Archive for the ‘Crispr’ Category

The International Society for Pharmaceutical Engineering (ISPE) today announced the 2022 Facility of the Year Awards (FOYA) Category Winners at the 2022 ISPE Europe Annual Conference in Madrid, Spain.

NORTH BETHESDA, Md., April 26, 2022 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) today announced the 2022 Facility of the Year Awards (FOYA) Category Winners at the 2022 ISPE Europe Annual Conference in Madrid, Spain.

Awardees Include:

The FOYA judges' panel has also awarded Honorable Mention to:

FOYA is the premier global awards program recognizing innovation and creativity in manufacturing facilities serving the pharmaceutical industry. The award-winning projects selected by the FOYA program set the standard for pharmaceutical facilities of the future by demonstrating excellence in facility design, construction, and operations.

"The future of the pharmaceutical industry is being shaped every day by innovative companies worldwide. Companies like the 2022 FOYA Category Winners have a clear commitment to excellence and set the high bar for quality in the design and social impact consideration of their facilities," said Thomas Hartman, President & CEO, ISPE. "They incorporate a thoughtful, unique, and adaptive approach to innovation, operability, sustainability, and reliability while introducing flexibility allowing for the manufacturing of multiple product modalities. Further, these modern facility designs introduce digitization strategies that accelerate timelines from product development to product licensure. ISPE is proud to recognize these companies."

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ISPE 2022 Facility of the Year (FOYA) Category Awards Winners

The Innovation Category was awarded to CRISPR Therapeutics for its facility in Framingham, Massachusetts, USA. CRISPR Therapeutics has harnessed the CRISPR/ Cas9 gene-editing platform to develop and deliver potentially curative therapies to patients with serious diseases. The technology has game-changing implications for patients and partners. The project was awarded a FOYA award for Innovation based on the innovative design of the facility, which provides an end-to-end solution for production and fills operations. The FOYA judging committee commends CRISPR for creating a flexible, digitally enabled facility that can bring the promise of innovation to life.

Janssen Biologics, BV won the Project Execution Category for its Vaccine Launch Facility (VLF) Expansion in Leiden, The Netherlands. This Johnson & Johnson (J&J) biopharmaceutical production and laboratory testing facility produces clinical and commercial bulk active pharmaceutical ingredients and provides analytical testing services for J&J's global portfolio of vaccines. The existing VLF represented an opportunity to enable large-scale COVID-19 vaccine drug substance manufacturing by building a new, 25,000 square-foot sterile manufacturing facility adjacent to the existing VLF. This fast-tracked project was developed to design and build the new facility within nine months and to secure regulatory approval for initial commercial batches produced in the facility within 12 months. The ambitious timeframe required a Herculean effort and flawless collaboration on the part of all involved parties, including best-in-class design and construction partners and an integrated, cross-functional team within J&J.

Takeda Pharmaceuticals International AG won the Supply Chain Category for its Alofisel Global Program in Madrid, Spain; Grange Castle, Ireland; Osaka, Japan; and California, USA. Alofisel is a first-in-class stem cell therapy product and the first allogeneic mesenchymal stem cell therapy to receive approval by the European Medicines Agency. The project was designed with a product shelf life of only 48 hours and requires seamless cold chain transportation. Takeda had to completely rethink the supply chain to get the product from the plant to the hospital to be administered to the patient within a very short time frame. The program is recognized in this year's awards for its novel and innovative approach to end-to-end supply chain management as well as the program's innovative design in expanding the Alofisel manufacturing network from its initial plant in Madrid, Spain, to other regions across the globe with new facilities in the US, Japan, and Ireland.

The Pharma 4.0 Category was awarded to Takeda Pharmaceuticals International AG in Singen, Germany for its TaSiVa project. The TaSiVa facility took an innovative approach to the project of implementing pharma 4.0 technologies as part of the overall project delivery, which also complemented the companywide digital transformation. It included several key collaborations with suppliers and academia to develop pharma 4.0 solutions. The facility was built with state-of-the-art process equipment and then layered with advanced digital technologies in several key areas. A complete IT infrastructure upgrade was completed at the site during the early phase of the project thus providing the platform to utilize advanced information technology (IT)/ operational technology (OT) solutions as part of the project delivery. The project exemplifies how the application of innovation in advanced digital technologies leads to improved outcomes in terms of safety, product quality, and productivity in a pharmaceutical manufacturing facility.

The first of two companies to be awarded in the Social Impact Category is Catalent for its Project Mercury in Bloomington, Indiana. Catalent's Project Mercury was delivered in the face of the global pandemic. With an unknown manufacturing process for a vaccine candidate under development, the team pivoted on existing projects to ensure success, adding 40% more scope including secondary packaging and inspection. The project added 40,000 sq ft to cover the most stringent of the unknown needs of the process, reducing the risk to supply. The project team also cut six months off their schedule and beat the clock while managing the complexities of execution within the COVID-19 restricted environment and delivering the needed capacity to meet important pandemic demands. They applied a great amount of effort and budget into adding additional safety measures to keep workers safe throughout the constant threat of the COVID-19 virus along with including three major elements of sustainability into their plans for Project Mercury: People, Planet, and Profits.

The second of two companies to be awarded in the Social Impact Category is Janssen Biologics, BV for its Vaccine Launch Facility (VLF) Expansion in Leiden, The Netherlands. During the VLF expansion construction activities were executed during an increased level of positive COVID cases in The Netherlands. J&J kept the personal safety of all project team members as its top priority by implementing various safety measures to reduce the risk of exposure to the COVID virus. These additional safety measures resulted in no significant stoppages or slowdowns of work during construction.

Iovance Biotherapeutics, Inc. was awarded an Honorable Mention for its Iovance Cell Therapy Center (iCTC) in Philadelphia, Pennsylvania. With only one chance of success and Iovance having a production timeline of 22 days, there is no room for error when developing therapies. Their facility was designed with significant redundancies to support its operation 24 hours a day, 365 days of the year. Iovance had a goal to "be the first company in the world to commercially produce a personalized therapy for solid tumors" and as a relatively small company, their achievement in that first, as well as having an excellent facility was recognized by the judges.

The 2022 FOYA Category Winners will be formally recognized at the ISPE Facility of the Year Awards Banquet, held in conjunction with the 2022 ISPE Annual Meeting & Expo, taking place 30 October2 November 2022. The banquet will feature acceptance speeches from the FOYA recipients and presentations from noted industry leaders. The 2022 FOYA Overall Winner will be announced at the conference during the ISPE Membership Meeting and Awards Lunch on 1 November 2022.

About the ISPE Facility of the Year Awards Program Established in 2005, The Facility of the Year Awards (FOYA) recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation while sharing the development of new applications of technology and cutting-edge approaches. Visit ISPE.org/FOYA for more information.

About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world's largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancements across the entire pharmaceutical lifecycle. The 20,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.

Media Contact

Amy Henry, ISPE, 813-960-2105, ahenry@ispe.org

SOURCE ISPE

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2022 ISPE Facility of the Year Category Award Winners Announced - Yahoo Finance

The Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR/Cas9) segment is a leading segment in terms of revenue by product type in the gene editing tools market, and accounted for an approximate revenue share of 75% in 2018. CRISPR/Cas9 gene editing tools are most widely used by scientists to create transgenic animals that include zebrafish, pigs, mice, rats, and primates. Among all the distribution channels in the gene editing tools market, the academic and research institutes segment is expected to be most prominent segment, followed by biotech and pharmaceutical companies.

Prevalence of Cancers and Rare Genetic Diseases Establish a Strong Base for Innovation of Gene Editing Tools

The rising prevalence of cancer and other genetic disorders, such as sickle cell disease, heart disease, diabetes, Alzheimers disease, obesity, and others, is among the key factors impacting the growth of gene editing tools market. Cancer is registered to be the second most prominent cause of death worldwide. According to the World Health Organization (WHO), the number of deaths due to cancer worldwide in 2015 was 8.8 million. However, cancer alone was responsible for an estimated 9.6 million deaths globally in 2021.

Worldwide, approximately about 1 in 6 deaths occur owing to cancer. An analysis states that approximately 70% of deaths due to cancer occur in low- and middle-income countries. Thus, gene editing is most preferred for the management of rare genetic disorders, which is driving the demand for gene editing, thus generating a favourable revenue opportunity for gene editing tools.

The growing prevalence and incidence of rare genetic disorders, majorly Sickle Cell Disease (SKD), cancer, and Alzheimers disease, is leading to the high demand for genome editing, and is one of the leading factors that is contributing significantly to the growth of the gene editing tools market. Moreover, gene editing tools, such as CRISPR, TALENs, and ZFNs, find precise applications in the treatment of cancer. Owing to the high efficiency and accuracy of the CRISPR-Cas9 gene editing technique, it has emerged as a potential tool for cancer therapy. Among its various applications, CRISPR-Cas9 has a high clinical potential to detect novel target genes for cancer therapy.

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Biomedical Community Eyes Potential Application of Gene Editing Tools

Introduction of technologically advanced gene editing tools is expected to boost the growth of gene editing tools market. Recent advancements in CRISPR gene editing tools and their ease of use have generated significant interest in the biomedical community. Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-based gene editing has high potential to cater to the therapeutic landscape of induced disorders, owing to the presence of key players in the industry such as Intellia, CRISPR Therapeutics, and Editas. CRISPR gene editing tools offer precise gene-targeted treatments for -thalassemia and SKD. Among gene editing tools, there are potential applications for CRISPR in the gene editing tools market in human therapeutics as well as veterinary therapeutics.

Regional Players Focusing on Product Reach & Connectivity

North America, followed by Europe, is a prominent region in the global gene editing tools market. North America accounts for a revenue share of about 25.0% in 2021 in gene editing tools market. Europe accounting for the second-largest revenue share, and is followed by South Asia in the gene editing tools market. India, China, and Japan are among the emerging markets in the gene editing tools market. Japan is among the fastest-growing emerging markets in the global gene editing tools market, and is projected to grow at a CAGR of more than 6% during the forecast period of 2022-2028.

The gene editing tools market report tracks some of the key companies operating in gene editing tools market, such as Thermo Fisher Scientific Inc., ERS Genomics, CRISPR THERAPEUTICS, Merck KGaA, Editas Medicine, Takara Bio USA, New England Biolabs, Intellia Therapeutics, Inc., and GenScript Biotech Corporation. Majority of the key regional players in the gene editing tools market are focused on increasing their product reach and connectivity with the help of domestic distributors of gene editing tools. Moreover, the manufacturers of gene editing tools are focused to strengthening their businesses in high-growth markets, such as India, Japan, China, and Argentina, by expanding their sales and distribution channels across these countries.

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Gene Editing Tools Market by CategoryBY Product:

BY Application:

BY End User:

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Gene Editing Tools Market size is estimated to total US$ 1.6 Billion by 2029 - Digital Journal

When we talk about Cathie Wood stocks, were referring to the picks made by one of the top investors during the pandemic years.

Her flagship ARK Innovation ETF generated more than 150% returns for its stockholders and continued climbing for the better part of last year.

Cathie Woods ETFs have experienced some major losses in the latter half of 2021. From October to December last year, her fund lost more than $8 billion in value.

Her funds primarily hold disruptive stocks which can experience massive gains and losses, and there are many with incredible long-term cases. However, she seems unfazed by developments and has doubled down on her bets.

Investors continue to have faith in the star stock pickers abilities despite the lackluster performance. For example, these three Cathie Wood stocks that offer amazing upside potential.

Crispr Therapeutics(NASDAQ:CRSP)is a speculative biotech stock working on gene-editing technology.

The company hopes to make this technology the norm for disease treatment. Multiple therapies are in the trial stage and studied for various conditions, including diabetes, cancer, and other diseases.

The business currently generates minimal revenue as its products arent commercialized yet. Its market valuation is based purely on its fundamentals. CRSP is a disruptor, and most investors are banking on its long-term ability to surprise the market. However, it is likely to have a rocky road ahead involving regulatory hurdles and clinical trials.

The company has the opportunity to become market-leading biotech in treating serious diseases. If it can effectively achieve its objectives, then it will establish a strong moat, and it could grow into its massive $4.5 billion value.

Block(NYSE:SQ), formerly called Square, is a fintech giant boasting an incredible track record of growing revenues.

It launched as a payments solution which quickly became popular with small enterprises. It expanded into personal banking, transfers, and other profitable verticals, attracting millions of new users.

Its sales have grown more than 63% in the past five years.

SQ stock shed more than 58% in the past year as a result of the broader tech sell-off. Nevertheless, its underlying business boasts robust fundamentals and a strong growth runway ahead.

Its consumer and seller ecosystems are remarkably popular in the younger demographic. Additionally, its focus on emerging technologies such as blockchain is starting to pay dividends and could set it apart from its competition.

The companys revenue rose 86% last year, meaning its business will faces tough comparisons in the upcoming quarters. However, to expect the phenomenal growth to continue from the pandemic years is wishful thinking from investors.

Block will continue firing as its ecosystems further penetrate its target markets. Moreover, investments in other profitable areas will add a new direction to its business.

