DetailsCategory: Proteins and PeptidesPublished on Monday, 01 June 2020 18:40Hits: 389

PHILADELPHIA, PA, USA I June 01, 2020 I Spark Therapeutics, a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, today announced the publication of new research in the journal Nature Medicine demonstrating that treatment with immunoglobulin G-degrading (IgG) enzyme of Streptococcus pyogenes (IdeS) resulted in rapid and transient reduction of neutralizing anti-adeno-associated virus (AAV) antibodies and restored gene therapy efficacy in controlled laboratory tests of animal models.

One of the main challenges associated with AAV-mediated gene therapy is neutralizing antibodies that can impact the ability to administer gene therapy, saidFederico Mingozzi, Ph.D., chief scientific officer atSpark Therapeutics. The IdeS technology has the potential to eliminate anti-AAV antibodies that allow for the extended use of gene therapy in a larger segment of candidates who may have been excluded due to pre-existing or developing neutralizing antibodies and also enable vector re-administration.

The study was conducted by an international collaboration of researchers from Spark Therapeutics in the U.S., and Genethon, the Centre de Recherche des Cordeliers (Inserm, Sorbonne Universit, Universit de Paris) and the National Centre for Scientific Research (CNRS) in France.

AAV-mediated gene therapy allows for the treatment of a growing number of diseases in patients today, however the presence of neutralizing anti-AAV antibodies can lead to limitations of this technology. Specifically, neutralizing anti-AAV IgG pre-exist in up to seventy percent of the population and block the entry of viral vector particles in a given target tissue. Furthermore, high-titer anti-AAV antibody levels usually develop following vector administration and persist long-term thereafter, preventing vector re-administration. To date, researchers have been limited in their ability to bypass the neutralizing activity of anti-AAV IgG.

Study FindingsThe study demonstrated that treatment with the IgG-degrading enzyme IdeS, an endopeptidase from Streptococcus pyogenes that specifically hydrolyses human IgG, resulted in a rapid and transient elimination of neutralizing anti-AAV IgG and restored gene therapy efficacy. IdeS is an endopeptidase able to degrade circulating IgG that is currently being tested in transplant patients.

Researchers demonstrated efficacy in vivo using animal models of liver gene transfer, including hemophilia A and B. Hemophilia is a rare genetic bleeding disorder that causes a delay in clot formation as a result of a deficiency in coagulation factor VIII or IX for hemophilia A or B, respectively. In both mice and non-human primates with neutralizing anti-AAV IgG, IdeS treatment prior to the injection of AAV vectors eliminated neutralizing IgG and rescued the expression of the factor VIII or IX in hepatocytes.

Furthermore, administration of AAV vectors systematically induces a neutralizing anti-AAV immune response, making gene therapy inefficient upon subsequent injections of AAV vectors. The study also demonstrated that treatment with IdeS restores the efficacy of the re-administration of AAV vectors, allowing for efficient transgene expression in non-human primates. The research shows that IdeS allows the repeated administration of AAV vectors by blocking the neutralizing activity of anti-AAV IgG in small and large animal models.

Additional studies in the field of gene therapy have the potential to translate these findings to human trials, with the goal of opening a therapeutic window for patients with neutralizing anti-AAV antibodies. Spark will assess and investigate the potential impact of the IdeS technology on its current gene therapy programs and potential applications in the future.

About Spark Therapeutics AtSpark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challengethe inevitability of genetic diseases,includingblindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.We currently have four programs in clinical trials.At Spark, a member of the Roche Group, we see the path to a world where no life is limited by genetic disease. For more information, visit http://www.sparktx.com, and follow us on Twitter and LinkedIn.

SOURCE: Spark Therapeutics

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Study Demonstrating Role of IdeS in Enabling of Gene Therapy in the Presence of Neutralizing Anti-AAV Antibodies Published in Nature Medicine |...

Recommendation and review posted by Bethany Smith

Researchers at Bedford-based Nanoscope Technologies LLC have received a multi-year, $2-million plus Small Business Innovation ResearchAward from the National Eye Institute (NEI), a division of the National Institutes of Health (NIH), for its gene therapy treatment.

Nanoscopes research is advancing the development of a therapeutic gene and delivery platform for treating degenerative eye diseases, including dry age-related, macular degeneration (dry-AMD). The projected deliverable is a non-viral, spatially-targeted gene delivery platform for AMD therapy. It would restore visual response with targeted delivery of ambient-light, activatable opsin into the retina.

Our opto-genetic platform and laser delivery technologies are synergistic and will allow treatment for fully- and partially-degenerated retina, said Samarendra Mohanty, Ph.D., Principal Investigator of the grant and Chief Scientific Officer at Nanoscope.

This technology provides a unique therapeutic option for treating dry-AMD patients for which there is no approved therapy, said Vittorio Porciatti, Head of Research at the Bascom Palmer Eye Institute in south Florida.

The Nanoscope team developed Multi-Characteristic Opsins (MCOs) to sensitize cells toward low level of white light so that vision is improved at ambient room light. Not requiring any external stimulation device and sensitivity to broad range of colors makes our approach unique as there is less chance of phototoxicity and damage to the retina, said Nanoscope CEO Sulagna Bhattacharya.

Gene delivery by commonly used viral transfection may lead to unexpected inflammatory and immunological responses.To minimize collateral damage while inserting therapeutic genes, Nanoscopes process uses a low-power, near-infrared (NIR) laser beam whose intensity is locally enhanced by use of gold nanoparticles bound to the targeted cell membranes. This platform technology is being explored for delivery of genes for vaccination against diseases such as COVID-19.

Nanoscope is focused on advancing cell-gene therapy through various patented key platform technologies. Founded in 2009 by Mohanty, it has received multiple SBIR awards, National Institutes of Health R01 grants, and patents that focus on optical stimulation, gene delivery and imaging for neural activity monitoring.

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Tech Fort Worth client receives $2M research award from NEI - Fort Worth Business Press

Recommendation and review posted by Bethany Smith

Regeneron Pharmaceuticals and Intellia Therapeutics announced on Monday that they will be expanding an existing collaboration. Regeneron will have the rights to develop products for additional in viro CRISPR/Cas9-based therapeutic targets. In addition, both companies will work on creating products for the treatment of hemophilia A and B.

Regeneron will receive the non-exclusive rights to independently develop and commercialize ex vivo gene edited products, and Intellia will receive an upfront payment of $70 million. Regeneron will make an additional equity investment in Intellia of $30 million.

"The Regeneron team works hard to push the boundaries of science and technology, and we believe the precise in vivo gene insertion capabilities jointly developed with Intellia could be a promising therapeutic platform with significant potential in many diseases, including those that have been historically difficult to treat, said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer, Regeneron. We're pleased to expand our work with Intellia, a like-minded group of scientists focused on maximizing the potential of CRISPR/Cas9 in order to help as many patients as possible."

Both companies have made significant advances with Intellias CRISPR/Cas9 platform to perform the targeted insertion of therapeutic proteins and antibodies. In preclinical studies, Intellia and Regeneron demonstrated the first CRISPR/Cas9-mediated targeted transgene insertion in the liver of non-human primates. This generated normal or higher levels of circulating Factor IX, a blood-clotting protein that is missing or defective in hemophilia B patients.

"We're excited to work with Regeneron on what could potentially be a cure for hemophilia A and B in this expansion of our successful collaboration that builds on our leading insertion capabilities," said Intellia's Chief Executive Officer and President, John M. Leonard, M.D. "We believe that our CRISPR/Cas9-based technology addresses the limitations of current replacement and gene therapy approaches, and importantly, may provide a durable, potentially life-long solution to these genetic diseases."

Regeneron and Intellia arent the only companies looking for treatments for hemophilia. BioMarin Pharmaceutical, Inc. provided updates to the previously reported results from its open-label Phase 1/2 study on May 31. The trial looked into valoctocogene roxaparvovec as a form of treatment for adults with severe hemophilia A. People with this condition lack the necessary functioning Factor VIII proteins to help their blood clot.

All subjects in both the 6e13 vg/kg and 4e13 vg/kg cohorts remain off prophylactic Factor VIII treatment since being given a single dose of valoctocogene roxaparvovec. Cumulative mean annualized bleed rates remain less than one in both cohorts and below pre-treatment baseline levels.

Overall, the safety profile of valoctocogene roxaparvovec remains consistent with previously reported data, and no participants experienced thrombotic events. The U.S. Food and Drug Administration is currently reviewing the biologics license application from BioMarin.

"It's been a privilege to participate in this pioneering research and to observe how the patients on the study have done so much to improve our understanding of gene therapy research for hemophilia A. This additional data is an important step toward a potential first treatment of its kind for this devastating disease," said Professor John Pasi, M.B., Ch.B., Ph.D., from Barts and the London School of Medicine and Dentistry; chief investigator for the valoctocogene roxaparvovec Phase 1/2 study, and a principal investigator for the Phase 3 study. "Each year of data increases our knowledge of safety and efficacy and contributes to the growing body of scientific data on gene therapies in general and hemophilia A in particular."

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Regeneron and Intellia Expand Their Hunt for Hemophilia A and B Treatments - BioSpace

Recommendation and review posted by Bethany Smith

TORONTO and MARLBOROUGH, Mass., June 02, 2020 (GLOBE NEWSWIRE) -- With Health Canada and the Food and Drug Administration beginning to approve and reimburse cell and gene therapies in significant numbers, the demand for cell and viral vector manufacturing will continue to grow. Consequently, the industrialization challenges associated with the variability of cell and gene therapies, and with manufacturing them on a commercial scale, must be overcome. CCRM and Cytiva, formerly part of GE Healthcare Life Sciences, have renewed their Collaboration Agreement for continued operation of the Centre for Advanced Therapeutic Cell Technologies (CATCT), which was created to accelerate the development and adoption of cell manufacturing technologies for novel regenerative medicine-based therapies.

Together, CCRM and Cytiva have established a commercialization hub where great minds, state-of-the-art equipment and a spirit of innovation meet, says Michael May, President and CEO of CCRM. Continuing to partner in the operation of CATCT will enable us to move the cell and gene therapy industry closer to fulfilling its promise of creating cures, and enabling treatments to get to patients.

By creating an innovative platform and approach to tackle the issues facing commercialization of living therapies, we are supporting the viability of the regenerative medicine industry, says Catarina Flyborg, Vice President, Cell & Gene Therapy, Cytiva. In CATCT, we are creating the technologies, processes and equipment that will enable our customers, and the broader industry, to achieve its goals and help patients.

Established in 2016, CATCT is a partnership between CCRM and Cytiva, with initial funding from the Federal Economic Development Agency for Southern Ontario (FedDev Ontario). Its staff of 40 works in a 10,000 ft (~930 m) process development facility, located in the MaRS Discovery District, next to Torontos world-leading hospitals and the University of Toronto.

The global regenerative medicine market was valued at US$23.8 billion (2018), and it is anticipated to grow to US$151 billion by 2026 with an annual growth rate of 26.1 per cent.i Operating CATCT allows CCRM and Cytiva to address the manufacturing bottlenecks that would otherwise have the potential to impede the industrys growth.

CATCTs key areas of expertise are:

The work conducted in CATCT can be categorized as follows: the first is fee-for-service development projects that advance customers therapeutic technologies towards industrialization; second, the teams New Product Introductions (NPIs) efforts provide core biological expertise in Cytivas product development process; finally, internal technology development builds additional capabilities and innovative solutions for cell and gene therapies.

A recent success stemming from the work being done in CATCT is the involvement of CCRM and Cytiva in a consortium led by iVexSol Canada, with conditional funding from Next Generation Manufacturing Canada (NGen), to build an advanced manufacturing platform for lentiviral vectors. As core partners in this consortium, which was announced in August 2019, CCRM will provide supporting manufacturing infrastructure and downstream processing capabilities, and Cytiva will share expertise of manufacturing processes, and access to and use of specialized tools and technology.

The new collaboration agreement between CCRM and Cytiva has a three-year term and it became effective on October 15, 2019. The funding will be a combination of in-kind contributions, milestone payments, reinvested fee-for-service revenue and any successful grant opportunities. FedDevs funding of CATCT was for a three-year term and ended in December 2018.

About CCRM CCRM, a Canadian not-for-profit organization funded by the Government of Canada, the Province of Ontario, and leading academic and industry partners, supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, strategic investors and entrepreneurs, CCRM accelerates the translation of scientific discovery into new companies and marketable products for patients, with specialized teams, funding, and infrastructure. CCRM is the commercialization partner of the Ontario Institute for Regenerative Medicine and the University of Torontos Medicine by Design. CCRM is hosted by the University of Toronto. Visit us at ccrm.ca.

About CytivaCytiva is a 3.3 billion USD global life sciences leader with nearly 7,000 associates operating in 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture and delivery of transformative medicines to patients. Visit http://www.cytiva.com for more.

For more information, please contact:

Stacey JohnsonDirector, Communications and Marketing, CCRM416-946-8869stacey.johnson@ccrm.ca

Colleen ConnollySenior Communications Manager, Cytiva774-245-3893Colleen.Connolly@cytiva.com

ihttps://www.fortunebusinessinsights.com/industry-reports/regenerative-medicine-market-100970

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Toronto centre solving cell manufacturing challenges to benefit patients and global industry CCRM and Cytiva, formerly part of GE Healthcare Life...

Recommendation and review posted by Bethany Smith

Cell therapy manufacturing costs could be reduced dramatically using immobilized growth factors in culture according to research.

Industry interest in cell therapies has increased significantly in recent years. According to a report by US industry group PhRMA, there are 362 cell and gene therapies in clinical development, up from 289 in 2018.

The surge in cell therapies entering the clinic is the result of years of pioneering research by Americas biopharmaceutical research companies, according to PhRMA.

Image: iStock/Sviatlana Zyhmantovich

It also reflects the potential revenue cell therapies can generate. According to analysis by market research firm Bioinformant while prices vary, all cell therapies are expensive.

For example, cell therapies for wound care cost between $1,500 and $2,500 per administration, while those delivered via injection can cost up to $200,000 per shot. Cell-based gene therapies are valued in the $500,000 to $1 million range.

But revenue is not the only factor. The prices also reflect the high cost of goods sold (COGS) for a cell therapy according to Bioinformant.

The cost of manufacturing a cell product cannot be compared with small molecule products manufactured by pharmaceutical companies or biomolecules produced by biotechnology companies. Cell therapies are costlier to develop, with autologous cell products commanding the highest price tags.

In general, the manufacturing cost of autologous cell product is many times higher than that of an allogeneic product and this is reflected in the market pricing the authors wrote.

Growth factors as the name suggests are proteins that stimulate cell growth. They are one of the most costly components of the cell therapy manufacturing process according to a 2018 study published in Frontiers in Medicine.

