Archive for October, 2021
BrainStorm to Present at the 2021 Cell & Gene Meeting on the Mesa – WSAZ-TV
Published: Oct. 4, 2021 at 6:00 AM EDT
NEW YORK, Oct. 4, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research, will deliver a presentation at the2021 Cell & Gene Meeting on the Mesa, being held as a hybrid conferenceOctober 12-14, and October 19-20, 2021.
Dr. Lindborg's presentation highlights the expansion of Brainstorm's technology portfolio to include autologous and allogeneic product candidates, covering multiple neurological diseases. The most progressed clinical development program, which includes a completed phase 3 trial of NurOwn in ALS patients, remains the highest priority for Brainstorm. Brainstorm is committed to pursuing the best and most expeditious path forward to enable patients to access NurOwn.
Dr. Lindborg's presentation will be in the form of an on-demand webinar that will be available beginning October 12. Those who wish to listen to the presentation are required to registerhere. At the conclusion of the 2021 Cell & Gene Meeting on the Mesa, a copy of the presentation will also be available in the "Investors and Media" section of the BrainStorm website underEvents and Presentations.
About the 2021 Cell & Gene Meeting on the Mesa
The meeting will feature sessions and workshops covering a mix of commercialization topics related to the cell and gene therapy sector including the latest updates on market access and reimbursement schemes, international regulation harmonization, manufacturing and CMC challenges, investment opportunities for the sector, among others. There will be over 135 presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering and broader regenerative medicine technologies.
The conference will be delivered in a hybrid format to allow for an in-person experience as well as a virtual participation option. The in-person conference will take place October 12-14 in Carlsbad, CA. Virtual registrants will have access to all content via livestream during program dates. Additionally, all content will be available on-demand within 24 hours of the live program time. Virtual partnering meetings will take place October 19-20 via Zoom.
About NurOwn
The NurOwntechnology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwntechnology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).
For more information, visit the company's website atwww.brainstorm-cell.com.
Safe-Harbor Statement
Statements in this announcement other than historical data and information, including statements regarding future NurOwnmanufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect,""likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwntreatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwntreatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwntreatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
ContactsInvestor Relations:Eric GoldsteinLifeSci Advisors, LLCPhone: +1 646.791.9729egoldstein@lifesciadvisors.com
Media:Paul TyahlaSmithSolvePhone: + 1.973.713.3768Paul.tyahla@smithsolve.com
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BrainStorm to Present at the 2021 Cell & Gene Meeting on the Mesa - WSAZ-TV
DTx Pharma to Present at the OIS Retina Innovation Showcase – Business Wire
SAN DIEGO--(BUSINESS WIRE)--DTx Pharma, Inc. (DTx), a privately-held biotechnology company creating novel RNA-based therapeutics to treat the genetic drivers of disease, announced that Dr. Arthur Suckow, Co-Founder and CEO, will present at the Ophthalmology Innovation Summits Retina Innovation Showcase on October 7, 2021, during the Annual Scientific Meeting of the American Society of Retina Specialists.
Dr. Suckow will make a presentation during the Spotlight on Cell and Gene Therapy session and discuss DTx Pharmas most advanced program for retinitis pigmentosa (RP). RP is a rare disorder that affects roughly 1 in 4,000 people, both in the United States and worldwide. People with the disease tend to initially develop night blindness, followed by total blindness, as a result of the death of their photoreceptor cells. No therapeutic options exist for this condition that can be caused by more than 300 mutations of 100 different genes.
DTx Pharmas proprietary FALCON (Fatty Acid Ligand Conjugated Oligonucleotide) delivery platform is designed to improve the efficacy of RNA therapies by using fatty acids as targeting ligands to enable the delivery of oligonucleotide therapies to tissues and cell types throughout the body. Using this novel technology platform, DTx Pharma can improve the cellular uptake of targeted RNA therapies and apply therapies to multiple cell types in the eye, with the goal of developing a gene agnostic therapy for RP.
There are no effective therapeutics for this debilitating disease. We look forward to presenting our preclinical data this week and to working with the experts in retinitis pigmentosa to evaluate a game-changing therapeutic in patients over the next several years, says Dr. Suckow.
About DTx Pharma
DTx Pharma, Inc. is a privately held biotechnology company based in San Diego, CA creating novel RNA-based therapeutics to treat the genetic drivers of disease. The companys proprietary delivery technology platform utilizes fatty acids as targeting ligands to enable the delivery of oligonucleotide therapies to tissues and cell types throughout the body. In preclinical studies, DTx has demonstrated cellular uptake and broad activity of oligonucleotides in the retina, muscle, heart, neurons, T cells, and other specialized cell types. To advance the FALCON platform toward and into clinical development, DTx has raised more than $100M in combined investment from several of the worlds leading healthcare investors including RA Capital Management and Access Biotechnology, pharmaceutical companies such as Eli Lilly and Company, the National Institute of Health (NIH), and research foundations such as the CMT Research Foundation (CMTRF). To learn more about DTx Pharma, please visit http://www.dtxpharma.com and follow DTx on LinkedIn and Twitter @DTxPharma.
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DTx Pharma to Present at the OIS Retina Innovation Showcase - Business Wire
Glioma subtype may hold the secret to the success of immunotherapies – Michigan Medicine
Bench-to-bedside
Armed with this knowledge, further experiments showed that giving G-CSF, which is already used clinically as an immune system booster in cancer patients to mice with non-mutant IDH1 also increased their survival. And giving it in combination with the immune-stimulating gene therapy had an even bigger impact.
The team also confirmed that patients who have gliomas with mutated IDH1 also have higher levels of G-CSF circulating in their blood a clue that the findings will be applicable beyond the mouse models.
The next step, says Lowenstein, will be to work on moving these findings into a clinical trial, building on the current, ongoing trial using the immunotherapy/gene therapy combination.
Our study shows two main things: Patients with the IDH1 mutation may benefit from immunotherapy due to the G-CSF their tumors are producing, he said. And patients without the mutation may benefit from combining treatment with G-CSF and immunotherapy.
Additional authors include Brandon L. McClellan, Ruthvik P. Avvari, Rohit Thalla, Stephen Carney, Margaret S. Hartlage, Santiago Haase, Maria Ventosa, Ayman Taher, Neha Kamran, Li Zhang, Syed Mohammed Faisal, Felipe J. Nez, Mara Beln Garcia-Fabiani, Wajd N. Al-Holou, Daniel Orringer, Jason Heth, Parag G. Patil, Karen Eddy, Sofia D. Merajver, Peter J. Ulintz, Joshua Welch, Chao Gao, Jialin Liu and Gabriel Nez all of U-M; Shawn Hervey-Jumper of University of California, San Francisco; and Dolores Hambardzumyan of the Tisch Cancer Institute, Mount Sinai School of Medicine, New York.
Funding for the work was provided by National Institutes of Health and National Institute of Neurological Disorders & Stroke (R37-NS094804, R01-NS105556, R21- NS107894, R01- NS076991, R01-NS082311, R01-NS096756; the U-M Department of Neurosurgery; the Pediatric Brain Tumor Foundation, Leahs Happy Hearts Foundation, Ians Friends Foundation, Chad Tough Foundation, Pediatric Brain Tumor Foundation, and Smiles for Sophie Forever Foundation, National Cancer Institute (T32-CA009676), American Brain Tumor Association Basic Research Fellowship and a Rogel Cancer Center Scholar Award.
Paper cited: G-CSF secreted by mutant IDH1 glioma stem cells abolishes myeloid cells immunosuppression and enhances the efficacy of immunotherapy, Science Advances. DOI: 10.1126/sciadv.abh3243
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Glioma subtype may hold the secret to the success of immunotherapies - Michigan Medicine
Viral Vectors and Plasmid DNA Manufacturing Market 2021; Growing Number of Gene Therapy Candidates, Coupled with their Rapid Progression through…
DUBLIN, September 30, 2021--(BUSINESS WIRE)--The "Viral Vectors And Plasmid DNA Manufacturing Market Size By Product Type, By Application, By End Product, By Geographic Scope And Forecast" report has been added to ResearchAndMarkets.com's offering.
The Global Viral Vectors and Plasmid DNA Manufacturing Market was valued at USD 583.71 Million in 2020 and is projected to reach USD 1,866.90 Million by 2028, growing at a CAGR of 15.40% from 2021 to 2028.
A growing number of patients opting for gene therapy is a major factor propelling the growth of the Viral Vectors and Plasmid DNA Manufacturing market. Gene therapy is a leading field in medical science, which promises new treatment development for patients suffering from various disease. Genetically modified therapies have emerged as a promising treatment approach for various diseases (primarily ones that currently have no cure), including inherited disorders and certain viral infections. Demand for plasmid DNA is rising steeply because of a boom in gene therapy development.
This report provides an all-inclusive environment of the analysis for the Viral Vectors And Plasmid DNA Manufacturing Market. The market estimates provided in the report are the result of in-depth secondary research, primary interviews and in-house expert reviews. These market estimates have been considered by studying the impact of various social, political and economic factors along with the current market dynamics affecting the Viral Vectors And Plasmid DNA Manufacturing Market growth.
Along with the market overview, which comprises of the market dynamics the chapter includes a Porter's Five Forces analysis which explains the five forces: namely buyers bargaining power, suppliers bargaining power, threat of new entrants, threat of substitutes, and degree of competition in the Viral Vectors And Plasmid DNA Manufacturing Market. It explains the various participants, such as system integrators, intermediaries and end-users within the ecosystem of the market. The report also focuses on the competitive landscape of the Viral Vectors And Plasmid DNA Manufacturing Market.
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The report will provide a valuable insight with an emphasis on the global market including some of the major players such as Merck KGaA, Lonza, FUJIFILM Diosynth Biotechnologies U.S.A., Inc., Cobra Biologics Ltd., Brammer Bio, Waisman Biomanufacturing, Genezen, YPOSKESI, Advanced BioScience, Laboratories, Inc. (ABL, Inc.), Novasep Holding S.A.S, ATVIO Biotech Ltd, and Others.
Key Topics Covered:
1 Introduction
2 Research Methodology
3 Executive Summary
3.1 Market Overview
3.2 Global Viral Vectors and Plasmid DNA Manufacturing Market Regional Insights
3.3 Global Viral Vectors and Plasmid DNA Manufacturing Market Geographical Analysis
3.4 Global Viral Vectors and Plasmid DNA Manufacturing Market, by Product Type
3.5 Global Viral Vectors and Plasmid DNA Manufacturing Market, by Application
3.6 Global Viral Vectors and Plasmid DNA Manufacturing Market, by End Product
3.7 Future Market Opportunities
3.8 Global Market Split
4 Market Outlook
4.1 Global Viral Vectors and Plasmid DNA Manufacturing Market Outlook
4.2 Market Drivers
4.2.1 Increasing Number of Patients Opting for Gene Therapy
4.2.2 Rising Prevalence of HIV/Aids and Growing R&D Funding from Several Organizations
4.3 Restraints
4.3.1 Manufacturing Challenges Pertaining to Large Scale Production of Vectors
4.4 Opportunities
4.4.1 Growing Healthcare Infrastructure and Government Support
4.4.2 Growing Number of Gene Therapy Candidates, Coupled With Their Rapid Progression Through Various Phases of Clinical Development
4.5 The Impact of Covid-19
4.6 Porters Five Force Model
4.7 Product Life Line
5 Market, by Product Type
5.1 Overview
5.2 Viral Vector
5.3 Plasma DNA
5.4 Non-Viral DNA Vectors
6 Market, by Application
6.1 Overview
6.2 Cancer
6.3 Inherited Disorder
6.4 Infectious Diseases
6.5 Others
7 Market, by End Product
7.1 Overview
7.2 DNA Vaccines
7.3 Gene Therapy
7.4 Immunotherapy
7.5 Others
8 Market, by Geography
8.1 Overview
8.2 North America
8.3 Europe
8.4 Asia-Pacific
8.5 Row
9 Competitive Landscape
10 Company Profiles
For more information about this report visit https://www.researchandmarkets.com/r/cnmete
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ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210930005708/en/
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Viral Vectors and Plasmid DNA Manufacturing Market 2021; Growing Number of Gene Therapy Candidates, Coupled with their Rapid Progression through...