Teladoc Health(NASDAQ:TDOC) is a leader in virtual health care and has been developing a moat with its tremendous services ecosystem.

The telehealth specialist was a pandemic darling; however, its shares have fallen off a cliff since February of last year. It has shed off its frothy valuation and now presents itself as an attractive long-term investment.

The companys top line grew a spectacular 86% from the previous year to $2 billion. The business is still unprofitable, but there was a healthy improvement in this department last year.

Its loss per share came in at $2.73 per share compared with a loss per share of $5.36 in 2020. The telemedicine markets massive opportunities and competitive edge will help the business rake in consistently growing revenues and turn a profit soon.

Fortune Business Insights estimates that the global Telehealth market will likely grow at a tremendous 32%, from $90 billion in 2021 to a whopping $640 billion in 2028.

Moreover, the company estimates that around 92 million of the 298 million insured Americans have access to a Teladoc product. There is massive upside potential with Teladoc and this sell-off makes it an attractive buy at current levels.

On the date of publication, Muslim Farooque did not have (either directly or indirectly) any positions in the securities mentioned in this article.The opinions expressed in this article are those of the writer, subject to the InvestorPlace.comPublishing Guidelines.

Muslim Farooque is a keen investor and an optimist at heart. A life-long gamer and tech enthusiast, he has a particular affinity for analyzing technology stocks. Muslim holds a bachelors of science degree in applied accounting from Oxford Brookes University.

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3 Cathie Wood Stocks to Count on in Q2 - InvestorPlace

The Most Up To Date Market Insights And Analysis Performed In The PersuasiveCRISPR Gene Detection And Diagnostic Business Reportbrings marketplace clearly into focus. Businesses get highly benefited with the different segments covered in the market research report which provides better market insights to them with which they can drive the business into right direction. Under market segmentation topic of this report, research and analysis is done based on application, vertical, deployment model, end user, and geography. Depending on clients demand, huge amount of business, product and market related information has been brought together with CRISPR Gene Detection And Diagnostic report that eventually helps businesses create better strategies.

Data Bridge Market Research analyses that theCRISPR Gene Detection And Diagnostic Marketto grow at a CAGR of 11.65% and to account USD 4,708.89 million by 2028 and in the forecast period of 2022-2028.

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Global CRISPR Gene Detection and Diagnostic Market research reportalso provides the latest manufacturing data and industry future trends, allowing you to identify the products and end users driving profits growth and productivity. The Market report lists the most important competitors and provides the insights strategic industry Analysis of the key factors influencing the market. The report includes the forecasts, investigation and discussion of significant industry trends, market volume, market share estimates and profiles of the leading industry Players. Global CRISPR Gene Detection and Diagnostic Industry Market Research Report is providing exclusive vital statistics, information, data, trends and competitive landscape details.

The Segments and Sub-Section of CRISPR Gene Detection and Diagnostic Market are shown below:

By Type (Predictive & Presymptomatic Testing, Carrier Testing, Prenatal & New-born Testing, Diagnostic Testing, Pharmacogenomic Testing, Others)

By Disease (Alzheimers Disease, Cancer, Cystic Fibrosis, Sickle Cell Anaemia, Duchenne Muscular Dystrophy, Thalassemia, Huntingtons Disease, Rare Diseases, Other Diseases)

By Application (Cancer Diagnosis, Genetic Disease Diagnosis, Cardiovascular Disease Diagnosis, Others)

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COMPANIES MENTIONED INCLUDE (we can also add the other companies as you want.):

Abbott

Ambry Genetics

BD

Biocartis

BIO-HELIX

bioMerieux SA

Blueprint Genetics Oy

Cepheid

deCODE genetics

Illumina, Inc

Invitae Corporation

Luminex Corporation

..

No. of CRISPR Gene Detection and Diagnostic Market Report Pages: 350

Complete Report is Available (Including Full TOC, List of Tables & Figures, Graphs, and Chart) @https://www.databridgemarketresearch.com/toc/?dbmr=global-crispr-gene-detection-and-diagnostic-market

No of Figures: 60

The report also focuses on global major leading industry players of Global CRISPR Gene Detection and Diagnostic Market providing information such as company profiles, product picture and specification, price, capacity, cost, production, revenue and contact information. Upstream raw materials and equipment and downstream demand analysis is also carried out.

CRISPR Gene Detection and Diagnostic MarketScenario

CRISPR basically identifies unique genetic material instantly and accurately. This technology is cheaper, reliable and accurate than of previous DNA editing techniques.

Increased funding by government and market players for gene editing technologies in the forecast period are the major factors that will influence the growth of CRISPR gene detection and diagnostic market. Furthermore, rise in the numbers of clinical trials and research & development activities for treatment of various diseases are the driving factor accelerating the growth of the CRISPR gene detection and diagnostic market.

Rising innovations and adoption and constant competition among the existing players has led to technological development and advancement in the technology which leads to further provide beneficial opportunities for the CRISPR gene detection and diagnostic market growth.

Global CRISPR Gene Detection and Diagnostic Market Scope and Market Size

The CRISPR gene detection and diagnostic market market is segmented on the basis of type, disease and application. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

On the basis of type, the genetic testing market is segmented into predictive and presymptomatic testing, carrier testing, prenatal and newborn testing, diagnostic testing, pharmacogenomic testing and others.

Based on disease, the genetic testing market is segmented into Alzheimers disease, cancer, cystic fibrosis, sickle cell anemia, duchenne muscular dystrophy, thalassemia, huntingtons disease, rare diseases, and other diseases.

Based on application, the genetic testing market is segmented into cancer diagnosis, genetic disease diagnosis, cardiovascular disease diagnosis, and others.

Historical year 2010-2018; Base year 2019; Forecast period- 2022 to 2028 [** unless otherwise stated]

The countries covered in the CRISPR Gene Detection and Diagnostic market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, 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), Brazil, Argentina and Rest of South America as part of South America.

Some of the Major Highlights of TOC covers:

Chapter 1: Methodology & Scope

Definition and forecast parameters

Methodology and forecast parameters

Data Sources

Chapter 2: Executive Summary

Business trends

Regional trends

Product trends

End-use trends

Chapter 3: CRISPR Gene Detection and Diagnostic Industry Insights

Industry segmentation

Industry landscape

Vendor matrix

Technological and innovation landscape

Chapter 4: CRISPR Gene Detection and Diagnostic Market, By Region

Chapter 5: Company Profile

Business Overview

Financial Data

Product Landscape

Strategic Outlook

SWOT Analysis

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CRISPR Gene Detection and Diagnostic Market 2022-Global Industry Size, Share, Forecasts Analysis, Company Profiles, Competitive Landscape and Key...

The research and analysis firm Datavagyanik has published the updated version of its report Detailed Analysis, Business Opportunities and Forecast of Plant Breeding and CRISPR Plants Market by Countries. The updated version of the report is released with the latest data, industry trends and competitive benchmarking. The report uses analytical models to study country-level market patterns and to make forecasts for the next ones during the time frame (2022-2030).

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The regions covered in the Plant Breeding and CRISPR Plants study are North America, Europe, Asia Pacific, Latin America, the Middle East and Africa. and Canada.

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In addition, the report provides country-level analysis. To help strategic decision makers, It includes a competitive landscape to measure the market competition based on various factors such as drivers, restraints and opportunities. Key questions answered by this study

How big was the Plant Breeding and CRISPR Plants market in historical years

How will the Plant Breeding and CRISPR Plants market grow in forecast years i.e. from 2022 to 2030? What is the annual growth rate?

Who are the key target audiences for the Plant Breeding and CRISPR Plants market?

Derivative analysis through consumption and spending perspective.

Micro and macro factors in Plant Breeding and CRISPR Plants?

Internal and external variables in Plant Breeding and CRISPR Plants?

Purchasing power from the point of view of the end consumer.

What marketing techniques should a company use to promote its brand, product or service?

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Which segment and region are driving the market growth and how?

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Who are the visionaries, leaders, challengers and market niches? Which Players in the Plant Breeding and CRISPR Plants Market?

Strategic initiatives by Plant Breeding and CRISPR Plants market players and their impact on market growth.

Which goals have to be mapped

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Plant Breeding and CRISPR Plants Market Competitive Analysis, New Trends and Forecasts (2022-2030) Political Beef - Political Beef

New Jersey, USA,-The global Crispr And Crispr Associated Genes Market is comprehensively and in-depth examined in the report, focusing on the competitive landscape, regional growth, market segmentation and market dynamics. For the preparation of this comprehensive research study, we have used the latest primary and secondary research techniques. The report provides Porter's five forces analysis, tappet analysis, competitive analysis, manufacturing cost analysis, sales and production analysis, and various other types of analysis to provide a complete overview of the global Crispr And Crispr Associated Genes market. Each segment of the global Crispr And Crispr Associated Genes market is carefully analyzed on the basis of market share, CAGR and other important factors. The global Crispr And Crispr Associated Genes market is also presented statistically with the help of annual growth, CAGR, sales, production and other important calculations.

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Our report contains current and latest market trends, market shares of companies, market forecasts, competition benchmarking, competition mapping and an in-depth analysis of the most important sustainability tactics and their impact on market growth and competition. To estimate quantitative aspects and segment the global Crispr And Crispr Associated Genes market, we used a recommended combination of top-down and bottom-up approaches. We examined the global Crispr And Crispr Associated Genes market from three key perspectives through data triangulation. Our iterative and comprehensive research methodology helps us to provide the most accurate market forecasts and estimates with minimal errors.

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Crispr And Crispr Associated Genes Market Breakdown by Type:

Crispr And Crispr Associated Genes Market breakdown by application:

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Crispr And Crispr Associated Genes Market Report Scope

Regional market analysis Crispr And Crispr Associated Genes can be represented as follows:

This part of the report assesses key regional and country-level markets on the basis of market size by type and application, key players, and market forecast.

The base of geography, the world market of Crispr And Crispr Associated Genes has segmented as follows:

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Crispr And Crispr Associated Genes Market Size and Forecast (2022-2030) By Top Keyplayers | Thermo Fisher Scientific, Editas Medicine, Caribou...

Editas Medicine, Inc.

Marks the first-ever in vivo delivery of an experimental CRISPR gene editing medicine to a pediatric patient

Company on track to complete dosing of the pediatric mid-dose cohort in the first half of 2022 and expects to initiate dosing of the pediatric high-dose cohort this year

CAMBRIDGE, Mass., April 11, 2022 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced the administration of EDIT-101, an experimental CRISPR gene editing medicine, to the first pediatric patient enrolled in the BRILLIANCE clinical trial, which is designed to test the safety of EDIT-101 for the treatment of Leber congenital amaurosis 10 (LCA10), a CEP290-related retinal degenerative disorder. This marks the worlds first in vivo, or inside the body, dosing of a pediatric patient with a CRISPR gene editing experimental medicine.

Administering the experimental medicine to the first pediatric patient in the BRILLIANCE trial marks a significant milestone toward delivering on the potential of CRISPR gene editing medicines being safe and effective in treating LCA10, which often results in significant vision loss and blindness early in life, said James C. Mullen, Chairman, President, and CEO, Editas Medicine. Currently, there are no approved treatments for LCA10, and we look forward to sharing future updates from the BRILLIANCE trial, including sharing additional clinical data, later this year.

Enrolling this first pediatric patient in the BRILLIANCE trial is an important step toward bringing potentially life-changing treatments to children with genetic retinal diseases. We are excited to be involved in research focused on testing potential new treatments for untreatable diseases like LCA10, said trial principal investigator for the site, Tomas S. Aleman, MD, the Irene Heinz-Given and John LaPorte Research Associate Professor at the Scheie Eye Institute of the Perelman School of Medicine at the University of Pennsylvania, and a retinal degeneration specialist with the Division of Pediatric Ophthalmology at Children's Hospital of Philadelphia (CHOP).

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Albert M. Maguire, MD, the F.M. Kirby Professor of Molecular Ophthalmology at Penn and a member of the Center for Advanced Retinal and Ocular Therapeutics, is the surgeon in the trial, in collaboration with Childrens Hospital of Philadelphia (CHOP), the nation's first hospital devoted exclusively to the care of children and the source of many breakthroughs and firsts in pediatric medicine. CHOPs Clinical In Vivo Gene Therapy (CIGT) program provided the clinical operations support to conduct the work at CHOP.

Editas Medicine initiated enrollment in the pediatric mid-dose cohort in the BRILLIANCE trial following the Independent Data Monitoring Committee (IDMC) endorsement based on an analysis of safety data from a clinical trial in adult patients that tested low-dose and mid-dose levels of the experimental medicine. The Company remains on track to complete testing of the pediatric mid-dose in the first half of 2022 and expects to initiate testing of the pediatric high-dose this year.

Previously, Editas Medicine completed dosing of all adult cohorts in its BRILLIANCE study and announced preliminary EDIT-101 clinical results demonstrated a favorable safety profile and encouraging signals of clinical benefit. The Company expects to provide a clinical update on the BRILLIANCE trial in the second half of 2022. The update is expected to provide safety and efficacy assessments on all adult patients who have had at least six months of follow-up evaluations, which will include at least 12 months of data on the adult mid-dose cohort, and at least six months of data on the adult high-dose cohort. Additionally, the Company is expanding enrollment in one or more of the previously completed adult cohorts to explore dose response and support establishment of registrational trial endpoints, which are anticipated by year-end.