The authors who looked at production strategies for allogenic therapies said Identifying mimetic-based alternatives to costly growth factors or leaner media alternatives would help to substantially reduce cost of goods.

Another approach is to immobilize growth factors used in cell culture according to the team behind a study due to be published in Frontiers in Bioengineering and Biotechnology.

Author Marion Brunck, associate professor at the Monterrey Institute of Technology and Higher Education (ITESM), told Bioprocess Insider Immobilizing growth factors is a good idea in general, as the process stabilizes the protein and prevents its degradation, internalization, i.e. bioactivity does not decrease at the same rate as with soluble proteins.

However, some growth factors must be internalized for the transduction cascade to occur appropriately, in these situations, a different approach may be sought out, for example immobilizing the growth factor by physical entrapment which allow a gradual release in culture media.

The take home message is that it may be a very good idea to decrease production cost but the biology of the growth factor (GF) and its signaling mechanistics must be well known.

Brunck added that, The impact of GF immobilization on cost will definitely vary depending on each individual process. In some cases, culture media accounts for more than half of the cost of goods, and within the cost of culture media, GF is again a big contributor.

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growth factors to cut cell therapy COGS - Bioprocess Insider - BioProcess Insider

Recommendation and review posted by Bethany Smith

A business intelligence report on the global Gene Therapy market offers quantitative estimation of the opportunities and qualitative assessment various growth dynamics. The study highlights estimations of the opportunities in the historical period, and offers several projections during the forecast period.

The following are taken into consideration:

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Key Focus Areas of Report on Global Gene Therapy Market

The study on the Gene Therapy market includes detailed market estimations of opportunities in various segments and their share/size globally in each year during the forecast period. The following are the broad insights that form the backbone of the evaluation of the Gene Therapy market.

Segmental Analysis Comprise the following.

Based on End-use Industry/Application,

Based on Product/Technology,

Based on Region,

Top players include

What Businesses Can Hope to Get in Business Intelligence on Gene Therapy Market?

The study insights on the Gene Therapy market growth dynamics and opportunities highlights various key aspects, in which crucial ones are:

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Insights and Perspectives that make this Study on Gene Therapy Market Stand Out

The analysts who have prepared the report have been keen observers of the dynamism due to macroeconomic upheavals. Using the best industry assessment quantitative methods and data integration technologies, they have come out with a holistic overview of the future growth trajectories of the Gene Therapy market. Fact-based insights and easy-to-comprehend information based on wide spectrum of market data is what makes this study different from competitors.

The following evaluations create a differentiating approach towards understanding the market dynamics and presenting the crux to its readers:

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Fact.MR is a fast-growing market research firm that offers the most comprehensive suite of syndicated and customized market research reports. We believe transformative intelligence can educate and inspire businesses to make smarter decisions. We know the limitations of the one-size-fits-all approach; thats why we publish multi-industry global, regional, and country-specific research reports.

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Rise and Opportunities in Gene Therapy Market, Poised to Register Downturn due to COVID-19 Pandemic - The Cloud Tribune

Recommendation and review posted by Bethany Smith

Global Cell And Gene Therapy Consumables market report comprises of detailed explanation of the market definition, classifications, applications, commitments and market trends. The above-mentioned report provides the levels and revenue of the CAGR for the historical year 2016, the base year 2017 and the forecast period for the Cell And Gene Therapy Consumables market between 2020 and 2027. Getting data regarding competitive landscape is a great gain of this market document. Consequently, the actions or actions of most important market game enthusiasts and brands are analyzed within the Cell And Gene Therapy Consumables Research Report. It provides data on all recent developments, launches of products, joint ventures, mergers and acquisitions by the various key market dominant players and brands. These key players company profiles are provided in this report. In the 2020-2027 forecast period, the market will touch new heights. This Cell And Gene Therapy Consumables report lays down all the restrictions and drivers for the market derived from SWOT analysis.

Negative consequences of internet of things could act as a market restraint for Cell And Gene Therapy Consumables in the above mentioned foretasted period.

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Key market [emailprotected]

The report provides both qualitative and quantitative research of cell and gene therapy consumables market as well as provides comprehensive insights and development methods adopted by the prominent market players. Some of the key market participants in the cell and gene therapy consumables market are Amgen Inc., ATLANTA BIOLOGICALS, bluebird bio, Inc., Cook Medical, Dendreon Pharmaceuticals LLC, Fibrocell Science, Inc., General Electric, Kolon TissueGene, Inc., Orchard Therapeutics plc, Pfizer, Inc., PromoCell GmbH, RENOVA THERAPEUTICS, Sibiono GeneTech Co. Ltd., Spark Therapeutics, Inc., Vericel, ViroMed Co., Ltd., and Vitrolife. These players have adopted growth strategies such as new product launches, partnerships, collaborations, mergers and acquisitions, and joint ventures (JVs) in order to gain a competitive advantage. For instance, in May 2019, General Electric launched chronicle automation software for cell therapy. In October 2018, bluebird bio, Inc. received an approval from European Medicines Agency (EMA) for its investigational LentiGlobin gene therapy for the treatment of adolescents and adults with transfusion-dependent -thalassemia (TDT).

Key Market Competitors: Global Cell And Gene Therapy Consumables Market

Cell And Gene Therapy Consumables Market Country Level Analysis

Cell And Gene Therapy Consumables market is analysed and market size, volume information is provided by country, product type, cable category, application and end use as referenced above.

The countries covered in the Cell And Gene Therapy Consumables market report are the U.S., Canada and Mexico in North America, Brazil, Argentina and Rest of South America as part of South America, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, Rest of Europe in Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA).

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Rapid Business Growth Factors

In addition, the market is growing at a fast pace and the report shows us that there are a couple of key factors behind that. The most important factor thats helping the market grow faster than usual is the tough competition.

Competitive Landscape and Cell And Gene Therapy Consumables Market Share Analysis

Cell And Gene Therapy Consumables market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, regional presence, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to Cell And Gene Therapy Consumables market.

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Table Of Contents: Global Cell And Gene Therapy Consumables Market

Part 01: Executive Summary

Part 02: Scope Of The Report

Part 03: Research Methodology

Part 04: Market Landscape

Part 05: Pipeline Analysis

Part 06: Market Sizing

Part 07: Five Forces Analysis

Part 08: Market Segmentation

Part 09: Customer Landscape

Part 10: Regional Landscape

Part 11: Decision Framework

Part 12: Drivers And Challenges

Part 13: Market Trends

Part 14: Vendor Landscape

Part 15: Vendor Analysis

Part 16: Appendix

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Cell And Gene Therapy Consumables Market to Witness Huge Growth by 2027 | Amgen Inc., ATLANTA BIOLOGICALS, bluebird bio, Inc., Cook Medical, Dendreon...

Recommendation and review posted by Bethany Smith

TOKYOToshiba Corporation (TOKYO: 6502, hereinafter Toshiba) and a team led by Professor Yozo Nakazawa at the Department of Pediatrics, Shinshu University, (hereinafter "Shinshu University"), have together developed a tumor-tropic liposome technology for gene therapy*1. The technology uses unique, nano-sized biodegradable liposomes developed by Toshiba to accurately and efficiently deliver therapeutic genes to targeted cancer cells, and achieves safer gene delivery than viruses used as carriers.

The tumor-tropic liposome developed by Toshiba can deliver therapeutic genes selectively to tumor cells, not normal cells. Shinshu university and Toshiba have demonstrated that the tumor-tropic liposome can deliver the therapeutic gene to T-cell leukemia cells and achieve a 30-fold increase in uptake and 400-fold increase in gene expressionthan normal T-cells. The technology is expected to reduce burdens on patients during treatment, and offers the potential to develop new treatments for other cancers.

Shinshu University and Toshiba presented the technology at the 2020 Annual Meeting of the American Society for Gene & Cell Therapy (ASGCT 2020) on May 12 (presenter: Shoji Saito, Shinshu University School of Medicine).

Gene therapy applies the latest advances in biotechnology to treatment of disease at the level of gene expressionusing information from a gene to synthesize a functional gene product in an affected cell. In cancer therapy, it inserts therapeutic genes into target cells, where they can repair and enhance cell functions. While a highly promising way forward, even for cancers that are difficult to treat, gene therapy is not yet settled science, and there are still hurdles to overcome, including how best to get genes into cells.

Therapeutic genes need a carrier to introduce them into a cell, because the nucleic acid that encodes the DNA and RNA that triggers gene expression cannot penetrate the cell membrane. Current approaches often achieve this by using a virus as the carrier. However, it brings with concerns for the risk of infection and cell tropism.

Shinshu University and Toshiba are collaborating in research to utilize biodegradable liposomes as non-virus carriers of therapeutic genes. They have developed tumor-tropic liposomes that safely and effectively deliver therapeutic genes to targeted cancer cells.

Toshiba has applied its know-how in materials technology to the design of liposomes with lipids that degrade naturally in cells, as their major component. The companys research has confirmed that adjusting lipid composition to cell membrane characteristics realizes liposomes that can carry therapeutic genes to specific target cells (Figure 1). The delivery is also highly efficient, as a comparison of tumorous cells and normal T cells found that the former surpassed the latter in therapeutic gene uptake and expression by 30-times and 400 times respectively.

Figure 1 The biodegradable liposome technology targeted by the research

Shinshu University has demonstrated that the biodegradable liposome is an effective and efficient carrier for delivering therapeutic genes into tumor cells by experimentally administering tumor-tropic liposomes carrying therapeutic genes into T-cell tumor bearing mice. The results also confirmed successful suppression of tumor growth (Figure 2). As there is no effective treatment for relapsed or refractory T-cell tumors, Shinshu University is continuing research toward a solution.

Figure 2 Verification of the effects of tumor-tropic liposomes on mice bearing T-cell tumors

Toshiba will continue to contribute its specialized capabilities in materials science to the collaboration with Shinshu University, in support of further enhancing the delivery and application of cancer-directed liposomes and promoting the widespread use of gene therapy.

*1 Gene Therapy

A method of treating a disease by inserting a gene into a cell in order to restore, enhance or suppress its function. It is based on the physiological action of a protein produced by the gene.

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Shinshu University and Toshiba Develop Tumor-Tropic Liposome Technology that Carries Therapeutic Genes into Cancer Cells - BioSpace

Recommendation and review posted by Bethany Smith

In its forthcoming study ofGlobalGene therapy Market,Quince Market Insights offers crucial insights into the global market forGene therapy. In terms of revenue, the global market forGene therapyis expected to record a CAGR ofXXpercent over the forecast period, due to various factors with regard to which QMI provides detailed insights and forecasts.

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The demand forGene therapyis projected to report a growth rate ofXXper cent year-over-year by2028. The demand forGene therapyis segmented by product type, end-users, and regions.

During consideration of segments and sub-segments some industry standards and parameters are considered. Historical information on theGene therapymarket as well as future occurrences which could impact market growth includes a microscopic market view. In view of the value for the base year, the market volume or demand is determined. Main regions are kept in mind with special emphasis on the highest demand and growth countries. The report details country-specific economic indicators and drivers with the investment opportunities offered to the investors concerned. Key insights are written into a table and easily readable structured.

The growth of the market forGene therapyis related to the dental industry that would benefit a great deal from the ongoing change in production using digital methods. As the technology continues to advance traditional methods, further improvements in treatments and outcomes resulting from digital manipulation are improved.Products are more furiously embraced in emerging markets because they are cost-effective and offer good quality that fits the present condition and certain points ofGene therapyrefund policies.

Gene therapymarket research report provides an in-depth analysis of the market overall, primarily on issues bordering on the market size, growth scenario, opportunity potentials, business environment, trend analysis and competitive market analysis ofGene therapy. The information includes the profile of the company, annual turnover, the types of products and services it provides, income generation, which gives businesses direction to take important steps.Gene therapyresearch reportprovides pin-point analysis of varying dynamics of competition and is ahead of competitors in theGene therapylike:Alliance for Regenerative Medicine, Gilead Sciences, Inc., Novartis AG, Sibiono GeneTech Co. Ltd.

This report analyses the trends that drive the growth of each segment on a global as well as regional level, and provides potential takeaways that could prove significantly useful for manufacturers preparing to enter the market.

In this article, we addressed the specific approaches these businesses have adopted with regard to developing their products, creating new manufacturing facilities, consolidating the market and advanced R&D initiatives. The study ends with key takeaways for players already present on the market and new players preparing to enter the marketGene therapy.

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Market Segmentation:

By Product: Yescarta Kymriah Luxturna Strimvelis GendicineBy Application: Ophthalmology Oncology Adenosine Deaminase Deficient Severe Combined ImmunodeficiencyBy Region: North America North America, by CountryUSCanadaMexico North America, by Product North America, by Application Western Europe Western Europe, by CountryGermanyUKFranceItalySpainThe NetherlandsRest of Western Europe Western Europe, by Product Western Europe, by Application Asia Pacific Asia Pacific, by CountryChinaIndiaJapanSouth KoreaAustraliaIndonesiaRest of Asia Pacific Asia Pacific, by Product Asia Pacific, by Application Eastern Europe Eastern Europe, by CountryRussiaTurkeyRest of Eastern Europe Eastern Europe, by Product Eastern Europe, by Application Middle East Middle East, by CountryUAESaudi ArabiaQatarIranRest of Middle East Middle East, by Product Middle East, by Application Rest of the World Rest of the World, by CountrySouth AmericaAfrica Rest of the World, by Product Rest of the World, by Application

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Gene Therapy Market 2020 | Worldwide Analysis By Financial Overview, Research Methodologies and Forecast To 2028 - Azizsalon News

Recommendation and review posted by Bethany Smith

In recent years, we have seen a trend towards the launch of new gene and cell therapies with record-breaking price tags. Such headline-grabbing launches are becoming more and more frequent, as the pipeline for advanced therapies at all stages of development continues to grow at a rapid pace[1]. We are also seeing industry and payers adopting new innovative pricing models for those products, such as outcome-based reimbursement and annuity payment models. In this article, we discuss these emerging alternative pricing models and consider the impact they may have on related licensing arrangements.

Current trends

In May 2019 AveXis, a subsidiary of pharmaceutical giant Novartis, announced that it had received approval from the US Food and Drug Administration to market its gene therapy Zolgensma for the treatment of paediatric patients with spinal muscular atrophy (SMA). Although this is the first promise of a cure for this debilitating and lethal condition, the media coverage focussed instead on Zolgensmas price tag, which at $2.1 million per patient makes it (currently) the worlds most expensive single-dose medicine.

Zolgensma is illustrative of a general trend in gene and cell therapies that have reached the market in recent years and established a new standard of pricing for single-treatment medicines. While manufacturers point to the relative cost-effectiveness of such treatments (which may offer a one-off cure for severe conditions that otherwise would require several years worth of conventional treatments and care) public and private payers are concerned about this new escalating pricing paradigm.