Celsion Corporation Adds Key Resources to its Vaccine Development Initiative and Clinical Trial Capabilities – Yahoo Finance
LAWRENCEVILLE, N.J., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, announces the strengthening of its management team with a new hire and a promotion in its vaccine development program, and the hiring of a veteran clinical trial project manager for its Phase II GEN-1 immunotherapy study in advanced ovarian cancer. These changes all are effective immediately and are as follows:
Carlo Iavarone, Ph.D. joins as Senior Director, Non-Clinical Research
Subeena Sood, Ph.D. promoted to Senior Manager, Biology and Preclinical Studies
Beth J. Llewellyn joins as Director of Clinical Operations
Dr. Iavarone will serve as project leader for the PLACCINE vaccine initiative. He will be based in Huntsville, Ala. and brings to Celsion more than 15 years of experience investigating and leading the development of vaccines, including molecular target identification and characterization of RNA vaccines. Most recently, from 2019 until 2021 he was a science advisor for both Guidepoint and Clora, providing input for a viral target and RNA vaccine delivery system. Dr. Iavarone joined GlaxoSmithKline in 2015 as a senior scientist studying small molecules and RNA vaccines in animal and human cell lines. From 2007 until 2015 he held positions of increasing responsibility at Novartis, including as a principal scientist for a melanoma vaccine project.
Dr. Iavarone has authored more than 15 papers on oncology and vaccine research that were published in peer-reviewed journals. He holds a Ph.D. in Molecular Pathology and Physiopathology from Federico Il University in Naples, Italy, and did his post-doctoral work at Novartis in Siena, Italy.
Dr. Sood is responsible for assay development and in vivo experiments for the PLACCINE DNA vaccine and gene therapy program, and also is based in Huntsville. She has experience with several pharmaceutical companies in experiment design, pharmacological and biochemical assays, manufacturing process design and development, and optimization and implementation of Quality by Design. Dr. Sood joined Celsion as manager of animal research in 2019, where she has designed and conducted all preclinical research. Prior to Celsion, since 2017 she was a Formulation Scientist II at Novocol Healthcare. From 2016 to 2017 Dr. Sood was a Research Associate II at Nektar Therapeutics, and from 2015 to 2016 she was a Quality Control Chemist I at Par Pharmaceuticals. She also worked in regenerative medicine as a Research Fellow at Medstar Heart Institute, Washington Hospital Center in Washington, D.C. from 2010 to 2013.
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Dr. Sood has authored more than 25 articles published in peer-reviewed journals, mainly in the area of cardiology and oxidative stress. She received her Ph.D. in Pharmacology from the All India Institute of Medical Sciences in New Delhi, and was a post-doctoral associate at the Baylor College of Medicine.
Ms. Llewellyn is responsible for the management of the ongoing Phase II OVATION 2 Study with GEN-1 in advanced ovarian cancer and will be based at our corporate office in Lawrenceville. Previously she was the President of 2L Pharma, a clinical operations consulting firm she founded in 2014. Her work included preparing protocols for Investigational New Drug submissions to the U.S. Food and Drug Administration, clinical trial site qualification and compliance and functioning as a liaison between clinical trial sites, contract research organizations and study sponsors. From 2011 to 2014 she was a Clinical Operations Management Consultant for Alba Therapeutics with oversight for all clinical activities related to a Phase IIb protocol investigating the use of a novel pharmaceutical agent for celiac disease. From 2010 to 2011 she was a Clinical Research Associate for Nabi Biopharmaceuticals, where she was responsible for providing in-house and field study monitoring, operational guidance and general assistance for multiple protocols investigating the use of a novel vaccine.
Ms. Llewellyn has been involved in over 30 clinical trials in a variety of therapeutic areas including oncology and infectious disease. She received a B.A. in psychology from Ohio University. Her graduate training in experimental psychology included studies in research design and statistical analysis.
As we continue to advance the development of our PLACCINE DNA-mediated vaccine platform and or Phase II study of GEN-1, we are delighted to deepen our bench strength with these talented and experienced professionals, said Michael H. Tardugno, Chairman, President and Chief Executive Officer of Celsion. Dr. Iavarone brings impressive clinical development experience particularly in RNA vaccines, which is so important Celsions work to develop a SARS-CoV-2 vaccine utilizing a DNA plasmid that encodes for multiple viral antigens.
Dr. Sood has been instrumental in the successful development of assays used to evaluate biological activity of our first generation of vaccines. She has proven herself to be a capable scientific leader, whose expertise will be relied upon as we complete our preclinical work to establish proof of concept using for the PLACCINE platform Covid-19 as a benchmark vaccine.
Lastly, as we advance our Phase 2 study with GEN-1 in advanced ovarian cancer, we welcome Ms. Llewellyn to Celsion. She is charged with ensuring that trial enrollment proceeds as planned, and we are confident she will capably address any protocol issues that might arise, Mr. Tardugno continued. Overall, we believe that with this strengthened team we are better able to realize the promise of Celsions technologies for the benefit of patients and our stockholders.
About Celsion Corporation
Celsion is a fully integrated, clinical stage biotechnology company focused on advancing a portfolio of innovative cancer treatments, including immunotherapies, DNA-based therapies and directed chemotherapies through clinical trials and eventual commercialization. The companys product pipeline includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer. ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, is under investigator-sponsored development for several cancer indications. Celsion also has two feasibility stage platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies. Both are novel synthetic, non-viral vectors with demonstrated capability in nucleic acid cellular transfection. For more information on Celsion, visit http://www.celsion.com.
Forward-looking Statements
Forward-looking statements in this news release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon current beliefs, expectation, and assumptions and include statements regarding the platform having the potential to provide broad protection against coronavirus disease 2019 (COVID-19), and possible future mutations of SARS-CoV-2 or other coronaviruses. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of the Companys platform to provide broad protection against COVID-19, and possible future mutations of SARS-CoV-2 or other coronaviruses, the issuance of a patent to the Company for use of its technology platform for treating or preventing infection with the SARS-CoV-2 virus that causes COVID-19, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in the Celsion's periodic filings with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
Celsion Investor ContactJeffrey W. ChurchExecutive Vice President and CFO609-482-2455jchurch@celsion.com
LHA Investor RelationsKim Sutton Golodetz212-838-3777kgolodetz@lhai.com
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Celsion Corporation Adds Key Resources to its Vaccine Development Initiative and Clinical Trial Capabilities - Yahoo Finance
Taysha Gene Therapies Receives Orphan Drug Designation from the European Commission for TSHA-101 for the Treatment of Infantile GM2 Gangliosidosis -…
DALLAS--(BUSINESS WIRE)--Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, today announced that it has been granted orphan drug designation from the European Commission for TSHA-101, an AAV9-based bicistronic gene replacement therapy in development for GM2 gangliosidosis, also called Tay-Sachs or Sandhoff disease.
GM2 gangliosidosis is a fatal neurodegenerative disease caused by deficiency in the lysosomal enzyme -hexosaminidase A, also known as Hex A. The prognosis is devastating, with infantile forms often leading to death within the first four years of life and juvenile onset patients rarely surviving beyond mid-teens, said Suyash Prasad, MBBS, M.Sc., MRCP, MRCPCH, FFPM, Chief Medical Officer and Head of Research and Development of Taysha. Residual Hex A activity correlates with the severity of GM2, and based on our understanding of this correlation, small increases in Hex A activity are likely to lead to significant improvements in clinical outcomes and quality of life. Based on dose-dependent improvements in survival in preclinical models, we are highly encouraged that our novel bicistronic gene therapy approach with TSHA-101 has the potential to be a life changing therapy for patients suffering from this rapidly progressive disorder with no current treatment options.
GM2 gangliosidosis is a rare and fatal monogenic lysosomal storage disorder that is part of a family of neurodegenerative genetic diseases that includes Tay-Sachs and Sandhoff diseases. The disease is caused by defects in the HEXA or HEXB genes that encode the two subunits of the -hexosaminidase A (Hex A) enzyme. These genetic defects result in progressive dysfunction of the central nervous system. Residual Hex A enzyme activity determines the severity of the disease. The infantile form of the disease has an onset of symptoms usually before six months of age with residual Hex A enzyme activity of less than 0.1%. Juvenile onset occurs between 1.5 and five years of age with residual Hex A enzyme activity of approximately 0.5%. Early adult onset of the disease has residual Hex A enzyme activity of between 2% to 4%. There are no approved therapies for the treatment of the disease, and current treatment is limited to supportive care.
TSHA-101 is an investigational gene therapy that delivers the HEXA and HEXB genes that make up the -hexosaminidase A enzyme. The two genes are driven by a single promoter within the AAV9 bicistronic vector ensuring that the 2 sub-units of Hex A are produced in a one-to-one ratio within each cell, which is important to ensure efficient production of the transgene. TSHA-101 is the first and only bicistronic vector currently in clinical development and has been granted Orphan Drug and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA). TSHA-101 is administered intrathecally and is currently being evaluated in a single arm, open-label Phase 1/2 clinical trial for the treatment of infants with GM2 gangliosidosis sponsored by Queens University. Preliminary clinical safety and biomarker data are expected by year-end 2021.
The European Commission grants orphan drug designation for medicines being developed for the diagnosis, prevention or treatment of treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union. Orphan designation in the European Union includes benefits such as protocol assistance, reduced regulatory fees and market exclusivity.
About Taysha Gene Therapies
Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available at http://www.tayshagtx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as anticipates, believes, expects, intends, projects, and future or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning the potential of our product candidates, including TSHA-101, to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, TSHA-101s eligibility for accelerated approval in the United States and Europe, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed, and the potential market opportunity for these product candidates. Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (SEC) filings, including in our Annual Report on Form 10-K for the full-year ended December 31, 2020, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, both of which are available on the SECs website at http://www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.
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Taysha Gene Therapies Receives Orphan Drug Designation from the European Commission for TSHA-101 for the Treatment of Infantile GM2 Gangliosidosis -...
Ottawa biotech startup Virica gets multimillion-dollar funding injection for gene therapy-boosting technology – Ottawa Business Journal
An Ottawa biotech startup has raised millions of dollars to scale up its technology that aims to supercharge production of a key component in emerging gene therapies for cancer and other diseases.
Virica Biotech announced the series-A round, which was led by New York-based Dynamk Capital, on Monday. The company did not reveal the exact value of the deal, which is expected to close later this year with additional contributions from follow-on investors, but co-founder and CEO Jean-Simon Diallo said it was a multimillion-dollar investment.
Founded in 2018, Virica Biotech makes specialized compounds that help boost production of viral vectors, which deliver material into infected cells thats designed to fix defective genes responsible for diseases such as cancer and hereditary blindness.
Diallo used a cooking analogy to describe the process, likening viral vectors to kernels of popcorn that need the catalyst his firm provides to rapidly reproduce.
If you dont apply some heat, youre going to get maybe a few popped kernels, but thats it, he said. Adding our (product) basically allows you to fully pop the popcorn. Were kind of supercharging the microwave, if you will.
Diallo began working on the technology alongside pioneering Ottawa Hospital cancer researcher Dr. John Bell a decade ago as a way to help cancer-fighting viruses bypass the human immune systems defences.
When financing proved hard to come by due to the lengthy approvals process for such therapies, Diallo found another use for the compound that didnt require the same stringent testing: an additive to boost the effectiveness of traditional vaccines that contain virus particles.