About EDIT-101 EDIT-101 is a CRISPR/Cas9-based experimental medicine under investigation for the treatment of Leber congenital amaurosis 10 (LCA10), a CEP290-related retinal degenerative disorder. EDIT-101 is administered via a subretinal injection to reach and deliver the gene editing machinery directly to photoreceptor cells. EDIT-101 has been granted Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) and Orphan Designation from the European Medicines Agency (EMA).

About BRILLIANCEThe BRILLIANCE Phase 1/2 clinical trial of EDIT-101 for the treatment of Leber congenital amaurosis 10 (LCA10) is designed to assess the safety, tolerability, and efficacy of EDIT-101 in patients with this disorder. Clinical trial sites are enrolling up to five cohorts testing up to three dose levels in this open label, multi-center study. Both adult and pediatric patients (3 17 years old) with a range of baseline visual acuity assessments are eligible for enrollment. Patients receive a single administration of EDIT-101 via subretinal injection in one eye. Patients are monitored every three months for a year after dosing and less frequently for an additional two years thereafter. Additional details are available on http://www.clinicaltrials.gov (NCT#03872479).

About Leber Congenital AmaurosisLeber Congenital Amaurosis, or LCA, is a group of inherited retinal degenerative disorders caused by mutations in at least 18 different genes. It is the most common cause of inherited childhood blindness, with an incidence of two to three per 100,000 live births worldwide. Symptoms of LCA appear within the first years of life, resulting in significant vision loss and potentially blindness. The most common form of the disease, LCA10, is a monogenic disorder caused by mutations in the CEP290 gene and is the cause of disease in approximately 20-30 percent of all LCA patients.

About Editas MedicineAs a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cas12a genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. For the latest information and scientific presentations, please visit http://www.editasmedicine.com.

Forward-Looking Statements This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words anticipate, believe, continue, could, estimate, expect, intend, may, plan, potential, predict, project, target, should, would, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the initiation, timing, progress and results of the Companys preclinical and clinical studies and its research and development programs, including completing dosing of the pediatric mid-dose cohort in the first half of 2022, initiating dosing of the pediatric high-dose cohort in the BRILLIANCE trial in 2022, and establishing registrational trial criteria by year-end 2022, and the timing for the Companys receipt and presentation of data from its clinical trials and preclinical studies, including a clinical update on the BRILLIANCE trial in the second half of 2022. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of pre-clinical studies and clinical trials and clinical development of the Companys product candidates; availability and timing of results from pre-clinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Companys foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption Risk Factors included in the Companys most recent Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release represent the Companys views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, the Company explicitly disclaims any obligation to update any forward-looking statements.

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Editas Medicine Announces Dosing of First Pediatric Patient in the BRILLIANCE Clinical Trial of EDIT-101 for LCA10 - Yahoo Finance

The study analyzes crucial trends that are currently determining market growth. This report explicates on vital dynamics, such as the drivers, restraints, and opportunities for key market players along with key stakeholders and emerging players associated withCRISPR and Cas Gene Market. The study also provides the dynamics that are responsible for influencingthe future status of the marketover the forecast period.

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A detailed assessment of the value chain analysis, business execution, and supply chain analysis across regional markets has been covered in the report. A list of prominent companies manufacturing CRISPR and Cas Gene, along with their product portfolios, enhances the reliability of this comprehensive research study.

Report Summary

The study offers comprehensive analysis on diverse features, including demand, product development, revenue generation, and sales of CRISPR and Cas Gene across regions.

A comprehensive estimate on the market has been provided through an optimistic as well as a conservative scenario, taking into account sales during the forecast period. Price point comparison by region with global average price is also considered in the study.

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Regional analysis includes

Inspected Assessment on Regional Segments

Key sections have been elaborated in the report, which have helped deliver projections on regional markets. These chapters include regional macros (political, economic, and business environment outlook), which are expected to have a momentous influence on the growth of the CRISPR and Cas Gene Market during the forecast period.

Country-specific valuation on demand for CRISPR and Cas Gene Markets has been offered for each regional market, along with market scope estimates and forecasts, price index, and impact analysis of the dynamics of prominence in regions and countries. For all regional markets, Y-o-Y growth estimates have also been incorporated in the report.

Detailed breakup in terms of value & volume for emerging countries has also been included in the report.

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In Fact.MRs study, a unique research methodology is utilized to conduct extensive research on the growth of the CRISPR and Cas Gene Market, and reach conclusions on the future growth parameters of the market. This research methodology is a combination of primary and secondary research, which helps analysts ensure the accuracy and reliability of the drawn conclusions.

Secondary resources referred to by analysts during the preparation of the market study include statistics from governmental organizations, trade journals, white papers, and internal and external proprietary databases. Analysts have interviewed senior managers, product portfolio managers, CEOs, VPs, marketing/product managers, and market intelligence managers, all of whom have contributed to the development of the research report as a primary resource.

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DNA-free Cas Genes Market is Expected to Witness Healthy Growth at 21.2% CAGR through 2026 Blackswan Real Estate - Blackswan Real Estate

The term genomics sounds quite interesting, although it is mainly confused with genetics. Genetics refers to the study of genes, whereas genomics is a broader term which encompasses the study of an organisms entire set of genes (genome).

Some facts to know

Do read: What is genetic engineering and how can it benefit healthcare?

Exploiting genomics in medicine

Genomic medicine is a speciality of medical science that uses an individual's genomic information to make diagnostic and therapeutic decisions. Some of the recent advances in genomic medicine are discussed below:

Image source: Vadimgozhda | Megapixl.com

Precision medicine

Precision medicine exploits an individual's genetic information for disease diagnosis and treatment. However, it doesn't only consider the genome but utilises other factors such as the environment of a person and their health history.

Precision medicine bypasses the 'one size fits all' approaches that are the same for everyone and develops individual-specific approaches.

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)

CRISPR is a gene editing tool and can be simply compared with a text editor, for a clear understanding. Also known as 'molecular scissors', the technique is used to edit genetic code. CRISPR shines a ray of hope in treating fatal diseases, including cancer and HIV.

Despite its great potential in medical science, the technique holds several apprehensions and questionable applications. Due to this reason, CRISPR is currently considered non-ethical in human beings and is banned in several countries, including the USA.

Gene therapy

Gene therapy involves the insertion of a healthy foreign genetic material into a person's cell to treat a disease. It is a one-shot cure as it corrects the underlying genetic cause of disease.

The first CAR T-cell-based gene therapy got approval in 2017 in the United States by the Food and Drug Administration (FDA). Gene therapies also hold a promising future for cancer treatment.

Concerns regarding gene-based techniques

Also read: Telix (ASX: TLX) adds new asset in its cancer treatment pipeline

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The role of genomics in medicine: A look at pros and cons - Kalkine Media

This article was originally published here

Mol Biotechnol. 2022 Jan 29. doi: 10.1007/s12033-021-00431-7. Online ahead of print.

ABSTRACT

Biotechnological approaches have always sought to utilize novel and efficient methods in the prevention, diagnosis, and treatment of diseases. This science has consistently tried to revolutionize medical science by employing state-of-the-art technologies in genomic and proteomic engineering. CRISPR-Cas system is one of the emerging techniques in the field of biotechnology. To date, the CRISPR-Cas system has been extensively applied in gene editing, targeting genomic sequences for diagnosis, treatment of diseases through genomic manipulation, and in creating animal models for preclinical researches. With the emergence of the COVID-19 pandemic in 2019, there is need for the development and modification of novel tools such as the CRISPR-Cas system for use in diagnostic emergencies. This system can compete with other existing biotechnological methods in accuracy, precision, and wide performance that could guarantee its future in these conditions. In this article, we review the various platforms of the CRISPR-Cas system meant for SARS-CoV-2 diagnosis, anti-viral therapeutic procedures, producing animal models for preclinical studies, and genome-wide screening studies toward drug and vaccine development.

PMID:35091986 | DOI:10.1007/s12033-021-00431-7

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The Trend of CRISPR-Based Technologies in COVID-19 Disease: Beyond Genome Editing - DocWire News

A gene-editing treatment known as CRISPR appears to have positive results for people suffering from a rare visual disorder.

According to new reports, researchers injected seven volunteers with CRISPR to treat a rare vision disorder. Unlike other treatments, scientists designed CRISPR to fight diseases at a genetic level. Following the experiment, some of the volunteers noted a marked improvement in their eyesight. The affected individuals were all born with vision disorders, however, thanks to CRISPR, theyre now able to see better.

This is the first time scientists injected CRISPR directly into the human body. Previously, scientists had removed affected cells from the body and then conducted tests using the gene-editing procedure in the safety of a lab. From there, the scientists infused the modified cells back into the patients. With this experiment, though, the seven volunteers were injected directly with the treatment.

Scientists at the Casey Eye Institute conducted the study. The institute itself is part of the Oregon Health & Science University. Dr. Mark Pennesi shared the results of the CRISPR trial at the International Symposium on Retinal Degeneration late last year.

Following the injections, one of the patients shared that she was now able to safely navigate the area where she works. Another patient said that he could now see colors for the first time after the treatment. Both volunteers had suffered from LCA, or Leber congenital amaurosis, a severe vision impairment.

CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats. Scientists engineered the treatment in 2012. It was intended to act as a biological tool for altering DNA. In the past ten years, though, scientists have found a multitude of other users for the gene-editing procedure.

Thats where the most recent study comes into play. By injecting the CRISPR directly into the body, scientists were able to see how it would more greatly affect it as a whole. Additionally, being able to inject it directly would allow them to treat disorders and diseases in areas where it isnt safe to remove cells, like the brain.

Because it focuses on editing things at a genetic level, scientists hope that CRISPR will open new doors to fighting cancer and other diseases. Once improved and thoroughly studied, it could become one of the most powerful treatments the medical community has available.

Its a really amazing technology and very powerful, Pennesi told NPR back in September.

Now that were seeing some additional pushes for the treatment, we could see some other studies appearing in the coming months. Of course, it is worth noting that not all the volunteers experienced any improvements. As such, theres no real timetable for when CRISPR could become a more widespread treatment.

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This remarkable tech can actually improve the eyesight of the visually impaired - BGR

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market report will be very beneficial to both of the sides in the market that is an established firm and a relatively new entrant. It helps the established firms to know about the moves which are being performed by their competitors whereas it helps the new entrants by educating them about the market situations and the industry trends. This market report includes market share appraisals for regional and global levels, detailed overview of parent market potential and niche segments/regions exhibiting promising growth, in-depth analysis of the global order management software market and current & future trends to elucidate imminent investment pockets.

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The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market is expected to witness market growth at a rate of 26.88% in the forecast period of 2021 to 2028. Data Bridge Market Research report on clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market provides analysis and insights regarding the various factors are expected to be prevalent throughout the forecast period while providing their impacts on the markets growth. The rise in the demand in the food industry for better products with improved quality and nutrient enrichment is escalating the growth of clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market.

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The major players covered in the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market report are Applied StemCell, ACEA BIO, Synthego, Thermo Fisher Scientific, GenScript, Addgene, Merck KGaA, Intellia Therapeutics, Inc, Cellectis, Precision Biosciences, Caribou Biosciences, Inc., Transposagen Biopharmaceuticals, Inc, OriGene Technologies, Inc., Novartis AG, New England Biolabs, Rockland Immunochemicals Inc., ToolGen, Inc., TAKARA BIO INC., Agilent Technologies, Inc., Abcam plc, and CRISPR Therapeutics AG among other domestic and global players.

Competitive Landscape and Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market Share Analysis

The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing 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, global presence, production sites and facilities, company strengths and weaknesses, product launch, clinical trials pipelines, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companies focus related to clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market.

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) gene is referred to as a genome editing technology that permits the genetic material to be added, altered and removed in an organisms DNA.

Major factors that are expected to boost the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the forecast period are the rise in the incidence ofgeneticdisorders and the utilization of genome editing. Furthermore, the private and government funding is further anticipated to propel the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market. Moreover, the rise in thetechnologydevelopment in the CRISPR gene editing is further estimated to propel the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market. On the other hand, the off target effects and delivery is further projected to impede thegrowthof the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the timeline period.

In addition, the growing of the gene and cell therapy area and the CRISPR gene editing scope in the agriculture sector will further provide potential opportunities for the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the coming years. However, the ethical issues and consequences regarding the human genome editing might further challenge the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the timeline period.

The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market.

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market Scope and Market Size

The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market is segmented on the basis of therapeutic application, application, technology, services, products and end users. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

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Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market Country Level Analysis

The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market is analysed and market size information is provided by country, therapeutic application, application, technology, services, products and end users as referenced above.

The countries covered in the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market report are U.S., Canada and Mexico in North America, Peru, Brazil, Argentina and Rest of South America as part of South America, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, Hungary, Lithuania, Austria, Ireland, Norway, Poland, Rest of Europe in Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Rest of Asia-Pacific (APAC) in Asia-Pacific (APAC), South Africa, Saudi Arabia, U.A.E, Kuwait, Israel, Egypt, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA).