Health care systems may be able to absorb such high prices for rare diseases with small patient populations. However, the current reimbursement systems will be under severe pressure if (as is hoped) pipelines for advanced cell and gene therapies result in treatments for common conditions such as diabetes or heart disease. The Institute for Clinical and Economic Review in the US has estimated that if gene therapies are developed to treat only one in ten American patients with a genetic condition approximately 1% of the total population the cumulative budget impact could rise to $3 trillion[2]. For comparison, the projected total healthcare spend in the US for 2019 is $3.8 trillion[3].

Alternative Pricing Models

The pharmaceutical industry has sought to counter criticism over the high price tags for gene and cell therapies by coupling these revolutionary therapies with new and unconventional pricing and reimbursement mechanisms.

One alternative structure that has been adopted is an annuity based model which spreads the payment for an expensive treatment over several years in a pre-agreed payment plan, thus minimising the up-front cost to payers.

Another approach adopted by the industry, and perhaps an even clearer way to demonstrate value to payers, has been to tie reimbursement to patient outcomes. The industry has negotiated several of these outcomes-based reimbursement models with public and private payers for cell and gene therapies. Reimbursement payments to the drug maker under this model are conditional upon the patient reaching specific clinical outcomes by set deadlines. Depending on the model, a patients failure to meet the specified clinical outcome can result in the drug maker having to refund payments received and/or forfeit any subsequent payments.

These new models are also being blended to create payment plans which combine annuity-style payments with rebates and outcomes-dependent instalments. We expect that in the years to come other creative payment models will emerge and be adapted from other therapy areas. For example, in Australia, the government has used a subscription style model that allowed it to pay a lump sum to drug makers for unlimited access for patients to curative hepatitis C treatments such as Sovaldi for a period of time.

Example annuity and outcomes-based reimbursement models for cell and gene therapies:

Licensing challenges

Cell and gene therapies often have their roots in academic research laboratories and the main players in this field of treatments have close ties and valuable licensing agreements with academic research institutions. For example, AveXis, the biotech company that developed Zolgensma, started as a spin-out to continue research conducted at the Center for Gene Therapy at Nationwide Childrens Hospital in Columbus, Ohio. To further its spinal muscular atrophy work, the biotech also licensed a patent owned by Martine Barkats, a researcher at the Institut de Myologie, Paris. Shortly after, AveXis was bought by Novartis for $8.7 billion. Cell and gene therapies such as Zolgensma will generally have more constituent parts (such as promoters, viral vectors and cell lines) than other more conventional small molecule therapies. This means that a party commercialising a cell or gene therapy will often need to license in more third party intellectual property or materials than a manufacturer of a conventional small molecule therapy. Most cell and gene therapies reaching the market are therefore likely to be underpinned by one or more licence agreements.Licensing challenges

While much has been said about the impact of alternative pricing and reimbursement mechanisms on drug makers, payers and patients, we want to also consider the impact on licensors of the intellectual property which enables the development and manufacture of a therapy. In particular, how future pricing and reimbursement models can impact the royalties payable by licensees to their licensors. One inherent challenge is that these licences are generally negotiated many years before the commencement of discussions with payers on pricing and reimbursement mechanisms, making it very difficult to predict which scenarios will be relevant down the line. The positions of all of the stakeholders in the pricing debate are also constantly evolving, especially as data on the cost-effectiveness of annuity and outcomes-based models continues to accumulate. One factor which makes things particularly difficult for licensors in forecasting potential future royalty streams for these products is that a licensor would rarely have any involvement in negotiations regarding pricing and reimbursement so will have no control over the model adopted.

Annuity model challenges

Generally a licensor will only receive royalties once the licensee has itself received (or at least invoiced) payment from payers. An annuity payment model is therefore likely to mean that royalties will also be paid in instalments potentially spread over a number of years following treatment of a patient. While in practice this may not be a large change for licensors to adjust to (as annual payments for these high price treatments are not out of line with other orphan drug costs, most of which need to be taken over a long period of time) there are also other factors to consider.

One concern that has been raised with annuity payment models is that there may be an increased risk of non-payment as over time licensees may face difficulties in collecting payments, for example because a payer stops complying with payment schedules or becomes insolvent. This may have the knock-on effect of reducing royalties due to a licensor. Licensors may seek to reduce this non-payment risk by asking that royalties are payable on sums invoiced by a licensee, rather than sums received (although this is likely to be resisted by a licensee or perhaps only accepted with caveats). Annuity-based models are also typically more complicated and more expensive for a licensee to manage administratively and those costs are likely to be deductible from sales totals before a licensors royalties are calculated.

From a legal drafting perspective, care would also need to be taken by the licensor when defining payment terms and the royalty term (which is commonly linked to patent expiry) to ensure that the licensor continued to receive royalties in respect of patients who are treated within the royalty term, notwithstanding the fact that payment may not be received until after the patents and royalty term has expired.

Outcome-based model challenges

In relation to outcome-based models, a fundamental concern for both licensors and licensees is the uncertainty associated with a model which involves an upfront payment of the full treatment price but a refund payable some months or years down the line if the clinical outcomes are not met.

If royalties are payable on net sales of the therapy on a regular basis (e.g. quarterly or annually) then unless the licence includes a mechanism to take account of outcomes-based refunds made by the licensee to payers, the licensee could find itself out of pocket, unable to recover royalties paid to the licensor despite having had to refund the therapy price to the payer. To counter this risk, a licensee may seek to build in a royalty claw back mechanism into the licence, or to delay the point at which royalties are payable until after the relevant patient has met the required outcome. However, a licensor is unlikely to accept a significant delay in payment of royalties, particularly where the licensee has itself been paid. Academic licensors, with an obligation to invest income from technology transfer activities into research and the provision of education, are particularly unlikely to agree a royalty claw back structure which could force them to refund royalties or milestones a year or more after having received them.

One alternative option may be to agree that the licensee can make deductions against future royalty payments. A further alternative could be for some portion of the royalties paid to be retained in escrow for a period of time, to be released to the licensor upon achievement of a positive clinical outcome or expiry of a set period of time. However, escrow arrangements necessarily increase the complexity of agreements and are difficult to negotiate upfront when payment and reimbursement models and the associated outcome triggers have not yet been set.

A compromise?

As we have outlined in this article, although there are some things each party can consider at the outset of negotiating a licence, getting into protracted negotiations about hypothetical scenarios is unlikely to be attractive to either party.

The parties may wish to adopt an alternative approach of including robust governance provisions in the licence to deal specifically with this issue. For example, establishing a committee comprised of representatives of both parties to oversee and review issues relating to pricing and reimbursement. This may give the licensor a clearer oversight (and potentially input) into decisions which may impact future royalty streams and may present the licensee with an opportunity to propose alternative payment structures to support its desired pricing model. This could be combined with a mechanism for proposing and agreeing amendments to payment provisions in the licence if necessary to accommodate pricing and reimbursement issues which were unforeseen at the outset. Of course the success of such mechanisms will depend on the strength of the relationship between the parties and a combined willingness to work together and potentially compromise. It would also be important to ensure it is clear what happens where the parties cannot agree (e.g. escalation? expert determination? preservation of the status quo?). However, in a future where pricing and reimbursement issues are only likely to become more complex and of key importance to the success of complex treatments such as cell and gene therapies, it will be interesting to see whether this is a route industry explores.

Conclusion

The launch in recent years of a number of advanced cell and gene therapies with blockbuster price tags has heralded a new era for drug pricing and associated payment and reimbursement issues. It is a trend that looks likely to continue if current pipelines can also deliver much anticipated advanced therapies for common conditions. The high prices associated with these products present a myriad of issues however, not only for patients, payers and healthcare providers, but also for the licensors of the underlying intellectual property underpinning such treatments as industry adopts innovative new payment and reimbursement models which may impact on royalty streams.

When negotiating a licence to technology underpinning a cell or gene therapy the parties should consider how less conventional pricing mechanisms may impact the royalty structure. However, while there are some issues licensees and licensors may be able to consider upfront, it is difficult to anticipate the issues that may become relevant at a stage where pricing models have not been set, particularly as there is no one-size-fits-all pricing approach.

We have proposed an increased use of robust governance processes in a licensing relationship as one option to consider. It will also be interesting to see whether any trends emerge in relation to upfront and milestone payments in response to the challenges outlined above. In particular, licensees may push for more back-loaded or performance-related milestone payments to reflect the risks associated with pricing models which take a longer term view of the cost benefits of these types of therapies. We look forward to seeing what innovative approaches licensors and licensees adopt to adapt to these challenges in the years to come.

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Cell and gene therapies - Lexology

Recommendation and review posted by Bethany Smith

LAS VEGAS, June 2, 2020 /PRNewswire/ -- Diabetic Peripheral Neuropathy Market will increase because of the rising global burden of diabetes that is driving prevalence of diabetic neuropathy, advancement in early diagnosis as well as launch of the promising therapies which will positively impact DPN market.

DelveInsight added a new report titled "Diabetic Peripheral Neuropathy MarketInsights, Epidemiology, and Market Forecast-2030" to its portfolio.

Key Highlights from Diabetic Peripheral Neuropathy Market report are:

Request for sample pages to know more onDiabetic Peripheral Neuropathy Epidemiology and Market Forecast

Diabetic Peripheral Neuropathy is a painful condition that is caused by nerve damage from diabetes. It is a common prevalent complication in neurological damage of Type 1 and Type 2 diabetes.

There is a huge patient population pool affected by the disease; the Diabetic Peripheral Neuropathy market report covers the disease epidemiology that is segmented into Total Diagnosed Prevalent Cases of DPN, Total Prevalent Cases of Painful DPN and Gender-specific Prevalent cases of DPN in the 7MM from 2017 to 2030.

The total Painful Diabetic Peripheral Neuropathy Prevalent Cases were 3,857,945 in the United States in 2020. Also, females are more affected by the disease as compared to males for Diabetic Peripheral NeuropathyPrevalent in the US in 2020.

Click here to know more onDiabetic Peripheral Neuropathypipeline

Among the 7MM, the US accounts for 58% of the overall market size of DPN. Among the EU-5 countries, Germany accounts for the highest market size for DPN. Diabetic Peripheral Neuropathy market has a diverse pipeline with several promising therapies. Also, Gene therapy has been developed for DPN pain management. Of the emerging therapies, the most anticipated product to get launched is VM202 Apart from this, other products include VM202 (Helixmith), NYX-2925 (Aptinyx), WST-057 (4% pirenzepine) (WinSanTor, Inc.), Ricolinostat (Regenacy Pharmacuticals), NRD.E1 (Novaremed Ltd.), Cebranopadol (Grnenthal GmbH), GRC 17356 (Glenmark Pharmaceuticals), and others are also expected to enter the market by 2030 as effective therapies. The potential launch of these emerging drugs will aid in overall market growth. There are a couple of market drivers which will be driving the market. One such factor will be an early diagnosis of the DPN because of the advancements happening in the DPN diagnostic approaches. As the patient pool for diabetic peripheral neuropathy is quite large, and there is no treatment for reversal of disease, this indication withholds a plethora of opportunities for drug development companies. No doubt that the clinical pipeline contains a large number of drugs; however, previously multiple clinical trial failures gave a setback and limited the research and development in the DPN domain. So far it has been clear that path traversed is not easy in DPN research as the long-term clinical trials and low success rate in meeting the clinical endpoints may become threats for the investors to fund further.

There aremany key players robustly involved in developing potential drugs and they are a ray of hopefor DPN patients such as:1. VM2022. NYX-29253. WST-0574. Ricolinostat5. ISC 175366. NRD135S.E17. Cebranopadol8. GRC 173569. MEDI735210. Trazodone/GabapentinAnd many others

The key players involved in Diabetic Peripheral Neuropathy market are:1. Helixmith2. Aptinyx3. WinSanTor, Inc4. Regenacy Pharmacuticals5. Ichnos Science6. Novaremed7. Grnenthal GmbH8. Glenmark Pharmaceuticals9. AstraZeneca10. AngeliniAnd many others

The reasons for buying Diabetic Peripheral Neuropathy market report:

Table of contents

1. Key Insights

2. Executive summary

3. Diabetic Peripheral Neuropathy Market Overview at a Glance

4. Diabetic Peripheral Neuropathy Epidemiology and Market Methodology

5. Diabetic Peripheral Neuropathy Disease Background and Overview

6. Diabetic Peripheral Neuropathy Epidemiology and Patient Population

6.1. Key Findings

6.2. Total Diagnosed Prevalent cases of Diabetic Peripheral Neuropathy in 7MM

6.3. United States

6.4. EU5

6.5. Germany

6.6. France

6.7. Italy

6.8. Spain

6.9. United Kingdom

6.10. Japan

7. Diabetic Peripheral Neuropathy Treatment and Management

8. Diabetic Peripheral Neuropathy Unmet need

9. Diabetic Peripheral Neuropathy Marketed Drugs

9.1. Key cross competition

9.2. Qutenza: Grnenthal

9.3. Tarlige: Daiichi Sankyo

10. Diabetic Peripheral Neuropathy Emerging drugs

10.1. Key cross competition

10.2. VM202: Helixmith

10.3. NYX-2925: Aptinyx

10.4. WST-057: WinSanTor

10.5. Ricolinostat: Regenacy Pharmaceuticals

10.6. Cebranopadol: Grnenthal

10.7. ISC 17536: Ichnos Science

10.8. NRD135S.E1: Novaremed

10.9. MEDI7352: AstraZeneca

10.10. Trazodone/Gabapentin: Angelini

11. Diabetic Peripheral Neuropathy Market Size

11.1. Key Findings

11.2. Total Market Size of Painful Diabetic Peripheral Neuropathy in 7MM

11.3. Diabetic Peripheral Neuropathy Market Outlook: 7 MM

11.4. United States

11.5. EU5

11.6. Germany

11.7. France

11.8. Italy

11.9. Spain

11.10. United Kingdom

11.11. Japan

12. Diabetic Peripheral Neuropathy Reimbursement policies

13. Market Drivers

14. Market Barriers

15. SWOT Analysis

16. KOL Views

17. Diabetic Peripheral Neuropathy Case Report

18. A Case Report of Diabetic Peripheral Neuropathy

19. Bibliography

20. Appendix

21. Diabetic Peripheral Neuropathy Report Methodology

22. DelveInsight Capabilities

23. Disclaimer

24. About DelveInsight

Request a WebEx Demo to get a walk-through of the Diabetic Peripheral Neuropathy Market Report:https://www.delveinsight.com/sample-request/diabetic-peripheral-neuropathy-market

Related Reports:

Diabetic Peripheral Neuropathy Epidemiology Forecast-2030 report delivers an in-depth understanding of the disease, historical, forecasted epidemiology trends of DPN in the 7 MM.

