StemCell Therapy

Oct. 28, 2020 11:00 UTC

OXFORD, England--(BUSINESS WIRE)-- Oxford Biodynamics Plc (AIM: OBD), a biotechnology company developing personalized medicine tests based on 3D genomic biomarkers, has signed a Human Material and Data Transfer Agreement with Oregon Health & Science University (OHSU) as part of its EpiSwitch COVID-19 disease severity test program.

Some people infected with COVID-19 become severely ill and hospitalized, while many only experience mild illness. Under the terms of the agreement, samples from OHSU will be used to further the development of the Companys COVID-19 severity test, aimed at forecasting individuals risks of severe disease progression in advance, to inform risk mitigation decisions and help optimize acute and long-term treatment.

Ranked among the best hospitals in the US,1 OHSU has been operating right at the frontline throughout the pandemic. Since 28 February, with the first US COVID-19 hotspot on its doorstep, OHSU has seen 3,950 patient cases, as of 26 October.2 Clinicians have encountered and treated patients experiencing a wide range of responses, from asymptomatic through to severe cases who were admitted to intensive care or succumbed.

OHSU is the first US Academic Medical Centre to join Oxford BioDynamics disease severity program on a non-commercial basis as part of the COVID-19 Technology Access Framework initiative it is involved with.3 OHSU is providing clinical research samples from patients with the full spectrum of manifestations of COVID-19, together with in-depth expert description and annotation. These add to Oxford BioDynamics growing bank of 500+ samples from cohorts across the world. The Company is developing the worlds first 3D genomic test to determine likelihood of disease severity (prognostic).

Dr Jon Burrows, CEO of Oxford BioDynamics commented: We are gratified that our disease severity program has attracted the attention and support of a prestigious institution like OHSU. The well-annotated samples provided by this world-class facility will deepen our understanding of patient response and enhance development of our test. We are continuing to grow our network of leading international institutions interested in analysing how the 3D genome informs COVID-19 response.

Oxford BioDynamics is developing the disease severity test based on its proprietary EpiSwitch technology which has been reduced to practice.4 EpiSwitch will be used to retrospectively analyse the OHSU samples, comparing the 3D genomes of the patients to how they responded to the virus. The 3D structure of a patients genome contains important molecular regulatory information, about what makes certain patients particularly vulnerable to hyperinflammation and severe side effects, when exposed to COVID-19 infection. Oxford BioDynamics is establishing a panel of biomarkers to forecast the expected severity when infected with COVID-19. This will help to assess an individuals level of risk and assist in patient prognoses. Having this information could significantly help patient triage and treatment, ease the burden on healthcare systems and human resources.

Bill Messer, MD, PhD, Assistant Professor of Molecular Microbiology and Immunology, School of Medicine, OHSU added: With the second wave of COVID-19 sweeping the globe, it is clear that we have a way to go in the fight against this virus. In April, we joined the COVID-19 Technology Access Framework, which aims to expedite the development of promising technologies to diagnose, treat and prevent COVID-19. Oxford BioDynamics shares the same mission, and their technology and its prognostic capabilities hold potential in helping both patients and the health care system. We are glad to contribute our samples and knowledge to help advance development of the Companys COVID-19 disease severity test.

References:

1. https://www.ohsu.edu/health/ohsu-health-care-awards-and-recognition 2. https://news.ohsu.edu/2020/10/19/preparing-for-the-novel-coronavirus-at-ohsu 3. https://news.ohsu.edu/2020/04/16/ohsu-expedites-promising-new-technologies-to-tackle-covid-19 4. https://www.oxfordbiodynamics.com/wp-content/uploads/2020/06/SITC2019_P142_avelumab.pdf

- ENDS -

NOTES TO EDITORS:

About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) ("Oxford BioDynamics") is a biotechnology company focused on the discovery and development of 3D genomic biomarkers for use within the pharmaceutical and biotechnology industry.

The Company's award-winning, proprietary technology platform, EpiSwitch, aims to accelerate the drug discovery and development process, improve the success rate of therapeutic product development and take advantage of the increasing importance of personalised medicine.

In particular, EpiSwitch can reduce time to market, failure rates and the costs at every stage of drug discovery. Additionally, the technology provides significant insights into disease mechanisms for drug discovery and product re-positioning programs, enabling the personalization of therapeutics for patients in the context of challenging pricing environments where improved clinical outcomes are critical.

In April 2019, Oxford BioDynamics received the Queen's Award for Enterprise: Innovation. The Queen's Awards for Enterprise are the most prestigious awards for UK businesses.

The Company is headquartered in the UK and listed on the London Stock Exchange's AIM under the ticker "OBD". For more information please visit our website, http://www.oxfordbiodynamics.com, or follow us on Twitter or LinkedIn.

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IRVING, Texas, Oct. 27, 2020 /PRNewswire/ -- Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, announced today that it has raised $310 million in growth capital.

The financing includes $235 million in equity financing co-led by Highland Capital Management and Coatue, with participation from funds and accounts advised by T. Rowe Price Associates, Inc., OrbiMed, Millennium Management, Neuberger Berman, ClearBridge Investments, First Light Asset Management and other undisclosed investors.

The Company also raised $75 million in debt from Sixth Street as an extension to the $150 million in structured debt financing Sixth Street invested in September 2018. Sixth Street also participated in the equity round. Following the conclusion of this financing, Vijay Mohan, Co-founding Partner at Sixth Street, has been appointed to the board of directors.

Caris will dedicate the new capital to fund its continued growth in precision medicine to reinvent cancer care, accelerate innovative product development and pursue new initiatives in both the clinical trial and biopharmaceutical markets.

"Caris puts the patient at the center of everything we do, and focuses on fulfilling the promise of improving patient outcomes across all cancer types worldwide. As tumor profiling becomes standard practice, it's important that we continue to grow rapidly as we maintain our leadership position," said David D. Halbert, Chairman and CEO of Caris Life Sciences. "We continue to advance our market-leading tumor profiling platform, clinical trial delivery service, grow our clinical and R&D laboratory facilities, expand our biopharmaceutical partnerships and further expand our investments in AI-powered innovation with our Precision Oncology Alliance collaborators. We are thrilled that our new partners share our vision to be the industry-leader in the precision medicine space."

"This financing represents the first significant external equity investment in Caris. We are tremendously proud to partner with a diverse and high-quality syndicate of leading investors with deep domain knowledge in healthcare and technology," said Brian J. Brille, Vice Chairman of Caris Life Sciences.

"We've reached an inflection point in the ability to use precision medicine to guide treatment decisions for cancer patients. Caris has built the leading clinically-focused comprehensive tumor profiling platform, providing the broadest coverage of actionable biomarkers, unparalleled physician support, and proprietary molecular signature analytics that will continue to enhance the utility of its testing platform for clinicians," said Nate Burns, Portfolio Manager and Head of Healthcare at Highland Capital Management. "The Company is also leveraging its unique multi-omics capabilities and extensive patient outcomes database to pursue compelling new pipeline opportunities including high-sensitivity liquid biopsy diagnostics and novel drug-target identification partnerships. We look forward to working with Caris and are excited about the tremendous growth opportunity ahead."

"By growing its platform, increasing its research and testing capacity, and strengthening its client partnerships, Caris has steadily advanced its position as the leading tumor profiling company," said Vijay Mohan, Co-founding Partner at Sixth Street. "We are proud to continue to support Mr. Halbert, Mr. Brille and the entire Caris team on their mission to help physicians and cancer patients make more personalized and precise treatment decisions. We look forward to our board engagement as Caris keeps leading as an innovator in precision medicine."

About Caris Life SciencesCaris Life Sciences is a leading innovator in molecular science focused on fulfilling the promise of precision medicine through quality and innovation. The company's suite of market-leading molecular profiling offerings assesses DNA, RNA and proteins to reveal a molecular blueprint that helps physicians and cancer patients make more precise and personalized treatment decisions. MI Exome whole exome sequencing with 22,000 DNA genes, and MI Transcriptome whole transcriptome sequencing with 22,000 RNA genes along with cancer-related pathogens, bacteria, viruses and fungi analysis run on every patient provides the most comprehensive and clinically relevant DNA and RNA profiling available on the market.

Caris is also advancing precision medicine with Caris MAI (Molecular Artificial Intelligence) that combines its innovative service offerings, Caris Molecular Intelligence with its proprietary artificial intelligence analytics engine, DEAN, to analyze the whole exome, whole transcriptome and complete cancer proteome. This information, coupled with mature clinical outcomes on thousands of patients, provides unmatched molecular solutions for patients, physicians, payers and biopharmaceutical organizations.

Caris Pharmatech is changing the paradigm and streamlines the clinical trial process by assisting biopharma companies with accessing research-ready oncology sites for clinical trials. With over 200 research sites within the Caris Pharmatech Just-In-Time (JIT) Oncology Network, biopharma companies can identify and enroll more patients, faster. Caris Pharmatech Just-In-Time Clinical Trial Solutions focus on rapid site activation and patient enrollment to streamline the drug development process. By implementing Caris' Just-In-Time Trial-Matching System, Caris will automatically match patients to clinical trials and sites can be activated and eligible to enroll patients within one week.

