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Sotrovimab (VIR-7831), an Investigational Antibody Utilizing Xencor’s Xtend Technology, Receives U.S. FDA Emergency Use Authorization for the…

Posted: May 27, 2021 at 8:04 am

MONROVIA, Calif.--(BUSINESS WIRE)--Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for sotrovimab (previously VIR-7831), an XmAb-engineered antibody developed by Vir Biotechnology, Inc. (Vir) and GlaxoSmithKline plc (GSK). Sotrovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Xencor has provided Vir non-exclusive licenses to XmAb Fc technologies, including Xtend, designed to enhance the half-life of novel antibodies being investigated as potential treatments for patients with COVID-19.

"We are proud that Xtend technology was integrated into sotrovimab for the purpose of reducing the dose administered and potentially enhancing its lung tissue bioavailability and are grateful to Vir and GSK for advancing this important medicine. Xtend has demonstrated, in multiple antibodies and through numerous human clinical trials, the ability to extend antibody drug half-life and reduce dosing frequency in patients, an important feature in anti-viral therapy for pandemic use," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Our partnership with Vir exemplifies our commitment to enabling the broad use of XmAb Fc technologies and to rapidly developing potential treatments for COVID-19 and other serious infectious diseases. Though the vaccine rollout is underway, antibody treatments remain an important therapeutic measure to reduce the number of hospitalizations and deaths due to COVID-19."

Vir and GSK are evaluating sotrovimab in an extensive ongoing clinical development program. In March 2021, the partners submitted an EUA application to the FDA based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which demonstrated an 85% reduction in hospitalization for more than 24 hours or death in high-risk adults receiving sotrovimab compared to placebo, the primary endpoint of the trial.

The emergency use of sotrovimab is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

License Agreement with Vir Biotechnology, Inc.

Xencor previously entered into a technology license agreement with Vir Biotechnology, Inc., pursuant to which Vir has non-exclusive access to multiple Xencor Fc technologies, including Xtend Fc technology, designed to extend the half-life of novel antibodies that Vir is investigating as potential treatments for patients with COVID-19. Under the terms of the agreement, Vir is solely responsible for the activities and costs related to research, development, regulatory and commercial activities for their COVID-19 drug candidates, and Xencor is eligible to receive royalties on net sales in the mid-single digit percent range.

Vir is also developing and commercializing antibodies with Xencor's Fc technologies as potential treatments for patients with influenza and hepatitis B virus infection. Vir is solely responsible for the activities and costs related to research, development, regulatory and commercial activities for these additional candidates, and Xencor is eligible to receive development, regulatory and sales-based milestone payments, as well as royalties on net sales in the low- to mid-single digit percent range.

About Xtend XmAb Fc Technology

Xencors Xtend XmAb Fc domains have been shown to increase circulating half-life by increasing binding affinity to the receptor FcRn. FcRn is present inside lysosomes in endothelial cells lining the blood vessels and functions to rescue antibodies from the degradation that makes most proteins short-lived in circulation. Half-life extension can be exploited to potentially improve therapeutic antibody performance in several ways, such as increasing dosing interval or decreasing drug quantities at the same dosing interval compared to a parent antibody. Xtend technology is currently in multiple clinical-stage programs and one approved therapy, Alexions Ultomiris (ravulizumab-cwvz).

About Cytotoxic XmAb Fc Technology

Xencors Cytotoxic XmAb Fc domain is designed to improve the immune systems elimination of tumor and other pathologic cells by antibody-dependent cellular cytotoxicity (ADCC). The Cytotoxic Fc domain is engineered to increase binding affinity to activating Fc receptors to enhance activation of natural killer (NK) cells and other immune cells such as macrophages, which play a role in immunity by engulfing and digesting foreign material. Xencor's cytotoxic Fc technology is currently in multiple clinical-stage programs and one approved therapy, MorphoSys' Monjuvi (tafasitamab-cxix).

Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc. Monjuvi is a registered trademark of MorphoSys AG.

About Xencor, Inc.

Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases. Currently, 22 candidates engineered with Xencor's XmAb technology are in clinical development internally and with partners. Xencor's XmAb antibody engineering technology enables small changes to the structure of proteins resulting in new mechanisms of therapeutic action. For more information, please visit http://www.xencor.com.

Forward-Looking Statements

Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by our use of words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, and similar terms, or by express or implied discussions relating to the efficacy of sotrovimab (VIR-7831), Xtends ability to enhance the immune function of novel antibodies, including by extending antibody drug half-life and reducing dosing frequency in patients, the ability of XmAb Fc technologies, generally, to enhance antibody effectiveness and facilitate the rapid development of potential treatments for COVID-19 and other serious infectious diseases, the importance of antibody treatments to reduce the number of hospitalizations and deaths due to COVID-19, Xencors eligibility to receive royalties and sales-based milestone payments under its agreements with Vir, as well as the likelihood, timing and magnitude of such payments, and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2020 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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Sotrovimab (VIR-7831), an Investigational Antibody Utilizing Xencor's Xtend Technology, Receives U.S. FDA Emergency Use Authorization for the...

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Scientists have determined the oldest age humans can live to | TheHill – The Hill

Posted: at 8:04 am

Researchers studying the relationship between aging and the ability to cope with stress found that the limits of a human lifespan lie anywhere from 120 to 150.

Based on data collected from an iPhone app and medical records from volunteers in both the United States and United Kingdom, the studys authors measured subjects resilience to stressors. With age, the researchers found a decline in the subjects ability to recover.

As we age, more and more time is required to recover after a perturbation, and on average we spend less and less time close to the optimal physiological state, study author Timothy V. Pyrkov said in a press release.

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The study, which was published in the scientific journal Nature, additionally found that even the healthiest volunteers were subject to the same fundamental laws of aging. The group concluded that no strong life extension is possible by preventing or curing diseases without without intercepting fundamental laws of the aging process.

"Aging in humans exhibits universal features common to complex systems operating on the brink of disintegration, said Peter Fedichev, co-founder and CEO of Gero, a biotech company involved in the research.

This work is a demonstration of how concepts borrowed from physical sciences can be used in biology to probe different aspects of senescence and frailty to produce strong interventions against aging, he added in the press release.

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Andrei Gudkov, senior vice president and chair of the Department of Cell Stress Biology at Roswell Park Comprehensive Cancer Center, was involved in the study and called the research a conceptual breakthrough.

It explains why even most effective prevention and treatment of age-related diseases could only improve the average but not the maximal lifespan unless true anti-aging therapies have been developed, Gudkov concluded.

The oldest human on record lived to be 122.

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Scientists have determined the oldest age humans can live to | TheHill - The Hill

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Human life limit is between 120 and 150, according to new study – Metro.co.uk

Posted: at 8:04 am

Its good news for people in their 70s and 80s. (Picture: Getty Images)

Its a question as old as time: can humans live forever?

The ancient quest for immortality could now have an answer: no.

Between 120 and 150 years is the limit, according to a new scientific study.

Researchers at human life extension startup Gero took a variety of measurements from adults in the US, UK and Russia, like blood cell counts and number of steps taken per day.

They found that regardless of external factors, or nationality, these numbers declined with age leading to a loss of biological resilience to things like disease, stress or injury.

The study, published in Nature Communications, concluded that this decline in resilience signals that the end of life is an intrinsic biological property of an organism and that it signifies a fundamental or absolute limit of human lifespan.

This means that even if, by sheer chance, you manage to dodge diseases like cancer and heart disease, or getting hit by a car, your body will still decline to such a point its unable to fight off everyday threats, like bacteria and viruses.

This decline in the bodys ability to return to equilibrium, as measured in blood cell counts and steps counted, suggests that the maximum lifespan for humans lies somewhere in the 120 to 150 years range.

