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Outlook on the Advanced Therapy Medicinal Products CDMO Global Market to 2028 – Rising Number of Clinical Trials for ATMP is Driving Growth -…
Posted: December 22, 2021 at 1:36 am
DUBLIN, Dec. 21, 2021 /PRNewswire/ -- The "Global Advanced Therapy Medicinal Products CDMO Market Size, Share & Trends Analysis Report by Product (Gene Therapy, Cell Therapy, Tissue Engineered), Phase, Indication, Region, and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.
The global advanced therapy medicinal products CDMO market size is expected to reach USD 12.9 billion by 2028, according to the report. It is expected to expand at a CAGR of 12.0% from 2021 to 2028.
The advanced therapy medicinal products are a group of biological products for human use that involve gene therapy products, cell therapy products, and tissue-engineered products. The growth of the market is credited to the increasing clinical trials of ATMP and the rising awareness and belief among researchers regarding the benefits of advanced therapy. The COVID-19 pandemic has significantly disrupted the cell and gene therapy industry due to the complexity in the manufacturing process.
The COVID-19 pandemic has adversely affected the overall medical industry, but the pandemic boosted the operations and development of advanced therapy due to the high requirement of the products such as mesenchymal stromal cells (MSCs) for the treatment of the virus. The regulations put forward by the FDA and government authorities have created a safe environment for the healthcare workers and allowed emergency approval for the supply of essential raw materials and faster development of the vaccines and other therapy products.
Technological advancement has been a major part of tissue engineering in the last few years. This method helps to replace or restore the injured tissues and organ function. Similarly, gene and cell therapy is attracting many patients for the treatment of rare diseases, the cases of which are augmenting globally.
Advanced Therapy Medicinal Product CDMO Market Report Highlights
Key Topics Covered:
Chapter 1 Methodology and Scope
Chapter 2 Executive Summary
Chapter 3 Advanced Therapy Medicinal Products CDMO Market: Variables, Trends, & Scope3.1 Market Segmentation and Scope3.2 Market Dynamics3.2.1 Market Driver Analysis3.2.1.1 Rising number of clinical trials for ATMP3.2.1.2 Increasing outsourcing activities3.2.1.3 Growing awareness of the treatment3.2.2 Market Restraint Analysis3.2.2.1 Stringent regulatory approvals3.2.2.2 High cost of outsourcing3.3 Penetration & Growth Prospect Mapping3.4 Advanced Therapy Medicinal Products CDMO: Market Analysis Tools3.4.1 Industry Analysis - Porter's3.4.1.1 Porter's Five Forces Analysis3.4.2 PESTEL Analysis
Chapter 4 Advanced Therapy Medicinal Products CDMO Market: Product Estimates4.1 Market Share Analysis, 2020 & 20284.2 Gene Therapy4.2.1 Gene therapy market, 2016 - 2028 (USD Billion)4.3 Cell Therapy4.3.1 Cell therapy market, 2016 - 2028 (USD Billion)4.4 Tissue Engineered4.4.1 Tissue engineered market, 2016 - 2028 (USD Billion)4.5 Others4.5.1 Market, 2016 - 2028 (USD Billion)
Chapter 5 Advanced Therapy Medicinal Products CDMO Market: Phase Estimates5.1 Market Share Analysis, 2020 & 20285.2 Phase I5.2.1 Phase I market, 2016 - 2028 (USD Billion)5.3 Phase II5.3.1 Phase II market, 2016 - 2028 (USD Billion)5.4 Phase III5.4.1 Phase III market, 2016 - 2028 (USD Billion)5.5 Phase IV5.5.1 Phase IV market, 2016 - 2028 (USD Billion)
Chapter 6 Advanced Therapy Medicinal Products CDMO Market: Indication Estimates6.1 Market Share Analysis, 2020 & 20286.2 Oncology6.2.1 Oncology market, 2016 - 2028 (USD Billion)6.3 Cardiology6.3.1 Cardiology market, 2016 - 2028 (USD Billion)6.4 Central Nervous System6.4.1 Central nervous system market, 2016 - 2028 (USD Billion)6.5 Musculoskeletal6.5.1 Musculoskeletal market, 2016 - 2028 (USD Billion)6.6 Infectious Disease6.6.1 Infectious disease market, 2016 - 2028 (USD Billion)6.7 Dermatology6.7.1 Dermatology market, 2016 - 2028 (USD Billion)6.8 Endocrine, Metabolic, Genetic6.8.1 Endocrine, metabolic, genetic market, 2016 - 2028 (USD Billion)6.9 Immunology & inflammation6.9.1 Immunology & inflammation market, 2016 - 2028 (USD Billion)6.10 Ophthalmology6.10.1 Ophthalmology market, 2016 - 2028 (USD Billion)6.11 Haematology6.11.1 Haematology market, 2016 - 2028 (USD Billion)6.12 Gastroenterology6.12.1 Gastroenterology market, 2016 - 2028 (USD Billion)6.13 Others6.13.1 Others market, 2016 - 2028 (USD Billion)
Chapter 7 Advanced Therapy Medicinal Products CDMO Market: Regional Analysis
Chapter 8 Company Profiles8.1 Strategic Framework8.2 Company Profiles8.2.1 Celonic8.2.1.1 Company Overview8.2.1.2 Financial performance8.2.1.3 Product Benchmarking8.2.1.5 Strategic Initiatives8.2.2 Bio Elpida8.2.2.1 Company Overview8.2.2.2 Financial performance8.2.2.3 Product Benchmarking8.2.2.6 Strategic Initiatives8.2.3 CGT Catapult8.2.3.1 Company Overview8.2.3.2 Financial performance8.2.3.3 Product Benchmarking8.2.3.6 Strategic Initiatives8.2.4 Rentschler Biopharma SE8.2.4.1 Company Overview8.2.4.2 Financial performance8.2.4.3 Product Benchmarking8.2.4.6 Strategic Initiatives8.2.5 AGC Biologics8.2.5.1 Company Overview8.2.5.2 Financial performance8.2.5.3 Product Benchmarking8.2.5.6 Strategic Initiatives8.2.6 Catalent8.2.6.1 Company Overview8.2.6.2 Financial performance8.2.6.3 Product Benchmarking8.2.6.6 Strategic Initiatives8.2.7 Lonza8.2.7.1 Company Overview8.2.7.2 Financial Performance8.2.7.3 Product Benchmarking8.2.7.5 Strategic Initiatives8.2.8 WuXi Advanced Therapies8.2.8.1 Company Overview8.2.8.2 Financial performance8.2.8.3 Product Benchmarking8.2.8.5 Strategic Initiatives8.2.9 BlueReg8.2.9.1 Company Overview8.2.9.2 Financial performance8.2.9.3 Product Benchmarking8.2.9.6 Strategic Initiatives8.2.10 Minaris Regenerative Medicine8.2.10.1 Company Overview8.2.10.2 Financial performance8.2.10.3 Product Benchmarking8.2.10.5 Strategic Initiatives8.2.11 Patheon8.2.11.1 Company Overview8.2.11.2 Financial performance8.2.11.3 Product Benchmarking8.2.11.5 Strategic Initiatives
