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Category Archives: Cell Medicine

BrainStorm Cell Therapeutic’s COO and CMO, Dr. Ralph Kern, to Present at the 10th Annual California ALS Research Summit – GlobeNewswire

Posted: January 22, 2020 at 4:44 am

NEW YORK and LOS ANGELES, Jan. 21, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, will present at the 10th Annual California ALS Research Summit, January 24-25 at Cedars-Sinai Medical Center, Los Angeles, California.

Dr. Kern will provide an update on BrainStorms Phase 3 ALS Clinical Trial on Friday, January 24, 10:30 -11:10 AM PT, during the session: CIRM funded Stem Cell Clinical Trials in California Updates.

Dr. Kern stated, This prestigious Summit works to increase, expedite and promote the amount and level of amyotrophic lateral sclerosis (ALS) research done in California that has been reinforced and amplified by the international ALS scientific and medical community. I am pleased to have the opportunity to share all that BrainStorm has accomplished in our fully enrolled Phase 3 clinical trial of NurOwn(NCT03280056).

Chaim Lebovits, President and CEO of BrainStorm, stated, California continues to be a global leader in stem cell research and scientific funding. Due to Californias commitment to stem cell scientific investigation, BrainStorm is at an inflection point as we bring our investigational therapy, NurOwn, toward the submission of a biological license application. In July 2017, BrainStorm was awarded a grant of $15.9 million from the California Institute for Regenerative Medicine (CIRM) and three of Californias most prestigious medical centers: University of California, Irvine, Cedars-Sinai Medical Center, and California Pacific Medical Center have contributed immensely to advancement of NurOwn. Everyone at BrainStorm is proud Dr. Kern will have the opportunity to present to the ALS community of California all that has been accomplished due to their ongoing support and encouragement.

About The California ALS Research Summit:

The California ALS Research Summit is the tenth annual gathering of researchers, investigators, clinicians, biotech companies, government representatives, partner organizations, and advocates in ALS and related fields in the State of California.

The purpose of the Summit is to help increase, expedite and promote the amount and level of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's Disease) and related research done in California; and to foster networking, collaboration and cooperation among investigators, their peers and their colleagues to identify, develop and deliver new and effective treatments, ideas and, ultimately, cures for ALS.

The result of our efforts is an ongoing roadmap for ALS research in California, which will provide the basis for partnering within the state and other supporters to further studies to find new treatments and ultimately a cure for the disease.

About NurOwn

NurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at http://www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

Or:Katie GallagherLaVoieHealthSciencesPhone: + 1 617-374-8800 x109kgallagher@lavoiehealthscience.com

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BrainStorm Cell Therapeutic's COO and CMO, Dr. Ralph Kern, to Present at the 10th Annual California ALS Research Summit - GlobeNewswire

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Commentary: Why the world needs more than antibiotics to cure infections – CNA

Posted: January 22, 2020 at 4:44 am

LONDON: The world is in the midst of aglobal superbug crisis.

Antibiotic resistance has been found in numerous common bacterial infections, including tuberculosis, gonorrhoea and salmonellosis, making them difficult if not impossible to treat.

Were on the cusp of apost-antibiotic era, where there are fewer treatment options for such antibiotic-resistant strains. Given estimates that antibiotic resistance will cause10 million deaths a year by 2050, finding new methods for treating harmful infections is essential.

Strange as it might sound, viruses might be onepossible alternative to antibioticsfor treating bacterial infections. Bacteriophages (also known as phages) are viruses that infect bacteria.

Theyre estimated to be the most abundant organisms on Earth, with probably more than trillions of bacteriophages on the planet. They can survive in many environments, including deep sea trenches and the human gut.

While phages are efficient killers of bacteria, they dont infect human cells and are harmless to humans.

FIGHTING VIRUSES WITH VIRUS

Although phage therapy wasused in the 1930s, it has since become a forgotten cure in the West. Although the treatment became commonplace in the former Soviet Union, it wasnt adopted by western countries largely because of the discovery of antibiotics, which became widespread after World War II.

Bacteriophages are effective against bacteria because theyre able to attach themselves to the cell if they recognise specific molecules called receptors. This is the first step in the infection process. After attaching to the bacterial cell, the phage then injects its DNA inside the bacteria.

This causes one of two things to happen. After being injected with the phages DNA, the virus will take over the bacterial cells replication mechanism and start producing more phages.

This process is known as a lytic infection. This disintegrates the cell, allowing the newly produced viruses to leave the host cell to infect other bacterial cells.

But sometimes, the phage DNA gets incorporated into the bacterial hosts chromosome instead,becoming a prophage. It usually remains dormant but environmental factors, such as UV radiation or the presence of certain chemicals such asthose found in sunscreen, can cause the phage to wake up, start a lytic infection, take over the host cell and destroy it.

Lytic bacteriophagesare preferred for treatment because they dont integrate into the bacterial hosts chromosome.

But its not always possible to develop lytic bacteriophages that can be used against all types of bacteria. As each type of phage is only able to infect specific types of bacteria, they cant infect a bacterial cell unless the bacteriophage can find specific receptors on the bacterial cell surface.

However, engineering techniques can remove the bacteriophages ability to integrate into the hosts genome, making them useful for treatment.