The worlds oldest recorded living person is Jeanne Calment, a French citizen who reportedly lived to 122 though there is some skepticism about the claim.

Efforts to extend human life, or achieve immortality, have become a particular focus of Silicon Valley, with firms like Googles Calico and the Jeff Bezos and Peter Thiel-backed startup Unity Biotechnology looking to reverse the natural decline resulting from aging.

Humans are naturally living a great deal longer thanks to advances in diet and medical science: the United Nations estimates that todays population of centenarians (people living over 100), of 450,000, will balloon to 25 million by 2100.

Its not the first time that a scientific attempt at calculating an upper age limit has drawn attention. In 2016, a study also published in Nature used decades of mortality data to put the average limit on human life around 115.

But the studys methods were widely criticised, with one critic saying the authors had just shoveled the data into their computer like youd shovel food into a cow.

Another notable study, published in 2018 in the prestigious Science journal, looked at Italian pensioners. Unlike the Nature study two years prior, it found that once humans reach a plateau after a certain age, instead of a steep decline, suggesting that there is no hard and fast limit on age.

The wildly different findings of various longevity studies are often a result of using very different data sets, which can have varying levels of integrity, and the various statistical methods that researchers use to analyse them.

However, the researchers of the Gero study think theyre on to something with their latest work: study co-author Peter Fedichev says the fact that both blood cell counts and step counts paint exactly the same future is notable, as most biologists look at the two biomarkers as unconnected and pretty different.

Fedichev is also optimistic that, rather than put a hard boundary on life, this could enable future research to expand that limit: Measuring something is the first step before producing an intervention, Fedichev said.

Now that the end of life has, supposedly, been measured, his team can find ways to intercept the loss of resilience.

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Human life limit is between 120 and 150, according to new study - Metro.co.uk

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Xencor and Bristol Myers Squibb Enter License Agreement for Use of Xtend XmAb Technology in SARS-CoV-2 Neutralizing Monoclonal Antibody Combination…

Posted: at 8:04 am

MONROVIA, Calif.--(BUSINESS WIRE)--Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, today announced it has entered into a technology license agreement with Bristol-Myers Squibb Company (NYSE:BMY) under which Bristol Myers Squibb will have non-exclusive access to Xencors Xtend Fc technology to extend the half-life of a novel antibody combination therapy that is intended to neutralize the SARS-CoV-2 virus (SARS-CoV-2 mAb Duo) for treatment or prevention of COVID-19. SARS-CoV-2 mAb Duo was discovered by researchers at The Rockefeller University and was subsequently licensed by Bristol Myers Squibb. Phase 1 clinical evaluation to assess dosing and safety of the antibody combination is being conducted by investigators at Rockefeller University Hospital, while the initial Phase 2 and 3 studies are being planned as part of the NIH ACTIV-2 trial examining treatment of infected outpatients.

Xencors Xtend Fc domains have been incorporated into more than a dozen clinical-stage programs or commercialized medicines, including two programs under investigation for the treatment of COVID-19 and five for other infectious diseases, said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. This reflects the potential of Xencors XmAb protein engineering platforms to enhance the therapeutic performance of novel antibody candidates. By extending half-life, we improve upon a candidates product profile and potentially reduce costs both of which are important features, particularly for an anti-viral therapy intended for pandemic use. We are committed to partnering with industry and the academic community to support the development of potential treatments for COVID-19, as well as other areas of urgent unmet medical need.

Under the terms of the agreement, Bristol Myers Squibb will have sole responsibility for supporting and advancing the research, development, regulatory and commercial activities for SARS-CoV-2 mAb Duo. Xencor is eligible to receive royalties from net sales of products including these antibodies.

