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TCR therapy an attractive alternative to CAR T for immunotherapy – Drug Target Review

Chimeric antigen receptor (CAR) T-cell therapies have produced encouraging clinical outcomes, demonstrating their therapeutic potential in mitigating tumour development. However, another form of T-cell immunotherapy based on T-cell receptors (TCR) has also shown great potential in this field. Here, Nikki Withers speaks to Miguel Forte who elaborates on the process and explains why he is excited about seeing an idea translate into an industrial proposition.

STIMULATING the natural defences of a persons immune system to kill cancer cells, known as immunotherapy, has become a novel and exciting approach to treat cancer. For example, the role of T cells in cell-mediated immunity has inspired the development of several strategies to genetically modify T cells, such as chimeric antigen receptor (CAR) T-cell therapy, to target cancer cells. In recent years, CAR T-cell therapy has received much attention from researchers and the press alike, and the landmark approval and clinical successes of Novartis Kymriah (the first FDA-approved treatment to include a gene therapy step in the United States) and Gilead/Kite Pharmas Yescarta (the first CAR T-cell therapy for adults living with certain types of non-Hodgkin lymphoma) has prompted a surge of further research. However, this approach which involves isolating cells from a patient, bioengineering them to express CARs that identify and attach to tumour cells and injecting them back into the patient has several limitations, according to Miguel Forte, former CEO of Zelluna Immunotherapy and currently CEO of Bone Therapeutics.

Forte has been working on a T-cell immunotherapy approach that primarily focuses on the T-cell receptors (TCRs). Similar to CAR therapies, TCR therapies modify the patients T lymphocytes ex vivo before being injected back into the patients body. However, they differ in their mechanisms for recognising antigens. CAR T-cell therapy can be compared to a policeman, with a photograph of the criminal, being able to identify them on the street, explained Forte. It is an artificial way of guiding those cells to the cancer when the cancer cells are in suspension. The difficulty with CAR is that it cannot always penetrate and deliver an effect in solid tumours. TCR therapy, which utilises the natural mechanisms that T cells use to recognise the antigen and therefore the cancer, is better suited to penetrate the tumour ie, the policeman is able to go inside the building where a criminal is hiding.

It is obviously more costly at the beginning of the development when you are fine tuning your process, compared to when you progress to a larger scale as you approach the market

Of note, this approach targets the TCR- peptide/major histocompatibility complex (MHC) interaction, which enables eradication of tumour cells. Intracellular tumour-related antigens can be presented as peptides in the MHC on the cell surface, which interact with the TCR on antigen-specific T cells to stimulate an anti-tumour response. Imagine you, or the cells, are not just a soldier in an army but a captain that can bring other immune cells into the mix. TCRs and these cells, once they go in, have a direct kill activity and an immunostimulatory activity to other cells to have a more comprehensive effect of killing the tumour cells. Forte concluded that this approach is scientifically appealing and could bring value to a large array of solid tumours.

The benefits of TCR therapies are evident; however, as with all new approaches, it is not without its challenges. The first relates to the manufacturing of these therapies; the process requires extracting patient material, changing it and then returning it to the patient. Unlike drug discovery with small molecules where you have an inert, well-defined, chemically-established component, with biologics you go up a notch in terms of complexity, Forte explained, adding that while small molecules are unidimensional, biologics are three-dimensional and, thus, more complex and challenging to manufacture. You need to remember that your product, the cells, are a living being. It is something that replicates, changes and responds to its environment. This makes it a lot more challenging to characterise and define the right specifications of the product. The initial challenge is to put in place a consistent and reliable manufacturing process.

Generating the necessary pre-clinical data can also prove challenging; studies are easier to conduct in animal models when you are working with chemical entities rather than human cells, according to Forte. Finally, when the product does get to clinic, there are elements of manufacturing, supply and logistics that can prove challenging; however, companies are starting to provide solutions for this. Working in cell and gene therapy we need to apply what we have done with other products, explained Forte. You need to adapt to the complexity and diversity of the product you have in hand. Here, you have a live product. Something that responds. It is similar to having a child; you can modulate it, but you can never fully control the behaviour of something you are shaping.

Bringing a new drug to market, from drug discovery through clinical trials to approval, can be a costly process, especially when developing cell-based therapies. These are more expensive than developing chemistry or biologics, but when biologics started to be developed, they were also very expensive, explained Forte. We are now seeing a reduction of those costs as more companies are developing products and consequently more solutions are surfacing.

Forte was involved in developing his first cell therapy product about 10 years ago. At this time, it was difficult; a lot of solutions you had to build in house. Nowadays, you can import this from solutions already available so you can concentrate on the specificity; for instance, the viral vector for gene editing your cells or the cytokine concentration for the expansion of your cells. He added that as these therapies grow, so too does the competition, resulting in reduced costs. However, the price and return on investment must correlate with benefit. It is obviously more costly at the beginning of the development when you are fine tuning your process, compared to when you progress to a larger scale as you approach the market.

The well-publicised success story of Emily Whitehead a six-year-old leukaemia patient who was one of the first patients to receive CAR T-cell therapy is a prime example of the success of immunotherapy treatments. Even though these patients may need to continue medications, they can live a relatively normal life. The gene- edited cells remain in the individual and continue to control the cancer by restoring the immune systems capabilities, said Forte. He hopes that similar results will be seen with TCR therapies: Hopefully, a significant fraction of patients will have a clinical and biological response that will reduce the tumour bulk, give them a quality life and remain doing so by controlling the cancer for a significant amount of time.

Forte concluded that the possibilities for TCR- based immunotherapies are exciting and hopefully products will be developed that will deliver an immediate and sustained effect in cancer patients.

About the author

MIGUEL FORTE

Miguel is currently the CEO of Bone Therapeutics and visiting Professor at the Lisbon University in Portugal. He also serves as Chief Commercialization Officer and Chair of the Commercialization Committee of the International Society of Cellular Therapy (ISCT) and is Member of Board of Directors of ISCT and ARM. Miguel was CEO of Zelluna Immunotherapy until the end of 2019. Miguel holds a masters degree from the Faculty of Medicine of the University of Lisbon, Portugal, a PhD in Immunology from the University of Birmingham, UK, an accreditation as Specialist in Infectious Diseases and a certificate on Health Economics of Pharmaceuticals and Medical Technologies (HEP). He is Fellow of the Faculty of Pharmaceutical Medicine of the RCP in the UK.

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Global Hemophilia Gene Therapy Market 2020:Global Industry Size, Share, Trends, Status and 2026 Forecast Spark Therapeutics, Freeline Therapeutics,…

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SORRENTO AND SMARTPHARM TO COLLABORATE TO DEVELOP NOVEL GENE-ENCODED ANTIBODY VACCINE INTENDED TO PROTECT AGAINST COVID-19 – Yahoo Finance

Collaboration to leverage synergies between Monoclonal Antibody and Non-Viral Gene Delivery Platforms

SAN DIEGO and BOSTON, March 23, 2020 (GLOBE NEWSWIRE) -- In response to the government call for rapidly deployable countermeasures, Sorrento Therapeutics, Inc. (Nasdaq: SRNE, Sorrento) and SmartPharm Therapeutics Inc. (SmartPharm) today announced a research and development collaboration to develop a next-generation, gene-encoded antibody vaccine for COVID-19. The collaboration will utilize monoclonal antibodies against SARS-CoV-2 virus discovered and/or generated by Sorrento that will be encoded into a gene for delivery utilizing SmartPharms non-viral nanoparticle platform.

Over the past 10+ years, Sorrento has extensively utilized the G-MABTM Library, one of the largest and most diverse fully human antibody libraries in the biopharma space, for discovering potent immuno-oncology and anti-infective antibodies against over 100 drug targets. In the effort to more quickly resolve the global COVID-19 crisis, our company has initiated a rapidly accelerated program for the identification of potent neutralizing antibodies against SARS-CoV-2 coronavirus antigens that may be used for either treatment or prophylaxis, said Henry Ji, CEO of Sorrento Therapeutics. We expect our platform to produce many candidate neutralizing antibodies for SmartPharm to incorporate into its powerful gene delivery platform. We look forward to our partnership with SmartPharm as part of our goal to make a meaningful impact in this truly global effort.

As a company founded by infectious disease physicians, including myself, we are passionate about applying our novel gene delivery platform to this national and global health crisis, said Jose Trevejo CEO of SmartPharm Therapeutics. Given the disproportionate mortality in elderly and immune-compromised, it is critical that we develop novel technologies that will better protect our populations that are particularly vulnerable to severe coronavirus infection.

Unlike classical antigen-based vaccines, which rely on a patients immune system to establish efficacy, SmartPharms gene-encoded antibody platform is designed to directly neutralize the coronavirus by producing the protective antibody directly in the muscle of the individual. This gene-encoded monoclonal antibody delivery platform or Gene MAb bypasses the in vitro antigen production process and potential for vaccine-induced side-effects in immunized individuals. This is especially important in susceptible populations like the elderly, where antigen-based vaccines are significantly less effective for the prevention of respiratory infections such as influenza or coronavirus. The companies expect that this novel approach will enable faster progression to clinic, pending agreement with the FDA.

As part of the collaboration, Sorrento and SmartPharm expect to develop a gene-encoded antibody or antibodies that can be administered as a prophylaxis against SARS-CoV-2 infection. Plans for the collaboration may include candidate development as well as filing of an IND application in the next few months.

About SmartPharm Therapeutics

SmartPharm Therapeutics Inc. is a privately held, pharmaceutical company focused on developing next-generation, non-viral gene therapies for the treatment of serious or rare diseases with the vision of creating Biologics from Within. SmartPharm is currently developing a novel pipeline of non-viral, gene-encoded proteins for the treatment of conditions that require biologic therapy such enzyme replacement and tissue restoration. SmartPharm commenced operations in 2018 and is headquartered in Cambridge, MA, USA. For more information, please visit http://www.smartpharmtx.com.

About Sorrento Therapeutics, Inc.

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (G-MAB library), clinical stage immuno-cellular therapies (CAR-T, DAR-T), intracellular targeting antibodies (iTAbs), antibody-drug conjugates (ADC), and clinical stage oncolytic virus (Seprehvir).

Story continues

Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (RTX), and ZTlido (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. Resiniferatoxin is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido was approved by the FDA on February 28, 2018. For more information visit http://www.sorrentotherapeutics.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related toSorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the collaboration and expected scope, terms and timing thereof and plans related thereto; the expected timing for the initiation and completion of ongoing studies for coronavirus using antibodies and data read-outs related thereto; the number of antibodies expected to be identified; the expected timing for commencing and completing registrational studies, including any potential for faster progression to the clinic, and for submitting an IND application for antibody technology for the treatment and/or prevention for coronavirus; the potency of any antibodies and ability to provide efficacy; any potential market for antibody therapy for the treatment and prevention of coronavirus and Sorrentos potential position in the anti-viral immunity industry. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's and its subsidiaries', affiliates and partners technologies and prospects and collaborations with partners, including, but not limited to, the collaboration with SmartPharm, using gene-encoded antibodies for the treatment and prevention of coronavirus infections; risks related to seeking regulatory approvals and conducting and results of clinical trials; the clinical and commercial success of the treatment and prevention of coronavirus infections using gene-encoded antibodies; the viability and success of using gene-encoded antibodies for treatments in anti-viral therapeutic areas, including coronavirus; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks related to seeking regulatory approvals and conducting clinical trials; risks of supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its strategies; risks related to Sorrentos debt obligations; risks related to the global impact of COVID-19 and other risks that are described in Sorrento's most recent periodic reports filed with theSecurities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year endedDecember 31, 2019, and subsequent Quarterly Reports on Form 10-Q filed with theSecurities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Media and Investor Relations

Contact: Alexis Nahama, DVM (SVP Corporate Development)

Telephone: 1.858.203.4120

Email:mediarelations@sorrentotherapeutics.com

Sorrento and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.COVIDTRAP, Saving-Lifeand Improving-Lifeare trademarks of Sorrento Therapeutics, Inc.ZTlido and G-MAB are trademarks owned by Scilex Pharmaceuticals Inc. and Sorrento, respectively.Seprehvir, is a registered trademark of VirttuBiologics Limited, a wholly-owned subsidiary of TNK.Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.All other trademarks are the property of their respective owners. 2020 Sorrento Therapeutics, Inc. All Rights Reserved.

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SORRENTO AND SMARTPHARM TO COLLABORATE TO DEVELOP NOVEL GENE-ENCODED ANTIBODY VACCINE INTENDED TO PROTECT AGAINST COVID-19 - Yahoo Finance

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Outlook on the Global Virus Filtration Industry to 2025 – Largest Drivers of Virus Filtration Market Growth – ResearchAndMarkets.com – Business Wire

DUBLIN--(BUSINESS WIRE)--The "Virus Filtration Market Size, Outlook and Growth Opportunities, 2019- 2025" report has been added to ResearchAndMarkets.com's offering.

The 'Virus Filtration market outlook to 2025' report includes the latest predictions of the global Virus Filtration market along with geography, therapy area, and applications. The report specifically focuses on different types of Virus Filtration with special attention to their emergence over the forecast period to 2025.

The research report provides objective measures to tap into future opportunities that will be available over the next six-years. It also highlights key areas to watch over the future along with detailed insights into drivers and challenges across different Virus Filtration applications and products.

Companies Mentioned

The Virus Filtration market report aggregates the current market size based on volume and average price data. It also includes a six-year outlook to 2025 based on anticipated growth rates for each sub-segment and industry as a whole.

The base case outlook in the next six-years for different types of Virus Filtration, across different verticals and countries, is provided. It additionally examines the key dynamics around companies, markets, along with key trends, drivers and challenges facing the Virus Filtration worldwide.

The report covers a broad region from the Asia Pacific, North America, Europe, Latin America, and Middle East Africa from 2018 to 2025. 12 countries across these regions are analyzed independently in the Virus Filtration report. Impact of domestic market conditions, price variations, competition, government policies, healthcare spending, technological and local market conditions are assessed for country-level forecasts.

Global spending on healthcare continues to increase significantly with the aging population, increased access to treatment and ongoing advancements in technology. This provides strong support for Virus Filtration market growth in the medium to long term future. While growth will remain steady in the developed markets, Asian and other emerging markets will be key for Virus Filtration market growth from 2019 to 2025.

To address the expanding need for advanced Virus Filtration products, companies are rapidly embracing the new market dynamics, primarily focusing on new launches, specifically to suit local and regional demand patterns. Accordingly, detailed discussion about broader implications of key strategies, product launches, and other latest Virus Filtration market developments are included in the research work.

Key Topics Covered:

1. Table of Contents

2. A Review of 2018 and Outlook to 2025

2.1. Trend Analysis

2.2. Critical Success Factors

2.3. Demand and Growth Dynamics by Type

2.4. Demand and Growth Dynamics by Application

2.5. Demand and Growth Dynamics by Market

3. Strategic Analysis

3.1. Largest Drivers of Virus Filtration Market Growth

3.2. Different Challenges Faced by Virus Filtration Companies

3.3. Five Forces Analysis

4. Global Virus Filtration Market Outlook by Product

4.1 Kits, Reagents, and Consumables

4.2 Filtration Systems

4.3 Services

5. Global Virus Filtration Market Outlook by Application

5.1 Biological

5.1.1 Vaccines and Therapeutics

5.1.2 Blood and Blood Products

5.1.3 Cellular and Gene Therapy Products

5.1.4 Tissue and Tissue Products

5.1.5 Stem Cell Products

5.2 Medical Devices

5.3 Water Purification

5.4 Air Purification

6. Global Virus Filtration Market Outlook by End User

6.1 Pharmaceutical and Biotechnology Companies

6.2 CRO's

6.3 Research Institutes

6.4 Medical Device Companies

7. Asia Pacific Virus Filtration Market Outlook

7.1 Leading Virus Filtration Types contributing to Asia Pacific market

7.2 Top Applications contributing to Asia Pacific Virus Filtration

7.3 Top countries contributing to Asia Pacific Virus Filtration

8. Europe Virus Filtration Market Outlook

8.1 Leading Virus Filtration Types contributing to Europe market

8.2 Top Applications contributing to Europe Virus Filtration

8.3 Top countries contributing to Europe Virus Filtration

9. North America Virus Filtration Market Outlook

9.1 Leading Virus Filtration Types contributing to North America market

9.2 Top Applications contributing to North America Virus Filtration

9.3 Top countries contributing to North America Virus Filtration

10 South and Central America Virus Filtration Market Outlook

10.1 Leading Virus Filtration Types contributing to South and Central America market

10.2 Top Applications contributing to South and Central America Virus Filtration

10.3 Top countries contributing to South and Central America Virus Filtration

11 Middle East Africa Virus Filtration Market Outlook

11.1 Leading Virus Filtration Types contributing to Middle East Africa market

11.2 Top Applications contributing to Middle East Africa Virus Filtration

11.3 Top countries contributing to Middle East Africa Virus Filtration

12 Company Profile Snapshots

12.1 Top Companies Operating in Virus Filtration market

13 Recent Industry Developments

14 Appendix

For more information about this report visit https://www.researchandmarkets.com/r/cjw9dh

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Outlook on the Global Virus Filtration Industry to 2025 - Largest Drivers of Virus Filtration Market Growth - ResearchAndMarkets.com - Business Wire

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Twelve Women Who Have Shaped The History of the BioHealth Capital Region – BioBuzz

The BioHealth Capital Region (BHCR) and its life science ecosystem have a rich and deep history of pioneering scientific innovation, research, development, and commercialization. The regions history has been written by life science anchor companies, scientific research universities, government research organizations, rich startup culture, and serial entrepreneurs, all of whom have played critical roles in transforming the BHCR into one of the most innovative and productive biocluster in the world.