Headquartered in Irving, Texas, Caris Life Sciences has offices in Phoenix, Denver, New York, and Basel, Switzerland. Caris provides services throughout the U.S., Europe, Asia and other international markets. To learn more, please visit http://www.CarisLifeSciences.com or follow us on Twitter (@CarisLS).

About Highland Capital ManagementHighland Capital Management ("Highland") is a multibillion-dollar global alternative investment platform. Established in 1993 with a focus on the leveraged loan market, Highland has evolved over its more than 25-year history, building on its credit expertise and value-based approach to expand into other asset classes. Today, in addition to high-yield credit, Highland's investment capabilities include real estate, private equity and special situations, public equities, structured credit, and sector- and region-specific verticals built around specialized teams. The platform serves both institutional and retail investors worldwide, offering access to alternatives in a range of investment vehicles and fund structures. Highland operates globally, with offices in Dallas, Texas (headquarters), Buenos Aires, Rio de Janeiro, Singapore, and Seoul. For more information visit http://www.highlandcapital.com.

About CoatueCoatue is one of the largest technology investment platforms in the world with approximately $20 billion in assets under management. Our dedicated team of engineers and data scientists work closely with investment professionals to add value to founders and executive teams in our portfolio. With venture, growth and public funds, we back entrepreneurs from around the globe and at every stage of growth. Some of our private investments have included Airtable, Ant Financial, Anaplan, ByteDance, Chime, Databricks, DoorDash, Instacart, Meituan, Snap and Spotify.

About Sixth StreetSixth Street is a global investment firm with approximately $47 billion in assets under management and committed capital. Sixth Street operates eight diversified, collaborative investment platforms across our growth investing, adjacencies, direct lending, fundamental public strategies, infrastructure, special situations, agriculture and par liquid credit businesses. Our long-term oriented, highly flexible capital base and "One Team" cultural philosophy allow us to invest thematically across sectors, geographies and asset classes. Founded in 2009, Sixth Street has more than 275 team members including over 140 investment professionals operating from nine locations around the world. For more information, visit http://www.sixthstreet.com.

Media and Investor Relations Contact:Argot Partnerscaris@argotpartners.com212-600-1902

Corporate Development Contact:Narendra ChokshiCaris Life Sciencesnchokshi@carisls.com917-689-3511

General Media Contact:Lindsey BailysGCI Healthlindsey.bailys@gcihealth.com212-798-9884

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Caris Life Sciences Raises $310 Million in Growth Capital from a Broad Syndicate of Leading Investors - BioSpace

DENVER--(BUSINESS WIRE)--Translational Drug Development (TD2), a precision oncology contract research organization (CRO), and VieCure have announced a strategic partnership that will provide patients receiving care in community oncology practices with best-in-class precision oncology treatments while enhancing patient awareness of tailored treatment and clinical studies that are most likely to benefit them.

A paradigm shift has occurred in favor of precision oncology, in which the molecular profile of a patients tumor is guiding treatment related decision-making. There has been an unprecedented increase in the number of approved novel immunotherapy and targeted agents across different indications over the past five years. The combination of TD2 and VieCure will allow a greater number of oncologists to embrace the latest clinical guidance, increase access to trials, have ease of access to next generation tumor sequencing, and facilitate enhanced access to the right care, for the right patient, at the right time.

We believe community oncology practices are critical to the success for new oncology medicines and this partnership increases the likelihood of clinical benefit for patients and overall success of clinical trials," said Stephen Gately, President and CEO at TD2. VieCures platform puts critical patient data like genomics, and proteomics at oncologists fingertips as they meet with their patients so that they are immediately aware of potential precision oncology trials that their patient is eligible for.

Access to de-identified real-time patient data will enhance TD2s ability to identify the right patients with much greater fidelity and speed, ultimately resulting in better outcomes for cancer patients.

The VieCure Platform is the ideal vehicle to help drive precision oncology adoption in community-based practice, said Dr. Fred Ashbury, Chief Scientific Officer at VieCure, Our Artificial Intelligence engine supports clinicians by presenting options that may have otherwise gone unnoticed, further emphasizing the need for clinical decision support tools at the point of care to help manage the precision oncology revolution.

Participating community oncology practices will have access to industry-sponsored clinical trials codified into the VieCure platform. This will improve trial design and speed up the opening of precision oncology clinical trials and the real time collection of data in the community oncology setting. This relationship will result in a greater number of patients having access to new and novel therapies.

About TD2

TD2, based in Scottsdale, Arizona, focuses on oncology medicine development with unparalleled experience conducting translational studies from bench-to-bedside against all tumor times and hematology indications. TD2 provides end-to-end solutions, including translational preclinical services; regulatory strategic guidance, planning and document submission service; and clinical trail design and execution for innovative oncology-focused companies. TD2 has provided its services to more than 600 biotech and pharma companies, maintaining hundreds of studies per year. Among them, the team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.

About VieCure

VieCure has developed a proprietary artificial intelligence informatics software platform in conjunction with a clinical inference engine and smart electronic medical record in oncology. The VieCure platform is a real-time decision support system that combines clinical knowledge with patient data to assist oncologists and hematologists in generating personalized treatment plans and managing a patients treatment throughout diagnosis, cancer therapy, and ongoing follow-up care. For more information, please visit http://www.viecure.com and connect with VieCure on LinkedIn, Facebook and Twitter.

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TD2 and VieCure Partner to Bring Best-in-Class Cancer Medicines and Access to Precision Oncology Clinical Trials to Patients in Community Oncology...

Global Healthcare Biomarkers Market Report Covers Market Dynamics, Market Value Chain, And Future Prospective

Healthcare Biomarkers marketis experiencing a growth that the global industry has never-ever seen before. The considerable growth and development are basically due to the current increasing demand and supply on the global platform. The current market dossier provides the necessary details such as the monetary fluctuations, industrial trade, future scopes, and global market status in a smooth-tongued pattern.

The Healthcare Biomarkers market report has some of the major players Johnson & Johnson, Qiagen N.V., GE Healthcare, Agilent Technologies, Roche Diagnostics, Merck, Thermo Fisher Scientific, Bio-Rad Laboratories, Abbott Laboratories, Epigenomics AG, Siemens Healthcare GmbH leading the current global market mentioned. The research report has all the vital details about the past, present, and future aspects of the Healthcare Biomarkers market mentioned with great transparency.

Click here for the free sample copy of the Healthcare Biomarkers Market report

An Overview About the Table of Contents:

Global Healthcare Biomarkers Market Overview Target Audience for the Healthcare Biomarkers Market Economic Impact on the Healthcare Biomarkers Market Global Healthcare Biomarkers Market Forecast Business Competition by Manufacturers Production, Revenue (Value) by Region Production, Revenue (Value), Price Trend by Type Market Analysis by Application Cost Analysis Industrial Chain, Sourcing Strategy, and Downstream Buyers Marketing Strategy Analysis, Distributors/Traders Market Effect Factors Analysis

In the global market, there is always a tough competition going on between the various players so as to top the chart. The current Healthcare Biomarkers market seems to have succeeded in sowing its seed of success and is enjoying the benefits of the reaping taking place on a global platform. The most important aspect provided in the report is the variation in the financial scale that can give the clients a complete idea about the current monetary gain and loss. The geographical segmentation North America (United States, Canada and Mexico), Europe (Germany, UK, France, Italy, Russia and Turkey etc.), Asia-Pacific (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Malaysia and Vietnam), South America (Brazil, Argentina, Columbia etc.), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa) gives the readers an entire data about the growth and development taking place across the world. The informative report also presents some data based on the market bifurcations, growth factors, futuristic aspects, industrial policies, and product supply and demand for a better piece of understanding.

Read Detailed Index of full Research Study at::https://www.marketdataanalytics.biz/global-healthcare-biomarkers-market-report-2020-by-key-players-72994.html

Key Insights encompassed in the Healthcare Biomarkers market report

Latest technological advancement in the Healthcare Biomarkers market Studying pricing analysis and market strategies trailed by the market players to enhance global Healthcare Biomarkers market growth Regional development status off the Healthcare Biomarkers market and the impact of COVID-19 in different regions Detailing of the supply-demand chain, market valuation, drivers, and more

One of the vital data mentioned in the report includes that of the overall market segmentation based on the product type, applications, end-users, and various other subtypes. The market segmentation {Safety biomarker, Validation biomarker, Efficacy biomarker}; {Diagnostics development, Personalized medicine, Drug discovery & development, Disease risk assessment, Other} helps the clients and other readers obtain a crystal-clear context about the Healthcare Biomarkers market. The knowledgeable aspects mentioned in the current scientific report is made available at the tip of the finger with just a click.

Questions answered by the Healthcare Biomarkers market report:

Which are regions witnessing the highest growth during the forecast period? How the surging prices of raw materials will affect the growth of the Healthcare Biomarkers market? Which are major market players? How are the market players intensifying their global presence? If yes, how? What are the key strategies used by the market players to improve their market position post the COVID-19 pandemic?

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NEW YORK, Oct. 29, 2020 /PRNewswire/ -- The research antibodies and reagents market is projected to reach USD 14.1 billion by 2025 from USD 10.1 billion in 2020, at a CAGR of 6.7% during the forecast period. The research antibodies and reagents market has evolved owing to factors such as growth in proteomics and genomics research, rising demand for high-quality antibodies for research reproducibility, and increasing R&D activity and expenditure in the life sciences industry. Fueled by the growing demand for personalized medicine and structure-based drug design, the global research antibodies and reagents market is expected to witness significant growth in the coming years.