For more information about this report visit https://www.researchandmarkets.com/r/rjc62f
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Outlook on the Advanced Therapy Medicinal Products CDMO Global Market to 2028 - Rising Number of Clinical Trials for ATMP is Driving Growth -...
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MiNA Therapeutics Appoints Two Independent Directors With Extensive Industry Experience to Support Next Phase of Growth – BioSpace
Posted: at 1:36 am
Dec. 21, 2021 07:00 UTC
LONDON--(BUSINESS WIRE)-- MiNA Therapeutics Limited (MiNA or the Company), the pioneer in small activating RNA (RNAa) therapeutics, announces the expansion of its Board, with the appointment of Susan Clement-Davies and Professor Sir Robert Lechler as Independent Directors, effective 1 January 2022.
Susan is an experienced life sciences financier with over 25 years of capital markets and investment banking experience, including as Managing Director of Equity Capital Markets at Citigroup Global Markets Limited and Managing Director at Torreya Partners LLC. Susan is currently a Non-Executive Director of Scancell Holdings, a UK listed biotechnology company developing innovative immunotherapies, EvgenPharma plc, a UK-listed clinical stage drug development company, and Exploristics, a world-leading provider of biosimulation software and biostatistics services for clinical trials. Susan is also Corporate Finance Advisor for Theolytics, a biotechnology company developing anticancer viral therapies, and an Advisor for Oxford Sciences Innovation, the worlds largest university-partnered venture firm. In addition, Susan is a member of the Innovation Advisory Group for the Chelsea and Westminster Hospital NHS Foundation Trust.
Robert is a recognised leader in biomedical research, management and governance with over 40 years of distinguished experience in academic medicine, having started his immunology career in 1979. Since then, Robert has held various leadership roles in a range of hospitals and laboratories, including serving as Head of Imperial College Londons Division of Medicine, Vice Principal (Health) of Kings College School, and Executive Director of Kings Health Partners Academic Health Sciences Centre. He has also been at the forefront of scientific innovation, nationally, through his Presidency of the Academy of Medical Sciences, Membership of the UK Council for Science and Technology, and Chairmanship of the UK MHRA Clinical Trials Expert Advisory Group. In 2012, Robert was Knighted in the Queens Birthday Honours for his services to academic medicine, which has centred around immunology, cancer and transplantation. He is currently a Non-executive Director of Quell Therapeutics, a biopharmaceutical company specialising in addressing a range of autoimmune and inflammatory diseases through cell therapy.
Nagy Habib, Chairman and Head of R&D of MiNA Therapeutics, commented: We are thrilled to welcome Susan and Robert to MiNAs Board of Directors to support our strengthened senior leadership team as we remain focused on driving the Companys next phase of growth. Susan's expertise in finance and as a biopharma company director, combined with Roberts leadership in biomedicine will be invaluable as we continue to advance our pipeline through clinical development and expand our partnerships to scale and amplify the impact of our pioneering RNAa technology for patients.
Susan Clement-Davies, Independent Director of MiNA Therapeutics, commented: I am extremely excited to be joining MiNA. What the team has achieved, particularly in recent years, is impressive and I hope to bring my experience in the life sciences sector to further unlock MiNAs significant potential.
Professor Sir Robert Lechler, Independent Director of MiNA Therapeutics, commented: This is a fantastic opportunity to be involved with a pioneering company in such an interesting space. The Companys RNAa approach and pipeline is a truly innovative way of treating diseases and I look forward to guiding MiNA on its journey, which I believe will be highly successful.
About MiNA Therapeutics MiNA Therapeutics is the leader in small activating RNA therapeutics. Harnessing innate mechanisms of gene activation, small activating RNA therapeutics are a revolutionary new class of medicines that can restore or boost normal function in patients' cells. We are advancing a proprietary pipeline of new medicines with an initial focus on cancer and genetic diseases, while collaborating with leading pharmaceutical companies to apply our technology platform across a broad range of therapeutic areas. Based on our unique know-how in RNA activation we are expanding the possibilities of RNA-based medicine for patients. http://www.minatx.com
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Scientists Used CRISPR Gene Editing to Choose the Sex of Mouse Pups – Singularity Hub
Posted: at 1:35 am
Do you want a boy or a girl? can be an awkward question.