Engineered phages have even successfully treated a drug-resistantMycobacterium abscessus infectionin a 15-year-old girl.

TARGETED TREATMENT

The reason bacteriophages are so effective against bacteria is because theyre only able to infect specific species. Antibiotics instead target a wide range of bacteria, including friendly bacteria not causing the infection.

But this also means that a single phage wont kill all strains of a disease-causing bacteria. And because bacteria areconstantly evolving, they can develop mechanisms that prevent phage infection. For example, if the bacterial cell has evolved and changed its surface receptors, the bacteriophage wont be able to attach itself and kill the bacteria.

As part of this evolutionary process, bacteria canrapidly become resistantto a single bacteriophage. But because there aremany types of bacteriophages, we can use a phage cocktail containing a combination of different bacteriophages totarget a broader rangeof bacterial strains within a species.

This decreases the chances a bacteria becomes resistant to all phages used in treatment. Bacteriophages can also be engineered toinfect more strainsof bacteria.

COMPLICATIONS DO EXIST

However, the presence of what are known asCRISPR systemsmight complicate the possibility of using bacteriophages in treatment. CRISPR is a bacterias natural defence system that allows it tobecome immuneto genetic material, such as phages, through infection, vaccination or the transfer of antibodies.

Bacteria may be resistant to bacteriophages if they have previously encountered similar types and developed immunity.

But bacteriophages have also developedanti-CRISPRproteins that can neutralise the host bacterias CRISPR systems.

This means a phage can still be effective, despite the presence of the bacterial CRISPR system. Not all bacteriophages have genes that neutralise anti-CRISPR proteins. But with the ability to engineer phage genomes, these could be incorporated into phages that are to be used for treatment in the future.

Although phage therapy isnt routinely used in western medicine, phage cocktails are available treatments in Russia and Georgia. Phage therapy is also acommon part of medical carein Georgia, especially in paediatric, surgical care and burns hospital settings.

Phages are used on their own or in combination with antibiotics and their use hasnt been linked to anyadverse effects.

With antibiotic-resistant infections becoming more common, bacteriophages offer the ability to treat such infections.

But forbacteriophages to become commonplacein treating bacterial infections, there needs to becontinued researchinto phage biology to better understand how they interact with bacteria.

Finding effective treatments for bacterial infections other than antibiotics is the first step in fighting further instances of antibiotic resistance.

Manal Mohammed IS Lecturer in Medical Microbiology at the University of Westminster. Andrew Millard is Lecturer in Bacteriophage Bioinformatics at the University of Leicester. This commentary first appeared in The Conversation.

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Commentary: Why the world needs more than antibiotics to cure infections - CNA

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Applied Cells Announces Evaluation of Its New MARS Platform at The University of Pennsylvania – P&T Community

Posted: January 22, 2020 at 4:44 am

SANTA CLARA, Calif., Jan. 20, 2020 /PRNewswire/ -- University of Pennsylvania (Penn) andApplied Cells Inc., a Santa Clara, California based biotechnology company, announced today that they have entered into aCollaborative Research Agreement to evaluate Applied Cells new generation cell isolation and sample preparation system, "MARS", in cancer and immunology research at Penn.

Applied Cells proprietary innovative MARS platform, short named after "Multi-physics Automated Reconfigurable Separation", is ideal for high-throughput, high-efficiency, high-recovery, automated cell separation and sample preparation. Modular design of MARS allows flexible configurations to meet versatile workflows for rare cell analysis, immune cell profiling, and cell therapy, with capabilities including target cell enrichment, cell purification, and cell concentration.

"We are excited by the opportunity to evaluate the MARS instrument from Applied Cells, as if we are successful, it will allow us to identify rare populations for diagnostic markers and potentially isolate new cellular therapeutics," said Jonni Moore, PhD, Professor of Pathology and Laboratory Medicine at the Hospital of the University of Pennsylvania. "Applied Cells MARS system could be a powerful companion to our cell isolation and identification technologies, and we are very excited by this prospect."

"Applied Cells is bringing benefit to our customers by enabling successful isolation of target cells from complex blood and tissue samples for broad downstream analysis platforms," said Yuchen Zhou, Founder and CEO of Applied Cells. "Teaming up with Penn, a world leader in medical research and modern medicine, enables us to bring our leading-edge products into the hands of researchers at the forefront of advanced medicine discoveries, and help them achieve their goals more quickly and bring greater value to our society as whole."

About University of Pennsylvania

University of Pennsylvania (Penn or UPenn) is a private Ivy League research university in Philadelphia, Pennsylvania. Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $7.8 billion enterprise. The Perelman School of Medicine has been ranked among the top medical schools in the United States for more than 20 years, according to U.S. News & World Report's survey of research-oriented medical schools.

About Applied Cells

Applied Cells Inc. is a company founded in Silicon Valley of California. With capabilities of bridging Silicon Valley knowhows and biomedical needs, combined with fast growing intellectual property portfolio, Applied Cells aims to disrupt the status quo in cellular sample preparation technologies with integrating its novel immuno-separation, active-microfluidics, and fluidics control technologies into next generation cell handling and processing products to help enable advanced cancer diagnosis and cancer treatment.