Investors soon took note, and the company raised nearly a million dollars in seed funding by early 2020, just as the pandemic triggered a worldwide R&D effort to develop a new vaccine against COVID-19.
While his compound doesnt work on mRNA vaccines that have widely used in the fight against the coronavirus, Diallo says the pandemic gave his firm a proverbial shot in the arm nonetheless.
It forced us to get set up very quickly, he explained. There was certainly a lot of interest in the technology. COVID kind of got us moving. We realized that the opportunity for improving the manufacturing yield of gene therapies in particular was quite enormous.
Diallo says Virica now has contracts with more than 20 manufacturers of gene therapies that hope his products will make their treatments cheaper and more effective.
The firms revenues have more than doubled in the past 18 months, and Diallo expects Viricas headcount to grow from 16 to at least 30 by next year as demand for its technology ramps up. In addition, he says he still sees a big upside in the vaccine market, which now accounts for about 15 per cent of the firms sales.
Historically, the vaccine industry has always been very slow to move, he said. Hopefully, (the COVID) crisis will change things a little bit for the better because everybody had to kind of roll up their sleeves and innovate.
Virica was initially based out of Bayview Yards as part of Invest Ottawas pre-accelerator program. But the growing startup struggled to find suitable lab space in the region until the new Ottawa of Ottawa Health Innovation Hub helped it secure a 3,000-square-foot facility at the University of Ottawa Heart Institute that officially opened this week.
Diallo, a biochemistry professor at uOttawa and a senior scientist at the Ottawa Hospital Research Institute, said he considered moving the company to Montreal and Toronto. He called on the citys business and political leaders to beef up support for biotech ventures like his that are in the early stages of commercializing their products.
We were really glad to be able to stay in Ottawa, Diallo said. There is a biotech sector in Ottawa, it is growing and we need to work together to foster it. Otherwise, people like me are going to leave. Its that simple.
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Ottawa biotech startup Virica gets multimillion-dollar funding injection for gene therapy-boosting technology - Ottawa Business Journal
Global Nucleic Acid Therapeutics CDMO Market to Reach $4463.7 Million by 2030 – ResearchAndMarkets.com – Business Wire
DUBLIN--(BUSINESS WIRE)--The "Nucleic Acid Therapeutics CDMO Market - A Global and Regional Analysis: Focus on Product, Technology, and End User - Analysis and Forecast, 2021-2030" report has been added to ResearchAndMarkets.com's offering.
The global nucleic acid therapeutics CDMO market was valued at $1,546.4 million in FY2020 and is estimated to reach $4,463.7 million by 2030.
The completion of human genome sequencing and the elucidation of the molecular pathways that are critical in the disease molecule interaction have offered an unprecedented opportunity and growth for the development of nucleic acid-based therapeutics. However, to keep with the manufacturing and development of such therapies, the pharmaceutical companies have established partnerships with the contract development and manufacturing company (CDMO) which are the viable alternatives to the in-house development of the drugs. Moreover, the success of the respective business model has also led these CDMOs to become an integral part of such pharmaceutical companies' value chain.
The increasing willingness to outsource drug development to the CDMOs, and the rising need for pharmaceuticals have resulted in the expansion of the global market for nucleic acid therapeutics CDMO.
In the past decade, there has been a vast increase in the amount of gene sequence information that has the potential to revolutionize the way diseases are categorized and treated. Traditional diagnoses, largely anatomical or descriptive in nature, are likely to be superseded by the molecular characterization of the disease. The fact that certain genes drive key disease processes will also enable the rational design of gene-specific therapeutics. Antisense oligonucleotides represent a technology that can play multiple roles in this process. Further, at present, there are 16 nucleic acid therapies approved by the FDA and EMA and many more in the pipeline implying the reliance and acceptance over the usage of such therapies in the market.
Market Growth Drivers
Market Challenges
Market Opportunities
Key Questions Answered in this Report:
Key Topics Covered:
1 Markets
1.1 Industry Outlook
1.2 Product Definition
1.3 Global Nucleic Acid Therapeutics CDMO Market Footprint, ($ Million), 2020-2030
1.4 Current Nucleic Acid Therapeutic CDMOs Landscape
1.5 Significant Usage of Nucleic Acid in Therapeutics
1.6 Types of Nucleic Acid Synthesized for Therapeutics
1.7 Market Dynamics
1.7.1 Market Drivers
1.7.1.1 Accelerating Shift of the Pharmaceutical Market Toward Innovative Biologic and Cell and Gene Therapy Products
1.7.1.2 Reduction in Overall Manufacturing Cost at CDMOs
1.7.1.3 Rising Approvals of Nucleic Acid Therapeutics
1.7.2 Restraints
1.7.2.1 Lack of Expertise in Nucleic Acid Manufacturing
1.7.2.2 Supply Chain and Logistical Challenges
1.7.2.3 Difficult Therapeutic Classification Due to Wide Variety of Nucleic Acids
1.7.3 Opportunities
1.7.3.1 Increasing Outsourcing Trend Among Pharmaceutical Companies
1.7.3.2 Accelerating Research and Development Along with Technology
1.7.3.3 Growth in Developing Countries
2 Competitive Landscape
3 Chemical Synthesis Method
4 Technology
5 End-User
6 Products
7 Regions
8 Markets - Competitive Benchmarking & Company Profiles
For more information about this report visit https://www.researchandmarkets.com/r/1x5210
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
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Global Nucleic Acid Therapeutics CDMO Market to Reach $4463.7 Million by 2030 - ResearchAndMarkets.com - Business Wire
Alcohol Is the Breast Cancer Risk No One Wants to Talk About – WIRED
Martinez had never organized a social media campaign and doesnt consider herself social media savvy. But after ARG won the $100,000 grant, she was running focus groups, coordinating an advisory group of cancer organizations, building a team of co-investigators and partnering with the ARG communications specialist. The young women made it very clear they did not want to be told what to do, Martinez says of the focus groups. Drink less for your breasts felt more like a helpful suggestion.
Planning for the social media campaign began just as the pandemic forced a national shutdown. As the pandemic dragged on, alcohol consumption rose, especially among women. Days of heavy drinking among women, defined as four or more drinks within a couple of hours, rose by 41 percent, according to a survey by the RAND Corporation. (The study compared a baseline survey of 1,540 adults conducted in the spring of 2019 with their responses during a follow-up in the spring of 2020.)
But pushing back against alcohol consumption isnt simple. As the US found during a disastrous prohibition period from 1920 to 1933, opposing alcohol is not popular. When Sharima Rasanayagam,chief scientist for Breast Cancer Prevention Partnersin San Francisco, gives talks about environmental causes of breast cancer, her audience is raptuntil she mentions alcohol. People like to drink and they dont like to hear that, she says. She tells them that quantity matters: At the very least, drink less.
Its a message she delivers with care, to avoid giving women a reason for self-blame if they develop breast cancer and wonder Why me? Cases of breast cancer cant be tied to alcohol alone, because many factors, including genetics and environmental exposures, contribute to the disease, she explains in a YouTube video linked to the Breast Cancer Prevention Partners website. But Rasanayagam notes that risks add upand alcohol is one that women can reduce. Fewer drinks, whether over time or in one day, mean less exposure to acetaldehyde and potentially less effect on estrogen. Its been shown that the less you drink, the lower your risk, she says. (Breast Cancer Prevention Partners is an advisor to the Drink Less for Your Breasts campaign.)
Its a nuanced message but, in its own way, a bold one, as framed in a social media campaign, says David Jernigan, an alcohol policy expert at Boston University, who has been working in the field for 35 years. What Priscilla is doing in California is groundbreaking, he says.
Jernigan asserts that the harm from alcoholwhich also includes drunk driving and an association with violencewarrants a large-scale response similar to anti-tobacco efforts. He notes that in Estonia, a campaign urging Lets drink less by half! actually lowered per capita consumption by 28 percent. (Estonias alcohol policy also included restrictions on advertising, more enforcement of driving-under-the-influence laws, higher taxes, and a focus on treatment.)
The World Health Organization is also developing a global action plan; the current draft sets a goal of reducing per capita consumption by 20 percent by 2030 (with 2010 consumption levels as the baseline). It urges nations to develop and enforce high-impact policy options, such as higher alcohol taxes, restrictions on advertising, and emphasizes awareness of health risks.
Jernigan calls that effort a good step that doesnt go far enough. He favors the development of an international treaty on alcohol, similar to the Framework Convention on Tobacco Control, the first such negotiated through the World Health Organization. It has been signed by 168 countries that committed to taking steps to restrict tobacco advertising, raise cigarette taxes, and prevent youth smoking.
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Alcohol Is the Breast Cancer Risk No One Wants to Talk About - WIRED
Why Black Women Are Twice as Likely to Die of Endometrial Cancer and What MSK Is Doing to Change It – On Cancer – Memorial Sloan Kettering
When Linda Collins was diagnosed with endometrial cancer in her early 60s, she wanted to find the best treatment possible.
After doing her research, she felt confident she would receive the care she needed at Memorial Sloan Kettering Cancer Center.
She also knew what she needed to give her peace of mind. When I called the MSK Patient Access Service to ask about an appointment, I told them that as a Black woman, I would feel more comfortable with a female doctor who is a person of color.
She explains that years before, I had a white, male gynecologist who dismissed concerns that I had. Respectfully, it seemed like he couldnt be bothered. And I have great insurance!
Linda searched the MSK website and knew she had found the doctor she hoped for in Carol Brown, a gynecologic oncology surgeon and MSKs Chief Health Equity Officer.
Dr. Carol Brown, gynecological oncology surgeon
Dr. Brown has devoted her career to improving cancer disparities that mean some groups of people suffer far worse outcomes, particularly Black people.
In May 2021, she launched an important new initiative as the leader of the Endometrial Cancer Equity Program (ECEP).Endometrial cancer develops in the lining of the uterus (womb) and is also sometimes referred to as uterine cancer.
The programs goals are to educate Black women about endometrial cancer, help those diagnosed find appropriate care, and ultimately find treatments to improve outcomes for all women facing the disease, like Linda.
The numbers are truly shocking.
Black women are nearly twice as likely to die of endometrial cancer as white women, even though the disease is actually slightly more common in white women than in Black women.
The number of cases of endometrial cancer is also on the rise, with the greatest increase among Black women.
Dr. Brown stresses that many factors play a role in the troubling disparity in endometrial cancer, including poorer access to health care in some communities, a lack of awareness among some providers, and research efforts that often have not included enough people who are Black, Hispanic, and Asian.
Dr. Brown says research also suggests another important factor may be a cruel twist of biology.
Dr. Brown points out that the disparity in survival between Black and white women diagnosed with endometrial cancer hasnt changed in four decades. Theres no question that if the difference was only about access to health care, the disparity would have at least narrowed. Thats what weve seen happen in cervical cancer and most forms of breast cancer, when you compare Black and white women. But not endometrial cancer.
One distinction coming into clearer focus is that Black women are more often diagnosed with rare but aggressive forms of endometrial cancer.
Black women are more likely to have papillary serous carcinoma of the endometrium as well as carcinoma sarcoma, Dr. Brown says. Cancers caused by these two types of cancer cells definitely lead to worse outcomes and that in itself is a biologic difference.
Ying Liu is a medical oncologist whose specialty is the genetic component of gynecological cancers. She works alongside Dr. Brown investigating cancer disparities.
Dr. Liu explains that one aspect we are looking at is whether these biological differences in the kinds of cancer more commonly found in Black women are not as well targeted by current treatments. That may explain some of the disparity in survival rates between Black and white patients.
The ultimate goal of research at MSK is to better understand these biological differences in endometrial tumors, down to the molecular level, and then use this knowledge to identify weaknesses in the tumors that are more common in Black women. Then, its about finding therapies to treat them.