Diabetic Peripheral Neuropathy Pipeline Insight, 2020 report by DelveInsight outlays comprehensive insights of present clinical development scenario and growth prospects across the Diabetic Peripheral Neuropathy market.

About DelveInsight

DelveInsight is a premier Business Consulting and Market Research firm, focused exclusively on the life science segment. With a wide array of smart end-to-end solutions, the firm helps the global Pharmaceutical, Bio-Tech and Medical devices companies formulate prudent business decisions for improving their performances to stay ahead of the competitors.

Contact us:

Shruti Thakurinfo@delveinsight.com+91-9650213330DelveInsight

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Diabetic Peripheral Neuropathy Market is Expected to Increase with a CAGR of 12% for the Study Period of 2017-2030: DelveInsight - P&T Community

Recommendation and review posted by Bethany Smith

Worldwide Gene Therapy Market, [Forecast 2020-2029] Succinct Study Report is in-depth survey on the current state of the global Gene Therapy industry with focus on short term and long term impact analysis of COVID-19/CORONAVIRUS. The report provides key statistics on the market status of the Gene Therapy manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry.

The Gene Therapy Market report covers detailed competitive outlook including the market share and company profiles of the key participants operating in the global market. Vital key players profiled in the report include Novartis, Kite Pharma Inc, GlaxoSmithKline PLC, Spark Therapeutics Inc, Bluebird bio Inc, Genethon, Transgene SA, Applied Genetic Technologies Corporation, Oxford BioMedica PLC, NewLink Genetics Corp., Amgen Inc. Company profile includes assign such as company summary, SWOT analysis and current developments, financial summary, product specifications, production value, business strategy and planning. This report analyzes the top players in global market, and splits the Gene Therapy market by vector type, gene type, application, and region.

|| Access insightful study with over 100+ pages, list of tables & figures, profiling 10+ companies. Ask for Free Sample Copy(PDF) @https://marketresearch.biz/report/gene-therapy-market/request-sample

Through the statistical analysis, the report depicts the global total market of the Gene Therapy industry including capacity, production value, cost/profit, supply/demand, production and import/export. The total market is further divided by company, by country, and by application/type for the competitive landscape analysis. The report then estimates the 2020-2029 market development trends of the Gene Therapy industry. Analysis of upstream raw materials, downstream demand and current market dynamics is also carried out in this report.

In the end, the report makes some important proposals for a new project of the Gene Therapy Industry before evaluating its feasibility. Overall, the report provides an in-depth insight into the 2020-2029 global Gene Therapy industry covering all important parameters.

The Final Report will cover the impact analysis of COVID-19 on this industry (Global and Regional Market).

>>>>Download Here- Short Term & Long Term Impact Analysis of Gene Therapy Market<<<<

Promising Regions & Countries Mentioned In The Gene Therapy Market Report:

North America (U.S. & Canada)

Latin America (Brazil, Mexico, Argentina, Rest of Latin America)

Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC, Poland, Turkey, Russia, Rest of Europe)

Asia-Pacific (China, India, Japan, South Korea, Indonesia, Malaysia, Australia, New Zealand, Rest of Asia-Pacific)

The Middle East and Africa (Israel, GCC [Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman], North Africa, South Africa, Rest of The Middle East and Africa)

Years Considered For This Report:

Historical Years :2013-2018

Base Year :2019

Estimated Year :2020

Forecast Period: 2020-2029

A complete value chain of the global Gene Therapy Market is presented in the research report. It is associated with the review of the downstream and upstream components of the Gene Therapy Market. The market is bifurcated on the basis of the categories of products and the customer application segments. The market analysis demonstrates the expansion of each segment of the global Gene Therapy Market. The research report assists the user in taking a decisive step that will be a milestone in developing and expanding their businesses in the global Gene Therapy Market.

For any special requirements about this report[Click Here- For Enquiry & Report Customization]please let us know and we can provide custom reports.

Key Answers Captured in Report?

Which geography would have better demand for products/services?

What are the strategies adopted by big players in the regional market?

Which country would see the steep rise in CAGR & year-on-year (Y-O-Y) growth?

What is the current & expected market size in the next five years?

What is the market feasibility for long term investment?

What opportunity the country would offer for existing and new players in the market?

What is the risk involved for suppliers in the geography?

What factors would drive the demand for the product/service in the near future?

What is the impact analysis of various factors in market growth?

There Are 13 Chapters To Thoroughly Display The Gene Therapy Market:

Chapter 1:Global Gene Therapy Market Overview, Product Overview, Market Segmentation, Market Overview of Regions, Market Dynamics, Limitations, Opportunities and Industry News and Policies.

Chapter 2:Global Gene Therapy Market Chain Analysis, Upstream Raw Material Suppliers, Major Players, Production Process Analysis, Cost Analysis, Market Channels and Major Downstream Buyers.

Chapter 3:Value Analysis, Production, Growth Rate and Price Analysis by Type of Gene Therapy.

Chapter 4:Downstream Characteristics, Consumption and Market Share by Application of Gene Therapy.

Chapter 5:Production Volume, Price, Gross Margin, and Revenue ($) of Gene Therapy by Regions (2013-2020).

Chapter 6:Gene Therapy Production, Consumption, Export and Import by Regions (2013-2020).

Chapter 7:Gene Therapy Market Status and SWOT Analysis by Regions.

Chapter 8:Global Competitive Landscape, Product Introduction, Company Profiles, Market Distribution Status by Players of Gene Therapy.

Chapter 9:Gene Therapy Market Analysis and Forecast by Type and Application (2020-2029).

Chapter 10:Global Market Analysis and Forecast by Regions (2020-2029).

Chapter 11:Global Industry Characteristics, Key Factors, New Entrants SWOT Analysis, Investment Feasibility Analysis.

Chapter 12:Market Conclusion of the Whole Report.

Chapter 13:Appendix Such as Methodology and Data Resources of This Research

....For Detailed InformationClick Here For Complete TOC

Why MarketResearch.Biz?

Robust research methodology of Gene Therapy market

Technically renowned study with overall Gene Therapy industry know-how

Focus on Gene Therapy drivers, restraints, opportunities, and threats till 2029

Based on complete research, we offer the clear view of real Gene Therapy market scenario and help clients with making an important business judgment

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Concise Report 2020: Gene Therapy Market Competitive Landscape and Industrial Growth| The Impact of COVID-19 Disruption During 2029 - News Distinct

Recommendation and review posted by Bethany Smith

The report titledGlobalGene TherapyMarketpresents a much-awaited study on the global market which summarizes the market in terms of definitions, applications, types, and leading key players/manufacturers ofGene Therapyindustry. The report comprises insights related to the present scenario of the market and the industry scenario over the forecast time-span from 2020 to 2025. The report reveals a comprehensive study on market dynamics including drivers, restraints and opportunities, recent trends, and industry performance analysis, and detailed value chain assessment. It features global and regional data and over top key players profiles, this report gives the guide to exploring opportunities in theGene Therapyindustry. The report is partitioned based on driving players, applications, and regions.

NOTE: This report takes into account the current and future impacts of COVID-19 on this industry and offers you an in-depth analysis of GlobalGene TherapyMarket.

DOWNLOAD FREE SAMPLE REPORT:https://www.fiormarkets.com/report-detail/376052/request-sample

About The Industry:

The previous, current market situation, and prospects of the market are examined. The comprehensive competitive analysis section includes detailed profiling of leading manufacturers operating in the global market. Highlights of the segmentation study covered in this report include price, revenue, sales, sales growth rate, and market share by product. It enfolds insightful analysis of competition intensity, segments, environment, and product innovations to provide deep comprehension of the completeGene Therapymarket environment. An extensive analysis of market-changing market trends, driving factors, growth potentials, investment opportunities, threats, and restraints has been given in the report.

Top companies profiled in this report include:Spark Therapeutics LLC, Bluebird Bio, UniQure N.V., Juno Therapeutics, GlaxoSmithKline, Chiesi Farmaceutici S.p.A., Bristol Myers Squibb, Celgene Corporation, Human Stem Cell Institute, Voyager Therapeutics, Shire Plc, Sangamo Biosciences, Dimension Therapeutics and others.

The report is a professional and comprehensive research report on the worlds major regional market conditions, focusing on the main regions:North America, Europe, Asia Pacific, South America, and the Middle East and Africa.

Moreover, the report is presented in an efficient way that involves basic terminology, a basic outline, agreements, and certain facts as per comprehension. Clients needs ensure a thorough understanding of market capacities. It provides market-driven results deriving feasibility studies for client needs. The report presents an overview of key marketing strategies and key sales channels adopted in the globalGene Therapymarket.

BROWSE COMPLETE REPORT AND TABLE OF CONTENTS:https://www.fiormarkets.com/report/global-gene-therapy-market-by-type-germline-gene-376052.html

Analysis of Key Aspects Covered In TheGene TherapyMarket Report:

Industry Scenario: Definitions, classifications, applications, and globalGene Therapymarket overview; product specifications; manufacturing processes; cost structures, raw materials

Key Market Dynamics: The report includes production strategies and methodologies, development platforms, and the product model. The latest market trends, development outlines, and research methodologies are provided for the projected period.

Competitive Landscape: The competitive analysis involves the market share of major players, along with the new projects and strategies adopted by players in the past five years. Comprehensive company profiles cover the product

Customization of the Report:This report can be customized to meet the clients requirements. Please connect with our sales team ([emailprotected]), who will ensure that you get a report that suits your needs.

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Global Gene Therapy Market Size to Expand Significantly by the End of 2025 - Cole of Duty

Recommendation and review posted by Bethany Smith

GUILDFORD, Conn., June 02, 2020 (GLOBE NEWSWIRE) -- InveniAI LLC, a global leader pioneering the application of artificial intelligence (AI) and machine learning (ML) to transform innovation across drug discovery and development, is pleased to announce a strategic partnership with TB Alliance, a non-profit organization dedicated to the discovery, development, and delivery of better, faster-acting and affordable tuberculosis (TB) drugs. TB Alliance will make use of InveniAIs AI and machine learning platform, AlphaMeld, to identify and accelerate transformative therapies for the management, treatment, and cure of TB, which remains the worlds top infectious disease killer.

TB is an infectious respiratory disease that seriously endangers health. Approximately one-quarter of the world's population is estimated to be infected with latent TB, of which 13 million are living in the United States. Globally, about 10 million people develop active TB each year and 1.5 million die from their disease. TB bacteria are becoming increasingly resistant to conventional six-month antibiotic treatments, with an estimated 500,000 people developing drug-resistant forms of TB each year.

Our mission is to develop and deliver new TB treatments that address the significant unmet needs that TB patients face today, said Nader Fotouhi, Ph.D., Chief Scientific Officer, TB Alliance. There has been growing interest in developing novel immunotherapeutic strategies that address drug-resistant TB as well as shorten the length of treatments, which can impose a significant burden on patients. Stimulating the immune system to help the body fight disease may provide a unique strategy to effectively treat patients with TB and drug-resistant TB. We are excited to deploy AI-powered technology as we strive to reshape the TB treatment landscape.

Immunomodulatory approaches have proven successful for treating many infectious diseases and have gained momentum for those diseases with an immune component such as oncology, neuro-inflammation, and immuno-metabolism, among others. There are several pathways, targets, and drugs that represent a fertile ground to apply AI and ML to create novel concepts efficiently, rapidly, and at scale. This important collaboration with the TB Alliance comes at an opportune time coinciding with significant success in the clinical development of assets delivered by AlphaMeld, said InveniAIs President and CEO, Krishnan Nandabalan, Ph.D.

About TB Alliance TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australias Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Cystic Fibrosis Foundation, European & Developing Countries Clinical Trials Partnership, Germanys Federal Ministry of Education and Research through KfW, Global Health Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Medical Research Council (United Kingdom), National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, Rockefeller Foundation, United Kingdom Department for International Development, and the United States Agency for International Development. For more information, visit https://www.tballiance.org.

About AlphaMeld AlphaMeld is an AI-based platform powered with machine learning algorithms. The platform accelerates innovation by identifying alpha signals for targets, drugs, and healthcare products and technologies. Primed with data sets that have been cleaned curated and connected for over a decade the platform generates testable hypotheses based on an ideal mode of pharmacotherapy (antibody, protein replacement, siRNA, mRNA, small molecule, cell and gene therapy, and gene-editing modalities), disease severity, gene ontology, disease pathways, proteinopathies, standard of care, emerging innovation, and enabling technologies while factoring in medical, scientific, strategic, and commercial considerations. AlphaMeld operates in real-time and in a rapidly changing and diverse data environment.

About InveniAIInveniAI LLC, based in Guilford, Conn., is a global leader pioneering the application of artificial intelligence (AI) and machine learning (ML) to transform innovation across drug discovery and development by identifying and accelerating transformative therapies for diseases with unmet medical needs. The company leverages AI and ML to harness petabytes of disparate data sets to recognize and unlock value for AI-based drug discovery and development. Numerous industry collaborations in Big Pharma, Specialty Pharma, Biotech, and Consumer Healthcare showcase the value of leveraging our technology to meld human experience and expertise with the power of machines to augment R&D decision-making across all major therapeutic areas. The company leverages the AlphaMeld platform to generate drug candidates for our industry partners and internal drug portfolio. For more information, visit http://www.inveniai.com.

Contact:Anita Ganjoo, Ph.D.CommunicationsInveniAIT: +1 203-273-8388aganjoo@inveniai.com

Thomas LynchCommunicationsTB AllianceT: +1 917-648-0671Thomas.lynch@tballiance.org

Original post:
InveniAI Announces Strategic Partnership with TB Alliance to Advance the Development of Transformative Therapies for Tuberculosis - GlobeNewswire

Recommendation and review posted by Bethany Smith

Other

In addition, the report categorizes product type and end uses as dynamic market segments that directly impact the growth potential and roadmap of the target market. The report highlights the core developments that are common to all regional hubs and their subsequent impact on the holistic growth path of the Gene Therapy market worldwide. Other valuable aspects of the report are the market development history, various marketing channels, supplier analysis, potential buyers and the analysis of the markets industrial chain.

