StemCell Therapy

BALTIMORE, March 31, 2021 /PRNewswire/ --University of Maryland School of Medicine (UMSOM) Dean E. Albert Reece, MD, PhD, MBA, a widely recognized visionary leader who elevated the UMSOM into a top-tier biomedical research and patient-focused academic center, announced that he will complete his 16-year tenure as Dean, at the end of the next academic year. He will return to the UMSOM faculty where he will lead a new Center, and continue research and teaching.

Dr. Reece, who is also Executive Vice President for UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor, was appointed as the UMSOM's 30th Dean in 2006. Over the course of his Deanship, he led the UMSOM through a period of unprecedented, record-breaking growth and achievements across all its areas of operation, enabling the UMSOM to reach major milestones in research, clinical care, reputation, and global impact. He is considered to be one of the most successful Deans in the U.S., as well as in our institution's rich 214-year history.

Under his leadership:

Dr Reece commented, "I deem it a distinct honor and privilege to have led the UMSOM over several years. Much of the accomplishments and successes in the UMSOM are due to the excellent team I have been blessed to work with, and the support of the UMB leadership over the years. The support from the UMSOM Board of Visitors, the alumni, Directors, Chairs, Dean's senior staff, and assistants have been truly invaluable." He continued, "I am most pleased to pass the baton to a new Dean who undoubtedly will take the UMSOM to new heights."

A leading physician-scientist, and member of the prestigious National Academy of Medicine (NAM), Dr. Reece has served on the NAM's Governing Council and the Executive Committee. He holds faculty appointments as Professor in the Departments of Obstetrics and Gynecology, Medicine, and Biochemistry & Molecular Biology. During his entire Deanship, Dr. Reece remained active in his NIH multi-million-dollar research laboratory group, studying the bio-molecular mechanisms of diabetes-induced birth defects. This laboratory was transitioned to become the Center for Birth Defects Research. Dr. Reece promoted his mentee and lab associate, Peixin Yang, PhD, Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences, to direct the Center with him. The Center is now supported by seven NIH RO1 grants. Notably, Dr. Reece and his colleagues have unraveled the molecular mechanism into the causation of diabetes-induced birth defects, and have identified and patented molecular targets to be used in preventive and therapeutic strategies.

At the national level, Dean Reece is well known among medical school deans for his mentoring of faculty across the U.S. who aspired to leadership positions. Through his active participation in the AAMC's Dean's Fellowship Program, many senior faculty members have "shadowed" Dean Reece during his tenure and received valuable mentoring from him.

Dean Reece has served on many medical, governmental and civic organization committees, including serving as Chair of the Council of Deans of the Association of American Medical Colleges (AAMC). He currently serves on the board of Research America, and has been recently named to the Board of the Lasker Foundation. During his career, he has served additional organizations, agencies, and cultural/educational institutions, including the Secretary of Health & Human Services Committee on Infant Mortality, The March of Dimes Birth Defects Foundation, the Harvard/ Massachusetts General Hospital Scientific Advisory Committee, and the Baltimore Symphony Orchestra.

Dr. Reece is a sought-after Visiting Professor and Lecturer at numerous institutions both nationally and internationally. He has published extensively in the scientific literature-12 books including revisions and more than 500 publications.

He has received from various universities and government organizations numerous special awards, citations, and honorary degrees in recognition of his distinguished leadership, lifetime achievement, and major contributions to science and medicine.

"I was heavily involved in the recruitment of Dean Reece when he came to UMSOM as Dean," said former University System of Maryland (USM) Chancellor "Brit" Kirwan, PhD. "I consider his appointment to be one of the most important efforts I was involved in as Chancellor of the University System of Maryland. Under Dr. Reece's leadership, our School of Medicine has soared to new heights of excellence as a powerhouse in medical research, a highly regarded institution for training the next generation of doctors, and a valued source of community engagement. His irrepressible commitment to excellence in all aspects of the School's mission has been transformative. He leaves a legacy of accomplishment that will endure for the benefit of generations to come," he said.

A Leader in Service

As Dean, Dr. Reece has also been a prominent leader in the local business and health care community as well. He has been a visible member of the local community and a familiar face to residents who attend the UMSOM's various community programs. Each year at Thanksgiving, Dean Reece has been a fixture at "Project Feast," where he serves dinner and engages with community residents. He is also well known by the hundreds of participants (both and adult and children) who are "students" in UMSOM's highly successful and longstanding "Mini-Med School" and "Mini-Med School for Kids" programs. At each Mini-Med School Graduation Ceremony, Dean Reece greets and delivers special completion certificates to each community participant.

With a new charter and new leadership, the UMSOM's Program in Health Equity and Population Health, Directed by Erin Hager, PhD, Associate Professor of Pediatrics, and Deputy Director Laundette Jones, PhD, MPH, Associate Professor of Epidemiology & Public Health, now combines research, education, and service to advance health equity by addressing the critical health issues often influenced by the social determinants of health. In recent years, the Program has generated 331 active grants with funding of $128 million.

Bruce E. Jarrell, MD, FACS, president of the University of Maryland, Baltimore, said,"I wish to thank Dean Reece for his outstanding leadership in creating an even stronger medical school and wish him all the best as he transitions out of the deanship. Dean Reece leaves the School of Medicine in an excellent position for a new leader to take the school into a post-COVID world."

Growth of the Academic Enterprise

During his Deanship at UMSOM, Dr. Reece presided over dramatic growth of an academic enterprise that now totals 45 academic units, including 25 departments and 20 research centers, institutes, and programs. He expanded the UMSOM's academic facilities to 17 buildings, covering more than 2.5 million square feet of research and academic space, and led the planning and construction of a 430,000 square foot, state-of-the-art advanced research facility. Subsequently, he launched a nationwide investigator recruitment effort, resulting in 30 teams of top NIH-funded scientists from leading institutions across the country, joining the UMSOM's faculty of more than 3,500 physicians and scientists. He also led the complete renovation of Leadership Hall into an elegantly designed 700-seat theatre-style structure that now hosts major conferences and special events.

Over the past five years, Dean Reece has successfully recruited a new generation of department chairs with the appointment of top physicians and scientists from both inside and outside the UMSOM.

From the beginning of his tenure as Dean, Dr. Reece was keenly focused on elevating the UMSOM's leadership position in biomedical research, building on the foundation laid by his predecessor, a visionary leader, Dean Emeritus Donald Wilson, MD.Dean Reece laid out a specific plan to focus on "Big Science Research," with the goal of fundamentally changing the health care landscape and making a lasting and direct impact on patients' health and well-being.

Soon after joining UMSOM as Dean, Dr. Reece and Dr. Bruce Jarrell ( who served as the UMSOM Executive Vice Dean), successfully recruited two well-known and highly accomplished scientists and their research teams to the UMSOM: Claire Fraser, PhD, who established a new Institute for Genome Sciences (IGS), and Robert Gallo, MD, who transitioned the Institute of Human Virology (IHV) to the UMSOM. In the ensuing years, Dean Reece launched additional centers, such as STAR (Shock Trauma, Anesthesiology Research Center), and the Center for Epigenetic Research in Child Health & Brain Development, the Center for Blood Oxygen Transport and Hemostasis, and others, now totaling 20. He also significantly expanded the Center for Vaccine Development & Global Health.

In 2013, in the midst of a challenging economy and a dearth of commercial construction, Dean Reece embarked on an ambitious plan to construct a new world-class research facility for UMSOM. Despite significant challenges, Dean Reece, along with then-University System of Maryland Chancellor, Brit Kirwan, PhD, and with former UMB Presidents, the late Dr. David Ramsay, and Jay Perman, MD (now USM Chancellor), relentlessly pursued, and successfully implemented, a multi-faceted plan to make the new facility a reality.

In December, 2017, the UMSOM opened its new 430,000 square-foot research building Health Sciences Research Facility III (HSRF III), becoming the largest building ever constructed in the University System of Maryland, and setting a new standard of excellence in biomedical research, innovation, and discovery. Working in HSRF III's state-of-the art laboratories with cutting edge genomic technology, faculty physicians and scientists are now working together on breakthrough treatments for cancer, diabetes, and heart disease.

In 2013, Dr. Reece launched Accelerating Innovation and Discovery in Medicine (ACCEL-Med), a major UMSOM initiative designed to increase the pace and scope of clinical and basic sciences research. The Accel-Med initiative was launched with the first UMSOM "Festival of Science," which has become an annual full-day symposium highlighting the breakthrough research being conducted by UMSOM faculty. A cornerstone of Accel-Med was the Dean's formation of the UMSOM's first "Scientific Advisory Council" (SAC) to review and evaluate the UMSOM's research efforts on an annual basis. The Council, which included preeminent scientists, Nobel laureates and National Academy members, continues today.

At the inaugural Festival of Science, Dean Reece announced the opening of new core biomedical research facilities with funding from National Institutes of Health (NIH), called the Center for Innovative Biomedical Resources (CIBR). It was the first time that the UMSOM had established a center of excellence for state-of-the-art technologies, high-tech instrumentation, and expertise to support biomedical research, clinical practice, and health care. Dean's Challenge Awards were also established to provide seed funding to UMSOM scientists and encourage collaborations across departments. In 2021, the UMSOM has climbed to the top tier of medical schools in federal research funding.

"Dean Reece's mark on the School of Medicine is unmistakable; he's been integral to its enormous success," said University System of Maryland Chancellor Jay A. Perman, MD. "It's fitting that Dean Reece leaves the deanship at a time when the school is enjoying such well-deserved acclaim, nationally and internationally. I wish him all the best as he transitions into a role that gives him the same personal and professional satisfaction as have his 15 years leading the UMSOM."

Major National Designation and Clinical Expansion

Dean Reece led significant growth of the UMSOM's clinical practices across the State of Maryland during his tenure as Dean:

Added Cynthia Egan, current Chair of the UMSOM Board of Visitors: "There are many grateful patients whose care and cures have come from the exemplary leadership of the School of Medicine under Dean Reece. His relentless focus for excellence in research, academics, and developing extraordinary faculty and practitioners have advanced UMSOM to be a powerful force in delivering the best of medicine. It has been and will continue to be a true privilege to work with Dean Reece."

Commitment to Diversity, Equity and Inclusion

Dean Reece is known by faculty, staff, and colleagues for his "relentless pursuit of excellence" mantra, and his sincere dedication to making an impact on people's lives every day. He has been recognized for initiating a long-term school-wide culture transformation in diversity, equity, and inclusion. Through his leadership and close collaboration with faculty, students, and staff, the Culture Transformation Initiative (CTI) has become a top priority for the institution, with new programs aimed at ensuring equity in opportunity, recruitment, promotion, and compensation.

Dr. Reece's commitment to increasing diversity across the UMSOM has ignited positive changes and has resulted in growing numbers of women (40-60 percent) and under-represented minorities among senior leadership, faculty, and students. Specifically, women now make up more than 40 percent of UMSOM's senior leadership; the percentage of women faculty has increased to 40 percent, with under-represented minorities making up 11 percent. In the UMSOM student body, 60 percent of students are now women, and 25 percent are under-represented minorities.

Shaping the Future of Medical Education

Dr. Reece, as a scholar and educator, shaped the future of medical education in significant ways. He launched the first program for MD students in the nation on the Foundations of Research and Critical Thinking (FRCT), ensuring that the new generation of physicians would be equipped with the problem-solving and decision-making skills required for the future. Dr. Reece himself has consistently taught in the course. To further provide MD students with experience in data analysis and personalized medicine, the UMSOM was also the first medical school to offer pharmaco-genetic testing to all of its MD students to determine individualized responses to medication.

In 2020, despite the challenges posed by the COVID-19 pandemic that restricted in-class instruction for MD students, Dr. Reece and his team in Academic Affairs successfully renewed and launched a new innovative MD program of medical study and training -- the Renaissance Curriculum. Developed over several years, this fully integrated curriculum takes a systems-based, holistic approach to learning, combining instruction in both the health and disease processes of the body related to major organ systems. Given its optimized format, the Renaissance Curriculum also allows students to enter the clinical portion of medical school earlier.

He has overseen the significant growth of UMSOM's Community Education Pipeline Program. The program, directed by two biomedical scientists, Greg Carey, PhD, Associate Professor Microbiology and Immunology and Director of Student Summer Research and Community Outreach in the Office of Student Research, and Bret Hassel, PhD, Professor of Microbiology and Immunology and Assistant Director for Training & Education. They have established education programs for undergraduate and high school students, as well as educational opportunities for STEM research and mentoring of students from a wide variety of backgrounds.

Michael Cryor, President of the Cryor Group, who served with Dean Reece for 10 years as Chair of the UMSOM's Board of Visitors, said, "As Chair Emeritus of the medical school's Board of Visitors, I have been witness to many facets of unparalleled growth at the medical school under Dean Reece's leadership-increased research funding, pivotal roles in vaccine development here and around the world and an increasing focus on student education. I was a member of the search committee to select the candidate who would follow the celebrated tenure of Dr. Donald Wilson. We were convinced Dean Reece was the right choice. His successful tenure is proof positive that we made the right selection," he said.

The Power of Partnership

Dean Reece's career at the University of Maryland has been marked by a collaborative approach to leadership and management at every level.

His close collaboration with the University of Maryland Medical System was highlighted as a national model in a 2012 article that he co-authored with former UMMS President & CEO Robert Chrencik, MBA, CPA, in the journal, Academic Medicine. The article, entitled, Fully Aligned Academic Health Centers: A Model for 21st-Century Job Creation and Sustainable Economic Growth, described the unique and highly effective alignment established between UMSOM and UMMS. Dr. Reece and Mr. Chrencik coined the phrase, "The Power of Partnership," noting that alignment of the clinical and research missions resulted in significant economic benefits for the State of Maryland.

The close partnership Dean Reece established between UMSOM and UMMS also resulted in expanded UMSOM faculty clinical practice locations in UMMS hospitals as well. New multi-specialty locations were established in Harford, Howard, and Prince George's County, with state-of-the-art facilities for urgent care, vascular surgery, trauma, orthopaedics, and other specialties.

Mohan Suntha, MD

"Throughout his tenure as Dean of the University of Maryland School of Medicine, Dr. Reece has been an unabashed champion of discovery-based medicine," said UMMS President and CEO Mohan Suntha, MD, MBA."His relentless focus has led to incredible advances and recognition for the university while simultaneously advancing our patient care mission. I have been truly blessed to call him a friend, mentor, and colleague throughout his 15 years at the helm of the School of Medicine."

Added Bert W. O'Malley, MD, President and CEO, University of Maryland Medical Center (UMMC). "From working with Dean Reece, and knowing of his many accomplishments, it is clear that he has a unique combination of visionary talent along with the ability to execute with surgical precision and exceed all expectations. I've greatly enjoyed our partnership in advancing the mission of academic medicine and look forward to continuing to work with him during his transition and in his new role."

Dean Reece also prioritized opportunities for UMSOM's collaboration with other universities in the USM, and with other schools at UMB. During his tenure, there was a significant increase in collaborative research efforts across the USM, with marked growth of interdisciplinary funding between UMSOM-both with the other schools at UMB, as well as with other USM campuses.

About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 45 academic departments, centers, institutes, and programs; and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically based care for nearly 2 million patients each year. The School of Medicine has more than $563 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 student trainees, residents, and fellows. The combined School of Medicine and Medical System ("University of Maryland Medicine") has an annual budget of nearly $6 billion and an economic impact more than $15 billion on the state and local community. The School of Medicine, which ranks as the 8th highest among public medical schools in research productivity, is an innovator in translational medicine, with 600 active patents and 24 start-up companies. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit http://www.medschool.umaryland.edu.

SOURCE University of Maryland School of Medicine

http://www.medschool.umaryland.edu

The rest is here:
UM School of Medicine Dean Announces He Will Transition From The Deanship In 2022 After Completing 16-Year Tenure - PRNewswire

TSX.V: CHIP.H

CALGARY, March 29, 2021 /PRNewswire/ -Health Logic Interactive Inc. ("Health Logic" or the "Company") (TSX.V: CHIP.H),is pleased to announce its wholly owned operating subsidiary, My Health Logic Inc. ("My Health Logic"), has entered into a license agreement (the "License Agreement")with an arm's length third party (the "Licensor") pursuant to which My Health Logic has a worldwide, exclusive license to the UAL-Chip, a patent pending lab-on-chip ("LOC") technology that has the potential to be used in a smartphone connected, hand-held device to provide rapid point-of-care ("POC") diagnosis of Chronic Kidney Disease ("CKD").