Contributions to the BHCRs legacy of life science achievement have emerged from all staffing levels, various labs, countless executive teams, numerous entrepreneurs and biohub support organizations. Contributions have arisen from an intricate tapestry of backgrounds and cultures.

Women, in particular, have had a strong hand in shaping the history of the BHCR. In celebration of Womens History Month, were taking a closer look at the achievements of female life science leaders that have laid the groundwork for the next generation of women trailblazers in the BHCR and made the region what it is today.

Dr. Fraser is one of the most influential figures in BHCR history. In 1995, she was the first to map the complete genetic code of a free-living organism while at the Institute for Genomic Research (TIGR) in Rockville, Maryland. It was there that the automation of the DNA sequencing process made the idea of large-scale sequencing efforts tangible. As President and Director of TIGR, Fraser and her team gained worldwide public notoriety for its involvement in the Human Genome Project, which was completed in 2000 with the presentation of a working draft of the fully sequenced human genome.

As a leader, Fraser provided her researchers with the infrastructure to collaborate and apply multi-disciplinary team science and empowered them to think big. She is also most importantly known for how she challenged her team to ask the right questions, which is the root of scientific progress and success.

Her work at TIGR and as part of the Human Genome Project are foundational events in the regions history, as it marked the BHCR as the epicenter of genomic research and helped spark the regions biotech boom. In fact, it was a controversial partnership with TIGR that gave Human Genome Sciences(HGSi) the first opportunity to utilize any sequences emerging from TIGR labs. The mass of genetic information and sequences, especially that associated with diseases, that HGSi acquired catapulted them into biotech history and an important anchor company within the region.

Dr. Fraser is widely viewed as a pioneer and global leader in genomic medicine; she has published approximately 320 scientific publications and edited three books; she is also one of the most widely cited microbiology experts in the world. She founded the Institute for Genome Sciences at the University of Maryland in 1997. The institute currently holds 25 percent of the funding thats been awarded by the Human Microbiome Project and has been referred to as The Big House in genetics.

Dr. Judy Britz is yet another female life science pioneer that put the BHCR on the map. While working as a research scientist at Electro-Nucleonics Inc., Dr. Britz developed one of the first licensed blood screening tests for HIV, and launching a storied career that has spanned approximately 25 years. She is also a serial entrepreneur that has successfully raised $50M in capital and served as the top executive for two highly successful Maryland-located companies.

Dr. Britz was the first woman to lead the states biotech initiative as the first announced Executive Director of the Maryland Biotech Center. The center was launched under the Maryland Department of Commerce to deploy a strategic life science economic development plan under Governor Martin OMalleys $1.3B, 2020 Vision and to be a one-stop-shop and information center to promote and support biotechnology innovation and entrepreneurship in Maryland.

Judy was the first woman to lead Marylands life sciences initiative, bringing industry experience and perspective to the states economic development activities, a focus still maintained under Governor Hogans leadership today, shared Judy Costello, Managing Director, Economic Development BioHealth Innovation, Inc., who served as Deputy Director under Dr. Britz.

Much of the work done by Dr. Britz and her team laid the foundation and seeded the commercialization efforts that have blossomed into the thriving #4 Biotech Hub that we have today.

GeneDx was founded by Dr. Bale and Dr. John Compton in 2000. The company recently celebrated its 20th anniversary. Since its founding, GeneDx has become a global leader in genomics and patient testing. Under her leadership, the Gaithersburg, Maryland company has played an important role in the history of genetic sequencing and the rise of the BHCR as a global biohealth cluster.

GeneDx was the very first company to commercially offer NGS (Next Generation Sequencing) testing in a CLIA (Clinical Laboratory Improvement Amendments) lab and has been at the leading edge of genetic sequencing and testing for two decades. The companys whole exome sequencing program and comprehensive testing capabilities are world-renowned.

Prior to launching GeneDx, Dr. Bale spent 16 years at NIH, the last nine as Head of the Genetic Studies Section in the Laboratory of Skin Biology. She has been a pioneer during her storied career, publishing over 140 papers, chapters and books in the field. Her 35-year career includes deep experience in clinical, cytogenetic, and molecular genetics research.

Prior to being named CEO and Chair of the Board of Sequella in 1999, Dr. Nacy was the Chief Science Officer and an Executive VP at EntreMed, Inc. EntreMed was one of the most influential BHCR companies in the 1990s. EntreMed, MedImmune, Human Genome Sciences and Celera Genomics all played critical roles in creating the globally recognized, top biocluster that the BHCR has become.

After earning her Ph.D. in biology/microbiology from Catholic University, Nacy did her postdoc work at the Walter Reed Army Institute of Research in the Department of Rickettsial Diseases; her postdoc performance earned a full-time position at Walter Reed that started a 17-year career at the institute. After a highly successful run, Nacy left Walter Reed to join EntreMed.

Today, Dr. Nacy leads Rockville, Marylands Sequella, a clinical-stage pharmaceutical company focused on developing better antibiotics to fight drug-resistant bacterial, fungal and parasitic infections. Sequellas pipeline of small molecule infectious disease treatments have the potential to improve the treatment and outcomes for the over 3 billion people worldwide that are impacted by increasingly drug-resistant infectious diseases.

Emmes Corporation is the largest woman-led organization in the BHCR and is headed by Dr. Lindblad, who started her career at Emmes in 1982 as a biostatistician. She has been with Emmes for nearly 40 years, ascending to become VP in 1992, Executive VP in 2006 and ultimately the companys CEO in late summer of 2013.

Dr. Lindblad has published more than 100 publications and presentations has served as a reviewer of grant and contract applications for the National Institutes of Health (NIH) and has chaired or served on Safety and Data Monitoring Committees across multiple disease areas. Emmes is a life science anchor company for the BHCR, employing more than 600 staff globally with its headquarters in Rockville, Maryland.

Under Kings leadership, GlycoMimetics (GMI), an oncology-focused biotech, went public, secured an exclusive global licensing agreement with Pfizer and was instrumental in raising significant amounts of capital for the company. She was also the first woman Chair of Biotechnology Innovation Associations (BIO, 2013-14), where she still plays an active role on BIOs Executive Committee.

A graduate of Dartmouth College and Harvard Business School, King has had a celebrated career in both biopharma and finance. Prior to becoming CEO of GMI, King served as an Executive in Residence for New Enterprise Associates (NEA), one of the leading venture capital firms in the U.S. She has also held the position of Senior Vice President of Novartis-Corporation. King joined Novartis after a remarkable ten year run with Genetic Therapy, Inc. where she was named CEO after helping Genetic Therapy navigate the organization through various growth stages, including the companys sale to Novartis. King was named the Maryland Tech Councils Executive of the Year in 2013, the Top 10 Women in Biotech by FierceBio and has served on multiple boards across her career.

Dr. Connolly has had a pioneering career in the life sciences. She was the very first woman to graduate from Johns Hopkins Universitys Biomedical Engineering Doctoral Program in 1980. She was also a member of the first female undergraduate class entering Stevens Institute of Technology in 1971.

For decades, Dr. Connolly tirelessly worked to build up what is now known as the BHCR. In 1997, shortly before the region gained wider recognition as a biotech hub, she was the first person to be designated the state of Marylands biotechnology representative. Dr. Connollys career has spanned academia, government, and industry, including co-founding a startup and working as the Business Development Director for EntreMed, Inc., an original BHCR anchor company. She is the former Director of Maryland Industrial Partnerships Program (MIPS) and was inducted into the College of Fellows by the American Institute for Medical and Biological Engineering (AIMBE) in 2013.

Dr. Kirschstein played an enormous role in shaping the BHCR as NIH Deputy Director from 1993 to 1999 during the regions early formative years. She also served as Acting Director of NIH in 1993 and from 2000 to 2002. A pathologist by training, she received her medical degree from Tulane University in 1951 and went on to a long, successful career at the Division of Biologics Standards that lasted from 1957 to 1972.

While at the Division of Biologics Standards, Dr. Kirschstein played an important role in testing the safety of viral vaccines and helped select the Sabin polio vaccine for public use. She eventually ascended to Deputy Director of the group in 1972 and was later appointed the Deputy Associate Commissioner for Science at the FDA. In 1974 she became the Director of the National Institute of Medical Sciences at NIH and served in that role for 19 years.

Her awards and accolades are too numerous to list, but one notable honor came in 2000 when she received the Albert B. Sabin Heroes of Science Award from the Americans for Medical Progress Education Foundation.

Lastly, we want to recognize four additional women for their contributions to launching an organization that has impacted thousands of women by promoting careers, leadership, and entrepreneurship for women in the life sciences Women In Bio.

Women In Bio (WIB), one of the most important and influential support organizations for women in the life sciences, was founded in 2002 to help women entrepreneurs and executives in the Baltimore-Washington-Northern Virginia area build successful bioscience-related businesses. WIB started as a BHCR organization but has expanded its footprint to 13 chapters across the U.S. with 225 volunteer leaders and 2,600 members. The non-profit group has created a forum for female life science entrepreneurs and executives based on its core philosophy of women helping women.

WIB founders are Anne Mathias, a local venture capitalist and current Senior Strategist with Vanguard;

Elizabeth Gray, co-founder of Gabriel Pharma and current Partner at Willkie Farr & Gallagher LLP;

Robbie Melton, former Director of Entrepreneurial Innovation at TEDCO and current Director of Kauai County, Hawaiis Office of Economic Development;

and Cynthia W. Hu, COO, and General Counsel at CASI Pharmaceuticals.

In conclusion, we can not fairly capture the true history of life science and the BioHealth Capital Region without giving special recognition to Henrietta Lacks. In 1951 a Johns Hopkins researcher created the first immortal human cell line from cervical cancer cells taken from Lacks. That cell line, known as HeLa, is the oldest and most commonly used human cell line which was essential in developing the polio vaccine and has been used in scientific landmarks such as cloning, gene mapping and in vitro fertilization.

Though she was a black tobacco farmer from southern Virginia, her impact on science and medicine is unquestionable. She never knew that the Doctor took a piece of her tumor that would be used by scientists who had been trying to grow tissues in culture for decades without success. For some reason, that is still unknown, but her cells never died and the first immortal human cell line was born.

Thank you to all of the women who have been so influential in shaping the field of science, the industry of biotechnology and the BioHealth Capital Region.

Steve has over 20 years experience in copywriting, developing brand messaging and creating marketing strategies across a wide range of industries, including the biopharmaceutical, senior living, commercial real estate, IT and renewable energy sectors, among others. He is currently the Principal/Owner of StoryCore, a Frederick, Maryland-based content creation and execution consultancy focused on telling the unique stories of Maryland organizations.

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Twelve Women Who Have Shaped The History of the BioHealth Capital Region - BioBuzz

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Coronavirus weekend update: Plans outlined to prepare hospitals for surge in patients – Mountain View Voice

Santa Clara County is working with local hospitals to prepare for an expected surge in coronavirus patients, county Board of Supervisors President Cindy Chavez and Santa Clara Valley Medical Center CEO Paul Lorenz said at a press conference on Sunday.

Lorenz said there are approximately 2,500 hospital beds in the county. Roughly 400 of the beds are dedicated to pediatric care and 350 are for critical care, 75% to 80% of which are currently occupied. Approximately 290 additional beds can be converted to an "ICU level of care," he said.

"If in fact the demand goes beyond our capacity, we are working with the county emergency operations center to come up with a communitywide search plan," he said. "That plan would include looking at all 2,100 adult beds that we can equip and staff for critically ill patients."

Lorenz added that "less acute patients" could then be taken to alternative facilities in the county to free up room at hospitals.

The county is also looking to hire more health care workers and is bringing retired employees back into the workforce. The county can reach out to the state and federal governments for additional staff should that be necessary, Lorenz said.

"We need to have the surge capacity in place as quickly as possible," he said. "We are moving as rapidly as we can. ... All of the hospitals in this county have prepared their own surge capacity plans, and that allows those facilities to ramp up their own facilities beyond what they're currently staffed at.

"I think the most important variable in all of this is to maintain our health care workforce and to grow that workforce ... and the ability for us to equip those hospital beds with ventilators and other necessary equipment. We are also moving very rapidly with the county EOC, the state and the federal government to make sure we have those items in place as quickly as possible."

He said the community has been "really helpful" in following the directions of local health officials, adding that local emergency rooms are now seeing a "much lower volume." Anyone with symptoms of COVID-19 is being asked to call their health care provider or 211 before going to urgent care or an emergency room.

"We were not expecting to have the results so quickly of the emergency rooms not being crowded because people are actually taking those steps, and that's really critical," Chavez said. "We want to make sure we have beds for people who are in the highest need."

Chavez provided another piece of good news: Community members have donated thousands of masks, gowns and other personal protective equipment for health care workers amid a national shortage of such items. The Valley Medical Center Foundation is continuing to collect monetary donations online and protective equipment, which can be dropped off beginning at 8 a.m. Monday, March 23, at the foundation's office on the Santa Clara Valley Medical Center campus, 2400 Clove Drive in San Jose.

Masks and gloves that aren't hospital grade are also needed for local food bank workers, she noted.

Chavez also encouraged those who are healthy and want to volunteer to deliver meals to sign up at siliconvalleystrong.org.

Access a recording of the press conference here.

Santa Clara County

Santa Clara County reported two more deaths and 39 new infections as a result of the coronavirus on Sunday afternoon, bringing the total number of cases to 302.

Chavez said in a press conference Sunday that the ninth and 10th recorded deaths in the county were women in their 60s and 40s, respectively. Both women died Saturday, March 21. The woman in her 40s was hospitalized Monday, March 16, according to the county. Further information was not provided.

Officials also announced in a press release Sunday that Santa Clara County Director of Communications and Public Affairs Maria Leticia Gmez has tested positive for COVID-19.

She became ill on March 13 and received her positive test result on Sunday, March 22.

Gmez agreed to share her health status publicly, according to the press release. She has been isolated at home since March 13.

"The county has instructed all employees, including those who have been in contact with Ms. Gmez, that they should not go to work if they show any symptoms of illness," the county said. "We are also notifying all members of the county workforce with whom Ms. Gmez may have had contact while contagious that they may have been exposed."

Of Santa Clara County's COVID-19 cases, 108 people are hospitalized; 77 are presumed to have been community transmitted; 75 are close contacts of known cases; 22 are associated with international travel; and 10 people have died, according to the county's public health department.

On Saturday, the county reported 67 new cases of coronavirus, which marked the biggest jump in cases in one day for the county.

"This increased case count is not unexpected given community transmission, an increase in provider reporting, and growing testing capacity through the commercial market," according to a county press release.

San Mateo County

As of Sunday morning, March 22, San Mateo County announced seven new COVID-19 cases, bringing its county total to 117, and one death.

Parking restrictions near Windy Hill Preserve

Portola Valley Town Manager Jeremy Dennis issued an emergency order on Sunday that prohibits parking adjacent to the entrances to Windy Hill Preserve's trails on Portola and Alpine roads and Willowbrook Drive, according to a Sunday afternoon email sent out to residents by Mayor Jeff Aalfs.

"Our experiences (including reports from many of you) over the last two days at Windy Hill indicate that not only are some of the trails incompatible with social distancing, the use of our streets for parking and trail entry is creating unsafe conditions as well," Aalfs wrote.

The order will be enforced beginning Monday, March 23, "until the County Order is lifted," he said. There will be increased signage in the affected areas.

Windy Hill, a Midpeninsula Regional Open Space District preserve, is among several local spots that have seen an uptick in visitors in recent days. The National Park Service announced in a tweet Saturday night that it would close multiple gates at Point Reyes National Seashore beginning Sunday, March 22, "after unprecedented visitation."

The open space district reaffirmed Friday, March 20, that its preserves and trails are open to the public with new health and safety measures in place, including: restrooms are closed; areas with high use will be intermittently closed without notice to promote safe social distancing; group gathering areas are closed; and group activities are suspended.

Aalfs noted in his email that town staff "has been in touch with San Mateo and Santa Clara County officials, MROSD officials, the Sheriff's Office, and others in discussion about the use of open space facilities during the current shelter in place crisis," but did not specify whether further measures are being considered at this time.

SAFE farmers market

For three weeks beginning Thursday, March 26, the SAFE (Sanitary Allocation of Food Essentials) Portola Valley Farmers Market will operate from 2 to 6 p.m. at the site of the usual Thursday farmers market, 765 Portola Road, according to an email from the town Sunday.

The market will be pre-order only with drive-thru pickup. Food will be prepacked, and households will be limited to five bags per order. The deadline for all orders will be 7 p.m. the Wednesday before the market, and products for the following week's market will become available online at noon every Friday.