Dr. Brown explains at MSK we probably have one of the largest groups of Black female patients in the country where we can analyze the genetics of their endometrial cancer tumors as well as their personal genetics.
Lindas diagnosis was an aggressive papillary serous carcinoma, the type that more commonly affects Black women. Fortunately, the cancer was caught at an early stage.
Linda recalls that within days of our first appointment, Dr. Brown performed a laparoscopic hysterectomy, which involves a much smaller incision, and also removed my fallopian tubes, ovaries, and nearby sentinel lymph nodes. To reduce the chance the cancer could come back, Linda underwent a short course of radiation.
Linda says of her treatment, the staff was just fantastic. And I love Dr. Brown. She was so proactive and always took the time to answer all my questions.
Today, Linda is doing the things she loves. She is a pillar of her community in the Bronx, serving as president of her building association, leading clothing drives for homeless shelters, and serving as a liaison with police associations, among other efforts.
After a 32-year career, most of it in government, she says I just love to serve people.
She also wanted to be sure she was around for her family, retiring from the working world in her mid-50s. She explains as a Black woman, you have the sense that your life expectancy might not be as long as the next person.
Dr. Brown and her colleagues hope their new initiative can help.
Since May 2021, the ECEP has participated in community events that have reached more than 500 women in predominately Black neighborhoods that stretch across Long Island, Brooklyn, and Queens.
In addition, Dr. Brown and colleagues including MSK nurse practitioner Latasha Anderson-Dunkley have screened over 20 women at high risk who have been identified through the ECEP. The goal is to assess whether the women have cancer or precancerous conditions and get them appropriate care.
Dr. Brown says its particularly important that women and their providers are aware of endometrial cancer because as cases rise, the symptoms of the disease are not always clear cut.
Traditionally, providers have focused on symptoms that include bleeding in post-menopausal women, who often have other symptoms such as obesity and diabetes, she explains. But this cancer can present as just a heavier-than-usual period bleeding in your 40s. Thats true of all women and particularly Black women.
For Linda, making women aware of how they can protect their health is just what the doctor ordered. To me, outreach and education is so important, because you dont know what you dont know. Too often, this kind of outreach doesnt happen in communities of color. But if it does, it can save lives.
Key Takeaways
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Why Black Women Are Twice as Likely to Die of Endometrial Cancer and What MSK Is Doing to Change It - On Cancer - Memorial Sloan Kettering
Murder Island review a contest to solve the killing of a young woman? Bad timing – The Guardian
Its possible that the timing is not propitious for the launch of a new entertainment series centred on the investigation of a young womans murder. The outrage surrounding the conviction of a serving Metropolitan police officer for the rape and killing of Sarah Everard, and the visibility it has given to the endemic violence against women, is a hurdle to overcome. Channel 4s six-part offering Murder Island also has a further point of connection with the case and the context. One of its participants is former chief superintendent Parm Sandhu, who last week gave an interview to Radio 4s World at One about her experience in the Met. She discussed female officers unwillingness to report sexist and misogynist behaviour for fear that the men will close ranks, and said that the fear that most women police officers have got is that when you are calling for help, you press that emergency button on your radio, theyre not going to turn up and youre going to get kicked in the street.
On the other hand, the vulnerability of women to rapists and murderers is not exactly new information and it hasnt curbed appetites for its exploitation as entertainment before now. So maybe this is by the by. Plus, Murder Islands USP is that it is a new genre a hybrid drama/reality show that keeps the involvement of police proper to a minimum. Instead, four pairs of amateur detectives will compete to solve a murder mystery written by Ian Rankin, about the stabbing of Charly Hendricks in a cottage on a remote Scottish island by a person or persons unknown. One team will be eliminated at each stage of the investigation the winners get a 50,000 prize.
Put like that, I am even less sure than I was that this counts for rather than against the new venture.
Context aside, how does the new format fare? The reality show element sings its customary siren song, giving us competitors spanning the full range of capability. At one end of the spectrum are Andrew and Nick, ambitious, articulate and with the lean, hungry look of leopards on the prowl. Andrews father and grandfather were detectives and he is hoping genetics will out. Although they have to be warned like the rest about making assumptions rather than gathering evidence and seeing what it tells them, they seem to have a basic grasp of procedure and, when it comes to assessing timelines and comparing testimonies, logic. If you had money and cared enough, you would bet on them to win.
At the other end there are Dot and Rox, who have to be told not to stand in the blood pool at the crime scene. They became friends when they worked in the same pub, and reckon they know how to read people. This will be very useful once we move to an all-intuition criminal justice system, but, as things stand, makes them merely extremely fun to watch. Told off by Simon Harding, one of the former detectives who is overseeing and evaluating the teams, for taking more photos of the processed crime scene than he would take on holiday, they wonder aloud how boring his holidays must be.
As we cut between the reality show scenes, full drama scenes play out with the fictional characters. As the competitors travel around the village interviewing Charlys friends, acquaintances and other people of interest played by actors, a story builds of a proposed development on the island that is cleaving the community, Charlys activism on behalf of those against the scheme and a possible love triangle between her, Jean the shopkeeper and particularly dour local Hamish. There is also a pregnancy, mysterious events in the far-flung land of Glasgow that have yet to be fully uncovered and the pubs owner Toby looks shifty to us all.
The goal of all hybrid genres is to double the value of watching. On most occasions, however, it simply halves it because neither contribution is fully developed and each undercuts the others momentum. Murder Island, judged on the first episode, falls into the latter camp. Things may improve as teams are eliminated, allowing the hour to tighten up. It will help, too, if the interactions between the detectives and the actors become less stagey and awkward as they relax into the situation and its strange demands.
How much context matters, of course, is up to us.
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Murder Island review a contest to solve the killing of a young woman? Bad timing - The Guardian
One Major Effect Vitamin D May Have in Preventing Breast Cancer, New Study Suggests | Eat This Not That – Eat This, Not That
One question to startOctober: Are you getting enough Vitamin D?The benefits from Vitamin D seem never-ending, and now a new women's health study may point to yet one more. Biology researchers in a region with an "elevated risk of breast cancer" have zeroed in on a specific link between the disease and a nutritional deficiency.
Keep reading to learn more about the possible link between breast cancer and Vitamin D. Also, readThe #1 Best Juice to Drink, Says Nutritionist.
In a new issue of the peer-reviewed journal, Nutrition and Cancer, three genetics and biochemistry researchers in Pakistan have published a new study, in which they state, "Pakistani females are at elevated risk of breast cancer."
They also note that Vitamin D deficiency is "an ignored contributing factor" to the illness, "despite a strong association."
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The study included 154 women who had been diagnosed with breast cancer, and 248 selected at random for the control group.
The researchers note that out of these 402 women, 51.5% "were completely ignorant of their [Vitamin D] level." Between the women who weren't aware of their Vitamin D intake versus those who held some awareness, the researchers noted higher incidence of breast cancer among those who were entirely uncertain.
RELATED:These Foods May Increase Your Breast Cancer Risk, Says New Study
Upon analysis, the team discovered a couple insightful trends. They found that women ages 41 to 50 years old were most prone to a Vitamin D deficiency.
Interestingly, women in cities were 12% more likely to suffer a Vitamin D deficiency than women who lived in rural areas.
A possible explanation for this may be greater outdoor exposure to sunlight, which triggers the body to produce Vitamin D. Perhaps more importantly, the higher Vitamin D levels among rural woman might highlight the importance of having access to fresh, nutritious foods, thanks to their proximity to agriculture.
RELATED:The #1 Way to Tell If You Need More Vitamin D, Says Dietitian
The researchers state: "It was concluded that [Vitamin D] deficiency is a highly contributing factor for breast cancer so every female must be aware of the importance of [Vitamin D] and should maintain a sufficient level of this crucially important vitamin."
For more Vitamin D wisdom, readSimple Ways to Avoid Vitamin D Deficiency, Say Experts.
Also, keep reading:
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One Major Effect Vitamin D May Have in Preventing Breast Cancer, New Study Suggests | Eat This Not That - Eat This, Not That
Wisconsin Dairy Expo: Faye and Faroh finish first at the International Brown Swiss Show – Wisbusiness.com
MADISON, WIS. Cutting Edge Thunder Faye was crowned the Grand Champion Female at the International Brown Swiss Show at World Dairy Expo. Faye won the Aged Cow, Six-Year-Old & Over Class before taking the Senior Champion Female title. Faye was also awarded the $1,000 Udder Comfort Grand Champion Cash Award, the Alan Hetts Memorial Trophy, the Vid Vye Memorial Trophy and the Swiss Bell. Following Faye, the Reserve Grand Champion Female was won by Cutting Edge F Faroh-ETV. Faroh won the Senior Three-Year-Old Class before winning Intermediate Champion Female. Both Faye and Faroh are owned by Ken Main and Kenny Joe Manion of Copake, New York.
Reserve Senior Champion Female honors were awarded to Iroquois Acres Jong Cali, the second-place Aged Cow Six-Year-Old & Over Class exhibited by Matthew Pacheco of Kerman, California. Reserve Intermediate Champion Female, Siegrets Damian Pinapple, was second place in the Senior Three-Year-Old Cow Class and was shown by Leslie & Linda Bruchey of Westminster, Maryland.
Pit-Crew Formula Tawny, leased by Abby Foss and owned by Pit-Crew Genetics of Cambridge, Minnesota, was the Junior Champion Female. Tawny was the winning Winter Yearling Heifer while the first-place Fall Heifer Calf, Wright-Way Famous Tik Tok-ET, exhibited by Landree & Dakota Fraley of Muncy, Pennsylvania, was named Reserve Junior Champion Female.
Elite Dairy 2 of Copake, New York was awarded Premier Breeder and was presented the Ira Inman Award. Winning both Premier Exhibitor and Premier Exhibitor of the Heifer Show, in addition to Premier Breeder of the Heifer Show, was Pit-Crew Genetics of Cambridge, Minnesota. Voelkers Td Carter was named Premier Sire and Premier Sire of the Heifer Show.
Official judge Lynn Harbaugh of Marion, Wisconsin, and associate judge Phillip Topp of Botkins, Ohio placed a total of 343 animals in the 2021 International Brown Swiss Show.
Complete class results can be found atworlddairyexpo.com.
Serving as the meeting place of the global dairy industry, World Dairy Expo brings together the latest in dairy innovation and the best cattle in North America. The dairy industry will return to Madison, Wis. for the 54thevent, September 28 October 2, 2021, when the worlds largest dairy-focused trade show, dairy and forage seminars, world-class dairy cattle show and more will be on display. Download the World Dairy Expo mobile event app, visitworlddairyexpo.comor follow WDE onFacebook,Twitter,LinkedIn,Spotify,InstagramorYouTubefor more information.
‘We’re Angry’: Medical Journal Apologizes for Referring to Biological Women with Trans-Inclusive Phrase – CBN News
The editor of a leading medical journal has apologized in the wake of outrage stemming from a recent cover of the publication referring to biological women as bodies with vaginas.
In the latest issue of The Lancet, the British-based journal featured a quote on the front cover from a peer-reviewed piece on the anatomy and physiology of bodies with vagina.
Richard Horton, editor-in-chief of the journal,issued a statementthis week in response to the backlash the publication faced for the terminology.
[W]e have conveyed the impression that we have dehumanized and marginalized women, he said. [I] apologize to our readers who were offended by the cover quote and the use of those same words in the review. At the same time, I want to emphasize that transgender health is an important dimension of modern health care, but one that remains neglected.
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Horton defended the article by stating the article in question calls for greater efforts to overcome the lack of knowledge and stigma too often associated with menstruation.
These are serious issues that demand serious actions, he explained. We encourage people to read the full review and support a growing movement against menstrual shame and period poverty.
Critics saw the terminology as demeaning and an erasure of the female experience.