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Table of Content

1 Introduction of Gene Therapy Market

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

2 Executive Summary

3 Research Methodology of Verified Market Research

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

4 Gene Therapy Market Outlook

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

5 Gene Therapy Market, By Deployment Model

5.1 Overview

6 Gene Therapy Market, By Solution

6.1 Overview

7 Gene Therapy Market, By Vertical

7.1 Overview

8 Gene Therapy Market, By Geography

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

9 Gene Therapy Market Competitive Landscape

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

10 Company Profiles

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

11 Appendix

11.1 Related Research

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Gene Therapy Market Research Report 2020: Key Players, Applications, Drivers, Trends and Forecast to 2026 - WaterCloud News

Recommendation and review posted by Bethany Smith

The report covers the forecast and analysis of the Cell and Gene Therapy Consumables market on a global and regional level. The study provides historical data from 2015 to 2018 along with a forecast from 2020 to 2027 based on revenue (USD Million). The study includes drivers and restraints of the Cell and Gene Therapy Consumables market along with the impact they have on the demand over the forecast period. Additionally, the report includes the study of opportunities available in the Cell and Gene Therapy Consumables market on a global level.

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In order to give the users of this report a comprehensive view of the Cell and Gene Therapy Consumables market, we have included a competitive landscape and an analysis of Porters Five Forces model for the market. The study encompasses a market attractiveness analysis, wherein all the segments are bench marked based on their market size, growth rate, and general attractiveness.

The report provides company market share analysis to give a broader overview of the key players in the market. In addition, the report also covers key strategic developments of the market including acquisitions & mergers, new service & product launches, agreements, partnerships, collaborations & joint ventures, research & development, and regional expansion of major participants involved in the market on a global and regional basis.

The study provides a decisive view of the Cell and Gene Therapy Consumables market by segmenting the market based on product type, application/therapeutics, and regions. All the segments have been analyzed based on present and future trends and the market is estimated from 2019 to 2027. The regional segmentation includes the current and forecast demand for North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

A rise in the awareness about the gene & cell therapies will propel the market growth during the period from 2020 to 2027. Nevertheless, conducting randomized control tests will inhibit the expansion of the market during the forecast timeline. However, the growing trend for treating neurodegenerative ailments through the use of gene treatment will proliferate the market growth over the forecast period.

The expansion of the market during the forecast timespan is owing to the high frequency of chronic ailments including cancer and heart disorders. Apart from this, inflation in the occurrence of these disorders produces lucrative demand for enhanced therapies and this will culminate in the market demand over the forecast time span.

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Based on the product type, the market is sectored into Kits & Buffers, Diagnostic Assay, Culture Medium, and Cryopreservation Media. Application/ Therapeutics- wise, the market for cell and gene therapy consumables are classified into Cardiovascular, Urology, Dermatology, Critical Care, Respiratory, Endocrine & Metabolic, Neuroscience, Hematology & Oncology, Obstetrics, Immunology, and Gastroenterology.

Some of the key players in the market include Amgen Inc., ATLANTA BIOLOGICALS, bluebird bio, Inc., Cook, Dendreon Pharmaceuticals, LLC, Fibrocell Science, Inc., General Electric, Kolon TissueGene, Inc., Orchard Therapeutics plc., Pfizer, Inc., PromoCell GmbH, RENOVA THERAPEUTICS, Sibiono GeneTech Co. Ltd., Spark Therapeutics, Inc., Vericel, Helixmith Co., Ltd., and Vitrolife.

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Cell And Gene Therapy Consumables Market Size, Share And Top Key Players During 2020-2027 - WaterCloud News

Recommendation and review posted by Bethany Smith

This intensive research presentation on the given Biopreservation market is well crafted by various research experts with ample investments in both primary and secondary research methodologies, to specifically incur substantial information on the discussed Biopreservation market forecasts that tangibly have a lingering influence on strategic business discretion and investment planning.

Top Leading Key Players are:

LabVantage Solutions, Thermo-Fischer Scientific, Custom Biogenic Systems, Biomatrica, Qiagen and more.

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The report also sheds decisive light on other core aspects such as sales channel management, distribution network, cost valuation and consumer preferences. This intensive research presentation on Biopreservation market through this analytical survey on is poised to offer report readers with ample competitive edge to fabricate revenue specific market decisions. This report on the discussed Biopreservation market also sheds critical understanding on the historical growth trail, mediated by several market components that collectively influenced the uncompromised growth trail. Report analysts and research experts in have vividly documented a thorough analytical review of market beginning with appropriate details about market definition, overview, opportunity assessment and the like, later succeeding with decisive understanding on market segmentation encompassing primarily on all the growth propellants in the Biopreservation market.

Decisive input on competition intelligence, internationally acknowledged analytical tools such as SWOT analysis, PESTEL analysis as well PORTERs Five Point analysis have all been critically analyzed in this decisive report to logically decipher competition intensity, opportunity assessment as well as barrier analysis, duly brainstormed by market analysts in their comprehensive report on the Biopreservation market.

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Global Biopreservation market is segmented based by type, application and region.

Based on Type, the market has been segmented into:

By Cell Provider Outlook, market is segmented into:

Tumor cellshESCiPSCMSCCD19+CD34+Others

Based on application, the market has been segmented into:

By Application, market is segmented into:

Drug discoveryBio-bankingVeterinary IVFHuman spermHuman eggsRegenerative medicineGene therapyCell therapyOthersBy Product Outlook, market is segmented into:

Laboratory information management systemMediaEquipment.

The report highlights various factors and reasons that collectively influence the psyche of market participants and stakeholders and their collective comprehension about the need and requirement of Biopreservation market offerings available indiscretion for a wide variety of services and solutions that have a tangible and durable impact on consumer buying preferences and eventual buying behavior.

A birds eye view analytical approach has been primary to gauge decisive market trends in the discussed Biopreservation market, citing specific input on essential factors such as overall household income and the core factors that mediate reliance on the aforementioned Biopreservation market. This contemporary research presentation and detailed market research synopsis on the Biopreservation market is a real time presentation of all the specific market developments that have a lingering impact on current growth trajectory, besides also harping on vital predictions in the realm of future growth scope.

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Biopreservation Market Analysis 2020 by Technologies, Production, Rising Demand, Industry Share, End-User and Company Profiling till 2025 - Cole of...

Recommendation and review posted by Bethany Smith

As Benchmarks shrimp facility in Florida begins to gear up towards commercial production, Oscar Hennig, operations director of Benchmark Genetics shrimp-breeding programme who has been in the shrimp sector for nearly 30 years explains to The Fish Site what he hopes to achieve.

Benchmark Genetics

Ive been involved in the sector since 1991, starting off on farms in Australia. After finishing my masters in aquaculture in Florianpolis [in southern Brazil] I received a scholarship from the government of Japan for a two-year research project with shrimp immunology at the Shimonoseki National Fisheries University. From there I returned to Brazil for two years running a diagnostics lab for shrimp at the LABOMAR research institute. In the meantime, to make ends meet, I leased a growout farm. P. vannamei [whiteleg shrimp] farming was just starting in north-east Brazil and there was the need for expertise to help the transition from P. subtilis [southern brown shrimp].

At the end of 1999 I moved permanently to Hawaii, to manage a satellite facility of the Oceanic Institute, in Kona. I have been in Kona ever since, working as breeding-programme manager for different companies, with P. monodon [giant tiger prawn], P. stylirostris [blue shrimp] and mainly P. vannamei.

At the end of 2016 I was hired as a director for Benchmark Genetics, after Benchmark had bought CENIACUA, a P. vannamei breeding programme in Colombia. My role has been to bring this to the international arena.

Oscar Hennig

I was impressed by the CENIACUA facility, and the crew running it, in Cartagena we had as much space as we wanted and as many people as we needed, as the jobs were in the local community.

However, Cartagena doesnt have great logistics and we realised that we need a base in the US to improve our ability to export our stocks.

[The Central Florida town of] Fellsmere was suitable for a number of reasons, not least for being close to three international airports. It is also 30km from the coast, which helps with our biosecurity and also to protect us from the hurricanes that can devastate the Florida coast.

Back in 2017, when we selected the site, my only concern was that we were sourcing water from a well this can impact the fertilisation ratio but weve managed to produce steady numbers of nauplii.

Benchmark Genetics

The water comes from 750m deep, and the well brings a sterile (zero dissolved oxygen), ~32 ppt saline water that is second to none. Due to the inland location, discharging water is a challenge, so all our systems work on recirculation or on biofloc.

All activities are conducted indoors from maturation, to algae, to grow-out, to packing so the biosecurity is excellent.

Im proud of how its turned out and Im really happy with the team weve created. There are currently 15 people involved and theres plenty of space to expand. At the moment were operating at about one fifth of our capacity, as were conducting presale trials, in order to fine tune the lines of shrimp that are needed in our main markets China, Vietnam, Indonesia and Thailand and these are now being tested in a commercial environment.

Most shrimp producers only offer one product but there are so many production systems used by the global shrimp industry and we saw that one size does not fit all. As a result, we decided to cater for a range of options and have launched three lines commercially.

The first, which weve been developing since 2008, is resistant to whitespot, EMS and other diseases. Called BMK Protect this is mainly for customers in northern China, and other areas facing disease challenges. It shows its true potential in harsh/disease conditions.

The second line was bred specifically to improve performance in sites with low salinity: shrimp farming is becoming increasingly popular in water thats less than 5 ppt. It now accounts for roughly 60 percent of Indian shrimp production, 50 percent in China, 15 percent in Vietnam and 15 to 20 percent in Thailand.

The third line, called BMK Yield, balances growth rates with survival to ensure steady production. It produces a consistent yield and a high rate of survival, making it ideal for farms that are working with processing plants, as it allows the farmer to provide a steady supply of raw material.

Benchmark Genetics

At this moment we are using some of that capacity to produce PLs for farmers, in the US and abroad. The PPL will go to our partners multiplication centres worldwide. China has been the main market during this presale year, and BMK Protect has been the number one line. The other two are doing well in the presale, but their evaluation still ongoing.

Breeding without ablation is not a big deal for us; it takes more planning and a few adjustments but nothing major. It is not done at the commercial hatcheries [as opposed to broodstock production facilities] due to a ~30 percent reduction in nauplii production. This reduction off nauplii output is mainly due to the lower frequency of female spawning, not due to lower levels of nauplii per spawn.

We believe that PL produced by non-ablated females are stronger. We ran some trials to support this belief and found that the eggs were bigger in non-ablated females, which makes sense as they have more time to go through the maturation process. We have other trials in mind that we will pursue once we get back to a normal routine.

Consolidation of the industry at different levels and partnership with local companies. I see the industry moving in two extreme directions: high-density, enclosed, biosecure farming systems and extensive open ponds, with not much left in the middle.

There was a small decline in sales during February and it has been hard to get cargo space and to predict when flights would go logistics have been crazy and transport prices also increased. However, I am optimistic that, once Covid-19 is a thing of the past, people will be wanting to celebrate life and demand for shrimp will increase beyond levels prior to this pandemic. As a result, our plan to expand is still in place.

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A new Benchmark in shrimp production - The Fish Site

Recommendation and review posted by Bethany Smith

Mller pulled up a series of graphs and charts on her laptop. These showed that, per capita, Iceland had had more COVID-19 cases than any other Scandinavian country, and more than even Italy or Britain. There was an outbreak in a nursing home in the town of Bolungarvk, in northwestern Iceland, and one in the Westman Islands, an archipelago off the southern coast, which seemed to have started at a handball game. (In Europe, handball is a team sport thats sort of a cross between basketball and soccer.)

The numbers in the beginning were terrible, Mller said. She attributed the countrys success in bringing the caseload down in part to having got an early start. The trio, along with officials from Icelands university hospital, had begun meeting back in January. We saw what was going on in China, she recalled. We saw the pictures of people lying dead in emergency departments, even on the street. So it was obvious that something terrible was happening. And, of course, we didnt know if it would spread to other countries. But we didnt dare take the chance. So we started preparing. For example, it was discovered that the country didnt have enough protective gear for its health-care workers, so hospital officials immediately set about buying more.

Meanwhile, Mller began assembling a backup team. You know, everybody knows everyone in Iceland, she said. And so I rang up the president of the Icelandic Medical Association and the head of the nurses association. Doctors who had recently retired, nurses who had gone on to other jobsall were urged to sign up. When new cases started to be diagnosed in a great rush, the backup team, along with doctors whose offices had been shut by the pandemic, counselled people over the phone. If you were seventy, if you had high blood pressure, you got called every day, Mller told me. But, if you were young and healthy, maybe twice a week. And Im sure that this led to fewer hospital admittances and even to fewer intensive-care admittances.

This, in turn, appears to have cut down on fatalities. Icelands death rate from COVID-19 is one out of every one hundred and eighty confirmed cases, or just 0.56 per centone of the lowest in the world. The figure is so low that it raised some doubts. Mllers department decided to look into how many Icelanders had perished for any reason since the outbreak began. It turned out that over-all mortality in Iceland had actually gone down since the coronavirus had arrived.

I asked Mller about masks. In Massachusetts, an executive order issued by the governor requires that masks be worn by anyone entering a store, taking a cab, or using public transit, and violators can be fined up to three hundred dollars. In Iceland, masks arent even part of the public conversation. Mller said that wearing one might be advisable for a person who is sick and coughing, but that person shouldnt be walking around in public anyway. We think they dont add much and they can give a false sense of security, she said. Also, masks work for some time, and then they get wet, and they dont work anymore.

Mller was careful not to suggest that Iceland had beaten the virus. She seemed almost embarrassed by the idea of claiming credit for herself, for the trio, or for Iceland. The furthest she would go, when pressed, was to say, We are a nation thats used to catastrophes. We deal with avalanches, earthquakes, eruptions, and so on. Among the slides she showed me about the countrys experience with COVID was one labelled Success?

Iceland was one of the last (more or less) habitable places on earth to be settled by humans, sometime toward the end of the ninth century. Genetic analysis performed by deCODE shows that the islands original inhabitants were mainly men from Norway and women from the British Isles. (It seems likely that the women were seized by the Vikings and brought along by force.)

For centuries, hardly anyone from anywhere else bothered to travel to Iceland; it just didnt seem worth the effort. Isolation, combined with low population density, tended to keep out epidemicsthe island was, for example, spared the Black Death. But, when disease did slip in, the effects on a population that lacked immunity could be devastating. In 1707, an Icelander contracted smallpox during a trip to Copenhagen. He died on his way home and was buried at sea. His clothes continued on to the town of Eyrarbakki, on the islands southern coast, sparking an outbreak that, by 1709, had killed about a quarter of the country.

Today, Iceland is still far from anywhere. Its nearest neighbor, Greenland, is mostly ice, and the capital city of Nuuk is almost nine hundred miles away. But jets and cruise ships have turned Reykjavk into a bucket-list destination; last year, almost two million foreign tourists visited, four times the number that visited just a decade ago. Icelands first COVID casualty was, perhaps not surprisingly, a vacationer. The man, whose name was not released, was Australian. He died on March 16th, shortly after arriving at a medical clinic in Hsavk, a small town on the northern coast known for whale-watching. His widow, who also tested positive, was ordered into isolation, a development that prompted an outpouring of sympathy from Icelanders. A woman named Rakel Jnsdttir set up a Facebook group, With Love from Us, so that people could post messages to her; more than ten thousand people joined. You may not see us, you may not know us, but we all think of you and have you in our hearts, Jnsdttir wrote.