Media contact:Yuchen Zhou232432@email4pr.com650-539-4318

View original content:http://www.prnewswire.com/news-releases/applied-cells-announces-evaluation-of-its-new-mars-platform-at-the-university-of-pennsylvania-300988899.html

SOURCE Applied Cells Inc.

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Applied Cells Announces Evaluation of Its New MARS Platform at The University of Pennsylvania - P&T Community

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Jeffrey Epstein had multiple sheets, electrical cord, prescription meds and note in jail cell where he kil – The Sun

Posted: January 5, 2020 at 3:50 am

MULTIPLE bed sheets, an extension cord and prescription medicine were reportedly found in Jeffrey Epstein's jail cell after his suicide.

Prison guards found a number of bed sheets - enough for several inmates - in his cell despite a prior suicide attempt while awaiting trial on sex charges, an upcoming 60 Minutes investigation reveals.

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A handwritten note, pen, paper, an extension cord and medication were also uncovered, according to the report set to air Sunday.

When Epstein's body was eventually discovered, sources told 60 Minutes that one prison guard could be overheard saying "breathe, Epstein, breathe."

Inmates could later be heard chanting the same, according to the 60 Minutes report.

Federal corrections officers reportedly called emergency services and tried to revive the 66-year-old's lifeless corpse on August 9.

His body was reportedly taken to the emergency room after it was found, a move that forensic pathologist Dr. Michael Baden says goes against Bureau of Prisons protocol.

"No, that's not normal protocol," said Baden, who was hired by Epstein's brother to investigate his death.

"The EMS people normally - and especially in jail - should not move a dead body."

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In cases of suicide, correctional service staff and other law enforcement personnel should "handle the site with the same level of protection as any crime scene in which a death has occurred," according to the BoP's program statement.

The New York City Department of Corrections didn't immediately respond to a request for comment from Sun Online.

Law enforcement officials confirmed on August 10 that the billionaire had taken his own life at Metropolitan Correctional Center in New York.

He had been held without bail pending trial on child sex-trafficking charges.

The two prison guards responsible for checking in on Epstein the night of his suicide allegedly fell asleep and surfed the internet during his jail cell death, according to court testimony.

Tova Noel and Michael Thomas were later charged with falsifying records to cover up their failure to watch the shamed sex offender.

Noel and Thomas pleaded not guilty in November and were released on $100,000 bond each, the New York Post reported.

Rumors about a suicide conspiracy swirled weeks after Epstein's death when sources told The Washington Post that video showing his July suicide attempt inside the maximum security prison was unusable.

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CREDIBLE THREATS Ghislaine Maxwell has 24-hr security guarding her due to death threats'

PLOTTING HIS COMEBACK Weinstein 'in rehab & intends to rebuild career if found not guilty

TO THE RESCUE Hero teens save friend from man who tried to abduct pal from mall arcade

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A lawyer for the financier's former cellmate claimed the video no longer existed on December 18.

Two days later, it was revealed that the CCTV footage was preserved by MCC staff, sparking an FBI probe into the circumstances surrounding Epstein's death.

Epstein pleaded guilty to soliciting prostitution from underage girls in 2008.

He was forced to register as a sex offender and paid restitution to three dozen victims identified by the FBI.

Ghislaine Maxwell, the British socialite accused of procuring underage girls for the billionaire, is currently hiding in safe houses in the UK and Israel to evade the scandal.

Her evasion has caused trouble for other Epstein pals like Prince Andrew, who reportedly begged Maxwell to publicly defend his name.

The alleged madam is the only witness to Virginia Roberts' claims she was forced to have sex with the disgraced Duke of York when she was 17.

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Jeffrey Epstein had multiple sheets, electrical cord, prescription meds and note in jail cell where he kil - The Sun

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Cell & Advanced Therapies Supply Chain Management Markets, Forecast to 2030 – In 2018, Approx $13Bn Was Invested in This Domain, Representing a 73%…

Posted: January 5, 2020 at 3:50 am

DUBLIN, Jan. 3, 2020 /PRNewswire/ -- The "Cell and Advanced Therapies Supply Chain Management Market, 2019-2030: Focus on Technological Solutions" report has been added to ResearchAndMarkets.com's offering.

Cell and Advanced Therapies Supply Chain Management Market: Focus on Technological Solutions, 2019-2030

report features an extensive study of the growing supply chain management software solutions market.

The focus of this study is on software systems, including cell orchestration platforms (COP), enterprise manufacturing systems (EMS), inventory management systems (IMS), laboratory information management systems (LIMS), logistics management systems (LMS), patient management systems (PMS), quality management systems (QMS), tracking and tracing software (TTS), and other such platforms that are being used to improve / optimize various supply chain-related processes of cell and advanced therapies.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the supply chain management software solutions market. Based on multiple parameters, such as number of cell and advanced therapies under development, expected pricing, likely adoption rates, and potential cost saving opportunities from different software systems, we have developed informed estimates of the evolution of the market, over the period 2019-2030.

In addition, we have provided the likely distribution of the current and forecasted opportunity across:

Advanced therapy medicinal products, such as cell and gene therapies, have revolutionized healthcare practices. The introduction of such treatment options has led to a paradigm shift in drug development, production and consumption. Moreover, such therapies have actually enabled healthcare providers to treat several difficult-to-treat clinical conditions.