North America dominates the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market due to the considerable investments made by biotechnology and pharmaceutical companies. Furthermore, the rise in the healthcare infrastructure will further boost the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the region during the forecast period. Asia-Pacific is projected to observe significant amount of growth in the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market due to the increasing of the per capita income. Moreover, the early accessibility of authorized therapies is further anticipated to propel the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the region in the coming years.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, disease epidemiology and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

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Patient Epidemiology Analysis

The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market also provides you with detailed market analysis for patient analysis, prognosis and cures. Prevalence, incidence, mortality, adherence rates are some of the data variables that are available in the report. Direct or indirect impact analysis of epidemiology to market growth are analysed to create a more robust and cohort multivariate statistical model for forecasting the market in the growth period.

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Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market 2022 Business Outlook with Pandemic Scenario Analysis and...

It has been more than a year since Markus Mapara, MD, a professor of medicine and director of blood and marrow transplantation at Columbia University Irving Medical Center in New York, first used an experimental CRISPR gene-editing treatment in a patient with sickle cell disease, an inherited blood disorder that can cause severe pain, organ damage, and premature death.

Although the clinical trial is still in early stages and has only been tested in a few patients, so far, the results are promising.

[The patient is] doing phenomenally well, says Mapara, who is a hematologist, oncologist, and blood transplant physician. He has not had a single crisis.

Sickle cell disease, which currently affects about 100,000 people living in the United States and millions worldwide, is the result of a genetic mutation that produces an abnormal type of hemoglobin, the protein that red blood cells use to deliver oxygen throughout the body. The abnormal cells take on a sickle, or curved, shape, which can clot within narrow blood vessels.

This is a huge health problem for these patients, Mapara says. It has a huge impact on their quality of life and well-being.

At the moment, a bone marrow transplant from a healthy donor is the only curative option, but this approach can have severe complications.

Youre running into risks of introducing foreign cells into a recipient, Mapara says. [The body] may reject them, or the donor cells might attack the recipient.

But with the development of CRISPR (which stands for clustered regularly interspaced short palindromic repeats), new opportunities for treatment using the patients own cells have opened up.

[CRISPR is] a tool that scientists and clinicians around the world are using to understand our genetics, the genetics of all living things, and most importantly to intervene in genetic disease.

Jennifer Doudna, PhD, University of California, Berkeley

CRISPR, as it is known today, was developed by two scientists, Jennifer Doudna, PhD, who runs a lab at the University of California, Berkeley, and Emmanuelle Charpentier, PhD, scientific and managing director of the Max Planck Unit for the Science of Pathogens in Berlin, Germany, who were awarded the 2020 Nobel Prize in chemistry for their work on this technology.

The scientists worked together to uncover precisely how bacteria have evolved to fight off viruses and to apply that same process to engineer human cells. In particular, Doudna and Charpentier found that an enzyme known as Cas9 can be guided by a programmable RNA to locate specific genetic sequences in any organism. The enzyme then works like a pair of scissors, cutting the DNAs double helix and allowing for sequences to be deleted, added, or replaced.

Its a tool that scientists and clinicians around the world are using to understand our genetics, the genetics of all living things, and most importantly to intervene in genetic disease, Doudna said during a speech at Learn Serve Lead 2021: The Virtual Experience, the AAMCs annual meeting, in November.

The technology has been celebrated throughout the scientific community as a significant advancement that is changing the way research is done across fields. CRISPR has been used to experiment with gene-edited mosquitos to reduce the spread of malaria, for engineering agriculture to withstand climate change, and in human clinical trials to treat a range of diseases, from cancer to transthyretin amyloidosis, a rare protein disorder that devastates nerves and organs.

Still, the technology comes with significant ethical implications, including ensuring it does not have unintended negative consequences, that it is used equitably, and that a consensus is reached on where to draw the line in the technologys use.

AAMCNews spoke with researchers, physicians, ethicists, and educators on the cutting edge of CRISPR technology about its enormous potential for both good and harm to the future of humanity.

The clinical trial that Mapara enrolled his patient in last year was one of the first to attempt to use CRISPR to treat a genetic disorder in humans.

Though researchers and physicians are pursuing several gene therapy treatments for sickle cell disease and beta thalassemia, a similar blood disorder, this approach targets the gene that stops the production of fetal hemoglobin. Experts have found that people produce fetal hemoglobin up until about three months after birth, at which time their cells begin to produce adult hemoglobin, Mapara explains. It is the adult hemoglobin in people with sickle cell disease and beta thalassemia that takes the irregular shape and causes health problems.

For a physician-scientist it is a dream come true when you can be part of and witness the development of a revolutionary new treatment modality.

Markus Mapara, MD, Columbia University Irving Medical Center

You get rid of the repressor and have enhanced production again of fetal hemoglobin, he says, explaining that the patients who are now producing higher numbers of fetal hemoglobin rather than the mutated adult hemoglobin are experiencing fewer crises.

National Public Radio has been documenting the journey of the first person to join the clinical trial, Victoria Gray, since her first treatment in 2019.

This is really a life changer for me, Gray told NPR last December.

Mapara says that the initial results of the clinical trial were published in December 2020 and that follow-up results continue to be very promising.

This is really a potential game-changer for those patients, he says. For a physician-scientist it is a dream come true when you can be part of and witness the development of a revolutionary new treatment modality.

CRISPR is also being used in a clinical trial aimed at treating Lebers Congenital Amaurosis, a genetically determined progressive form of congenital visual loss and blindness.

While there are more than 300 genes that are linked to vision defects, this trial focuses on one gene mutation that causes a particularly severe form of degeneration.

Its what we call a problem with splicing of mRNA, says Mark Pennesi, MD, PhD, who leads Oregon Health & Science Universitys involvement in the trial and is the Kenneth C. Swan professor of ophthalmology in the OHSU School of Medicine and chief of the OHSU Casey Eye Institutes Paul H. Casey Ophthalmic Genetics Division. The mutation creates a little stop sign in the sequence so the whole protein doesnt get produced [for the treatment, guide] RNAs will target sequences on either side of the stop sign, the Cas [CRISPR-associated] protein will cut them out, and the DNA will repair itself. Hopefully, the cells will start to make the protein.

Its groundbreaking. The eye is one of the most accessible parts of the brain and vision is such an important thing for people. This really does open the door for many other therapies.

Mark Pennesi, MD, PhD, Oregon Health & Science University School of Medicine

Last year, clinicians at OHSUs Casey Eye Institute performed the CRISPR procedure on a patient, marking the first time CRISPR has been used in a human in vivo, or within the body, as opposed to removing the genetic material for editing.

Its groundbreaking, Pennesi says. The eye is one of the most accessible parts of the brain and vision is such an important thing for people. This really does open the door for many other therapies We are hoping we could use CRISPR in neurological or muscular diseases.

Initial results from the clinical trial involving six patients show that the procedure is safe and that it could improve vision.

One patient treated at our site has gone public, he says. Shes experienced an improvement in visual acuity, she can see objects, and she feels she is actually seeing color.

Pennesi says they will continue to increase the doses of the treatment in order to monitor if results improve and adds that they hope to eventually make this treatment available to children, who are more likely to experience reduced effects of degeneration.

Its really a wonderful time to be in this field because its changing from a field where we had no options to now one where we do, he says.

CRISPR is also causing a buzz in the field of cancer treatment.

At the University of Pennsylvania in Philadelphia, physicians and researchers have used CRISPR to genetically engineer immune cells to better fight tumors.

Edward Stadtmauer, MD, section chief of hematological malignancies at Perelman School of Medicine at the University of Pennsylvania and principal investigator of the clinical trial, started working on this project around 2016, when CRISPR technology was very new.

Stadtmauer had long been working with CAR T-cell therapy, which edits the immune T-cells by adding a warhead to the outside that targets cancer cells. While this method has been extremely effective with many blood cancers, Stadtmauer hypothesized that CRISPR could take the treatment to the next level.

Using the technology, Stadtmauer and his team were able to take the patients T-cells, remove three genes and add one gene that, together, lengthened the life of the immune cell and made them more potent at targeting cancer. It was the first investigational use of multiple edits with CRISPR to alter the human genome.

Remarkably, and probably to me the most important finding of the study was that these triple gene-edited cells with the additional insertion of another gene actually had tremendous proliferation and expansion ability and continue to survive for nine months to a year later without any sign that they were going down in their number, Stadtmauer says. He adds that patients who received the edited cells did not experience any serious unintended consequences or severe side effects. Those things were reassuring and why we consider it to be safe.

While these results are promising, there is still much research to be done to maximize the technologys potential in cancer treatment. Blood samples from the three patients involved in the trial showed that the edited cells thrived, but none of the patients responded to the therapy.

One of the limitations of using your own cells is that the cells may not be as functional in a patient as cells from a healthy, younger person because of age or exposure to chemotherapy, Stadtmauer says. And the other problem is that it can take a month or so from the day that the patient gets the cells harvested to actually infusing the cells, and that requires patients who are sick with their disease to have some sort of bridging therapy to keep them well until the product is created. So, the most exciting current approach is to use allogenic or donor immune cells as a source for an off-the-shelf product that can be infused in a timely manner and directed at whatever antigens you want and there's a tremendous amount of research going on right now in this promising area.

One of the most remarkable things about CRISPR technology is how rapidly it has developed. But as exciting as this is for the advancement of science and medicine, experts in fields ranging from research to bioethics, including Doudna, have cautioned that the advancement should not outpace the tackling of ethical complications that arise.

Among these is determining who will have access to advanced gene therapies.

We have to really grapple with equity and accessibility, Doudna said at the AAMC annual meeting. We have to be cognizant of how to be sure that everyone who can benefit from this technology has access to it.

This is an issue that Eric Kmiec, PhD, had on the top of his mind in 2015, when he became the founding director of the Gene Editing Institute at ChristianaCare in Newark, Delaware, the only institute of its kind that is based in a community health system.

All due respect to major medical centers they do amazing work but somehow the community cancer center always felt to me to be on the ground in cancer, Kmiec says. We ought to think about how those technologies are going to affect all people.

The Gene Editing Institute has what Kmiec calls a bench to bedside paradigm. He and his researchers have offices in the same building where the oncologists are seeing patients. They attend grand rounds and have an open-door policy with the physicians. A surgical oncologist regularly attends lab meetings where research is discussed.

Interacting with the clinicians almost daily taught me a lot about how challenging this damn thing [treating cancer] is, Kmiec says. A lot of really bright people have worked on cancer therapy for years we have to sculpt our approach on what the clinicians are telling us usually [researchers] come in and tell clinicians how to use tech. We did the opposite.

The institutes commitment to equity goes beyond the development of therapies that reach underserved populations; it also extends to diversifying the recruitment base for the next generation of CRISPR scientists. In a partnership with Delaware Technical Community College, it created CRISPR in a Box, an educational kit that gives high school and community college students the tools to study and use CRISPR in the classroom. The resource has been accompanied by a concerted outreach effort that includes instructional videos and opportunities for students to interact with scientists through Zoom to help explain the technology.

Kmiec is hopeful that lighting the spark of interest in CRISPR and showing young people, particularly people of color and those who come from under-resourced communities, that using this technology does not require an advanced degree will inspire a more diverse labor force in the future.

We want to engage communities of color not just to learn about something we already know about, but to engage directly in [its development], Kmiec says. [That way] the minority groups will be standing with us at the finish line.

Austin Keeler, PhD, a postdoctoral student at the University of Virginia, uses CRISPR in the lab to alter the genetic makeup of mouse embryos to create transgenic animals for research. Though he finds CRISPRs potential exciting, he thinks a lot about its ethical implications on issues that currently resemble science fiction more than reality. These thoughts inspired the subject of a course he teaches to undergraduate students entitled Homo CRISPR Future Humans?

Keeler provides his students with resources to explain how gene editing works and then opens up classroom time to discussions about a variety of its current and potential uses: from gene-editing mosquitoes to control the spread of malaria to the use of CRISPR for cosmetic changes in humans.

I wanted to hammer home how fast weve moved into this technology and how much potential it has to drastically change our lives, Keeler says. It is going to have profound ramifications in their adulthood and in the lives of their children. Im not sure how much of what is happening has made its way to outside of academia.

These ethical issues have made headlines in recent years. In 2018, a Chinese biophysicist, He Jiankui, announced to the world that he had created the first genetically altered babies. He had used CRISPR to edit the germline of three embryos to make them less susceptible to HIV.

The announcement was met with outrage from scientists and ethicists alike and He was ultimately sentenced by the Chinese government to three years in prison for illegal medical practice. It was a reminder that the technology, which is so efficient and easy to use, has the potential to be abused without clear regulations and oversight.

Like any new technology, CRISPR comes with risks, Doudna said at the AAMCs annual meeting. It was clear early on that there were going to be some real ethical challenges.

In an effort to facilitate public discourse on these challenges, Doudna will be participating in the Third International Summit on Human Genome Editing in March 2022, where stakeholders from across the world will discuss the current state of the science as well as ethical and cultural considerations, the development of regulations, and the role of the public in directing the research agenda, among other issues.