About Xtend XmAb Fc Technology

Xencors Xtend XmAb Fc domains have been shown to increase circulating half-life by increasing binding affinity to the receptor FcRn. FcRn is present inside lysosomes in endothelial cells lining the blood vessels and functions to rescue antibodies from the degradation that makes most proteins short-lived in circulation. Half-life extension can be exploited to potentially improve therapeutic antibody performance in several ways, such as increasing dosing interval or decreasing drug quantities at the same dosing interval compared to a parent antibody. Xtend technology is currently in multiple clinical-stage programs and one approved therapy, Alexions Ultomiris (ravulizumab-cwvz).

Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc.

About Xencor, Inc.

Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases. Currently, 22 candidates engineered with Xencor's XmAb technology are in clinical development internally and with partners. Xencor's XmAb antibody engineering technology enables small changes to the structure of proteins resulting in new mechanisms of therapeutic action. For more information, please visit http://www.xencor.com.

Forward-Looking Statements

Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, and similar terms, or by express or implied discussions relating to Xencors business, including, but not limited to, statements regarding the development of the SARS-CoV-2 mAb Duo for the treatment or prevention of COVID-19, the potential sales of products including the SARS-CoV-2 mAb Duo, the likelihood or magnitude of potential royalty payments to Xencor under the terms of the technology license agreement, the quotations from Xencor's president and chief executive officer and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2020 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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Xencor and Bristol Myers Squibb Enter License Agreement for Use of Xtend XmAb Technology in SARS-CoV-2 Neutralizing Monoclonal Antibody Combination...

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The ‘absolute limit’ of the human lifespan is 150, scientists say – Newshub

Posted: at 8:04 am

In this latest study scientists used human blood count data from the UK Biobank to calculate a single variable called the 'dynamic organism state indicator' (DOSI), which was "associated with expected variables such as age, illness, and lifestyles".

The more a person's DOSI figure fluctuated over time, the less resilient they were - so less able to recover from health setbacks.

The progressive loss of resilience as people age pointed to 150 as being the absolute upper limit for the human lifespan - and there's nothing we know of yet which can push that back further.

"No dramatic improvement of the maximum lifespan and hence strong life extension is possible by preventing or curing diseases without interception of the aging process, the root cause of the underlying loss of resilience," the study reads.

"The loss of resilience cannot be avoided even in the most successfully aging individuals and, therefore, could explain the very high mortality seen in cohorts of super-centennials characterized by the so-called compression of morbidity."

The 'compression of morbidity' refers to a phenomenon seen amongst centenerains, who live lives generally free of serious illness but die not long after getting sick - their excessive age making them less resilient, so the illness takes them out quicker than it might someone who's still in double-digits.

"The proximity of the critical point revealed in this work indicates that the apparent human lifespan limit is not likely to be improved by therapies aimed against specific chronic diseases or frailty syndrome... We conclude that the criticality resulting in the end of life is an intrinsic biological property of an organism that is independent of stress factors and signifies a fundamental or absolute limit of human lifespan."

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The 'absolute limit' of the human lifespan is 150, scientists say - Newshub

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In Focus: Women faculty continue to ask the University for support following the tenure clock extension’s end – Daily Northwestern

Posted: at 8:04 am

Instead of digging through archives in Paris and Geneva, history Prof. Helen Tilley, a single mother, spent the spring of her sabbatical researching and writing on the bed while her then-11-year-old daughter completed virtual assignments next to her.

Tilley, a Northwestern faculty member since 2012, was on research leave in Cambridge, England. When COVID-19 caused worldwide shutdowns, Tilley and her daughter remained in their rented townhouse bedroom, which didnt have room for a desk.

Her daughter would interrupt her several times each day about making lunch, walking the dog or completing her homework. Although Tilley said she wanted to help her daughter, the situation wasnt conducive to getting her research work done.

You want to be calm and positive about the interruptions, and you want to accept that thats going to make it bearable for her to be out of school, she said. Every day is this balancing act of, How much can I get written today?