In the past two decades, more than 30 such therapy products have been approved; recent approvals include Zolgensma (2019), RECELL System (2018), AmnioFix (2018), EpiFix (2018), EpiBurn (2018), Alofisel (2018), LUXTURNA (2017), Yescarta (2017), and Kymriah (2017). Further, according to a report published by The Alliance for Regenerative Medicine in 2019, more than 1,000 clinical trials are being conducted across the globe by over 900 companies.

In 2018, around USD 13 billion was invested in this domain, representing a 73% increase in capital investments in this domain, compared to the previous year. It is worth highlighting that, based on an assessment of the current pipeline of cell therapies and the historical clinical success of such products, it is likely that around 10-20 advanced therapies are approved by the US FDA each year, till 2025.

The commercial success of cell and advanced therapies is not only tied to whether they are capable of offering the desired therapeutic benefits, but also on whether the developers are able to effectively address all supply chain requirements. The advanced therapy medicinal products supply chain is relatively more complex compared to the conventional pharmaceutical supply chain. As a result, there are a number of risks, such as possible operational inefficiencies, capacity scheduling concerns, process delays leading to capital losses, and deliverable tracking-related issues, which need to be taken into consideration by therapy developers.

This has generated a need for bespoke technological solutions, which can be integrated into existing processes to enable the engaged stakeholders to oversee and manage the various aspects of the cell and advanced therapies supply chain, in compliance to global regulatory standards. Over the years, several innovative, software-enabled systems, offering supply chain orchestration and needle-to-needle traceability, have been developed.

The market has also recently witnessed the establishment of numerous partnerships, most of which are agreements between therapy developers and software solutions providers. Further, given the growing demand for cost-effective personalized medicinal products, and a myriad of other benefits of implementing such software solutions, the niche market is poised to grow significantly in the foreseen future.

Amongst other elements, the report features:

In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry's evolution.

The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:

Key Topics Covered

1. PREFACE1.1. Scope of the Report1.2. Research Methodology1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION3.1. Context and Background3.2. An Introduction to Cell and Advanced Therapies3.2.1. Classification of Advanced Therapy Medicinal Products3.2.2. Current Market Landscape3.3. Cell and Advanced Therapies Supply Chain3.3.1. Key Processes3.3.2. Challenges Associated with the Cell and Advanced Therapies Supply Chain3.4. Software Solutions for Cell and Advanced Therapies Supply Chain Management3.4.1. Cell Orchestration Platform3.4.2. Enterprise Manufacturing System3.4.3. Inventory Management System3.4.4. Laboratory Information Management System3.4.5. Logistics Management System3.4.6. Patient Management System3.4.7. Quality Management System3.4.8. Tracking and Tracing System3.5. Growth Drivers and Roadblocks3.6. Emergence of Digital Technologies in Supply Chain Management3.6.1. Blockchain Technology3.6.2. Internet of Things3.6.3. Augmented Reality3.6.4. Big Data Analytics3.6.5. Artificial Intelligence

4. CURRENT MARKET LANDSCAPE4.1. Chapter Overview4.2. Cell and Advanced Therapies Supply Chain Management: Overall Market Landscape4.2.1. Analysis by Type of Software Solution4.2.2. Analysis by Key Specification and Benefit4.3.3. Analysis by Application4.3.4. Analysis by End User4.3.5. Analysis by Mode of Deployment4.3.6. Analysis by Scale of Management4.3.7. Analysis by Regulatory Certifications / Accreditations4.3. Cell and Advanced Therapies Supply Chain Management: Developer Landscape4.2.1. Analysis by Year of Establishment4.2.2. Analysis by Location of Headquarters4.2.3. Analysis by Size of Company4.3.4. Analysis by Support Services Offered4.3.5. Leading Developers: Analysis by Number of Software Solutions

5. COMPANY COMPETITIVENESS ANALYSIS5.1. Chapter Overview5.2. Methodology5.3. Assumptions and Key Parameters5.4. Competitiveness Analysis: Overview of Supply Chain Management Software Solution Providers5.4.1. Small-sized Companies5.4.2. Mid-sized Companies5.4.3. Large Companies

6. CORE SUPPLY CHAIN MANAGEMENT SOFTWARE SOLUTIONS: COMPANY PROFILES6.1. Chapter Overview6.2. Brooks Life Sciences6.2.1. Company Overview6.2.2. Financial Information6.2.3. BiobankPro: Software Description6.2.4. Recent Developments and Future Outlook6.3. Cryoport6.3.1. Company Overview6.3.2. Financial Information6.3.3. Cryoportal: Software Description6.3.4. Recent Developments and Future Outlook6.4. MasterControl6.4.1. Company Overview6.4.2. MasterControl Platform: Software Description6.4.3. Recent Developments and Future Outlook6.5. SAP6.5.1. Company Overview6.5.2. Financial Information6.5.3. SAP S/4HANA: Software Description6.5.4. Recent Development and Future Outlook6.6. Savsu Technologies6.6.1. Company Overview6.6.2. Financial Information6.6.3. evo Cold Chain 2.0: Software Description6.6.4. Recent Development and Future Outlook6.7. TraceLink6.7.1. Company Overview6.7.2. Financial Information6.7.3. Digital Supply Chain Platform: Software Description6.7.4. Recent Developments and Future Outlook