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Based on product, the reagents segment holds the highest market share during the forecast period.Based on product, the research antibodies and reagents market are segmented into reagent and antibodies.The reagent segment accounted for the larger market share in 2019.

The reagents market is experiencing notable growth due to the growing applications of biosciences and biotechnology within the pharmaceutical and healthcare fields.

Based on technology, the flow cytometry segment is expected to register the highest CAGR during the forecast period.Based technology, the research antibodies and reagents market is segmented into western blotting, flow cytometry, ELISA, Immunohistochemistry, Immunofluorescence, Immunoprecipitation, and other technologies.The flow cytometry segment is expected to witness the highest growth during the forecast period.

This is mainly due to this technique is its ability to perform simultaneous multi-parameter analysis on single cells within a heterogeneous mixture.It offers high throughput and the automated quantification of cell features.

These factors, along with technological innovations in flow cytometry and growing cancer research, are driving the growth of this segment. By application , the proteomics holds the highest market share during the forecast period.

Based on application, the research antibodies and reagents market is segmented into proteomics, drug development and Genomics. Proteomics held the largest share of the global research antibodies and reagents market in 2019.The growth of the segment is due to as it efficiently maps drug-protein and protein-protein interactions. Moreover, proteomic technologies have minimized the cost, time, and resource requirements for chemical synthesis and biological testing of drugs. Proteomic technologies, such as electrophoresis, ELISA, microarrays, and MS-based proteomics, are highly efficient for analytical laboratory testing.

By enduser , the pharmaceutical & biotechnology holds the highest market share during the forecast period.The research antibodies and reagents market is segmented into the pharmaceutical & biotechnology companies, academic & research institutions and Contract Research Organizations.The pharmaceutical & biotechnology companies held the largest share of the global research antibodies and reagents end-user market in 2019.

The large share of this segment is attributed to the wide use of research antibodies in drug development for the identification and quantification of biomarkers and various analytical procedures. By Region, The Asia Pacific region is expected to register the highest CAGR during the forecast period.

The Asia Pacific research antibodies and reagents market is expected to grow at the highest CAGR from 2020 to 2025.The growth of this market is primarily due to growing proteomics and genomics research and increasing research funding, investments by pharmaceutical and biotechnology companies, and growing awareness of personalized therapeutics in the region. Also high-growth countries, such as China, India, Japan, South Korea, Taiwan, Australia, and Singapore are the major contributors to the Asia Pacific research antibodies and reagents market. This region is expected to grow at the highest pace during the forecast period primarily due to growing proteomics and genomics research and increasing research funding, increasing investments by pharmaceutical and biotechnology companies, and growing awareness about personalized therapeutics.

Break of primary participants was as mentioned below: By Company Type Tier 135%, Tier 245% and Tier 320% By Designation C-level35%, Director-level25%, Others40% By Region North America45%, Europe30%, Asia Pacific20%, Latin America- 3%, Middle East and Africa2%

Key players in the research antibodies and reagents marketThe key players operating in the researsch antibodies and reagents systems include Thermo Fisher Scientific (US), Merck Group (Germany), Abcam plc (UK), Becton, Dickinson and Company (US), Bio-Rad Laboratories (US), Cell Signaling Technology (US), F. Hoffmann-La Roche (Switzerland), Danaher Corporation (US), Agilent Technologies (US), PerkinElmer (US), Lonza (Switzerland), GenScript (China), and BioLegend (US).

Research Coverage:The report analyzes the research antibodies and reagent market and aims at estimating the market size and future growth potential of this market based on various segments such as product, distribution channel, and region.The report also includes a product portfolio matrix of various research antibodies and reagents products available in the market.

The report also provides a competitive analysis of the key players in this market, along with their company profiles, product offerings, and key market strategies.

Reasons to Buy the ReportThe report will enrich established firms as well as new entrants/smaller firms to gauge the pulse of the market, which in turn would help them, garner a more significant share of the market. Firms purchasing the report could use one or any combination of the below-mentioned strategies to strengthen their position in the market.

This report provides insights into the following pointers: Market Penetration: Comprehensive information on product portfolios offered by the top players in the global research antibodies and reagent market. The report analyzes this market by product and distribution channel. Product Enhancement/Innovation: Detailed insights on upcoming trends and product launches in the global research antibodies and reagent market. Market Development: Comprehensive information on the lucrative emerging markets by product and distribution channel Market Diversification: Exhaustive information about new products or product enhancements, growing geographies, recent developments, and investments in the global research antibodies and reagent market. Competitive Assessment: In-depth assessment of market shares, growth strategies, product offerings, competitive leadership mapping, and capabilities of leading players in the global research antibodies and reagent market.

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NEW YORK--(BUSINESS WIRE)--Medidata, a Dassault Systmes company, the global leader in creating end-to-end solutions that support the entire clinical trial process, will convene stakeholders in drug and device development, clinical operations, data management, biostatistics and digital medicine innovation industries for NEXT Global on October 27-29, 2020.

With a focus on improving clinical trials through advanced technology and enhancing the patient experience, the three-day, all virtual event will bring together experts to discuss topics critical to pharmaceutical and biotechnology companies, medical device and diagnostics companies, and contract research organizations (CROs) running clinical trials during the COVID-19 pandemic.

The COVID-19 pandemic is reshaping the life sciences industry and is acting as a catalyst for dramatic change, said Tarek Sherif, co-founder and co-CEO of Medidata. Digital transformation of life sciences is happening at an accelerated pace, from research to clinical trials, manufacturing and through to commercialization. Nowhere is this more apparent than in clinical studies, where the use of advanced analytics is powering faster, safer and more effective treatments. Medidatas platform is at the forefront of enabling clinical development to improve the patient experience and patient outcomes.

To see and hear how Medidatas industry-leading Rave platform and its innovative patient-centric approach is at the core of digitally transforming clinical trials, attendees will participate in sessions with the following themes:

Presentations from Medidata experts, customers, partners and industry experts will focus on the next phase of digital transformation in clinical trials and drug development through:

The right unified technology can embrace the waves of change and increase precision in medical therapies and treatments, said Glen de Vries, co-CEO of Medidata. NEXT Global will showcase technology solutions that accelerate clinical development, powering smarter treatments and healthier people.

Medidata is a wholly owned subsidiary of Dassault Systmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.

About Medidata

Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,600+ customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systmes company (Euronext Paris: #13065, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at http://www.medidata.com and follow us @Medidata, The Operating System for Life SciencesTM.

Medidata and Medidata Rave are registered trademarks of Medidata Solutions, Inc., a wholly owned subsidiary of Dassault Systmes.

About Dassault Systmes

Dassault Systmes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual experience twins of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production. Dassault Systmes brings value to more than 270,000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit http://www.3ds.com.

3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, EXALEAD, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systmes, a French socit europenne (Versailles Commercial Register # B 322 306 440), or its subsidiaries in the United States and/or other countries.

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Medidata NEXT Global 2020 to Focus on the Virtualization of Clinical Trials, the Power of Analytics and Improving the Patient Experience in the...

Oct. 26, 2020 16:00 UTC

OAKLAND, Calif.--(BUSINESS WIRE)-- In a step toward the full realization of genomic medicine, Fabric Genomics (Formerly Known As Omicia, Inc.), a leader in AI-based genomic analysis and interpretation, has announced a co-marketing agreement that will provide translational researchers around the world with integrated sample prep to reporting workflows. Combining Roches newly released KAPA HyperExome Probes (RUO) with the Fabric Enterprise bioinformatics and analysis platform will make genetic research faster, less costly and more accurate by providing an end-to-end solution from sample prep through analysis.

Fabric Genomics pioneered AI-driven genomic interpretation, and its Fabric Enterprise software platform for genomic data analysis and reporting is in use by clinical research laboratories, healthcare institutions and country sequencing programs around the world, including Rady Childrens Institute for Genomic Medicine, LabCorp and Genomics England. Last week Fabric Genomics released Fabric GEM, a novel algorithm that quickly identifies the likely genetic cause of rare diseases; the new technology is fully integrated within the Fabric Enterprise platform.

Roches exome sequencing workflow includes the KAPA HyperPrep and HyperPlus library preparation kits and exome probes, which allow users to quickly prepare samples for sequencing while delivering high on-target rates and 98% sensitivity for SNP detection.

In addition to improving turnaround times for genomic sequencing, the combination of these technologies will allow laboratories to increase automation and lower operational costs with improved scalability. Clinical research labs that are expanding assay menus will benefit from reduced costs of development and faster validation.

Clinical research labs have a need to take a collected sample from library prep quickly, all the way through to analysis, and our agreement with Roche demonstrates our commitment to supporting these critical workflows, said Martin Reese, PhD, co-founder and CEO of Fabric Genomics. Using our Fabric Enterprise analysis platform with Roche KAPA HyperExome Probes ensures high coverage of disease-causing genes, which is of the utmost importance in accelerating the identification of rare variants. Combining these technologies into a single workflow will lead to higher quality results and increased reliability of sequencing-based diagnostics in routine care. With widespread adoption of sequencing technology innovation, we can further our shared goal of improving personalized care.