Tilley said her daughters school wasnt prepared for virtual learning. After three weeks of online work, Tilley said she began to find other ways to keep her daughter engaged and excited about learning, essentially creating a whole curriculum on top of her research.

She said everyone responsible for raising children is constantly trying to figure out how to balance their childs needs while also advancing their own career.

What do women do when they have a career goal, and then they have community issues that also rear their head where peoples well-being, your kids well-being matters or your students well-being matters? Tilley said. I go for the well-being first. Its so important, especially for young people, to give security and to give support, because thats what will make a difference in their lives.

Over the past year, many faculty members, particularly women, have prioritized wellness over research and academic productivity. But when it comes to earning tenure, a near-lifelong appointment at a university, the quality and quantity of a candidates research, as well as their national reputation in their field, is crucial.

Time spent teaching, holding service positions within a department and working with students could all impact professors chances of being promoted. But positive Course and Teacher Evaluation Council surveys, or CTECs, dont quite compare with an internationally-recognized name or research.

Across the country, fewer women are tenured compared to men. Women hold 49 percent of total faculty positions, but just 38 percent of tenured positions which means they typically earn less than those on the tenure track. At NU, a 2017 Provosts Office report found that male full professors make just under five percent more than their female equivalents, and women spend more time at the associate professor level. Access to the data is restricted to University faculty members.

Even associate professors, who are tenured, have yet to reach the highest academic rank: full professor. The promotion comes with a salary increase, but women are 10 percent less likely to be promoted to full professor, according to the American Association of University Professors.

Pre-pandemic, (it was) an unequal playing field for women anyway, Tilley said. Its an unequal playing field for parents, the primary caregiver, which tends to be women, though its not always.

Thrashing in these waves

The early stages of the pandemic disproportionately impacted women faculty across the country, who conducted less research, wrote fewer articles and had to respond to increased caregiving responsibilities in academia and at home.

There was already a gender gap in publishing before the pandemic one study found that between 2014 and 2018, women accounted for just 38 percent of academic authors. And studies have confirmed gender disparity continued during the early months of the pandemic. There has been little research published about the recent months of the pandemic, but anecdotal evidence suggests this has continued into 2021.

Studies show men have submitted more articles for review during the pandemic. One study compared over 1,000 early papers on COVID-19 to more than 37,000 general papers from 2019 in the same journals, and found womens authorship has dropped 16 percent overall.

One possible explanation for this disparity stems from changes in academic caregiving responsibilities. Faculty members said this has included supporting students as they navigate virtual learning and personal difficulties, such as the loss of family and friends. Professors also reported spending time assisting students in obtaining the technology they need and finding alternate ways to teach and connect with them.

Political science Prof. Mary McGrath faced increased at-home caregiving expectations in addition to her academic responsibilities. Instead of focusing on conducting research or publishing articles, she was taking care of her children, then ages 2 and 4, while her husband self-isolated due to health concerns from his kidney transplant.

It was like me and my two boys thrashing in these waves, she said. I didnt know what else was going on in the world, except from seeing what was happening in The New York Times.

McGrath and her husband have handled child care themselves, each adjusting their schedule to take care of their sons when the other is working. Dressing and feeding her kids in the morning can take two hours, she said, so taking her next steps toward tenure was on her mind but not at the top of her to-do list.

I was just trying to maintain my sanity and keep my two kids alive, she said.

The track to tenure

Academic tenure was formally established in 1940 by the AAUP and the Association of American Colleges and Universities to provide lifelong employment to faculty members who show notable success in research and teaching.

A tenured professor can be dismissed only under extreme circumstances, such as sexual assault, fraud or the discontinuation of their program or department. While the exact figure at NU is not publicly available, as salary and funding is determined on a case-by-case basis, the average median salary of a tenured NU faculty member with a promotion to full professor was over $175,000 during the 2017-18 academic year, and over $136,000 for associate professors. NUs data regarding gender disparities at the professor level is not publicly available.