7. CELL ORCHESTRATION PLATFORMS: EMERGING TRENDS AND PROFILES OF KEY PLAYERS7.1. Chapter Overview7.2. Supply Chain Orchestration Platforms7.2.1. Key Functions of Supply Chain Orchestration Platforms7.2.2. Advantages of Supply Chain Orchestration Platforms7.2.3. Supply Chain Orchestration Platform Implementation Strategies7.3. Supply Chain Orchestration Platform: Trends on Twitter7.3.1. Scope and Methodology7.3.2. Historical Trends in Volume of Tweets7.3.3. Popular Keywords7.4. Key Industry Players7.4.1. Be The Match BioTherapies7.4.2. Clarkston Consulting7.4.3. Haemonetics7.4.4. Hypertrust Patient Data Care7.4.5. Lykan Bioscience7.4.6. MAK-SYSTEM7.4.7. sedApta Group7.4.8. Stafa Cellular Therapy7.4.9. Title 21 Health Solutions7.4.10. TrakCel7.4.11. Vineti

8. FUNDING AND INVESTMENT ANALYSIS8.1. Chapter Overview8.2. Types of Funding8.3. Cell and Advanced Therapies Supply Chain Management: Recent Funding Instances8.3.1. Analysis by Number of Funding Instances8.3.2. Analysis by Amount Invested8.3.3. Analysis by Type of Funding8.3.4. Analysis by Number of Funding Instances and Amount Invested across Different Software Solutions8.3.5. Most Active Players: Analysis by Amount Invested8.3.6. Most Active Investors: Analysis by Participation8.3.7. Geographical Analysis by Amount Invested8.4. Concluding Remarks

9. PARTNERSHIPS AND COLLABORATIONS9.1. Chapter Overview9.2. Partnership Models9.3. Cell and Advanced Therapies Supply Chain Management: Recent Collaborations and Partnerships9.3.1. Analysis by Year of Partnership9.3.2. Analysis by Type of Partnership9.3.3. Analysis by Partner's Focus Area9.3.4. Analysis by Type of Software Solution9.3.5. Most Active Players: Analysis by Number of Partnerships9.3.6. Analysis by Regions

10. PLATFORM UTILIZATION USE CASES10.1. Chapter Overview10.2. Cell and Advanced Therapies Supply Chain Management: Recent Platform Utilization Use Cases10.2.1. Analysis by Year of Utilization10.2.2. Analysis by User's Focus Area10.2.3. Analysis by Type of Software Solution10.2.4. Most Active Players: Analysis by Number of Utilization Instances10.2.5. Most Active Players: Regional Analysis by Number of Utilization Instances

11. VALUE CHAIN ANALYSIS11.1. Chapter Overview11.2. Cell and Advanced Therapies Value Chain11.2. Cell and Advanced Therapies Value Chain: Cost Distribution11.3.1. Donor Eligibility Assessment11.3.2. Sample Collection11.3.3. Manufacturing11.3.4. Logistics11.3.5. Patient Verification and Treatment Follow-up

12. STAKEHOLDER NEEDS ANALYSIS12.1. Chapter Overview12.2. Cell and Advanced Therapies Supply Chain Management: Needs of Different Stakeholders12.2.1. Comparison of Stakeholder Needs

13. COST SAVINGS ANALYSIS13.1. Chapter Overview13.2. Key Assumptions and Methodology13.3. Overall Cost Saving Potential of Supply Chain Management Software Solutions, 2019-203013.3.1. Cost Saving Potential in Donor Eligibility Assessment, 2019-203013.3.2. Cost Saving Potential in Sample Collection, 2019-203013.3.3. Cost Saving Potential in Manufacturing, 2019-203013.3.4. Cost Saving Potential in Logistics, 2019-203013.3.5. Cost Saving Potential in Patient Verification and Treatment Follow-up, 2019-2030

14. MARKET FORECAST14.1. Chapter Overview14.2. Key Assumptions and Forecast Methodology14.3. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market, 2019-203014.3.1. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by Application14.3.2. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by End User14.3.3. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by Type of Software Solution14.3.4. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by Mode of Deployment14.3.5. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by Geography14.4. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by Application, Type of Software Solution and Mode of Deployment14.4.1. Cell and Advanced Therapies Supply Chain Management Solutions Market for Donor Eligibility Assessment, 2019-203014.4.2. Cell and Advanced Therapies Supply Chain Management Solutions Market for Sample Collection, 2019-203014.4.3. Cell and Advanced Therapies Supply Chain Management Solutions Market for Manufacturing, 2019-203014.4.4. Cell and Advanced Therapies Supply Chain Management Solutions Market for Logistics, 2019-203014.4.5. Cell and Advanced Therapies Supply Chain Management Solutions Market for Patient Verification and Treatment Follow-up, 2019-2030

15. EXECUTIVE INSIGHTS15.1. Chapter Overview15.2. Thermo Fisher Scientific15.2.1. Company Snapshot15.2.2. Interview Transcript: Bryan Poltilove, Vice President and General Manager15.3. Cell and Gene Therapy Catapult15.3.1. Company Snapshot15.3.2. Interview Transcript: Jacqueline Barry, Chief Clinical Officer15.4. McKesson15.4.1. Company Snapshot15.4.2. Interview Transcript: Jill Maddux, Director, Cell and Gene Therapy Product Strategy, and Divya Iyer, Senior Director, Corporate Strategy and Business Development15.5. TrakCel15.5.1. Company Snapshot15.5.2. Interview Transcript: Martin Lamb, Chief Business Officer