The market will also offer special delivery for residents of the Sequoias retirement community and those in vulnerable populations.

For more information or to pre-order, visit the SAFE Portola Valley Market website.

Menlo Park-based lab to process coronavirus tests from new Hayward center

A partnership with a Menlo Park genetics laboratory firm will allow Hayward to open a dedicated center offering free COVID-19 coronavirus testing on Monday, March 23.

The COVID-19 testing center at the city's fire station at 28270 Huntwood Ave. can handle up to 370 tests a day, "But we don't expect it to get that high," said city spokesman Chuck Finnie.

Tests are intended for those displaying symptoms, first responders, and health care workers with recent suspected exposures to the novel coronavirus.

The intent is "to take pressure off hospital emergency rooms, provide quicker answers for recently exposed first responders and health care workers, and to enhance the region's capacity to suppress new transmissions through isolation after testing," the city said in an announcement Sunday.

"We don't want the wondering and the worried to come they need to stay home," Finnie said. "We want sick people to come."

He added, "It's not a test people are going to want to take unless they have to. It's not pleasant."

The test involves swabbing of nasal cavities and the back of the throat.

Hayward Fire Department firefighter-paramedics will staff the center, with assistance from ambulance company emergency-medical technicians.

"No referral from a medical doctor is required to be screened," the city said.

The center will operate from 9 a.m. to 6 p.m. daily and is free and open to "anyone regardless of where they live or immigration status," according to the announcement.

"We know it's going to be chaotic on the first day," Finnie said.

People will first undergo a two-part screening for illness, which includes fever, cough and/or shortness of breath, and/or other respiratory symptoms.

At an initial drive-up station, people will be asked about symptoms, then either be cleared to leave or sent to a walk-up tent to be screened for illness.

The city has appropriated funding for the center with the hope of reimbursement from county and state public health agencies.

The center is made possible through a city partnership with Menlo Park-based Avellino Lab USA Inc., a company that specializes in "gene therapy and molecular diagnostics with a focus in precision medicine for eye care."

The laboratory will analyze the tests and "Results can be available in as little as six hours or the next day in most cases."

Finnie said Avellino is a civic-minded company that is supplying the tests "at a very, very good price" and is also looking for similar partnerships with other jurisdictions to open additional centers.

He said officials from Fremont were assessing the Hayward center on Sunday.

Menlo fire begins pandemic response unit

The Menlo Park Fire Protection District now has a Pandemic Emergency Response Unit staffed by a two-person team. The unit is tasked with taking calls of suspected COVID-19 cases, according to a press release issued Saturday.

The district recently received seven calls of suspected COVID-19 in one day and expects to see that number go up.

Staff assigned to the unit will utilize the "highest level of Emergency Medical Services" and personal protective equipment. The district said they will aim to minimize contact with whoever may have COVID-19 while on a call to decrease possible exposure to the disease.

They will also be responsible for decontaminating each scene they visit and fire apparatus used on the call to prevent traces of the virus on equipment, clothing and/or the apparatus as outlined by district guidelines.

"We believe that by raising the bar on our personal protective clothing and by putting this new special response unit in place, we can slow or help to hopefully more effectively stop its spread," Chief Harold Schapelhouman said in the press release.

Some fire district personnel have volunteered to serve on the unit, he said.

"The number of our off-duty firefighters grew again today, as yet another Menlo Park Firefighter, the seventh, was home sick and scheduled for testing.

"At some point, we know one of our firefighters will contract COVID-19," Schapelhouman added, "most are not in the risk categories and all are extremely healthy and fit based upon the daily expectations of our profession, but our collective goal is to delay, or stop, spread for as long as possible."

Increasing health care capacity

To create more space at hospitals, Santa Clara County has teamed up with the U.S. Office of Public Health Preparedness and Response to establish a temporary Federal Medical Station at the Santa Clara Convention Center to accommodate up to 250 people, according to a statement issued Saturday. The station will be managed by the federal office to serve patients in need of short-term, subacute care and do not have COVID-19. It will be equipped with beds, supplies and medicines, according to the county.

The station, being developed with federal, state and local agencies, is expected to help make more acute hospital beds available.

Chavez said Sunday that the county is considering other sites besides the convention center for coronavirus response efforts but didn't offer any specific details.

The state can also increase capacity at clinics, mobile health care units and adult day care facilities as part of its COVID-19 response under an executive order issued by Gov. Gavin Newsom on Saturday. In addition, local governments are allowed to work with retired employees in addressing the public health crisis. The order also "reinforces the importance of the delivery of food, medicine and emergency supplies," according to a press release from the governor's office. To read a copy of the order, visit gov.ca.gov.

Reporting violations and fraud

On Saturday, Santa Clara County announced an updated resource for the public to report nonessential businesses they see operating in violation of the shelter-at-home order, which was issued on Tuesday and will last through April 7.

The public can notify the Santa Clara County District Attorney's Office of such breaches at a new phone number, 408-792-2300. Callers can leave a voicemail in English, Spanish and Vietnamese.

Additionally, the U.S. Department of Justice is encouraging people to report suspected fraud schemes related to the coronavirus by calling the National Center for Disaster Fraud hotline at 866-720-5721 or by sending an email to disaster@leo.gov. So far there have been reports of individuals and businesses selling fake cures for COVID-19 online; phishing emails from entities posing as the World Health Organization or the Centers for Disease Control and Prevention; malicious websites and apps that appear to share virus-related information to gain and lock access to devices until payment is received; and people seeking donations for illegitimate or nonexistent charities, according to the department.

Shelter at home orders

Last week started off with the announcement of a shelter-at-home order for most of the Bay Area and ended with a similar mandate extending throughout the state, actions taken in response to the growing coronavirus crisis.

On Monday, March 16, public health leaders from six Bay Area counties joined together to announce the shelter-at-home order for their respective jurisdictions. The measure limits the public to essential activities, such as health care operations; businesses that provide food, shelter and social services; and other necessities.

The state followed suit through its own order announced Thursday night by Gov. Gavin Newsom, who pointed to more than 1,030 confirmed cases and 18 deaths across California as factors in the decision.

Bay City News Service contributed to this report.

Find comprehensive coverage on the Midpeninsula's response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.

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Follow the Mountain View Voice on Twitter at @MVvoice, Facebook and Instagram at @MVvoice for breaking news, local events, photos, videos and more.

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Coronavirus weekend update: Plans outlined to prepare hospitals for surge in patients - Mountain View Voice

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The Progress & Ongoing Challenge of 3D Bioprinting Cardiac Tissue – 3DPrint.com

In the recently published 3D bioprinting and its potential impact on cardiac failure treatment: An industry perspective, authors Ravi K. Birla and Stuart K. Williams explore the potential for tissue engineering in cardiac medicine, and the eventual assembly of a bioprinted heart.

While heart failure usually requires a transplant, it can be challenging to find a suitable donor. Once a transplant is completed, there is a long road ahead too via a permanent need for immune suppression therapytreatment that is hard on patients. The usual survival rate for patients is typically under 13 years.

There are currently more than 6.2 million patients in the US with heart failure, and heart failure accounted for 78,356 mortalities in 2016, stated the authors.

In this study, the researchers review the challenges of bioprinting for the creation of heart tissue, as well as the logical and systematic process to bioprint human heart.

While medical science is full of progressive tools, treatments, and devicesespecially for heart patientsno technology has been more promising for the eventual fabrication of organs than tissue engineering. With the potential to yield a biofabricated heart, made up of both biologic and artificial construct, a total heart could feasibly emerge with modular parts for easy replacing.

Definition of tissue engineeringthe building blocks of tissue engineering are cells, biomaterials, and bioreactors. Cells are the functional elements of all tissue and organs, while biomaterials are designed to simulate the mammalian extracellular matrix and provide structural support. Bioreactors are custom devices to deliver physiological cues for 3D tissue/organ development and maturation. Electrical stimulation is delivered by parallel electrodes, while uniaxial stretch, illustrated by the single arrow, is designed to apply cyclic movement of the bioengineered tissue.

Cardiac tissue engineering encompasses:

The ability to bioengineer components of the heart or the entire bioartificial heart, both have applications in changing the standard of care for patients with heart disorders, explained the authors. Depending on the severity of the patient, a cardiac patch may be sufficient to augment lost contractile function, while in cases of chronic heart failure, a total bioartificial heart may be required.

In addition to spatial regulation of the cells, bioprinting also allows accurate placement of the biomaterials. This is where 3D bioprinting provides a powerful tool that allows us to accurately position different cell types in a very specific pattern, thereby allowing tight control over the heart bioengineering process.

Overview of cardiac tissue engineeringthe field of cardiac tissue engineering includes methods to bioengineer contractile 3D heart muscle, biological pulsating pumps, bioengineered left ventricles, bioartificial valves and vascular grafts, and biofabricated hearts. Contractile 3D heart muscle is designed to replicate the properties of mammalian heart muscle tissue and can be used as a patch to augment left ventricle pressure after myocardial infarction. Pulsating pumps are designed to generate intra-luminal pressure and can be used as biological pumps. Left ventricles can be used as a component of the heart or to replace under-performing ventricles in pediatric cases of hypoplastic left heart syndrome. Valves and vascular grafts can be used to replaced mammalian valves and blood vessels or as components of the bioengineered heart.

Major components of the human heartthe human heart consists of four chambers, four valves, the cardiac conduction system, contractile cardiomyocytes, and a complex vasculature. The four chambers are the left and right ventricle and aorta, while the four valves are the aortic and mitral valves and pulmonary and tricuspid valves. The cardiac conduction system consists of the SAN, AVN, bundle of His, and the Purkinje fibers. Cardiac vasculature consists of the greater vessels as well as the smaller micro-circulation. Cardiomyocytes are the cells responsible for heart muscle contraction.

So far, most research involving bioprinting of cardiac tissue has shown the initial feasibility of bioprinting hearts. With the amount of research and tools available today, such progress is inevitable.

Based on the current state of the art in whole heart bioengineering, we can safely say that human hearts will be available for clinical transplantation though we cannot assign a specific timeframe for this fate to be accomplished, state the authors.

Bioprinting of the human heart has its beginnings in the initial history of tissue engineering in 2003, and then further in research a few years later.

The 3D bioprinting processisolated cells are suspended in a custom formulated bioink and loaded into a syringe. Examples of cells required to bioprint hearts include contractile cardiomyocytes, conducting pacemaker and Purkinje cells, structural fibroblast cells and vascular smooth muscle cells, and endothelial cells. Pneumatic pressure is used to extrude the cell-loaded bioink through the printing tip, and a layer by layer approach is used to build tissue and/or organ

Scientific breakthroughs for 3D bioprinting human hearts.

There has continued to be rapidly growing success in bioprinting and the subsequent fabrication of heart tissue, allowing scientists to realize less of fantasy in such exercisesand more of a reality.

Process for bioprinting human heartspatient MRI images are used to model the heart. Dermal fibroblasts are isolated from patient skin biopsies and converted to iPS cells and then to cardiomyocytes. Cardiomyocytes are combined with bioinks and used to bioprint patient-specific human hearts. Bioprinted hearts are conditioned in bioreactors and used for transplantation.

The roadmap for bioprinting a heart includes:

The single most important challenge that needs to be overcome in the field, and one that in general staggers the field of cardiac stem cell therapy, is the immaturity of reprogrammed cardiomyocytes, conclude the researchers. Conversion of iPS cells to cardiomyocytes is now standard and reproducible, the differentiated cells resemble an embryonic phenotype, and driving these cells to an adult phenotype remains a critical challenge in the field of cardiac stem cell therapy.

Once reproduced by independent research labs, coupled with the availability of commercial bioreactors for electromechanical stimulation, the availability of mature cardiomyocytes will provide a clear pathway to 3D bioprint human hearts for clinical transplantation.

Bioprinting is used in a wide variety of applications today, from cardiac patches and cellularized hearts to the creation of heart valves, and more, ultimately shaping an overall transformation of cell culture. What do you think of this news? Let us know your thoughts! Join the discussion of this and other 3D printing topics at 3DPrintBoard.com.

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The therapeutic options are still insufficient – Bandera County Courier

How many sufferers are currently on the Covid 19 Charit stations, and what is the treatment of the patients who come to you?

We have on our Covid 19 ward currently has nine patients, including some who are doing reasonably well but cannot be well cared for at home, and those who are a little more serious and who need support from one to two liters of oxygen per minute. Some of them also have to be checked repeatedly to determine whether they need to be transferred to the intensive care unit and mechanically ventilated. And finally there are eleven ventilated patients in our Covid intensive care unit today.

When should ventilation be?

What is important is the respiratory rate, i.e. the frequency with which the patient breathes and the saturation of his blood with oxygen . We observe: How much oxygen do I give, how much is received? This is a good parameter for the extent of lung damage. The patient experiences exhaustion at a certain point, then we have to ventilate. Covid 19 has something very destructive to the lung cells.

[Die neuesten Entwicklungen und Hintergrnde zum Coronavirus knnen Siehier in unserem Newsblog mitverfolgen.]

If everything goes well, the situation will improve within three days, so that we can weave the patient, ie wean from the ventilator, but it can also take a week or two last. This type of ventilation is not enough for a subgroup, here we use a kind of replacement lung outside the body. All of this is not new territory for intensive care medicine, but it is very complex and personnel-intensive.

Sick every year 750. 000 People with pneumonia, 290. 000 from them to the hospital. So there is plenty of experience with pneumonia. What is special about the current situation?

If you look at the classic bacterial pneumonia, then come against the bacteria use antibiotics. In these cases, you can often see a black-and-white effect: seriously ill people quickly get well with medication. That is now different in the treatment of the Covid virus infection 19 Antibiotics play no role at first, they may come into play later with complications caused by bacteria. What we have so far against Covid 19 is insufficient.

Which drugs are used?

First there is an old preparation from HIV treatment, Kaletra, which contains the active substances against retroviruses lopinavir and retonavir contains. However, the effect and possible side effects have to be weighed here, because the agent can, for example, increase liver values. In the New England Journal of Medicine (NEJM), a paper from China has just appeared in which its use made no difference. However, there was only very late, namely twelve to 13 days after Beginning of the disease, therapy started.

Then there is a candidate from Ebola research, the active ingredient Remdesivir. According to the first findings, it seems to be rather effective, but of course the experiences are not endless. Studies are ongoing and you can use it as part of an individual healing attempt. However, it is currently difficult to get hold of the drug, it is not supplied in large quantities. It is very important that you can only have it within the framework of a formalized process. There is a narrow treatment window: the patient must be intubated, but he must not have circulatory failure.

What about the malaria drug hydroxychloroquine, about which a violent dispute has arisen between the virologists in France after a small, uncontrolled study?

Hydroxycloroquine appears with every new virus infection because it has a certain effectiveness. However, this active ingredient also has side effects, especially on the cardiac conduction system. It is therefore important to monitor the patient's ECG. A large randomized clinical trial of hydroxychloroquine is currently underway under the direction of the University Hospital in Tbingen.

What about clinical studies, science comes In view of the tense situation in everyday clinical practice, rightly so?

Yes, we will do better than a few years ago at EHEC! In the end, there were no really new insights. This is changing this time, we are closely networked, randomized clinical studies are being carried out that span several centers, and the procedures are being coordinated. Not everyone can do what they want. We have come together in competence networks. Physicians, large clinics and scientists from basic research have been working well together for years in the CAP network for pneumonia acquired outside the hospital, which was funded by the Federal Ministry of Research and is now working as a foundation. Large international clinical trials are now underway.

The French national research institution Inserm announced yesterday that its Aegis the substances Kaletra, Remedesvir and Hydrochloroquine, which we have just spoken about to be compared in a large international study called Discovery, the WHO launched the large-scale study Solidarity. Agents that are already being used against other diseases are being tested. How about the ACE2 inhibitor, of which there is currently a lot of talk ?

We have Access to the inhibitor that attaches to ACE2 and its associated protease and can thus block virus uptake into the cell, and we will also test it in a study. However, this ACE2 inhibitor has so far only proven its effectiveness in cell culture. The question remains whether and in what dose it works in humans. I know of a dozen other drug candidates whose investigation is planned as part of studies in our clinic. This also includes some experimental approaches that are used to block signaling pathways in the cell so that the virus cannot replicate, or in which stem cells are used. Another approach is to restore the tightness of the vessels. With severe pneumonia, there is water in the lungs where there used to be air. The lungs look white on the x-ray.

What about the idea , use blood plasma from people who have survived the disease to heal the sick?

This is obvious and is currently being pursued. If you think about it further, you could use antibody-based therapy. The cells that made the antibody in a previous patient are isolated beforehand and ultimately let them produce large amounts of antibody.

In addition to this search for new therapies Research on other questions is also important: In the BMBF-funded project PROGRESS-net, we have been dealing with the genetic differences between patients with severe pneumonia for some time. We want to understand why some of them have to go to intensive care later because they develop lung failure and possibly sepsis. And we want to be able to predict it.

What situation are we in now and how will it go on? Currently the therapeutic instruments are very modestly equipped. It is now the phase of science and clinical trials. However, unlike Italy at the moment, we have the chance not from Covid 19 to be overwhelmed if we test sensibly and know where we stand.