David Curtis, an honorary professor of genetics, evolution, and environment at University College London,arguedits difficult to imagine why any medical researcher would want to submit their paper to The Lancet journal when they are happy to refer to women on their front cover with language which would be considered inappropriate even in a red light district.
Another critic, Claire Heuchan, an author who describes herself as a black radical feminist,condemned the characterizationas sexist and hypocritical, noting The Lancet has not referred to biological males as bodies with penises.
This framing makes it sound like a coincidence that bodies with vaginas have been neglected medicine, as if it were not the product of a discrimination and oppression specific to the female sex, she wrote. Medical misogyny exists and refusing to acknowledge women perpetuates it.
Dr. Jane Clare Jones, who classifies herself as a philosopher and a feminist, took issue with Hortons apology,writingshe is not offended, as the editor suggested.
Were angry with your colluding with the political erasure of women, she explained. Especially in a context when you are supposed to be rectifying that historic erasure.
The dustup over The Lancets description of women came the same week people on social media rebuked the left-leaning American Civil Liberties Unionfor censoring a pro-abortion quoteby the late U.S. Supreme Court Justice Ruth Bader Ginsburg.
In 1993, as part of her written responses to questions submitted during her Senate confirmation hearing, Ginsburg wrote: The decision whether or not to bear a child is central to a womans life, to her well-being and dignity. It is a decision she must make for herself. When government controls that decision for her, she is being treated as less than a fully adult human responsible for her own choices.
The ACLU, however, edited her quote to be more trans-inclusive by removing any reference to women or female pronouns.
***As the number of voices facing big-tech censorship continues to grow, please sign up forFaithwires daily newsletterand download theCBN News appto stay up-to-date with the latest news from a distinctly Christian perspective.***
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'We're Angry': Medical Journal Apologizes for Referring to Biological Women with Trans-Inclusive Phrase - CBN News
The 2021 winners: Cool Science Image Contest – University of Wisconsin-Madison
Ten images and two videos created by University of WisconsinMadison students, faculty and staff have been named winners of the 2021 Cool Science Image Contest.
A panel of nine experienced artists, scientists and science communicators judged the scientific content and aesthetic and creative qualities of scores of images and videos entered in the 11th annual competition. The winning entries showcase animals and plants, the invisibly small structures all around us, and stars and nebulae millions of millions of miles away.
An exhibit featuring the winners is open to the public at the McPherson Eye Research Institutes Mandelbaum and Albert Family Vision Gallery on the ninth floor of the Wisconsin Institutes for Medical Research, 111 Highland Ave., through December. A reception open to the public for the contest entrants will be held at the gallery on Oct. 7 from 4:30 to 6:30 p.m.
Winning submissions were created with point-and-shoot digital cameras, cutting-edge microscopes, and telescopes of both the backyard and mountaintop variety.
Because sometimes, theres no substitute for the visual.
An image often can convey meaning more effectively than words, says Ahna Skop, a longtime contest judge, artist and UWMadison professor of genetics and active ambassador for science. We know from marketing and education research that adding a picture with words to a slide increases retention of knowledge by 65 percent. The visual communication of science is critical for the transference of knowledge broadly.
Story continues after gallery
1 A winterover one of the two staff members who stay through the minus-100-degree Fahrenheit nights of Antarcticas coldest months hikes underneath the stars and aurora to the South Pole home of IceCube, a UWMadison-led neutrino telescope frozen in a cubic kilometer of ice.
Yuya Makino,assistant scientist, IceCube Neutrino Observatorydigital camera
2 The large holes in this cross-section of a stalk of desert stringybark, Eucalyptus arenacea, are conduits through the plant tissue that help researchers quantify the way the plant native to dry parts of Australia adapts to a new, wetter environment.
Kennah Konrad,undergraduate student, Botany;Duncan Smith,graduate student, Botanycompound microscope
3 Fluorescent antibodies highlight the extensive nervous system of a mouse heart. By creating maps of cardiac nerves with unprecedented accuracy, researchers can explore how those nerves influence heart function.
Rebecca Salamon,graduate student, Cell and Regenerative Biologyconfocal microscope
4 Messier 42, known as the Orion Nebula, is in the sword of the constellation Orion and is one of the brightest nebulae in the sky. At just 1,400 light-years away and 24 light-years across, it is one of the closest and largest regions of dense gas and dust in which stars are formed.
Jeffrey E. Shokler,associate director, Office of Undergraduate Advisingrefractor telescope and CCD camera
5 The carnivorous sundew plant snags insect meals with armloads of tentacles that it can move to tighten its grip and bog down prey in sticky secretions. The leaves roll up around a meal to facilitate digestion by enzymes and absorption of the nutrients.
Nisha Iyer,postdoctoral fellow, Wisconsin Institute for Discoverydigital camera
6 Mazes of tiny structures less than 15 billionths of a meter across and made of some of the smallest ribbons of graphene layers of carbon just a single atom thick ever fabricated represent an important step toward graphene-based telecommunications devices.
Joel Siegel and Margaret Fortman,graduate students, Physics;Jian Sun,graduate student, Materials Science;Jonathan Dwyer,PhD alumnus, Chemical Engineeringscanning electron microscope
7 A pair of mating dragonflies pause on the surface of a Minnesota pond. Dragonfly coupling begins with the male (with blue markings) gripping the female with claspers at the very end of his abdomen. To complete the act, the female will bend her abdomen underneath her body to meet the males abdomen and create a characteristic heart shape.
Shin-Tsz (Lucy) Kuoundergraduate student, Computer Science and Economicsdigital camera
8 White matter, the connective nerve tissue of the brain, has been colored according to the predominant orientation of fibers red, right-left; green, front-back; blue, up-down in different regions of the human brain to reveal pathways traversing the regions. Understanding white matter organization may offer insights into normal brain development as well as into the study of neurological disorders.
Jose Guerrero,postdoctoral fellow, Medical Physics;Andrew Alexander,professor, Medical Physics;Peter Ferrazzanoprofessor, Pediatricsmagnetic resonance imaging scanner
9 The yellow connecting arms, called axons, of diseased human brain cells grow willy-nilly across boundaries of inhibitory chemicals (the red stripes). Healthy axons would precisely follow the dark lanes, giving researchers the opportunity to test the effects of disease-causing mutations on axon growth.
Timothy Catlettgraduate student, Cell and Molecular Biology;Timothy Gomez,professor, Neuroscienceconfocal microscope
10 By varying the exact size and shape of these micrometer-wide, star-shaped pillars etched into a silicon wafer, researchers can carefully manipulate light passing through a lens to correct for aberrations that would otherwise focus different wavelengths of light on different points in space.
Gregory Holdman,graduate student, Physicsfocused ion beam and scanning electron microscope
Recurrent neural networks are the computing engines behind state-of-the-art applications from self-driving cars to speech recognition like Amazons Alexa. The behavior of these networks is challenging to characterize, but it can be visualized for small networks. This video displays the behavior of a network with just three neurons, showing the way their output evolves by mapping their values in blue. The result, a fractal structure called a strange attractor, could help researchers better understand the behavior and characteristics of these kinds of networks.
David J. Nowak, alumnus and auditing student; Robert D. Nowak, professor, Electrical and Computer Engineering
Captured at 20,000 frames per second, this video shows the shock-wave-induced mixture of two gasses raw imagery on the left; adjusted to better reflect concentration of the lighter gas on the right. Experiments like this are run in the 9-meter-tall Wisconsin Shock Tube, depicted at left, to simulate and explore mixing at the interface of materials in extreme conditions like nuclear fusion, supernovae and hypersonic propulsion.
Josh Herzog, postdoctoral fellow, and Professor David Rothamer, both of Mechanical Engineering; Riccardo Bonazza, professsor, Engineering Physics
Continued from above gallery
There can be an ineffable sort of something that makes a particularly effective science image its the Cool in Cool Science Image Contest but the good ones have much in common.
Youll know it when you see it. Its like seeing Starry Night or the Mona Lisa for the first time, in person. They hit you deep and quickly, Skop says. They are beautiful to the eye, simple, and convey meaning. Some images just take your breath away.Looking deeper they exquisitely communicate the secrets of science beautifully.
The Cool Science Image Contest recognizes the technical and creative skills required to capture images or videos that capably reveal something about science or nature while also leaving an impression with their beauty or ability to induce wonder. The contest is sponsored by Madisons Promega Corp., with additional support from the UWMadison Division of the Arts.
Winning entries are shared widely on UWMadison websites, and all entries are showcased at campus science outreach events and in academic and lab facilities around campus throughout the year. Because there was no opportunity to show off the 2020 contest winners in-person, this years exhibit is a double-feature for both the 2020 and 2021 contests. See last years winners.
The contest judges were:
Steve Ackerman, professor of atmospheric and oceanic sciences and vice chancellor for research and graduate education
Terry Devitt, emeritus director of research communications, University Communications
Kevin Eliceiri, director, Laboratory for Optical and Computational Instrumentation
Michael King, visual communications specialist, College of Agricultural and Life Sciences
Steve Paddock, former scientist, Molecular Biology
Kara Rogers, science writer and editor, Encyclopedia Britannica
Ahna Skop, professor of genetics
Kelly Tyrrell, director of research communications, University Communications
Craig Wild, videographer, University Communications
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The 2021 winners: Cool Science Image Contest - University of Wisconsin-Madison
Bear incidents are rising in the North Bay. Biologists sent in a wildlife tracker to find out why – San Francisco Chronicle
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Meghan Walla-Murphy stooped to examine a twisted pile of dried poop, obscured by golden grass on an arid ridge in eastern Napa County. It may have belonged to one of the feral pigs that run rampant in the area. Or it may have been evidence of black bears, whose presence in Wine Country appears to be on the rise.
Walla-Murphy picked it up for a closer look.
No undigested identifiers, she said. Probably pig. She set it down and kept hiking.
Walla-Murphy, 46, is an ecological consultant and wildlife tracker who lives in western Sonoma County. Two years ago, she started the North Bay Bear Collaborative, an effort to bring together state wildlife experts, land managers, property owners, nonprofits, tribes and researchers for discussions about cultivating a bear culture in California.
On a recent survey near Atlas Peak in Napa County, Walla-Murphy and a pair of volunteers found 13 signs of bear scat and claw marks on the trunk of an oak.
Volunteer Alan Studley holds what appears to be a charred deer skull found in the slopes of Foss Valley.
The bears are here in the North Bay now, Walla-Murphy said. So, how do we figure out how to live with them?
Incidents involving black bears are escalating in the mountainous areas of Napa, Sonoma and Marin counties, and state wildlife biologists want to know why. Nuisance reports have jumped from an average of about 67 per year from 2010 to 2016 to more than 200 last year and upward of 200 so far this year, according to the California Department of Fish and Wildlife.
Sightings reported to the department have also climbed significantly in the past decade. One of the creatures was even spotted two years ago sauntering through downtown Napa highly unusual behavior.
A running theory is that the rise signals the southern expansion of a large black bear population in Mendocino and Humboldt counties, which could portend more bear-human encounters to come in the greater Bay Area.
If the bears are getting pushed toward the Bay Area, thats their southern limit. Theres real potential for human-wildlife conflicts, said Stacy Martinelli, a wildlife biologist at Fish and Wildlife. Were trying to understand whats going on, so we can make some management decisions before that happens.
Ecological consultant Meghan Walla-Murphy (left) of Sonoma County leads volunteers on a hunt for bear scat in the hills above Foss Valley in Napa County.
First, they need to know how many bears are roaming around.
In decades past, wildlife managers divined population estimates from the number of unique bear teeth provided by hunters and aerial surveys via helicopter crude, imperfect tactics at best. Estimates from Fish and Wildlife put the state black bear population at 30,000 to 40,000 in 2016, up from 10,000 to 15,000 in 1992. Activity around Lake Tahoe, the unofficial black bear capital of California where the animals live about one per square kilometer, is fairly well documented, but its a mystery most everywhere else.