16. CONCLUDING REMARKS16.1. Chapter Overview16.2. Key Takeaways

17. APPENDIX 1: LIST OF ADDITIONAL SUPPLY CHAIN MANAGEMENT SOFTWARE SOLUTIONS

18. APPENDIX 2: TABULATED DATA

19. APPENDIX 3: LIST OF COMPANIES AND ORGANIZATIONS

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Trabectedin Targets Leukemic Cells and Restores Immune Cell Function in Models of Chronic Lymphocytic Leukemia – Cancer Therapy Advisor

Posted: January 5, 2020 at 3:50 am

The marine-derived compound trabectedin depletes both human primary leukemic cells and myeloid-derived suppressor cells, according to a new study published in Cancer Immunology Research.1 The researchers think their findings could lead to a new therapy that targets both leukemic cells and the protumor microenvironment, repairing the immune dysfunction that is characteristic of chronic lymphocytic leukemia (CLL).

CLLis characterized by lymphocyte accumulation in the blood, bone marrow, andlymphoid tissues.2 Recent advances in CLL therapy have come fromfinding and targeting the appropriate molecular pathways of the disease,explained Kanti R. Rai, MD, a professor of medicine and molecular medicine atthe Donald and Barbara Zucker School of Medicine at Hofstra/Northwell whowasnt involved in the study. Dr Rai said that, for instance, the Brutontyrosine kinase inhibitor ibrutinib binds to the receptor and affects B-cellreceptorsignaling. Another drug, venetoclax, an antagonist to BCL2, can effectivelyinduce apoptosis in CLL cells. However, treatment of this disease remainschallenging due to its immunosuppressive nature. If we [are] to attain a cure,newer compounds have to be identified which have a different mechanism ofcontrolling CLL, he said.

Patientswith CLL have dysfunctional T cells, noted Maria Teresa Bertilaccio, PhD, whois an assistant professor in the department of experimental therapeutics at TheUniversity of Texas MD Anderson Cancer Center in Houston, and the correspondingauthor of the study. Patients [with CLL] have immunosuppression features, sothey might develop an infection because their immune system is not working,she told Cancer Therapy Advisor. Our approach is not only to eradicateleukemia, but also to rearm the immune system to give patients a better qualityof life.

Trabectedintargets tumor-associated macrophages (TAMs); TAMs are thought to support CLLgrowth. A previous study by the Bertilaccio group showed that depleting TAMs byblocking CSF1R signaling reprograms the tumor microenvironment toward anantitumor phenotype.3 This led them to hypothesize that trabectedincould simultaneously target both leukemic cells and nonmalignant cells in thetumor microenvironment.

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Free Gene Therapy Available for Patients with Alzheimer’s – HealthITAnalytics.com

Posted: January 5, 2020 at 3:50 am

January 03, 2020 -Maximum Life Foundation (MaxLife), a non-profit organization focused on aging research, is providing a promising free gene therapy for ten patients with Alzheimers disease.

According to the Alzheimers Association, Alzheimers disease is the sixth leading cause of death in the US. Over five million Americans have the condition, leading to costs of $277 billion a year.

With this gene therapy, researchers have seen improvements in Alzheimers symptoms and the recovery of normal brain functions in experiments with mice. In human cell experiments, the therapy had the same effects through the rejuvenation of microglia, the brains first line of defense against infection, and neurons.

In August 2018, a patient received a low dose of the therapy with no adverse side effects. To date, the patients disease hasnt progressed.

MaxLife will grant 100 percent of the therapy costs to help bring pioneering gene therapy to cure this disease and make Alzheimers disease a thing of the past, said David Kekich, MaxLifes CEO.

Studies have proven that aging is the leading factor in many life-threatening diseases, including Alzheimers. This new gene therapy aims to treat the cellular degeneration caused by aging.

The new treatment is offered by Integrated Health Systems, a gene therapy facilitator that is seeking to treat other adult aging-related diseases with no known cure, including sarcopenia, chronic kidney disease, and atherosclerosis.

This technology could halt many of the big age-associated killers in industrialized countries, said Kekich. Compassionate care helps patients with no other option to get access to experimental therapies that may benefit both themselves and society as a whole.

Other healthcare organizations have stressed the need to leverage gene therapies and precision medicine to improve treatment for Alzheimers and other diseases. A recent study published in Frontiers in Aging Neuroscience discussed how precision medicine tactics will help improve cognitive disease treatment.

Taking a precision medicine approach, the question is no longer Does treatment work? but Who does treatment work for? Identifying the characteristics of non-responders becomes as important as responders in understanding the impact of a particular intervention, the team said.

Such an approach may result in considerable health benefits by allowing more effective selection of individuals for treatments based ona prioriknown profiles of disease risk and their potential response to treatment.

Researchers at Massachusetts General Hospital (MGH) also recently discovered that certain genetic variants may help protect individuals against Alzheimers disease, a finding that could hold important implications for precision medicine therapies.