We are in a different situation from the plague in the Middle Ages, where people are were smart enough to use contact blocks, but the epidemic only came to a halt after there were no longer enough victims. We can hope that in the end a new therapeutic or a new vaccine will put an end to the spook.

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The Forefront of Treating Hair Loss in Women – Yahoo Lifestyle

Hair loss has long been a chief complaint among women, especially as they age. It affects some 30 million women in the United States alone, according to the Cleveland Clinic, and will significantly impact more than 50 percent of women during their lifetime. The most common cause is female-pattern hair loss (FPHL), also known as androgenetic alopecia. It's a chronic and progressive condition that has a genetic component, but it's also caused by factors related to the actions of hormonesovarian cysts, use of high androgen index birth control pills, pregnancy, and menopause, explains Ken L. Williams Jr., D.O., hair restoration specialist, surgeon, founder of Orange County Hair Restoration in Irvine, California.

Other medical conditions are also to blame for hair loss in women, including thyroid disorders, polycystic ovary syndrome, anemia, and chronic illnessand the use of certain medications, many of which treat these conditions, can also lead to hair loss in women. "Certain types of autoimmune disorders result in a slightly different and often less dramatic hair loss problem known as alopecia areata, an inflammatory condition that causes hair to come out in clumps or patches," says Dr. Williams Jr.

Luckily, we've come a long way in terms of treating hair loss. After all, 100 years ago, remedies involved things like snake oil and bat and chicken dung. "In more recent years, clinically tested topical and oral products, such as Minoxidil and Propecia, have become available, as well as procedures like PRP (platelet rich plasma therapy), and hair transplants," shares Anabel Kingsley, consultant trichologist and brand president for Philip Kingsley. She finds a holistic, personalized, multi-pronged approach to be the most effective way to treat any form of hair loss. "Since there is no 'one size fits all,' you want to optimize all possible factors that can affect the hair growth cycle, such as general health, nutrition, and stress levels, as well as the condition of your hair and scalp," she says.

At Philip Kingsley, she treats clients with their Trichotherapy Regime ($215, saksfifthavenue.com), which is specifically formulated for women with fine hair and reduced volume. "It tackles hair loss from all possible angles via the scalp with intensive daily Scalp Drops($89, neimanmarcus.com),a daily Stimulating Scalp Tonic ($28, net-a-porter.com), a thickening protein spray, and targeted masks to optimize the scalp environment," Kinglsey explains. "It also contains carefully formulated nutritional supplements to help give hair support from within."

Related: The Best Shampoos to Support Thinning Hair and Fight Female Hair Loss

Over-the-counter solutions won't work for every person suffering from hair loss, but there are a number of medical interventions that can stimulate hair growthanti-androgen medication, for example, is recommended for clients experiencing prolonged hair loss. "These medications help prevent further hair loss and encourage some hair regrowth from dormant hair follicles," says Dr. Williams Jr. There is also stem cell therapy, which has expanded greatly over the last few years in treating medical disease. "As opposed to embryonic cells, the initial stigma of using stem cells has decreased since the discovery of using bone marrow, fat cells, umbilical cord cells, and even skin cells to extract stem cells," he explains.

Surgery is also an option, and there are currently two primary surgical techniques or methods used in performing hair transplantation: Follicular Unit Transplantation (FUT) and Follicular Unit Extraction (FUE). "With the FUT technique, a section of scalp is excised with a scalpel, the scalp is brought together with sutures or staples and the hair follicles or hair grafts are inserted into tiny slits placed by the surgeon in the balding recipient area," Dr. Williams Jr. says. "The follicles with a single hair are placed in the front rows to define and create a natural hairline and the more dense, natural occurring follicular units are placed by hand in areas where hair density is needed the most."

FUE, a minimally invasive technique that is being hailed as the most significant improvement in hair surgery, uses a minimal depth scoring punch device to loosen the follicle from the surrounding tissues. "With the FUE procedure, a 0.9 or 1.0 millimeter punch minimal depth scoring excision is used in the skin around the upper part of the follicular unit (hair follicles)," he continues. "The hair follicle is then extracted directly from the scalp and manually placed into tiny slits in the balding area similar to the strip method."

There are still several hair restoration solutions left to be discoveredand experts believe most of us will see the concept of hair cloning come to fruition in their lifetime. "Hair cloning would in effect, disassemble a few hair follicles, multiply these cells in the laboratory and then reintroduce them into the scalp to both rejuvenate miniaturizing hair follicles and induce brand new hairs," Dr. Williams Jr. says. "Other groups have tried this but it has been found that when human follicle cells are cultured, they rapidly lose their functionality."

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Study reveals gene therapy may help in treating cardiac disease – The Siasat Daily

California: In a breakthrough study, researchers have found a potential treatment for life-threatening cardiac diseases by using gene therapy.

Danon disease is a very rare, life-threatening condition where the fundamental biological process of removing and recycling proteins does not work.

This impairment results in dysfunction of the heart, skeletal muscle, neurologic system, eyes, and liver. Most patients die or require heart transplants by the third decade of life.

In the study, which was published in Science Translational Medicine, researchers have identified a novel way to treat Danon disease using gene therapy.

Heart transplant is not always available for patients and does not treat the other organs affected in Danon disease. We knew we needed to find therapies specifically designed to address the underlying cause, said the lead researcher Eric Adler.

Danon disease is a result of mutations in the gene LAMP2. For nearly a decade, Adler and a team of researchers at UC San Diego Health have been working to determine whether gene therapy could provide a new treatment approach.

Gene therapy involves either replacing or repairing a gene that causes a medical problem or adding genes to help the body treat disease. In this case, Adler and the team focused on adding a specially designed gene that restores the LAMP2 function, resulting in improved cardiac and liver function.

We utilised mice that were a model for Danon disease and missing this specific LAMP gene. We applied gene therapy to a group of these mice and compared to mice that did not receive treatment, said Adler.

The mice that received gene therapy expressed positive results in heart, liver and muscle function. The hearts overall function of ejecting blood and relaxing improved, as did the bodys ability to degrade proteins and metabolism.

Danon disease is more common in males, and symptoms begin in early childhood or adolescence.

In many cases, the condition is inherited by a parent, typically the mother. We believe Danon disease is actually more common than we think, but it is often misdiagnosed, said Adler.

By utilising gene therapy, we were able to identify a possible new treatment approach other than a heart transplant. This study is a significant step for patients with Danon disease, Adler added.

Prior studies in Adlers lab have focused on using a patients skin cells to create stem cells. These stem cells were used to create a heart model, allowing researchers to study Danon disease at the cellular level.

The approach has provided new insight into the diseases pathology and led to the idea of using gene therapy. Our work is also proof that using stem cells to model diseases has great potential for helping develop new medicines, said Adler.

The next step, said Adler, is testing in patients with Danon disease. A Phase I clinical trial for safety and efficacy has begun.

This is the first trial using gene therapy to treat a genetic cardiac disorder and three patients are currently being treated, which means were that much closer to finding a cure for this terrible disease, and may be able to use similar methods to treat other diseases, said Adler.

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Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine in Patients with COVID-19 Associated Respiratory Illness – PRNewswire

LEXINGTON, Mass., March 24, 2020 /PRNewswire/ --Partner Therapeutics, Inc. (PTx) announced that Leukine (sargramostim, rhu-GM-CSF)is being assessed in the SARPAC trial (sargramostim inpatients withacute hypoxic respiratory failure due toCOVID-19 EudraCT #2020-001254-22) at University Hospital Ghent to treat patients with respiratory illness associated with COVID-19. Major medical centers in Germany, Italy and Spain are considering joining the study. The study will evaluate the effect of Leukine on lung function and patient outcomes.

"Patients with COVID-19 who progress to acute hypoxic respiratory failure due to COVID-19 have very limited treatment options and a high mortality rate," said Prof. Bart Lambrecht, Principal Investigator for the trial at University Hospital Ghent and the Flanders Institute of Biotechnology (VIB). "We rapidly initiated this study with Leukine, because GM-CSF has profound effects on antiviral immunity, can provide the stimulus to restore immune homeostasis in the lung, and can promote lung repair mechanisms."

Granulocyte macrophage colony stimulating factor (GM-CSF) is essential for the health of the lungs. Alveolar macrophages, a cell type found in the lungs, are dependent on GM-CSF for differentiation and normal functioning. GM-CSF is an immunomodulator that plays a critical role in host defense against pathogens and maintaining proper functioning of the immune system.1 GM-CSF confers resistance to influenza by enhancing innate immune mechanisms.2 In animal studies, GM-CSF reduced morbidity and mortality due to acute respiratory distress syndrome (ARDS) from viral pneumonia.3 In clinical studies, use of Leukine showed beneficial effects in patients with viral pneumonia.4,5 Recent data highlight the importance of understanding the immune status of patients and role of immunomodulating agents like GM-CSF to activate the immune system to help clear virus and reduce the risk of secondary infections.6

"Partner Therapeutics is committed to investigating Leukine in patients with COVID-19 and we are working with academic and government agencies here in the US and in Europe in this effort," said Dr. Debasish Roychowdhury, Chief Medical Officer at Partner Therapeutics. "We believe, like many investigators and scientists, that GM-CSF has multiple ways by which it may help these patients, including playing a role in clearing the infection, boosting the immune system and repairing damaged tissues."

"In pre-clinical studies, GM-CSF protects the lungs from viral pneumonia and the influenza A virus", stated E. Scott Halstead, MD, PhD, Associate Professor, Penn State University College of Medicine, Department of Pediatrics, Division of Pediatric Critical Care Medicine. "Preliminary data indicate an apparent benefit of inhaled Leukine therapy for autoimmune pulmonary alveolar proteinosis ("aPAP") and suggest it has reduced the need for whole lung lavage therapy for patients receiving treatment. Collectively, the data suggest that aerosolized Leukine may prove to be a meaningful therapy to decrease mortality and increase ventilator-free days in patients with respiratory disorders associated with viruses such as COVID-19 and Influenza A."

For the treatment of COVID-19 associated acute hypoxic respiratory failure and ARDS, Leukine will be used in nebulized form for direct inhalation or through intravenous administration for patients already on a respirator. Nebulized Leukine has been studied in phase 2 and phase 3 randomizedtrials in pulmonary conditions that affect alveolar macrophages, such as aPAP. IV administration of Leukine has been studied extensively in other conditions and in phase 2 randomized trials in ARDS.

Leukine was initially approved in the United States in 1991 and has been approved for use in five clinical indications. Its safety and tolerability profile are well understood. In 2018, Leukine was approved for use as a medical countermeasure to treat Acute Radiation Syndrome (ARS) and has been procured for use by the U.S. Strategic National Stockpile. Leukine is distributed outside the U.S. on a named-patient basis through PTx's designated program manager, Tanner Pharma Group. The use of Leukine to treat respiratory disorders associated with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

About Leukine(sargramostim)Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF. GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, epithelial repair, and augmentation of innate host defense by effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity.

Important Safety Information for LEUKINE (sargramostim)

Contraindications

Warnings and Precautions

Adverse Reactions

Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

Indications and Usage

LEUKINE (sargramostim) is a leukocyte growth factor indicated for the following uses:

About Partner Therapeutics, Inc.: PTx is an U.S.-based commercial-stage biotech company focused on the development and commercialization of therapeutics that improve health outcomes in the treatment of cancer. PTx's development focus spans the entire range of cancer therapy from primary treatments to supportive care. The company believes in delivering great products with the purpose of creating the best possible outcomes for patients and their families.

References

Cited References

Other RelevantReferences

SOURCE Partner Therapeutics, Inc.

http://www.partnertx.com

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This pediatrician helps trans kids and moonlights playing klezmer – The Jewish News of Northern California

Dr. Ilana Sherer, 38, has a general pediatrics practice in Dublin at the Palo Alto Medical Foundation/Sutter Health with a specialty in caring for gender-nonconforming and transgender youth. Shes also a violinist with Saul Goodmans Klezmer Band. She lives with her wife and two children in Oakland.

J.: You like to say youre the best klezmer violin-playing pediatrician in the Bay Area. How did that come to happen?

Ilana Sherer: Classical violin was a huge part of my life from age 5 through high school. At a Hillel event in college, I sat next to someone in a klezmer band. There was a deep learning curve, but I played through college and then in medical school. Ive played quite a bit here but its more limited now because of my kids. I grew up in a pretty mainstream Jewish community and klezmer helped me see there were other ways to connect to Judaism. Once I entered the klezmer/Yiddish world, I thought about how this is what my grandparents spoke, and how Yiddish culture has these really strong leftist roots.

Did you always know you would be a doctor?

When I was growing up, I was often told by my parents and others Youre going to be a doctor, but I wouldnt go along with what people thought I should do. For a time I thought I might be a research scientist, but then I realized I didnt like working in a lab. There was one person there who was a medical student studying to become a pediatrician. I went along with them to a clinic and thought This is what I want to do. Everyone was right all along, but I had to figure it out myself.

When did you choose to specialize in gender-variant children?

I worked at an LGBT health center during medical school. We treated a lot of transgender people, many of whom experienced homelessness and different kinds of abuse. I saw a 20/20 episode with a transgender college student, teenager and child. The kid was doing really well, and it was an aha moment. I thought, What can we do to protect these kids, to keep them from struggling the way the adults are? When I got to UCSF for residency, I was directed to Stephen Rosenthal, who was creating the [Child and Adolescent Gender Center at UCSF Medical Center].

There are a lot of Jews working in this field, true?

Once, at the center, we were trying to schedule our next meeting and realized that everyone in the room but one person was Jewish. I see it as part of the social justice terrain and my personal responsibility as a queer person and a Jew. These are the kids who need us to support and advocate for them in the way the generation before advocated for me.

How do you explain the rise in trans or nonbinary children, and at younger ages?

Kids are now taught they can be whoever they want to be. Were breaking down this imaginary social binary that tells you what each gender should do, but were also telling kids that you are in charge of how you live your best life and your best self. Not all kids who experiment will continue identifying as transgender, but they feel comfortable exploring it. In the past, a boy wearing a dress would get teased. Now, kids have the freedom to explore how they present and dress.

With a relatively small body of research, how do you know which treatment protocols to follow?

We dont start any medical intervention until puberty. Most children who present as transgender now do so early, sometimes as early as 2 or 3, but we dont need to do anything but support and love them until puberty. Then, they can take hormone blockers, which are fully reversible.

South Dakotas state representatives introduced a law that would make it illegal for doctors to give such hormone blockers to children, but ultimately, it was defeated.

Its so heartbreaking. Doctors providing this care in climates like that are my heroes. I admire those who are sticking their necks out. I feel very protected and lucky to be in the Bay Area.

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This pediatrician helps trans kids and moonlights playing klezmer - The Jewish News of Northern California

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Dr. HE Obesity Clinic: Weight loss clinic in Turkey – Treatment Abroad

"; images = images + ""; images = images + ""; images = images + ""; images = images + ""; images = images + ""; images = images + ""; images = images + ""; images = images + ""; images = images + ""; images = images + ""; images = images + ""; jQuery('.imgGallery').prepend(images); jQuery('.each_image:first').show()}function navigateSliderNext(){coutner_img = parseInt(jQuery('#thecnt0').html());counter_img++;if(counter_img>total_img){counter_img=1}jQuery('#thecnt0').html(counter_img);jQuery('.each_image').hide()jQuery('.each_image[id="is'+counter_img+'"]').show()}function navigateSliderPrev(){coutner_img = parseInt(jQuery('#thecnt0').html());counter_img--;if(counter_imgAbout Dr. HE Obesity Clinic

Dr. HE Obesity Clinic in Istanbul, Turkey offers expert assessment and surgical treatment for obesity from leading bariatric surgeon, Assoc Prof Dr Hasan Erdem, and his team. With extensive pre- and post-operative counselling and a one-to-one patient-orientated approach, the clinic is committed to finding the best treatment solution for each individual case. All surgery is carried out at partner hospitals in Istanbul. Treatment options available include sleeve gastrectomy, gastric bypass and non-surgical weight loss (gastric balloon).

Assoc Prof Dr Hasan Erdem is one of Turkey's leading bariatric surgeons and has performed more than 5000 weight loss surgeries to date.

Dr Erdem qualified from the Istanbul Medical School of Istanbul University in 2002 and completed his specialist training in general surgery at Bezmialem Vakif Gureba Teaching Hospital in Istanbul. Following his national service at a government hospital, he worked as Chief Assistant in General Surgery at the Training and Research Hospital of Istanbul, where he carried out research into advanced laparoscopic and robotic surgery.

Dr Erdem established his private clinic in Istanbul in 2016. The author of a number of scientific publications in the fields of obesity, metabolic and robotic bariatric surgery, he was granted the title Associate Professor of Obesity and Metabolic Conditions in 2018.

Read what patients have to say about Dr. HE Obesity Clinic on Trustpilot

Sleeve gastrectomy or gastric sleeve, is a keyhole procedure to remove approximately 80% of the stomach, including the area where the hunger hormone, ghrelin, is produced. The resulting smaller gastric volume and loss of appetite thus leads to rapid weight loss.