We really dont know as much as we should know about whats happening with bears in different places around the state, Martinelli said.
In the past two years, Fish and Wildlife has embarked on a study that uses genotyping to identify and sex individual black bears in the North Bay by their DNA. Its a relatively new and much less disruptive method that has helped the state more accurately monitor populations of deer, elk and the Sierra Nevada red fox, which was recently listed as an endangered species.
State biologists hope to eventually track bears movements and plot their home ranges as well, which could help the North Bays rural residents better prepare to coexist with their furry new neighbors. Bears have been known to show up at vineyards this time of year to munch ripe grapes off the vine and suck down water from irrigation ponds.
This approach hinges, in part, on the expertise of Walla-Murphy and participation from the bear collaboratives volunteers: The biologists need DNA samples, and the best way to get them is by finding bear excrement. Another way to gather DNA is by setting out hair snares in bear territory designed to snag fur from the animals. But that involves the labor-intensive process of lugging bales of barbwire into remote areas.
Meghan Walla-Murphy hikes into Foss Valley in Napa County during a recent scat survey.
For the past year, Walla-Murphy has orchestrated volunteer surveys in Sonoma, Napa and Marin, and collected hundreds of scat specimens. The samples are processed at UC Davis and logged into a growing database of individuals with identifiers such as Sonoma Female 1 as well as their locations. The more samples Walla-Murphy and her revolving group of volunteers collect, the clearer the picture of bear activity becomes.
With a robust flow of these data points, we can study reproductions, survival, their space use and if theyre concentrating, say, near places where people are leaving their trash out, said Ben Sacks, a UC Davis professor of mammalian genetics who is handling the DNA analysis. There is tremendous potential for these noninvasive genetic methods and a lot of untapped applications.
A deeper dive into the scat specimens could illuminate the bears diets and show whether a given female is pregnant, Sacks said. But thats beyond the scope of the current study. For now, the goal is to get an accurate count and a snapshot of where theyre ranging.
Several factors could be pushing more black bears south toward the Bay Area: drought, food shortages, wildfires or just steady growth of a healthy population.
Usually its not one reason, its multiple reasons, Martinelli said.
Back on the scat hunt in Napa, Walla-Murphy led two volunteers across a ridgeline above Foss Valley, a narrow avenue largely given over to grape-growing, which partially burned in the Glass Fire last year. Amid the blackened landscape, new plant life was emerging: Wildflowers blossomed, and bright, leafy tufts of oak resprouted from charred root crowns.
Walla-Murphy has surveyed this area for years and noticed that the fire didnt chase away the bears for long, like one might have assumed. The animals were present before the fire and returned almost immediately afterward.
Wildlife tracker Meghan Walla-Murphy (second from right) and two volunteers look across vineyards in Napa Countys Foss Valley. The North Bays black bear population is growing.
The fires are often creating more food forage-ability for bears, Walla-Murphy said. We see deer and foxes and bobcats come back right away as well. The animals know how to live with fire.
Within that simple observation is an insight Walla-Murphy hopes will steer the direction of bear management in California: A more natural landscape supports more natural animal behavior, which makes living with wildlife easier for humans.
If we can really begin to steward and tend our landscapes better so that theres more diversity and theyre regenerative and they have more forage for wildlife, that ideally will keep the bears in their natural habitat rather than pushing them into cities for food, she said.
Gregory Thomas is The San Francisco Chronicles editor of lifestyle a outdoors. Email: gthomas@sfchronicle.com Twitter: @GregRThomas
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Bear incidents are rising in the North Bay. Biologists sent in a wildlife tracker to find out why - San Francisco Chronicle
Pune-based J K Trust to soon attain 100 IVF pregnancies from Gir cow Samadhi – The Indian Express
Samadhi, a cow, is likely to become the proud mother of 100 calves with the application of in-vitro fertilisation. At Phaltan in Satara district, farmer Dayaram Thengil, is overjoyed that eight surrogate cows from his herd, are carrying the pregnancies through IVF of Samadhi, a Gir cow.
Dr Shyam Zawar, chief scientist at J K Trust a city-based NGO working in the field of animal husbandry, which has set up a state-of-the-art in-vitro fertilisation-embryo transfer laboratory at Vadgaon Rasai told The Indian Express that a cow in its lifespan of 15-16 years will give birth to a maximum of 8-10 calves. Our lab was set up in 2016 to produce IVF embryos from elite indigenous cows such as Gir and Sahiwal, Zawar said. The cattle IVF and ET technology, which is being widely used around the world, can be customised and adapted to suit Indian climatic conditions, Zawar said.
The Trust has succeeded in establishing 74 IVF pregnancies from Samadhi in just 12 months and plans to reach 100 IVF pregnancies in the next two months.
Of these 74 IVF pregnancies, 30 IVF calves have already taken birth at various farms across the country, including Pune, Ahmednagar and Satara districts.
Of the 10 recipient cows, eight are confirmed pregnant and they are about to calve in a weeks time. The semen used for IVF was that of the famous Brazilian Gir bull namely Espanto, Zawar told The Indian Express.
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Dayaram, too, said he was amazed when eight of his cows were confirmed pregnant in such a short time. IVF is a reproductive technique where matured eggs are harvested from a female and fertilised with sperm in a laboratory. The fertilised egg is planted in the body of the female animal after 6-7 days when cell division starts. The embryo develops normally after its gestation period.
IVF is mostly used in bovine animals to plant an embryo of superior genetics into a surrogate mother. After the normal gestation period of nine months, the calves that are reared have the traits of the original mother and father. Normally, in such cases, the egg is harvested from an animal with proven milk yielding capacity and crossed with the sperm of a male whose mother has well documented genetics. Once fertilised, the zygote is planted in the womb of the surrogate mother, whose qualities the calf does not inherit.
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Pune-based J K Trust to soon attain 100 IVF pregnancies from Gir cow Samadhi - The Indian Express
Israeli group to research link between menstrual changes and COVID vaccines – Haaretz
A little over a week after S., 34, received her second vaccination against COVID, at a time when she was menstruating, she was surprised to discover that she had begun menstruating again.
It was strange because my period is as regular as a Swiss watch. At first, I didnt give it any thought, but two weeks later I got my period again for seven days. Two weeks after that, bleeding that lasted four days. It turned out that for almost six months there were more days when I bled than when I didnt. After I talked to my friends, I realized the phenomenon is much more widespread, she said.
Growing evidence from Israel and abroad is showing that the phenomenon extends much beyond S.s social circle. In February, shortly after women of childbearing age began receiving the second shot, many of them posted on social media that they were experiencing changes in their menstruation shortly after the shot, such as irregularity and increased bleeding. Other women reported that they had begun bleeding years after menopause.
The medical establishment could not explain the phenomenon or associate it with the vaccination, among other things because irregular menstruation is common and influenced by many factors. It is usually not considered exceptional. However, the mounting complaints and increased concern women were showing over taking the shots due to the phenomenon, has spurred the medical community to look into the matter. Preliminary research has been published in Britain and the United States, and the U.S. government has allocated $1.67 million for research on the subject.
Prof. Roni Maimon, chairman of the Israel Society of Obstetrics and Gynecology, is moving ahead on the first Israeli study of the subject. In terms of biochemistry and endocrinology, we havent found a connection between disruption of menstruation and the vaccination. However, because we live in an age of evidence-based medicine, we decided to look into the phenomenon among a large number of women in Israel, he said. The exact number of women who will participate in the study is not yet decided.
The Health Ministry said it doesnt have exact data on the extent of the phenomenon in Israel. It has received reports, but because the condition is common and does not require hospitalization, there is no way to know how common it was in the population [before the vaccinations] and whether it is now more common. The ministry said similar reports have been received by major healthcare agencies abroad, and that the phenomena appear to be temporary and carry no risk.
The issue has become a topic of discussion on social media in terms of whether to take the third shot. For example, on the Facebook page Medicine for Women in Israel, one woman wrote: The two first shots brought on my period early, and six months later I began to experience bleeding between periods and irregular periods, and at the moment they cant figure out why Im very undecided about the booster.
The matter has also raised concerns aboutpossible damage to fertility. As H., 39, told Haaretz: After the first and second shots I had some irregularities in my period . The doctor explained that its because the immunological system is connected to the hormonal system, and its not really dangerous. However, H. added, In June, I started trying to get pregnant by artificial insemination. When they started talking about the booster, I was in the middle of hormone treatment. I asked the doctor whether to get the booster, and he said he didnt recommend it, that if I got pregnant, I should take it only after they see a heartbeat. When the insemination didnt work, I took got the booster.
Based on the data that has been collected, the theory is that the symptoms are connected to the vaccination but that they apparently do not stem directly from a specific vaccination. Experts believe this is the immune systems response to various vaccinations, including those not based on mRNA, like those of Pfizer and Moderna.
Dr. Ido Solt, head of Maternal Fetal Medicine at Rambam Health Care Campus in Haifa, said that although the phenomenon is connected to vaccination, it is apparently insignificant because it appears with Pfizer, Moderna and other vaccinations even though they use a different method of immunization. The theory is that this is not about a specific component of the vaccine, but rather another manifestation of an immunological response, he said.
Solt added that the papillomavirus vaccine is also known to cause menstrual irregularity. At present, women of childbearing age who contracted COVID reported phenomena of this type, Solt said.
In light of this, the treatment policy is that if the changes go one for more than two or three periods, or if a woman in menopause begins to menstruate, the case is treated as if she had not been vaccinated, Solt explained.
Its true that the vaccination impacts menstruation and can cause bleeding, but there is no evidence that this harms menstruation or fertility, Solt added. He said the symptoms had been compared to occurrences in the general population and in clinics and no negative effect had observed.
Conclusions so far
In Britain, health care authorities and researchers have said that data collection in a published study was based on voluntary reporting by women, which makes it difficult to reach definitive conclusions. Different research approaches need to be used to examine the differences between vaccinated and unvaccinated women with these symptoms.
The study, published about two weeks ago in the medical journal BMJ examined more than 30,000 reports of women with irregular menstrual symptoms from the beginning of the vaccination drive and until September 2. Most of the women who reported irregularities said things returned to normal by their next period, according to the researchers, who are from the Imperial College School of Medicine and Westminster Hospital. Unplanned pregnancies occurred at similar rates among vaccinated and unvaccinated women, and pregnancy rates at fertility clinics were similar in vaccinated and unvaccinated women.
The research indicated that the symptoms appeared among women vaccinated with vaccines using different means of immunization. The study concluded that if there is a connection between vaccination and menstruation, it is not due to a specific component in the vaccine.
In response to the study, Dr. Joe Mountfield, vice chancellor of the Royal College of Obstetrics and Gynecology, was quoted as saying there is no proof that the temporary changes would impact a womans future fertility. He recommended that taking the vaccination was important especially if a woman was planning to get pregnant, because of the higher risk pregnant women run of contracting COVID.
The Israeli Fertility Association will be holdings its annual conference on Monday, at which the impact of the vaccination on male and female fertility will be discussed. Dr. Talia Eldar-Geva, head of endocrinology and genetics at Shaare Zedek Medical Center and a former head of the association said, There is still no work dealing with long-term effects on fertility, but in the short term, there is no difference in response to fertility treatments, the number of eggs or the quality of the fetuses among men and women who have been vaccinated.
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Israeli group to research link between menstrual changes and COVID vaccines - Haaretz
NIH awards Brown $10.8M to expand data-informed research to fight human disease – Brown University
PROVIDENCE, R.I. [Brown University] Five years after an $11.5 million federal grant launched the COBRE Center for Computational Biology of Human Disease at Brown University, the National Institutes of Health has awarded $10.8M in new funds to Brown to build on the centers early success.