Christopher Scott, PhD, a bioethicist and the Dalton Tomlin professor of medical ethics and health policy at Baylor College of Medicine in Houston, Texas, is currently working on a National Institutes of Health-funded project that will be the first comprehensive empirical study into how society might go about regulating the ethical use of genome editing moving forward.

Like any new technology, CRISPR comes with risks It was clear early on that there were going to be some real ethical challenges.

Jennifer Doudna, PhD, University of California, Berkeley

Scotts team has met with dozens of people, including lawyers, disability rights advocates, ethicists, and futurists, but has also focused on engaging members of the public who are not regularly involved in discussions about scientific technology.

We get their feedback about their opinions and values, Scott says of the members of the public. The results have been super eye-opening.

As part of the study, groups of laypeople were presented with different future scenarios involving gene editing and were asked about their comfort level with them. Scott has found that, in general, there is a major distinction between somatic cell editing, which is the altering of often disease-causing genes that are not involved in reproduction, and germline editing, which changes heritable traits.

With germline editing, the answer was, generally, We shouldnt do that yet, Scott says. One question [posed] was, If it were as safe as we could make it, [should it be done?] There were not a lot of unanimous, absolutely, yes we should do that [answers].

Keeler observed similar reservations among the students in his class. Many of the students were disturbed at the idea that a humans genetic traits could be changed without their consent. Some worried that, if someday it is possible to enhance certain traits that are perceived as beneficial, it might further increase inequities between the super elites and people not afforded such enhancements.

You have all the normal ethical issues that arise in the context of using technologies that can be used in ways one might find problematic, says Inmaculada de Melo-Martin, PhD, a professor of medical ethics in medicine at Weill Cornell Medicine Medical College in New York. [For example,] selecting for particular traits, or against particular traits, [and] what this means for the things we value.

Although some of these technologies are not yet possible, Scott says that its important to create clear governance structures and ethical guidelines now before the next generation of gene editing technologies develop.

There is a way to deliberate this with foresight rather than with hindsight, Scott says.

So far, there is little international consensus on what is acceptable when it comes to experimental gene editing in humans. In the meantime, responsibility rests on researchers and the institutions that support them to examine the ethics of their own work.

This technology is so powerful. It can provide so many benefits its easy to just put aside the possible concerns and say we will solve those problems when they arise, de Melo-Martin says. My concern is that the possibilities, the promises of these interventions, are so significant that it can prevent us from realizing we need to be careful and pay attention to what the consequences might be.

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The future of CRISPR is now - AAMC

Sonodynamic therapy (SDT) is an emerging approach involving low-intensity ultrasound and specialized chemical agents known as sonosensitizers. It releases harmful reactive oxygen species (ROS) at the tumor site.

Cancer cells can activate antioxidant defense systems to counteract it, so the treatment is not considered very effective.

Scientists reported breaching these defenses using CRISPR/Cas9 gene editing in a new study. CRISPR/Cas9 gene-editing allows sonodynamic therapy to shrink tumors in a mouse model of liver cancer effectively.

Cancer cells can quickly overcome sonodynamic therapy by activating a nuclear factor erythroid 2-related factor 2 (NFE2L2) gene. The NFE2L2 deploys the cells detoxification and antioxidant enzyme defenses. Cas9 gene-editing technology is known for breaking down gene expression in the lab.

Hence, scientists wondered if they could increase sonodynamic therapys effectiveness by using this technology to reduce NFE2L2 expression.

Scientists started with encapsulating the CRISPR/Cas9 system and a ROS precursor molecule in lipid nanoparticles. They then treated hepatocellular carcinoma cells in a petri dish with the nanoparticles.

The cells lysosomes then took the lipid nanoparticles. ROS formation caused by ultrasound treatment ruptures lysosomes. It also enables the CRISPR/Cas9 system to enter the nucleus and break down NFE2L2 gene expression. The ROS also damaged other cellular components.

As a result, the therapy kills more cancer cells without NFE2L2 gene editing.

Scientists injected the nanoparticle treatment into mice with implanted human hepatocellular carcinoma tumors. After 15 days of follow-up, scientists did not find any tumor in the mice. The tumors in the mice disappeared and didnt come back.

Scientists acknowledged, Mice treated with sonodynamic therapy alone had fewer tumors than untreated mice, but the addition of the CRISPR/Cas9 gene-editing significantly improved the therapys effectiveness. Because gene editing occurs only in tumor tissues under ultrasound irradiation, it wont cause gene mutations in healthy tissues.

Journal Reference:

Read more:
CRISPR/Cas9 gene-editing increases the effectiveness of ultrasound cancer therapy - Tech Explorist

Bacteria get a bad rap, and often deservedly so: Different strains cause a range of infections and diseases, including pneumonia, strep throat, and tuberculosis. However, any well-researched health food advocate can list the many benefits of the bacteria present in yogurt, and your local pub would be doomed without the strains integral to crafting their signature brews. What might be even more surprising is that a recent, revolutionary gene-editing technology, once exclusively the subject of science fiction, is based on the bacterial genome.

Bacteria and archaea, the original hosts of the CRISPR-Cas9 system, use this DNA-protein system to defend themselves from viruses. CRISPRs are DNA sequences that repeat in the genome of a bacterium, interspersed with fragments of genetic code from past viral invaders. When a virus enters a bacterial cell, the remnants of that same virus held in the bacterias DNA help identify and eliminate the virus. Once a virus is identified by a bacterium, Cas9 proteins try to figure out whether the new viral intruder matches any of the genetic information contained in the CRISPRs sequences of their DNA. If the virus matches the stored genetic information, the Cas9 protein will cleave it into pieces.

In 2011, researchers, including Nobel laureates Jennifer Doudna and Emmanuelle Charpentier, discovered that Cas9 proteins can be used to cut genomes that do not contain viral information, inspiring a plethora of research projects that have widened the scope of biotechnological possibility.

One such project is spearheaded by Daniel Sapozhnikov, a PhD candidate in the Department of Pharmacology and Therapeutics at McGill, and Moshe Szyf, a professor in the same department. The project aims to develop a way to remove methyl groupsone carbon atom bonded to three hydrogensfrom genes. Many diseases and disorders are dependent on whether specific genes are expressed, or turned on. Since varying amounts of methylation are associated with whether or not a gene is active, then being able to remove methyl groups could have important consequences for gene manipulation in scientific studies.

Since the 1980s, its been shown that [] genes with less [methylation] tend to be expressed [more] and genes with more tend to be expressed [less], Sapozhnikov said in an interview with The McGill Tribune. Thats basically the same conclusion that we have been stuck with in 2020. Without the ability to manipulate the DNA methylation levels at specific genes, there is really not much causational evidence for how DNA methylation and gene expression interact.

In order to better understand the relationship between methylation and gene expression, Sapozhnikov and Szyf developed a technique to demethylate select regions of a cells DNA.

CRISPR-Cas9 plays an integral role in the demethylation technique developed by Sapozhnikov and Szyf. By using guide RNA and Cas9 to block the methylation of genes, the effect of DNA demethylation can be evaluated in different cases. The specific system of CRISPR-Cas9 the team used is known as dCas9, which is CRISPR-Cas9 with a modified protein that prevents the cutting of DNAa potentially lethal consequencewhile retaining the important function of gene targeting. Once the dCas9 protein reaches the desired target of a genome, it binds to the site, preventing methylation of whatever it is attached to by physically blocking the process.

Although other teams have developed techniques for demethylation, Sapozhnikov believes that their method is the most exact.

There have been other tools that have been made that do similar things, but we argue that our tool is better from a causational perspective because [] it has fewer other activities, Sapozhnikov said.

The technique developed by Sapozhnikov and Szyf only works to remove methyl groups. Understanding the correlation between demethylation and gene expression could help the development of therapies to treat the numerous problems that arise from the improper functioning of gene expression.

CRISPR-Cas9 is still a very new technology, and it can often have unforeseen consequences in the cells it is used onnot to mention the ethical concerns raised by editing someones DNA, which is a topic of heavy debate and even outrage amongst the scientific community. Despite the many unanswered questions, CRISPR-Cas9 represents an incredible step toward revolutionary gene therapy, and with research like that of Sapozhnikov and Szyf, important new uses will continue to be explored.

Read more:
CRISPR-Cas9, the unwitting revolutionary - McGill Tribune

Agreement with Corteva Agriscience and Broad Institute of MIT and Harvard grants FuturaGene access to gene editing technology to research and develop varieties of eucalyptus that are adapted to climate change

SAO PAULO, Brazil, December 08, 2021--(BUSINESS WIRE)--FuturaGene, a wholly owned subsidiary of world-leading eucalyptus pulp producer, Suzano, will use patented genome editing technology from global pure-play agriculture company, Corteva Agriscience, and non-profit research organization, the Broad Institute of MIT and Harvard, to develop new, improved eucalyptus varieties.

FuturaGene intends to apply the gene editing technology to research and develop new varieties of eucalyptus that are more productive, resistant to diseases and pests and have improved fiber properties. In addition, the company aims for the new varieties to be more resilient to climate change and to serve as an alternative to products derived from fossil fuels. FuturaGene has the option to convert the worldwide research license to cover commercial applications.

Dr. Stanley Hirsch, CEO of FuturaGene, commented: "With our extensive experience and growing pipeline, FuturaGene is well placed to apply gene editing technology from our licensors to develop eucalyptus varieties that can help the world meet the growing demand for renewable wood-based products. This includes fibers and the potential to replace carbon-intensive fossil fuel-based materials, such as plastics, in a sustainable way.

"Our ability to share the benefits of this major enabling technology with small farmers within our supply chain, royalty free, was an important part of our negotiations with the licensors. This commitment is strongly aligned with Suzanos sustainability goal to mitigate income inequality and help lift people out of poverty. FuturaGene has always seen shared value as a vital part of our purpose".

The multi-institutional license covers CRISPR-Cas9 patent rights owned by a collection of leading universities and institutes.

Story continues

The licensed genome editing technology gives scientists the ability to edit an organism's DNA by altering and silencing genes or adding genetic material at specific locations in a highly targeted way. This can potentially be used to change wood properties, ablate susceptibilities to disease or chemical agents, or select for and instill desirable traits. The technology therefore has huge potential in forestry to help farmers optimize productivity.

- Ends -

About FuturaGene

FuturaGene is a leader in plant genetic research and development for increasing productivity and resilience in the global renewable forestry sector. With facilities in Brazil and Israel, the company develops sustainable, ecologically sound technology to meet the ever-increasing demands for fiber, alternatives to fossil fuel-based products such as plastics and energy crops in the face of declining land and water resources and climate change. In April 2015, FuturaGene became the first company in the world to obtain regulatory approval to commercially deploy a yield enhanced genetically modified eucalyptus variety. Since July 2010, FuturaGene has been a wholly owned subsidiary of Suzano S.A., the worlds leading eucalyptus pulp producer and one of Latin Americas largest paper producers.

For more information, visit http://www.futuragene.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211208005555/en/

Contacts

For additional information please contact: FuturaGene Sara El Kadri+55 11 997398249Global Communications and Public Affairs Manager, FuturaGenesara.kadri@futuragene.com

Agnes Stephens+44 207 457 2002Media relations, Instinctif Partnersfuturagene@instinctif.com

Read more:
FuturaGene Secures License to CRISPR-Cas9 Technology to Develop Sustainable Varieties of Eucalyptus with Improved Productivity, Stress Resistance and...

Gene editing techniques like CRISPR could revolutionize the poultry industry in the future, improving yield, resistance to disease and leading to better welfare.

Gene editing itself has become a topic of much research and great interest in the academic and in the commercial work, Mark Fife, Ph.D., head of biotechnology, Aviagen, said during the Poultry Tech Webinar Series.

CRISPR functions like a pair of molecular scissors. The technique can cut DNA from a specific location at the gene, deleting the sequence entirely or replacing it with an alternative sequence.

It has several applications from medical to plants to livestock and aquaculture and micro-organisms. The bulk of the stories in the news refer to potential breakthroughs in human medicine, such as cancer treatments and genetic disorders.

In livestock, much of the discussion about gene editing currently applies to disease resistance, yield and quality, welfare and sex determination. For example, in cows, CRISPR has been used to create polled cattle and heat tolerant cattle, which can be beneficial to both welfare and management.

Poultry require a slightly different gene editing approach compared to other livestock. For mammals, a technique called somatic cell nucleic transfer (SCNT) is used, but it requires access to the developing embryo.

In chickens, thats obviously a different story because we cant access the embryo to implant the edit, Fife explained,

Instead, the process used for avian species makes genetic edits to primordial germ cells, the progenitors for sperm and ovum cells in the chicken.

What we do is we get into the developing embryo at a very early stage, about two and a half days into embryonic development. We then isolate the primordial germ cells, he added.

Researchers can perform various gene edits on the primordial germ cells, which continue to grow and develop in cell culture. At HH stage 14-17 of the chick development, the primordial germ cells are reinserted into the embryo, resulting in a chimeric chicken.