Sleeve gastrectomy is suitable for people aged between 18 and 65 who have failed to lose weight by means of diet or exercise and who have a BMI of 40 or higher. It may also be considered in patients with a BMI of 35-40 who have co-morbidities such as diabetes, hypertension or sleep apnoea.

With the lowest complication risk and highest lifelong comfort compared to other methods, sleeve gastrectomy has become the favoured procedure with bariatric surgeons worldwide.

Gastric bypass offers a permanent solution to the diseases associated with obesity, particularly type 2 diabetes. It is suitable for patients who have a history of multiple unsuccessful attempts at losing weight with diet, those with excess weight that may jeopardise health, people with a BMI of 40 or higher, or people with a BMI of 35-40 with any obesity-associated co-morbidity.

Performed laparoscopically (keyhole surgery), the procedure shrinks the stomach to a small pouch and causes the food to bypass the upper portion of the small intestine. This has a dual effect: both the amount of food that can be ingested and the amount of nutrients that can be absorbed is reduced.

Most patients who undergo gastric bypass surgery successfully lose weight and maintain their excess weight loss in the long term. The role of a dietician is important in the postoperative period to ensure that patients adapt to the dietary changes required, however the rates of postoperative patient satisfaction are high in terms of the psychological and physical effects.

An intragastric balloon is a soft, expandable balloon that is inserted endoscopically into the stomach. Once placed, the balloon is filled with liquid, generating a feeling of fullness when smaller food portions are ingested. A gastric balloon may be in place for 6 or 12 months.

The gastric balloon is designed to work in conjunction with dietary and lifestyle changes. It is suitable for overweight people with a BMI over 25 who have failed to lose weight with diet or exercise, who have lost motivation or who do not want to undergo a surgical procedure.

Dr. HE Obesity Clinic welcomes patients from around the world and has dedicated patient coordination and consultation services in English, German, Bulgarian, French, Spanish, Armenian, Italian and Arabic.

For more information, call the clinics 24/7 Obesity Help Desk on 90 543 346 10 37 or fill out the online form to get a free consultation.

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What is normal body temperature? How to know if you have a fever – Insider – INSIDER

Since 1851, normal human body temperature has been considered 98.6F (37C), established by Carl Reinhold August Wunderlich, 'the father of clinical thermometry'.

However, the German physician also observed variances in temperature depending on age and gender, and noted that normal body temperature is better described as a range.

Here's what you need to know about your body temperature, when it's considered a fever, and how to take it properly.

The human body isn't consistently one temperature, and depending on your age, the time of day, and even the activities you've been doing, it's more accurate to describe a normal body temperature range: between 97F (36.1C) and 99F (37.2C), according to Mayo Clinic.

"Temperature can vary between individuals, where some well members of a family are consistently warmer than others," says Charles Brantly, MD at Central Health. "This is not necessarily a bad thing. The normal range for the vast majority of people is between 36C and 37C."

A 2017 study of 35,488 people published in the British Medical Journal found the average body temperature to be 36.6C, slightly lower than what Wunderlich found in 1851. Moreover, a 2020 study from Stanford University School of Medicine, which assessed temperatures taken from three different databases over a 157-year period, found that the average body temperature has decreased over time a drop of 0.03C per birth decade.

The study authors indicate that the change in body temperature could be linked to improvements in human health and lifespan, as body temperature is an indication of metabolic rate. In this study, a slower metabolic rate was correlated with a longer life.

While core body temperature for men and women is roughly the same, in one study, women were found to generally have a lower skin temperature in some areas, because of their higher percentage of body fat. Brantly says that women can also have varying temperatures during their monthly menstrual cycle, and points out many other factors that can affect temperature on a day-to-day basis.

"On average children tend to be slightly warmer than adults, and those over 65 are cooler," says Brantly. "Exercise, hydration status, and clothing will all affect your day time temperature as well."

Chawapon Kidhirunkul, MD at BDMS Wellness Clinic, also says that time of day can impact your temperature. "Our temperature drops at night during sleep and increases over the day," Kidhirunkul says. "The lowest temperature is at around 4 a.m., and the highest peak at 5 p.m."

This rise in temperature is due to increased cortisol the stress hormone in the body as we go through the day. Kidhirunkul adds that another factor can be food, which usually increases temperature slightly after a meal.

High body temperature is one of the first symptoms of illness. According to Cleveland Clinic, 100.4F is considered a fever for adults, and children may feel feverish at slightly lower temperatures, depending on how you take the temperature.

A fever is an indication that your body is fighting off an infection, and is a common response to many kinds of viruses and illnesses. It's often associated with other symptoms like chills, headaches, tiredness, body aches, and sweating.

If you're feeling feverish, Brantly advises measuring your temperature and recording it several times a day, as thermometers aren't always accurate and your temperature may rise and fall throughout the day.

Fever is also a common symptom of the coronavirus. If you think you may have a fever associated with other symptoms of coronavirus, follow the CDC guidelines for taking care of yourself and preventing the spread of the virus.

There are several options when taking your temperature, such as armpit, forehead, mouth, ear, and rectal methods, according to Kidhirunkul.

The most common and easiest method of taking your temperature is in the mouth, however, Kidhirunkul says rectal temperatures are the most accurate. When it comes to a professional setting, Brantly notes that most hospitals and clinics rely on ear thermometers, though these are more expensive.

The UK's National Health Service recommends digital thermometers, which are inexpensive and easy to use. To take an oral temperature reading at home, follow these steps:

1. Put the thermometer under the tongue.

2. Close your lips around the thermometer to hold it in place.

3. The time the thermometer takes depends on the manufacturer's instructions: set a timer, or if it's digital, it may already have a timer function.

4. Once the time is up, remove the thermometer and then read it.

5. Make sure to clean the thermometer before putting it away.

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What is normal body temperature? How to know if you have a fever - Insider - INSIDER

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IVF journey: tips to manage the emotional stress – Raconteur

Head to a motor racing circuit and you might be surprised to find one of the drivers sharing his experience of a bumpy fertility journey, as well as talking tyres and podium positions.

It might seem out of place, but for Toby Trice its a chance to share the tough emotional stress of in vitro fertilisation, or IVF, with a wider audience.

I had all this anger, frustration and stress, which I released through go-karting, says the 29 year old, who has been through IVF and the pain of unexplained infertility with partner Katie.

That led to me embarking on a motorsport career and I realised I could use it to start conversations about fertility and IVF. I want to send out a strong message that you can talk about what you are going through.

Uncertainty, guilt, sadness, anxiety: the emotional stress of IVF has been documented by Fertility Network UK, which found fertility problems and treatment cause high levels of distress.

IVF is not just about the four weeks of treatment, but potentially years of disappointments and hopes, explains Tim Child, medical director at Oxford Fertility and associate professor at Oxford Universitys Nuffield Department of Womens and Reproductive Health. Patients have very often been through the ringer by the time they get to IVF.

The process can be gruelling, both physically and emotionally, with no guarantees of success. While everyone is different, particular points where IVF emotional stress can spike are during internal pelvic scans to check for follicles in the ovaries, during egg collection carried out under a light general anaesthetic or intravenous sedation and on embryo transfer day.

For a heterosexual couple, the man could face anxiety about producing a sperm sample, while the woman might be apprehensive about the daily self-injecting of drugs during the IVF cycle.

Adjunctive therapies such as reflexology, acupuncture, yoga and psychotherapy can be useful around these times to help manage the stresses, says Child.

Clinic-led support groups can be a source of help and, for Kelly Da Silva, her own eight-year journey through multiple rounds of artificial insemination and IVF prompted a desire to help others.

As well as setting up her own childless support organisation and online community The Dovecote, she began working with the Care Fertility clinic where she had her treatment. The 37-year-old pioneered monthly walk-and-talk events in green spaces across the country, as well as Skype events.

Peer-to-peer support can be really cathartic, she explains. The exercise aspect also helps low mood and can be something that gets neglected.

I realised I could start conversations about fertility and IVF. I want to send out a strong message that you can talk about what you are going through

Da Silva has also set up a buddy scheme, matching those going through the same stage and type of treatment. Plus, I am buddying up men, same-sex couples and women having donor sperm or eggs, she says. Not everyone is on the same journey.

The focus on matching those on similar journeys is important, as the Human Fertilisation and Embryology Authoritys latest statistics show significant increases in same-sex partnerships and single patients among the 75,000 IVF cycles in the UK each year.

Female same-sex partnerships now make up 5.9 per cent of IVF cycles, while single patients make up 3 per cent.

Helen George, a psychotherapist specialising in fertility issues and founder of BME Voices Talk Mental Health, says counselling in an emotionally safe space can help prepare for IVF.

It also provides the opportunity to explore the lasting implications of having IVF treatment using donor eggs, sperm or surrogacy, she adds.

Its something that Gloucestershire couple Heidi and Gary Stephens advocate. While Heidi, 34, had counselling through the IVF process, Gary, 50, believes he would have benefited from the emotional help, especially as he went through surgical sperm recovery to retrieve blocked sperm.

I dont like talking about my worries, but inside it was eating me away, he says. You have to remain positive, but its such a lottery. With hindsight, I would have seen a counsellor.

While IVF treatment is filled with uncertainty, theres an area that can be controlled: nutrition. Nutritionist Dr Marilyn Glenville, a specialist in womens health, says regulating blood sugar has the biggest impact on helping women going through the rollercoaster of hormones.

The same hormone, cortisol, that manages stress also manages blood sugar, so we can end up feeling more stressed, she says.

Reducing refined sugars, such as the comforting chocolate muffin after that internal pelvic scan, and replacing it with high-quality, fresh foods, can minimise additional emotional stress. Supplements containing magnesium and B vitamins act as natural tranquillisers, says Glenville, while chromium can help tackle sugar cravings.

Meanwhile, work can prove a further painpoint, with Fertility Network UKs research finding 58 per cent of people said work affected their treatment.

Although theres currently no statutory right to time off for IVF treatment, more employers are now taking the issue seriously and creating their own policies.

Nurse Natalie Herring, 32, and her husband Ian, 36, struggled with fertility before undergoing IVF and she says being open with her employer helped.

Im very lucky as my employer has an IVF policy, which is best practice, so I was very open with my manager, she says. They were so supportive, there to listen and help me as much as they could if I needed it.

With more than 1.1 million IVF cycles now having taken place in the UK, and more than 300,000 babies born through IVF, the chances are patients are not the first in their workplace dealing with IVF.

Professor Geeta Nargund, medical director at CREATE Fertility and lead consultant for reproductive medicine services at Londons St Georges Hospital, concludes: If we want people to be more open and honest about fertility issues, we need to raise awareness, educate and get the conversation started. Its time to lift the stigma and help people with emotional support.

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Suncor Energy provides a corporate update including revised 2020 capital program, operating costs and production outlook – GlobeNewswire

CALGARY, Alberta, March 23, 2020 (GLOBE NEWSWIRE) -- Suncor released a corporate update today, including revised 2020 corporate guidance for capital, operating costs and production outlook, reflecting the significant decline in the crude oil price and uncertainty surrounding the economic impact of COVID-19.

The simultaneous supply and demand shocks are having a significant impact on the global oil industry. We are adjusting our spending and operational plans to be prepared in the event the current business environment persists for an extended period of time, said Mark Little, president and chief executive officer. Our business model and financial strategy are designed to withstand volatile environments.

Suncors business model is built on long life, low decline assets and capturing the full value of the barrel through integration. This model, paired with disciplined adherence to financial management and capital allocation, has consistently delivered value to shareholders while maintaining a strong balance sheet. Suncors credit metric history and strong levels of liquidity through various cycles are evidence of this discipline.

A key strategy for weathering the unprecedented market challenges is remaining focused on creating maximum value from production, rather than being volume focused. Suncor believes this is critical to creating long term shareholder value and that the integrated model is an important competitive advantage. With growing global oil inventories, Suncors ability to upgrade, refine, and sell production to consumers through its retail network will continue to generate significant value.

Our actions to respond to these unprecedented market challenges will result in reductions in capital spending and operating costs as well as a significant increase to the financial liquidity of the business in 2020, as detailed below.

CAPITAL GUIDANCE UPDATE

The revised capital program is expected to be between $3.9 and $4.5 billion, a $1.5 billion or 26% decrease compared to the original 2020 capital guidance midpoint. The updated capital spend is concentrated on sustaining capital and continuing with a limited number of low capital intensity, value creating projects, as follows:

Suncors original capital guidance was $5.4 to $6.0 billion, with approximately 50% allocated to economic investment and 50% to sustaining capital. By the end of Q1 2020, Suncor is expected to have spent approximately $1.3 billion in capital. In order to sustain the financial strength of the business within the current economic environment, it is crucial to reduce the capital budget. Suncor is able to make these reductions because of the flexibility previously built into the budget. The targeted reductions include a combination of reducing economic investment and sustaining capital by deferring and cancelling projects, while maintaining a focus on safety and asset reliability over the long term.

The Syncrude / Suncor interconnecting pipelines, deployment of autonomous haul trucks at Fort Hills, and investments in technology for the Supply and Trading business and core business systems will continue to be funded and proceed on schedule. The Cogeneration Facility at Base Plant, Forty Mile Wind project, and some offshore E&P step out development timelines have been extended for up to two years. The operator of West White Rose has announced that work has been suspended for an indefinite period. We have also deferred new in-situ well pads until financial conditions improve and cancelled several small economic investment projects across the business.

PRODUCTION & OPERATING COST GUIDANCE UPDATE

Across the company, Suncor remains committed to the health and safety of all personnel, and on the safety and continuity of the operations. To limit the risk and transmission of COVID-19, only location essential personnel are working at Suncor sites and offices.

It is evident that as a result of significant efforts to limit the impact of COVID-19 through social distancing and having non-essential personnel stay home across many countries around the world, petroleum demand has declined. This is particularly true for jet fuel and gasoline. Product demand in Canada is starting to decline and is expected to continue over the next few quarters. Suncor has begun to adjust refinery utilisations as a result. Due to significant uncertainty, we have not yet updated our guidance in this area, although we anticipate it will be lower. An update will be provided on the first quarter earnings call in early May.

Suncors updated upstream production guidance includes the best estimate, at this time, of the impact on crude markets of lower global product demand and industry wide lower refinery utilizations. Global upstream production will need to be reduced or remain in storage unsold. However, this is highly uncertain and is directly related to how long it will take to significantly reduce the global threat of COVID-19.

The value over volume strategy maximizes integration of Suncors upstream production through its upgraders and refineries, while reducing exposure to Alberta bitumen prices. This results in higher per barrel margin even though unit costs may be higher.

Crude by rail is now uneconomic and our updated guidance excludes any production volumes associated with rail transportation under the Province of Albertas Special Production Allowance program. Mandatory production curtailment is assumed to continue through 2020, which results in some assets operating at less than efficient rates.

Fort Hills continues to be disproportionately impacted by mandatory production curtailment with the asset operating at lower than optimal facility utilization. The Fort Hills partners have agreed to reduce Fort Hills to a one train operation, running at full utilization. This will increase cash flow, particularly when bitumen prices are extremely low, as we are able to significantly reduce variable costs. However, unit costs for the remaining production will be higher because of this decision as a result of fixed costs being covered by lower volumes. These assets have far less flexibility versus Suncors in-situ assets to ramp up and down. The partners will continue to monitor market conditions and re-evaluate these decisions as market conditions change.

The Syncrude annual coker turnaround was planned in Q2 but is now deferred until Q3 with a minor impact on volumes. The impact of COVID-19 on Suncors planned maintenance schedules is currently being assessed. This includes evaluating alternate options for the Terra Nova Asset Life Extension, as Spain is no longer able to accommodate the dry dock slot due to that countrys COVID-19 response. MacKay Rivers return to operations has been intentionally extended to May due to COVID-19 concerns and low bitumen prices.

Suncor is also reducing total operating expenditures across the business by more than $1 billion versus $11.2 billion of expenditures in 2019. Updated asset-based cash cost per unit guidance below reflects the revised production guidance and reduced operating expenditures.

Guidance for Oil Sands operations and Syncrude cash operating costs per barrel remain unchanged at $24.00 - $26.50 (US $17.00 - $18.75) and $35.00 - $38.00 (US $24.75 - $27.00), respectively. Fort Hills cash operating costs per barrel have been updated and are now expected to be $34.00 - $37.00 (US $24.00 - $26.25).

The production guidance table below is inclusive of the planned reductions in production volumes as Suncor continues to execute the strategy of generating value over volume.

Suncor'scorporate guidanceprovides management's outlook for 2020 in certain key areas of the company's business. Users of this forward-looking information are cautioned that actual results may vary materially from the targets disclosed. Readers are cautioned against placing undue reliance on this guidance.

CORPORATE & FINANCIAL UPDATE

Safety is at the core of Suncor values. As a result, the Investor Showcase, previously planned for May 2020, has been deferred to manage the risk of COVID-19 transmission. The AGM will be held on May 6th, 2020 but the Board and full executive team will not be present in person at the meeting. Unlike prior years, the AGM will not be open to the general public and will be limited to registered shareholders only. Suncor is discouraging physical attendance and instead requests shareholders view the meeting via webcast with details to be provided at a later date.