KAPA products are for research use only (RUO). Not for use in diagnostic procedures.

About Fabric Genomics

Headquartered in Oakland, California, Fabric Genomics was founded by industry veterans and innovators with a deep understanding of bioinformatics, large-scale genomics and clinical diagnostics. Fabric Genomics is making genomics-driven precision medicine a reality. The company also provides clinical decision-support software that enables clinical labs, hospital systems and country sequencing programs to gain actionable genomic insights, resulting in faster and more accurate diagnoses and reduced turnaround time. Fabrics end-to-end genomic analysis platform incorporates proven AI algorithms, and has applications in both hereditary disease and oncology.

To learn more, visit https://fabricgenomics.com/roche/ and follow us on Twitter and LinkedIn.

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Fabric Genomics to Co-market Comprehensive Sample-to-Genomic Analysis Sequencing Solutions for Hereditary Genetics - BioSpace

Mid-cap stocks are oftenunfairlyoverlooked. In a coronavirus-stricken economy where giant tech companies keep powering the market higher as small companies struggle to survive, mid-caps are an excellent compromise. They generally have lower valuations than the most beloved blue chips and stronger businesses than the small fries.

In fund tracker Morningstars Mid-Cap Blend category, the $552 million Madison Mid Cap fund (ticker: GTSGX) is one of the best. The no-load fund has beaten 95% of its category peers in the past three years and 85% of them in the past 15. Equally important, it is less volatile than its Russell Midcap benchmark, while matching the indexs 11.8% average annual return in the past 10 years. (Although officially this Y-share class of the fund has a $25,000 minimum investment, brokers such as Fidelity, Charles Schwab, TD Ameritrade, and E*Trade allow clients to get into the fund with an investment of $2,500 or less.)It has an expense ratio of 0.95%.

Manager Rich Eisinger, 55, has been at the helm since 1998, but he also relies on Haruki Toyama, co-manager since 2015, and Andy Romanowich, co-manager since 2019. Eisingers connection with Toyama, 49, goes way back. They first met at an investment club in the 1990s at Cornell Universitys business school, and both were Warren Buffett fans. We showed up at a room for new club members, and this fellow student got up, and started talking about options this and options that, and Rich and I kind of looked at each other and were like, Whats this guy talking about? We just want to buy great companies at a cheap price, Toyama recalls. They have been friends since then, swapping investment ideas, going on research trips together, and sharing investment philosophies.

Eisingers investment style, like Buffetts, has evolved from a more traditional value approachseeking cheap stocksto trying to invest in great businesses with strong durable cash flows. Over time, weve realized, especially in the mid-cap space, the value of paying up for a great business and watching that free cash flow compound over many years, Eisinger says. Madison Mid Cap tends to hold stocks for the long termthe funds turnover ratio is 25%, indicating a typical holding period of four years. Forty percent of our portfolio weve owned for over a decade, Toyama says.

The fund is also concentratedanother Buffett hallmarkhaving just 29 stocks as of Sept. 30. Concentration increases individual stock risk, as any blowups in a 5% position hurt returns more than a 1% one, for instance. But the funds volatility is low, despite its small number of stocks, reflecting the high quality of its holdings and the rarity of individual company blowups.

To make it into the portfolio, a company should have a strong business model with an economic moat that prevents competitors from reducing profits. It must also have a superior management team with preferably strong insider ownership, conservative accounting and earnings projections, and a history of wise capital-allocation decisions regarding share buybacks, acquisitions, and debt repayment. Finally, the valuation must be reasonable for a strong business.

Note: Holdings as of Sept. 30. Returns through Oct. 26; all returns are annualized.

Sources: Madison Funds; Morningstar

Health-care diagnostics company Laboratory Corp. of America Holdings (LH), commonly known as LabCorp, exemplifies the funds buy-and-hold strategy. Were in the 17th year now of ownership, Eisinger says. LabCorp and Quest Diagnostics (DGX) are the two largest clinical diagnostics labs in the country, controlling 25% of the independent lab business, he says. Eisinger sees a long runway for earnings growth between 10% to 11% a year because LabCorp is the low-cost provider of diagnostic tests relative to hospital labs. Theres more emphasis on [health-care] cost containment than theres ever been, so [LabCorp] is going to start gaining more market share in the next decade.

Moreover, in 2015 LabCorp acquired drug developer Covance, which specializes in personalized medicine, such as targeted gene therapies. Covance can utilize LabCorps huge database of patients to get candidates for their drug trials and their drug development, Eisinger says. That patient access should give Covance an advantage in the burgeoning personalized medicine business.

Another favorite, property and casualty insurer Arch Capital Group (ACGL), has a CEO, Marc Grandisson, who embodies the Buffett-like qualities that the fund managers seek. In fact, in the 1990s, Grandisson actually worked at Berkshire Hathaway (as did his predecessor, Constantine Iordanou, who is now retired). Under Grandissons aegis, Arch has been an excellent capital allocator and one of the few insurers to make a profit from its policy underwriting, Toyama says. Historically, the industry has lost money underwriting, and made it up in investments, he says, referring to how insurers typically use money from policy premiums to buy bonds and stocks.

Archs insurance underwriting has been successful because Grandisson is willing to walk away from business when a policy type becomes less profitable or commodity-like due to competition, Toyama says. It has decreased its major casualty insurance business over the years as it got more price competitive, he explained. The companys stock has taken a shellacking in 2020, down 29%, because of claims related to Covid-19. But it is precisely after such calamities that insurance premiums go up and profitability increases, Toyama says. The fund is staying put.

Typical of a high-quality mid-cap portfolio, many of the funds holdings are industry leaders but not household names. So 16% of its portfolio is in technology, but not in the Amazon.coms (AMZN) of the world. Instead, the fund invests in companies like tech research publisher and consultant Gartner (IT).

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Gartner has a very attractive business model in that its core product is a written research service that is sold on a subscription basis, Romanowich says. So, it has very visible, highly recurring revenue. The company has a major advantage as the leading research intermediary between tech buyers and sellers, he says. Gartner knows what end users want, and what corporations tech road maps look like. They also know what tech vendors are thinking and what their technology road maps look like.

That informational advantage provides an economic moat any Warren Buffett fan would admire.

Write to editors@barrons.com

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This Mid-Cap Stock Fund Wins With Warren Buffetts Strategy - Barron's

Regenerative medicine is a part of translational research in the fields of molecular biology and tissue engineering. This type of medicine involves replacing and regenerating human cells, organs, and tissues with the help of specific processes. Doing this may involve a partial or complete reengineering of human cells so that they start to function normally.

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Regenerative medicine also involves the attempts to grow tissues and organs in a laboratory environment, wherein they can be put in a body that cannot heal a particular part. Such implants are mainly preferred to be derived from the patients own tissues and cells, particularly stem cells. Looking at the promising nature of stem cells to heal and regenerative various parts of the body, this field is certainly expected to see a bright future. Doing this can help avoid opting for organ donation, thus saving costs. Some healthcare centers might showcase a shortage of organ donations, and this is where tissues regenerated using patients own cells are highly helpful.

There are several source materials from which regeneration can be facilitated. Extracellular matrix materials are commonly used source substances all over the globe. They are mainly used for reconstructive surgery, chronic wound healing, and orthopedic surgeries. In recent times, these materials have also been used in heart surgeries, specifically aimed at repairing damaged portions.

Cells derived from the umbilical cord also have the potential to be used as source material for bringing about regeneration in a patient. A vast research has also been conducted in this context. Treatment of diabetes, organ failure, and other chronic diseases is highly possible by using cord blood cells. Apart from these cells, Whartons jelly and cord lining have also been shortlisted as possible sources for mesenchymal stem cells. Extensive research has conducted to study how these cells can be used to treat lung diseases, lung injury, leukemia, liver diseases, diabetes, and immunity-based disorders, among others.

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Global Regenerative Medicine Market: Overview

The global market for regenerative medicine market is expected to grow at a significant pace throughout the forecast period. The rising preference of patients for personalized medicines and the advancements in technology are estimated to accelerate the growth of the global regenerative medicine market in the next few years. As a result, this market is likely to witness a healthy growth and attract a large number of players in the next few years. The development of novel regenerative medicine is estimated to benefit the key players and supplement the markets growth in the near future.

Global Regenerative Medicine Market: Key Trends

The rising prevalence of chronic diseases and the rising focus on cell therapy products are the key factors that are estimated to fuel the growth of the global regenerative medicine market in the next few years. In addition, the increasing funding by government bodies and development of new and innovative products are anticipated to supplement the growth of the overall market in the next few years.

On the flip side, the ethical challenges in the stem cell research are likely to restrict the growth of the global regenerative medicine market throughout the forecast period. In addition, the stringent regulatory rules and regulations are predicted to impact the approvals of new products, thus hampering the growth of the overall market in the near future.

Global Regenerative Medicine Market: Market Potential

The growing demand for organ transplantation across the globe is anticipated to boost the demand for regenerative medicines in the next few years. In addition, the rapid growth in the geriatric population and the significant rise in the global healthcare expenditure is predicted to encourage the growth of the market. The presence of a strong pipeline is likely to contribute towards the markets growth in the near future.