CKD is a life-changing chronic condition that is harmful for patients and extremely expensive to treat unless caught early. Over 850 million people globally and 37 million people in the United States have CKD, and total healthcare costs for treatment of CKD in the US exceed $120B per year. The key to preventing the major harms from CKD, such as kidney failure, kidney dialysis, and death, is early testing and treatment; however, approximately 90% of those afflicted by CKD do not realize they have it. We believe that providing patients and caregivers a low-cost, accessible tool for early diagnosis and treatment is an opportunity to help millions of at-risk patients and start to bend the cost curve for health systems worldwide.

UAL-Chip technology has the potential to drive a much-needed disruption of the legacy systems used for CKD testing and accelerate the trend towards automation, digitization and personalization in the healthcare industry. The UAL-Chip can utilizemicrofluidic technology to test for the albumin levels in urine and deliver rapid results to a users' smartphone and their healthcare practitioner. Currently, <50% of at-risk patients are tested; we expect that introducing digitally connected home testing solutions would increase this number by removing one of the current barriers to testing, being attendance at a central lab, and would also provide My Health Logic with the opportunity to develop a robust platform for continuous digital patient monitoring and care for CKD of all stages.

"CKD is common, costly and harmful for patients and communities. It is also under-recognized. Bringing the CKD diagnosis into the home is a disruptive approach that could bridge the screening gap for millions of patients, allowing early detection and treatment, preventing harms for millions, and reducing health costs by billions" Dr. Claudio Rigatto, Co-Inventor, Seven Oaks General Hospital

"Our lab-on-chip platform can give accurate results rivalling central laboratories in precision but in an accessible, low cost and rapid form usable in the home, fulfilling the dream of true point-of-care diagnosis and personalized medicine." Dr. Francis Lin, Lead Inventor

Highlights of the Market:

Highlights of the Technology:

The Technology was invented by the world-renowned team of nephrologists at Seven Oaks General Hospital including Dr. Navdeep Tangri, Dr. Paul Komenda, and Dr. Claudio Rigatto, and biomedical engineering LOC expert Dr. Francis Lin. The team of inventors are expected to play an active role in the ongoing development of the lab-on-chips, and MATLOC device as we pursue regulatory approvals with Health Canada and the US Food and Drug Administration ("FDA") via an accelerated 510K pathway. In addition to the ongoing guidance from the inventors, the Company plans to on board and engage strategic industry thought leaders and experts to best guide My Health Logic through the development process to successful commercialization, for which there is no guarantee.

My Health Logic's obligations under the License Agreement include: (a) developing, manufacturing and selling products that incorporate the licensed technology ("Licensed Products"); (b) marketing Licensed Products in the US and Canada within 6 months of receiving regulatory approval; (c) reasonably filling market demand for Licensed Products following marketing; (d) obtaining all necessary governmental approvals for the activities in (a); and (e) spending at least $650,000 on the development of Licensed Products during the first four years of the License Agreement. As consideration for the license and other rights under the License Agreement, My Health Logic will pay Licensor annual royalties on net sales of Licensed Products, cover past patent costs, pay annual license maintenance fees and make certain payments upon the occurrence of milestone events in the regulatory approval process with respect to Licensed Products.

The Company is also pleased to announce that it plans to conduct a non-brokered private placement for gross proceeds of up to $1.4M, subject to approval of the TSX Venture Exchange.

About the Company

Health Logic Interactive, through its wholly owned operating subsidiary My Health Logic, is developing and commercializing consumer focused handheld point-of-care diagnostic devices that connect to patient's smartphones and digital continued care platforms. The Company plans to use their patent pending lab-on-chip technology to provide rapid results and facilitate the transfer of that data from the diagnostic device to the patient's smartphone. The Company expects this data collection will allow it to better assess patient risk profiles and provide better patient outcomes. Our mission is to empower people with the ability to get early detection anytime, anywhere with actionable digital management for chronic kidney disease. For more information visit us at:www.healthlogicinteractive.com

Neither the TSX Venture Exchange nor its regulation services provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward Looking Statements

Cautionary Note Regarding Forward-Looking Statements: This release includes certain statements and information that may constitute forward-looking information within the meaning of applicable Canadian securities laws. Forward-looking statements relate to future events or future performance and reflect the expectations or beliefs of management of the Company regarding future events. Generally, forward-looking statements and information can be identified by the use of forward-looking terminology such as "intends" or "anticipates", or variations of such words and phrases or statements that certain actions, events or results "may", "could", "should", "would" or "occur". This information and these statements, referred to herein as "forwardlooking statements", are not historical facts, are made as of the date of this news release and include without limitation, statements regarding discussions of future plans, estimates and forecasts and statements as to management's expectations and intentions with respect to, among other things: development, manufacture and sale of Licensed Products; performance of obligations under the License Agreement; plans to engage the inventors and other experts to assist with regulatory approval and commercialization of Licensed Products; plans for and expected benefits of the licensed technology; and the Offering.

These forwardlooking statements involve numerous risks and uncertainties and actual results might differ materially from results suggested in any forward-looking statements. These risks and uncertainties include, among other things: My Health Logic's ability to develop, manufacture and sell the Licensed Products, perform its obligations under the License Agreement and otherwise implement its business strategies; My Health Logic's ability to obtain regulatory approval of Licensed Products; and the Company's ability to obtain regulatory approval of the Offering and complete the Offering on the proposed terms.

In making the forward looking statements in this news release, the Company has applied several material assumptions, including without limitation, that: My Health Logic will be able to develop, manufacture and sell the Licensed Products, perform its obligations under the License Agreement and otherwise implement its business strategies; My Health Logic will be able to obtain all necessary regulatory approvals with respect to Licensed Products; and the Company will be able to obtain all necessary regulatory approvals with respect to the Offering, and the Company will be able to complete the Offering on the proposed terms.

Although management of the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Readers are cautioned that reliance on such information may not be appropriate for other purposes. The Company does not undertake to update any forward-looking statement, forward-looking information or financial out-look that are incorporated by reference herein, except in accordance with applicable securities laws. We seek safe harbor.

SOURCE Health Logic Interactive Inc.

https://www.healthlogicinteractive.com/

Read this article:
Health Logic Interactive Inc., Acquires Next-Generation Lab-On-Chip Medical Diagnostic Technology - PRNewswire

PARIS--(BUSINESS WIRE)--Seventure Partners, one of Europes leaders in financing innovation and a world leader in life science microbiome investment, has published an analysis highlighting the close links between Covid-19 and the individuals microbiome.

The report titled Understanding the potential to monitor and modulate the COVIBIOME to improve patient resilience and outcome analyses a number of features of Covid-19 that are believed to have links to the microbiome, including:

In recent years, we have seen an increasing amount of data that indicate that the microbiome is likely to have strong links with our immune system and our immune health. As our understanding steadily grows on how Covid-19 affects our body, it also gives us an opportunity to understand how our microbiome is affected and how we can use this knowledge to improve treatments or enhance protection. Our report reveals a series of scientific findings on the connection between the virus and our microbiome, said Isabelle de Cremoux, CEO and Managing Partner, Seventure Partners, who led Health for Life Capital fund raising and microbiome strategy and author of the report.

To request a copy of the report, please email contact@seventure.fr

-ENDS-

Notes to Editors

About Seventure Partners

With 850m net commitments under management as of the end of 2020, Seventure Partners is a leading venture capital firm in Europe. Since 1997, Seventure Partners has been investing in innovative businesses with high growth potential in two fields: Life sciences across Europe, Israel, Asia and North America, and Digital technologies in France and Northern Europe.

In life sciences, the main areas of focus include classic approaches such as biotechnology and pharmaceuticals, diagnostic and medtech, industrial biotechnology, as well as beyond the pill approaches such as MICROBIOME-linked innovations, nutrition, foodtech, digital/connected health, wellbeing and personalized medicine & personalized nutrition.

About Health for Life Capital

Seventure Partners launched Health for Life Capital, the first venture capital fund focused mainly on investments beyond the pill in the microbiome and nutrition space. Europe is the primary focus of the fund, but it also invests in North America, Asia and Israel.

The 160m first fund launched in 2014 has invested in 20 companies at the forefront of their fields, such as Enterome, Vedanta Biosciences, MaaT Pharma, Eligo Bioscience, Ysopia Bioscience, TargEDys, A-Mansia Biotech, BiomX, Microbiotica, LiMM Therapeutics, Siolta Therapeutics, DayTwo, Zipongo (renamed Foodsmart), Cambrooke, Mdoloris Medical Systems, MycoTechnology, etc.

In 2019 it launched second fund Health for Life Capital II with a target fund size of over 200m which invested in Axial Therapeutics, BCD, Citryll, Dermala, Ervaccine, Federation Bio, Galecto, etc.

Both first fund and second fund attracted strategic investments from prestigious organizations including Danone, Novartis, US based global food ingredient providers (to be disclosed), Lesaffre, Tornier, Tereos, Unigrains and Bel, as well as financial institutions, family offices and entrepreneurs.

Read the original:
Seventure Partners: New Report Reveals Links Between Covid-19 and the Microbiome - Business Wire

DUBLIN, March 30, 2021 /PRNewswire/ -- The "Global Cell and Gene Therapy Drug Delivery Devices Market: Focus on Product Type, Commercialized Drug Delivery Devices, Country Data (16 Countries), and Competitive Landscape - Analysis and Forecast, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

The global cell and gene therapy drug delivery devices market was valued at $55.75 thousand in 2019, and is expected to reach $375.13 thousand by 2030, registering a CAGR of 16.61% during the forecast.

Cell and gene therapy drug delivery industry is a transformative industry whose full potential is only just beginning to emerge. Cell and gene therapy involves the extraction of cells, protein, or genetic material (DNA) from the donor, and altering them to provide highly personalized therapy. Cell and gene therapies may offer longer-lasting effects than traditional medicines.

One of the significant drugs of the cell and gene therapy industry is CAR-T cell-based medicines, which include both cell therapy and gene therapy. Various market players are actively investing in the research and development of the cell and gene therapy industry. The players are offering improved and new products, which meet the critical needs of patients.

The growth is attributed to major drivers in this market such as the increasing prevalence of cancer and chronic diseases, increased funding in the cell and gene therapy market, rising need to develop novel treatment options for rare diseases, and rising biopharmaceutical R&D expenditure, and rising number of the FDA approvals of cell and gene therapies & clinical trials. The market is expected to grow at a significant growth rate due to various potential opportunities of growth that lie within its domain, which include drug approvals and strong pipeline of cell and gene therapies.

Various new cell and gene-based therapy approaches use biological engineering to improve the immune system's capacity to fight disease while sparing healthy tissues in the body. For instance, there are antibody-based therapies that can make T-cells more effective by increasing their interactions with cancer cells. Other modifications, such as adding complexity to the CAR-T and cancer cell interaction, which can further sharpen T-cells' cancer-targeting ability by reducing damage to normal cells.

The increase in the geriatric population and an increasing number of cancer cases, and genetic disorders across the globe are expected to translate into significantly higher demand for cell and gene therapy drug delivery devices market.

Furthermore, the companies are investing huge amount in research and development of cell and gene therapies and associated drug delivery devices products. The clinical trial landscape of various genetic and chronic diseases has been on the rise in the recent years, this will fuel the cell and gene therapy drug delivery devices market in future.

Within the research report, the market is segmented based on product type, commercialized drugs, and region. Each of these segments covers the snapshot of the market over the projected years, the inclination of the market revenue, underlying patterns, and trends by using analytics on the primary and secondary data obtained.

Competitive Landscape

The exponential rise in the application of precision medicine on a global level has created a buzz among companies to invest in the development of novel cell and gene therapy drug delivery devices.

Due to the diverse product portfolio and intense market penetration, Novartis AG, Kite Pharma Inc., and Dendreon Pharmaceuticals LLC. have been the pioneers in this field and been the major competitors in this market.

The other major contributors of the market include companies such as Vericel Corporation, Amgen Inc., Bausch & Lomb Incorporated, Spark Therapeutics, Inc., and Becton, Dickinson and Company.

Based on region, North America holds the largest share of cell and gene therapy drug delivery devices market due to substantial investments made by biotechnology and pharmaceutical companies, improved healthcare infrastructure, rise in per capita income, early availability of approved therapies, and availability of state-of-the-art research laboratories and institutions in the region. Apart from this, Asia-Pacific region is anticipated to grow at the fastest CAGR during the forecast period.

Key Topics Covered:

1 Technology Definition

2 Research Scope

3 Key Questions Answered in the Report

4 Research Methodology

5 Market Overview5.1 Introduction5.2 Cell and Gene Therapies and Drug Delivery Devices Industry5.3 Cell and Gene Therapy Drugs and Their Clinical Importance5.4 Cell and Gene Therapy Drug Delivery Devices Market: Current Scenario5.5 Cell and Gene Therapy Drug Delivery Devices Market: Future Perspective

6 Global Cell and Gene Therapy Drug Delivery Devices Market and Growth Potential, 2020-20306.1 Overview6.2 Pipeline Analysis6.2.1 Drug Delivery Systems in Development: Current Scenario6.2.1.1 Ongoing Clinical Trials of Drug Delivery Systems6.2.1.2 Limitations of Cell and Gene Therapy Drug Delivery Devices6.2.1.3 Recent Advancements in Gene Therapy Drug Delivery6.3 Cell and Gene Therapy Drug Delivery Devices Market and Growth Potential6.4 Cell and Gene Therapy Drug Development and Commercialization Landscape6.5 Impact of COVID-19 on Cell and Gene Therapy Drug Delivery Devices Market6.5.1 Impact of COVID-19 on Global Cell and Gene Therapy Drug Delivery Devices Market Growth Rate6.5.2 Impact of COVID-19 on Supply Chain of Cell and Gene Therapy Drug Delivery Devices Market6.5.3 Clinical Trial Disruptions and Resumptions

7 Emerging Technology Landscape7.1 Potential Technologies in Cell and Gene Therapy Drug Delivery Devices Market7.2 Microchip Technology7.3 Nanotechnology-Based Drug Delivery Devices7.4 Lipid Nanoparticles in Gene Therapy

8 Market Dynamics8.1 Impact Analysis8.2 Market Drivers8.2.1 Increasing Prevalence of Cancer and Chronic Diseases8.2.2 Increased Funding of Cell and Gene Therapies8.2.3 Rising Number of FDA Approvals of Cell and Gene Therapies, and Clinical Trials8.3 Market Restraints8.3.1 Stringent Legal Requirements and Regulations8.3.2 Injuries and Infections Caused by Needles8.4 Market Opportunities8.4.1 Strong Pipeline of Cell and Gene Therapies

9 Industry Insights9.1 Regulatory Scenario of Cell and Gene Therapy Drug Delivery Devices Market9.1.1 Overview9.1.2 Risk Assessment of Medical Devices9.1.3 Regulation of Medical Devices in the U.S.9.1.4 Regulation of Medical Devices in Europe9.1.5 Regulation of Medical Devices in Asia-Pacific9.2 Pricing and Reimbursement of Cell and Gene Therapy Drug Delivery Devices

10 Patent Landscape

11 Global Cell and Gene Therapy Drug Delivery Devices Market (by Product Type)11.1 Overview11.2 Subretinal Injection Cannula11.3 Extension Tube11.4 Intravenous Catheter11.5 Sterile Insulin Syringe11.5.1 Sterile Insulin Syringe (Size 1.0 ML, 31-Gauge Needle)11.5.2 Sterile Insulin Syringe (Size 0.5 ML, 22 Gauge Needle)11.6 Pre-Filled Syringe11.6.1 Pre-Filled Syringe (Size 1.0 ML, 22-26 Gauge Needle)11.6.2 Pre-Filled Syringe (Size 4.0 ML, 22-26 Gauge Needle)11.7 Infusion Bags11.7.1 Infusion Bags (Size 10 ML to 50 ML)11.7.2 Infusion Bags (Size 68 ML)11.7.3 Infusion Bags (Size 60 ML)11.7.4 Infusion Bags (Size Up to 65 ML)

12 Global Cell and Gene Therapy Drug Delivery Devices Market (by Commercialized Drugs)12.1 Commercialized Drugs12.1.1 Luxturna12.1.2 Kymriah12.1.3 Provenge12.1.4 Zolgensma12.1.5 Yescarta12.1.6 Strimvelis