The corporate target of $2 billion of incremental free funds flow by 2023 continues to be a critical target of Suncors by enhancing margin, improving business processes, and reducing operating and sustaining capital costs. However, in order to maintain balance sheet strength, financial flexibility and liquidity, the execution timeline of a number of these initiatives has been revised, as outlined in the capital section above. As a result, full achievement of the $2 billion target is anticipated to be delayed by up to 2 years to 2025.

Disciplined capital allocation remains core to delivering value to shareholders. Given the current business environment, share repurchases have been suspended.

Suncors strategy of maintaining a strong balance sheet and liquidity throughout all market environments remains a key focus. As of December 31, 2019, Suncor had approximately $6.7 billion of liquidity, no debt maturities in 2020, $1.4 billion in 2021, and $225 million in 2022. As of March 31, 2020, Suncor has significantly increased its liquidity securing an additional $2.3 billion of credit facilities with its key banking partners. This increased financial flexibility ensures the company will have access to adequate financial resources should it be required.

Our strategy has been, and continues to be, to drive shareholder returns through our integrated model while maintaining financial strength and flexibility, said Mark Little. Our actions are intended to ensure the long-term health of our business while reliably delivering critical energy to consumers.

LEGAL ADVISORY FORWARD-LOOKING INFORMATION

This news release contains certain forward-looking information and forward-looking statements (collectively referred to herein as "forward-looking statements") within the meaning of applicable Canadian and U.S. securities laws. Forward-looking statements in this news release include references to: Suncor's belief that its business model and financial strategy are designed to withstand volatile environments; the belief that remaining focused on creating maximum value from production, rather than being volume focused is critical to creating long term shareholder value and that Suncor's integrated model is an important competitive advantage in achieving this; the expectation that, with growing global oil inventories, Suncors ability to upgrade, refine and sell production to consumers through its retail network will continue to generate significant value; the expected impacts of Suncor's actions to respond to the unprecedented market challenges; the expectation that Suncor's capital spending program will be between $3.9 and $4.5 billion (and the expectations of where that spending will be directed and the timing of the various capital projects); Suncor's commitment to the health and safety of all personnel, and on the safety and continuity of the operations; expectations for the first quarter of 2020, including total upstream production of approximately 743,000 boe/d, Oil Sands operations production of approximately 378,000 bbls/d, Synthetic Crude Oil production of approximately 331,000 bbls/d, Bitumen production of approximately 47,000 bbls/d, Fort Hills production of approximately 80,000 bbls/d, net to Suncor, Syncrude production of approximately 175,000 bbls/d, net to Suncor, E&P production of approximately 110,000 boe/d, Suncor Refinery Throughput of approximately 445,000 bbls/d, Suncor Refinery Utilization of 96% and Refined Product Sales of approximately 545,000 bbls/d; Suncor's expectations relating to product demand and the impacts it may have on refinery utilizations; that Suncor's value over volume strategy will reduce exposure to Alberta bitumen process which will result in higher per barrel margins even though unit costs may be higher; operations; the expected impact of the Government of Alberta mandatory production curtailments and assumption relating to the duration thereof; the expected impacts of the decision to reduce Fort Hills to a one train operation; Suncor's expectations with respect to planned maintenance and turnarounds, including the timing thereof and the impact of such maintenance and turnarounds; that MacKay Rivers return to operations will occur in May; the plans to reduce total operating expenditures by more than $1 billion across Suncor's business; Suncor's $2 billion incremental free funds flow target, including the projects that are expected to drive Suncor towards this target and the timing of achieving this target; Suncor's expectations around production, including planned average upstream production of 740,000 - 780,000 boe/d and planned ranges for Oil Sands operations (410,000 435,000 bbls/d), made up of Synthetic Crude Oil (310,000 325,000 bbls/d) and Bitumen (100,000 110,000 bbls/d), Suncor's working interest in Fort Hills 55,000 65,000 bbls/d), Suncor's working interest in Syncrude (165,000 180,000 bbls/d) and Explorationand Production (100,000 115,000 boe/d); Suncor's expected Oil Sands operations cash operating costs, projected to be in the range of $24.00 - $26.50 (US $17.00 $18.75) per barrel; expected Fort Hills cash operating costs, projected to be in the range of $34.00 - $37.00 (US $24.00 $26.25) per barrel; expected Syncrude cash operating costs, projected to be in the range of $35.00 $38.00 (US$24.75 $27.00) per barrel; Suncor's expected Refinery Throughputs (440,000 460,000 bbls/d) and Utilization (95% 99%) and Suncor's expected Refined Product Sales (530,000 560,000 bbls/d); the timing of upcoming debt maturities; Suncor's belief that its financial flexibility ensures the company will have access to adequate financial resources should it be required; and Suncor's belief that its actions will ensure the long-term health of its business while reliably delivering critical energy to consumers. In addition, all other statements and information about Suncor's strategy for growth, expected and future expenditures or investment decisions, commodity prices, costs, schedules, production volumes, operating and financial results and the expected impact of future commitments are forward-looking statements. Some of the forward-looking statements may be identified by words like "guidance", "outlook", "will", "expected", "estimated", "focus", "planned", "believe", "anticipated", "forecast", "target" and similar expressions.

Forward-looking statements are based on Suncor's current expectations, estimates, projections and assumptions that were made by the company in light of its information available at the time the statement was made and consider Suncor's experience and its perception of historical trends, including expectations and assumptions concerning: the accuracy of reserves and resources estimates; commodity prices and interest and foreign exchange rates; the performance of assets and equipment; capital efficiencies and cost-savings; applicable laws and government policies; future production rates; the sufficiency of budgeted capital expenditures in carrying out planned activities; the availability and cost of labour, services and infrastructure; the satisfaction by third parties of their obligations to Suncor; the development and execution of projects; and the receipt, in a timely manner, of regulatory and third-party approvals.

Forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties, some that are similar to other oil and gas companies and some that are unique to Suncor. Suncor's actual results may differ materially from those expressed or implied by its forward- looking statements, so readers are cautioned not to place undue reliance on them.

Assumptions for the Oil Sands operations, Syncrude and Fort Hills 2020 production outlook include those relating to reliability and operational efficiency initiatives that the company expects will minimize unplanned maintenance in 2020. Assumptions for the Exploration and Production 2020 production outlook include those relating to reservoir performance, drilling results and facility reliability. Factors that could potentially impact Suncor's 2020 corporate guidance include, but are not limited to:

Suncor's MD&A, together with Suncor's most recently filed Annual Information Form, Form 40-F and Annual Report to Shareholders and other documents Suncor files from time to time with securities regulatory authorities describe the risks, uncertainties, material assumptions and other factors that could influence actual results and such factors are incorporated herein by reference. Copies of these documents are available without charge from Suncor at 150 6th Avenue S.W., Calgary, Alberta T2P 3E3; by email request toinvest@suncor.com;by calling 1-800-558-9071; or by referring tosuncor.com/FinancialReportsor to the company's profile on SEDAR atsedar.comor EDGAR atsec.gov. Except as required by applicable securities laws, Suncor disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

NON-GAAP FINANCIAL MEASURES

Oil Sands operations cash operating costs, Fort Hills cash operating costs, Syncrude cash operating costs and free funds flow are not prescribed by Canadian generally accepted accounting principles ("GAAP"). These non-GAAP financial measures are included because management uses the information to analyze business performance, including on a per barrel basis, as applicable, and it may be useful to investors on the same basis. These non-GAAP financial measures do not have any standardized meaning and, therefore, are unlikely to be comparable to similar measures presented by other companies. These non-GAAP financial measures should not be considered in isolation or as a substitute for measures of performance prepared in accordance with GAAP. These non-GAAP financial measures are defined in the Non-GAAP Financial Measures section of the MD&A and, for the period ended December 31, 2019, are reconciled to the comparable GAAP measure in the MD&A. Oil Sands operations cash operating costs of $24.00 - $26.50 (US $17.00 - $18.75) per barrel is based on the assumptions that: (i) Suncor will produce 410,000 435,000 bbls/d at Oil Sands operations (of which 310,000 325,000 bbls/d will be synthetic crude oil and 100,000 110,000 will be bitumen); and (ii) natural gas used at Suncor's Oil Sands operations (AECO - C Spot ($CAD)) will be priced at an average of $1.75/GJ over 2020. Fort Hills cash operating costs of $34.00 - $37.00 (US $24.00 - $26.25) per barrel is based on the assumptions that: (i) Fort Hills production (net to Suncor) will be 55,000 65,000 bbls/d; and (ii) natural gas used at Fort Hills (AECO - C Spot ($CAD)) will be priced at an average of $1.75/GJ over 2020. Syncrude cash operating costs of $35.00 - $38.00 (US $24.75 - $27.00) per barrel is based on the assumptions that: (i) Syncrude will produce 165,000 180,000 bbls/d of synthetic crude oil (net to Suncor); and (ii) natural gas used at Syncrude (AECO - C Spot ($CAD)) will be priced at an average of $1.75/GJ over 2020. The Syncrude cash operating costs per barrel and Fort Hills cash operating costs per barrel measures may not be fully comparable to similar information calculated by other entities (including Suncor's Oil Sands operations cash operating costs per barrel) due to differing operations.

Suncor Energy is Canada's leading integrated energy company. Suncor's operations include oil sands development and upgrading, offshore oil and gas production, petroleum refining, and product marketing under the Petro-Canada brand. A member of Dow Jones Sustainability indexes, FTSE4Good and CDP, Suncor is working to responsibly develop petroleum resources while also growing a renewable energy portfolio. Suncor is listed on the UN Global Compact 100 stock index.Suncor's common shares (symbol: SU) are listed on the Toronto and New York stock exchanges.

For more information about Suncor, visit our web site atsuncor.com, follow us on Twitter@Suncorortogether.suncor.com

Media inquiries:833-296-4570media@suncor.com

Investor inquiries:800-558-9071invest@suncor.com

Link:
Suncor Energy provides a corporate update including revised 2020 capital program, operating costs and production outlook - GlobeNewswire

Recommendation and review posted by Bethany Smith

The U.S. Military’s Behind-the-Scenes Moves To Protect Nuclear Readiness Amid Coronavirus – Newsweek

The Defense Department shifted many of its domestic bases to "health protection condition" Charlie on Sunday, the latest in a series of moves to protect military forces, families and bases from coronavirus. HPCON Charlie also known as "substantial threat of sustained community transmission" is the fourth highest of five levels.

Though Pentagon officials continue to insist that the coronavirus pandemic has had no impact on operational readiness of the armed forces, behind the scenes military exercises and deployments are being scaled down and canceled, and plans are being put in place to sustain essential operations. That includes the so-called triad of bombers, land-based missiles and submarines that make up the U.S. nuclear arsenal.

Last week, the head of U.S. Strategic Command (STRATCOM), Adm. Charles A. "Chas" Richard, said that nuclear readiness was unaffected by coronavirus. The nuclear forces, he said, "remain ready to execute" their war plans despite coronavirus and that the pandemic has had "no impact to our ability" to carry out missions.

Adm. Richard said that his Omaha, Nebraska-based command "had plans in place that we have updated and are executing,'' to deal with a pandemic. The nuclear force, he said, was designed to operate isolated for long periods of time.

But an active force that is constantly kept on alert is also one that is more exposed. According to a military tally compiled as of Sunday and reviewed by Newsweek, units feeding STRATCOM have a cumulative 106 uniformed personnel not on duty due to coronavirus, either because of confirmed cases or "protective self-quarantine." Six bases are listed where bombers, missiles, aerial refueling tankers and supporting command and communications units that support the nuclear force are reporting coronavirus cases, according to the data compiled by the Defense Department.

One positive case of coronavirus was reported Saturday at Whiteman air force base in Johnson County, Missouri, where the B-2 stealth bomber force is deployed. Three of those bombers returned to base over the weekend from a "deterrent" mission deployment to Europe. That mission, observers say, was cut short in comparison with previous bomber deployments.

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The United States currently has a total of about 850 nuclear warheads on alert 400 nuclear-armed land-based intercontinental missiles in three western states, and 450 warheads on five ballistic missile submarines in the Atlantic and Pacific Oceans. These are the weapons that are ready to instantly respond to presidential commands, according to the Federation of American Scientists. An additional 1,300 warheads can be brought up to alert status quickly on four or five additional submarines and on 60 nuclear-configured B-2 and B-52 bombers at bases, all in a matter of a few days.

Last week, Air Force Chief of Staff Gen. David L. Goldfein said that the nuclear deterrent has had no changes in its operations due to coronavirus.

An example of those operations is the deployment of the three B-2 stealth bombers to Europe on March 8, the bombers and their maintainers first landing at Lajes Field in the Azores, an archipelago of nine islands 850 miles off the coast of Portugal. The next day, the bombers flew to RAF Fairford in Gloucestershire in the southwest U.K. There, they conducted various practice missions over the North Sea on March 12, an Icelandic Air Policing mission on March 16 and 17, over the North Sea on March 18, and then over the Arctic Ocean on March 20. The bombers practiced flying with British, Dutch and Norwegian fighter planes, practicing escort and the procedures for the bombing of Russia.

"A credible deterrent for the high North region," Lt. Gen. Steven Basham said, in describing the operations. "Operating B-2s in the Arctic allow us to shape that environment by demonstrating our resolve to deliver combat power anywhere in the world if called upon."

"The world expects that NATO and the U.S. continue to execute our mission with decisiveness, regardless of any external challenge," said Gen. Jeff Harrigian, commander of U.S. Air Forces in Europe.

As for the nuclear arsenal itself, the Department of Energy, which is responsible for the nuclear warheads, said last week that it would continue "its National Essential Functions, Primary Mission Essential Functions, and Mission Essential Functions" despite coronavirus shifts to telework and other social distancing operations.

No nuclear warheads are currently being produced, the production run of the W76 Trident submarine missile warhead life extension program ending last December. The nuclear warhead producers were to have shifted the production line to producing a new bomb the B61 Mod 12 starting this month, but because of technical hold-ups, production of that warhead has now been delayed until late 2021.

Instead, the Department is in a constant cycle of keeping the existing stockpile of bomber and missile warheads healthy. Nuclear weapons expert and observer Hans Kristensen of the Federation of American Scientists says that includes "taking apart and surveying existing warheads in the stockpile" at the rate of about a dozen or so warheads per month. This is primarily accomplished at the Pantex plant in Amarillo, Texas, though the two nuclear laboratories Los Alamos in New Mexico and Livermore in California also get involved in more complex and problem cases discovered in what are called "surveillance" activities. The current U.S. nuclear stockpile is made up of seven different basic types of warheads, and some sampling of each is shipped from active bases back to Pantex and the laboratories in a complex and secret ongoing process.

Kristensen says that though there have been few signs of how coronavirus is impacting nuclear forces, the B-2 mission in Europe was "dramatically shortened" in comparison with previous years. "Last fall when they deployed the B-2s, they were there [at RAF Fairford] for a month," he says. Kristensen is been closely following bases where nuclear weapons are deployed, as well as the operations of the force, expecting that there will be significant changes if the virus persists in its growth.

Though U.S. European Command says its readiness remains high "for the foreseeable future," it admits it is already curtailing numerous military exercises due to coronavirus. In the coming months, Gen. Tod Wolters, overall European commander says, it is likely that between 30 and 65 percent of exercises will be reduced or canceled. Other commands have similarly canceled or postponed Russia-oriented military exercises, including a Red Flag exercise planned for Alaska and a high-profile test of a new all-domain warfighting system planned for next month, one that would have practiced the integration of nuclear, conventional, cyber and space weaponry.

"My organization is designed to be able to operate isolated for long periods of time," STRATCOM commander Adm. Richard insists.

The 3,000 person headquarters in Omaha has taken steps to institute social distancing, and it has shifted some people and functions to alternate and subordinate commands, improving redundancies and guarding against spread of the virus.

Though alerts, exercises, and the shuffling around of warheads continues, a senior officer at U.S. Strategic Command (who requested anonymity because he is not authorized to public speak on the matter) says that everyone is anticipating that there will be significant changes are coming. "There isn't a command headquarters, including STRATCOM," the senior officer says, "where there aren't people with coronavirus symptoms or in self-quarantine."

For now, Kristensen says, "probably the healthiest people in America are those who are coming back from the longest submarine patrols," which currently last as long as 78 days.

They've been underwater since almost the beginning of the year.

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The U.S. Military's Behind-the-Scenes Moves To Protect Nuclear Readiness Amid Coronavirus - Newsweek

Recommendation and review posted by Bethany Smith

Coronavirus: Hayward to open testing facility – East Bay Times

HAYWARD Officials said they plan to open a city fire station Monday as a site to test people for possible exposure to the COVID-19 virus.

In a statement Sunday, officials said the center at Hayward fire station No. 7, 28720 Huntwood Ave., will help to ease pressure at regional hospital emergency rooms seeking increased foot traffic.

The center will focus on testing first responders and health-care workers, but its biggest purpose is to reinforce the importance of post-testing isolation, city staff said.