Only 31 percent of faculty members on the tenure track at NU are women, according to the 2019 Diversity and Inclusion Report, which measured the Universitys progress on its diversity and inclusion initiatives and the demographics of students, faculty and staff.

According to the AAUP, tenure was established to give select professors near-complete freedom of speech and research, as they cannot be fired for controversial research findings or political opinions.

To be tenured, non-Feinberg School of Medicine faculty must submit a dossier to their department during their sixth year at NU including a curriculum vitae, copies of their research and at least five letters from tenured professors at other institutions. It also includes a personal statement with the candidates past teaching, research and service experience and future plans in these areas, according to the Policy on Tenure and Promotion Standards and Procedures.

To be more competitive, candidates for tenure often include over eight letters from professors at other institutions, and these can describe a candidates status compared to other professors in their field, the policy states.

The dossier then goes to a departmental committee and the school dean, followed by the Promotions and Tenure Committee. According to the policy, the candidates department writes a letter on the candidate and their work, and the committee provides a short summary of its discussion with an explanation for its vote.

After the addition of a letter from the schools dean explaining the recommendations and rationale for each faculty member, the provost and president review the decisions before they are finalized. The dean informs the candidate of the decision, and the Board of Trustees approves the decisions over the summer.

While teaching and service are important for faculty who want to be tenured at a research university like NU, political science Prof. Karen Alter said the candidates quantity of research and the journals reputations are crucial.

NUs Policy on Tenure and Promotion Standards and Procedures echoes this sentiment, stating that the quality, importance and creativity of scholarly work is most important when evaluating research, but the quantity of published work is a factor.

Provost Kathleen Hagerty did not respond to a request for interview, but she has been working with the OWF since the fall.

At an October 2020 forum between OWF members and senior administrators, Hagerty said she supported the OWFs efforts. She added that she looked forward to working with OWF members to reduce preexisting inequities in academia, especially as they are exacerbated by the pandemic.

Treading water

In a September letter to senior administrators, the OWF called on the University to take 11 actions to increase gender equality and combat the pandemics impact. The letter included excerpts from 196 responses collected as part of an anonymous survey sent to all women faculty.

Responses outlined the professional and personal impacts of increased daily child care and household responsibilities.

I have (only) had about 60 percent of my normal working hours because of caretaking needs, one respondent wrote. Ive turned down an opportunity to write for a major popular newspaper because I dont have child care. Ive put my research on hold and feel as though Im treading water.

Another respondent said shes provided a higher level of emotional support to her students since the start of the pandemic. This has included coaching and supporting six students as they prepared for an exam and four separate two-hour Zoom sessions with one student, for example.

Additionally, the respondent wrote that she supported Black students after the murder of George Floyd, and helped international students navigate the Trump administrations policy changes to visa guidelines for those enrolled in virtual school.

Women faculty members of color also helped students process the police brutality and anti-Asian violence that have occurred over the past year. Although professors said theyre happy to support their students, the added volume of work takes an emotional toll on them.

The letters requests included a meeting with the deans and provost to discuss other suggestions, guaranteeing faculty the option to work remotely for the entire year, providing teaching relief and more options for child care and granting access to on-campus offices.

These pandemic-related uncertainties and increased responsibilities prompted NU to delay tenure decisions by a year. This decision was made as professors scrambled to move their classes online while simultaneously adjusting to life during the pandemic.

Sociology Prof. Christine Percheski was at home with her two young children, then ages 3 and 5, when NU shut down last March. She and her spouse kept a nearly constant watch over them while transitioning her graduate workshop to a virtual format.

As associate chair of her department, she had to support faculty and graduate students, coordinate teaching assistants and troubleshoot, all without a dedicated office space and with her children running underfoot.

When stay-at-home orders ended, Percheskis nanny was able to help with child care again. She said she and her husband are lucky they have assistance with child care, as many others cant afford it.