As you can see, not only is it very different from somatic cell nuclear transfer, it also takes a very long time, said Fife.

Recent advancements in this gene editing technique have resulted in poultry resisted to the avian leukosis virus and avian influenza.

Gene editing currently faces regulatory hurdles throughout much of the world. In the U.S., gene editing is highly regulated by the Food and Drug Administration (FDA). Meanwhile, the process is completely prohibited in Europe, although a post-Brexit UK is currently looking at deregulating gene edited crops.

Although everyone is incredibly excited by this at the moment, the gene editing peak is probably at a max and we are talking about food security, sustainability and animal welfare. But often what happens with technology is we hit this trough of disillusionment, Fife said.

Hopefully, this technology will clear regulatory hurdles and enter the sight of the slope of enlightenment and the plateau of productivity, he added.

Aviagens breeding techniques are exclusively based on traditional and established selection methods, Fife said, and although the company also recognizes its potential value as a research tool, there are no plans to introduce gene editing or any other genetic modification technique for commercial breeding purposes.

For more on the technologies set to advance the poultry industry, join industry-changing innovators, researchers, entrepreneurs, technology experts, investors and leading poultry producers at the Poultry Tech Webinar Series, scheduled for November 2, 4, 10, 11, 17, 30 and December 2.

During the webinar series, industry experts will preview whats coming next from prospective solutions to developing technology for the poultry industry.

This webinar series is proudly sponsored by: Arm & Hammer, Aviagen, Baader, Boehringer Ingelheim, Cargill, Ceva, Chore-Time, Cobb, Evonik, Marel, Phibro Animal Health, Staubli and Zoetis.

Visit our website for more details on the webinar series, topics and speakers.

Register for free today and join us for a glimpse at the future of the poultry industry.

Read more here:
Will CRISPR transform the poultry industry? | WATTPoultry - WATTAgNet Industry News & Trends

EMERYVILLE, Calif.--(BUSINESS WIRE)--Metagenomi, a genetic medicines company with a versatile portfolio of next-generation gene editing tools, today announced that the company will share data related to their novel, compact, and hypo-immune gene editing systems at the 63rd Annual Meeting and Exposition of the American Society of Hematology (ASH), which is taking place in Atlanta, GA and virtually, December 1114.

The development of CAR T therapies and other genetically engineered cell therapies in recent years has resulted in significant benefits for patients, yet there remains a large unmet need for gene editing systems that can be used to develop novel immunotherapy approaches to treat blood cancers, said Brian C. Thomas, PhD, CEO and Co-Founder of Metagenomi. At ASH, we are presenting data on our novel nucleases that display highly efficient and specific gene editing both in vivo and ex vivo and hold significant potential to drive the development of new and efficacious therapies for patients.

In a poster titled A Novel Type V CRISPR System with Potential for Genome Editing in the Liver, it is shown that Metagenomis novel Type V CRISPR-associated nuclease was highly active in the liver of mice when systemically administered via lipid nanoparticles (LNP). The nuclease was derived from a unique natural environment and is phylogenetically distinct from previously identified Type V systems. Moreover, no antibodies to the nuclease were detected in serum from 50 healthy human donors, while between one third and half of the same serum samples contained antibodies that bind to spCas9, which is derived from a Streptococcus bacteria that commonly infects humans. In summary, this novel Type V CRISPR-associated nuclease is a promising new gene editing system for in vivo editing of the liver.

In a separate poster titled Novel CRISPR-Associated Gene Editing Systems Discovered in Metagenomic Samples Enable Efficient and Specific Genomic Engineering for Cell Therapy Development, three novel gene editing systems were used to make reproducible and efficient edits to human immune cells, demonstrating utility for the next generation of cell therapy development for blood cancers. Metagenomis novel gene editing systems were used to disrupt the T cell receptor alpha-chain constant region and the T cell receptor beta-chain constant region in approximately 90 percent of cells. Beta-2 microglobulin was edited in 95 percent of T cells. A chimeric antigen receptor (CAR) construct was also shown to be integrated in up to 60 percent of T cells. Novel gene editing systems were deployed in NK cells to disrupt CD38 a cell surface immune modulator that can be targeted in the development of cancer immunotherapy and to integrate a CAR construct that led to robust CAR-directed cellular cytotoxicity. B cell editing occurred in approximately 80% of target cells with successful transgene integration. Whats more, as these gene editing systems are taken from environmental samples as opposed to human pathogens, pre-existing immunity is expected to be rare. In summary, these novel systems were shown to result in highly efficient and specific gene edits in human immune cells and display the potential for use in cell therapy development.

Details of the presentations are below:

Presentation Title: A Novel Type V CRISPR System with Potential for Genome Editing in the LiverSession Title: 801. Gene Therapies: Poster IPresenting Author: Morayma Temoche-Diaz, PhDPublication Number: 1862 Session Time: Saturday, December 11, 5:30 p.m. ET

Presentation Title: Novel CRISPR-Associated Gene-Editing Systems Discovered in Metagenomic Samples Enable Efficient and Specific Genome Engineering for Cell Therapy DevelopmentSession Title: 801. Gene Therapies: Poster IIIPresenting Author: Gregory Cost, PhD, Vice President of Biology, MetagenomiPublication Number: 3984 Session Time: Monday, December 13, 6:00 8:00 p.m. ET

About Metagenomi

Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful gene editing systems that are ultra-small, extremely efficient, highly specific and have a decreased risk of immune response. These systems fuel our pipeline of novel medicines and can be leveraged by partners. Our goal is to revolutionize gene editing for the benefit of patients around the world. For more information, please visit https://metagenomi.co/.

See the original post:
Metagenomi to Present Preclinical In Vivo and Ex Vivo Gene-Editing Data at the 63rd American Society of Hematology (ASH) Annual Meeting - Business...

One 2021 study looked at the genome of Solanum sitiens a wild tomato species which grows in the extremely harsh environment of the Atacama Desert in Chile, and can be found at altitudes as high as 3,300m (10,826ft). The study identified several genes related to drought-resistance in Solanum sitiens, including one aptly named YUCCA7 (yucca are draught-resistant shrubs and trees popular as houseplants).

They are far from the only genes that could be used to give the humble tomato a boost. In 2020 Chinese and American scientists performed a genome-wide association study of 369tomato cultivars, breeding lines and landraces, and pinpointed a gene called SlHAK20 as crucial for salt tolerance.

Once the climate-smart genes such as these are identified, they can be targeted using Crispr to delete certain unwanted genes, to tune others or insert new ones. This has recently been done with salt tolerance, resistance to various tomato pathogens, and even to create dwarf plants which could withstand strong winds (another side effect of climate change). However, scientists such as Cermak go even further and start at the roots they are using Crispr to domesticate wild plant species from scratch, "de novo" in science speak. Not only can they achieve in a single generation what previously took thousands of years, but also with a much greater precision.

De novo domestication of Solanum pimpinellifolium was how Cermak and his colleagues at the University of Minnesota arrived at their 2018 plant. They targeted five genes in the wild species to obtain a tomato that would be still resistant to various stresses, yet more adapted to modern commercial farming more compact for easier mechanical harvesting, for example. The new plant also had larger fruits than the wild original.

"The size and weight was about double," Cermak says. Yet this still wasn't the ideal tomato he strives to obtain for that more work needs to be done. "By adding additional genes, we could make the fruit even bigger and more abundant, increase the amount of sugar to improve taste, and the concentration of antioxidants, vitamin C and other nutrients," he says. And, of course, resistance to various forms of stress, from heat and pests to draught and salinity.

Excerpt from:
The tomatoes at the forefront of a food revolution - BBC News

An enduring and persistent (albeit until now unresolved) issue in the patent interferences involving the Broad Institute, Harvard University, and MIT (collectively, "Broad") as Senior Party and the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") as Junior Party has been the question of whether Broad had committed inequitable conduct in prosecuting its patents- and applications-in-interference. CVC raised the issue in its proposed motions in Interference No. 105,048 (see "CRISPR Interference Motions Set" and "PTAB Redeclares CRISPR Interference and Grants Leave for Some (But Not All) of Parties' Proposed Motions") and in this '115 Interference (see "CRISPR Interference Parties Propose Motions"). In both interferences, the Board denied CVC authorization to file its motions grounded in inequitable conduct as being premature but granted leave for CVC to file a motion for authorization to file their inequitable conduct motion at the end of the priority phase.

That day never came in the '048 Interference, because the Board granted Broad's motion that there was no interference-in-fact and the Broad prevailed (see "PTAB Decides CRISPR Interference -- No interference-in-fact"). In this '115 Interference, CVC made much the same allegations made in the earlier interference (see "CRISPR Interference Parties Propose Motions"). According to CVC, "Broad made at least one affirmative material misstatement during prosecution of each of Broad's involved patents, applications, or parent applications to which they claim priority" -- specifically, in a declaration by named inventor Zhang regarding actual reduction to practice of CRISPR-Cas9 in eukaryotic cells prior to May 2012. CVC asserted that these statements were untruthful because the CRISPR system did not comprise tracrRNA, which is necessary for CRISPR to be functional. CVC asserted that it was undisputed that tracrRNA is necessary for CRISPR function, using disclosure from U.S. Provisional Patent Application No. 61/736,527 as well as in the Broad's involved patents and independent prior art. CVC also asserted that Dr. Zhang's "conception" arose only after reading a Berkeley prior art disclosure. The proposal for this motion extensively analyzed purported evidence for actual reduction to practice to show the Broad's asserted failure, alleging that the Broad "cherry-picked data" that "intentionally omitted the context that shows his claims of successful DNA cleavage to be false." This motion applied to all the Broad's patents- and applications-in-interference because the alleged untruthful statements were submitted in all applications.

CVC also made similar allegations for another declaration submitted by a different inventor, which they contend evinced "a larger pattern of deception." These allegations were supported by an e-mail from a Zhang lab member and named inventor on the Broad's provisional application (albeit in a context where there seems to exist an axe to grind against Dr. Zhang):

The 15-page declaration of [Feng Zhang] and Le Cong's luciferase data is mis- and overstated to change the examiner's decision, which seems to be a joke. . . .

After seeing your in virto [sic, in vitro] paper, Feng Zhang and Le Cong quickly jumped to the project without letting me know. My lab notebooks, emails and other files like dropbox or gel pictures recorded every step of the lab's failure process. I am willing to give more details and records if you are interested or whoever is interested to clear the truth. . . .

We did not work it out before seeing your paper, it's really a pity.

It appears, however, that CVC's time may have come. On June 25th, CVC by e-mail requested leave to file its inequitable conduct motion which included an assertion that "there are new justifications for [the] requested motion" (which Broad opposed). The Board denied this request by Order under 37 C.F.R. 41.104(a) on July 8th. However, on November 12th, the Board entered an Order under 37 C.F.R. 41.104(a) granting CVC leave to file a paper of no more than five pages that listed its "additional justifications" for filing its inequitable conduce motion. On November 18th, in a Paper entitled "CVC's Additional Justifications Supporting Authorizing a Motion for Unpatentability due to Inequitable Conduct," CVC filed its list pursuant to the Board's November 12th Order. In that Paper, the CVC provided the following allegations:

1. That Dr. Zhang testified in the '115 Interference that "demonstrate[ed] that his 2014 Declaration [in the '048 Interference] knowingly mischaracterized his March 2011 experiments.

2. That "the record in this ['115] interference shows that Zhang's 2015 Declaration misrepresents his alleged possession of 'a single molecule' guide RNA."

Regarding the first allegation, CVC argues that statements made by Dr. Zhang in a Declaration dated January 30, 2014 were "knowingly false." The statement in question reads as follows:

Exhibit 7 [i.e., experiments conducted in March 2011, as first revealed in this interference] shows that prior to May 2012, I conceived and reduced to practice . . . [a]n engineered, programmable, non-naturally occurring Type II CRISPR-Cas system . . . . [Ex. 3424]

The bases for CVC's allegation of knowing falsehood include 1) that Dr. Zhang had "since conceded that those experiments did not include any tracrRNA, which he knew was a necessary component when he signed his 2014 Declaration"; (2) that Dr. Zhang in two instances (during cross-examination and in a 2020 inventor declaration) "admitted . . . , that he did not begin introducing any form of tracrRNA into his experiments until April of 2011," supported by his further admission that "he learned about the existence of tracrRNA only after reading Deltcheva et al. (Ex. 3214), which first published in Nature on March 30, 2011" made during his deposition and that he began adding "the native tracrRNA" on April 5, 2011. From this CVC drew the conclusion that because this was after the March 2011 experiments, Dr. Zhang had made a materially false statement in this regard in his earlier declaration. CVC then argues that this timeline and truthful testimony (after the fact) was consistent with the deposition testimony CVC elicited from Dr. Marraffini (see "CVC Files Motion in Opposition to Broad Priority Motion") regarding CVC's contention that "[Dr.] Zhang did not know that tracrRNA was part of the DNA-cleavage complex until June 26, 2012." Because "[b]y the time [Dr.] Zhang signed his 2014 Declaration, however, he did know that tracrRNA was a necessary part of the Type II CRISPR-Cas9 system" and "[Dr.] Zhang knew that his March 2011 experiments did not include any form of tracrRNA," CVC contends that "[i]t was therefore knowingly false to declare that these experiments 'describe and enable' and 'reduced to practice' the claimed Type II CRISPR-Cas9 system," which was Dr. Zhang's testimony in his 2014 declaration.