Global Regenerative Medicine Market: Regional Outlook

In the past few years, North America led the global regenerative medicine market and is likely to remain in the topmost position throughout the forecast period. This region is expected to account for a massive share of the global market, owing to the rising prevalence of cancer, cardiac diseases, and autoimmunity. In addition, the rising demand for regenerative medicines from the U.S. and the rising government funding are some of the other key aspects that are likely to fuel the growth of the North America market in the near future.

Furthermore, Asia Pacific is expected to register a substantial growth rate in the next few years. The high growth of this region can be attributed to the availability of funding for research and the development of research centers. In addition, the increasing contribution from India, China, and Japan is likely to supplement the growth of the market in the near future.

Global Regenerative Medicine Market: Competitive Analysis

The global market for regenerative medicines is extremely fragmented and competitive in nature, thanks to the presence of a large number of players operating in it. In order to gain a competitive edge in the global market, the key players in the market are focusing on technological developments and research and development activities. In addition, the rising number of mergers and acquisitions and collaborations is likely to benefit the prominent players in the market and encourage the overall growth in the next few years.

Some of the key players operating in the regenerative medicine market across the globe are Vericel Corporation, Japan Tissue Engineering Co., Ltd., Stryker Corporation, Acelity L.P. Inc. (KCI Licensing), Organogenesis Inc., Medtronic PLC, Cook Biotech Incorporated, Osiris Therapeutics, Inc., Integra Lifesciences Corporation, and Nuvasive, Inc. A large number of players are anticipated to enter the global market throughout the forecast period.

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TMR Research is a premier provider of customized market research and consulting services to busi-ness entities keen on succeeding in todays supercharged economic climate. Armed with an experi-enced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Regenerative Medicine Market Poised to Garner Maximum Revenues During 2025 - The Think Curiouser

AllTheResearchs latest research report provides an overview of theRegenerative Medicine market with segmentation, regional analysis and discussion of important industry trends, market share estimates and profiles of the leading key players. The identified trends that are very helpful for business decisions. The Regenerative Medicine Industry report is a valuable source of guidance for the new and prominent growths of the enterprise, the competitive evaluation, and nearby assured analysis for the reviewing size.

The global Regenerative Medicine market was valued at US$ 13.56 Mn in 2018 and is expected to reach US$ 55.67 Mn in 2026, growing at a CAGR of 23% during the forecast period.

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Company Profiles mapped in Regenerative Medicine market with Competitive Intelligence:

Market Segmentation by Type, Application and Region

Based on Product Type:

Based on Application:

The Global Regenerative Medicine market analyses and researches the Regenerative Medicine development status and forecast in the United States, Europe, China, Japan, Southeast Asia, India and Central and South America. The Global Regenerative Medicine Market focuses on global major leading industry players providing information such as company profiles, product picture and specification, capacity, production, price, cost, revenue, and contact information. Upstream raw materials and equipment and downstream demand analysis is also carried out.

The Regenerative Medicine industry development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed, and overall research conclusions offered. The Regenerative Medicine Market report provides key statistics on the market status of the Regenerative Medicine manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry.

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AllTheResearch was formed with the aim of making market research a significant tool for managing breakthroughs in the industry. As a leading market research provider, the firm empowers its global clients with business-critical research solutions. The outcome of our study of numerous companies that rely on market research and consulting data for their decision-making made us realise, that its not just sheer data-points, but the right analysis that creates a difference.While some clients were unhappy with the inconsistencies and inaccuracies of data, others expressed concerns over the experience in dealing with the research-firm. Also same-data-for-all-business roles was making research redundant. We identified these gaps and built AllTheResearch to raise the standards of research support.

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Regenerative Medicine Market By Key Players, Product And Production Information Analysis And Forecast To 2026 - PRnews Leader

Over the last three months I served on the Patient and Medical Advisory Committee for Prop. 14, which will renew support for the California Institute for Regenerative Medicine (CIRM).

It has been an honor and privilege to advocate for CIRM, because the research, education, and clinical trials it supports will save lives and reduce suffering. Were a diverse group, including patients, advocates, scientists, and students - brought together by the power of a state agency that has enabled a cure for children born without an immune system - so called bubble babies, and treatments for blindness and cancer.

In addition to a possible cure for diabetes, more than 90 other regenerative treatments and cures are in clinical trials. It is impossible to argue with these accomplishments.

Given that, some will argue against the economics of supporting CIRM through Prop. 14, which will involve the sale of $5.5 billion in bonds over the next 20 years. Contrast that to the $300 billion per year spent in California on healthcare.

Even if the only thing that comes from CIRM support is a cure for diabetes, it will pay for itself many times over, given that diabetes cost California $30 billion per year. But CIRM wont just enable a cure for diabetes - treatments and cures are being developed for dozens of other chronic diseases and conditions.

Can we afford Prop. 14 now, in the middle of the COVID-19 recession? We can. Bond repayments wont start for five years. After that, state revenue stimulated by CIRM will cover bond payments until 2030. At the same time, renewing support of CIRM will create 100,000 jobs. That is exactly the sort of stimulus we need right now.

View post:
Letters to the Editor: We can afford Prop. 14; Voting for Jordan Cunningham; Poll workers should be tested before, after election - Santa Maria Times

Over the last three months I served on the Patient and Medical Advisory Committee for Prop. 14, which will renew support for the California Institute for Regenerative Medicine (CIRM).

It has been an honor and privilege to advocate for CIRM, because the research, education, and clinical trials it supports will save lives and reduce suffering. Were a diverse group, including patients, advocates, scientists, and students - brought together by the power of a state agency that has enabled a cure for children born without an immune system - so called bubble babies, and treatments for blindness and cancer.

In addition to a possible cure for diabetes, more than 90 other regenerative treatments and cures are in clinical trials. It is impossible to argue with these accomplishments.

Given that, some will argue against the economics of supporting CIRM through Prop. 14, which will involve the sale of $5.5 billion in bonds over the next 20 years. Contrast that to the $300 billion per year spent in California on healthcare.

Even if the only thing that comes from CIRM support is a cure for diabetes, it will pay for itself many times over, given that diabetes cost California $30 billion per year. But CIRM wont just enable a cure for diabetes - treatments and cures are being developed for dozens of other chronic diseases and conditions.

Can we afford Prop. 14 now, in the middle of the COVID-19 recession? We can. Bond repayments wont start for five years. After that, state revenue stimulated by CIRM will cover bond payments until 2030. At the same time, renewing support of CIRM will create 100,000 jobs. That is exactly the sort of stimulus we need right now.

Originally posted here:
Letters to the Editor: We can afford Prop. 14 - Hanford Sentinel

The report on Global Orthopedic Regenerative Medicine Market is a dependable point of reference heralding high accuracy business decisions on the basis of thorough research and observation by seasoned research professionals at CMI Research. The report on global Orthopedic Regenerative Medicine market evidently highlights the causal factors such as demand analysis, trend examination, and technological milestones besides manufacturing activities that have been systematically touched upon to instigate systematic growth projection.

This CMI Research report on global Orthopedic Regenerative Medicine market systematically studies and follows noteworthy progresses across growth trends, novel opportunities as well as drivers and restraints that impact growth prognosis.

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Which market players and aspiring new entrants may witness seamless entry?

Curasan, Inc., Carmell Therapeutics Corporation, Anika Therapeutics, Inc., Conatus Pharmaceuticals Inc., Histogen Inc., Royal Biologics, Ortho Regenerative Technologies, Inc., Swiss Biomed Orthopaedics AG, Osiris Therapeutics, Inc., and Octane Medical Inc.

Predicting Scope: Global Orthopedic Regenerative Medicine Market, 2020-2027

Elaborate research proposes global Orthopedic Regenerative Medicine market is likely to experience an impressive growth through the forecast span, 2020-2027, ticking a robust CAGR of xx% USD. The Orthopedic Regenerative Medicine market is anticipated to demonstrate a whopping growth with impressive CAGR valuation. The Orthopedic Regenerative Medicine market is also likely to maintain the growth spurt showing signs of steady recovery.

For appropriate analysis of all the market relevant information as well emerging trends and historical developments in the Orthopedic Regenerative Medicine market, CMI Research has referred to various primary and secondary research practices and contributing factors.

Regional Overview: Global Orthopedic Regenerative Medicine Market

The report specifically sheds light upon note-worthy business discretion, popular trends investment probabilities aligning with budding opportunities as well as breakthrough developments in policies and monetary inclination echoing investor preferences in Orthopedic Regenerative Medicine space.

Competitive Landscape: Global Orthopedic Regenerative Medicine Market

Further in the report, readers are presented with minute details pertaining to significant company profiles, product development, on pricing, production and vital information on raw material and equipment developments also form crucial report contents in this CMI Research report.