I was glad to be able to help my colleagues and our students, but it is draining and taxing work, she said. I love teaching, but I also love my research and Ive just had very little time for research in the past few months.

Percheski has taught more over the course of this academic year, which she said has taken up more energy. But she said shes also been able to spend more time doing research as the year continues and vaccinations roll out.

Keith Bender, a professor at the University of Aberdeen, has been conducting research on how the pandemic has impacted women faculty members. Although all professors are dealing with challenges, regardless of gender, fewer women are tenured and more are teaching track faculty, so they end up with more teaching responsibilities, Bender said.

This causes women to bear the brunt of transitioning classes to a virtual format and other related work, which is even more difficult when compounded with increased child care, Bender said.

Department disparities

Not all women faculty members at NU are experiencing the pandemic the same way individual schools and departments are taking their own approaches to equitable treatment.

The OWF has focused on taking action, writing reports and finding solutions. Separately, Feinbergs Women Faculty Organization has supported women faculty members by holding a virtual meet and greet for them to connect. Theyve also hosted other online programming, such as speaker events and mentoring, said WFO co-chair and Feinberg Prof. Lisa Hirschhorn.

For some, the pandemic has created small opportunities to connect with family and students. Kellogg Prof. Angela Lee said she found herself with more time during the pandemic because she didnt have to travel as much. Shes used the time to reach out to other faculty members and check in with students, especially international students, hosting daily, then weekly, coffee chats to build community.

Lee said another silver lining to the pandemic was the ability to teach from anywhere. Virtual classes gave Lee the ability to spend over a month in Canada with her daughter and grandchildren.

Medill Prof. Susan Mango Curtis said Medill has tried to be helpful, and has provided a lot of technology support. However, she said women faculty typically mentor students more and have taken on a mothering role with their students, in addition to doing the bulk of child care and housework.

Even though she doesnt have any children at home right now, shes made an effort to help those who do, especially after raising a child herself. When Medill asked Curtis to move her class time so another woman could help her children with online classes, she was happy to change time slots.

I jumped to it, she said. I knew exactly what it felt like for someone struggling to deal with both worlds at the same time.

The tenure clock is ticking

When NU announced it was pausing the tenure clock, the timeline tenure-eligible faculty follow as they apply to receive the appointment, McGrath said it seemed like a lifeline. The extension means that the file will be submitted a year later than planned, and no additional research, service or teaching will be expected. However, she said the solution feels like a temporary fix.

Its not going to be adequate to recoup what has been lost and what has changed and how this is affecting everyones capacity to do their jobs and take care of their families, McGrath said.

Without the large chunks of time she used to have during her workday, she said she focuses during her childrens naps and after about 9 p.m. She said she tried to balance her familys needs and her research but both were suffering. McGrath told The Daily the delay was essential but insufficient to make up for lost time.

The Universitys tenure clock extension applies to tenure track-faculty who were still in their probationary period during the 2019-20 academic year. NU updated the policy this April, also giving tenure-eligible faculty who were hired during the 2020-21 academic year an automatic one-year extension.

Professors are typically granted tenure clock extensions for reasons like childbirth, adoptions or other extenuating circumstances, and they can only receive these on two occasions. However, the automatic extension does not count toward that maximum, nor does it prevent professors from receiving future tenure clock extensions.

Faculty can request a second pandemic-related extension that doesnt count toward their limit of two if COVID-19 has upended their plans. They receive these by going through the typical process for tenure clock extensions.

Despite the extra year, preparing dossiers during the pandemic is still difficult. While an extension gives faculty more time to write their personal statement, obtain recommendations and update their CV, the extra year wont always allow them to conduct research and complete larger projects. Many field and research projects needed to change entirely to be completed during the pandemic, Percheski said.

Percheski uses data at a federal restricted data center in Chicago, but it was closed for months, putting the project on hold. She said she couldnt even access some of the data necessary for her research for five months.