13 Global Cell and Gene Therapy Drug Delivery Devices Market (by Region)13.1 Overview

14 Competitive Landscape14.1 Key Developments and Strategies14.1.1 Overview14.1.2 Regulatory and Legal Developments14.1.3 Synergistic Activities14.1.4 M&A Activities14.1.5 Funding Activities14.2 Market Share Analysis

15 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/2mcxqt

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

http://www.researchandmarkets.com

Excerpt from:
Cell and Gene Therapy Drug Delivery Devices Market, 2030 - Market Opportunities in the Strong Pipeline of Cell and Gene Therapies - PRNewswire

The Daily Beast

Getty/Facebook Two weeks before he allegedly rammed his car into two police officers guarding the U.S. Capitol, killing one of them, Noah Green posted an article on his Facebook page titled, Lull Before the Storm.An Intro to the Honorable Elijah Muhammad and his divine warning to us all during these last days of our world as we know it. Satans rule over us is up, the 25-year-olds apocalyptic post said, linking to an article from Final Call, the official newspaper of the Nation of Islam.Greens social media posts suggest he was spiraling in the lead up to the attack on Friday. On the eve of his alleged assault, his brother, Brendan Green, told The Washington Post, he sent a worrying text after leaving the apartment where they lived together for the past few months.Im sorry but Im just going to go and live and be homeless. Thank you for everything that youve done. I looked up to you when I was a kid. You inspired me a lot, the text reportedly read. That messageand the deadly attack that occurred less than 24 hours latercapped off a period that was riddled with red flags. Officer Killed, Driver Fatally Shot After Ramming Into Capitol Building BarricadeAs congressional staff grabbed lunch on Friday, Green allegedly rammed his dark blue sedan into two officers guarding a barricade on a road outside the Capitol.He then jumped out of the car and lunged at officers with a knife, U.S. Capitol Police Chief Yogananda Pittman said, prompting them to fatally shoot him. A senior law enforcement official confirmed to The Daily Beast that Green was the suspect, though he has not yet been officially identified by police. One Capitol Police officer, William Billy Evans, died, and a second officer was left hospitalized. He was said to be in stable condition late Friday.Pittman said the suspect was not known to Capitol Police before the attack and there was no indication of any nexus to members of Congress. She also said there was no ongoing threat and the suspect didnt yell anything before being shot. She said that, while an investigation was ongoing, it did not appear to be terrorism-related.Greens social media posts last month described searching for a spiritual journey within the Nation of Islam, a religious Muslim sect that the Southern Poverty Law Center classifies as a hate group for its bizarre theology of innate black superiority over whites and deeply racist, antisemitic and anti-gay rhetoric.In a statement on Saturday, Greens family expressed sympathy for the officer who was killed on Friday, and said they were just as taken aback as the rest of the nation from this horrific event. Still, the family said, Green suffered from depression and potential mental illness, and had likely fell ill to the multitude of problematic situations that surround us in todays society. They also suggested head injuries he sustained playing football may have contributed to his mental state. Nothing indicated a clear motive for targeting the police, nor the U.S. Capitol building located hours from both the Indianapolis apartment he had recently lived in, and the semi-rural part of Virginia he grew up in.In two lengthy March 17 posts on Greens Facebook profile, which was taken down shortly after the incident, Green wrote about losing his job and being unwittingly drugged. He said it was a major goal to meet Nation of Islam leader Louis Farrakhan.There was no immediate indication that Fridays attack was religiously motivated, and the Nation of Islams Virginia branch and D.C. headquarters did not immediately respond to requests for comment.Green wrote about suffering unspecified setbacks in his life recently.To be honest these past few years have been tough, and these past few months have been tougher, he wrote in the March 17 post. I have been tried with some of the biggest, unimaginable tests in my life. I am currently now unemployed after I left my job partly due to afflictions, but ultimately, in search of a spiritual journey.Despite the lack of a job, he posted an image of a certificate that said hed donated $1,085 to the Nation of Islam as a Saviours Day 2021 gift.Greens brother, Brendan, told the Post that Noah had become paranoid in 2019 and accused football teammates of drugging him with Xanax. He moved out to his own apartment and then abruptly moved to Indianapolis, where he believed there were intruders getting into his apartment. It was around that time that Brendan said he flew out to see his brother and realized his mind didnt seem right.More recently, his brother said, Green up and moved to Botswana and suggested he had tried to take his own life by jumping in front of a car. After he returned home, Noah Green appeared to view the Nation of Islam as a way to keep himself anchored. In his most recent social media posts, Green wrote that he had been faced with fear, hunger, loss of wealth, and diminution of fruit in recent months, and was being sustained by faith centered on the belief of the Honorable Minister Louis Farrakhan as Jesus, the Messiah.He posted that he had graduated with distinction, landed a good job out of college, and pursued a graduate degree despite not growing up in the best of circumstances. He said he was on track to go into business, but his path was thwarted. Green wrote that he partially blamed his setbacks on the array of concerning symptoms he suffered as side effects of drugs I was intaking unknowinglyperhaps alluding to the alleged incident in 2019. Noah Green played football for Christopher Newport University and graduated in 2019. CNU Green played football in high school, and a bio from Christopher Newport University said he was born in Fairlea, West Virginia, and has seven brothers and two sisters. He grew up in a semi-rural area in Covington, Virginia. Calls to his siblings and parents went unanswered on Friday.Public records show he enrolled in a graduate course at Florida State University this year, after majoring in marketing at Glenville State College.In the Christopher Newport bio, he said his dream vacation spot was Jamaica and the person hed most like to meet was Malcolm X.Friends appeared shocked that the outgoing, football-playing, marketing student they knew was the same person they saw being stretchered from the Capitol on Friday.He was always super sweet to me and all of his friends loved him, we were all sad to see him leave Glenville, Alaina Funk, a friend of the suspect, told The Daily Beast.It was unclear from his Facebook page how recently he became involved with Nation of Islam. Older posts centered around football and college rather than religion. His grandmother, who died in 2019 from a long illness, was Baptist, her obituary said.But, by March, Greens posts appeared to be consumed by religious warnings about the end days.I encourage everyone to study Revelations, study the signs of the end times, study who the beast is, study who the anti-Christ is, study who the false prophet is, and study the created images during those times. The Minister is here to save me and the rest of humanity, even if it means facing death, he wrote on March 17, before ominously ending the post with, We have a little time.Court records in Indiana, where he temporarily lived in an Indianapolis apartment, show that he sought to change his name recently. In December 2020, he filed a petition to legally change his name to Noah Zaeem Muhammad. But after he failed to show up for a hearing earlier this week and the court apparently did not hear from him, the matter was dismissed and the case declared closed.with reporting by Pilar MelendezRead more at The Daily Beast.Get our top stories in your inbox every day. Sign up now!Daily Beast Membership: Beast Inside goes deeper on the stories that matter to you. Learn more.

More:
Legally blind Great Falls filmmakers share their vision in national challenge - Yahoo News

The Daily Beast

Getty/Facebook Two weeks before he allegedly rammed his car into two police officers guarding the U.S. Capitol, killing one of them, Noah Green posted an article on his Facebook page titled, Lull Before the Storm.An Intro to the Honorable Elijah Muhammad and his divine warning to us all during these last days of our world as we know it. Satans rule over us is up, the 25-year-olds apocalyptic post said, linking to an article from Final Call, the official newspaper of the Nation of Islam.Greens social media posts suggest he was spiraling in the lead up to the attack on Friday. On the eve of his alleged assault, his brother, Brendan Green, told The Washington Post, he sent a worrying text after leaving the apartment where they lived together for the past few months.Im sorry but Im just going to go and live and be homeless. Thank you for everything that youve done. I looked up to you when I was a kid. You inspired me a lot, the text reportedly read. That messageand the deadly attack that occurred less than 24 hours latercapped off a period that was riddled with red flags. Officer Killed, Driver Fatally Shot After Ramming Into Capitol Building BarricadeAs congressional staff grabbed lunch on Friday, Green allegedly rammed his dark blue sedan into two officers guarding a barricade on a road outside the Capitol.He then jumped out of the car and lunged at officers with a knife, U.S. Capitol Police Chief Yogananda Pittman said, prompting them to fatally shoot him. A senior law enforcement official confirmed to The Daily Beast that Green was the suspect, though he has not yet been officially identified by police. One Capitol Police officer, William Billy Evans, died, and a second officer was left hospitalized. He was said to be in stable condition late Friday.Pittman said the suspect was not known to Capitol Police before the attack and there was no indication of any nexus to members of Congress. She also said there was no ongoing threat and the suspect didnt yell anything before being shot. She said that, while an investigation was ongoing, it did not appear to be terrorism-related.Greens social media posts last month described searching for a spiritual journey within the Nation of Islam, a religious Muslim sect that the Southern Poverty Law Center classifies as a hate group for its bizarre theology of innate black superiority over whites and deeply racist, antisemitic and anti-gay rhetoric.In a statement on Saturday, Greens family expressed sympathy for the officer who was killed on Friday, and said they were just as taken aback as the rest of the nation from this horrific event. Still, the family said, Green suffered from depression and potential mental illness, and had likely fell ill to the multitude of problematic situations that surround us in todays society. They also suggested head injuries he sustained playing football may have contributed to his mental state. Nothing indicated a clear motive for targeting the police, nor the U.S. Capitol building located hours from both the Indianapolis apartment he had recently lived in, and the semi-rural part of Virginia he grew up in.In two lengthy March 17 posts on Greens Facebook profile, which was taken down shortly after the incident, Green wrote about losing his job and being unwittingly drugged. He said it was a major goal to meet Nation of Islam leader Louis Farrakhan.There was no immediate indication that Fridays attack was religiously motivated, and the Nation of Islams Virginia branch and D.C. headquarters did not immediately respond to requests for comment.Green wrote about suffering unspecified setbacks in his life recently.To be honest these past few years have been tough, and these past few months have been tougher, he wrote in the March 17 post. I have been tried with some of the biggest, unimaginable tests in my life. I am currently now unemployed after I left my job partly due to afflictions, but ultimately, in search of a spiritual journey.Despite the lack of a job, he posted an image of a certificate that said hed donated $1,085 to the Nation of Islam as a Saviours Day 2021 gift.Greens brother, Brendan, told the Post that Noah had become paranoid in 2019 and accused football teammates of drugging him with Xanax. He moved out to his own apartment and then abruptly moved to Indianapolis, where he believed there were intruders getting into his apartment. It was around that time that Brendan said he flew out to see his brother and realized his mind didnt seem right.More recently, his brother said, Green up and moved to Botswana and suggested he had tried to take his own life by jumping in front of a car. After he returned home, Noah Green appeared to view the Nation of Islam as a way to keep himself anchored. In his most recent social media posts, Green wrote that he had been faced with fear, hunger, loss of wealth, and diminution of fruit in recent months, and was being sustained by faith centered on the belief of the Honorable Minister Louis Farrakhan as Jesus, the Messiah.He posted that he had graduated with distinction, landed a good job out of college, and pursued a graduate degree despite not growing up in the best of circumstances. He said he was on track to go into business, but his path was thwarted. Green wrote that he partially blamed his setbacks on the array of concerning symptoms he suffered as side effects of drugs I was intaking unknowinglyperhaps alluding to the alleged incident in 2019. Noah Green played football for Christopher Newport University and graduated in 2019. CNU Green played football in high school, and a bio from Christopher Newport University said he was born in Fairlea, West Virginia, and has seven brothers and two sisters. He grew up in a semi-rural area in Covington, Virginia. Calls to his siblings and parents went unanswered on Friday.Public records show he enrolled in a graduate course at Florida State University this year, after majoring in marketing at Glenville State College.In the Christopher Newport bio, he said his dream vacation spot was Jamaica and the person hed most like to meet was Malcolm X.Friends appeared shocked that the outgoing, football-playing, marketing student they knew was the same person they saw being stretchered from the Capitol on Friday.He was always super sweet to me and all of his friends loved him, we were all sad to see him leave Glenville, Alaina Funk, a friend of the suspect, told The Daily Beast.It was unclear from his Facebook page how recently he became involved with Nation of Islam. Older posts centered around football and college rather than religion. His grandmother, who died in 2019 from a long illness, was Baptist, her obituary said.But, by March, Greens posts appeared to be consumed by religious warnings about the end days.I encourage everyone to study Revelations, study the signs of the end times, study who the beast is, study who the anti-Christ is, study who the false prophet is, and study the created images during those times. The Minister is here to save me and the rest of humanity, even if it means facing death, he wrote on March 17, before ominously ending the post with, We have a little time.Court records in Indiana, where he temporarily lived in an Indianapolis apartment, show that he sought to change his name recently. In December 2020, he filed a petition to legally change his name to Noah Zaeem Muhammad. But after he failed to show up for a hearing earlier this week and the court apparently did not hear from him, the matter was dismissed and the case declared closed.with reporting by Pilar MelendezRead more at The Daily Beast.Get our top stories in your inbox every day. Sign up now!Daily Beast Membership: Beast Inside goes deeper on the stories that matter to you. Learn more.

Continue reading here:
Pfizer Announces Vaccine Is 100% Protective Against Coronavirus In Kids As Young As 12 - Yahoo News

Anthony Atala receives an award for his innovations in 3D printing to create human organs at the Smithsonian Magazines 2016 American Ingenuity Awards after at National Portrait Gallery on December 8, 2016 in Washington, DC. Photo credit: Leah Puttkammer, Getty Images

Regenerating a solid organ for transplant might be years away from reaching patients. But regenerative medicine technology as a tool for discovering and testing new drugs? Thats already happening.

In Winston-Salem, North Carolina, scientists are 3D printing miniature organs that replicate the anatomy and function of a heart, liver, lungs, even the brain, said Anthony Atala, a professor of urology at Wake Forest University. Their lifetimes last just months, but thats more than enough time to assess a drug in ways that lab tests or even animal tests cannot.

After tens of millions of dollars of investment, by the time a drug gets into a Phase 1 clinical trial through the FDA, 90% of those drugs end up failing, Atala said, speaking on March 24 during the Oracle Health Sciences Connect 2021 conference. Its due to the testing that is not really accurate. Therefore, the strategy is to create these miniature organs.

Atala is the director of the Wake Forest Institute for Regenerative Medicine (WFIRM), which is conducting research on about 40 different tissues and organs. So far, the institute has launched 15 technologies that use human cells to engineer tissues and organs.

The drug testing happens on organoids, an invitro system that stands in for an organ. These miniature organs can be made in both healthy and diseased states, Atala said. These chips can create the human equivalent of physiological responses. For example, scientists can prompt a heart attack or a stroke to assess what a drug would do to an organ affected by those conditions.

WFIRMs drug discovery research represents a convergence of technologies. This body-on-a-chip technology is used to screen libraries of compounds for both safety and efficacy ahead of animal studies and clinical trials, Atala said. Data are cataloged at every step of the process. Artificial intelligence can then be applied to find patterns in the data, improving predictive modeling for drug development.

The Wake Forest research is being conducted as part of the Humanoid Sensor Consortium, a partnership comprised of pharmaceutical companies, academic institutions, and government agencies. The WFIRMs own drug discovery collaborators include the Biomedical Advanced Research and Development Authority (BARDA), which has provided $25 million for research into potential countermeasures to chemical agents. The Defense Threat Reduction Agency (DTRA) has provided more than $26 million in funding for the development of countermeasures for nerve agents.

The technologies that are closest to helping patients are part of a new approach to personalized medicine. The miniature organs are used to help oncologists make treatment decisions. A patients own tissue is used create tumors on a chip, which is then used to test different chemotherapies. These chips are currently being evaluated in clinical trials.

Instead of trying out a treatment for six months and finding out it doesnt work, and then trying another regimen, by then the tumor might be too far gone, Atala said. We can now try to define what the best treatment is before the patient receives the first dose.

Regenerated organs are on the way, Atala said. Engineered skin products are entering the market. The next regenerative tissue products will be a bit more complex, taking on tubular structures. WFIRM has regenerated urethras by taking a small tissue sample from a patient and expanding those cells in a lab. Those cells populate a bioresorbable scaffold, which can then be implanted in the patient.

Solid organs pose the biggest challenge for regenerative medicine. These organs are comprised of many more cells that must be nourished by blood supply. WFIRMs research includes kidneys. A small tissue sample from a patient is expanded in a lab, yielding kidney units capable of producing urine. These kidney units can then be implanted in the patient. Atala said that this research is advancing to Phase 3 testing for patients in end-stage renal failure.

When WFIRM started in 2004, the scientists did not begin the research with an eye on which patients could be helped most by regenerative medicine technology, Atala said. But now, it seems the greatest area of need appears to be kidney transplant patients.