Accordingly, should the Board agree that Dr. Zhang's testimony amounts to a knowingly false statement, CVC argues that under Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1292 (Fed. Cir. 2011) (en banc), these statements would be material to patentability per se. Because Dr. Zhang's averments in his declaration were "for the purpose of removing prior art to obtain allowance of claims" (and indeed "the examiner expressly relied on Zhang's 2014 Declaration in her reasons for allowance in each of Broad's 13 involved patents and involved '551 application), CVC argues that an intent to deceive was an appropriate inference for the Board to draw (supported by Dr. Zhang's statement in his declaration that "I understand that . . . if I can show conception and actual reduction to practice prior to the filing dates of the [art] . . . then I have removed the [art] from being prior art . . . ." (emphasis added in CVC's brief).

Regarding the second allegation, CVC raises Dr. Zhang's 2015 declaration wherein "[Dr.] Zhang attests that Figure 4B in a 2012 grant proposal to the National Institutes of Health ("the NIH grant") showed that "a single RNA can be used as a guide in the CRISPR-Cas9 system." Ex. 3424. This testimony is inconsistent with Dr. Zhang's testimony (and Broad's arguments) in this interference, wherein "[Dr.] Zhang and Broad have represented in this proceeding that the same Figure 4B of the NIH grant shows a dual-molecule guide system and not a single-molecule guide system" (emphasis added). CVC adds Dr. Zhang's further assertions from his 2015 declaration:

Having generated the figure of part B in the above illustration from the January 12, 2012 R01 NIH grant application, prior to January 12, 2012, I appreciated the mammalian expression system illustrated could be constructed, and when introduced into a mammalian cell could express products and function in vivo for cleavage and genome editing, as illustrated above, and as actually done prior to November 30, 2011, with appreciation that a single RNA can be used as a guide in the CRISPR-Cas system, including as shown by . . . the illustration of the NIH R01 grant application . . . . [Ex. 3424]

CVC then cited the phrase "used as a guide" in this passage of Dr. Zhang's deposition testimony in contrast with Dr. Zhang's deposition testimony in this interference to refer to "RNA that's guiding Cas9 to the target" and consequently that "[Dr.] Zhang declared to the Office that Figure 4B 'show[ed]' that he appreciated that 'a single RNA can be used as a guide in the CRISPR-Cas system.'" Once again, CVC argues that this statement is "knowingly false" because here "[Dr.] Zhang has admitted in this proceeding [i.e., in his 2020 inventor declaration in this interference] that Figure 4B in fact shows a dual-molecule guide system." CVC also notes that Broad has taken this position (that Figure 4B shows a dual-molecule embodiment of CRISPR) in this interference, inter alia, "[i]n support of its motions to change the count and de-designate claims corresponding to the count (both of which the Board denied), citing several arguments in Broad's motions and replies to CVC's oppositions to these motions. Further, CVC argues that a proper interpretation of Figure 4B as not showing a single-molecule RNA-comprising embodiment of CRISPR is consistent with Dr. Maraffini's testimony "that he first conveyed such a system to Zhang on June 26, 2012, by showing him CVC's work" (neatly wrapping in CVC's arguments that if Df. Zhang had achieved a single-molecule RNA-comprising embodiment of CRISPR in eukaryotic cells he had done so by deriving the invention from CVC's inventors). Once again, CVC argues that Dr. Zhang's statements in this instance are "unmistakably false and thus per se material" and that the examiner relied upon these statements in allowing the '551 application. And, CVC argues, the Board can infer an intent to deceive in view of Dr. Zhang's participation inter alia in an examiner interview "that involved discussion of 'whether there need be consideration of interference [sic] as to [CVC] applications.'"

CVC further asserts that the Board should hear its motion before Final Judgment, based on circumstances where "the factual record is complete, no discovery is required, and resolution is in the public interest," citing McDonald v. Miyazaki, Interference No. 104,544, Paper 149. There, where "an inventor submitted a declaration during prosecution that misrepresented certain experiments and activities in an effort to antedate prior art," the Board entered judgment cancelling all involved claims on inequitable conduct grounds saying these circumstances were "the sort of over-reaching and truth-shaving that Rule 56 was enacted to prevent." According to CVC, Dr. Zhang's and Broad's inequitable conduct here has been "[e]ven more egregious and pervasive."

Under these circumstances, CVC asserts in support of its demand that the Board hears (and presumably decides this motion before Final Hearing) that "the PTAB has a duty to protect the public from inequitably procured patents and to enforce Rule 56 to prevent abuse of declaration practice, as the examining corps is not equipped to police such misconduct."

View original post here:
Inequitable Conduct by Senior Party Broad Alleged in Interference No. 106115 (and PTAB May Finally Hear Evidence About It) - JD Supra

More evidence for the efficacy of a groundbreaking new gene-editing medical procedure has emerged, deepening hope it will provide one-shot treatments or even cures for cancer, sickle cell anaemia and other conditions.

Some people suffering from a rare severe visual disorder were able to see more clearly after being treated using the gene-editing technology known as CRISPR, according to reports.

For the first time, CRISPR gene-editing tools were injected directly into the human body, in this case to tackle the leber congenital amaurosis (LCA) condition that made it difficult for the volunteers to navigate their surroundings or see colours.

A volunteer in the experiment can now see colours and regained more peripheral vision.

Image: Mass Eye and Ear

In 2012, CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats, was first engineered as a biological tool capable of precisely altering DNA. Over the last decade, scientists around the world have continued to improve the safety and efficacy of CRISPR technologies, opening the door to potentially treating a range of genetic diseases.

For years, scientists have been trying to devise treatments that directly address the root cause of disease on the genetic level. Many commonly-used drugs act like a sledgehammer and non-specifically treat disease, which can lead to negative side effects and have varying impact across patients.

CRISPR falls into a category called precision medicine, which can precisely address the specific genetic defect causing a particular disease.

CRISPR works by combining scissor-like proteins with other molecules to locate troublesome parts of a persons DNA blueprint the genome.

CRISPR allows scientists to remove these disease-causing regions of the genome or replace them with DNA that stops or reverses the illness.

CRISPR is already used for a range of applications, from simple diagnostic tools to basic research purposes. During the pandemic, scientists created a CRISPR-based test for COVID-19.

But its wider rollout as a therapy depends on more trials and examination of possible side effects. Over a year following the CRISPR-based treatment of a patient with sickle cell disease, positive health improvements suggest that gene editing may offer a viable cure for many genetic diseases, but broad testing and long-term monitoring remain vital.

The application of precision medicine to save and improve lives relies on good-quality, easily-accessible data on everything from our DNA to lifestyle and environmental factors. The opposite to a one-size-fits-all healthcare system, it has vast, untapped potential to transform the treatment and prediction of rare diseasesand disease in general.

But there is no global governance framework for such data and no common data portal. This is a problem that contributes to the premature deaths of hundreds of millions of rare-disease patients worldwide.

The World Economic Forums Breaking Barriers to Health Data Governance initiative is focused on creating, testing and growing a framework to support effective and responsible access across borders to sensitive health data for the treatment and diagnosis of rare diseases.

The data will be shared via a federated data system: a decentralized approach that allows different institutions to access each others data without that data ever leaving the organization it originated from. This is done via an application programming interface and strikes a balance between simply pooling data (posing security concerns) and limiting access completely.

The project is a collaboration between entities in the UK (Genomics England), Australia (Australian Genomics Health Alliance), Canada (Genomics4RD), and the US (Intermountain Healthcare).

The application to LCA volunteers at Oregon Health & Science Universitys Casey Eye Institute in the US is a first of its kind.

To date, CRISPR treatments involved taking cells from a patient and changing parts of the subjects DNA before reinserting the edited cells back into the patient. Once back inside the body, the cells could multiply and hopefully eliminate the disease.

In the Oregon trials, however, the CRISPR tools were injected directly into the seven volunteers without removing any of their cells. In their case, it was inserted into the retina of the eye.

This new technique holds out hope for treatment of conditions in parts of the body from which cells cant be safely removed, such as the brain.

Its a really amazing technology and very powerful, Dr Mark Pennesi, Professor of Ophthalmology at the Institute told NPR.

One of the Oregon volunteers, Carlene Knight, said she was able to safely navigate her surroundings following the procedure, while another, Michael Kalberer, found he could see colours for the first time.

At his cousins wedding, Kalberer discovered that he could see the DJs strobe lights change colour and identify them to my cousins who were dancing with me, he told NPR. That was a very, very fun, joyous moment.

The trial is still ongoing and other volunteers didnt experience the same improvement. So its too soon to say when CRISPR will be able to treat sufferers of other genetic illnesses as effectively.

The views expressed in this article are those of the author alone and not the World Economic Forum.

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What is CRISPR technology and can it improve poor eyesight? | World Economic Forum - World Economic Forum

-Initiation of patient enrollment expected by year-end-

-Initiation of patient enrollment expected by year-end-

ZUG, Switzerland and CAMBRIDGE, Mass. and SAN DIEGO, Nov. 16, 2021 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, and ViaCyte, Inc., a clinical-stage regenerative medicine company developing novel cell replacement therapies to address diseases with significant unmet needs, today announced that Health Canada has approved the companies Clinical Trial Application (CTA) for VCTX210, an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D). Initiation of patient enrollment is expected by year-end.

With the approval of our CTA, we are excited to bring a first-in-class CRISPR-edited cell therapy for the treatment of type 1 diabetes to the clinic, an important milestone in enabling a whole new class of gene-edited stem cell-derived medicines, said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. The combination of ViaCytes leading stem cell capabilities and CRISPR Therapeutics pre-eminent gene-editing platform has the potential to meaningfully impact the lives of patients living with type 1 diabetes.

Being first into the clinic with a gene-edited, immune-evasive cell therapy to treat patients with type 1 diabetes is breaking new ground as it sets a path to potentially broadening the treatable population by eliminating the need for immunosuppression with implanted cell therapies, said Michael Yang, President and Chief Executive Officer of ViaCyte. This approach builds on previous accomplishments by both companies and represents a major step forward for the field as we strive to provide a functional cure for this devastating disease.

The Phase 1 clinical trial of VCTX210 is designed to assess its safety, tolerability, and immune evasion in patients with T1D. This program is being advanced by CRISPR Therapeutics and ViaCyte as part of a strategic collaboration for the discovery, development, and commercialization of gene-edited stem cell therapies for the treatment of diabetes. VCTX210 is an allogeneic, gene-edited, stem cell-derived product developed by applying CRISPR Therapeutics gene-editing technology to ViaCytes proprietary stem cell capabilities and has the potential to enable a beta-cell replacement product that may deliver durable benefit to patients without requiring concurrent immune suppression.

Story continues

About CRISPR TherapeuticsCRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

About ViaCyteViaCyte is a privately held clinical-stage regenerative medicine company developing novel cell replacement therapies based on two major technological advances: cell replacement therapies derived from pluripotent stem cells and medical device systems for cell encapsulation and implantation. ViaCyte has the opportunity to use these technologies to address critical human diseases and disorders that can potentially be treated by replacing lost or malfunctioning cells or proteins. ViaCytes first product candidates are being developed as potential long-term treatments for patients with type 1 diabetes to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. To accelerate and expand ViaCytes efforts, it has established collaborative partnerships with leading companies, including CRISPR Therapeutics and W.L. Gore & Associates. ViaCyte is headquartered in San Diego, California. For more information, please visit http://www.viacyte.com and connect with ViaCyte on Twitter, Facebook, and LinkedIn.

CRISPR Therapeutics Forward-Looking StatementThis press release may contain a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements made by Dr. Kulkarni and Mr. Yang in this press release, as well as regarding CRISPR Therapeutics expectations about any or all of the following: (i) the safety, efficacy and clinical progress of our various clinical programs including our VCTX210 program; (ii) the status of clinical trials (including, without limitation, activities at clinical trial sites) and expectations regarding data from clinical trials; (iii) the data that will be generated by ongoing and planned clinical trials, and the ability to use that data for the design and initiation of further clinical trials; and (iv) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies, including as compared to other therapies. Without limiting the foregoing, the words believes, anticipates, plans, expects and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the potential for initial and preliminary data from any clinical trial and initial data from a limited number of patients not to be indicative of final trial results; the potential that clinical trial results may not be favorable; potential impacts due to the coronavirus pandemic, such as the timing and progress of clinical trials; that future competitive or other market factors may adversely affect the commercial potential for CRISPR Therapeutics product candidates; uncertainties regarding the intellectual property protection for CRISPR Therapeutics technology and intellectual property belonging to third parties, and the outcome of proceedings (such as an interference, an opposition or a similar proceeding) involving all or any portion of such intellectual property; and those risks and uncertainties described under the heading "Risk Factors" in CRISPR Therapeutics most recent annual report on Form 10-K, quarterly report on Form 10-Q and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC's website at http://www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

CRISPR Therapeutics Investor Contact:Susan Kim+1-617-307-7503susan.kim@crisprtx.com

CRISPR Therapeutics Media Contact:Rachel Eides+1-617-315-4493rachel.eides@crisprtx.com

ViaCyte Investor Contact: David Carey, Lazar-FINN Partners+1-212-867-1768david.carey@finnpartners.com

ViaCyte Media Contact: Glenn Silver, Lazar-FINN Partners+1-973-818-8198glenn.silver@finnpartners.com

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CRISPR Therapeutics and ViaCyte, Inc. to Start Clinical Trial of the First Gene-Edited Cell Replacement Therapy for Treatment of Type 1 Diabetes -...