The team studied a patient who carried a mutation in a gene known to cause early onset Alzheimers but didnt show signs of mild cognitive impairment until her seventies. This is nearly three decades after the typical age of onset. Evaluating this patient, and patients like her, could help researchers understand more about the progression of Alzheimers.

This single case opens a new door for treatments of Alzheimers disease, based more on the resistance to Alzheimers pathology rather than on the cause of the disease. In other words, not necessarily focusing on reduction of pathology, as it has been done traditionally in the field, but instead promoting resistance even in the face of significant brain pathology, said Yakeel T. Quiroz, PhD, clinical neuropsychologist and neuroimagingresearcher at MGH.

With the new gene therapy, MaxLife will add to the growing body of research exploring the use of precision medicine and genetics in chronic disease treatment.

If we can prove a benefit to patients that have no other option now, we can potentially treat Alzheimers disease in people in early to mid-stage Alzheimers, finally creating effective medicine at the cellular level, states Kekich. If successful, this treatment could potentially be used on other diseases such as Parkinsons and ALS.

To apply for a free therapy or for more information, click here.

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Dr Saw Khay Yong on founding KL Sports Medicine Centre and its revolutionary work in stem cell therapy – Options The Edge

Posted: January 5, 2020 at 3:50 am

Spectators exclaimed in horror at the 2018 MotoGP Asia Talent Cup race when Danial Syahmi Sharil almost lost his life in a serious accident. The 16-year-old rising star had a terrifying collision that saw him thrown off his motorcycle and then run over by a fellow racer on the Sepang International Circuit that November, suffering serious injuries in his lower left leg. A helicopter immediately rushed him to Hospital Kuala Lumpur where the fractured bones in his leg were removed during emergency surgery. It was thought to be the end of the young talents promising career.

Fast forward a year and Danial is recovering steadily at the Kuala Lumpur Sports Medicine Centre (KLSMC), reclaiming his mobility with regenerated bones and nursing dreams of getting back to racing again. It is an aspiration the centres founder and director, Dr Saw Khay Yong, thinks is entirely possible. Probable, in fact.

It is a sunny weekday morning and most of the colourful therapy beds facing verdant Bukit Damansara are occupied by patients of all ages and nationalities. This is a medical centre unlike any other. The physiotherapy area we are in is spacious and bright with sunlight pouring in through the large windows. Patients are engaged in a variety of exercises, and the mood seems almost cheerful, unlike the typically sombre atmosphere of a physiotherapy unit.

Carmel Dwan is chattering genially with her therapist as she is put through her paces. She was living in England when she was told she needed a total knee replacement but read about Saws innovative stem cell technology and decided to seek treatment here. Instead of living with a metal knee and restricted mobility, she flies in to Kuala Lumpur a couple of times a year for stem cell injections that, within two years alongside non-invasive surgery, will see her regain ease of movement. Im completely pain-free now and almost as good as new, she testifies.

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For thefull story, pick up a copy ofThe Edge Malaysia(Jan 6, 2020) at your nearest news stand.Save bysubscribingto us for your print and/or digital copy.

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Researchers at Baylor College of Medicine Discover How to Improve Bone Repair – Gilmore Health News

Posted: January 5, 2020 at 3:50 am

Researchers at Baylor College of Medicine have discovered a new mechanism that helps maintain and repair bones in adults. Ultimately, this could help develop new therapeutic strategies to improve bone healing.

Knee Bones

Osteoporosis is a skeletal disease characterized by reduced bone density and changes in the microarchitecture of bones. These changes weaken the bone and increase the risk of fracture. This disease develops particularly in older people. Today, a new study could eventually lead to the development of therapeutic strategies to improve bone healing in these patients. According to the results published in the journal Cell Stem Cell on the 5th December, 2019 researchers have discovered a new mechanism that contributes to the maintenance and repair of bones in adults.

Read Also: HGH Is Now A Solid Treatment For Osteoporosis According To Studies

Adult bone repair relies on the activation of bone stem cells, which still remain poorly characterized. Bone stem cells have been found both in the bone marrow inside the bone and also in the periosteum the outer layer of tissue that envelopes the bone. Previous studies have shown that these two populations of stem cells, although they share many characteristics, also have unique functions and specific regulatory mechanisms. said Dr. Dongsu Park, assistant professor of molecular and human genetics, pathology and immunology at Baylor College of Medicine, where the study was conducted.

Of these two populations, periosteal stem cells are the least known. Although the scientists know that this is a heterogeneous population of cells that can contribute to the thickness, formation and repair of bone fractures, no one has yet been able to distinguish between the different subtypes of bone stem cells in order to study the regulation of their different functions.

Here, however, Dongsu Park and colleagues were able to develop a technique in mice to identify different subpopulations of periosteal stem cells, define their contribution to the repair of bone fractures and identify the specific factors that regulate their migration and proliferation under physiological conditions.

In rats, they discovered specific markers for this class of cells. They identified a specific subset of stem cells that contribute to lifelong bone regeneration in adults. They also observed that periosteal stem cells react to inflammatory molecules, chemokines, which are normally produced in bone injuries.

Read Also: The Exciting Future of Joint and Cartilage Repair

In detail, periosteal stem cells have receptors that bind to the CCL5 chemokine. The CCL5 chemokine sends a signal to the cells to migrate to the injured bone and repair it. By suppressing the CCL5 gene in rats, the researchers found defects in bone repair that delayed healing. However, when they gave CCL5 to rats that had lost CCL5, the bones recovered faster.

