severe COVID-19 with onset at least 7 days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic or moderate/severe COVID-19 disease. An interim analysis will be performed when 67% of the desired number of these cases has been reached.

For further information, including media-ready images, b-roll, downloadable resources and more, click here.

About NVX-CoV2373

NVXCoV2373 is a vaccine candidate engineered from the genetic sequence of SARSCoV2, the virus that causes COVID-19 disease. NVXCoV2373 was created using Novavax recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVXCoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVXCoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in two ongoing Phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavaxhas secured$2 billionin funding for its global coronavirus vaccine program, including up to$388 millionin funding from theCoalition for Epidemic Preparedness Innovations(CEPI).

About Matrix-M

Novavax patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc.(Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.Novavaxis undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies.Novavaxis a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit http://www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward-Looking Statements

Statements herein relating to the future ofNovavaxand the ongoing development of its vaccine and adjuvant products are forward-looking statements.Novavaxcautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading Risk Factors in the Novavax Annual Report on Form 10-K for the year endedDecember 31, 2019, and Quarterly Report on Form 8-K for the period endedJune 30, 2020, as filed with theSecurities and Exchange Commission(SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with theSEC, available atsec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

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InvestorsSilvia Taylor and Erika Trahanir@novavax.com240-268-2022

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Novavax Initiates Phase 3 Efficacy Trial of COVID-19 Vaccine in the United KingdomClinical trial to enroll up to 10000 volunteers across the UK to...

Starting in 2022, food producers will be required to label genetically engineered foods.

Nearly 70 percent of processed foods at U.S. grocery stores contain at least one genetically engineered ingredient. Even though most scientists believe that genetically engineered foods pose no health risks, around half of Americans polled by Pew Research Center think genetically engineered foods are worse for ones health.

After decades of controversy, many genetically engineered foods will require labels in the United States starting in 2022, due to the national bioengineered food disclosure standard adopted by the U.S. Department of Agriculture (USDA) in 2018.

Almost 80 percent of Americans polled by the Mellman Group in 2015 strongly favor mandatory labeling of what is commonly known as genetically modified organisms, or GMOs. But for years, members of Congress had attempted to pass GMO labeling laws with no success. In 2014, however, Vermont was the first state in the United States to pass a GMO labeling law.

Given fear that other states would follow Vermonts example and subject food producers to a variety of requirements nationally, congressional gridlock eventually thawed. In July 2016, the same month the Vermont labeling requirements were slated to take effect, President Barack Obama signed federal legislation that now preempts states from imposing labeling requirements. That legislation also directed the USDA to develop a federal labeling standard.

USDA officials compiled a list of bioengineered foods to help delineate exactly what needs to be labeled under this program. For a food to be added to this list, it needs to be food authorized for and in commercial production somewhere in the world. Thirteen different foods currently meet these criteria, including at least one type of pineapple, salmon, corn, and soybean. USDA officials review and update this list annually.

A food manufacturer may choose between three different labeling options to comply with this standard. The first option, which is similar to requirements of the preempted Vermont law, calls for food to be labeled with the phrase bioengineered food. If the food product is a multigradient food, the regulation requires the label to state that the product contains a bioengineered food ingredient.

A second option allows for manufacturers to use a new bioengineered symbol. This symbol, designed specifically not to disparage biotechnology, depicts a stem growing from a field with a sun in the background. Around the symbol appears the word bioengineered.

A third option allows manufacturers to use an electronic label, like a QR code, which a consumer can scan using a smartphone to obtain more information.

The USDA labeling standard does not address the question of whether or how food manufacturers can label foods to indicate the absence of genetically engineered ingredients. The USDA maintains that the U.S. Food and Drug Administration retains regulatory authority over absence claims. Currently, the Non-GMO Project remains a popular private labeling regime that privately certifies food that reportedly does not contain genetically engineered ingredients.

While the USDA program allows food manufacturers to choose from a variety of labeling options, there are a few exemptions that allow manufacturers to bypass labeling. First, any food served at a restaurant or similar establishment, such as a salad bar or food truck, is exempt from the program. Second, very small food manufacturers, specifically those with annual receipts less than $2.5 million, are exempt from the program. Third, any food labeled as USDA organic will also be presumptively free of genetically engineered food under this program and will not require a label. Finally, meat or dairy products derived from animals fed genetically engineered crops will not require a label.

Although this program finally establishes a nationwide genetic engineering label for food, something critics have long fought for, some stakeholders argue that the requirements fall short.

Advocates from the Non-GMO Project argue that the USDA program is misleading given that the categorical exemption for meat and dairy products derived from animals fed genetically engineered crops prevents the program from providing meaningful disclosure.

Groups such as the Organic Trade Associationargue that the National Bioengineered Food Disclosure Standard falls short of fully informing U.S. consumers. The association argues that, among other things, the option to include an electronic label without the need for on-pack language is misleading to consumers. Similarly, the Environmental Working Group opposes the electronic labeling option and argues that rural consumers without expensive phones or living with irregular service will be unable to use these kinds of labels.

Both of these major criticisms, however, concern parts of the statutory mandate under the 2016 Act. Specifically, the 2016 Act calls for the USDA to permit an electronic label option and forbids the labeling of meat derived from animals fed with genetically engineered crops.

The USDA labeling requirements will become mandatory in January, 2022.

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The Newest Label Coming to a Grocery Store Near You - The Regulatory Review