The center a federal Center of Biomedical Research Excellence funded by the NIHs National Institute of General Medical Sciences uses sophisticated computer analyses to advance research aimed at understanding and fighting human diseases.
Director David Rand, a professor of biology at Brown, said the renewal funds will enhance the centers research infrastructure, enable strengthened collaboration among scientists working with computational and bioinformatics tools, and support four new research projects. Rand said there is a computational revolution happening in the biomedical sciences, as researchers need computational analyses to help them make sense of massive amounts of available data.
Even those working in wet labs or clinics who dont use computers in their daily work will at some point need assistance in analyzing complex data sets, he said.
Rand compared the current moment to the molecular biology revolution thats been changing science since the 1970s, when DNA cloning and sequencing became standard tools used by researchers across diverse fields. Computational analysis is bringing groups together today in a similar way, he said. For example, people working in engineering, computer science, basic biology and medicine will face situations where they need to convert data sets into information that can help them find solutions and answer questions. While their research projects are highly distinct, he said, the data analysis work shares common themes.
In addition to helping researchers with individual projects, we view the Center for Computational Biology of Human Disease as a vehicle for raising the level of computational ability for researchers in the community overall, Rand said.
To provide that service to COBRE project leaders and researchers across Brown, the center is home to a Computational Biology Core a group of four scientists, data analysts and software engineers who support data-intensive research. With the renewal grant, center leaders will work to build sustainable support for the group through continued funding to its scientists and support to ensure that four members are at the Ph.D.-level (past budget included support for two Ph.D.s and two masters-level scientists).
Everyone has large data sets and needs to convert these into useful information, and we aim to help people achieve that goal, Rand said. The center brings together researchers in the lab and clinic with exceptionally skilled and creative data scientists to turn data into information.
Funds from the grant will also support the research of junior faculty investigators and help position them to earn additional, longer-term funding for their work enabling them, Rand said, to build upon discoveries and continue their research while freeing up center funds to seed innovative new projects. With the initial $11.5 million from the NIH in the centers first phase, faculty projects at the Center for Computational Biology of Human Disease generated an additional $17.9 million in grants in areas of research such as human genomics, immunology and infectious disease, microbiome and machine learning approaches to complex genetics.
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NIH awards Brown $10.8M to expand data-informed research to fight human disease - Brown University
Tracerco secures subsea inspection for life extension project of over 18 risers in the Gulf of Mexico | Oil and Gas Technology – Oil & Gas…
Under the contract, Tracerco will deploy DiscoveryTM, a subsea computed tomography (CT) scanner designed for external scanning of pipelines and which operates along the same general principles as CT scanners used in hospitals.
As methods of oil and gas extraction have improved, many fields are still producing substantial quantities of oil and gas, and as such, operators are looking for methods to monitor and verify their risers condition to ensure ongoing integrity and extend their operational life. For life extension, regulators typically require a physical inspection to ensure the condition of the riser and CT, a technique which has an unparalleled ability to accurately and non-intrusively see through an item, can provide this information.
Technologies using CT such as DiscoveryTMprovide operators with valuable inspection data on the entire pipeline, spanning the range from product to coating and all areas in between. It is a non-intrusive external scanning technique and is easily capable of scanning through several inches of pipeline steel with no requirement to remove any protective coating, regardless of thickness and material.
Tracerco was the first company to develop a subsea CT system and still holds the fundamental patent for the concept of subsea CT scanning dating back to 2011, says Jim Bramlett, Commercial Manager North America for Tracerco, Over the years since, DiscoveryTMhas incorporated numerous additional patented innovations for optimizing the system.
DiscoveryTMwill be used to inspect the risers and determine whether they can be extended past their original design life by gathering real time data on a variety of integrity issues including pipeline corrosion, pitting and wall thinning. This will allow the operator to work with the local authorities to get their permit extended and potentially realise billions in continued revenues from the asset.
DiscoveryTMprovides the integrity insights to know the unknown enabling critical decisions regarding life extension to be made, continues Jim, and it does this while the risers are still in full operation. No need to interfere with production.
County moved to annex 10 years ago | News | athensreview.com – Athens Daily Review
News last week that after 20 years of an overcrowded courthouse, Smith County is purchasing property to build a new one, is a reminder of the move Henderson County made a decade ago.
After searching for years for the ideal space to put the overflow of Henderson County offices, Commissioners Court arrived with a solution. In February 2010, the county reached an agreement with Prosperity to purchase the building, with ideas of using it for offices and document-storage space. The cost was about $2.7 million.
In September 2011, the County Judge, County Clerk, Tax Assessor/ Collector, and other departments that had been in the Courthouse for nearly a century, relocated across South Prairieville Street to the Courthouse Annex, a 33,500 square-foot building that once housed the Prosperity Bank.
Then in October, Commissioners Court voted to begin holding meetings in the annex, first in a room next to the county judges office, then later in the larger County Courtroom that is used today.
Before deciding on the annex, the county discussed possible use of other properties that were available around the city and even looked at a site on Loop 7 North.
The bank building became vacant when Prosperity exited the property at the end of April 2011. Then, County Judge Richard Sanders, the County Commissioners, the IT Department and the Maintenance Office went to work getting the spacious structure ready for the move.
With space open in the courthouse, the county began moving out of the decaying annex building on North Palestine Street that held the tax office and the Texas Agri-Life Extension Office.
Not only did the move save the county money compared to other options, it also kept the county government presence downtown. Since then, downtown Athens has become a more vibrant area, with new businesses and the Texan Theater to draw people to the Central Business District.
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County moved to annex 10 years ago | News | athensreview.com - Athens Daily Review
Evolution sells Mt Carlton – Creamer Media’s Mining Weekly
PERTH (miningweekly.com) Gold miner Evolution Mining has struck a A$90-million agreement with fellow listed Navarre Minerals to sell its Mt Carlton gold mine, in Queensland.
Mt Carlton was Evolutions first development project and has generated excellent returns for shareholders since it was commissioned in 2013. With the company focussed on delivery of growth projects at the cornerstone assets in the portfolio, we believe now is the time to hand Mt Carlton over to an emerging gold producer who can focus on extending the operations mine life, said Evolution executive chairperson Jake Klein.
Under the terms of the agreement, Evolution would be paid an initial A$40-million on the completion of the transaction, comprising a cash component and up to A$20.4-million worth of Navarre shares.
Up to A$25-million will be payable on cumulative gold production milestones from Crush Creek with A$5-million payable upon achievement of 50 000 oz, A$5-million payable upon achievement of 100 000 oz and A$15-million payable upon achievement of 175 000 oz, while up to A$25-million will be in the form of a 5% gold price linked royalty where the average spot gold price is greater than A$2 250/oz in a given quarter.
The royalty is payable on production from both Mt Carlton and Crush Creek from July 2023 for up to 15 years.
The exposure we have retained will enable Evolution shareholders to benefit from the future success of the operation. Evolution would like to thank our employees, contractors, suppliers, the traditional custodians of the land the Birriah People, and the local community for their contribution to Mt Carltons success. We are confident that Navarre will be a great partner for those stakeholders in the future, said Klein.
Navarre on Tuesday told shareholders that the transaction would instantly transform the company into a self-funded gold producer with premier exploration assets across Victoria and Queensland.
Mt Carlton is a proven, high-margin operation and an attractive vehicle for Navarre to transition from gold exploration company to producer particularly given the Mt Carlton operations successful history of production and its potential for significant mine life extension, said Navarre MD Ian Hollland.
Under the transaction, Navarre will inherit a well-established operation and a highly experienced site operating team and workforce which we are confident will fit in with Navarres own culture and focus on potential for further discovery and resource addition.
To fund the initial A$40-million up-front purchase price, Navarre will undertake a fully underwritten placement consisting of some 533-million shares, at a price of 7.5c each, to raise up to A$40-million.
Evolution has agreed to participate in the equity raise, with the companys shareholding in Navarre capped at 19.9%, with the final shareholding to be determined after the equity raise has been concluded.
Navarre on Tuesday said that the balance of the placement proceeds would go towards associated transaction costs and general corporate purposes.
The Mt Cartlon transaction is subject to a number of conditions, including Navarre acquiring shareholder approval to conduct the share placement, and to issue shares to Evolution.
The Mt Carlton operations comprise an openpit and underground mine, and a 950 000 t/y processing plant situated on a tenement package of approximately 815 km2.
Future mining operations at Mt Carlton will be supplemented by the nearby Crush Creek deposit, which hosts an initial high grade resource containing 126 000 oz goldat 3.5 g/t from only nine months of concentrated drilling. This asset was acquired by Evolution in late 2020.
In the 2021 financial year, the Mt Carlton operations produced 58 371 oz of gold at an all-in sustaining cost (AISC) of A$1 937/oz, including A$19.6-million of net mine cash flow in the fourth quarter alone. The operationis expected to produce between 45 000 oz and 50 000 oz of gold in the 2022 financial year at an AISC of A$1 650/oz to A$1 700/oz.
Evolution on Tuesday said that the sale of Mt Carlton lowers group AISC by A$40/oz to between A$1 180/oz and A$1 240/oz and reduces 2022 production to between 670 000 oz and 725 000 oz. Sustaining and major capital also reduce by between A$2-million and A$8-million and between A$10-million and A$15-million respectively.
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Evolution sells Mt Carlton - Creamer Media's Mining Weekly
Adagio Therapeutics Announces New Data Highlighting the – GlobeNewswire
ADG20 Continues to be Well Tolerated in Healthy Volunteers with Prolonged Half-Life and Serum Virus Neutralization Activity Observed out to Six Months in Ongoing Phase 1 Study
Data from Quantitative Systems Pharmacology/Whole-Body Physiologically Based Pharmacokinetic Modeling Support Evaluation of 300 mg Intramuscular Dose of ADG20 Given as a Single Intramuscular Injection in Ongoing Phase 2/3 Studies
Data to be Presented During IDWeek 2021 and 19th Annual Discovery on Target Conference
WALTHAM, Mass., Sept. 29, 2021 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc., (Nasdaq: ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today announced new data from the companys COVID-19 antibody program. Updated, six-month data from its ongoing Phase 1 study of ADG20 in healthy participants and data validating the selection of the 300 mg intramuscular (IM) dose given as a single injection that is being evaluated in the companys ongoing global Phase 2/3 treatment (STAMP) and prevention (EVADE) clinical trials will be presented during four poster sessions at the Infectious Disease Society of Americas IDWeek 2021, being held from Sept. 29 Oct. 3, 2021. In addition, Adagios chief scientific officer, Laura Walker, Ph.D., will present a subset of the ADG20 Phase 1 data as well as background on the identification and optimization of this differentiated antibody clinical candidate in an oral presentation at the 19th Annual Discovery on Target Conference on Sept. 30, 2021.
The continued strength of the safety and pharmacokinetic data from our Phase 1 study is encouraging and further underscores the potential impact an antibody like ADG20 which was designed to be potent, broadly neutralizing and delivered as a single IM injection could have on people with or at risk of COVID-19, said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. These Phase 1 data combined with our dose selection strategy, which relied on our innovative modeling approach, have allowed us to initiate and advance our pivotal trials of ADG20 in the treatment and prevention of COVID-19. We anticipate these data will support an Emergency Use Authorization (EUA) application in the first quarter of 2022, which could enable us to bring an important treatment option to patients.