Earlier this month, the much-anticipated UN Climate Change Conference came to an end. As part of the flurry of activity, the United States and the United Arab Emirates launched the Agriculture Innovation Mission for Climate, one of the first major international initiatives wholly dedicated to cutting back on farming emissions. More than 30 countries joined. Many states also signed on to two other agriculture-related pledges, one to reduce methane emissions 30 percent by 2030 and the other to reverse deforestation.

The Agriculture Innovation Mission for Climate, the methane goal, and the deforestation pledge all indicate that increasingly, states recognize the powerful relationship between farming and climate change. Food systems are responsible for one-third of global greenhouse gas emissions. Nitrous oxide from soil and fertilizers can warm the earth, as can methane from livestock digestion and manure. Deforestation motivated by agricultural expansion releases the carbon dioxide stored by plants and is itself responsible for more than ten percent of all emissions. The connection between farming and climate change runs both ways, and deforestation in particular creates a vicious cycle of warming. Climate change has already reduced the growth of agricultural productivity by 21 percent since 1961, and as time goes by, that penalty will worsen. To compensate, countries could wind up converting more forests into farms, which will then further release greenhouse gases.

In order to make agriculture more environmentally friendly, many states are trying to encourage organic farming. But improving agriculture to address the twin challenges of climate change and deforestation will require every tool available. That means natural solutions alone will not be enough. Instead, states will need to embrace modern science, including CRISPR (clustered regularly interspaced short palindromic repeats) technology.

CRISPR is a recent gene-editing invention that can help countries decarbonize their food systems by making crops that can still thrive in bad weatherreducing the need for more farmland. Scientists in Belgium, for example, are using CRISPR to develop a new kind of corn that can withstand heat and drought. U.S. scientists, meanwhile, are designing drought- and salt-tolerant soybeans and drought-resistant corn. They are also using CRISPR to create cereal plants that can better absorb nitrogen from the soil, which could decrease emissions and pollution from fertilizers.

To solve climate change, states must embrace modern science.

But CRISPR will realize its full potential only if many countries embrace the technology. And unfortunately, plenty of governments are letting CRISPR fall victim to the same regulatory and public opinion pitfalls that have hobbled genetically modified organisms, or GMOs. CRISPR technology is not the same as GMO technology; it does not introduce DNA from other species into plants. Yet many governments remain largely opposed to using either GMO or CRISPR technology for crops, shrinking the toolbox for addressing climate change.

Europe may pride itself on its climate change measures, but in agriculture, it is an example of what states shouldnt do. In 2018, the European Unions top court ruled that gene-edited crops were subject to the same stifling regulation that has largely kept GMOs out of European fields since the late 1990s. That means that instead of relying on modern technology, the EUs sustainable farming plan runs through its new Farm to Fork strategy, which will increase organic farming from nine percent to at least 25 percent of cropland in Europe. This may seem eco-friendly in theory, but in reality it is a counterproductive approach that will lower crop yields, requiring more land use for farming. The increase in organic farming under Farm to Fork, for example, would shrink cereal crop production in the EU by an estimated 21 percent. To compensate, Europe would have to convert approximately 3.7 million acres of its forests into farms, and the rest of the world would have to convert an additional 12.4 million acres. This would increase the amount of carbon released from the soil and destroy natural habits.

The EU is the main example of anti-GMO and anti-CRISPR government policies. But its not alone. New Zealand has explicitly stated that gene-edited plants must be regulated in the same prohibitive manner as GMOs. Mexico has not established any unique rules for gene-edited crops, so they are still covered under restrictive GMO regulations. India, the country with the worlds second-largest amount of cultivatable land (after the United States), has proposed deregulating only some types of gene-edited crops, and it is still relatively unclear as to which plants would actually be excluded.

Europes farming strategy will lower crop yields, breeding deforestation.

Thankfully, many other states are exempting CRISPR crops from GMO-style rules. Following the 2018 court ruling in Europe, a coalition of ten countriesArgentina, Australia, Brazil, Canada, the Dominican Republic, Guatemala, Honduras, Paraguay, the United States, and Uruguaysent a signed statement to the World Trade Organization arguing that gene-edited plants should be regulated the same way as conventional ones. The United Kingdom is now freeing itself from the EU ruling and pushing forward with research on CRISPR crops. Japan has signaled that it intends not to classify gene-edited plants as modified organisms under the Cartagena Protocol. China has yet to publicly speak up, but the country has invested heavily in genome editing, so it will also probably defend CRISPR. These governments clearly understand that addressing the challenges climate change poses for agriculture requires all the tools the world has, including gene editing.

But even if CRISPR were simply a new way to create GMOs, that wouldnt make it inherently dangerous. GMOs can accomplish tremendous goodincluding by making emission-friendly products that CRISPR cant. Genetic modification is better than gene editing at producing crops resistant to pests and diseases, which increases yields and allows for the production of more food on less land, decreasing deforestation. The use of insect-resistant, genetically modified Bt (Bacillus thuringiensis) crops, for example, has increased yields by an average of 25 percent globally. Genetic modification is also more effective than gene editing at making herbicide-resistant crops, which improves weed control and increases yields. And insect-resistant and herbicide-tolerant GMO plants have reduced tractor use for insecticide spraying and tillage, dramatically cutting yearly greenhouse gas emissions. Indeed, the yearly reduced usage is equivalent to taking 1.6 million cars off the road. States clearly shouldnt limit modern crop improvement to CRISPR.

At least in the United States, the public isnt reflexively opposed to genetic engineering. Instead, polls suggest that acceptance of the practice varies widely based on the type of application. In a Pew Research Center survey, for example, only 21 percent of respondents said genetic engineering was acceptable if used to create glowing aquarium fish. But 70 percent said that limiting mosquito reproduction to reduce disease is an appropriate use of technology, and 57 percent said the same of breeding animals with tissue and organs that could be given to humans. Some environmentalist groups have also signaled that they are open to genetic engineering, provided it advances their causes. The preservationist Sierra Clubwhich has historically opposed all genetically modified organismsrecently indicated it is receptive to planting genetically modified American chestnut trees, which could help restore a species that dominated eastern U.S. forests until it was nearly wiped out by blight in the late 1800s. That means gene editing has an opening. The vast majority of the world is concerned about climate change, as are most environmentalist organizations. It is possible that they will come to endorse, or at least accept, using CRISPR and GMOs to cut agricultural emissions.

But unlocking the potential of genetic engineering requires more than just favorable public opinion and environmentalist acquiescence. In order to get a wide range of CRISPR products that address climate change and appeal to consumers, developers and countries need better access to the technology. Various iterations of CRISPR gene editing are covered by over 6,000 patents in the United States alone, with 200 more filed every month. This complicated structure means that a developer may have to license many different patents in order to commercialize a single product. Without reform, this messy system may inhibit development.

States need to change their intellectual property laws. But even if they wont, there are steps that private actors can take to make gene editing more accessible. Wageningen University & Research in the Netherlands recently pledged to license its CRISPR patents for free to nonprofit organizations that are using the technology for noncommercial applications, a step that other patent holders should follow. Holders should also make sure their inventions are affordable for small developers and poor countries that dont have the money for massive licensing fees. They can do so through patent-sharing agreements, patent consolidation, and transparent pricing, which would go a long way toward allowing a variety of companies to commercialize CRISPR gene-edited crops. These measures would also help breed innovation: more developers means a wider variety of products.

Finally, regulatory bodies should increase the transparency of their decision-making processes regarding CRISPR by requiring that agricultural companies provide the same kind of information on gene-edited crops exempt from GMO regulations as they do for crops subject to GMO rules. To allow the technology to earn more consumer trust and to reduce public skepticism, developers should also provide product assessments that go beyond safety and show buyers evidence of the environmental benefits. The European Unions Farm to Fork strategy suggests that in many countries, officials and publics are still generally opposed to using modern biotechnology to make farming more sustainable. Fighting climate change and improving agricultures resilience requires a change of mindset. Companies and regulators need to act quickly to prevent unfounded fears of CRISPR from taking root; as the entrenched opposition to GMOs demonstrates, it can be difficult to win people over to a new technology or method once distrust has set in. The world cannot allow a similar dynamic to prevent CRISPR from helping stave off the worst-case climate scenarios.

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CRISPR and the Climate - Foreign Affairs Magazine

The endogenous manufacturing of CRISPR components, through greater research, would make India a commercially successful country in the field of Deep Science, according to Girish Krishnamurthy, CEO & MD, Tata Medical and Diagnostics Ltd.

Participating in a panel discussion on 'Gene-Editing On Centre Stage' at the 'Bengaluru Tech Summit 2021', Krishnamurthy opined that the therapeutics R&D is slow in India as compared to the West, hence seeking deeper research experiences is significant.

"The country also needs to address associated infrastructural issues like the building of cold storage, expanding supply chains and the sorts," he said.The CEO also highlighted the misconception amongst people that CRISPR is meant for therapeutic and not diagnostic purposes and that it needs to change. With basic technology and market being the most crucial focal points, a large number of its applications are to be looked at, serving both urban and rural India.Though grants are channelized from the Department of Biotechnology, Dr Saravanabhavan Thangavel, Assistant Investigator, Centre for Stem Cell Research, discussed the difficulty in attracting private funds to expand the CRISPR technology that deals with almost all primary deficiencies.Talking about the guidelines existing on Therapeutic diagnostics and products, Dr Shambhavi Nayak, Head of Research, Takshashila Institution expressed the vagueness in the policy.

"The Government should move to a facilitator role, making markets more accessible" she added, referring to the potential for Gene-Editing in itself as a boon.Dr Vaijayanti Gupta, Leas Scientist, CrisprBits Pvt Ltd., emphasized on the importance of understanding the licensing, patent rights, legal and ethical framework and the overall impact on health and well-being.

"As CRISPR is trying to hit single-cell and rapid diagnostics, investments from the private sector are essential to allow this space to develop from market angle", she said.Working on CRISPR in plants, particularly Banana, Dr Siddharth Tiwari, Scientist, National Agri-Food Biotechnology Institute, said the enzymes used to target carotenes development are of prime significance.

" While the releasing of genetically engineered crops in India is in the hands of Government, the non-transgenic approach is being preferred recently," he told and stressed the need for a sustained effort to support the endeavours that can bring it to the common man.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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Need to streamline research on CRISPR gene-editing technology: Experts - Business Standard

The most recent research will provide you with an overview of the global Plant Breeding and CRISPR Plants Market in general, as well as factors that may influence future growth, or lack thereof, as well as potential opportunities and current trends. This study examines the global markets structure, as well as market segmentation, growth rates, and revenue share comparisons. The market study reports research findings aid in the assessment of a range of essential variables, such as investment in a developing market, product success, and market share expansion.

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Major market player included in this report are:

A revenue market size analysis, as well as market drivers, restraints, and opportunities, are all included in the study. The report also includes a picture of the industrys main competitors competitive landscape, as well as the top businesses percentage market share. This research looks into the Plant Breeding and CRISPR Plants Market in great detail. The research reports market estimates and predictions are based on extensive secondary research, primary interviews, and in-house expert opinions. The impact of different political, social, and economic factors, as well as current market conditions, on market growth, is examined in these market projections and estimates.

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The segmentation of the global Plant Breeding and CRISPR Plants Market in terms of the various regions and countries involved, as well as a breakdown of revenues, market shares, and possible expansion prospects, are all covered in this section. This research looks at revenue growth at the global, regional, and country levels, as well as recent industry trends in each sub-segment.

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COVID-19 Impact Analysis

The influence of COVID-19 on the Plant Breeding and CRISPR Plants market at the global and country levels is examined in this research report. The demand and supply side effects of the target market are considered in this study. Primary and secondary research, as well as private databases and a paid data source, were used in this study. Market players will benefit from the COVID-19 impact study as they implement pandemic mitigation strategy.

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The Plant Breeding and CRISPR Plants market study contains a chapter on major global market participants, which includes a review of the companys business, financial statements, product description, and strategic aims. The companies covered in the report can be customized to meet the needs of a client. This chapter will go through each of the major industry competitors and their present market position in detail.

Furthermore, years considered for the study are as follows:

Target Audience of the Global Plant Breeding and CRISPR Plants Market in Market Study:

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Plant Breeding and CRISPR Plants Market Analysis By Industry Size, Share, Revenue Growth and Demand Forecast To 2027 Energy Siren - Energy Siren