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Segmentation Based on Orthopedic Regenerative Medicine Market Types:

By Procedure Cell TherapyTissue EngineeringBy Cell TypeInduced Pluripotent Stem Cells (iPSCs)Adult Stem CellsTissue Specific Progenitor Stem Cells (TSPSCs),Mesenchymal Stem Cells (MSCs)Umbilical Cord Stem Cells (UCSCs)Bone Marrow Stem Cells (BMSCs)By SourceBone MarrowUmbilical Cord BloodAdipose TissueAllograftsAmniotic FluidBy ApplicationsTendons RepairCartilage RepairBone RepairLigament RepairSpine RepairOthers

Global Orthopedic Regenerative Medicine Market Size & Share, By Regions and Countries/Sub-regions:

Asia Pacific: China, Japan, India, and Rest of Asia Pacific

Europe: Germany, the UK, France, and Rest of Europe

North America: the US, Mexico, and Canada

Latin America: Brazil and Rest of Latin America

Middle East & Africa: GCC Countries and Rest of Middle East & Africa

The regional analysis segment is a highly comprehensive part of the report on the global Orthopedic Regenerative Medicine market. This section offers information on the sales growth in these regions on a country-level Orthopedic Regenerative Medicine market.

The historical and forecast information provided in the report span between2020 and 2027. The report provides detailed volume analysis and region-wise market size analysis of the market.

Report Investment, a Priority: Explains CMI Research

This report also helps market participants to organize R&D activities aligning with exact market requirements

The report resonates critical findings on decisive factors such as downstream needs and requirement specifications as well as upstream product and service development

The report aids in reader comprehension of the market based on dual parameters of value and volume.

This CMI Research initiated research output on Orthopedic Regenerative Medicine market is a ready-to-refer handbook of noteworthy cues for easy adoption by market players and stakeholders

CMI Research skillfully underpins a vivid segment analysis of the global Orthopedic Regenerative Medicine market, rendering appropriate inputs about the revenue generation capabilities of each segment.

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Covid-19 Impact On Orthopedic Regenerative Medicine Market 2020 Future Development, Manufacturers, Trends, Share, Size And Forecast to 2027 |...

After kicking off the Prescription Drug User Fee Act (PDUFA) reauthorization process in July, the US Food and Drug Administration (FDA) has released the first set of meeting summaries in its ongoing negotiations with industry that will shape its prescription drug review program from FY2023-2027.The meeting summaries, while brief, provide insights into what FDA and industry hope to get out of the multi-billion-dollar agreement, with representatives from government and industry alike agreeing that the exploding field of advanced biologic therapies must be a priority. In some other areas, though, the wish lists diverged. (RELATED: PDUFA VII: FDA, industry preview their reauthorization wish lists, Regulatory Focus 23 July 2020).Steering committeeThe PDUFA reauthorization steering committee met three times in September to hash out the ground rules for the negotiations and review the major topics and proposals both sides will work through via designated working groups.FDA and industry both noted the impact of the COVID-19 pandemic on the agency and the reauthorization process at the first meeting on 15 September.Despite historic workload and operating challenges in the time period, the steps taken in PDUFA VI to protect the program from financial uncertainty have proven critical and important to maintaining FDAs operations, FDA said.During the meeting, FDA pitched six areas it wants to focus on for PDUFA VII: digital health and informatics, postmarket, CBER-specific enhancements, pre-market, regulatory decision tools and finance.Industry, on the other hand, expressed interest in build[ing] upon past user fee agreements and to ensure FDA and industry can mutually keep pace with scientific development. Topics presented by industry include: strengthening scientific dialogue, enhancing patient-centric drug review, supporting the next wave of advanced biologic therapies, modernizing regulatory evidence generation, advancing digital and IT technologies, enhancing innovation in quality and manufacturing, and optimizing FDA infrastructure, staffing, and resources.Industry also said it was keen on adopting some of the lessons from the COVID-19 pandemic and translating them into improved processes going forward.During the next steering committee meeting on 22 September, FDA and industry reviewed the overall timeline for reauthorization and the two sides sought clarification on each others proposed topics. The following week the committee met again and reviewed the timeline for communicating with Congress, agreed to topic assignments and looked at some of the overlap between the agencys COVID-19 response and PDUFA interests.CBER subgroupIncreased support for FDAs Center for Biologics Evaluation and Research (CBER) is set to be a focus for both FDA and industry in the negotiations.FDA told industry at the first CBER breakout meeting that it would like to see enhanced resources for its cell and gene therapy program, which has been overwhelmed by an influx of applications and meeting requests in recent years.FDA noted that its new regenerative medicine advanced therapy (RMAT) designation program has seen exponential growth and is now outpacing breakthrough therapy designations in the Office of Tissues and Advanced Therapies (OTAT), despite not receiving any dedicated resources for the fledgling program.With more resources, FDA told industry that it could spend more time on cell and gene therapy submissions, provide more opportunities for engagement and develop policy and guidance for sponsors. FDA also said it will seek dedicated resources for the RMAT program under PDUFA VII.Industry suggested three CBER-related commitments it would like to work into the reauthorization agreement, including workshops and guidance on the use of sponsor-specific prior knowledge in gene therapy submissions, evidentiary standards for RMAT designation and gene therapy manufacturing issues.Industry would like a public workshop to focus on key learnings from the RMAT program resulting in an update to the RMAT guidance, including potential uses of Real World Evidence (RWE) for regulatory decision making, FDA writes, noting that meaningful guidance on the matter may be difficult to develop due to the limited number of approved cell and gene therapy products and the fact that there have not been any products approved to date with RMAT designation.For gene therapy manufacturing, industry specifically said it would like to explore whether submitting portions of a chemistry, manufacturing and controls (CMC) module could facilitate biologics license approval (BLA) review. FDA said it has concerns that a partial submission could actually slow approval down if development is ongoing but agreed to carry the discussion forward.Regulatory decision toolsOn 29 September, the regulatory decision tools subgroup met for the first time, with FDA and industry reviewing potential areas of enhancement and agreeing to a schedule for the next several meetings.FDA raised four topics it would like to tackle in PDUFA VII, including model-informed drug development (MIDD), complex innovative trial designs (CID), patient-focused drug development (PFDD), and advancing translational models and tools for drug development (ATMT).For MIDD, FDA said its goal is to build on the lessons learned during PDUFA VI and to ensure the programs sustainability. Doing so would require public engagement and the development of comprehensive end-to-end guidance, which FDA said would necessitate increased staffing.Digital health and informaticsFDA and industry began discussions aimed at enhancing the use of digital health and informatics technologies under PDUFA VII on 30 September.FDA pitched three topics for discussion at the meeting, including a proposal for an integrated cloud-based technology environment, a framework for leveraging digital health technology-generated data in submissions, and CBER IT modernization.PremarketFDA and industry addressed several premarket issues in the first meeting of the premarket subgroup, including user related risk analysis (URRA) and human factor (HF) protocol review and developing efficacy endpoints for rare diseases.FDA proposed increasing the user fee timeline for reviewing HF protocols and said the current goals will be unsustainable in the future due to increasing volume and complexity of HF submissions. The two sides discussed the creation of a new user fee goal and timeline for review of URRA.FinanceAt the first of two finance subgroup meetings, FDA presented a host of goals for PDUFA VII: To enhance the operational capabilities, efficacy, and agility of the PDUFA program. FDA proposed continuing to advance resource capacity planning, updating the inflation adjustment to accurately account for program costs, enhancing flexibility in the operating reserve, eliminating a problematic limitation on allowable expenditures, streamlining annual reporting requirements, and implementing technical fixes.Industry representatives, however, stressed that their goal is to build on the enhancements made in PDUFA VI and to improve on user fee resource management, hiring and retention of review staff and performance reporting.During the second finance meeting, FDA and industry looked at a proposal to clarify the maximum and minimum amount of operating reserves to be maintained each year and a proposal to further implement the resource capacity planning (RCP) capability instituted in PDUFA VI.Stakeholder meetingFDA also released a meeting summary from the first round of stakeholder discussions. More than 60 stakeholder organizations, including patient groups, consumer representatives, public health advocates and medical associations, registered to attend the meeting, though a third of those registered did not attend.Some of the themes frequently cited by stakeholders included enhancing the incorporation of patient voice in drug development and regulatory decision making, modernizing FDAs infrastructure, ensuring FDA has adequate resources to recruit and retain qualified staff including in the areas of cell and gene therapy, increasing the strength and reach of patient and rare disease programs including improving diversity in clinical trials and patient engagement, enhancing FDAs use of regulatory science (e.g. COAs, MIDD, RWE), and improving the integration of and guidance for the use of real-world evidence (RWE), FDA reported. Stakeholders also raised decentralized trials and lessons learned during the COVID-19 pandemic as topics for future discussions.FDA tasked stakeholders with identifying their top issues for further discussion and said it would survey them to rank the topics on the agreed to shortlist.FDA

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PDUFA VII: FDA and industry set priorities in first round of negotiations - Regulatory Focus

At the very heart of our Biblical tradition is this commandment from the Book of Leviticus: You shall not stand idly by the blood of your fellow. (Leviticus 19:16)

If we see our sisters or brothers in danger, our job is simple: Provide that help, come to their aid, do what is in our power to protect them and save them.

In the midst of a global pandemic, we feel the call to protect and promote the health and well-being of others even more urgently. Right now, we hear the call to uphold the ultimate Jewish value of pikuach nefesh (saving a life).