But in certain circles, its a question thats asked every day. Take agriculture. In a perfect world, most cows would only birth females. Chicks would grow up to be all hens. Sexing a farm animal when theyre at a young age wouldnt be a thingespecially when it means male animals, without the ability to produce milk or eggs, are often culled at a young age to preserve resources.
There might be a better way. This month, a team tapped into the power of CRISPR to control the sex of the offspring in mice. By splicing CRISPR components into the parents genome, the team was able to flip onor offa switch that nearly perfectly determined the sex of their litters.
Unlike previous attempts, the baby mice could go on to have litters of their own of both sexes. The targeted gene used for the edit is conserved across evolution, suggesting the technique could work in more animals than just mice.
But its controversial. Essentially, the technique selectively kills off embryos of a certain sex, which immediately raises ethical red flags. For now, scientists arent concerned about the technology being used in humans due to its complexity. But the study is the latest to showcase biotechs increasing ability to manipulate reproduction.
Its an impressive result and a state-of-the-art solution to producing single-sex species, said Dr. Ehud Qimron at Tel Aviv University, who was not involved in the work.
Skewing the sex of offspring is nothing new. For over a decade, scientists have gradually hijacked the mosquito genome with gene drives to rewrite evolution. The idea is that the genetic edit would override natural selection, spreading across subsequent generations into a dominant gene. Instead of a genes usual 50-50 chance of inheritance, artificial gene drives have a far higher chance of infiltrating the next generation, fundamentally changing a species genetic code. When its a gene that biases the sex of their offspring, a species could gradually only have one sex, leading to their extinction.
Its a doomsday plan with potentially massive benefits, such as curbing malaria. Because female mosquitoes are generally the carrier for the disease, a gene drive that leads to only males is a sure-fire way to reduce transmission. In one study, within a dozen generations, the genetic edit was sufficient to collapse a whole colony of mosquitoes in the lab. Similar studies have been tried in mice.
Its not a perfect solution. The gene edit is powerfulmaybe too much so. With farm animals, the goal isnt to eradicate a species, but rather to bias the sex of the animal towards one side and increase animal welfare. Animal and animal products are used globally, and ethical discussions regarding animal usage are ongoing, said the authors. Over 100,000 male calves are culled each year, and stats for other common farm animals paint a similarly uncomfortable picture.
The new study took a different approach. With CRISPR, the team skewed the sex of only the next generation in mice, allowing the same-sex litters to eventually reproduce normally.
CRISPR has two parts: an RNA guide (the bloodhound that sniffs out the target gene) and Cas9 (a scissor protein that physically cuts the gene). Usually, the two components are encoded into a single carrier, dubbed a vector, and inserted into a cell or animal. By targeting a gene that is essential for reproduction, for example, its then possible to trigger spontaneous failed pregnancies in animals.
But how does that help with sex selection? Let me explain.
The first step was to find a gene critical for embryo survivalone that when disrupted causes synthetic lethality. The team honed in on Top1, well known for its role in DNA repair. Cutting the gene triggers embryos to fail at a very early stage, when theyre just 8 to 16 cells, not yet implanted into the uterine wall and far from viable.
The team then engineered a CRISPR system that targets the start codons of Top1a chunk of DNA that acts as an on switch to activate the gene. Heres the clever part. They split the two components of CRISPR into two vectors.
One part, which carries the genetic code for a guide RNA that targets Top1, was then inserted into a female mouses X chromosome. The other vector, carrying the code for Cas9 scissors, was edited into the males Y chromosome.
When combined, the two components meet up like peanut butter and jelly, forming the full recipe to disrupt Top1. This can only happen in X/Y embryosthose that define maleand so selectively interrupt these embryos from developing. X/X, or genetically female embryos, are spared, as they only contain half of the CRISPR mechanism. The system is flexible. If Cas9 scissors were attached to the males X chromosome, all X/X embryos were eliminated before they grew to 16 cells.
The efficiency of the edit was crazy at 100 percent. Mice born from these genetically-edited parents were completely normal, with a hefty body size and in larger numbers than normally expected, suggesting the edit may cause less stress on the mother. Unlike those born using gene drives, the mice grew up to have perfectly normal litters with both male and female offspring.
The results are a long time in the making. Back in 2019, a team led by Dr. Udi Qimron at Tel Aviv University used CRISPR to produce mice in which 80 percent of the offspring were females. With the new study, the efficacy leaps to 100 percent, with the choice towards either sex. If further tested in farm animals, the technique could be a boost to both animal welfare and conservation.
Its not an entirely comfortable solution for some. To Sue Leary, president of the non-profit Alternatives Research & Development Foundation, You cant solve an ethical problem with another ethical problem, which is genetic engineering. And given the animosity towards GMOs, the new technology, regardless of efficacy, may be dead in the water.
For now, the CRISPR edits arent feasible in humans due to their complexity. Whats clear, though, is that weve begun parsing the biological machinery behind gender selection. Add in recent work on genetically-engineered embryos, or eggs and sperm from stem cells, and were on the fast track for CRISPR to completely change our current conception of reproduction.