As you know, 80% of patients on the transplant wait list are actually waiting for a kidney, Atala said. So, if we can make a dent in that population, that would be a great thing.

See the original post here:
Regenerative medicine is already changing the way drugs are discovered and tested - MedCity News

VANCOUVER, British Columbia--(BUSINESS WIRE)-- Aspect Biosystems, a privately held biotechnology company pioneering the development of bioprinted therapeutics, is pleased to announce a new joint development program with JSR Corporation, a global leader in advanced materials innovation. This collaboration builds on the existing partnership between the two companies and will see the combining of Aspects proprietary microfluidic 3D bioprinting platform with JSRs advanced materials technology to develop implantable vascularized tissues for kidney regeneration and other applications in regenerative medicine.

The vascularized implantable tissues we develop through this collaboration will enable the next generation of regenerative medicine solutions by supporting longer-term function of therapeutic cells in the body, said Tamer Mohamed, President and CEO of Aspect Biosystems. We are excited to work with JSRs innovative team based in Japan, a country at the forefront of regenerative medicine, and we look forward to continue making breakthroughs with our broadly applicable technology platform.

In our work through JSR Life Sciences, we are seeing the need for advanced, innovative materials continue to grow throughout the biosciences, said Toru Kimura, CTO of JSR Corporation. This joint development program with Aspect Biosystems is testament to that and an important step in enabling and accelerating highly impactful areas in regenerative medicine.

About Aspect Biosystems

Aspect Biosystems is a biotechnology company creating bioprinted therapeutics as medicines of the future. Aspect is applying its microfluidic 3D bioprinting technology internally to develop these advanced cell therapies and partnering with leading researchers and industry innovators worldwide to tackle the biggest challenges in regenerative medicine. Learn more at http://www.aspectbiosystems.com.

About JSR Corporation

JSR Corporation is a multinational company with research-oriented organization that pursues close collaborations with leading innovators in a number of industries that are a key to the present and future welfare of human society: life sciences, synthetic rubbers, electronic materials, display and optical materials. JSR Corporation conducts its global life sciences business through JSR Life Sciences LLC. JSR Life Sciences provides specialized materials, products and services to the biopharma and life sciences industries both directly and through its subsidiaries MEDICAL & BIOLOGICAL LABORATORIES CO., LTD, KBI Biopharma, Inc., Selexis SA, and Crown Biosciences. Learn more at http://www.jsr.co.jp/jsr_e/ and https://www.jsrlifesciences.com/

View source version on businesswire.com: https://www.businesswire.com/news/home/20210330005431/en/

See original here:
Aspect Biosystems and JSR Corporation Enter Collaboration to Develop Bioprinted Vascularized Tissues for Regenerative Medicine - BioSpace

Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell therapy, and the increasing government spend related to these novel techniques, have now caught the eye of federal regulators and prosecutors. In this client alert, we profile some brief context of stem cell therapy, the governments regulations governing these techniques, and some of the best practices for those interested in this emerging space.

Stem cells are cells from which all other cells with specialized functions are generated (i.e., the bodys raw materials). Stem cells may duplicate themselves to create more stem cells or they may generate cells with a specific function like blood or brain cells.

Stem cell therapy is used to repair or replace damaged tissue or cells within the body. Many in the medical community are hopeful that stem cell therapy can be used to treat a wide array of conditions and diseases from multiple sclerosis to vision loss to traumatic spinal cord injuries to Lou Gehrigs disease just to name a few.

The Food and Drug Administration (FDA) oversees and regulates stem cell therapy treatments. While the FDA has acknowledged that stem cell therapy has the potential to treat diseases or conditions for which few treatments exist, there are still only a few treatments that have actually been approved by the FDA. Many treatments are still only in early investigatory stages.

The FDA has recognized the massive potential that stem cell therapy has in allowing patients treatments for various conditions. Consequently, in 2017, the FDA issued guidance indicating its intent to exercise enforcement discretion as a means to support and expedite the development of regenerative medicine products. This enforcement discretion period was to allow innovators time to determine whether to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application as appropriate. The FDA, however, has made clear its enforcement discretion policy only applies to products that do not raise potential significant safety concerns. What the FDA considers significant is debatable, creating uncertainty and ambiguity for those who might be relying on the FDAs enforcement discretion period.

Initially, the FDA stated that its enforcement discretion period would last through November 2020. But in July 2020, the FDA extended its enforcement discretion period through May 2021 a fast-arriving date. It remains unclear whether the FDA intends to extend the time period of its enforcement discretion any further, but either way, stem cell therapy providers would be well-served by planning for and expecting enforcement efforts to ramp up in the near future.

In 2019, the FDA went to great lengths to warn consumers of the potential fraud that may arise from what it called stem cell therapy hype, and encouraged consumers to make sure any stem cell therapy treatments were either approved or being studied as an IND. The FDAs concerns have led to multiple enforcement actions, including one just last month. On February 1, 2021, for example, the government announced the indictment of Ashton Derges, a healthcare provider in Missouri, who marketed stem cell shots as a successful treatment for various conditions, including COVID-19. According to the indictment, Derges was paid nearly $200,000 by patients for the stem cell shots, none of which actually contained stem cells at all. While this alleged fraud was not particularly sophisticated, it nonetheless marked a significant development: the governments first criminal prosecution of those touting stem cell therapies.

But blatant fraud is not the only type of stem cell therapy case the government has expressed interest in investigating. A primary concern of the government is the marketing and use of unproven stem cell treatments as miracle cures. A good case study of the risks associated with aggressive marketing of stem cell therapy is a case out of Florida involving US Stem Cell Clinic Inc. The clinic was marketing stem cell therapy to treat conditions and diseases such as Parkinsons disease, stroke, and brain injuries none of which were approved by the FDA. And, much of the marketing that US Stem Cell Clinic used promised almost miraculous results. As a result, last year, the FDA successfully permanently enjoined the US Stem Cell Clinic from selling or providing those stem cell therapy treatments. Notably, this case was pursued by the FDA despite the FDA explicitly stating its intent to be lenient with emerging stem cell therapy treatments.

Stem cell therapy is a groundbreaking medical tool with great possibilities to treat a plethora of diseases and conditions. As the industry continues to expand, so will the governments interest. Our firm continues to see an uptick in cases involving stem cell therapy treatments. And we have successfully assisted clients in avoiding unnecessary scrutiny by the FDA and other government regulators.

If you are in the stem cell therapy industry or are considering offering stem cell therapy treatments, we recommend that you:

View original post here:
The Governments Watchful Eye on Fraud Stemming from Stem Cell Therapy - JD Supra

Dublin, April 01, 2021 (GLOBE NEWSWIRE) -- The "Automated and Closed Cell Therapy Processing Systems Market By Cell Processing Steps, Scale of Operations, End Users and Geographical Regions: Industry Trends and Global Forecasts, 2020 - 2030" report has been added to ResearchAndMarkets.com's offering.

The "Automated and Closed Cell Therapy Processing Systems Market: Focus on Apheresis, Expansion, Harvest, Fill/Finish, Cryopreservation, Thawing, 2020-2030" report features an extensive study of the current market landscape and future opportunities associated with the automated and closed cell therapy processing systems. The study also features a detailed analysis of key drivers and trends related to this evolving domain.

One of the key objectives of the report was to estimate the existing market size and the future growth potential of the automated and closed cell therapy processing systems. Based on various parameters, such as number of cell therapies under development, expected pricing, likely adoption rates, and potential cost saving opportunities from different automated and closed cell processing systems, we have developed informed estimates of the evolution of the market, over the period 2020-2030.

Advanced therapy medicinal products (ATMPs), such as cell therapies and gene therapies, have revolutionized the healthcare sector. Over the past two decades, more than 30 ATMPs have been approved. Moreover, according to a recent report (published by The Alliance for Regenerative Medicine), over 1,050 clinical trials are currently being conducted by over 1,000 companies, worldwide, focused on the evaluation of cell and gene therapies.

However, despite the numerous advances in this field, there are certain challenges that need to be addressed in order to achieve commercial success. For instance, the current cell therapy manufacturing process is labor-intensive, time consuming and costly. Further, the production of most of these specialized therapeutic products requires manual labor and are typically carried out discretely (open processing), thereby, rendering the processes difficult to scale-up, with high risk of contamination.

Another concern faced by cell and gene therapy manufacturers is batch-to-batch variability, given that even a minor change in the production protocol can affect the quality of the resulting product. Consequently, cell therapies are exorbitantly priced, ranging from USD 300,000 to USD 500,000 per dose.

Experts believe that some of the existing challenges related to cell therapy manufacturing can be addressed through the adoption of automated and closed cell processing systems. These solutions have been demonstrated to be capable of enabling stakeholders to manage various aspects of the cell therapy manufacturing process efficiently, while complying to global regulatory standards. Other benefits of such systems include reduced risk of contamination, optimum utilization of facility and resources, limited in-process variation and consistent product quality.

Further, the use of such automated systems enable significant reductions (in the range of 40% to 90%) in labor costs. In recent years, the cost saving potential of these systems, coupled to their ability to streamline and simplify the complex cell therapy processing (from initial cell collection till final formulation), has effectively captured the interest of several stakeholders engaged in this domain. Given the growing demand for cost-effective, personalized medicine, coupled to the benefits of automated and closed systems, we believe that this niche market is poised to witness significant growth in the foreseen future.

Scope of the Report

An insightful product competitiveness analysis, taking into consideration various relevant parameters, such as supplier power (based on the experience/expertise of the developer in this industry) and portfolio-related parameters, such as number of systems offered, cells supported, type of culture supported, scale of operation, applications, end users, support services offered, regulatory certifications/accreditations obtained and key product specifications.

Elaborate profiles of industry players that are currently offering automated and closed cell therapy processing systems, featuring an overview of the company, its financial information (if available), and a detailed description of the system(s) they offer. Each profile also includes a list of recent developments, highlighting the key achievements, partnership activity, and the likely strategies that may be adopted by these players to fuel growth, in the foreseen future.

An analysis of the various partnerships pertaining to automated and closed cell therapy processing systems, which have been established since 2016, based on several parameters, such as year of partnership, type of partnership model adopted, type of therapy, type of cell processing step, key automated and closed cell processing systems, partner's focus area, most active players (in terms of number of partnerships signed), and geographical location of collaborators.

A detailed assessment of the current market landscape, featuring an elaborate list of over 60 automated and closed systems, along with information on the cell therapy processing step for which they are designed (apheresis, separation, expansion, harvest, fill/finish, cryopreservation and thawing), their key features (traceability, user-friendliness, configurability and scalability, process monitoring, touch-screen user interface, data management, integration with other systems and alert system), product specifications (length, width, depth, height and weight), type of cells supported (stem cells and immune cells), type of cell culture (adherent and suspension), scale of operation (pre-clinical, clinical and commercial), application (research and therapeutic), end users (hospitals/medical centers/clinics, research institutes/academic institutes, laboratories, commercial organizations), key support services offered (product support, technical support, training, installation, qualification/validation, maintenance, regulatory support and others) and regulatory certification/accreditations obtained (GMP/cGMP, GAMP, GCP, GTP/cGTP, IEC standards, ISO standards, 21 CFR Part 11 and other).

The report features detailed transcripts of interviews held with the following industry stakeholders:

Key Questions Answered

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/ly01kj

Read more from the original source:
Global Automated and Closed Cell Therapy Processing Systems Market Trends and Forecasts, 2020-2030: Cell Processing Steps, Scale of Operations, End...

WILLOWBROOK, Ill., March 31, 2021 /PRNewswire/ --Based in Willowbrook, Illinois, Russell Health, a national marketer and distributor of specialty medical products and services,was recently announced as one of The Silicon Review's "50 Leading Companies of the Year 2021."The feature strategically places the Russell Health brand alongside other tech innovators in industries including marketing, finance, software, sustainability, leadership and health. Russell Health's Profile features a Q&A with the leading tech publication covering the history of the Russell Health brand, services offered, anticipated trends in Stem Cell Recruitment Therapy, continued product category research, and more. Read the full feature here.

About Russell Health: Russell Health and its partners have distributed regenerative therapy products nationwide and achieved profound clinical outcomes in multiple therapeutic areas including cosmetics, wound care, pain management, podiatry, orthopedic, optometry and gynecology.

With their partners and suppliers, they work to provide innovative life-changing and sustaining products and therapies to patients and healthcare providers around the world.

Stem Cell Recruitment Therapy products take advantage of the body's ability to repair itself. Responsibly sourced acellular tissue allografts are helping people of all ages to recover from injuries and get their life back.

Quote about the current landscape and anticipated trends in Stem Cell Recruitment Therapy:

"We do not distribute 'Stem Cells' or 'Stem Cell Procedures'. All our products are acellular and do not contain live stem cells. By using a combination of growth factors and other endogenously synthesized molecules, Stem Cell Recruitment Therapyproducts help to assist the body with repair, reconstruction and supplementation of the recipient's tissue, as mentioned above. During the pandemic, we have seen a lot of patients and physicians searching for alternative treatments like ours that are safe and effective without posing any additional risks of infection while providing the clinic."(Ryan Salvino, CEO of Russell Health)

Quote about Russell Health's involvement in Stem Cell Recruitment Therapy research:

"We are currently working with some of the top leaders in the regenerative medicine field to continue to grow and provide new innovative products to our customers and their patients. We are always looking for new breakthrough products in the market to stay abreast on the new technologies and innovations in the field. We are consistently documenting patient results to provide clinicians with testimonialson how effective the Stem Cell Recruitment Therapy products are and how they are positively affecting patients' lives." (Jonathan Benstent, Vice President of Russell Health)

Visit Russell Health online to learn more about Stem Cell Recruitment Therapy. For media inquiries or to contact the Russell Health team directly, please visit http://www.russellhealth.comor email [emailprotected].

Contact: Veronica BennettPhone: 844-249-6200Email: [emailprotected]Mailing Address: 621 Plainfield Rd., Willowbrook, IL 60527Online: http://www.russellhealth.comSocial Media: http://www.linkedin.com/company/russell-health/

Related Images

silicon-review-50-leading-companies.jpeg Silicon Review 50 Leading Companies Russell Health - Stem Cell Recruitment Therapy

SOURCE Russell Health

View post:
Russell Health Highlighted in the Silicon Review's '50 Leading Companies of the Year 2021' - PRNewswire

By Pat Anson, PNN Editor

A California stem cell company has announced positive results from a small, early-stage clinical trial of an experimental stem cell therapy for knee osteoarthritis.

The Phase 1/2a trial conducted by Personalized Stem Cells (PSC) involved 39 patients with knee osteoarthritis who were given a single injection of autologous mesenchymal stem cells derived from their own body fat. Safety was the primary objective of the trial and there were no serious adverse events reported by the company.

The secondary objective of the trial was to assess the effectiveness of the therapy with the Knee Injury and Osteoarthritis Outcome Score (KOOS), a survey that asks patients about their pain, other symptoms, daily function, quality of life, and recreational activities. Nearly 80% of study participants improved above the minimal important change (MIC), with an average improvement over baseline of 2.2 times the MIC.

Osteoarthritis is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine.

Results from the PSC study have been submitted to the FDA for review. The company hopes to get approval for a larger, Phase 2 randomized study of its stem cell therapy later this year.

We are pleased at the strong safety profile and efficacy results in this FDA-approved clinical study of stem cell therapy for knee osteoarthritis, said PSC founder and CEO, Dr. Bob Harman. We are proud to have reached this milestone in our first FDA approved clinical trial. This data supports our progress in the larger placebo-controlled clinical study.

While the FDA has approved hundreds of clinical trials of stem cells, it has not approved a single stem cell product as a treatment for arthritis or any orthopedic condition. That hasnt stopped stem cell clinics from offering regenerative medicine to patients or veterinarians from using it on animals.

VetStem Biopharma, the parent company of PSC, pioneered the use of adipose derived stem cells in veterinary medicine. Its laboratory has processed stem cells for nearly 14,000 dogs, cats, horses and other animals for use by veterinarians in the U.S. and Canada.

The 15 years of veterinary experience with adipose derived stem cell therapy of our parent company, VetStem Biopharma, provided the basis for our FDA study submission and approval and provided valuable insights into the study design and conduct, said Harman.

In addition to the Phase 2 trial for osteoarthritis, PSC plans to pursue FDA approval for a stem cell trial to treat traumatic brain injuries in humans. A clinical study using PSCs stem cell platform to treat respiratory distress syndrome in COVID-19 patients is currently underway.