Sometimes, we live out that value in an immediate way. We donate blood today, which can save lives in real time. We provide support for basic needs to ensure that people in our community have enough to eat right now. But if we truly wish to move the needle in the work of pikuach nefesh, we must also provide resources to fund research over many years, even decades, that will, ultimately, yield dramatic results.

To truly make a difference, to be Gods partners in bringing healing to the world, we must not stand idly by in both immediate and long-term ways.

California voters have an opportunity to do just this by voting yes on Proposition 14, which will advance the California Institute of Regenerative Medicines stem cell research to help those who are affected by ailments including heart disease, diabetes, Alzheimers, Parkinsons disease, sickle cell disease, spinal cord injuries, Covid-19, and so many other chronic illnesses and injuries.

Funding for this important and vital medical research helps save lives, and it will provide immediate economic stimulus, as well. Even as it funds long-term strategies to alleviate human suffering, Prop. 14 will create jobs during this challenging time. Recent studiessuggest that Prop. 14 would generate approximately $20 billion in increased economic activity in California, yielding more than 100,000 new jobs at every level. This far surpasses Prop. 14s estimated cost of $5.5 billion in bonds.

Critics of the proposition question the need for such funding on a state level today. They argue that Proposition 71, the initiative that originally created the California Institute of Regenerative Medicine, was passed in 2004 only because President George W. Bush had banned federal funding for stem cell research. Now that federal funding for stem cell research is allowed, the critics charge, its no longer Californias responsibility to fund such research; private and federal funding should be used to continue this important work.

However, relying on federal and private funds is too risky. Many in our country wish to stifle and limit stem cell research on religious grounds. Far more importantly, Jewish law on this matter is unequivocal: stem cell research is not just permitted, but, arguably, required as a matter of pikuach nefesh. Numerous halachic authorities have made this clear. It should, therefore, come as no surprise that some of the most exciting work in stem cell research is currently being done in Israel.

Medical experts agree that stem cell research and therapies will save lives and alleviate human suffering. In fact, it already has. One example is the stem cell work Dr. Donald Kohn at UCLA conducted to cure ADA-SCID bubble baby disease.

This work is too important for us to leave it to chance or to allow it to be cut off or limited.

We see Prop. 14s opportunity to provide such resources for life-saving research as a blessing, the fulfillment of core Jewish values.

Just one chapter before the commandment to not stand idly by, our Torah reminds us that the purpose of mitzvot, the very goal of Judaism, is to enhance life. We are commanded: in the pursuit of My laws and statutes you shall live. (Leviticus 18:5) The Rabbis of the Talmud interpret this verse to mean that the ultimate value, above all else, is life itself.

To be sure, it will take many years to realize the promise of current research. But like the well-known story of Honi, who came upon an old man planting a tree that would not bear fruit for another 70 years, we recognize that our efforts are not for ourselves alone. Just as our ancestors sacrificed so that our lives would be better, we commit ourselves to doing the same for our descendants.

The voices of our sisters and brothers cry out to us: friends and family members with diabetes; co-workers fighting against cancer; loved ones slipping away due to the cruel ravages of Alzheimers.

They call out to us in their pain. They are searching for hope.

We cannot stand idly by. We must generously sacrifice so that they and subsequent generations might live and be well.

There are quite literally lives to be saved. Join us by voting yes on Prop, 14 on Nov. 3.

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We can't stand idly by: Vote 'yes' on Prop. 14 for stem cell research - The Jewish News of Northern California

Global Market Vision has published a newly innovative statistical data, titled as Regenerative Medicine Market. It is a valuable source of statistical data for Regenerative Medicine market and includes accurate information, which uses primary and secondary research techniques. The research analyst provides comprehensive data, which enhances the growth of the industries. This report focuses on the basic requirement strategies of the businesses, which helps to enlarge the productivity. Additionally, it offers different market segments, such as application, types, size, end users, cost etc.

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It includes the research studies about the current trends in different sectors on the basis of their scope. The analyst of this report focuses on the static and dynamic pillars of the industries, for basic understanding of the strategies. In addition to this, it identifies the drivers and opportunities for the development of the businesses. Additionally, it focuses on restraints to analyze the issues from the existing business strategies. It focuses on the various aspects, such as application areas, platforms, and leading players operating across the globe.

Major Companies Profiled in this Report Includes: DePuy Synthes, Medtronic, ZimmerBiomet, Stryker, Acelity, MiMedx Group, Organogenesis, UniQure, Cellular Dynamics International, Osiris Therapeutics, Vcanbio, Gamida Cell, Golden Meditech, Cytori, Celgene, Vericel Corporation, Guanhao Biotech, Mesoblast, Stemcell Technologies, Bellicum Pharmaceuticals.

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Global Regenerative Medicine Market Segmentation:

By Type/Product, Regenerative Medicine market has been segmented into: Cell Therapy, Tissue Engineering, Biomaterial, Other

By Application/End User, Regenerative Medicine has been segmented into: Dermatology, Cardiovascular, CNS, Orthopedic, Others

Regions Covered in the Global Regenerative Medicine Market: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

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The reports conclusion leads into the overall scope of the global market with respect to feasibility of investments in various segments of the market, along with a descriptive passage that outlines the feasibility of new projects that might succeed in the global Regenerative Medicine market in the near future. The report will assist understand the requirements of customers, discover problem areas and possibility to get higher, and help in the basic leadership manner of any organization. It can guarantee the success of your promoting attempt, enables to reveal the clients competition empowering them to be one level ahead and restriction losses.

Global market research objectives:

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Table of Content (TOC):

Chapter 1 Introduction and Overview

Chapter 2 Industry Cost Structure and Economic Impact

Chapter 3 Rising Trends and New Technologies with Major key players

Chapter 4 Global Regenerative Medicine Market Analysis, Trends, Growth Factor

Chapter 5 Regenerative Medicine Market Application and Business with Potential Analysis

Chapter 6 Global Regenerative Medicine Market Segment, Type, Application

Chapter 7 Global Regenerative Medicine Market Analysis (by Application, Type, End User)

Chapter 8 Major Key Vendors Analysis of Regenerative Medicine Market

Chapter 9 Development Trend of Analysis

Chapter 10 Conclusion

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Regenerative Medicine Market Witnessing Significant Demand in the Global Market During 2020 2027 - Bipartisan Millennial

Colorado State University is no stranger to innovation, and in the past fiscal year, faculty, students, and staff received a record 69 new international and U.S. patents. These came from a similarly record-breaking 177 patent applications.

This feat put CSU, for the first time ever, on the National Academy of Inventors top 100 list of international universities for U.S. patents.

University patents ignite a culture of growth and innovation which in turn stimulates the economy, Jessica Landacre, executive director at the Intellectual Property Owners Association, which co-authored the NAIs report, said in a statement. Added NAIs President Paul Sanberg: The institutions included in this years report are leading innovation worldwide through their encouragement of academic discovery and invention.

The new patents were issued to researchers and inventors in the College of Agricultural Sciences; College of Business; Walter Scott, Jr. College of Engineering; College of Liberal Arts; College of Natural Sciences; College of Veterinary Medicine and Biomedical Sciences, and Facilities Management.

These patents have come through the Universitys technology transfer office, CSU Ventures. Technology transfer provides an avenue that helps to highlight important translational research at CSU and how it positively impacts peoples lives, locally and globally, said Sarah Hibbs-Shipp, director of outreach and communications for CSU Ventures. It also supports the land-grant mission of CSU.

In 2020, CSU Ventures selected Dr. Chris Orton, professor in the Department of Clinical Sciences, as the recipient of the Innovative Excellence Award. A leading authority in veterinary cardiovascular surgery, Orton is known for launching the first veterinary open-heart surgery program in the world.

One of Ortons patented technologies is licensed to Abbott Laboratories and contributed to the design of the companys Tendyne Transcatheter Mitral Valve Implantation system for human use. The system is approved for use in Europe, and is currently in review with the U.S. Food and Drug Administration. This life-changing therapy offers patients with significant mitral regurgitation a minimally invasive alternative to open-heart valve replacement surgery.

In addition to obtaining patents, faculty are also launching new startup companies with their innovations. Five were founded this past year with CSU intellectual property, with the assistance of CSU Ventures.

Startup companies are often the best path forward to bringing new technology to the marketplace, said Todd Headley, vice president of CSU Ventures. They also create jobs and have a positive impact on economic development.

Of the five startups, four of them were founded by CSU faculty and staff.

Of note, a COVID-related device technology developed by CSU researchers Brian Geiss of the Department of Microbiology, Immunology and Pathology; Chuck Henry of the Department of Chemistry; and David Dandy, of the Department of Chemical and Biological Engineering, was licensed to Quara Devices Ic. for further development. Ken Reardon of the Department of Chemical and Biological Engineering is the chief science officer of Quara Devices and helped initiate the licensing deal. The hope is that this small, inexpensive virus-detection technology will serve as the basis of a new product that could compete with standard diagnostic testing for the coronavirus that causes COVID-19.

In all, CSU investigators are currently working on more than 44 COVID-related projects.

These are wonderful demonstrations of how members of the CSU community were able to pivot their research and focus to solve real world, active problems, fully embodying the land-grant mission, Hibbs-Shipp said.