Icelanders, too, are big travellers: in 2018, more than eighty per cent of them vacationed abroad. I spoke to several people in Reykjavk whod brought the virus home from overseas. One was Brkur Arnarson, an art dealer. I went to speak to him at his gallery, i8, which was closed to the public at the time. (Rule 4b: Only those being interviewed should have direct interaction with the journalist.)

Arnarson, who represents, among others, the Danish-Icelandic artist Olafur Eliasson, had been in New York, attending the Armory Show, at the beginning of March. After the show ended, hed gone to a crowded party where finger food was served. Im not a news guy, he told me. But I knew what was going on here in Iceland, and I knew what was going on in Europe. And I was struck by how New Yorkers were so confident. They didnt believe it was going to happen, or, if it was going to happen, somehow it was going to be O.K.

Arnarson started to feel crappy almost as soon as he got home. His daughter signed the family up for COVID tests that were being offered by deCODE; when his came back positive, Arnarson went into isolation in a studio loaned to him by an artist friend. Every day, someone on the team of nurses and doctors phoned him. They asked, How are you doing? What are your symptoms? Are you getting all the help you need? he recalled. And that was really amazing. It was so comforting, knowing that they were doing this. He was given a number to call in case of an emergency: I dont think they were getting many calls, because they were so proactive. While he was in isolation, his wife and his daughter, whod originally tested negative for the virus, came down with it. They received the same treatment. None of them ended up going to the hospital or to a clinic.

Visit link:
How Iceland Beat the Coronavirus - The New Yorker

Recommendation and review posted by Bethany Smith

Article body copy

For almost five decades, biologist Jim Darling has studied the gray whales that regularly return to forage in the waters off the west coast of Canada instead of completing the lengthy migration undertaken by the main herd.

Approximately 27,000 eastern North Pacific gray whales make a monumental annual trek from breeding and calving lagoons along Mexicos Baja California peninsula to summer feeding grounds in the Bering, Beaufort, and Chukchi Seas. The northward migration lasts from February until May. Then, in October, the whales, led by pregnant females, leave the Arctic feeding grounds and again travel up to 11,000 kilometers to return to the warm lagoons of Baja.

However, about 250 animals opt to skip the full migration and spend from spring until fall feeding along the coast from Northern California to southeast Alaska.

Darling has watched generations of whales visit the coastal feeding grounds where they follow prey into areas such as Clayoquot Sound on the west coast of Vancouver Island, British Columbia. Depending on prey availability, other whales will spend extended residencies in Neah Bay or Puget Sound in Washington State, or in the waters off the California-Oregon border, among other feeding grounds.

Eastern North Pacific gray whales spend their winters in the warm calving lagoons of Baja California, Mexico, where they give birth and breed. They migrate to the food-rich waters of the Arctic for summer feeding. Some whales do not complete the full migration and stop to feed in places along the route, such as Clayoquot Sound, British Columbia. Map by Mark Garrison

Some animals visit for only one season, but many reappear annually, and mothers that have themselves grown up feeding along the coast bring their calves to the same locations, apparently instilling memories of the local ecosystem.

The calves return for years, and possibly all their lives, to the location their mother brought them when they were very young and where they were weaned, Darling says.

The calves are weaned in midsummer and then left alone, often hanging out with other calves for the rest of the summer and fall. While some are assumed to join the southward migration of the main herd as it passes Clayoquot Sound in December, others stay through the winter.

Mature females are key to the tendency to stay in coastal feeding areas because they are the ones that have the experience finding prey. That information is passed down to their offspring, says Darling, who, assisted by a photo-identification program, can identify many of the seasonally resident whales.

He recognizes Saddle, a male who was in Clayoquot Sound when Darlings study began in the 1970s; Blackjack, a female who has visited the area for 45 years; Elvis, a female who has had three calves since 1993; and Collage, a grandmother, first recorded in 1975, whose daughter and grand-calf also sometimes return to the sound.

A gray whale called Saddle is a longtime summer resident of Clayoquot Sound. Researcher Jim Darling has photographed the whale in Clayoquot Sound 20 times between 1974 and 2019. Individual whales can be identified by the distinct markings on their backs. Photo by Jim Darling

This is a community of whales. They know each other, in some cases for decades. They know how to sustain themselves herethis is their home. They are not just a random aggregation of whales that dont happen to migrate all the way north, Darling says.

A cross-border controversy is brewing that could put some of the whales that break off from the main migration, identified as the Pacific Coast Feeding Group (PCFG), directly in the harpoon sights of the Makah Tribe, based in Neah Bay, who have applied to hunt up to 25 whales over 10 years. (The Makah is the only tribe in the United States with an explicit treaty right to hunt whales. They legally killed one whale in 1999 and illegally killed another in 2007.) The proposal for the renewed hunt is being supported by the US National Marine Fisheries Service (NMFS), a branch of the National Oceanic and Atmospheric Administration (NOAA), which has asked an administrative law judge for a waiver to the Marine Mammal Protection Actlegislation that protects marine mammals in US waters from lethal activities.

Hearings into the waiver application, held in late 2019, wrapped up after NMFS, the Makah, and groups opposing the hunt presented evidence. The public comment period closed March 16, and the next step is for the judge to make a recommendation on whether the hunt should go ahead.

The Makah, and their close relatives the Nuu-chah-nulth people of Vancouver Island, British Columbia, have a long and rich tradition of whaling for subsistence and cultural purposes. The hunt persisted into the early 20th century as this photo from 1910 attests. Photo by Book Worm/Alamy Stock Photo

But while the United States is considering whether to allow the hunt, in Canada, the Committee on the Status of Endangered Wildlife in Canada (COSEWIC) recommended to the environment minister in October 2018 that the PCFG should be designated as endangered under the Species at Risk Act (SARA).

Fisheries and Oceans Canada (DFO) will ask for feedback on listing the whales later this year. If the recommendation to classify them as endangered is accepted, the population and their critical habitats will receive additional protection, and a recovery strategy will be put into action, says DFO communications advisor Lara Sloan.

That would mean that if the Makah hunt is approved in the United States, the very whales that are protected in Canada could be hunted just across the border.

Differences in how to treat the whales center on data interpretationwhether the whales should be regarded as a separate stock, which would give them extra protection, or be included with the overall eastern North Pacific gray whale population. US scientists view the PCFG as an aggregation rather than a stock, so deem a separate management plan unnecessary.

A successful hunt, taking the maximum allowable whales, would reduce the eastern North Pacific gray whale population by only about 0.009 percent a year, said Chris Yates, NMFS assistant regional administrator for protected resources, in a declaration to the hearings.

However, critics say that whether the PCFG is considered an aggregation or a unique stock, killing one whale out of 250 would have a significant effect.

The most faithful whales to our area will be the most punished, said Margaret Owens of the Peninsula Citizens for the Protection of Whales in a rebuttal to Yatess declaration.

Gray whales that take up summer residence in coastal areas go to where there is available food, including crustaceans such as mysids, crab larvae, amphipods, and ghost shrimp. Gray whales are also known to scoop up bottom sediments to gather food as this whale is doing in the shallow water of Grice Bay in Clayoquot Sound. Photo by Flip Nicklin/Minden Pictures

Darling and Timothy Frasier, an associate professor of biology at Saint Marys University in Halifax, Nova Scotia, conducted key research on the PCFG that helped convince COSEWIC to make the endangered status recommendation. Darling and Frasier have no doubt that the PCFG is a distinct group that acts differently from the main population and shows genetic differences, so should be managed separately.

More than a decade ago, Darling and Frasier began to investigate the genetics of these whales that seemed to show an affinity for the west coast of Vancouver Island. The pair published two research papers, in 2011 and 2013, which found that the whales using the coastal feeding areas possessed a unique genetic signature in their mitochondrial DNA.

Mitochondrial DNA is inherited from the mother and nuclear DNA is inherited from both parents. Although the PCFG whales are known to mix and mate with the main population, as is evident in their nuclear DNA, their preference for returning to coastal feeding areas is a behavior that shows up in their mitochondrial DNA signature, Frasier explains.

The mitochondrial DNA in the PCFG represent whales who learned about this feeding area, instead of the Arctic, from their mothers and then passed that along to their offspring generation after generation, Frasier says. [It] reflects the maternally-based knowledge transfer of migratory routes and feeding ground locations.

NMFS, however, has chosen to base its decision on mitochondrial and nuclear DNA from all whales using these coastal feeding areasincluding those that stay for only one seasoninstead of looking exclusively at whales that regularly return.

If you lump them all together and take all the whales that have ever been seen in the PCFG area and compare them to the rest of the population, that [mitochondrial DNA] signal gets diluted because youre including a lot of individuals that dont really qualify, Frasier says. Then, of course, you are going to come to different conclusions.

After Darling and Frasier completed their initial research, it was presented at a 2010 International Whaling Commission meeting. NMFS then did its own study, which yielded similar results. The matter of how to treat the PCFG seemed to be settledto the point that it brought a 2012 NMFS assessment of the impact of a Makah hunt to a halt.

A gray whale cow and her calf feed near the kelp in Clayoquot Sound. Photo by Jim Darling

Darling is baffled that, after accepting the research a few years ago, NMFS is now questioning the extent of the genetic and behavioral differences.

I really do not understand itit is so inexplicable if you are just looking at the biology, he says.

Current NMFS views are based on a report from a 2012 task force and agency-only workshop, convened to review North Pacific gray whale data. Workshop participants looked at all whales using the coastal feeding areas, including those temporarily recruited from outside the PCFG, and concluded there was insufficient evidence to classify the group as a separate stock, and that research should continue.

Donna Wieting, director of NOAAs Office of Protected Resources, cites the report in a 2018 letter to the Pacific Scientific Review Group (which advises NOAA on the status of marine mammals) saying, there remains a substantial level of uncertainty in the strength of the lines of evidence supporting demographic independence of the PCFG.

That view was echoed at the 2019 hearings on the renewed Makah hunt by NMFS wildlife research biologist David Weller.

He noted in a submission that when samples from PCFG whales were compared with whales sampled in one of the Mexican wintering lagoons, the 2012 task force found small but significant differences in mitochondrial DNA (inherited from the mother), but no significant differences in analyses of the nuclear DNA (inherited from both parents).

Calves likely follow their mothers to feeding areas and to some extent they return to those feeding areas in subsequent years. There was no evidence, however, that whales that frequent one feeding area are reproductively isolated from whales that frequent other feeding areas, Weller wrote in his declaration.

Other scientists are questioning how the decision was made and want to see a wider-ranging discussion.

Research biologist John Calambokidis, founder of Cascadia Research Collective, based in Olympia, Washington, has conducted extensive research on eastern North Pacific gray whales.

For management purposes, I absolutely do think [the PCFG] warrants treatment as a distinct group, based on both the photo ID information and the genetic data that has come out of two different studies, he says.

A gray whale spyhops in the waters of Clayoquot Sound. Photo by Flip Nicklin/Minden Pictures

Calambokidis questions the task forceworkshop method of deciding the status of the PCFG and the conclusion that, as there was insufficient evidence, further research was required.

I think NMFS should reconsider their status on the PCFG, especially because the workshop was inconclusive and there is now more information, he says. Hed also like to see the decision revisited by a wider group of scientists.

D. J. Schubert, a wildlife biologist with the Animal Welfare Institute, a nonprofit organization in Washington, DC, that is presenting at the hearings, believes the separate stock argument is compelling, and he also wants to see NMFS call another meeting of scientists to look at the evidence.

But they shouldnt limit it to just their scientists; they need to invite outside scientists who do most of the research on these whales, he says.

Oddly, although NMFS does not consider the PCFG whales a separate stock, in an apparent concession to documented differences, it has proposed restrictions to protect the group and a small population of western North Pacific gray whales if the hunt goes ahead. (Some of the western population, a group once considered extinct, were recently tagged and found in areas used by eastern North Pacific gray whales.)

Over a 10-year time frame, for instance, no more than 16 hunting strikes could be on PCFG whales, with a limit of eight strikes on females, and the hunt would be stopped if the number of PCFG whales falls below 192 animals.

In even-numbered years, the hunt would take place during the migration season, reducing the risk to PCFG whales, as the entire herd of 27,000 animals would be passing through the area. In odd-numbered years, the hunt would be held during the summer feeding season to reduce the risk to western North Pacific whales. But, inevitably, that timing would increase the risk of striking any PCFG whales feeding in the area.

To say they will hunt in the summer is absurd. That means the only whales that are present are the small population of local animals, which [COSEWIC] say are endangered, Darling says.

If the hunt is approved, in the heat of the moment it will be largely impossible to differentiate between a PCFG whale and the rest of the herd before shooting, says Frasier.

A theoretical option is to have someone who knows the whales out there and say, Thats not one of our residents, but, to me, thats not really workable, he says.

So far, DFO has not been part of the debate on the status of the PCFG, but that is likely to change if the government approves the SARA designation after public consultations that could be held this fall.

If the recommendations are accepted, then DFO will automatically receive the mandate to provide science advice on these units, including the designation of critical habitat, says Thomas Doniol-Valcroze, head of DFOs cetacean research program.

Adding to the uncertainty over the status and classification of the whales is that the entire eastern North Pacific gray whale population is undergoing an unusual mortality event (UME) with 326 gray whales found dead along the coast from Mexico to Alaska in 2019 and up to May 12, 2020. Scientists estimate that the carcasses found probably represent only between 3.9 and 13 percent of the whales that have died.

Although the current UME is not over, NMFS points to the populations recovery after a 19992000 UME that killed up to one-quarter of the eastern North Pacific gray whales as evidence of their resilience. This is despite the fact that the cause of the previous UME was undetermined.

The cause of the current UME is similarly unclear. Although some whales have shown evidence of emaciation, findings are not consistent, according to NOAA, which is assembling a team of scientists to review data and determine the next step. Climate change, a lack of adequate food in the Arctic, and a theory that the gray whale population has reached carrying capacitythe maximum number of animals for its habitatare among the considerations.

While the scientists wrangle over the outstanding questions of how to classify and manage the gray whales, and how and whether to insert the current UME into the equation, other groups question the revived Makah hunta right granted the nation in 1855on the grounds of animal rights or other more philosophical concerns.

For Darling, though, the focus should remain on science, not politics. This is not about whether whaling should occur, he says, its about getting the biology correct so the impacts and consequences of a hunt and other activities that affect the population are clearly understood.

NMFS is currently preparing a supplemental environmental impact statement. If the recommendation from the judge is for the hunt to proceed, the decision will then go to the NMFS assistant administrator, followed by a 20-day public comment period.