Go here to see the original:
Positive Results From Stem Cell Trial for Knee Osteoarthritis - Pain News Network

GOLDEN, CO / ACCESSWIRE / April 3, 2021 / Vitro Biopharma, Inc. (formerly Vitro Diagnostics, Inc.) announced the appointment of Dr. Caroline Mosessian, PhD, DRSc, FACMPE, ACHE as its acting Director of Regulatory Affairs. Dr. Mosessian has an extensive background in regulatory science including a PhD, MS and Masters in Healthcare Administration degrees from USC in LA. In 2016 she was honored with the prestigious Top Ranked US Executive Award awarded to the top 1% of the millions of active executives in the United States. She is a trusted advisor for strategic development and operations to a variety of technology firms promoting innovation excellence to enhance quality of life for patients, caregivers and providers while optimizing outcomes and overall corporate success. In addition to regulatory expertise, she has extensive experience in the development, management and licensing of intellectual property, government and private fund raising, strategic planning and clinical research operations. She is fluent in several languages that support her international business development skills. She is also actively involved in local, national and international charitable organizations that emphasize humanitarian aid.

She has led numerous clinical studies of medical devices and pharmaceuticals through regulatory agency approval including the FDA and EMA leading to successful development of multi-million dollar clinical programs. She presently assists Vitro Biopharma in the guidance, drafting and submission of its pending IND phase I application to the FDA (Randomized, Double-blinded, placebo-controlled study of the safety and efficacy of therapeutic treatment with AlloRx Stem Cells in adults with COVID-19). As a result, the FDA has authorized several expanded access/compassionate use INDs that employ IV infusion of AlloRx Stem Cells in the treatment of COVID-19 patients.

These results together with several additional clinical studies using MSCs are now providing substantial clinical evidence of safety and efficacy of stem cell therapy for COVID-19. Furthermore, since MSC therapy is independent of the genome of the virus, this MSC therapy is likely to be effective in treatment of COVID-19 patients infected with new variants resulting from viral mutation.

Dr. Jack Zamora, MD and CEO said, "We are elated to add Dr Mosessian to our regulatory team targeting FDA approval of AlloRx Stem Cells. She has been instrumental in establishing a strong working relationship between Vitro Biopharma and the FDA. She will also be a key driver of the execution of our pending Phase I trial and future INDs targeting additional indications of AlloRx Stem Cells."

Dr. Mosessian said, "I am inspired by Vitro Biopharma's mission to deliver innovative solutions and access to regenerative therapies to deliver unmet needs of the vulnerable patients. I feel fortunate to become part of the team thriving to achieve such an ambitious goal."

John Evans C.F.O. and Chairman of the Board said "We are pleased to have Caroline join the Board of Directors of the company, she adds such a wide breadth of experience in the regulatory, clinical and legal areas of board governance.

ABOUT VITRO BIOPHARMA

Out of years of research, we developed our patent-pending and proprietary line of umbilical cord derived stem cells AlloRx Stem Cells now being used in offshore regenerative medicine clinical trials. Our stem cells are used in regenerative medicine clinical trials with our partner in the Cayman Islands http://www.DVCStem.com. We have a recently approved clinical trial using our AlloRx Stem Cells to treat musculoskeletal conditions at The Medical Pavilion of the Bahamas http://www.tmp-bahamas.com in Nassau. Our nutraceutical stem cell activation product, STEMulize complements AlloRx Stem Cells as an adjuvant therapy to optimize therapeutic outcomes.

Vitro Biopharma has a proprietary and scalable manufacturing platform to provide stem cell therapies to critically ill Coronavirus patients and other conditions including multiple sclerosis, OA, Crohn's disease, and numerous medical conditions that are under-treated by the current standard of care. Our cGMP manufacturing is CLIA, ISO9001, ISO13485 certified and we are FDA registered. Our stem cells have been shown to be safe and effective in Phase I clinical trials.

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward-looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues, and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:Dr. Jack Zamora, MDChief Executive OfficerVitro Biopharma, Inc.(303) 999-2130 x 1www.vitrobiopharma.com

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/638885/Vitro-Biopharma-Retains-Leading-Health-Care-Executive-as-Acting-Director-of-Regulatory-Affairs-Director

Link:
Vitro Biopharma Retains Leading Health Care Executive as Acting Director of Regulatory Affairs & Director - Benzinga

The Latest Regenerative Medicine market evaluates the capabilities, organizations, infrastructure, determines measures to achieve success. Detailed Overview of the global Regenerative Medicine market allows the industry players to plan growth strategies and align them with their operating business models. The research study gives a better understanding of the key growth factors, transformations and risk management priorities in the global Regenerative Medicine market during the years 2021-2026.

It is a phenomenal compilation of important studies that explore the competitive landscape, segmentation, geographical expansion, and revenue, production, and consumption growth of the Regenerative Medicine Market. Players can use the accurate market facts and figures and statistical studies provided in the report to understand the current and future growth of the global Regenerative Medicine Market.

Research Report on Regenerative Medicine Market added by AllTheResearch consist of Growth Opportunities, Development Trends, and Forecast 2026. The global Regenerative Medicine Market size was valued at US$ 13.56 Mn in 2018 and is expected to grow at a CAGR of 23% for the forecast period ending 2026 reaching a Market value of US$ 55.67 Mn.

Request for Sample Copy with Complete TOC and Figures & Graphs at https://www.alltheresearch.com/sample-request/232

Top players Covered in Regenerative Medicine Market Study are:

Above mentioned companies were scrutinized to assess the competitive landscape of the global Regenerative Medicine market. The report provides company profiles of each player. Each profile includes company product portfolio, business overview, company governance, company financials, business strategies, manufacturing locations, and production facilities, company sales, recent developments, and strategic collaborations & partnerships, new product launches, company segments, application diversification, and company strength and weakness analysis.

Ask Your Queries to our Analyst regarding Regenerative Medicine Report at https://www.alltheresearch.com/speak-to-analyst/232

This Regenerative Medicine market report provides insights on new trade regulations, import-export analysis, industry value chain analysis, market size, consumption, production analysis, capacity analysis, regional and segment market share, product launches, product pipeline analysis, the impact of Covid-19 on the supply chain, key regions, untapped markets, patent analysis, product approvals, continuous innovations, and developments in the Market.

Based on type, Regenerative Medicine market report split into

Based on Application Regenerative Medicine market is segmented into

Regional Analysis Covered in this Report are:

For more Customization, Connect with us at https://www.alltheresearch.com/customization/232

Report Coverage

Major Points in Table of Content of Regenerative Medicine Market

To Buy the Full Report, Connect with us athttps://www.alltheresearch.com/buy-now/232

Important Questions Answered by Global Regenerative Medicine Market Report

For More Details Contact Us:

Contact Name: Rohan

Email: [emailprotected]

Phone: +1 (407) 768-2028

More here:
Industry Overview of Regenerative Medicine: Market Report Based on Development, Scope, Share, Trends, Forecast to 2026 The Bisouv Network - The...

Newswise WINSTON-SALEM, NC - March 30, 2021 - Personalized medicine research for aggressive abdominal cancers at Wake Forest Baptist Health received a boost from a $2.5 million grant from the National Cancer Institute that supports research efforts at Wake Forest Organoid Research Center (WFORCE), a joint effort between the Wake Forest Baptist Comprehensive Cancer Center and the Wake Forest Institute for Regenerative Medicine (WFIRM) to tailor personalized therapy for patients.

The funding supports development of a new drug testing platform to predict treatment outcomes for patients. The platform leverages tissue bioengineering advances and genomic technologies to reconstruct and grow patient-derived tumor organoids (i.e., fragments of a patients cancer) in the presence of different drugs to predict clinical responses of patients and guide treatment selection.

Creation of an organoid begins with a tissue biopsy of the tumor. Cells from this biopsy are then used to grow small tumors called organoids in the lab which behave similarly to the original tumor. The organoid model can accurately represent what occurs inside a patients body. Lastly, the best chemotherapy treatment is chosen by exposing the organoids to the various potential treatments and observing their response.

Konstantinos Votanopoulos, M.D., Ph.D., professor of surgery and director of WFORCE, and Lance D. Miller, Ph.D., associate professor in cancer biology, are the principal investigators of the grant, with Shay Soker, Ph.D., chief science officer and WFIRM professor, as a co-investigator.

WFORCE, which brings together researchers and clinicians to leverage the use of tissue organoid technology to tailor personalized therapy for patients, was formed in early 2020. To be awarded a competitive R01 grant of this size speaks to the need and transformational potential of WFORCE which combines world class multi-disciplinary clinical trial and patient care expertise through the NCI-designated Wake Forest Baptist Comprehensive Cancer Center and ground-breaking innovation and technology through WFIRM.

Every time cancer cells multiply, they generate the next generation of cancer cells with new properties, Votanopoulos said. As the cancer progresses, the patient ends up with not just a single tumor, but many different tumor clones with variable biologic behavior and response to treatment. Accurate mapping of tumor clonality, combined with response of each clone to therapy is the key for the development of personalized treatment strategies tailored to each patient separately.

Specifically, the research will look at determining clonality-based treatment response of high prevalence cancers such as colon, as well as very rare cancers with incidence less than 1 per 100,000 patients, such as appendiceal, that have spread throughout the abdomen where they grow as metastatic lesions on the surfaces of different organs.

How patients respond to treatment varies widely, and this represents a major clinical challenge our grant seeks to address, Miller said. This genetic variation that occurs when the cancer cells multiply is believed to explain why most, but not all of a patients cancer can initially respond well to chemotherapy, but eventually return in a drug-resistant form.

Soker said the project will generate new knowledge of how certain mutations, alone or in combination, impact response to specific drugs, adding that results of these studies will be leveraged in a future clinical trial.

Other key personnel on the grant are surgeon Edward A Levine, MD, pathologist Stacey ONeill, MD, tumor immunologist David Soto-Pantoja, MD,and bioinformatics expert Guangxu Jin, MD.

About the Comprehensive Cancer Center: The center is designated by the National Cancer Institute (NCI) as acomprehensive cancer center, one of three in North Carolina, and one of 51 in the country and has held this designation continuously since 1990. The designation recognizes Wake Forest for the highest levels of expertise and a commitment to patient care, cancer research, including clinical trials, and education. The rapid pace of discovery and the early availability of many new cancer treatments at NCI-designated Comprehensive Cancer Centers, gives us an advantage in offering our cancer patients early access to the latest therapies and treatment options, sometimes even months or years before non-NCI cancer centers.Wake Forest has a team of 120 clinicians representing all aspects of cancer care including those in the fields ofhematology and oncology,gynecologic oncology,radiation oncology,surgical oncologyandcolon and rectal surgery.

About the Wake Forest Institute for Regenerative Medicine:The Wake Forest Institute for Regenerative Medicine is recognized as an international leader in translating scientific discovery into clinical therapies, with many world firsts, including the development and implantation of the first engineered organ in a patient. Over 400 people at the institute, the largest in the world, work on more than 40 different tissues and organs. A number of the basic principles of tissue engineering and regenerative medicine were first developed at the institute. WFIRM researchers have successfully engineered replacement tissues and organs in all four categories flat structures, tubular tissues, hollow organs and solid organs and 15 different applications of cell/tissue therapy technologies, such as skin, urethras, cartilage, bladders, muscle, kidney, and vaginal organs, have been successfully used in human patients. The institute, which is part of Wake Forest School of Medicine,is located in theInnovation Quarterin downtown Winston-Salem, NC,andis driven by the urgent needs of patients. The institute is making a global difference in regenerative medicine through collaborations with over 400entitiesand institutions worldwide,through its government, academic and industry partnerships, its start-up entities, and through major initiatives in breakthrough technologies, such as tissue engineering, cell therapies, diagnostics, drug discovery, biomanufacturing, nanotechnology, gene editing and 3D printing.

Original post:
$2.5M award to fund joint organoid research program at Wake to treat aggressive cancers - Newswise

insightSLICE provide a deep analysis of the Global Regenerative Medicine Marketwhich evaluates business solutions, assess, research and development, application, benefits, advantage, scope, and operations. This report offers an in-depth analysis and development ofindustry major manufacturers, key drivers, opportunity, challenge, international suppliers also deep study on risks and entry barriers. It also offers competitive analysis on thelatest technology, trend, innovation, future scope, Industry Share, sales, revenue generation, investment analysis, and overall business scenario.

These studies also involve the important achievements of the market, research & development, new product launch, regional growth, leading competitors over the universal and local scale. The industry report analysis and insights of manufacturers steeringgrowth, revenue, share, supply, opportunity, challenges, and restrain development. It also the expansion of Industry regional as well as global fats and figure.

FREE |Get More Details on this Report, Download Now( Sample PDF) :https://www.insightslice.com/request-sample/594

Competitive landscape:

Competitive analysis was carried out in the report. This competitive analysis provides insightful data about industry market leaders. The purpose is to help customers understand the existing market participants and potential market participants in the industry. The way the report is made allows customers not only to make the right decisions about the industry, but also to maintain steady growth in the industry in the long run. The purpose is to guide customers towards the steady development of their industry growth.

Manufacturers covered in this report are:

3M Group, Novartis AG and Integra Lifesciences Holdings Corporation.

An overview of the markets regional outlook:

The Global Regenerative Medicine report provides information about market regions, which are further broken down into sub-regions and countries. In addition to market share in each country and region, this chapter of this report also contains information about profit opportunities. This chapter of the report mentions the share and market growth rate of each region, country, and subregion over the estimated time period.

Get Exclusive Discount @https://www.insightslice.com/request-discount/594

The impact of Covid-19 on this market:

The coronavirus (COVID-19) pandemic has affected every aspect of global life. The study comprehensively covers the impact of the COVID-19 pandemic on the Global Regenerative Medicine market and its key market segments. In addition, it covers the current and future impact of the pandemic and provides the post-COVID-19 situation to gain a deeper understanding of trends and dynamic changes in market conditions.

In addition, insightSLICE has access to a wide range of regional and global well-known paid databases, which helps the company determine regional and global market trends and dynamics. The research also includes key strategic developments, including R&D, new product launches, mergers and acquisitions, agreements, collaborations, partnerships, joint ventures, and the regional development of major competitors operating in the market on a global and regional scale.

What benefits do insightSLICE research studies provide?

Finally, the Global Regenerative Medicine Market report is a source of convincing research reports that can accelerate your business exponentially. The report provides the main regional settings, economic conditions, and the value, benefits, restrictions, generation, supply, demand, and market development speed and figures of the project.

If You Have Any Query, Ask Our Experts @ https://www.insightslice.com/request-customization/594

About Us:

We are a team of research analysts and management consultants with a common vision to assist individuals and organizations in achieving their short and long term strategic goals by extending quality research services. The inception of insightSLICE was done to support established companies, start-ups as well as non-profit organizations across various industries including Packaging, Automotive, Healthcare, Chemicals & Materials, Industrial Automation, Consumer Goods, Electronics & Semiconductor, IT & Telecom and Energy among others. Our in-house team of seasoned analysts hold considerable experience in the research industry.

Contact Info422 Larkfield Ctr #1001Santa Rosa,CA 95403-1408[emailprotected]+1 (707) 736-6633

Read more:
Regenerative Medicine Market is Expected to Develop at a Substantial CAGR in the Coming Years 2020 to 2030 | 3M Group, Novartis AG and Integra...

DUBLIN, April 1, 2021 /PRNewswire/ -- The "Cell Therapy Market Forecast to 2027 - COVID-19 Impact and Global Analysis By Therapy Type; Product; Technology; Application; End User, and Geography" report has been added to ResearchAndMarkets.com's offering.

According to this report the global cell therapy market is expected to reach US$ 12,563.23 million by 2027 from US$ 7,260.50 million in 2019. It is estimated to grow at a CAGR of 7.2% from 2020-2027. The growth of the market is attributed to increasing prevalence of chronic diseases, rising adoption of regenerative medicines, and surging number of approvals for cell-based therapies. However, the high cost of cell therapy manufacturing hinders the growth of the market.

The cell therapy market, based on therapy type, is bifurcated into allogeneic and autologous. In 2019, the allogeneic segment accounted for a larger share owing to the availability of substantial number of approved products for clinical use. For instance, in 2018, Alofisel developed by TiGenix (Takeda) is the first allogeneic stem cell-based therapy approved for use in Europe.