Image Credit: Graphic Compressor/Shutterstock.com
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Scientists Used CRISPR Gene Editing to Choose the Sex of Mouse Pups - Singularity Hub
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Report calls for broad public deliberation on releasing gene-edited species in the wild – EurekAlert
Posted: at 1:35 am
NEW YORK, December 21 -- A new report released by The Hastings Center, a leading ethics research institute, finds that the complex issues raised by releasing gene-edited species into the wild demand deep and broad public engagement. The report, Gene Editing in the Wild: Shaping Decisions Through Broad Public Deliberation, provides a path forward to move decision-making from the realm of experts to a more inclusive, values-based approach using the technique of public deliberation or deliberative democracy.
The goals of gene editing in the wild efforts are wide-ranging, and the benefits potentially transformative--such as preventing mosquitoes from spreading disease. But this work poses major trade-offs that require the publics consideration.
The reports twelve essays take up fundamental questions: how should public deliberation be designed? Who should participate? How should deliberation be linked to policy?
The introductory essay, Public Deliberation About Gene Editing in the Wild, summarizes the key design elements that can improve broad public deliberations about gene editing in the wild: Framing the question and deciding when to hold broad public deliberation, choosing participants, addressing power, and accounting for and capturing perspectives that are hard to express. The introduction was written by the special report editors: Michael K. Gusmano, Gregory E. Kaebnick, Karen J. Maschke, Carolyn P. Neuhaus, and Ben Curran Wills.
Regulating Gene Editing in the Wild: Building Regulatory Capacity to Incorporate Deliberative Democracy, by Karen J. Maschke and Michael K. Gusmano, says that there has not been enough attention to how we should connect public deliberation to the existing regulatory process. The authors argue that, while federal agencies may have capacity to undertake public deliberative activities, there may not be sufficient political support for them to do so.
Deliberative Public Consultation via Deliberative Polling: Criteria and Methods, by James S. Fishkin, makes the case that Deliberative Polling, an approach developed by the author, can be usefully employed to engage representative samples to deliberate in depth in controlled experiments so as to yield a picture of the publics considered judgments. Another it can be cost-effectively conducted online.
The Decision Phases Framework for Public Engagement: Engaging Stakeholders about Gene Editing in the Wild, by S. Kathleen Barnhill-Dilling, Adam Kokotovich, and Jason A. Delborne, puts forth a framework for shaping public engagement that tackles when and whom to engage on genetic engineering questions.
Empowering Indigenous Knowledge in Deliberations on Gene Editing in the Wild, by Riley Taitingfong and Anika Ullah, identifies Indigenous peoples as key stakeholders in decisions about gene-editing in the wild and argues that engagement activities need not only include Indigenous peoples but also should be designed, conducted, and analyzed in ways that confront longstanding power imbalances that dismiss Indigenous expertise.
The special report grew out of a Hastings Center project funded by the National Science Foundation, The complete report is available for download here.
For more information, contact:
Susan Gilbert or Mark Cardwellcommunications@thehastingscenter.org845-424-4040, ext. 244
Systematic review
Not applicable
Gene Editing in the Wild: Shaping Decisions through Broad Public Deliberation
15-Dec-2021
Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.
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Report calls for broad public deliberation on releasing gene-edited species in the wild - EurekAlert
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RNA and DNA Extraction Kit Market Study | Know the Post-Pandemic Scenario of the Industry – BioSpace
Posted: at 1:35 am
RNA and DNA extraction plays a crucial role in cancer genetic studies, which involves mutation analysis, comparative genomic hybridization, and microsatellite analysis. The rising incidences of cancer globally are creating a need for the advanced RNA and DNA extraction kit and are expected to drive market growth in the coming years.
Based on the product, the market is expected to segregate into RNA extraction kit and DNA extraction kit. Of these, the DNA extraction kit segment is expected to account for the leading share in the overall RNA and DNA extraction kit market. Additionally, the applications of DNA extraction kits mainly in the genetic engineering of animals and plants in pharmaceutical manufacturing. This is expected to fuel growth of RNA and DNA extraction kit market.
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Global RNA and DNA Extraction Kit Market: Notable Developments
Some of the most prominent competitors operating in the competitive landscape of global RNA and DNA extraction kit market include
Global RNA and DNA Extraction Kit Market: Drivers and Restraints
The rise and progress in customized drug have helped social insurance experts create exact sub-atomic focused on treatment dependent on a person's hereditary cosmetics and prescient information explicit to patients. The advancement of customized medication requires genome-mapping investigations of separated cells, which can be completed with the assistance of DNA and RNA extraction kits. DNA extraction kits are utilized to recognize quality polymorphisms identified with sickness or medication digestion though RNA extraction kits are utilized to break down RNA combination in separated cells. With the expanding appropriation of customized prescription, the demand for RNA and DNA extraction kits will likewise develop.
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There is a developing rate of malignant growth over the globe. The inside and out understanding of tumor hereditary qualities given by trend-setting innovations in malignant growth research has empowered the advancement of novel treatments to battle disease-causing qualities. The virtue, amount, and nature of separated RNA assume a huge job in the accomplishment of RNA examination and examination and consequent capacity of specific quality articulation. RNA extraction likewise helps in recognizing circulating tumor cells (CTCs) and non-intrusive observing of cutting edge malignant growths.
Global RNA and DNA Extraction Kit Market: Regional Outlook
On the basis of region, the RNA and DNA extraction kit market is segmented into North America, Europe, Latin America, Asia Pacific, and the Middle East & Africa. Of these, North America is expected to dominate the global RNA and DNA extraction kit market owing to robust innovation procedures running in the region. This factor is expected to offer robust growth opportunities to key players in RNA and DNA extraction kit market. Additionally, increasing demand for the automated systems coupled with the rising need for the RNA and DNA extraction kit across the extraction kits especially in the medical diagnosis is expected to drive growth of the market in coming years.