Phase 1 Trial UpdateAdagio is evaluating ADG20 in a Phase 1 randomized, double-blind, placebo-controlled single ascending-dose study to assess safety and tolerability, pharmacokinetics (PK), immunogenicity, and serum virus neutralizing activity of ADG20 ex vivo against SARS-CoV-2. Data from a six-month evaluation timepoint confirmed the extended half-life of ADG20, which approached 100 days based on data from the 300 mg IM dose that was given as a single injection. In addition, 50% serum virus neutralization titers at six months after a 300 mg IM dose of ADG20 were similar to observed peak titers with the mRNA-1273 vaccine and exceeded those achieved with the AZD1222 vaccine series. Importantly, ADG20 was well tolerated with no study drug-related adverse events (AEs), serious AEs, or injection-site or hypersensitivity reactions reported through a minimum of three months follow-up across all cohorts. Participants will continue to be followed through 12 months to assess safety and tolerability, PK, immunogenicity and serum virus neutralizing activity.
Phase 1 Poster Information: (633) Preliminary Results from a Phase 1 Single Ascending-Dose Study Assessing Safety, Serum Viral Neutralizing Antibody Titers (sVNA), and Pharmacokinetic (PK) Profile of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)
Dose Selection StrategyTo support dose selection for Adagios global Phase 2/3 STAMP and EVADE clinical trials, the company modified an existing quantitative systems pharmacology whole-body physiologically-based pharmacokinetic (QSP/PBPK) model to better characterize the PK of extended half-life monoclonal antibodies in serum and key sites of viral replication in the respiratory tract. Adagios model adequately a priori predicted the observed ADG20 serum PK in non-human primates (NHPs) and humans. The model was further optimized based on data from Adagios Phase 1 clinical trial and then applied for dose selection for STAMP and EVADE.
For the STAMP treatment trial, data compiled to date suggest that the 300 mg IM regimen has a projected ability to rapidly achieve and maintain target concentrations at key tissue sites of viral replication, including the ability to attain near complete (> 90%) and durable (> 28-day) SARS-CoV-2 receptor occupancy across a range of baseline viral loads. Further, for the EVADE prevention trial, data compiled to date suggest the 300 mg IM regimen has a projected ability to rapidly exceed target serum concentrations in the majority of simulated patients and to maintain potentially effective concentrations for up to 12 months.
Dose Selection Poster Information
The STAMP and EVADE clinical trials are currently ongoing and enrolling patients globally. For more information, please visit clincialtrials.gov.
About ADG20ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is being developed for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed and engineered to possess high potency and broad neutralization against SARS-CoV-2 and additional clade 1 sarbecoviruses, by targeting a highly conserved epitope in the receptor binding domain. ADG20 displays potent neutralizing activity against the original SARS-CoV-2 strain as well as all known variants of concern. ADG20 has the potential to impact viral replication and subsequent disease through multiple mechanisms of action, including direct blocking of viral entry into the host cell (neutralization) and elimination of infected host cells through Fc-mediated innate immune effector activity. ADG20 is administered by a single intramuscular injection, and was engineered to have a long half-life, with a goal of providing both rapid and durable protection. Adagio is advancing ADG20 through multiple clinical trials on a global basis.
About Adagio TherapeuticsAdagio (Nasdaq: ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The companys portfolio of antibodies has been optimized using Adimabs industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagios portfolio of SARS-CoV-2 antibodies includes multiple, non-competing broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers to support the completion of clinical trials and initial commercial launch. For more information, please visit http://www.adagiotx.com.
Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as anticipates, believes, expects, intends, projects, and future or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of ADG20, including the timing of our planned EUA application, initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our manufacturing capabilities and strategy; and our ability to successfully commercialize our product candidates. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, those risks described under the heading Risk Factors in Adagios prospectus filed with theSecurities and Exchange Commission(SEC) on August 6, 2021and in Adagios future reports to be filed with theSEC, including Adagios Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. Such risks may be amplified by the impacts of the COVID-19 pandemic. Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.
Contacts:Media Contact:Dan Budwick, 1ABDan@1abmedia.com
Investor Contact:Monique Allaire, THRUST Strategic Communicationsmonique@thrustsc.com
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Adagio Therapeutics Announces New Data Highlighting the - GlobeNewswire
"Stem cell-based therapeutics poised to become mainstream option – BSA bureau
In conversation with Dr Koji Tanabe, Founder and CEO, I Peace, Inc., The United States/Japan
To make the trial investments more meaningful and to avoid ambivalence in animal models, medical science is adopting novel in vitro models of specialised human pluripotent cell lines. Pluripotent stem cells(PSCs) have the agility to expand indefinitely and differentiate into almost any organ-specific cell type. iPSC-derived organs andorganoidsare currently being evaluated in multiple medical research arena like drug development, toxicity testing, drug screening, drug repurposing, regenerative therapies, transgenic studies, disease modeling and more across clinical developments. Innovative pharmacovigilance methodologies are preferring induced pluripotent stem cells (iPSCs) for pre-clinical and clinical investigational studies. Global Induced Pluripotent Stem Cell (iPSC) market is expected to reach $2.3 B by 2026. The iPSC market inAsia-Pacificis estimated to witness fast growth due to increasing R&D projects across countries likeAustralia,JapanandSingapore.
I Peace, Inc. a Palo Alto-based global biotech company with its manufacturing base in Japan, has succeeded in developing and mass-producing clinical grade iPS cells through its proprietary iPS cell manufacturing services. The human iPSC (hiPSC) lines at I Peace leverage differentiated cells across clinical research and medical applications. Biopsectrum Asia discovered more about Japan's stem cell manufacturing ecosystem with Dr Koji Tanabe, Founder and CEO, I Peace, Inc., (The United States/Japan). Tanabe earned his doctorate under Dr Shinya Yamanaka, a Kyoto University researcher who received the 2012 Nobel Prize in Physiology or Medicine for discovery of reprogramming adult somatic cells to pluripotent cells. I Peace is focusing on this Nobel Prize-winning iPSCs technology where Tanabe had played a key role in generating the worlds first successful human iPSCs as one of the team members and is currently industrialising it in the US and Japan.
How do you define Japans Stem cell manufacturing dynamics aligning with regional and APAC market potential?
We believe that human cells play a pivotal role in next-generation drug therapy. Clinical trials of iPSC applications are in full swing not only in Japan, but worldwide as well. In the US, the momentum of clinical trial research is astounding. Yet, mass production of GMP compliant cell products remains a challenge. Entry into this venture is no easy task. As a contract development and manufacturing organisation (CDMO), I Peace is geared to tackle that challenge and become the pioneer of mass production technology of clinical grade cell products.
Can you elaborate I Peaces cost-effective proprietary stem cell synthesis solution and its manufacturing scale?
The key advantage of iPSCs is the ability to create pluripotent cells from an individuals own cells. Furthermore, iPSCs can multiply indefinitely and evolve into any type of cell, making iPSCs an ideal tool for transplant and regenerative medicine and drug research. However, clinical applications of iPSCs to date, utilise heterogenic transplantation. It is because manufacturing of just one line of iPSCs requires a cost intensive clean room to be occupied for several months. Manufacturing process complexities also pose a barrier to cost reduction and mass production.
In contrast, I Peace has developed a proprietary, fully automated closed system for iPS manufacturing, enabling cost-effective production of multiple lines of iPSCs from multiple donors in a single room. Within a few years, we expect to manufacture several thousand lines of iPSCs simultaneously in a single room. With this technology, I Peace can efficiently generate an ample supply of various iPSCs for heterogenic transplant, while also fostering a society where everyone can bank their own iPSCs for potential medical use.
How does I-Peace better position its businesses objectives and go-to-market strategies?
I Peaces manufacturing facility and its processes have undergone rigorous audits and are certified to be in compliance with GMP guidelines of the US, Japan, and Europe. We have the capacity to manufacture clinical-grade iPSCs and iPSC-derived cells for clinical use in the global market. Our manufacturing staff have unparalleled expertise in the manufacturing of iPSCs, and their knowledge and experience make it possible to mass produce high quality clinical-grade iPSCs in the shortest possible time. Additionally, we streamlined the iPSC use licensing scheme to expedite collaborative ventures with downstream partners. We believe these strategies position I Peace as a global leader in iPSC technology.
How do you outline the concept of democratising access to iPSC manufacturing?
At I Peace, we envision a world in which everyone would possess their own iPSCs and if needed, receive autologous transplant medication using their own iPSC. We believe in the importance of raising awareness of Nobel Prize winning iPSC technology and we think much more needs to be done. We need to enlighten the public about iPSCs - what they are, how they are created, and how they play a role in next-generation medical therapies. We also need to underscore the benefits of early banking ones own iPSCs, such as autologous transplant and the fact that cells taken in the early stages of life are preferable over cells collected later in life.
To democratise iPSC access, it is also important to expedite application research. We work closely with downstream partners, and support their iPSC-derived drug therapy development efforts by providing iPSCs to meet their needs. We also collaborate with downstream partners in the development of promising therapies including the use of T-cells for cancer therapy, cardiomyocytes for the treatment of heart disease, and neurocytes for neurological disease.
What is your outlook around boosting public-private stakeholders initiatives to encourage awareness on stem-cell-based therapeutics?
iPSC research has advanced tremendously over the past 16 years, and even more so since Dr Shinya Yamanakas Nobel Prize award in 2012. The acceleration of applied research is paving the way for stem cell-based therapeutics to become a common treatment modality in the near future. As human cell manufacturing requires specialised professional skills and knowledge, it is important to promote functional specialisation. These specialisations include donor recruiting, cell manufacturing (where I Peace is the key player), and implementing cell transplant as a medical practice. We believe that creating a systematic industry structure will build awareness and further drive the growth of stem cell-based therapy.
Can you brief Japans licensing key notes to manufacture and process clinical-grade cells in the region?
Japan enacted three laws to promote the use of regenerative medicine as a national policy:
1) The Regenerative Medicine Promotion Act -- representing the country's determination to promote regenerative medicine;
2) The Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (PMD Act); and
3) The Act on the Safety of Regenerative Medicine (RM Act). The U.S. also has various tracks such as the Regenerative Medicine Advanced Therapy (RMAT) Designation, Breakthrough Therapy designation, and Fast Track designation.
Of significance, the PMD Act enables a fast-track for regulatory approval of regenerative medicalproducts in Japan. In compliance with the RM Act, I Peace was audited by the PMDA and licensed by the Ministry of Health, Labour, and Welfare to manufacture specific cell products.
Because cell product manufacturing regulations are not standardised globally, cell therapy developers are forced to source GMP iPSCs for each market. I Peace however, has overcome this hurdle. We have built in compliance with global GMP regulations, including FDA's cGMP regulations per 21 CFR 210/211 in our operation. As a result, we can provide cells for global use in multiple markets, accelerating both product development and regulatory approval.
Hithaishi C Bhaskar
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"Stem cell-based therapeutics poised to become mainstream option - BSA bureau
Breast Cancer Awareness: What people with a family history of cancer should know about the risk of breast cancer? – Times of India
Someone with a family history of breast cancer or with an acquired mutation in the BRCA1 or BRCA2 gene, can get themselves tested.
Breast examinations are the easiest way to diagnose breast cancer. Your doctor will examine your breasts and lymph nodes in your armpit, feeling for lumps.
Other ways are a mammogram, an X-ray of the breast. Ultrasounds or a biopsy can also help diagnose breast cancer. Breast magnetic resonance imaging (MRI) is an accurate method to check for breast cancer risks.
Those with inherited mutations in the BRCA1 or BRCA2 gene can get a BRCA gene test, a blood test that's done to determine if you have changes (mutations) in your DNA that increase the risk of breast cancer.
BRCA genetic testing can also guide treatment options for women with breast or ovarian cancer. Women with one cancerous breast can opt to get both their breasts removed, instead of having surgery only on the affected breast.
If one is diagnosed with breast cancer, depending on your breasts, your doctor will recommend treatment.
Surgery, radiation therapy, chemotherapy, hormone therapy or a targeted therapy are some of the common treatments for breast cancer. It is important to consult with your doctor before choosing any means of treatment.
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Breast Cancer Awareness: What people with a family history of cancer should know about the risk of breast cancer? - Times of India