Chronic diseases, such as cardiovascular disorders, neurological disorders, autoimmune disorders, and cancer, are the leading causes of death and disability worldwide. As per the Centers for Disease Control and Prevention (CDC), in 2019, nearly 6 in 10 people suffered from at least one chronic disease in the US. Cardiovascular diseases (CVDs) are a significant cause of mortality owing to the hectic lifestyle. As per the World Health Organization (WHO), CVDs are the number 1 cause of death globally, taking an estimated 17.9 million lives each year. Cancer is among the leading causes of mortality worldwide, and the disease affects a huge population; therefore, it acts as a huge financial burden on society. According to the WHO, in 2018, ~9.6 million deaths occurred due to cancer globally. However, growing research on developing effective treatments for the disease is positively affecting the market growth. Gene therapy and cell therapy are transforming the cancer treatment landscape; for example, Novartis Kymriah is used to treat diffuse large B-cell lymphoma. The launches of more such products would be driving the demand for cell therapy, thus driving the growth of the cell therapy market in the coming years.

The COVID-19 outbreak was first reported in Wuhan (China) in December 2019. The pandemic is causing massive disruptions in supply chains, consumer markets, and economy across the world. As the healthcare sector is focusing on saving lives of COVID-19 patients, the demand for cell therapy is reducing worldwide.

Vericel Corporation; MEDIPOST; NuVasive, Inc.; Mesoblast Limited; JCR Pharmaceuticals Co. Ltd.; Smith & Nephew; Bristol-Myers Squibb Company; Cells for Cells; Stemedica Cell Technologies, Inc; and Castle Creek Biosciences, Inc. are among the companies operating in the cell therapy market.

Reasons to Buy

Key Topics Covered:

1. Introduction1.1 Scope of the Study1.2 Research Report Guidance1.3 Market Segmentation1.3.1 Global Cell Therapy Market - By Therapy Type1.3.2 Global Cell Therapy Market - By Product1.3.3 Global Cell Therapy Market - By Technology1.3.4 Global Cell Therapy Market - By Application1.3.5 Global Cell Therapy Market - By End User1.3.6 Global Cell Therapy Market - By Geography

2. Cell Therapy Market - Key Takeaways

3. Research Methodology3.1 Coverage3.2 Secondary Research3.3 Primary Research

4. Global Cell therapy- Market Landscape4.1 Overview4.2 PEST Analysis4.2.1 North America - PEST Analysis4.2.2 Europe- PEST Analysis4.2.3 Asia Pacific- PEST Analysis4.2.4 Middle East and Africa - PEST Analysis4.2.5 South and Central America - PEST Analysis4.3 Expert Opinions

5. Global Cell Therapy Market - Key Industry Dynamics5.1 Key Market Drivers5.1.1 Increasing Prevalence of Chronic Diseases5.1.2 Rising Adoption of Regenerative Medicines5.1.3 Increasing Number of Approvals for Cell-Based Therapies5.2 Key Market Restraints5.2.1 High Cost of Cell Therapy Manufacturing5.3 Key Market Opportunities5.3.1 Increasing Adoption of Cell Therapy in Developing Regions5.4 Future Trends5.4.1 Shift Toward Automated Cell Therapy Manufacturing5.5 Impact Analysis of Drivers and Restraints

6. Cell therapy Market - Global Analysis6.1 Global Cell therapy Market Revenue Forecast And Analysis6.2 Global Cell therapy Market, By Geography - Forecast And Analysis6.3 Market Positioning

7. Cell therapy Market Analysis - By Therapy Type7.1 Overview7.2 Cell therapy Market Revenue Share, by Therapy Type (2019 and 2027)7.3 Allogeneic7.3.1 Overview7.3.2 Allogeneic: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)7.4 Autologous7.4.1 Overview7.4.2 Autologous: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)

8. Cell therapy Market Analysis - By Product8.1 Overview8.2 Cell therapy Market Revenue Share, by Product (2019 and 2027)8.3 Consumables8.3.1 Overview8.3.2 Consumables: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)8.4 Equipment8.4.1 Overview8.4.2 Equipment: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)8.5 Systems and Software8.5.1 Overview8.5.2 Systems and Software: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)

9. Cell therapy Market Analysis - By Technology9.1 Overview9.2 Cell therapy Market Revenue Share, by Technology (2019 and 2027)9.3 Viral Vector Technology9.3.1 Overview9.3.2 Viral Vector Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)9.4 Genome Editing Technology9.4.1 Overview9.4.2 Genome Editing Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)9.5 Somatic Cell Technology9.5.1 Overview9.5.2 Somatic Cell Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)9.6 Cell Immortalization Technology9.6.1 Overview9.6.2 Cell Immortalization Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)9.7 Cell Plasticity Technology9.7.1 Overview9.7.2 Cell Plasticity Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)9.8 Three-Dimensional Technology9.8.1 Overview9.8.2 Three-Dimensional Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)

10. Cell therapy Market Analysis - By Application10.1 Overview10.2 Cell therapy Market Revenue Share, by Application (2019 and 2027)10.3 Oncology10.3.1 Overview10.3.2 Oncology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)10.4 Cardiovascular10.4.1 Overview10.4.2 Cardiovascular: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)10.5 Orthopedic10.5.1 Overview10.5.2 Orthopedic: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)10.6 Wound Management10.6.1 Overview10.6.2 Wound Management: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)10.7 Other Applications10.7.1 Overview10.7.2 Other Applications: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)

11. Cell therapy Market Analysis - By End User11.1 Overview11.2 Cell therapy Market Share, by End User, 2019 and 2027, (%)11.3 Hospitals11.3.1 Overview11.3.2 Hospitals: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)11.4 Research Institutes11.4.1 Overview11.4.2 Research Institutes: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)11.5 Others11.5.1 Overview11.5.2 Others: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)

12. Cell therapy Market - Geographic Analysis12.1 North America: Cell Therapy Market12.2 Europe: Cell therapy Market12.3 Asia Pacific: Cell Therapy Market12.4 Middle East and Africa: Cell Therapy Market12.5 South and Central America: Cell Therapy Market

13. Impact of COVID-19 Pandemic on Global Cell Therapy Market13.1 North America: Impact Assessment of COVID-19 Pandemic13.2 Europe: Impact Assessment of COVID-19 Pandemic13.3 Asia-Pacific: Impact Assessment of COVID-19 Pandemic13.4 Middle East & Africa: Impact Assessment of COVID-19 Pandemic13.5 South & Central America: Impact Assessment of COVID-19 Pandemic

14. Cell Therapy Market- Industry Landscape14.1 Overview14.2 Growth Strategies Done by the Companies in the Market, (%)14.3 Organic Developments14.3.1 Overview14.4 Inorganic Developments14.4.1 Overview

15. Company Profiles15.1 Vericel Corporation15.1.1 Key Facts15.1.2 Business Description15.1.3 Products and Services15.1.4 Financial Overview15.1.5 SWOT Analysis15.1.6 Key Developments15.2 MEDIPOST15.2.1 Key Facts15.2.2 Business Description15.2.3 Products and Services15.2.4 Financial Overview15.2.5 SWOT Analysis15.2.6 Key Developments15.3 NuVasive, Inc.15.3.1 Key Facts15.3.2 Business Description15.3.3 Products and Services15.3.4 Financial Overview15.3.5 SWOT Analysis15.3.6 Key Developments15.4 Mesoblast Limited15.4.1 Key Facts15.4.2 Business Description15.4.3 Products and Services15.4.4 Financial Overview15.4.5 SWOT Analysis15.4.6 Key Developments15.5 JCR Pharmaceuticals Co. Ltd.15.5.1 Key Facts15.5.2 Business Description15.5.3 Products and Services15.5.4 Financial Overview15.5.5 SWOT Analysis15.5.6 Key Developments15.6 Smith & Nephew15.6.1 Key Facts15.6.2 Business Description15.6.3 Products and Services15.6.4 Financial Overview15.6.5 SWOT Analysis15.6.6 Key Developments15.7 Bristol-Myers Squibb Company15.7.1 Key Facts15.7.2 Business Description15.7.3 Products and Services15.7.4 Financial Overview15.7.5 SWOT Analysis15.7.6 Key Developments15.8 Cells for Cells15.8.1 Key Facts15.8.2 Business Description15.8.3 Products and Services15.8.4 Financial Overview15.8.5 SWOT Analysis15.8.6 Key Developments15.9 Stemedica Cell Technologies, Inc15.9.1 Key Facts15.9.2 Business Description15.9.3 Products and Services15.9.4 Financial Overview15.9.5 SWOT Analysis15.9.6 Key Developments15.10 Castle Creek Biosciences, Inc.15.10.1 Key Facts15.10.2 Business Description15.10.3 Products and Services15.10.4 Financial Overview15.10.5 SWOT Analysis15.10.6 Key Developments

16. Appendix16.1 About the Publisher16.2 Glossary of Terms

For more information about this report visit https://www.researchandmarkets.com/r/hxk6k0

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

http://www.researchandmarkets.com

See the rest here:
Worldwide Cell Therapy Industry to 2027 - Increasing Prevalence of Chronic Diseases is Driving the Market - PRNewswire

Request Download Sample Ask For Discount Company Profile

New Jersey, United States,-The Human Mesenchymal Stem Cells (hMSC) Market report provides in-depth knowledge and insights into the Human Mesenchymal Stem Cells (hMSC) market in terms of market size, market share, factors influencing growth, opportunities, and current and emerging trends. The report has the updated and latest information on the Human Mesenchymal Stem Cells (hMSC) market that has been further validated and verified by industry experts and professionals. The Human Mesenchymal Stem Cells (hMSC) market report provides historical, current, and forecast estimates of sales generation and profit for each segment and sub-segment of the Human Mesenchymal Stem Cells (hMSC) market in every key region around the world. The report also highlights the emerging growth opportunities in the business that are designed to support market growth.

The latest report is the latest study to offer 360 coverage of the Human Mesenchymal Stem Cells (hMSC) industry, which is facing the worst negative economic impact of the COVID-19 outbreak since the beginning of this year.

The report covers the following key players in the Human Mesenchymal Stem Cells (hMSC) Market:

PromoCell ThermoFisher KURABO Lifeline Cell Technology Merck

Segmentation of Human Mesenchymal Stem Cells (hMSC) Market:

The report provides an in-depth analysis of various market segments based on the product line, applications, major regions, and key companies in the industry. In addition, the report has a single section that provides a detailed analysis of the manufacturing process and includes information gathered from primary and secondary data collection sources. The main source for data collection is interviews with industry experts who provide accurate information about the future market scenario.

By the product type, the market is primarily split into:

Umbilical Cord Matrix hMSC Bone Marrow hMSC Adipose Tissue hMSC Other

By the application, this report covers the following segments:

Medical Application Research Other Applications

Human Mesenchymal Stem Cells (hMSC) Market Report Scope

Human Mesenchymal Stem Cells (hMSC) Geographic Market Analysis:

The latest business intelligence report analyzes the Human Mesenchymal Stem Cells (hMSC) market in terms of market reach and customer base in key geographic market regions. The Human Mesenchymal Stem Cells (hMSC) market can be geographically divided into North America, Asia Pacific, Europe, Latin America, the Middle East, and Africa. This section of the report provides an accurate assessment of the Human Mesenchymal Stem Cells (hMSC) market presence in the major regions. It defines the market share, market size, sales, distribution network and distribution channels for each regional segment.

Key Points of theGeographical Analysis:

** Data and information on consumption in each region** The estimated increase in consumption rate** Proposed growth in market share for each region** Geographic contribution to market income** Expected growth rates of the regional markets

Key Highlights of the Human Mesenchymal Stem Cells (hMSC)Market Report:

** Analysis of location factors** Raw material procurement strategy** Product mix matrix** Analysis to optimize the supply chain** Patent analysis** R&D analysis** Analysis of the carbon footprint** Price volatility before commodities** Benefit and cost analysis** Assessment and forecast of regional demand** Competitive analysis** Supplier management** Mergers and acquisitions** Technological advances

Visualize Human Mesenchymal Stem Cells (hMSC) Market using Verified Market Intelligence:-

Verified Market Intelligence is our BI-enabled platform for narrative storytelling of this market. VMI offers in-depth forecasted trends and accurate Insights on over 20,000+ emerging & niche markets, helping you make critical revenue-impacting decisions for a brilliant future.

VMI provides a holistic overview and global competitive landscape with respect to Region, Country, and Segment, and Key players of your market. Present your Market Report & findings with an inbuilt presentation feature saving over 70% of your time and resources for Investor, Sales & Marketing, R&D, and Product Development pitches. VMI enables data delivery In Excel and Interactive PDF formats with over 15+ Key Market Indicators for your market.

About Us: Verified Market Reports

Verified Market Reports is a leading Global Research and Consulting firm servicing over 5000+ global clients. We provide advanced analytical research solutions while offering information-enriched research studies.

We also offer insights into strategic and growth analyses and data necessary to achieve corporate goals and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance using industrial techniques to collect and analyze data on more than 25,000 high-impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

Our research spans over a multitude of industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverages etc. Having serviced many Fortune 2000 organizations, we bring a rich and reliable experience that covers all kinds of research needs.

Contact us:

Mr. Edwyne Fernandes

US: +1 (650)-781-4080UK: +44 (753)-715-0008APAC: +61 (488)-85-9400US Toll-Free: +1 (800)-782-1768

Email: [emailprotected]

Website: https://www.verifiedmarketreports.com/

See the original post:
Human Mesenchymal Stem Cells (hMSC) Market Size 2021 | Global Trends, Business Overview, Challenges, Opportunities and Forecast to 2027 The Bisouv...

Introduction

Metaplastic breast cancer (MpBC) is a unique histologic subtype of breast cancer, defined by characteristic intra-tumoural heterogeneity. Although rare, MpBC accounts for significant morbidity and mortality, and has a poor prognosis. MpBC tend not to respond well to systemic chemotherapies, and together with emerging data on the genomic landscape of MpBC, there is scope for applying precision oncology in the management strategies of MpBC. We focus herein on the molecular pathology of MpBC and the current status and potential of targeted therapies to manage MpBC.

The clinical features of MpBC are similar to other high-grade cancers of no special type (NST), however, they often present at amore advanced stage. They tend to be large in size, with dimensions ranging from 1.2 to >10 cm and often present as a palpable breast mass, with ill-defined borders on mammography, ultrasonography, and magnetic resonance imaging. MpBC represents 0.21% of all breast cancers the rates vary due to the differing definitions and classification systems used over time.

MpBC do not have any distinctive macroscopic features, with the tumor varying from well-circumscribed to having an irregular border. Microscopically, they comprise a heterogenous group with differing outcomes. In the absence of sufficient molecular and outcome data, the current WHO Classification of Tumours of the Breast1,2 has maintained a descriptive morphological classification system, based on the type of the metaplastic elements present. MpBC are classified monophasic (when there is only one metaplastic component) or biphasic (with two or more metaplastic components such as squamous and spindle, or mixed metaplastic and non-metaplastic components such as spindle and invasive carcinoma NST). Further, MpBC can also be classified into epithelial-only carcinomas (with low-grade adenosquamous carcinoma or pure squamous cell carcinoma), pure (monophasic) sarcomatoid (spindle cell or matrix-producing) carcinomas, and biphasic epithelial and sarcomatoid carcinomas.

The current WHO classification includes (i) adenosquamous carcinoma mostly low grade but can be high grade rarely and (ii) pure squamous cell carcinomas (iii) pure spindle cell carcinoma (iv) fibromatosis-like metaplastic carcinoma, (iv) metaplastic carcinoma with mesenchymal differentiation that includes chondroid (myxoid/cartilaginous), osseous (bone), rhabdomyoid (muscle) and neuroglial, and (v) mixed metaplastic carcinoma where the mix may be multiple metaplastic elements or a mixture of epithelial and mesenchymal elements. Examples of the heterologous elements are shown in Figure 1. The detailed morphology of the subtypes is beyond the scope of this review and the reader is directed to the WHO Tumour Classification of the Breast 5th Ed (2019).2

Figure 1 Examples of Metaplastic breast cancer morphologies. (A) High-grade, pleomorphic de-differentiated carcinoma (IBC-NST). (B) High-grade carcinoma with focal squamous differentiation. (C) Osteoid differentiation. (D) Chondroid differentiation. (E) Spindle differentiation. Scale bar is 100 m.