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5-Point Growth Formula
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The 5-point growth formula includes the following points:
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RNA and DNA Extraction Kit Market Study | Know the Post-Pandemic Scenario of the Industry - BioSpace
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Opinion: Allow Golden Rice to save lives – pnas.org
Posted: at 1:35 am
Vitamin A deficiency (VAD) has killed millions of children in less-developed countries for at least the last three decadesroughly 2 million annually in the early 1990s alone (14). Although the number is declining, it was estimated to be 266,200 (4) at the start of the millennium.
Widespread consumption of the genetically modified rice variety known as Golden Rice offers a potent and cost-effective strategy to combat vitamin A deficiency. Image credit: International Rice Research Institute; photo licensed under CC BY 2.0.
The consumption of the genetically modified rice variety known as Golden Rice (GR) offers a potent and cost-effective strategy to combat VAD. But this innovation has been cast aside owing to fear or false accusations, resulting in numerous lives needlessly lost (13). With the recent exception of the Philippines, governments have not approved the cultivation of GR (5). We believe it should be broadly approved and given the opportunity to save and improve lives.
In high-income nations where populations have access to a diversity of foods, VAD is rare. In many low-income nations, however, populations have limited access to foods rich in vitamin A or beta-carotene, a vitamin A precursor; hence, VAD rates can be dangerously high in children. There have been recent improvements: from 1991 to 2013, the VAD rate among children in low- and middle-income countries declined from 39% to 29%, with notable improvements among children in East and Southeast Asia (4). However, children in sub-Saharan Africa and South and Southeast Asia continue to disproportionately experience VAD and its associated risks: infectious and diarrheal diseases, irreversible blindness and other sensory losses, and premature death (1, 4, 6).
VAD has not been eradicated despite a variety of strategies used globally, including education on the value of dietary diversity, promotion of home gardens and maternal breastfeeding of infants, and community health programs including vitamin A supplementation with syrups or capsules (7). Principally, VAD is caused by insufficient dietary diversity, a result of poverty and agronomic and market constraints. Animal source foods and many kinds of produce are unavailable or expensive in local markets. Conversely, white rice or other cereal grains are easily available and inexpensive but primarily contain carbohydrates while lacking sufficient micronutrient levels.
GR, developed first in the 1990s and then modified in 2004 with transgenes from maize and a common soil bacterium Erwinia uredovora, could be an important public health intervention for VAD populations worldwide. This transgenic, or genetically modified, rice produces beta-carotene, a precursor to vitamin A, in the normally white endosperm (8) and has proven an effective source of vitamin A in humans (9). GR* is now awaiting final approval in Bangladesh. In July 2021, it was approved for cultivation in the Philippines. Other countries will likely follow.
A recent study has estimated that substituting conventional rice for GR could provide 89% to 113% and 57% to 99% of the recommended vitamin A requirement for preschool children in Bangladesh and the Philippines, respectively (10). Even if there were no other sources of vitamin A in the diets, this boost in dietary beta-carotene could do much to prevent diseases associated with VAD.
GR is also financially viable. In Bangladesh, the current practice of fortifying rice with vitamin A and zinc using food additives, although supported by the World Food Programme, increases the cost of rice by 5% to 6% and is applied to only about 1 million metric tonnes of rice of the roughly 25 million metric tonnes produced in Bangladesh per year (11). GR, by contrast, poses no extra cost to governments, growers, or consumers in comparison with white rice.
Meanwhile, VAD has continued to cause severe illness and death among certain populations worldwide, especially children (12). The total estimated deaths from VAD-related diarrheal diseases and measles in children under five years of age in 2013 was 94,500 and 11,200, respectively, totaling 105,700 deaths across the world (4). Had GR become a part of diets in vulnerable populations worldwide, a portion of these lives might have been saved. Hopefully, approval of the commercialization of GR in the Philippines will provide impetus for Bangladesh and other nations with high VAD rates to provide poor consumers with an option that may save lives and improve health.
Those who oppose transgenic or genetically modified organisms raised concerns that led policymakers to delay the approval of the technologies (13). One argument relates to biotechnology company profits. But because the GR technology to the public sector is available at no cost for humanitarian uses, this concern is irrelevant. There are no limitations, except export, on GR use: replanting or selling or giving away seed, or polishing for consumption or sale.
Greenpeace summarized a food security-related objection to GR in a 2012 statement (14): If introduced on a large scale, GR can exacerbate malnutrition and ultimately undermine food security. The implication: GR will worsen malnutrition because it leads to a diet based on one staple. However, the replacement of traditional rice with GR would not exclude the development of diversified diets; in the meantime, vitamin A status could improve for many in the population. And optimizing vitamin A delivery could improve public health in at-risk populations.
A reasonable objection concerns possible human or environmental health risks. The United Nations (UN) Cartagena Protocol on Biosafety (15) provides a framework for the regulation of genetically engineered crops in many countries, emphasizing the Precautionary Principle in assessing risks, and leaving out assessment of benefits. This Protocol was signed in 2000 and became effective in 2003, in the relatively early days of agricultural genetic engineering. Since then, multiple studies have reported on benefits of genetically modified organism (GMO) adoption through increased yields, reduced pesticide use, improved farmer income, reduced prices to consumers, and in some cases even improved food safety (16). Meanwhile, there have been no confirmed incidents of adverse human health or environmental effects from genetically engineered crops during nearly three decades of global use (16).