Suppression, through isolation after testing, or SIT, as we call it, is an approach that has proven to be most effective in countries on the leading edge of this pandemic, Hayward Fire Department Chief Garrett Contreras said.

Hayward Fire paramedics, supported by ambulance emergency-medical technicians, will run the center everyday from 9 a.m. to 6 p.m., and it will be free to the public without city-resident, doctor-referral or immigration-status barriers.

Those who come will first be screened for illness, including specific symptoms such as fever, cough and shortness of breath, before receiving a nasal-cavity and throat-back swab. Test results are expected back within six hours, or next day at the latest, city staff said.

Menlo Park-based Avellino Lab USA, a gene-therapy and molecular-diagnostics firm, is partnering with the city to open the center, and plans to work with the city to open other testing sites around the Bay Area.

For more information, call its hotline at 510-583-4949 from 8 a.m. to 5 p.m. seven days a week, or visit the citys COVID-19 Web site at http://www.hayward-ca.gov/covid-19.

Contact George Kelly at 408-859-5180.

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Coronavirus: Hayward to open testing facility - East Bay Times

Recommendation and review posted by Bethany Smith

Meet the queen nenue – Thegardenisland.com

Nenue are a large, gray, schooling fish that are generally known as chubs. There are several common species here in Hawaii that are often seen in large schools called gray chubs, highfin, brassy and bicolor chubs. These common, shallow-water fish can grow to about 20 inches long and are often seen right up close to shore where the feed of marine plants. They zoom back and fourth with the surge from the waves, and sometimes a snorkeler will get surrounded by over 100 nenue in a single, large, fast-moving school.

During breeding season the male chubs will often develop a spotted, black-and-white pattern, but from time to time divers see a bright yellow nenue.

It is truly a beautiful fish, and I have only seen five of them in all of my diving throughout the Hawaiian Islands. In old Hawaii the rare yellow chub was called the queen nenue, and was thought to be a very special fish.

Nenue are good to eat, and have been a sustainable food source for over 1,000 years for the Hawaiian people. They are often speared in shallow water or caught by throwing nets, but if the queen nenue was caught by accident it was immediately released. It was thought that the gray chubs would follow the queen and a fishermen could develop a good relationship with the local queen and she would lead fish into his net.

The yellow color of the queen nenue is caused by a genetic defect. The gray colors of the chub are created by black pigment in the skin that lays on top of a layer of yellow pigment. Two different genes control these colors, as is very common with fish and reptile species. Sometimes the black color is missing due to a genetic defect in the fish colony. The condition when the black color pigment is missing is called amelanistic. What is unusual about this uncommon color variation is the yellow fish still has black eyes.

Amelanistic fish and reptiles tend to die in the wild, as they are so brightly colored that get picked off by predators. But in captivity it is fairly easy to captive-breed these animals and produce an entire colony of bright yellow fish or reptiles.

Since their color pattern is controlled by just two genes you can take a yellow adult male and breed it with a normal gray female. All of the offspring will be gray, but they carry the gene for being amelanistic. If you then breed the yellow adult to one of his gray offspring the next generation will have 50% yellow babies. If you raise up the yellow babies and breed them together 100% of their offspring are yellow. This is how the now-famous albino Burmese python was produced that you often see for sale in pet stores on the mainland.

The queen nenue is not an albino as sometimes thought, because a true albino will lack all color and would be pure white with pink eyes. Sometimes there are nenue that are part yellow and part gray. This is another genetic variation we call piebald, and it is governed by a set of more-complicated genetics then the amelanistic color pattern.

Amelanistic color patterns in fish and reptiles are simply the lack of the black color controlling gene or genes, so the animals color is just what underlying color pattern is left.

So why do a few of these rare yellow nenue survive in the Hawaiian population? They do not seem to have any different feeding or behavior patterns then the regular gray chub, and I know they can live for quite a long time. I have seen a queen nenue at Tunnels Reef (Makua) in Kauai now for over five years, and one along Napali Coast at Nualolo for over eight years.

You can see the yellow nenue in action in the video The Worlds Guide to Hawaii Reef Fish on the marine life educational web page at http://www.underwater2web.com, and if you see one of these cool-looking fish where you live please let me know on my Facebook under my name Terry Lilley or Instagram at terry.lilley, as I am trying to find out if they occur on all of the Hawaiian Islands and also through out the Pacific Ocean.

Please stay tuned for a new Online Marine Educational Series expected to launch soon for all of the school kids that are having to stay home due to the coronavirus outbreaks we are currently having. I have enough online marine-life videos to keep the kids busy for years, and they are fun and educational for the parents to watch, too.

Aloha from under the surf.

Terry Lilley, a marine biologist, lives in Hanalei. His websites include underwater-2web.com and gofundme.com/5urrm4zw.

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Meet the queen nenue - Thegardenisland.com

Recommendation and review posted by Bethany Smith

How far should genetic engineering go to allow this couple to have a healthy baby? – Sydney Morning Herald

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One morning in 2005, Shelley Beverley woke up to find that she had gone deaf. She was 21, and living in Johannesburg with her older brother Neil. I was very scared, she says. It was just so sudden. She struggled through the rest of the day, hoping that her hearing would come back, but it didnt. In one sense, her hearing loss wasnt entirely a surprise: Beverleys grandmother had been deaf, Neil had lost his hearing when he was 13, and her mum, Mary, had lost hers when she was 32. We knew it ran in the family, she says, but I thought Id been lucky and not inherited it.

Beverley, 35, lives in Margate, a semi-rural district south of Hobart, with her husband James. The couple migrated to Australia from South Africa in 2010, looking for space, buying 2 hectares of lush green grass at the foot of a forested ridge near the mouth of the Derwent River. We love the wildlife here, says James, looking out the living room window. Weve seen pademelons, echidnas, quolls, blue-tongue lizards, even a Tassie devil. At dusk, hundreds of kangaroos emerge from the forest to gorge on the grass. Its very peaceful, says James. Its really helped us after everything thats happened.

Apart from their deafness, Beverleys family had largely enjoyed good health. Then, in September 2015, her mother, Mary, then 62, started experiencing fatigue and stomach pain. Doctors in Durban ordered a colonoscopy, but the procedure made her worse. Her feet became swollen and purple. Because of their hearing problems, Shelley and Mary had communicated mainly in text messages. But soon I began noticing that her wording got a bit funny, says Beverley. It didnt always make sense.

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Beverley flew to Durban in February 2016, but by that time her mother could no longer talk or walk. She was so weak that she couldnt move her hands or lift her neck. Two days after Beverley arrived in Durban, her mother caught a virus that caused fluid to build up on her lungs. The doctors tried unsuccessfully to drain it. Shortly afterwards, she died. She weighed just 36 kilograms. It was so fast, Beverley says. And we were still in the dark about what she had.

Shortly before Marys death, Neil had also fallen ill. He developed a number of mysterious symptoms, including facial twitches and seizures. He kept falling over and tripping, and experienced vomiting and headaches so severe he lost his vision for weeks at a time. His behaviour became strange showering with his clothes on, and hallucinating.

One day, Dad was driving him around and Neil started talking to all these little people he thought were around his feet, says Beverley. Doctors in Durban had trouble diagnosing him, so they sent a biopsy to London, where he was found to have a type of mitochondrial cytopathy one of a large family of chronic and progressive diseases that affect the muscles, brain and nervous system. As the family soon learnt, the condition has no cure and no effective therapies. One of the common early symptoms is hearing loss.

Neil died in June 2017, aged 34, by which time Beverley had discovered she also had the condition. It was fear, so much fear, she says. She began experiencing symptoms, including migraines and vision loss. She has since developed diabetes, hypertension, gastro-paresis (when your stomach muscles dont work), and pharyngeal dysphagia (difficulty swallowing). Every time I get sick now, the flu or something, I think, When am I going to need a wheelchair or a feeding tube? When will my legs stop working?

Mito has taken everything from me, she says. If I die, at least James will still have a part of me.

Beverley has bright blue eyes and long, straight, ash-brown hair. Shes got a lazy left eye and uncommonly pale skin, which she attributes to her condition. Oh, and I had bunions out in 2010, she says, laughing wryly.

She doesnt know how long shes got left, but she is determined to make it count. She has joined mito awareness groups, and is an active member of the Mito Foundation, which supports sufferers, and funds research. She has exhaustively researched the condition and takes every opportunity to educate doctors. Youd be surprised by how little they know about it, she says.

But her overriding focus has been on a cutting-edge, and currently illegal, procedure called mitochondrial donation, a form of IVF which would allow those with the condition to have children, safe in the knowledge they would not be passing it on. Mito has taken everything from me, she says. If I die, at least James will still have a part of me. I would like him to look at our child, and say, You have your mums smile or your mums eyes.

An IVF treatment known as mitochondrial donation could potentially save up to 60 Australian children a year from being born with the condition. Credit:

Mitochondrial donation has been labelled immoral and unethical, a slippery slope to designer babies, not to mention potentially unsafe. The only country in the world to have legalised it is the UK. A report by medical experts into the technologys potential application in Australia is due to be delivered to Health Minister Greg Hunt this month.

This fight is really personal to me, Beverley says. Short of a cure, people with mito should at least have the option of having healthy children.

Mitochondria are microscopic structures in human cells that provide the body with energy. For this reason, they are often described as the cells powerhouse. They are crucially important: if your mitochondria fail or mutate, your body will be starved of energy, causing multiple organ failure and premature death.

A stylised representation of a mitochondrion, which provides the body with energy. Malfunction can lead to organ failure and death.Credit:Josh Robenstone

Mito, which is maternally inherited, usually affects the muscles and major organs such as the brain, heart, liver, inner ears, and eyes. But it can cause any symptom in any organ, at any age. Indeed, the term mito includes more than 200 disorders, the symptoms of which are maddeningly varied and seemingly unrelated, leading to delayed diagnoses or incorrect diagnoses or, indeed, no diagnosis.

Many of these people have been fobbed off by doctors or laughed off by people who think they are hypochondriacs, says Dr David Thorburn, a mitochondrial researcher at the Murdoch Childrens Research Institute, in Melbourne, who has diagnosed some 700 cases over the past 28 years. Most people are relieved to finally know what it is, because that is the end of that part of their journey.

Its sometimes said babies produced as a result of mitochondrial donation would have three parents the mother, the father, and the donor.

Up to two million people worldwide have some form of mito. - Others, like Beverley, who have a less severe type of the disease, will get adult onset, and can expect to become ill in their 30s, 40s or 50s.

According to Thorburn, One of the things that most dismays families with mito is the lack of control they have over passing the condition down to future generations of their family.

Remaining childless is one way to stop the condition from being passed down, as is adopting, but as Thorburn acknowledges, There is an innate desire in many individuals to have their own children. For these people, mito donation offers the very real prospect that the condition is eliminated from future generations.

Mitochondrial replacement is a highly specialised procedure, requiring a level of manual dexterity sufficient to manipulate a womans egg, which is roughly the width of a human hair. Within that egg is a nucleus, where a persons genes are located, and the cytoplasm, the jelly-like substance that surrounds it. Mitochondria are found in the cytoplasm.

Mitochondrial replacement involves taking a donor females healthy egg, removing its nucleus and replacing it with the nucleus of the woman affected by mitochondrial disease, but whose nucleus is healthy. The egg is then fertilised using her partners sperm. (Another option is to fertilise the egg first, and then swap the nucleus.) The resulting embryo is then implanted into the mother.

Researcher David Thorburn: "Mito donation offers the very real prospect that the condition is eliminated from future generations."Credit:Josh Robenstone

Since more than 99.9 per cent of our genes are found in the eggs nucleus, which remains unaffected, the procedure will have no impact on the childs height, hair colour or mannerisms. Despite that, its sometimes said that babies produced as a result of mitochondrial donation would have three parents the mother, the father, and the donor.

The technology has been tested in mice for more than 30 years, but only since 2009 has research been done on human embryos, mainly in the UK. Almost from the start, the research was subject to sensational headlines about scientists playing God, and the possibility of genetic engineering, with much of the hysteria being fuelled by anti-abortion groups. The Catholic Church described it as a further step in commodification of the human embryo and a failure to respect new individual human lives.

In 2012, the Human Genetics Alert, an independent watchdog group in London, wrote a paper comparing any baby produced with mitochondrial replacement to Frankensteins creation, since they would be produced by sticking together bits from many different bodies. According to the Conservative British MP Jacob Rees-Mogg, the procedure was not a cure for disease, it is the creating of a different person.

Regulators subjected the technology to four separate scientific reviews, together with rounds of ethical debate and community consultation. In 2015, the UK Parliament voted to legalise the technology for use in humans, on the proviso that it only be available to those women at high risk of passing on the disease. Since then, 13 couples in the UK have received the go-ahead to undergo the procedure.

Its unclear how many children, if any, have been born: the parents have asked that details not be published. Meanwhile, scientists like Thorburn wait eagerly for news of any developments. I know the UK researchers well and have asked several of them, and they are keeping completely quiet about it in respecting the families wishes, he says.

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If there have been babies born in the UK using the procedure, they arent the first. In April 2016, a child was born using the technique in Mexico, to a Jordanian mother who carried a fatal mitochondrial condition known as Leigh syndrome. The doctor in charge, an American fertility specialist called Dr John Zhang, later admitted that he had gone to Mexico because the procedure is illegal in America. In Mexico, he admitted, There are no rules.

Even those who want mitochondrial donation legalised in Australia concede that much remains unknown about the procedure. Its long-term risks can only be understood through lifelong health check-ups, but this is impossible until any children conceived via this procedure become adults. Implications for subsequent generations also remain unclear.

No medical procedure is 100 per cent safe, says Sean Murray, CEO of the Mito Foundation. But we think we are at the stage now where the benefits of the technology are greater than the risks.

One of the issues around safety concerns the compatibility of the donors mitochondria with the recipients nuclear genes. A 2016 study in mice suggested that mismatched mitochondria affected their metabolism and shortened their lives. Another concern is known as carryover, whereby a tiny amount of mutant mitochondria is inevitably transferred from the affected mothers egg into the donor egg during the procedure.

Instead of it being wiped out, the mutation might then reappear in the descendants of any girls born as a result. For this reason, some people have proposed that the procedure be restricted to male embryos only, but this raises all kinds of ethical issues around selective breeding and sex selection.

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Indeed, it often seems as if the term ethical minefield was coined especially with mitochondrial donation in mind.

My primary ethical concern has to do with the sanctity of human life, says Father Kevin McGovern, a Catholic priest and member of the National Health and Medical Research Councils Mitochondrial Donation Expert Working Committee.

If mitochondrial donation is permitted here, the technique most likely to be used is pronuclear transfer, which requires that both the donors egg and the affected mothers egg be fertilised. [This is to ensure that both eggs are at the same developmental stage.] But once the nucleus is removed from the donors fertilised egg, it is discarded. For people who believe that life begins at conception, this is akin to murder. You are creating two lives and destroying one for spare parts.

The Catholic Church has consistently opposed mitochondrial donation. In a Senate inquiry into the technology in 2018, Dr Bernadette Tobin, director of the Plunkett Centre for Ethics at the Australian Catholic University, suggested the process was intrinsically evil.

The inquiry also heard from Father Anthony Fisher, Catholic Archbishop of Sydney, who raised concerns about the moral right of the child to know how he or she was conceived the problem of what he called genealogical bewilderment and the donors right to remain anonymous. He also worried that women might effectively become egg vending machines: The availability of human ova is often assumed when people talk about reproductive technology as if they were somehow there in a cupboard to be used. In fact, it means women have to be used to obtain these eggs. They are extracted by invasive procedures that do carry some risk.

A report by medical experts into mitochondrial donation and its potential application in Australia is due to be delivered to Health Minister Greg Hunt this month. Credit:Alex Ellinghausen

Equally troubling for the Australian Catholic Bishops Conference, the peak national body for the churchs bishops, was the fact that mitochondrial donation involved conceiving babies not by marital intercourse [but by] a technical procedure.

Most of these concerns are redundant, argues the Mito Foundations Sean Murray. We already have a well defined regulatory framework for dealing with all this, he says. As far as the donors right to remain anonymous, we would defer to the appropriate federal or state and territory regulations that apply for sperm or egg donations. In regard to a kids right to know they had a mitochondrial donor, societally there seems to be a preference to inform kids. Its important for them to understand their genetic lineage.

Then theres the matter of consent. The parents can wrestle with the ethical issues and weigh up all the risks, but the only person who cant consent to the procedure is the unborn child. Well, says Murray, they cant consent to being born with mito, either.

The Mito Foundations Sean Murray: "In regard to a kids right to know they had a mitochondrial donor, societally there seems to be a preference to inform kids."Credit:Joshua Morris

Murray, 47, is one of the founding directors of the Mito Foundation, which was established in Sydney in 2009. Mito runs in my family, he says. My older brother, Peter, died of it in 2009 at 45, and my mum passed away in 2011, at 70. What people often dont understand is that even in families that have mito, each member can have different mutational loads basically, different amounts of bad mitochondria. Peter got a high load, but I didnt. Thats why Im still here.

A computer scientist by training, Murray now works full-time on the foundation. Much of his job involves travelling around the country, explaining mito to politicians, journalists and philanthropists, raising funds for research and, most crucially, advocating for a change to the laws.