MpBC are typically, though not invariably triple-negative (TN), lacking expression of estrogen and progesterone receptors (ER/PR), and HER2. Analysis of the SEER data showed that HER2 positive MpBC had an improved overall survival compared to TN, and other MpBC including ER+/PR+/HER2-cases, which accounted for 20% of the cohort.3 Conversely, HER2-positive metaplastic squamous cell carcinomas were recently demonstrated to have a poorer prognosis than the TN metaplastic squamous variants.4 MpBC fit into the claudin-low and/or basal breast cancer intrinsic subtypes,5,6 although whether or not claudin low represents an intrinsic subtype or phenotype has recently come into question.7 A recent large meta-analysis reported that approximately three quarters of all MpBC stain positively for pan-cytokeratin biomarkers (AE1/3, MNF116) and basal cytokeratin biomarkers (34E12, CK5/6, CK14 and CK17). GATA3, a common diagnostic marker used to identify tumours of breast origin, is expressed by only 21% of MpBC, while a novel breast marker, TRPS1, was shown to be highly expressed in 86% of MpBC, as well as non-metaplastic TNBC and BC more broadly.8 Frequent expression of p63 was also noted, as was an absence of staining for CD34.9 Those cases lacking cytokeratin expression were studied in more detail, and determined to be carcinomatous rather than true primary sarcomas in most cases, further evidencing the inter-tumor heterogeneity of breast cancer broadly, and MpBC specifically.10 Indeed, a pure sarcoma of the breast is rare and is a diagnosis of exclusion, requiring extensive sampling; negative stains for p63 and a range of cytokeratins; and, a morphological examination for any evidence of epithelial differentiation.

For the adenosquamous and fibromatosis-like variants of MpBC, the grade is implicitly low, and prognostic outcome is better than for the majority of MpBC which are typically classified as high grade (grade 3) tumors. Although high histologic grading is a relatively consistent finding, its prognostic value is still uncertain.11 A subset of MpBC tumors with extreme, bizarre cytologic pleomorphisms has been reported,11 with a noted enrichment in the spindle phenotype.

With respect to the TNM classification system of cancer stage, MpBC present with a larger tumor size (TNM), with reports indicating that ~60% of MpBC have tumors between 2 and 5 cm (T2;12). As for triple-negative breast cancers more broadly, lymph node (LN; the N of TNM) positivity is not a prominent feature, with LN metastasis documented in about 24% of patients. Distant metastasis (TNM) occurs with or without LN spread in MpBC, and spread to the lungs and brain has been reported.13

The innate plasticity of MpBC has led to suggestions that it is a stem-cell like breast cancer, and a wealth of data show that MpBC express classic stem cell markers. It is presently considered that there exist three categories of breast cancer stem cell (CSC): an ALDH+ epithelial-like CSC; CD44+/CD24 mesenchymal-like CSCs; and, a hybrid epithelial/mesenchymal-like ALDH+/CD44+/CD24 (reviewed in detail in14). The work of Zhang et al15 demonstrated the increased expression of classic stem cell markers ALDH1 and CD44/CD24 ratios in a series of MpBC, much like the above-noted hybrid CSC state, and also expression of characteristic epithelial to mesenchymal transition (EMT) markers (increased ZEB1 and loss of E-cadherin). This expression of stem-like markers was also supported by Gerhard et al,16 with most of their series showing positivity for CD44 and loss of CD24, as well as an enrichment for vimentin and loss of the claudins and E-cadherin. Given that cancer stem cells have well-documented chemoresistance,17 it is unsurprising that MpBC, with their enrichment of both stem-like markers and the hallmarks of EMT,5,18 also respond poorly to chemotherapeutics. Notably, MpBC have a high frequency of PIK3CA mutations (see below) and these mutations correlate with poor response to neoadjuvant chemotherapy in breast cancer subtypes broadly,19 and this holds true in the metastatic setting.20 Drugs targeting the PI3K/AKT axis are emerging in the clinic, may be appropriate for MpBC, and are discussed further below.

As shown in Table 1, the research community has yet to robustly elucidate a molecular landscape for MpBC, most likely due to the extensive sample heterogeneity. There is limited concordance between studies on the mutations present, however this is likely influenced by the sequencing platform (exome vs panel), and also the subtype composition of the cohorts.

Table 1 Genetic Alterations Identified Across MpBC Cohorts and Morphologies

PI-3 Kinase and Ras signaling pathway mutations have been shown to be early events in MpBC pathogenesis.21 Mutation frequencies reported for MpBC range from 26%-75% for TP53, and 23%-70% for PIK3CA (Table 1) and this is supported by a recent meta-analysis of 14 studies encompassing 539 cases.22 Other than TP53 and PIK3CA, the most frequently identified mutations across multiple cohorts occur in PTEN, NF1, HRAS, PIK3R1. Emerging data support that the various morphologic elements feature subtly different mutation profiles, with for example, a lack of PIK3CA mutations found in those MpBC with chondroid differentiation.23 Chondroid tumors were also shown to lack mutations in TERT promoters.21 TERT promoter mutations were enriched in the spindle and squamous type tumors, while TP53 mutations were less likely to be in spindled tumors than other MpBC types.21 An increase in mutations in Wnt pathway genes has been reported for MpBCs,23 with WISP3/CCN6 mutations more frequently seen in the epithelial components, and 3/7 CTNNB1 mutations present only in the spindle compartment of the tumor.24

In spite of the private mutations in the different morphological components as noted above, evidence supports that the different histologies have a shared origin, and following a detailed exome sequencing study, Avigdor et al postulated that methylation and/or non-coding changes may also regulate the phenotypic differentiation.25 To clarify the outstanding elements of the genomic landscape of MpBC, a concerted effort must be made to standardize sequencing approaches on an adequately powered cohort of well-annotated MpBC.

Uterine carcinosarcoma (UCS) are considered the metaplastic cancers of the gynaecological tract, and a recent study performed a comparative analysis of 57 UCS with 35 MpBC.26 Genetic differences unique to the UCS were reported, with a significant enrichment for mutations in FBXW7 and PPP2R1A, and HER2 amplifications, while shared genomic features included alterations in TP53, PIK3CA, PTEN and EMT-related Wnt and Notch signalling components. Interestingly, unlike the UCS, almost half of the profiled MpBC had a dominant homologous recombination deficiency (HRD; signature 3) signature, and these same cases showed other features of a HRD including large scale transitions, and allelic imbalance extending to the telomeres.

In the absence of indications for hormone and anti-HER2 therapies, and given their typically large size at presentation, MpBC are managed with chemotherapeutics in addition to surgery (with/without radiation). However, early studies showed that systemic therapy was less effective in MpBC12 and this data has held true over time and is supported by the overall poor outcomes of MpBC patients.27 In fact, while 90% of diagnoses of MpBC are for localized disease, half of these patients will progress to advanced BC over time.28,29 Treatment in the neoadjuvant setting appears to afford little advantage, with a 1017% pathological complete response rate reported3033 for American studies, while studies in Japan and Turkey reported no complete responders.34,35 It is clear that efficacious treatments for MpBC are an unmet clinical need, and while some clinical trials specifically for MpBC are being initiated, the potential for novel therapeutic interventions must be capitalized upon.

MpBC are characteristically triple-negative BC, thus eliminating these patients from current tailored therapeutic options of hormone therapy and anti-HER2 therapy. This triple-negativity, does however make them eligible for a multitude of trials currently recruiting, including those assessing benefit of immune checkpoint inhibitors; a non-exhaustive list of open trials is presented in Table 2.

Table 2 Active Trials Open to Metaplastic Breast Cancer Patients

MpBC show frequent alterations in the PI3K/AKT/mTOR pathway making them candidates for targeted therapies such as everolimus, temsirolimus, and alpelisib. In a Phase I intervention, a 42% rate of partial/complete remission was reported for a combination of temsirolimus and bevacizumab (HIF inhibitor).36 A 25% response rate (complete/partial response) was achieved in MpBC treated with temsirolimus/everolimus in combination with standard chemotherapy and a 21% objective response rate was also reported for the regimen of doxorubicin, bevacizumab and temsirolimus/everolimus,37 however genetic analysis showed that while PI3K pathway alterations were associated with a significant improvement in objective response rate (31% vs 0%) they were not associated with an improved clinical benefit rate (44% vs 45%). Detailed analysis of this trial data showed an improvement in overall survival for the MpBC patients, and suggests that MpBC histology is an indicator for doxorubicin with bevacizumab and everolimus/temsirolimus.38 A lone MpBC participant in the BELLE-4 Phase II/III trial responded well to a combined therapy of paclitaxel and the PI3K inhibitor buparlisib39 although toxicity was noted, and indeed buparlisib was subsequently discontinued from development, with a significantly higher burden of adverse effects noted for buparlisib than alpelisb in the B-YOND (hormone receptor positive, phase Ib) trial.40 Pre-clinical data in MpBC patient derived xenograft models suggest that a combination of PI3K and MAPK inhibitors may be a potential avenue for therapy in PIK3CA mutated MpBC patients.41

CDK4/6 inhibitors (eg, ribociclib, palbociclib, abemaciclib) are now approved as standard of care for advanced, hormone receptor positive breast cancers, however this proliferation check-point may also be a useful target in TNBC, and trials are underway to determine the efficacy of this approach (reviewed in42), including in combination with immune checkpoint inhibitors (PAveMenT: NCT04360941). A recent case report demonstrated a dramatic but short-term benefit from combined dabrafenib and trametinib in an advanced MpBC patient.43 Dabrafenib and trametinib target BRAF and MEK signalling, respectively, and their application in MpBC has not previously been reported.

Although a pre-clinical study did not support the efficacy of PARP inhibitor olaparib in an MpBC-like mouse model,44 given the recent evidence of a dominant HRD signature in almost 50% of the MpBC profiled,26 the suggestion by Tray et al45 that PARP inhibition for MpBC needs further study is certainly warranted. These studies together support further investigations into a range of targeted therapies and highlight their potential value in MpBC.

The potential benefit of therapeutic modulation of the immune system in breast cancer is becoming increasingly clear for TNBC, as well as MpBC. A case report of a remarkable, durable response to pembrolizumab (anti-PD-1) in combination with nab-Paclitaxel in advanced, pre-treated spindled MpBC was reported in 2017.46 A similar combination of durvalumab (anti-PD-L1) and paclitaxel was also shown to provide a sustained, complete response in a second case report of advanced MpBC, this time with squamous features.47 In this case, 20% of tumor cells stained with medium intensity (clone SP142), and there was an absence of staining in the TILS; while in the former case, 100% of tumor cells stained positively for PD-L1 using the 22C3 clone. Indeed, there is no standardized definition criteria for PD-L1 staining at this stage, and the characterization of expression of this and other immune checkpoint markers across TNBC and MpBC has only recently emerged. As shown in Table 3, heterogeneity in percentage positivity of PD-L1 in tumor cells is reported across TNBC, with a higher rate of positivity consistently reported for MpBC. MpBC tumor cells show a range of PD-L1 expression from 17% to 80%, recording both cytoplasmic and membranous staining, and in the immune cells from 48% to 69%. Combinations of immune-checkpoint inhibitors are also being evaluated, with the DART (Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors, Table 2) trial facilitating an MpBC specific assessment.48 Primary endpoint data confirmed clinical activity of ipilimumab combined with nivolumab and resulted in 3 cases of 17 showing a durable response, which supports further investigation. It is hoped that trials such as the Morpheus-TNBC Phase 1/1b umbrella trial (Table 2, NCT03424005), will provide insights to further our understanding of the biomarkers and patient indicators for a range of immunotherapeutic interventions.

Table 3 PD-L1 Expression in Metaplastic Breast Cancer

The morphologically diverse metaplastic breast cancers account for significant global morbidity and mortality, in spite of their relatively rare frequency, due to their aggressive clinical course. As more molecular pathology data emerges on the genomic underpinnings of this intriguing tumor type, we are increasingly better placed to consider MpBC for targeted therapies and immunotherapies.

We apologize to those authors whose work we could not include due to space restrictions.

The authors report no conflicts of interest in this work.

1. Board WCoTE. Breast Tumours. Lyon, France: Interantional Agency for Research on Cancer; 2019.

2. Reis-Filho J, Gobbi H, McCart Reed A, et al. Metaplastic Breast Cancer. Board WCoTE, editor. Breast Cancer. Lyon, France: International Agency for Research on Cancer. 2019. 135138.

3. Schroeder MC, Rastogi P, Geyer CE, Miller LD, Thomas A. Early and Locally Advanced Metaplastic Breast Cancer: presentation and Survival by Receptor Status in Surveillance, Epidemiology, and End Results (SEER) 20102014. Oncologist. 2018;23(4):481488.

4. Lei T, Pu T, Wei B, et al. Clinicopathologic characteristics of HER2-positive metaplastic squamous cell carcinoma of the breast. J Clin Pathol. 2020.

5. Hennessy BT, Gonzalez-Angulo AM, Stemke-Hale K, et al. Characterization of a naturally occurring breast cancer subset enriched in epithelial-to-mesenchymal transition and stem cell characteristics. Cancer Res. 2009;69(10):41164124.

6. Taube JH, Herschkowitz JI, Komurov K, et al. Core epithelial-to-mesenchymal transition interactome gene-expression signature is associated with claudin-low and metaplastic breast cancer subtypes. Proc Natl Acad Sci U S A. 2010;107(35):1544915454.

7. Fougner C, Bergholtz H, Norum JH, Sorlie T. Re-definition of claudin-low as a breast cancer phenotype. Nat Commun. 2020;11(1):1787.

8. Ai D, Yao J, Yang F, et al. TRPS1: a highly sensitive and specific marker for breast carcinoma, especially for triple-negative breast cancer. Mod Pathol. 2020.

9. Rakha EA, Coimbra ND, Hodi Z, Juneinah E, Ellis IO, Lee AH. Immunoprofile of metaplastic carcinomas of the breast. Histopathology. 2017;70(6):975985.

10. Rakha E, Quinn CM, Pia Foschini M, et al. Metaplastic carcinomas of the breast without evidence of epithelial differentiation: a diagnostic approach for management. Histopathology. 2020. doi:10.1111/his.14290

11. McCart Reed AE, Kalaw E, Nones K, et al. Phenotypic and molecular dissection of Metaplastic Breast Cancer and the prognostic implications. J Pathol. 2019;247(2):214227. doi:10.1002/path.5184

12. Rayson D, Adjei AA, Suman VJ, Wold LE, Ingle JN. Metaplastic breast cancer: prognosis and response to systemic therapy. Ann Oncol. 1999;10(4):413419. doi:10.1023/A:1008329910362

13. Tzanninis I-G, Kotteas EA, Ntanasis-Stathopoulos I, Kontogianni P, Fotopoulos G. Management and Outcomes in Metaplastic Breast Cancer. Clin Breast Cancer. 2016;16(6):437443. doi:10.1016/j.clbc.2016.06.002

14. Sulaiman A, McGarry S, Han X, Liu S, Wang L. CSCs in Breast CancerOne Size Does Not Fit All: therapeutic Advances in Targeting Heterogeneous Epithelial and Mesenchymal CSCs. Cancers. 2019;11(8):8. doi:10.3390/cancers11081128

15. Zhang Y, Toy KA, Kleer CG. Metaplastic breast carcinomas are enriched in markers of tumor-initiating cells and epithelial to mesenchymal transition. Mod Pathol. 2012;25(2):178184. doi:10.1038/modpathol.2011.167

16. Gerhard R, Ricardo S, Albergaria A, et al. Immunohistochemical features of claudin-low intrinsic subtype in metaplastic breast carcinomas. Breast. 2012;21(3):354360. doi:10.1016/j.breast.2012.03.001

17. May CD, Sphyris N, Evans KW, Werden SJ, Guo W, Mani SA. Epithelial-mesenchymal transition and cancer stem cells: a dangerously dynamic duo in breast cancer progression. Breast Cancer Res. 2011;13(1):202. doi:10.1186/bcr2789

18. Nunes T, Hamdan D, Leboeuf C, et al. Targeting Cancer Stem Cells to Overcome Chemoresistance. Int J Mol Sci. 2018;19(12):12. doi:10.3390/ijms19124036

19. Yuan H, Chen J, Liu Y, et al. Association of PIK3CA mutation status before and after neoadjuvant chemotherapy with response to chemotherapy in women with breast cancer. Clin Cancer Res. 2015;21(19):43654372. doi:10.1158/1078-0432.CCR-14-3354

20. Mosele F, Stefanovska B, Lusque A, et al. Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol. 2020;31(3):377386. doi:10.1016/j.annonc.2019.11.006

21. Krings G, Chen -Y-Y. Genomic profiling of metaplastic breast carcinomas reveals genetic heterogeneity and relationship to ductal carcinoma. Mod Pathol. 2018;31(11):16611674. doi:10.1038/s41379-018-0081-z

22. Gonzalez-Martinez S, Perez-Mies B, Carretero-Barrio I, et al. Molecular features of metaplastic breast carcinoma: an infrequent subtype of triple negative breast carcinoma. Cancers. 2020;12(7):7. doi:10.3390/cancers12071832

23. Ng CKY, Piscuoglio S, Geyer FC, et al. The landscape of somatic genetic alterations in metaplastic breast carcinomas. Clin Cancer Res. 2017;23(14):38593870. doi:10.1158/1078-0432.CCR-16-2857

24. Hayes MJ, Thomas D, Emmons A, Giordano TJ, Kleer CG. Genetic changes of Wnt pathway genes are common events in metaplastic carcinomas of the breast. Clin Cancer Res. 2008;14(13):40384044. doi:10.1158/1078-0432.CCR-07-4379

25. Avigdor BE, Beierl K, Gocke CD, et al. Whole-Exome Sequencing of Metaplastic Breast Carcinoma Indicates Monoclonality with Associated ductal carcinoma component. Clin Cancer Res. 2017;23(16):48754884. doi:10.1158/1078-0432.CCR-17-0108

26. Moukarzel L, Ferrando L, Da Cruz Paula A, et al. The genetic landscape of metaplastic breast cancers and uterine carcinosarcomas. Mol Oncol. 2020. doi:10.1002/1878-0261.12813

27. Hennessy BT, Krishnamurthy S, Giordano S, et al. Squamous cell carcinoma of the breast. J Clin Oncol. 2005;23(31):78277835. doi:10.1200/JCO.2004.00.9589

28. Abouharb S, Moulder S. Metaplastic breast cancer: clinical overview and molecular aberrations for potential targeted therapy. Curr Oncol Rep. 2015;17(3):431. doi:10.1007/s11912-014-0431-z

29. El Zein D, Hughes M, Kumar S, et al. Metaplastic carcinoma of the breast is more aggressive than triple-negative breast cancer: a study from a single institution and review ofliterature. Clin Breast Cancer. 2017;17(5):382391. doi:10.1016/j.clbc.2017.04.009

30. Han M, Salamat A, Zhu L, et al. Metaplastic breast carcinoma: a clinical-pathologic study of 97 cases with subset analysis of response to neoadjuvant chemotherapy. Mod Pathol. 2019;32(6):807816.