Our findings contribute to a better understanding of the healing of adult bones. We believe this is one of the first studies to show that bone stem cells are heterogeneous and that different subtypes have unique properties that are regulated by specific mechanisms, said Dongsu Park. We have identified markers that allow us to distinguish between the subtypes of bone stem cells and have investigated what each subtype contributes to bone health. The understanding of how the functions of bone stem cells are regulated offers the possibility of developing new therapeutic strategies for the treatment of bone damage in adults.

Read Also: Implants from Own Stem Cells May Offer Solution to Back Pain, Researchers Say

In the long term, these findings may therefore have potential therapeutic applications, particularly in people with osteoporosis or diabetes.Indeed, people with diabetes may be prone to falls and fractures due to possible neurological, visual or renal complications. In addition, bone fragility in diabetics is likely to be due to changes in bone remodeling and, in particular, an increase in bone resorption.

https://www.cell.com/cell-stem-cell/fulltext/S1934-5909(19)30458-8?

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Understanding the Key Aspects of a Multiple Myeloma Diagnosis – Curetoday.com

Posted: January 5, 2020 at 3:50 am

A multiple myeloma expert helps newly diagnosed patients understand the standard of care for their disease.

Richter, an assistant professor of medicine at the Tisch Cancer Institute at the Ichan School of Medicine in Mt. Sinai Hospital located in New York City, noted that there are always exceptions to this rule, but the standard of care is to keep patients with multiple myeloma to continue therapy long term.

This standard of care, however, presents unique challenges and questions for newly diagnosed patients about to undergo treatment. In an interview during the 2019 CURE Educated Patient Summit on Multiple Myeloma in Charlotte, North Carolina, Richter had the chance to address the key aspects of a multiple myeloma diagnosis and how he addresses common questions from patients.

CURE: What does transplant eligible and transplant ineligible mean for patients?

Richter: The notion of transparent eligibility in the U.S. is not clearly defined. One of the people who trained me used to say, Do the patients have the tiger? relating back to Rocky, and essentially what this means is people who are younger tend to be more eligible. So, are you able to undergo the intensive nature of that procedure and chemotherapy?

If you're younger and healthier, you're generally transplant eligible. As you get older, with more medical problems, it becomes more of a risk. Everything in medicine from a Tylenol to a transplant has a risk and benefit. If you are 105 years old and had a heart attack last week, you're not going to be eligible. If you're 40 and otherwise healthy, you're eligible and everywhere in between is an evaluation of risks and benefits.

How would you describe the standard of care for patients with multiple myeloma?

In general, the standard of care is to attempt to get people onto three drugs. The three drugs usually mean a steroid, and then either an immunomodulatory drug, a proteasome inhibitor or a monoclonal antibody, and using those different combinations to come up with two or three-drug combinations, and actually in some cases four-drug combinations.

The general discussion of which one makes sense is we generally try to put some on a three-drug combination and the two most common ones now VRd (Velcade, Revlimid, and dexamethasone) is really a very big standard approach. There's some really wonderful, emerging data from the MAIA study, looking at taking Revlimid and dexamethasone and adding Darzalex (daratumumab) as a three-drug regimen for people who are not going on to transplant and some of that data looks amazing.

But for the most part, the precision that we use has to do not so much with the tumor but with the patient. Meaning for some diseases, the precision in the upfront setting is we look at a genetic marker and we target that. But for myeloma our upfront choice of therapy is saying, what are your comorbidities? What are your risks? For someone who has neuropathy, we may avoid Velcade. Someone has heart issues, we may avoid carfilzomib (Kyprolis) and if someone has difficult coming back and forth for long infusions, we may avoid Darzalex. So, most of the precision that we use is custom tailoring it not necessarily to the disease upfront, although that's part of it, but also to the patient.

What is the role of stem cell transplantation in treating patients with multiple myeloma?

The role of transplant is constantly evolving in myeloma. A generation ago, when we didn't have very good drugs, transplant was clearly the best thing to do because we didn't have good medicines. Transplant was the only way to get deep and durable remissions. Nowadays that we have such better therapies and even better ones along the way, it's being called into question about how much do we still need transplant. And it's a case by case basis, some people still clearly benefit from transplant.

It's an important discussion to have with your provider. But the risks have been well established for many years and we know how to manage them very well. Although there are risks for it, they're generally consolidated into a couple weeks to a couple of months, as opposed to being on long term treatment that can have ongoing risk of side effects. So, yes, they may be higher, but it's usually for a self-contained amount of time.

It's still a very important tool in our armamentarium to treat patients. Now, that being said, the majority of patients in the United States do not receive autologous transplant, so only about 30% and part of the reason has to do with the age of patients. The average age of a myeloma patient in the U.S. is 69, and many people in their 70s and 80s have other medical problems that make them not eligible for transplant.

There are some socioeconomic reasons, as well as referral patterns and access to care. I live in New York City, you can throw a rock and hit a transplant center, but there are parts of the country where the closest transplant center is hours and hours and hours away. And if you are older, sick or don't have easy transportation, it may be more difficult. So, many people do not receive transplant. However, many people nowadays may not even need it because our drugs have gotten so much better.

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