Mitochondrial donation falls foul of two pieces of legislation: the Research Involving Human Embryos Act 2002, and the Prohibition of Human Cloning for Reproduction Act 2002. The laws prohibit the implantation of a human embryo that contains more than two peoples genetic material. The laws were subject to a mandatory review in 2010, but the then Labor government recommended they remain the same.

In 2013, the Mito Foundation urged the government to revisit its decision. Two years later, it began lobbying in earnest. What we tried to get across was that the science around mito donation has come a long way since 2010, says Murray. Also, the process that the UK went through to legalise it really reassured us that the procedure is safe and effective.

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In the past five years, Murray and his colleagues have consulted with more than 100 MPs and senators. Only one of them, according to Murray, said I dont like this. They have also talked to dozens of industry experts, including academics and medical and research bodies, about the benefits of mitochondrial donation. Most of them get it straight away, he says. We are talking about a technique that will prevent the chance of having a morbidly ill child.

Now, a breakthrough appears imminent. In February 2019, Health Minister Greg Hunt asked the National Health and Medical Research Council to look into the matter, review the science and conduct public consultation. The NHMRC is due to hand its report to Hunt this month. The expectation among the mito community is that he will recommend the laws be changed. Any proposals would then need to be debated in Parliament, where issues around reproductive medicine have, in the past, been hotly contested.

Murray expects some opposition from more conservative MPs, but nothing like the rancour seen in the NSW Parliament during last years debate over legalising abortion. Shadow health minister Chris Bowen has, for his part, said that Labor will support changing the laws.

Mitochondrial sufferer Shelley Beverley at home in Tasmania. This fight is really personal to me. Credit:Peter Mathew

Whether this will help people like Shelley Beverley is unclear. If Hunt gives it the green light, it will take two years at least for mitochondrial donation to become available to prospective parents, given the time involved in drafting and passing legislation, establishing a regulatory regime and getting doctors up to speed with the technology.

This will probably be too late for Beverley. I really only have about a year left to give it a go, she tells me. After that, my symptoms may progress and biologically things get worse after 35. She says she would consider going to the UK for the treatment, but that at present they are not accepting international patients.

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In the meantime, she watches TV, and reads a little, but not too much. (It puts me to sleep.) She gardens: she has a bed of huge white and pink roses out the back of her house, as a memorial to her mother and brother. And she eats. James cooks for me. He lets me choose the best meat and potatoes! Ive put on weight since I met him. She describes James as something close to an angel. He will listen to every problem I have or feeling I experience. He will always put me first.

Beverley started going out with James when she was 21, right around the time she first went deaf. I was so scared that he wouldnt like me as much. I remember calling him and saying I was scared he would leave me. But James is still here. Im very lucky to have him, she says. If I go, I want him to have a part of me.

To read more from Good Weekend magazine, visit our page at The Sydney Morning Herald, The Age and Brisbane Times.

Tim Elliott is a senior writer with Good Weekend.

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Alcohol Consumption Linked to Lower Bone Formation Markers in Patients With HIV – Infectious Disease Advisor

Greater alcohol consumption is associated with lower serum bone formation markers in patients living with HIV (PLWHIV) with substance use disorder, according to study results published in Alcoholism: Clinical and Experimental Research.

Previous studies have established that low bone mass is common and fracture risk is increased for PLWHIV. Several factors may contribute to the low bone density, including the effect of HIV itself, low body mass index, hypogonadism, liver disease, and smoking and alcohol consumption.

As limited data are available on alcohol consumption and bone turnover markers, the goal of the current study was to investigate the association between alcohol consumption and bone turnover markers, specifically serum C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N-terminal propeptide (P1NP), in PLWHIV with substance use disorder.

The study cohort included 233 patients, and after exclusion of 35 due to fracture in the preceding year or missing data, the final sample was 198 individuals (median age, 50 years; 38% women). Almost all patients (93%) were prescribed antiretroviral medication, and most (72%) had HIV viral load suppression.

Approximately half (48%) of the study cohort met criteria for both current alcohol and drug dependence. At baseline and 12-month follow-up, the mean daily number of drinks was 1.93 and 1.51, respectively; mean number of heavy drinking days was 4.65 and 3.25, respectively.

Higher average number of drinks/day was significantly associated with lower P1NP (=-1.09; 95% CI, -1.94 to -0.23 per each additional drink). Bone formation was lower in patients who drank on 20 days in the past month (P1NP, -15.45 ng/mL; 95% CI, -26.23 to -4.67) compared with those who did not. Furthermore, a higher number of heavy drinking days was associated with lower bone formation (=-0.58, 95% CI, -1.05 to -0.12 per additional heavy drinking day).

There was a significant association between a phosphatidylethanol level 8 ng/mL and lower P1NP. In addition, an increase in mean drinks per day over 12 months was associated with a nonsignificant decrease in bone formation (=-1.14; 95% CI, -2.40 to 0.12; P =.08 per each additional drink).

As for the effect of change in alcohol consumption over time, the researchers reported that neither change in the number of heavy drinking days nor change in whether a participant had alcohol use on 20 days in a month was significantly associated with bone formation.

There were no significant associations between alcohol consumption and bone resorption.

The researchers acknowledged several study limitations, including that alcohol use was measured only during the 30 days before each study interview and not throughout the follow-up. Data were also missing on nadir CD4 levels and other markers to assess bone formation, and there was no HIV-uninfected comparator group.

Information about low [bone turnover markers] may provide motivation for [PLWHIV] to reduce alcohol use and mitigate risks related to abnormal bone metabolism, concluded the researchers.

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Reference

Kim TW, Ventura AS, Winter MR, et al. Alcohol and bone turnover markers among people living with HIV and substance use disorder [published online March 2, 2020]. Alcohol Clin Exp Res. doi:10.1111/acer.14303

This article originally appeared on Endocrinology Advisor

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Aytu BioScience Submits Notice of Commercialization to the FDA, Allowing for Company’s Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care…

Commercial Distribution of First 100,000 Tests to Commence Upon Receipt of Inbound Product Shipment

ENGLEWOOD, CO / ACCESSWIRE / March 23, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it has received confirmation from the U.S. Food and Drug Administration (FDA) that the company may begin distribution of its Coronavirus Disease 2019 ("COVID-2019") IgG/IgM Rapid Test throughout the United States. The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers results between 2 and 10 minutes at the point-of-care.

Aytu expects delivery of its first shipment of 100,000 tests this week. The Company has been in discussions with healthcare distributors, healthcare institutions, medical practices, and government agencies and is working quickly to begin distribution into the U.S. healthcare supply chain.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are moving as quickly as we can to bring the COVID-19 IgG/IgM Rapid Test to the U.S. professional medical community. With product now in transit to our warehouse in Colorado we're optimistic that we can have test kits ready for sale in the very near term. In the two short weeks since signing our distribution agreement, we have ordered our first 100,000 tests and have received confirmation from FDA that we may begin distribution. We are optimistic that we're now just days away from placing these COVID-19 test kits into the hands of healthcare professionals."

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 126 patient clinical trial and is CE marked.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Story continues

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

Contact for COVID-19 IgG/IgM Rapid Test-Related Inquiries:COVID-19@aytubio.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/582030/Aytu-BioScience-Submits-Notice-of-Commercialization-to-the-FDA-Allowing-for-Companys-Distribution-of-its-2-10-Minute-COVID-19-IgGIgM-Point-of-Care-Rapid-Test

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Aytu BioScience Expands Its Distribution Rights for Coronavirus 2019 (COVID-19) Point-of-Care Rapid Test to Canada and Mexico – Yahoo Finance

Company Expects to Seek Regulatory Clearance Under Health Canada and COFEPRIS Expedited Clearance Procedures

ENGLEWOOD, CO / ACCESSWIRE / March 19, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it extended its distribution right to commercialize the clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM Rapid Test. The test has been licensed from L.B. Resources, Limited (a Hong Kong Corporation). The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers clinical results between 2 and 10 minutes at the point-of-care. This amendment expands Aytu's commercial rights and grants Aytu the right to distribute and commercialize the COVID-19 test in North America, specifically including the United States, Canada and Mexico.

The Company expects to pursue expedited regulatory clearance of the product with Health Canada and COFEPRIS (Comisin Federal para la Proteccin contra Riesgos Sanitarios), the regulatory agencies in Canada and Mexico, respectively.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We have to be progressive in doing our part in combatting the spread of the COVID-19 virus. We need to ensure that screening is available across North America and providing broad access to screening tests has to be among our highest priorities as we collectively fight the coronavirus outbreak. With COVID-19 now designated as a global pandemic, we believe we should expand our efforts to assist healthcare providers with faster point-of-care detection."

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and is CE marked.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Story continues

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/581543/Aytu-BioScience-Expands-Its-Distribution-Rights-for-Coronavirus-2019-COVID-19-Point-of-Care-Rapid-Test-to-Canada-and-Mexico

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Aytu BioScience Expands Its Distribution Rights for Coronavirus 2019 (COVID-19) Point-of-Care Rapid Test to Canada and Mexico - Yahoo Finance

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Conn. first responders stunned to receive only expired respirators – EMS1.com

Meghan FriedmannNew Haven Register, Conn.

NEW HAVEN, Conn. North Branford Fire Chief William Seward was alarmed when he got the news: his department, which runs the towns ambulance service, would only receive one box of 35 respirators from the strategic national stockpile.

Whats more, all of those masks which Seward picked up today in Essex are expired.

Its beyond belief, Seward said. Although the town currently has enough supplies on hand, Seward worries about what will happen if COVID-19 cases spike a few weeks down the road, he said.

North Branford is not alone.

Two East Haven firefighters and their families were quarantined for two weeks Friday after the pair of first responders assisted a 79-year-old man who became the towns first confirmed case of COVID-19, the town said in a statement.

East Haven Fire Chief Matthew Marcarelli is worried that if too many members of his team get sidelined because of exposure, they wont be able to fight fires, he said.

The department is supporting them and their families and both firefighters are doing well, Marcarelli said.

Marcarelli was told that all of the 144,000 respirators in the states strategic stockpile are expired by at least 10 years, he said, adding that his department was allotted 220 respirators. They were all expired, and they were all sized small, he said.

And I dont know why any of this is coming as a surprise to the state, Marcarelli said. Theres been a pandemic plan since 2001.

The state is a major source of the respirators, which are currently difficult to find, according to Marcarelli.

Further down the Shoreline, Guilford got 110 respirators also expired, according to Assistant Fire Chief Michael Shove.

A memorandum from Lisa Bushnell, strategic national stockpile coordinator for the Connecticut Department of Public Health, indicates that in terms of personal protective equipment, many towns in the state are only receiving expired respirators at this time.

The Department of Public Health (DPH) is in possession of expired N95 respirators manufactured in 2006 that were not granted a shelf-life extension by the federal government, the memo says. We requested that the federal government consider an extension given the national PPE shortage, which was not granted. These expired Kimberly Clarke N95 respirators will not provide the appropriate protection factor of non-expired N95s, but are likely to minimally provide protection equivalent to a surgical face mask.

Hearst Connecticut Media obtained a copy of the letter, dated Thursday. Bushnell directed press inquiries to DPH spokesman Av Harris, who did not respond to a request for comment.

The state Department of Emergency Management and Homeland Security divides Connecticut into five regions, according to its website. The memorandum about the expired respirators went out to Region 2 towns, according to an email to which the record is attached.

Thirty Connecticut towns make up Region 2, according to the DEMHS website.

Guilford Assistant Fire Chief Michael Shove confirmed that his town is also facing a challenge in terms of access to PPE. Eligible for 105 respirators, his department received more equipment than the North Branford Fire Department but, again, all those respirators were expired, Shove said.

The state used each departments call volume to determine how many respirators they would receive, according to the email sent to Region 2 towns.

But the North Branford Fire Department transports more than 900 patients annually, Seward said, adding that the respirators are not reusable.

Whats more, medical experts today expanded the possible symptoms associated with COVID-19 so as to include certain gastrointestinal issues, according to Seward. That means personal protective equipment may be necessary for more calls, Seward said.

Shove confirmed Sewards account.

Although calls in North Branford are currently less frequent than normal, if COVID-19 cases surge, Seward said, the lack of personal protective equipment will be a challenge for us.

And its not just respirators first responders need. They also require gear like gloves and gowns, Shove said.

Shove hopes that Connecticut is able to prevent the surge in COVID-19 cases, or that manufacturers can ramp up PPE production, he said.

Hes not worried about the next two weeks, but he is worried about having sufficient supplies thereafter.

We could definitely use supplies, but theres nowhere to get supplies, he said, adding that many departments are in the same boat. All the chiefs have been vocal ... but the thing is, you cant change the past.

Shoves team will make the most of what they have, he said.

2020 the New Haven Register (New Haven, Conn.)

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Cancer services may be rationed to those most likely to survive, says NHS report – Telegraph.co.uk

Cancer services should be rationed to patients with the highest chance of survival if hospitals become overwhelmed with coronavirus, a new NHS protocol states.

It warns the frequency of treatments such as immunotherapy could be halved and long-term follow-up postponed indefinitely, as staff are diverted to fight Covid-19.

Published by NHS England last week, the document also predicts that access to CT scanners crucial for some cancer diagnoses could be limited because of their use by coronavirus patients.

Although its authors state that disruption of cancer services remains an unlikely scenario, they warn: We need to consider the small possibility that the facility for cancer services may be compromised due to a combination of factors including staff sickness and supply chain shortages among others.

In the event of disruption to cancer services, clinicians may also need to prioritise treatment for those most in need.

It comes after Prime MinisterBoris Johnson warned the NHS is facing an Italian-style crisis(as illustrated in the below video), and cancer patients in London alleged that their treatment plans have been postponed within the last few days.

Meanwhile on Saturday the National Institute for Health and Care Excellence (Nice) issued a new framework for intensive care which effectively allows doctors to ration precious beds and ventilators to those with the greatest chance of survival.

Hospital bosses were given permission by NHS England last Tuesday to suspend all non-urgent treatment, to ready services for a flood of Covid-19 patients that appears already to have started, particularly in London.

However, health leaders have promised to protect urgent services such as cancer.

Under the new protocol, cancer patients in hospitals under pressure from coronavirus will be grouped into one of six categories, with treatments rationed accordingly.

They range from, at the top, curative therapy with a greater than 50 per cent chance of success, to, at the bottom, non-curative therapy with an sub-50 per cent chance of palliation, or temporary tumour control yielding less than one years life extension.

One patient with advanced bowel cancer at the Royal Free hospital in London, who falls into category five, said she had been informed last week that her next batch of treatment, due to start in the next three to six weeks, would not take place for at least three months.

Its incredibly stressful, to be honest, she told The Telegraph.I wasnt told why the delay was happening but I cant believe that this outbreak wont affect treatment.

Friends I have made in the unit say their treatment plans have been altered as well.

The Royal Free denies that any treatments are being delayed by the coronavirus outbreak, insisting that cancer services are running normally.

The new NHS cancer protocols are predicated on the expectation that a surge of coronavirus cases would deprive cancer services of some personnel, due both to staff illness and redeployment, and equipment.

It even quotes an Italian doctor involved in fighting coronavirus in northern Italy, Daniele Macchine, who said: There are no more surgeons, urologists, orthopaedists, we are only doctors who suddenly become part of a single team to face this tsunami that has overwhelmed us.

This reflects the expectation, prompted by a letter from Chief Medical Officer Professor Chris Whitty earlier this month, that clinicians would have to work outside their normal areas of training.

Cancer doctors faced with hospital flooded with Covid-19 patients are urged to consider using 4-weekly or 6-weekly immunotherapy regimens rather than two-weekly and three-weekly, and considering treatment breaks for long-term treatments when risk of coronavirus is high.

Even where NHS cancer services are available, the new guidance published on Saturday from the Nice advises patients to consider delaying treatment because of their heightened risk from Covid-19.

These include those whose immune systems have been weakened by treatments such as chemotherapy and immunotherapy.

To deal with the expected surge in patients with Covid-19, the health service has struck a deal with private hospitals to make use of 20,000 staff and 8,000 beds. An extra 1,200 ventilators will also come into circulation from next week.

The new Nice guidance asks doctors to score patients on an nine point clinical frailty scale [CFS] as they might normally do.

At one end of the scale, with a score of one, are the Very Fit people who are robust, active, energetic and motivated, and who exercise regularly. At the other end, with a score of nine, are the Terminally ill.

This weekend a senior director a London acute trust said the NHS was only in the "foothills" of the outbreak.

He told Health Service Journal: The trusts in outer London seem to be hit much worse at the moment, probably about two weeks ahead of the rest of the country. Barnet, Lewisham and Greenwich, Epsom and St Helier, North Middlesex and Hillingdon are all struggling.

I was in denial about the seriousness of this virus a couple of weeks ago, but not anymore things are going completely nuts.

A spokesman for the Royal Free London said: "All cancer services are running as normal and treatments are not being delayed by the response to the Covid-19 outbreak."

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Cancer services may be rationed to those most likely to survive, says NHS report - Telegraph.co.uk

Recommendation and review posted by Bethany Smith


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