If the hunt is given the go-ahead by the assistant administrator, regulations will be finalized and discussions held with the Makah on the particulars of the hunt.

Whichever way the decision goes, the battle is unlikely to be over, as litigation will probably follow, says Schubert.

The gray whales are currently on their northward migration, and as they make their way up the west coast of North America, they face the uncertainties of a changing ocean. Scientists are also watching to see whether the number of mystery deaths will increase.

This year, the whales will not have to contend with Makah harpoons and rifles off Neah Bay, but there is no guarantee that the hunt wont become another hazard they face during future migrations.

Continued here:
Protected on One Side of the Border, Hunted on the Other - Hakai Magazine

Recommendation and review posted by Bethany Smith

I tie on my shoes every morning. Socks on first, toes pressed into the arch and then inched into the toe box. My heel finds itself at home in the back of my shoe, not through guidance but out of routine, and we are out the door for a run.

I am grateful that my feet dont fight against me the way my mind does. The last month has been a constant tug of war between numbing myself to the reality of another black person being killed for no discernible reason and letting it become all-consuming.

It feels like weve all become experts on crisis. Adjusting to our new reality, we are stretching our imaginations and getting creative with how we work, eat, live, and communicate during the age of the coronavirus.

But how does one begin to understand an epidemic of violence aimed at victims like George Floyd, Breonna Taylor, and Sean Reed? Before them, Eric Garner and Tamir Rice? And the story that has hit closest to home, Ahmaud Arbery? When police found his body, he was lying in the middle of the street, which was exactly where he was confronted, shot, and killed three months ago by Gregory and Travis McMichael for jogging.

I watched the video of Ahmaud being hunted and gunned down in Georgia, and I immediately regretted visiting the footage.

In running I find there is purposeful pain. I have learned to stretch the limits of discomfort to unlock my potential. Weekly two-hour long runs, grueling tempo sessions on the track, and intense speedwork will teach your body how to make sense of deep physical discomfort. I know pain. But watching that video was one of the most horrific, violent, and painful things Ive ever seen.

His murder took place in February and is only being revisited through our justice system and on social platforms because of video evidence. The same is true of George Floyd. The dehumanization of black and brown bodies seems to matter only when we are forced to look at these types of graphic episodes.

The limited scope of where, and how black people can exist, can have deadly consequences. Its often that individuals dont recognize black people out of place from where they expect to see us. Ahmaud, who, just as many Americans are now doing in the face of COVID-19, turned to running as a way to move through uncertainty. His crime? Occupying space his killers felt was not his within which to exist.

The misinterpretation and characterization of black peoples experiences is something I know well. When I was in high school, a parent approached my coach to inquire whether my mom was white. She had seen my dad at meets to confirm he is black, but the woman was searching for something to explain my discipline and focus. In her world, blackness didnt equate to those characteristics, and it certainly didnt add up to running cross country.

People frequently ask me why I, a distance runner, went to college at the University of Texas. I had the pedigree in high school to go to a powerhouse distance program, but I chose Texas. What was my reasoning behind attending a sprint specialty school as a distance runner?

Cortney White

I was looking for an opportunity to be in a more diverse and more inclusive environment. I was at an age, and time in my life, where I was seeking growth, and you do that by having a variety of people and experiences you are exposed to.

I didnt want to deal any longer with microaggressions of well-meaning friends reminding me that classmates were only asking me out not because I was desirable, but because they were curious about what a black girl would be like or teachers looking to me to give the black perspective on Huckleberry Finn. When I went to visit Texas, I saw the possibility of having a black roommate, a black female head coach, and a community where it wouldnt be a struggle to maintain a sense of self and identity, because I saw myself reflected in my peers.

I felt angry with myself that day for pressing play on the video showing Ahmaud Arberys murder. I knew before I opened that browser that his killers didnt really see him on that February afternoon. Just like that parent who asked if my mom was white never really saw me during my race. Sustained, preconceived notions of people distort authentic narratives. The human experience is vast, and racism cuts our stories short.

I keep hearing COVID-19 referred to as the great equalizer. There is this idea that we are all experiencing tragedy together, that this vortex our lives have suddenly been encapsulated in has funneled out inequalities.

But when I see Ahmauds mother on TV grieving her son, or when I read the staggering data of how COVID-19 has disproportionately affected black communities because of underlying health issues as a manifestation of genetics or poverty, I come to realize there are parts of this country that will never open back up to some Americansbecause they were never open to them to begin with.

Here is my reality: Im going running tomorrow. Im not afraid to go running, but it feels inconceivable that I even have to think about it. Its even more frightening that there will be people who dont run tomorrow. Who will tell their kids not to run tomorrow, or whose families will sit at home wondering if their loved ones will return home.

Its time to acknowledge that the running community, which has long been heralded as one of the most accessible, most inclusive communities, does not exclude itself from the impact that issues of intolerance and bigotry create in this country.

Sean RayfordGetty Images

As a professional runner, I make a living being singularly focused. I spend months at a time sequestered in the mountains at altitude training camps in order to be performance-ready. These deaths like Ahmauds, however, shock the system.

They bring us back from our individual realities and demand a collective response. I find it difficult to look at these tragedies as isolated incidents. You cannot overlook the structural breakdowns in our society that allow for a young man to be murdered in broad daylight, individuals instigating police action on innocent people, harassment in parks, targeted social distance stops, and leadership that calls exhausted and enraged protesters thugs because they are trying to navigate and stand up against police brutality after years of justice being demanded and denied. Moving forward means truly lamenting.

But expressing grief is hard when you are navigating two realities. I often feel compelled to maintain a certain demeanor as to not alienate myself. If I talk about whats going on, I cant be too angry. I dont want to offend anyone, or be overbearing with my opinions. I am on high alert to be disappointed, and above all discouraged, that human lives are being minimized to hashtags. It is frightening to see all the names and deaths that have been recorded, and even more unsettling to know that there are many more that have gone on unreported.

Im sad, Im righteously angry, and to be honest, Im exhausted. Ahmaud Arbery, Breonna Taylor, Sean Reed, and now George Floyd weigh heavily in my mind. Every day we are waking up to headlines that remind us of how fragile and undervalued black lives seem to be.

If we want our running community to be a force for change, and not a reflection of the biases that our nation endures, we have to be willing to consistently have a sustained conversation that will effect change and is capable of asking questions without immediate answers or solutions.

I hear people laughing about the inconveniences of having socially distant parties, and it feels forced to join in that laughter. All around me, I hear small talk about whether the lockdown was worthwhile, and guilt consumes me for taking part in those conversations.

I hear this chatter and all I can really think about is how sad it is that in Chicago, black people are 70 percent of COVID-19 deaths but make up only 30 percent of the population.

These patterns are appearing all over the U.S., yet this tragedy is often mocked or said to be blown out of proportion because of our refusal to really see and acknowledge the people it affects most.

Perceiving my body as a target for violence or fearing for my life during exercise may not be my exact experience. I do know, however, what its like to be viewed, but not really seen. To view Ahmaud was to see him as a criminal running away from something, because thats what black bodies do. To see him is to know that among many things, he was a son, a student, an athlete, and a friend.

His name is Ahmaud Arbery, his murder was no mistake, and he should be alive today. His execution could send a message that black Americans cant exercise, even when that exact action could help combat structural inequalities black Americans endureliving in food deserts and parts of the country with poor air quality, or lacking health insurance.

Ahmauds story is not a singular event. If we want our running community to be a force for change, and not a reflection of the biases that our nation endures, we have to be willing to consistently have a sustained conversation that will effect change and is capable of asking questions without immediate answers or solutions.

I dont know how you unlearn the type of hate that threatens black life. I do know that the work needs to happen everywhere, not just in individual communities in Georgia, Minneapolis, New York, or Louisville.

The ripple effects of racism that lead to the violence we are witnessing are likely to be appearing in our schools, workplaces, and communities. Who is in our running groups? Who do we follow on Instagram? What books are we reading, shows are we watching, or podcasts are we listening to? Do they feature stories with people of color? I believe challenging ourselves to have relationships and interactions that are diverse, transparent, and open to authentic dialogue can effect meaningful change.

Fighting racial injustice in America is an endurance sport. It is going to take time, and sustained focus, to galvanize our communities. Being tired is not enough. The race can be won, but it requires dutiful action from all of us.

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Marielle Hall - Racing to Stay Alive as a Black Runner - runnersworld.com

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The skeleton of a Central Asian women found at the bottom of a well after a violent death in an ancient city in Turkey is helping scientists understand population movements during a crucial juncture in human history.

Dubbed the Lady in the Well, her bones are found among 110 skeletal remains of people found at different site who lived in a region of blossoming civilization running from Turkey through Iran between 7,500 and 3,000 years ago.

After analyzing genome-wide data of the remains, the team discovered that populationsacross Anatolia, which is modern-day Turkey, and the Southern Caucasus, which roughly corresponds to modern Georgia, Armenia, and Azerbaijan, began to genetically mix some 8,500 years ago, resulting in a distinct admixture that gradually spread across the entire region.

However, the Lady in the Well showed evidence of long-distance migrations on an individual level during the late Bronze Age about 4,000 years ago, as either she or her ancestors traveled from Central Asia to the Mediterranean Coast.

The study was conducted by a team of international scientists in Europe, Asia and North America, led by the Department of Archaeogenetics at the Max Planck Institute for the Science of Human History.

The team analyzed the skeletal remains of 110 people unearthed in archaeological sites in in Anatolia, Northern Levant, and the Southern Caucasus, which revealed two influential genetic events.

Populations in Anatolia and the Southern Caucasus began to genetically mix some 8,5000 years ago.

This event led the introduction of new genetic lineages into the population that slowly began to spread across the entire nation.

This gradual change, which experts call cline in genetics, was observed a millennia laterin Anatolian populations that spanned from Central-North to Eastern Anatolia.

Rather than indicating stationary populations, as apparent genetic continuity often does, the authors argue the spread of genetic information from North and Central Anatolia to the Southern, the researches shared in a press release.2

The team suggests that the Caucasus mountains, which stretch from the Black Sea and the Caspian Sea, and Zagros mountains,a long range in Iran, Iraq and southeastern Turkey, indicated ongoing human mobility and development of a regional genetic melting pot in Anatolia.

Johannes Krause, co-director at Max Planck and senior author of the study, said: This far-reaching vortex of homogenization shows that ancient people within Western Asia biologically mix before their increasing connectedness and emerging sociocultural developments became visible in the archaeological record.

In contrast to the gradual changes taking place in Anatolia, the Northern Levant experienced an introduction of new populations.

Eirini Skourtanioti, lead author of the study, said: We found that the genetic makeup of Bronze Age populations from the ancient cities of Alalakh and Ebla in todays southern Turkey and northern Syria differed from preceding populations from the same area.

We detected subtle genetic changes that point to influences from external groups.

Along with the long-term transitions of entire populations, the team also uncovered proof of long-distance movements of individuals.

While investigating theAlalakh site in southern Turkey, the team found the lady in the well, whose genetic makeup is similar toBronze Age populations in Central Asia.

Her DNA showed she came from somewhere in Central Asia, some 2,000 miles away from where she was laid to rest in a watery grave.

The analysis also suggested that she was 40 to 45 years old when she died, which was probably between1625 BC and 1511 BC.

Researchers know she experienced a violent death due to the multiple injuries found on her skeleton.

Philipp Stockhammer, co-director of MHAAM and another senior author of the study, said: I was fascinated by our results for the lady in the well.

She provides a unique insight into individual female mobility over large distances. We know from literary sources that women traveled in this time throughout Western Asia very often as marriage partners.

However, the story of this woman of Central Asian origin will remain an enigma.

The lady in the well has raised multiple questions that scientists know can not be uncovered using analytical tools.

They wonder how this woman move from her home in Central Asia to Northern Levant?

Was she exiled from her home?

Was her death an accident or was the woman murdered?

Although there is much mystery that surrounds the lady in the well, researchers noted that she proves ancient humans traveled long distances in the pastand points to the existence of migrant communities in a globalized ancient world.

Ludwig Maximilian University Munich archaeologist and co-author of the study Philipp Stockhammer, said: How and why a woman from Central Asia or both of her parents came to Alalakh is unclear, said Trader? Slaves? Marriage?

What we can say is that genetically this woman is absolutely foreign, so that she is not the result of an intercultural marriage, he added.

Therefore, a single woman or a small family came this long distance.

The woman is killed. Why? Rape? Hate against foreigners? Robbery? And then her body was disposed in the well.

Read more here:
Skeletal remains of 'Lady in the Well' reveal long-distance migrations began 4000 years ago - Brinkwire

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My son is brown. Dark-brown-sugar-left-on-the-stove-to-caramelize brown. He is short and muscular, with a wide back and a high, track booty like his dad. He is deep-voiced despite his mere five years. Hes full of gumption, eye rolls, and head cocks, with a smart mouth and lip smacks. He is expressive.

That really hurts! He yelled at the nurse when he got his shots.

Dont pull on me! He protested when I yanked him in the car.

He doesnt know that all these things about him are what innately, unconsciously, unawarely, put him in danger. They make him endangered. But I know. After all, he is my son.

Mylen. His name means gracious, dear one, or Gift of God. In this country, I know he will only be seen as such to me, his father, and his family. Yet I dont want him to know this unfortunate truth. I dont want him to know the limitations that have been set on his life simply because genetics, ancestry, and my choice in whom to love, preternaturally predetermined for him to be born Black and male. A Black boy who may only be seen as such for a few more years.

But despite all this knowing, all this perception in the face of systemic oppression, I am still raising him to be fearless, and free.

We live in Jacksonville, Florida. The city, where in 2012, 17-year-old Jordan Davis was killed on Black Friday at a gas station after an argument over loud music by a privileged, racist white man. Months earlier, 17-year-old Trayvon Martin was killed in Sanford, a 90-minute drive south of Jacksonville. In April 2020, Ahmaud Arbery was killed in Glynn County, Georgia, a 90-minute drive north of Jacksonville.

I know intimately the unrest that is awakened when a Black body is forced into death. Were seeing it right now across the country and around the world. The gripping fear that takes hold in a mothers soul when she sees the news about the murder of someone elses son, who reminds her of her son my son. There is a saying in the : Mothers pray their sons will make it to the age of 25. The hope is that somehow, alchemy intervenes after the 25th trip around the sun that then, stray bullets, gang confrontations, and the second-class conditions that ghettoize any community where Black people live will no longer be a weapon that prospers.

These would have been my concerns if I still lived in the Southside of Chicago, the neighborhood of my origin. These would be my concerns if I lived in the Black neighborhoods of Jacksonville. But even though, Ive moved on up, the fears I feel regarding the longevity of my sons life have not let up.