Transgenic crops are subject to many required regulatory tests before approval, including animal feeding and invitro studies for toxicity and allergenicity. Yet opponents of these crops have continued to amplify suspicion on the long-term health effects of genetically engineered crops (17). Protection against such risks can be achieved through monitoring of the performance and the impacts of technologies and intervening when setbacks occur. However, the food safety assessments for transgenic crops in many countries are more demanding than for conventionally bred varieties. In fact, often less is known about the properties of plants developed by conventional mutagenesis than those developed by transgenic methods.
Another concern is that GR genes may intermingle with those of conventionally bred rice varieties. This uncertainty, however, applies not just to GR but also to any other new rice variety. Humans have consumed rice for more than 4,000 years, including varieties that have been crossed genetically across multiple strains. Transgenic methods of introducing novel genes is not inherently of greater concern, unless those genes produce proteins with potential adverse health effectssomething that food safety tests for approval can determine. Clearly the lives saved with VAD outweigh concerns about these so-called unknown risks. In response to such criticisms, in 2016 more than 150 Nobel Laureates have signed an open letter to the UN, governments of the world, and Greenpeace, urging a more balanced approach toward genetically modified crops in general and GR in particular: Scientific and regulatory agencies around the world have repeatedly and consistently found crops and foods improved through biotechnology to be as safe as, if not safer than, those derived from any other method of production. Opposition based on emotion and dogma contradicted by data must be stopped (18).
The arguments used by organizations to delay adoption of GR often resemble the arguments of anti-vaccination groups, including those protesting vaccines to protect against COVID-19. Some of the opponents of GR and agricultural biotechnology more generally see the introduction of GR as forcing the consumption of GMOs on the population. However, for the case of GR, consumers have the option of easily avoiding consumption because GR is very easily identifiable by its color.
The tragedy of GR is that regulatory delays of approval have immense costs in terms of preventable deaths, with no apparent benefit (13). The approval of GR is even more urgent with the ongoing pandemic, which has made access to healthcare services more difficult in vulnerable populations worldwide. The World Bank has recommended that micronutrient biofortification of staple crops, including specifically GR, should be the norm and not the exception in crop breeding (19).
Golden rice can effectively control VAD. Delaying the uptake of a genetically modified product shown to have clear health benefits has and will cost numerous lives, frequently of the most vulnerable individuals. Policymakers must find ways to overcome this resistance and accelerate the introduction and adoption of Golden Rice.
Author contributions: J.W., D.Z., and A.D. designed research; F.W., J.W., C.C., and A.D. performed research; F.W., J.W., and C.C. analyzed data; and F.W., J.W., D.Z., R.R., C.C., and A.D. wrote the paper.
Competing interest statement: A.D. is a member and the Executive Secretary of the Golden Rice Humanitarian Board. He is a volunteer, unpaid and without grants. R.R. is a member of the Golden Rice Humanitarian Board. He is a volunteer, unpaid and without grants. The Golden Rice Humanitarian Board (http://www.goldenrice.org) holds the rights for humanitarian applications of the nutritional technology created by Professors Ingo Potrykus and Peter Beyer and related licensed technology. The Board is not legally incorporated in any way. It is a group of individuals who voluntarily share the objective of making Golden Rice available to resource-poor populations as a public good, delivered by the public sector in locally adapted and preferred rice varieties, at no greater cost than white rice and with no use limitations except export. All other authors declare no competing interests.
Any opinions, findings, conclusions, or recommendations expressed in this work are those of the authors and do not necessarily reflect the views of the National Academy of Sciences.
*Many transformation events were produced (8), from which event GR2E has been selected on the basis of molecular structure and insertion in the rice genome, together with agronomic performance. It is the basis of the regulatory data generated and is the only form of GR which is offered for approval and use.
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It’s time for an alliance of democracies | TheHill – The Hill
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President Joe BidenJoe BidenFederal class action lawsuit filed over treatment of Haitian migrants Staffer who had contact with Biden tests positive for COVID-19 Overnight Defense & National Security New rules try to tackle extremism in the ranks MORE recently assembled the leaders of more than 100 democracies worldwide for a virtual Summit for Democracy. Not surprisingly, the gathering drew the ire of China and Russia, whose ambassadors penned a joint op-ed castigating it a vestige of Cold War mentality and calling on countries to stop using "value-based diplomacy" to provoke division and confrontation.
The summit was useful to begin conversations on how to confront the daunting challenges facing the free world. But it is not sufficient. The time has come to establish an Alliance of Democracies that would bring together the United States and its allies in Europe and the Indo-Pacific, and other willing democracies worldwide that share common interests and values and are prepared to act.
As Biden underscored in his introductory remarks, democracy is facing alarming and sustained challenges, including from autocrats, who seek to advance their own power and export and expand their influence around the world.China and Russia, in particular, have become more assertive in challenging key tenets of the rules-based global order, Democracies are on the defensive as they contend with these and other global threats. To succeed in this fundamental struggle between democracy and autocracy, democracies must strengthen cooperation.
An Alliance of Democracies would provide a highly visible platform for fostering solidarity in the face of common threats and challenges. The leading democracies in North America, Europe and the Indo-Pacific make up roughly three-quarters of global gross domestic product. In combination with the European Union, the transatlantic partnership provides nearly 80 percent of official developmental aid worldwide. And the 20 highest scoring countries in terms of soft-power influence are all democracies. These assets provide the United States and its allies with an enormous source of leverage in addressing global challenges.
But the Alliance of Democracies must be more than symbolic. Instead, its members must be prepared to take meaningful action to address the three defining challenges facing the democratic world. The first is the increasing assertiveness by China and Russia to make the world safer from autocracy. Moscow and Beijing are using diplomatic and economic coercion including military threats, cyber operations, malign finance and other wolf warrior diplomacy tactics to pressure smaller governments and global corporations to accommodate their interests.