Link:
CSU innovators break record with 69 new patents in the past year - Source

New York, Oct. 28, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Europe Cartilage Degeneration Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Procedure Type ; Application ; and End User and Country Regional Analysis and Market Forecasts by Procedure Type, Application and End User" - https://www.reportlinker.com/p05978846/?utm_source=GNW However, high cost of cartilage therapies and lack of reimbursement scenario are the factors restraining the growth of the market in this region.

Nevertheless, the growing number of product approvals and rising emphasis on regenerative medicines are likely to fuel the growth of the Europe cartilage degeneration market during the forecast period.Degeneration of cartilage leads to pain and chronic inflammation in joints of a human body.Furthermore, damaged cartilage can potentially influence the quality of a patients life.

Continuous research and developments are innovating new techniques and methodologies to deal with damaged cartilages. A few of these techniques comprise joint replacement, cell therapies, and chondroplasty.

Companies in the cartilage degeneration market are undertaking various R&D activities to introduce more innovative products. For instance, in September 2013, OligoMedic, Inc., a global designer, manufacturer, and distributor of osteoarthritis products, launched its CE mark injectable implant JointRep for the treatment of cartilage articular joint defect. Also, the new cartilage therapies are enabling the adoption of advanced cell technologies, which are, in turn, strengthening the procedural outcomes. Furthermore, in May 2017, Co.DON AG got European Medicines Agency (EMA) approval for its Spherox, a knee cartilage repair product for the treatment of symptomatic articular cartilage defects in femoral condyle and patella

The players operating in the cartilage degeneration market are focusing on establishing collaborations and partnerships for the development of advanced products with increasing procedural efficiency. For instance, in October 2018, Gelmetix, a UK-based player, and Stemmatters, a Portuguese regenerative medicine company, entered into a strategic partnership for the innovation and development of an advanced knee cartilage repair device. hus, the increasing number of product approvals, developments, advanced technologies, and strategic activities are projected to offer lucrative opportunities for the growth of the market.

The European economy is severely affected due to the exponential rise in the number of COVID-19 patients in this region.The Medical Device Regulation (MDR) requires manufacturers to conduct Post Market Clinical Follow-Up (PMCF) studies to demonstrate the continued safety and performance of their devices.

This is expected to impact the product launch and ongoing clinical trials of medical devices, thereby hampering the sales and market growth. Also, disrupted supply chains, extended lockdowns, and canceling of other medical procedures have adversely affected the growth of the cartilage degeneration market in Europe.The knee segment accounted for the largest share of the market in 2019.The growth of this segment is attributed to the increasing prevalence of knee injuries.

For instance, according to a study publishedbased on NCBI dataon an online newspaper, one in four adults suffer from chronic knee pain in this region. Moreover, the prevalence of knee pain has witnessed a massive growth of around 40.0% during the past 4 decades. Furthermore, the increasing awareness of benefits provided by cartilage repair is anticipated to drive the growth of the knee segment.

The major secondary sources associated with the Europe cartilage degeneration market report are the World Health Organization (WHO), British Journal of Sports Medicine, European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA), Organization for Economic Cooperation and Development (OECD), and others.Read the full report: https://www.reportlinker.com/p05978846/?utm_source=GNW

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

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Europe Cartilage Degeneration Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Procedure Type ; Application ; and End User and...

VALENCIA, Calif., Oct. 27, 2020 (GLOBE NEWSWIRE) -- AVITA Therapeutics, Inc. (NASDAQ: RCEL, ASX:AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today it plans to release its first quarter 2021 financial results after the market closes on Wednesday, November 11, 2020. In conjunction with such release, the Company plans to host a conference call and webcast that day at 1:30 p.m. Pacific time / 4:30 p.m. Eastern time to discuss its financial results and recent highlights.

Interested parties may access the live call via telephone by dialing (833) 614-1538 for domestic callers or (706) 634-6548 for international callers, using conference ID: 2688929. The live webinar for the call may be accessed by visiting the Events section of the Company's website at ir.avitamedical.com. A replay of the webinar will be available on the Companys website shortly after the conclusion of the call.

Authorized for release by the Chief Executive Officer of AVITA Therapeutics, Inc.

ABOUT AVITA THERAPEUTICS, INC.AVITA Therapeutics is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Therapeutics patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a RES REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Therapeutics first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.To learn more, visit http://www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSThis letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

FOR FURTHER INFORMATION:

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AVITA Therapeutics to Announce First Quarter 2021 Financial Results - GlobeNewswire

A new USC-led study suggests a change to the developmental -- and evolutionary -- story of the pituitary gland.

The pea-sized gland, nestled at the base of the brain, produces hormones that drive growth, aggression, sexual development and reproduction. For decades, the front lobe of the pituitary -- where the hormones are made -- was thought to be an evolutionary development that arose in vertebrates, along with the ear, the nose and the lens of the eye.

The widely accepted "new head hypothesis" holds that all of these body parts derive from a particular type of embryonic structure located in the ectoderm, or outermost layer of an embryo. Meanwhile, animals that have spinal cords but lack backbones, understood to represent an earlier evolutionary step, have a pituitary-like structure previously thought to have a distinct origin in the innermost embryonic layer, or endoderm.

In a paper published today in Science, USC researchers present evidence that, in some vertebrates, the endoderm also forms part of the pituitary's front lobe -- an idea that has been the subject of scientific controversy dating back more than 100 years. Findings from the study, which was supported by a major grant from the National Institutes of Health, suggest that the gland may have a longer evolutionary history than previously thought.

"We revisited very old observations with cutting-edge technology that proves this idea that there is an endodermal contribution to the pituitary," said senior author Gage Crump, professor of stem cell and regenerative medicine at the Keck School of Medicine of USC. "Our work revises ideas about what kind of embryonic structure the pituitary is, and when it first evolved."Developmental detective work

Crump and his colleagues studied zebrafish, a species useful as a lab model in part because their development is an open book to researchers; eggs are fertilized externally and embryos are nearly see-through. The research team used new lab methods of their own invention to label the zebrafish's embryonic cells and follow the cells that descended from them through adulthood.

Additionally, they used time-lapse imaging with a powerful microscope and single-cell RNA sequencing. That latter technology is related to DNA sequencing, but instead of characterizing the entire genetic code, it reveals only the genes that are expressed, and in what quantities, for each of thousands of cells at a time -- a powerful way of understanding the nature of the cells being studied.

In a series of experiments with time-lapse imaging of zebrafish embryos, the team documented Rathke's pouch, a structure from the outer layer previously believed to be the sole source of the pituitary's front lobe, fusing with Seessel's pouch, a structure from the inner layer. Their observations indicate that the endoderm was responsible for about 20 percent of the cells in the front lobe of the pituitary.

Another experiment tracking the fate of embryonic cells into adult zebrafish showed a mixture of ectodermally and endodermally derived cells in the pituitary. Delving into gene expression with RNA sequencing, the scientists found that cells from the inner endoderm layer ended up differentiating into all of the major types of hormone-producing cells in the pituitary. Furthermore, in genetically manipulated zebrafish embryos that lacked the ectodermal component , endodermal cells could form a pituitary-like structure on their own, albeit much smaller than the normal pituitary.

Taken together, these investigations clearly demonstrate an endodermal contribution to the zebrafish pituitary. This unexpected revelation suggests that the quasi-pituitary seen in certain more-primal nonvertebrate animals -- undersea creatures that are strange and largely obscure -- may have survived, in a form, among at least some of their backbone-bearing evolutionary descendants.

Crump, who also is the founding director of USC's PhD Program in Development, Stem Cells, and Regenerative Medicine, cautions that it remains to be seen whether the vestige endures in humans.

"It may be that fish retain this ancestral feature, but humans have lost it," he said. "We can see the pituitary is not a brand-new vertebrate structure like the nose or ear or lens, but instead was already present before vertebrates and subsequently incorporated new ectoderm contributions. By capturing this evolutionary relic in zebrafish, we have resolved the mystery of where the pituitary came from."

An old idea that came back around (surprisingly)

As far back as the mid-1910s, anatomists had reported that Rathke's pouch was closely associated with Seessel's pouch. Rathke's pouch has long been understood as the source of the pituitary's endocrine component. By contrast, the fate and purpose of Seessel's pouch has remained a mystery -- until today.

For researchers in the early 20th century (and more or less ever since), there were no good ways to further explore the relation between the two embryonic structures, and thus the possibility of an endodermal contribution to the pituitary. Hotly debated at first, the topic eventually faded into more of a historical curiosity.

Fortunately, first author Peter Fabian, a postdoctoral researcher at the Keck School, was well-versed in this precedent. While trying out one of those new techniques for labeling and tracking embryonic cells, developed by collaborators at Sanford Burnham Prebys Medical Discovery Institute, he noticed endodermal cells in the pituitary. A light bulb went off in his head.

"It was a serendipitous discovery," Crump said. "We're interested in the endoderm in general, but we hadn't set out to study the pituitary. Because this was such an unexpected observation, we really had to prove it with multiple lines of investigation."

Reference: Fabian P, Tseng KC, Smeeton J, et al.Lineage analysis reveals an endodermal contribution to the vertebrate pituitary.Science. 2020;370(6515)463-467. doi:10.1126/science.aba4767

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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A New Piece Added to the Pituitary Gland Puzzle Revises Evolutionary History - Technology Networks