Suburban sprawl in a meticulously pre-planned community: Thats where we dwell. We have a neighborhood watch. There are only three other Black families on our block. My son will go to a good school that reaps the benefits of our zip code and our property taxes. In that school, where he will start Kindergarten in the fall, he may be othered, labeled, ostracized, and deemed a problem child. I am not trying to speak negatively of my son; I simply understand the stakes he will face. Yet, against all these odds, I want him to know he can do anything, be anything, go anywhere, and say anything.

At the park, I beam as he climbs the chain-link fence, glowing with pride at his feat. At home, I allow him to express himself as long as he is respectful. I watch with lax eyes as he runs up and down our block training for a race against his imagination. I stand in awe when we play baseball in our backyard and he hits the ball to our roof, or over the neighbors fence.

There is power in his body, curiosity in his mind, swag in his demeanor, love in his heart, affection in his hug, tenderness in his kiss, and joy in his soul. I do not relish the day that we will have the talk about what he is, and what that means to others who dont look like him. I do not look forward to impressing upon him that his very existence is a threat, and that every second he draws breath is grace and mercy from those who can weaponize their false, fresh white tears against him. I do not want to tell him that even though his father wears blue and served in the Marine Corps, this does not keep him safe.

Mylen will live the majority of his life knowing that the essence of who he is will be disregarded because of how he presents in the world. That his Blackness and maleness is an affront to the descendants of colonizers, Columbusers, enslavers, and public liberals/closet Karens. There will be plenty of time for him to get to know the fear associated with passing police cars. He will have all of his life to learn the hurt when a white woman clutches her purse, or a white man sneers the word boy.

For now, this is our time. Before I instill him with fear, I want him to know what it is to be free. This could very well be the last time he knows such a feeling.

Help young kids of color feel seen with these beautiful Black and biracial dolls that are gorgeous and important.

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How Im Raising My Black Son to Be Free & Fearless Despite the Killings of Men Like Him - SheKnows

Recommendation and review posted by Bethany Smith

Almost three hours into his interrogation by Toronto police, the man who purposely crashed a van into pedestrians along a crowded Toronto sidewalk explained his motive, his dogma. Likely meant as a solemn homily, the words instead push the detective to laugh.

The 10 dead and 16 injured left along Yonge Street in 2018 were causalities of an uprising, the driver said, a beta uprising, if you will, against the Chads and the Stacys.

From his interrogator, Det. Rob Thomas, with the behavioural assessment section no less, a snicker slipped.

Who can blame him? Could there be a more absurd manifesto for mass murder?

Thomas forged ahead with a remarkable session over four and a half hours in which Alek Minassian revealed his online radicalization in the emerging incel ideology (short for involuntary celibate) that has become a woman-hating subculture.

Responses to incel ideology are evolving as violence sparked by its dogma continues, and an online community of fellow believers cheer each attack. While its ideas can evoke laughter of disbelief, its impact is deadly serious.

Last week was a milestone in how Canada responds to incel violence in two significant ways not only showing the hammer but extending a hand.

Incel violence was deemed an act of terrorism in Canada for the first time, when charges against a teenager accused of a deadly machete attack against female workers at a Toronto erotic massage parlour were upgraded to include murder terrorist activity.

At the same time, it is being addressed more urgently as a mental health and social issue needing specific intervention.

While police chase danger from incels as part of an ideological group, mental health professionals, social workers and anti-extremist activists focus on the individuals, the self-described lonely and unloved men behind incel culture and its violent ideas.

Efforts moved forward this week to look into the mindset of incels to short circuit a spiral from loneliness to loathing to violence.

There are certain players involved with the problem of violent extremism and terrorism and they have specific roles, said John McCoy, executive director of the Organization for the Prevention of Violence (OPV).

Youve got an intelligence-gathering agency and law enforcement agencies, but there is a gap and that gap is related to prevention.

While counter violent extremism is usually associated with Islamic jihadists and white supremacists, several organizations are now extending outreach to incels.

Counter violent extremist programming is about trying to prevent the escalation of those who are engaged with some kind of ideology that promotes violence from deciding to get up one day and do something about it like Minassian getting into a van, said McCoy.

McCoys Edmonton-based organization released a report this week to guide mental health practitioners, doctors, social workers, mentors and youth workers in dealing with incels.

Individuals who associate with the incel movement appear more likely than the general population to self-report anxiety, depression and other mood disorders, the OPV says.

Incels span a range of behaviour and belief.

While the violent fringe of the incel movement is being recognized as a threat, it is important to acknowledge the majority of incels are not violent and may be at a higher risk of self-harm than the general population, the report says.

Incels, at least online, often revel in an indifference to living; suicide seems an ever-present possibility with frequent references to the rope call or suifuel, which is something that fuels a desire to die.

One large incel forum conducts periodic polls of its members. In a poll this past March, 88 per cent said they were unhappy; 74 per cent had long-lasting anxiety or emotional distress; 77 per cent were not optimistic about the future and 71.5 per cent said they were on the autism spectrum. Its poll last year found 67.5 per cent of members had seriously considered suicide.

It is important to acknowledge the majority of incels are not violent

Moonshot CVE, a British deradicalization company that works with federal governments, is also turning attention to incels in Canada.

Public Safety Canada recently funded Moonshot for a detailed incel study. This week, it released its first report, designed to help frontline practitioners and social services interrupt incel mobilization to violence.

The Toronto van attack in 2018, and the more recent attack in February 2020, have put their capacity for real-world harm beyond doubt, the Moonshot report says.

It is also clear to anyone who spends time in these communities where both suicidal ideation and suicide itself are rampant incels also pose a significant threat to themselves. The first step in understanding how to engage with these at-risk men is to understand how they communicate and share their worldview.

To that end, Moonshots guide to incel symbols and terminology seeks to break down the jargon to allow informed outside engagement.

In an odd way, Minassian did a lot of that work.

During his four-hour interrogation he spoke in granular detail about the destructive incel worldview, such as dividing humanity into categories of betas, Stacys, Chads and normies.

(A beta is an incel, rejected by society and women because of unfair and unchangeable genetics; a Stacy is the archetype for attractive women who shun betas; a Chad is the name for sexually successful men who attract women despite being seen as dumb; normies are the masses with average looks.)

It sounds childish and comical but it is a meme-friendly way of sorting and explaining incel experiences.

Micah Clark, a Moonshot principal currently based in Ottawa, said incels are unique in the world of violent extremists.

Theyre the ones who adopted the concept of incel, theyve taken that on as their own identity, rather than being called something by other people, he said.

It is a community that has a lot of mental health and social heath needs A lot of these folks are at a very high risk of harming themselves and no one else.

While most incels really have a lot of disdain for themselves and a lot of self-hatred, they are also really into themselves

Then you suddenly have the stark terror of violent attacks and that can never be ignored.

Its a trickier movement to work with, said Clark. Its trickier to understand. They are much more self-aware around who they are and much more self-aware of the fact they are being observed.

They are quite fascinated with themselves. While most incels really have a lot of disdain for themselves and a lot of self-hatred, they are also really into themselves.

Clark said Moonshot has worked with many hardened, tough-nosed counter-terrorist types and former extremists.

And incels weird them out to a degree and in a way that no other movement does. Part of whats so disturbing is its so relatable loneliness and sadness and lack of connection. Its a human experience a lot of us feel and they have felt it in a way that is so far beyond what a lot of us have.

You can recognize that empathy without having to have any sympathy. You can recognize the human experience that led them to this place without having any acceptability around the misogyny, and rejecting it fundamentally.

These reports both highlight one obstacle in reaching incels: despite their self-declared needs, they tend to reject assistance.

The reaction of incels when non-incels engage in their forums is often hostile, rejecting any input from normies.

Accepting therapy and psychological intervention means rejecting incel dogma, Moonshots report says. Under incel dogma, physical appearance is all women care about in sex partners, so pro-social intervention is useless, incels counter.

As one incel post says: therapy dont fix your face.

Overcoming these barriers and making support more accessible will be key to preventing further acts of violence, says the OPV report.

Which means overcoming the irony of a community built on loneliness being hostile to outsiders.

Email: ahumphreys@postmedia.com | Twitter:

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Inside the minds of incels: Experts seek to short-circuit the spiral from loneliness to loathing to violence - National Post

Recommendation and review posted by Bethany Smith

KENILWORTH, N.J.--(BUSINESS WIRE)--Jun 1, 2020--

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending LYNPARZA for approval as monotherapy for the maintenance treatment of adult patients with germline BRCA 1/2 mutations (g BRCA m) who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.

The CHMP based its positive opinion on results from the Phase 3 POLO trial, which were previously published in TheNew England Journal of Medicine.

The trial demonstrated LYNPARZA nearly doubled the time patients with g BRCA m metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo (HR 0.53 [95% CI 0.35-0.82]p=0.004).

The safety and tolerability profile of LYNPARZA in the POLO trial was consistent with previous trials. The most common adverse reactions (ARs) 10% were fatigue/asthenia (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%). The most common Grade 3 ARs were anemia (11%), fatigue/asthenia (5%), decreased appetite (3%), abdominal pain (2%), vomiting (1%) and arthralgia (1%). Among patients taking LYNPARZA, dose interruptions due to an AR of any grade occurred in 35% and dose reductions due to an AR occurred in 17%. Discontinuation due to ARs occurred in 6% of patients receiving LYNPARZA.

Dr. Jos Baselga, executive vice president, oncology R&D, AstraZeneca, said, Patients with advanced pancreatic cancer have seen limited treatment advances over the last few decades. We are now one step closer to potentially bringing the first targeted medicine to certain biomarker-selected patients with advanced pancreatic cancer in the EU.

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, A pancreatic cancer diagnosis is devastating, and we are committed to research that aims to change the prognosis for patients. The POLO trial demonstrated that treatment with LYNPARZA extended time without disease progression in certain patients with advanced pancreatic cancer we are hopeful that we will be able to bring this treatment to patients in the EU soon.

LYNPARZA is approved in the U.S. as a first line maintenance treatment for patients with g BRCA m metastatic pancreatic cancer whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

Females

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

Males

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

Venous Thromboembolic Events: Including pulmonary embolism, occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.

ADVERSE REACTIONSFirst-Line Maintenance BRCA m Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/ nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), UTI (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

ADVERSE REACTIONSFirst-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

Most common adverse reactions (Grades 1-4) in 10% of patients treated with LYNPARZA/bevacizumab compared to a 5% frequency for placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%) and leukopenia (18%). In addition, the most common adverse reactions (10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%).

In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%), and decrease in platelets (35%).

ADVERSE REACTIONSMaintenance Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in clinical trials of LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%), and dyspepsia (20%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the maintenance setting (SOLO-2/Study 19 ) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

ADVERSE REACTIONSAdvanced g BRCA m Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in clinical trials of

LYNPARZA for advanced g BRCA m ovarian cancer after 3 or more lines of chemotherapy (pooled from 6 studies) were: fatigue/asthenia (66%), nausea (64%), vomiting (43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia (22%), decreased appetite (22%), and arthralgia/musculoskeletal pain (21%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA for advanced g BRCA m ovarian cancer (pooled from 6 studies) were: decrease in hemoglobin (90%), mean corpuscular volume elevation (57%), decrease in lymphocytes (56%), increase in serum creatinine (30%), decrease in platelets (30%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONSg BRCA m, HER2-negative Metastatic Breast Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Most common laboratory abnormalities (Grades 1-4) in > 25% of patients in OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

ADVERSE REACTIONSFirst-Line Maintenance g BRCA m Metastatic Pancreatic Adenocarcinoma

Most common adverse reactions (Grades 1-4) in 10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONSHRR Gene-mutated Metastatic Castration Resistant Prostate Cancer

Most common adverse reactions (Grades 1-4) in 10% of patients in clinical trials of LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr 30 mL/min).

INDICATIONS

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCA m Advanced Ovarian Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated (g BRCA m or s BRCA m) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance HRD Positive Advanced Ovarian Cancer in Combination with Bevacizumab

In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:

Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Maintenance Recurrent Ovarian Cancer

For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Advanced g BRCA m Ovarian Cancer

For the treatment of adult patients with deleterious or suspected deleterious germline BRCA- mutated (g BRCA m) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

g BRCA m HER2-negative Metastatic Breast Cancer

For the treatment of adult patients with deleterious or suspected deleterious g BRCA m , human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance g BRCA m Metastatic Pancreatic Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious g BRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

HRR Gene-mutated Metastatic Castration Resistant Prostate Cancer

For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please click here for complete Prescribing Information, including Patient Information (Medication Guide).

About POLO

POLO is a Phase 3 randomized, double-blinded, placebo-controlled, multi-center trial of LYNPARZA tablets (300 mg twice daily) as maintenance monotherapy vs. placebo. The trial randomized 154 patients with g BRCA m metastatic pancreatic cancer whose disease had not progressed on first-line platinum-based chemotherapy. Patients were randomized (3:2) to receive LYNPARZA or placebo until disease progression. The primary endpoint was progression-free survival and key secondary endpoints included overall survival, time to second disease progression, overall response rate and health-related quality of life. Phase 3 POLO results were published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting.

About LYNPARZA (olaparib)

LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR.

LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types.

About Pancreatic Cancer

Pancreatic cancer is the 12th most commonly occurring cancer worldwide and the 7th leading cause of cancer death globally. The disease has the lowest survival rate of the most common cancers, and is the only major cancer with a single-digit five-year survival rate (2-9%) in nearly every country. There were approximately 460,000 new cases worldwide in 2018. As there are often no symptoms, or symptoms may be non-specific in the early stages, it is most commonly diagnosed at an incurable stage. Around 80% of pancreatic cancer patients are diagnosed when the disease has metastasized and for these, the average survival is less than a year. Despite advances in treatment, few improvements have been made in diagnosis and treatment over the decades. Current treatment is surgery (for which approximately only 10-20% of patients are eligible), chemotherapy and radiotherapy, highlighting a critical unmet medical need for more effective treatment options. 12

About BRCA Mutations

BRCA 1 and BRCA 2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.

About the AstraZeneca and Merck Strategic Oncology Collaboration

In July 2017, AstraZeneca and Merck, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize certain oncology products including LYNPARZA, the worlds first PARP inhibitor, for multiple cancer types. Working together, the companies will develop these products in combination with other potential new medicines and as monotherapies. Independently, the companies will develop these oncology products in combination with their respective PD-L1 and PD-1 medicines.

Mercks Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit http://www.merck.com/clinicaltrials.

About Merck

For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the worlds most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the company) includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the companys management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the companys ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the companys patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys 2019 Annual Report on Form 10-K and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site ( http://www.sec.gov ).

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LYNPARZA (olaparib) Receives Positive Opinion from EU CHMP for First-Line Maintenance Treatment of Patients with Germline BRCA-Mutated Metastatic...

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