In response, the alliance could facilitate coordinated sanctions and other measures to deter such behavior, and provide a mechanism to provide joint assistance to targeted democracies. It could also help make democracies less vulnerable to economic coercion, including, for example, by facilitating alternative supply chains for sensitive technologies and critical energy supplies.
The second is backsliding within established democracies. Whether through the acquiescence of their electorate or manipulation of electoral processes, populist leaders in many democracies have been using their authority to undermine democratic norms. The alliance can serve as a mechanism to hold states accountable for their democratic practices at home. Building on the loose pledge system for leaders interventions at the Summit for Democracy, countries could be asked to make specific commitments to advance democratic renewal at home as part of their alliance membership obligations.
The third is the rise of emerging and potentially disruptive technologies. Such technologies including artificial intelligence, quantum computing, genetic engineering and 5G are developing rapidly and will significantly shape the future of geopolitics. While these innovations promise great benefits, they also carry serious risks, including security challenges. If China or other autocratic nations succeed in developing these technologies ahead of the democratic world, they could gain significant economic and military advantages. To counter this, the alliance should set common standards for advanced technologies that are consistent with liberal norms. The goal is to ensure that the democratic world and fundamental values prevail in the technological race.
Support for closer alignments among democracies is building. In hosting the Group of Seven (G7) summit earlier this year, British Prime Minister Boris JohnsonBoris JohnsonQueen cancels British royal family's Christmas gathering: report It's time for an alliance of democracies The Hill's Morning Report - Presented by National Industries for the Blind - Manchin says no; White House fires back MORE sought to advance the idea of a D-10 club of democracies. Lawmakers in Britain and Canada have expressed support for new coalitions of democracies, and the traffic light coalition making up the new government in Germany called for the creation of an Alliance of Democracies in a recent policy paper. In the United States, proposals for closer cooperation among democracies have drawn bipartisan support among lawmakers in Congress.
That China and Russia have spoken out so vehemently about the Summit for Democracy indicates a level of concern as to where this initiative might lead. Nevertheless, it would not serve the interests of the United States or its allies to provoke a new Cold War dynamic that could lead to escalating tensions or even direct confrontation. The reality is, however, that competition between democratic and autocratic powers is now an established feature of the current global system. The key question is how democracies will choose to respond. To minimize the risks of polarization, leading democracies should embrace a two-tracked approach: engaging with Beijing and Moscow though the United Nations, G20, and other venues in areas where cooperation may be feasible, and, at the same time, working through an Alliance of Democracies to uphold shared values and interests.
Bidens call to action with his Summit for Democracy could help propel the idea of an alliance forward. The administrations plan for a follow up summit next December could provide the building block for a sustainable cooperative network of democracies. The administration has rightly framed the current era as a historic inflection point between autocracy and democracy. An Alliance of Democracies would provide a signature initiative that is directly responsive to this challenge one that demonstrates leadership and can help align the democratic world in a common direction for will likely be a multi-decade era of strategic competition.
Ash Jain is director for democratic drder at the Atlantic Council.
Jonas Parello-Plesner is executive director of the Copenhagen-based Alliance of Democracies Foundation.
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Aridis Pharmaceuticals Announces a Pan-Coronavirus Monoclonal Antibody Cocktail That Retains Effectiveness Against the Omicron variant, other COVID-19…
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LOS GATOS, Calif., Dec. 21, 2021 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, announced today that its fully human monoclonal antibody (mAb) cocktail AR-701 is broadly reactive against the Omicron and other COVID-19 (SARS-CoV-2) variants, SARS (Severe Acute Respiratory Syndrome), MERS (Middle East Respiratory Syndrome Coronavirus), and seasonal ('common cold') human coronaviruses.
"Omicron has rendered current COVID-19 vaccines and monoclonal antibodies substantially less effective, and likely future COVID 19 variants will arise that continue this trend" said Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "AR-701 is the result of our successful search for a mAb therapy that is directed against a conserved region of the virus that would be less vulnerable to mutations and new variants such as Omicron. Our laboratory data suggest that AR-701 has the potential to be a future-proof COVID-19 therapy that can protect against SARS-CoV-2, SARS, or MERS pandemics," continued Dr. Truong. "To our knowledge AR-701 is the only COVID-19 therapy that targets two distinct viral mechanisms of action, making it much harder for the virus to generate resistance, and exhibits an unmatched combination of broad reactivity and high efficacy," continued Dr. Truong.
About AR-701AR-701 is a cocktail of two fully human immunoglobulin G1 (IgG1) mAbs discovered from screening the antibody secreting B-cells of convalescent SARS-CoV-2 infected (COVID-19) patients. AR-701 consists of AR-703 and AR-720 mAbs, each neutralizes coronaviruses using distinct mechanisms of action, namely inhibition of viral fusion and entry into human cells (AR-703) and blockage of viral binding to the human 'ACE2' receptor (AR-720). The two mAbs complement and enhance each other in a synergistic fashion, creating a potent first-in-class cocktail. AR-703 binds to the 'S2' stalk region of spike proteins from betacoronaviruses, including the SARS-CoV2 variants (beta, gamma, delta, epsilon), and binds to the Omicron variant with no loss in affinity compared to the original Wuhan strain. Multiple animal challenge models widely used to evaluate COVID-19 treatments support AR-701's broad efficacy, including:
The AR-701 mAbs are engineered to be active for 6-12 months in the blood. AR-701 is being developed as a long-acting intramuscular as well as a self-administered inhaled formulation for the treatment of COVID-19 patients who are not yet hospitalized. AR-701 mAbs were discovered through a collaboration with researchers at the University of Alabama in Birmingham and Texas Biomedical Research Institute (San Antonio, TX).