31. Al-Hilli Z, Choong G, Keeney MG, et al. Metaplastic breast cancer has a poor response to neoadjuvant systemic therapy. Breast Cancer Res Treat. 2019;176(3):709716.

32. Cimino-Mathews A, Verma S, Figueroa-Magalhaes MC, et al. A clinicopathologic analysis of 45 patients with metaplastic breast carcinoma. Am J Clin Pathol. 2016;145(3):365372.

33. Hennessy BT, Giordano S, Broglio K, et al. Biphasic metaplastic sarcomatoid carcinoma of the breast. Ann Oncol. 2006;17(4):605613.

34. Nagao T, Kinoshita T, Hojo T, Tsuda H, Tamura K, Fujiwara Y. The differences in the histological types of breast cancer and the response to neoadjuvant chemotherapy: the relationship between the outcome and the clinicopathological characteristics. Breast. 2012;21(3):289295.

35. Aydiner A, Sen F, Tambas M, et al. Metaplastic breast carcinoma versus triple-negative breast cancer: survival and response to treatment. Medicine. 2015;94(52):e2341.

36. Moroney J, Fu S, Moulder S, et al. Phase I study of the antiangiogenic antibody bevacizumab and the mTOR/hypoxia-inducible factor inhibitor temsirolimus combined with liposomal doxorubicin: tolerance and biological activity. Clin Cancer Res. 2012;18(20):57965805.

37. Basho RK, Gilcrease M, Murthy RK, et al. Targeting the PI3K/AKT/mTOR pathway for the treatment of mesenchymal triple-negative breast cancer: evidence from a phase 1 trial of mTOR inhibition in combination with liposomal doxorubicin and bevacizumab. JAMA Oncol. 2017;3(4):509515.

38. Basho RK, Yam C, Gilcrease M, et al. Comparative Effectiveness of an mTOR-based systemic therapy regimen in advanced, metaplastic and nonmetaplastic triple-negative breast cancer. Oncologist. 2018;23(11):13001309.

39. Yang MH, Chen IC, Lu YS. PI3K inhibitor provides durable response in metastatic metaplastic carcinoma of the breast: a hidden gem in the BELLE-4 study. J Formos Med Assoc. 2019;118(9):13331338.

40. Lu YS, Lee KS, Chao TY, et al. A phase ib study of alpelisib or buparlisib combined with tamoxifen plus goserelin in premenopausal women with hr-positive her2-negative advanced breast cancer. Clin Cancer Res. 2020.

41. Coussy F, El Botty R, Lavigne M, et al. Combination of PI3K and MEK inhibitors yields durable remission in PDX models of PIK3CA-mutated metaplastic breast cancers. J Hematol Oncol. 2020;13(1):13.

42. Matutino A, Amaro C, Verma S. CDK4/6 inhibitors in breast cancer: beyond hormone receptor-positive HER2-negative disease. Ther Adv Med Oncol. 2018;10:1758835918818346.

43. Seo T, Noguchi E, Yoshida M, et al. response to dabrafenib and trametinib of a patient with metaplastic breast carcinoma harboring a braf v600e mutation. case rep oncol med. 2020;2020:2518383.

44. Henneman L, van Miltenburg MH, Michalak EM, et al. Selective resistance to the PARP inhibitor olaparib in a mouse model for BRCA1-deficient metaplastic breast cancer. Proc Natl Acad Sci U S A. 2015;112(27):84098414.

45. Tray N, Taff J, Adams S. Therapeutic landscape of metaplastic breast cancer. Cancer Treat Rev. 2019;79:101888.

46. Adams S. Dramatic response of metaplastic breast cancer to chemo-immunotherapy. NPJ Breast Cancer. 2017;3:8.

47. Al Sayed AD, Elshenawy MA, Tulbah A, Al-Tweigeri T, Ghebeh H. Complete response of chemo-refractory metastatic metaplastic breast cancer to paclitaxel-immunotherapy combination. Am J Case Rep. 2019;20:16301635.

48. Adams S, Othus M, Patel S, et al. Dual anti-CTLA-4 and anti-PD-1 blockade in metaplastic carcinoma of the breast: dart (SWOG S1609, Cohort 36). J Clin Oncol. 2020;38.

49. Afkhami M, Schmolze D, Yost SE, et al. Mutation and immune profiling of metaplastic breast cancer: correlation with survival. PLoS One. 2019;14(11):e0224726.

50. Bataillon G, Fuhrmann L, Girard E, et al. High rate of PIK3CA mutations but no TP53 mutations in low-grade adenosquamous carcinoma of the breast. Histopathology. 2018;73(2):273283.

51. Beca F, Sebastiao APM, Pareja F, et al. Whole-exome analysis of metaplastic breast carcinomas with extensive osseous differentiation. Histopathology. 2020.

52. Edenfield J, Schammel C, Collins J, Schammel D, Edenfield WJ. Metaplastic breast cancer: molecular typing and identification of potential targeted therapies at a single institution. Clin Breast Cancer. 2017;17(1):e1e10.

53. Joneja U, Vranic S, Swensen J, et al. Comprehensive profiling of metaplastic breast carcinomas reveals frequent overexpression of programmed death-ligand 1. J Clin Pathol. 2017;70(3):255259.

54. Ross JS, Badve S, Wang K, et al. Genomic profiling of advanced-stage, metaplastic breast carcinoma by next-generation sequencing reveals frequent, targetable genomic abnormalities and potential new treatment options. Arch Pathol Lab Med. 2015;139(5):642649.

55. Tray N, Taff J, Singh B, et al. Metaplastic breast cancers: genomic profiling, mutational burden and tumor-infiltrating lymphocytes. Breast. 2018;44:2932.

56. Vranic S, Stafford P, Palazzo J, et al. Molecular profiling of the metaplastic spindle cell carcinoma of the breast reveals potentially targetable biomarkers. Clin Breast Cancer. 2020;20(4):326331.

57. Zhai J, Giannini G, Ewalt MD, et al. Molecular characterization of metaplastic breast carcinoma via next-generation sequencing. Hum Pathol. 2019;86:8592.

58. Dave B, Gonzalez DD, Liu ZB, et al. Role of RPL39 in Metaplastic Breast Cancer. J Natl Cancer Inst. 2017;109:6.

59. Mittendorf EA, Philips AV, Meric-Bernstam F, et al. PD-L1 expression in triple-negative breast cancer. Cancer Immunol Res. 2014;2(4):361370.

60. Beckers RK, Selinger CI, Vilain R, et al. Programmed death ligand 1 expression in triple-negative breast cancer is associated with tumour-infiltrating lymphocytes and improved outcome. Histopathology. 2016;69(1):2534.

61. Dogukan R, Ucak R, Dogukan FM, Tanik C, Citgez B, Kabukcuoglu F. Correlation between the Expression of PD-L1 and Clinicopathological parameters in triple negative breast cancer patients. Eur J Breast Health. 2019;15(4):235241.

62. Morgan E, Suresh A, Ganju A, et al. Assessment of outcomes and novel immune biomarkers in metaplastic breast cancer: a single institution retrospective study. World J Surg Oncol. 2020;18(1):11.

63. Lien HC, Lee YH, Chen IC, et al. Tumor-infiltrating lymphocyte abundance and programmed death-ligand 1 expression in metaplastic breast carcinoma: implications for distinct immune microenvironments in different metaplastic components. Virchows Arch. 2020;24.

64. Kalaw E, Lim M, Kutasovic JR, et al. Metaplastic breast cancers frequently express immune checkpoint markers FOXP3 and PD-L1. Br J Cancer. 2020.

65. Chao X, Liu L, Sun P, et al. Immune parameters associated with survival in metaplastic breast cancer. Breast Cancer Res. 2020;22(1):92.

Read more:
[Full text] An Update on the Molecular Pathology of Metaplastic Breast Cancer | BCTT - Dove Medical Press

LEEDS, England--(BUSINESS WIRE)--4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) - a novel class of drug derived from the microbiome, today announces the appointment of Paul Maier as Non-Executive Director of the Board. Mr Maier will also be a member of 4D's Audit and Risk Committee and will serve as the Companys audit committee financial expert under SEC and Nasdaq rules.

With over 25 years of extensive senior operational, international and financial management experience in the pharmaceutical and biotechnology industry, Paul will be able to provide 4D pharma with invaluable insights as we continue to execute across our business both clinically and operationally, said Duncan Peyton, Chief Executive Officer of 4D pharma. Pauls strong track record will support our Board with additional perspective and expertise.

I am excited to join 4D pharmas Board and support its goals to establish a larger global presence while working to bring its differentiated approach and pipeline of Live Biotherapeutics to patients in need, said Paul Maier, Non-Executive Director of 4D pharma. I look forward to working with 4D and offering my experiences in transactional and operational strategy as the company continues to grow, catalyzed by 4Ds upcoming NASDAQ listing.

Mr. Maier has over 25 years of investor and public relations, operational, regulatory, and finance expertise in the healthcare industry. Mr. Maier was previously the Chief Financial Officer of Sequenom Inc., where he was responsible for raising over $360 million in equity and debt financings, expanding institutional sell side research analyst coverage, as well as overseeing and establishing internal financial infrastructure. Previously, he was Senior Vice President and Chief Financial Officer of Ligand Pharmaceuticals (NASDAQ: LGND) where he helped build Ligand from a venture stage company to a commercial, integrated biopharmaceutical organization, raising over $1 billion in equity and debt financings including a successful IPO, and helped negotiate multiple R&D and commercial partnerships and transactions. He has also acted as an independent financial consultant to life sciences companies. Mr. Maier is currently a Board member of Eton Pharmaceuticals, Inc, Biological Dynamics and International Stem Cell Corporation (OTCQB: ISCO). He holds an MBA from Harvard University and a BS in Business Logistics from the Pennsylvania State University.

Additional Disclosures Required under the AIM Rules for Companies

In accordance with Schedule 2(g) of the AIM Rules, Paul Victor Maier (aged 73) currently holds the following directorships:Eton Pharmaceuticals, IncBiological Dynamics, IncInternational Stem Cell Corp.

Previous directorships held in the past five years:Ritter Pharmaceuticals, Inc (Mar 2015 May 2020)Apricus Biosciences, Inc (May 2012 Jan 2019)Mabvax, Inc (June 2014 July 2018)

Paul Maier does not currently hold any ordinary shares in the Company.

Save as set out above there are no further disclosures pursuant to Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies in respect of the appointment of Paul Maier.

About 4D pharma

Founded in February 2014, 4D pharma is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform, MicroRx, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism.

4D pharma's Live Biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has six clinical programs, namely a Phase I/II study of MRx0518 in combination with KEYTRUDA (pembrolizumab) in solid tumors, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumors, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma (NCT03851250), a Phase II study of MRx-4DP0004 in patients hospitalized with COVID-19 (NCT04363372), and Blautix in Irritable Bowel Syndrome (IBS) (NCT03721107) which has completed a successful Phase II trial. Preclinical-stage programs include candidates for CNS disease such as Parkinson's disease and other neurodegenerative conditions. The Company has a research collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics for vaccines.

For more information, refer to http://www.4dpharmaplc.com.

Forward-Looking Statements

This press release contains "forward-looking statements." All statements other than statements of historical fact contained in this announcement, including without limitation statements regarding timing of the clinical trial are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the United States Securities Exchange Act of 1934, as amended (the "Exchange Act"). Forward-looking statements are often identified by the words "believe," "expect," "anticipate," "plan," "intend," "foresee," "should," "would," "could," "may," "estimate," "outlook" and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company's current expectations, beliefs and assumptions concerning future developments and business conditions and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates.

All of the Company's forward-looking statements involve known and unknown risks and uncertainties, some of which are significant or beyond its control, and assumptions that could cause actual results to differ materially from the Company's historical experience and its present expectations or projections. The foregoing factors and the other risks and uncertainties that affect the Company's business, including the risks of delays in the commencement of the clinical trial and those additional risks and uncertainties described the documents filed by the Company with the US Securities and Exchange Commission (SEC), should be carefully considered. The Company wishes to caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any of its forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise, except to the extent required by law.

Additional Information about the Transaction and Where to Find it

This press release is being made in respect of a proposed business combination involving 4D and Longevity. Following the announcement of the proposed business combination, 4D filed a registration statement on Form F-4 (the Registration Statement) with the SEC which was declared effective on February 25, 2021. This press release does not constitute an offer to sell or the solicitation of an offer to buy or subscribe for any securities or a solicitation of any vote or approval nor shall there be any sale, issuance or transfer of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The Registration Statement includes a prospectus with respect to 4Ds ordinary shares and ADSs to be issued in the proposed transaction and a proxy statement of Longevity in connection with the merger. The proxy statement/prospectus has been mailed to the Longevity shareholders on or about February 26, 2021. 4D and Longevity also plan to file other documents with the SEC regarding the proposed transaction.

This press release is not a substitute for any prospectus, proxy statement or any other document that 4D or Longevity may file with the SEC in connection with the proposed transaction. Investors and security holders are urged to read the Registration Statement and, when they become available, any other relevant documents that will be filed with the SEC carefully and in their entirety because they will contain important information about the proposed transaction.

You may obtain copies of all documents filed with the SEC regarding this transaction, free of charge, at the SECs website (www.sec.gov). In addition, investors and security holders will be able to obtain free copies of the Registration Statement and other documents filed with the SEC without charge, at the SECs website (www.sec.gov) or by calling +1-800-SEC-0330.

Participants in the Solicitation

Longevity and its directors and executive officers and other persons may be deemed to be participants in the solicitation of proxies from Longevitys shareholders with respect to the proposed transaction. Information regarding Longevitys directors and executive officers is available in its annual report on Form 10-K for the fiscal year ended February 29, 2020, filed with the SEC on April 30, 2020. Additional information regarding the participants in the proxy solicitation relating to the proposed transaction and a description of their direct and indirect interests is contained in the Registration Statement.

4D and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of Longevity in connection with the proposed transaction. A list of the names of such directors and executive officers and information regarding their interests in the proposed transaction is included in the Registration Statement.

Originally posted here:
4D Pharma Appointments Paul Maier to the Board as Non-Executive Director - Business Wire