About Aridis Pharmaceuticals, Inc.
Aridis Pharmaceuticals, Inc. discovers and develops novel anti-infective therapies to treat life-threatening infections, including anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is utilizing its proprietary PEXTM and MabIgX technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture monoclonal antibody (mAbs) for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized for high potency by the donor's immune system; hence, they technically do not require genetic engineering or further optimization to achieve full functionality.
The Company is advancing multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company's pipeline is highlighted below:
Aridis' Pipeline
AR-301 (VAP). AR-301 is a fully human IgG1 mAb targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin and is being evaluated in a global Phase 3 clinical study as an adjunctive treatment of S. aureus ventilator associated pneumonia (VAP).
AR-320 (VAP). AR-320 is a fully human IgG1 mAb targeting S. aureus alpha-toxin that is being developed as a preventative treatment of S. aureus colonized mechanically ventilated patients who do not yet have VAP. Phase 3 is expected to be initiated in 2Q22.
AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients. This program is currently in Phase 2a clinical development in CF patients.
AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that are directed at multiple protein epitopes on the SARS-CoV-2 virus. It is formulated for delivery via intramuscular injection or inhalation using a nebulizer. AR-701 replaces AR-712 as the company's leading COVID mAb candidate.
AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.
AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa (P. aeruginosa) liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide.
AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV).
For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the need for additional financing, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2020 and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Contact:Media Communications:Matt SheldonRedChip Companies Inc.Matt@redchip.com1.917.280.7329
Investor RelationsDave GentryRedChipDave@redchip.com1-800-733-2447
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2021: when the link between the climate and biodiversity crises became clear – The Guardian
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Bats sweltering in their boxes, polar bears and narwhals using up to four times as much energy to survive, birds starving as Turkeys lakes dry up, and unique island species at high risk of extinction as the planet warms. If there was ever any doubt about the inextricable link between the climate emergency and the biodiversity crisis, those doubts were well and truly dispelled in 2021.
The science is clear: climate, biodiversity and human health are fully interdependent, Frans Timmermans, the European Commission vice-president who heads the European Green Deal; Achim Steiner, of the UN Development Programme; and Sandrine Dixson-Declve, of the Club of Rome, wrote before the Cop26 climate conference.
While the much-anticipated Cop15 Kunming biodiversity conference was delayed yet again, Cop26 brought together leaders from across the globe to discuss the climate emergency. Although the pledges on emissions cuts fell short of those required to limit the increase in temperatures to 1.5C, there were promises to halt and reverse global deforestation over the next decade.
Meanwhile, dozens of countries have committed to protecting 30% of the planets land and oceans by 2030, and in September, nine philanthropic foundations pledged $5bn (3.75bn) to finance the 30x30 pledge.
Despite the coronavirus pandemic and the many lockdowns, 2021 saw the worlds scientists, volunteers and conservationists continuing their efforts to protect nature. The International Union for Conservation of Nature launched its new green list of protected and conserved areas, researchers at the Natural History Museum worked on digitising its vast collection, Kenya held its first animal census, and a multimillion-pound project was launched that aims to describe and identify the web of life in large freshwater ecosystems with game-changing DNA technology.
In September, the IUCN world conservation congress in Marseille brought together innovators and policymakers from across the world for talks and debates on subjects as diverse as the universal declaration of the rights of the river, alien species, human-wildlife conflict, the use of smart technology in conservation, genetic engineering and much more.
Not all conservation efforts are down to scientists and policymakers though. There is growing recognition of the vital role communities and indigenous people play in conserving biodiversity and building livelihoods and this year we highlighted projects that included a shade-grown coffee initiative in Peru, islanders rallying to save the coco de mer nut in Seychelles and an army of nature recorders and seed conservers in the UK.
There was good news elsewhere. The flatpack homes for animals that fall victim to wildfires that we highlighted in April have since been trialled in Sydney, where a housing estate of the biodegradable cardboard pods has been put up to give shelter to wildlife after the bushfires.
In response to our piece on conservationists criticising Marks & Spencer for releasing 30 million honeybees, the British retailer filled 500 stores with little signs telling shoppers about the importance of native bumblebees in producing a number of foods. M&S has been really open to learning, said Gill Perkins, chief executive of the Bumblebee Conservation Trust, who believes it is the first UK supermarket to introduce bumblebee labels highlighting the work of these pollinators. She hopes others will follow suit.
Andrew Kerr, who spoke to the Guardian about wanting to create a UK eel rewilding programme, is having discussions with the relevant government ministry in January about the feasibility of getting rewilding permits sorted for this coming eel season.
Since we reported on the proposals to extend Barcelona airport, threatening neighbouring wetlands and a wealth of biodiversity, the plans have been put on hold. The future of the red wolf in North Carolina still hangs in the balance but the US Fish and Wildlife Service says it is planning to release nine wolves from captivity this winter. And an experimental feeding programme has been approved for Floridas manatees, after a record year of deaths.
Over the coming weeks, we will follow up on some of the stories that we covered during 2021 in more depth, but in the meantime, you might like to take a look at some of our favourite articles from the year that celebrate the planets beautiful and intricate biodiversity: why we need to stop treating soil like dirt; the wonderful world of fungi; the value of dead wood; how a wild night out could help you reconnect with nature; and, lastly, a lesson in why some things are worth waiting for, especially when they turn out like this
Find more age of extinction coverage here, and follow biodiversity reporters Phoebe Weston and Patrick Greenfield on Twitter for all the latest news and features
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