As an already-tenured professor, these delays wont determine Percheskis job security, but they will for others. If an assistant professor isnt granted tenure, they have a year to leave the University and find a job elsewhere.

Having to change a project or deal with personal issues arising from COVID-19 can complicate the path to tenure. With women being promoted and getting tenure at lower rates than men, these pandemic-related complications may further affect that disparity.

Its going to be hard to make up for this time, Percheski said. I dont know if one year is going to be enough, especially for those with caretaking needs, or whose research was really impacted, and who have to redo research designs or wait for archives to reopen.

Alter, who is on the editorial board of multiple journals, said she has watched submission rates soar, but men have been sending in more articles than women. This higher submission rate indicates men may publish more articles in top-ranked journals, giving them an advantage in the tenure process, she said. Because the quantity of published work is considered during the tenure review process, she said publishing research is crucial.

Due to the longer turnaround times caused by the pandemic, many faculty are submitting to less-prestigious academic journals because theres a greater chance of acceptance, she said. However, she said women have done this more, especially pre-pandemic, which can hurt the quality of the file for promotion and tenure.

Thats another way in which the male advantage is going to play out, (the) number of publications and placement of publications, Alter said. Itll play out starting next year, itll have a long tail.

Moving forward

The pandemic has altered academia and affected faculty even beyond transitioning classes to Zoom, taking care of their family members and contracting COVID-19. Community members have been pushing for tangible action to promote gender equality on campus.

The OWFs September call to action requested the implementation of ombudspeople at various institutional levels, providing support to faculty.

An ombudsperson is a neutral, independent, impartial and confidential third-party that works to solve academic and work-related problems and conflicts. In addition to conflict resolution, an ombudsperson directs faculty to University resources or policies.

After a nationwide search, NU named Sarah Klaper the first University ombudsperson two weeks ago. She will start on Aug. 1 after serving in the same position at Northern Illinois University for nine years. Klaper will report directly to the provost and is responsible for creating an Office of the Ombudsperson.

While this is a single position, an ombudsperson can advance the OWFs goal for University personnel tasked with reaching out to faculty and advocating for those who need accommodations and support.

The OWF also requested NU appoint a new associate provost for faculty. Hagerty held the role before becoming interim provost in April 2020, then provost on Sept. 1, 2020. After a 10-month vacancy, Sumit Dhar, formerly the chair of the Department of Communication Sciences and Disorders and the associate dean for research in the School of Communication, stepped into the position on Feb. 1.

All of the OWFs 11 requests have been acknowledged, and at least nine have been addressed in various ways. Some schools and departments have made advances quietly, such as reopening offices, reducing non-essential events and providing various avenues for teaching relief.

Alter said the OWF is still working toward equality while the pandemics lasting impacts remain to be seen.

Because (of) this year, you really cant use the standard practices to use the standard practices will exacerbate inequities, which is what everybodys been worried about, she said. So now we have a historic moment to actually address past inequities to say we cant use the old metrics.

Moving forward, faculty will keep fighting for equitable pay and inclusive promotion and hiring practices so women, gender minorities and faculty of color will be considered and their various experiences and hurdles will be taken into consideration when decisions are made.

On May 14, NU announced the Diverse Slates Candidate Policy, which defines new mandatory hiring practices as part of June 2020 commitments to social justice. It will require diverse representation on hiring committees and partnerships with affinity groups.

In addition to equity in hiring, NU has identified the need to rectify a gender gap in faculty salaries. University President Morton Schapiro told The Daily on May 21 that the disparity can be addressed by the current budget surplus.

Its been very difficult because weve been in a situation where weve kept salaries flat, Schapiro said. I think were now in a position, now that the budgets back in surplus, to really address any residual imbalances that were discovered Now that weve reinstituted increases for the faculty, its a chance to address it.

Right now, many women faculty are focusing their advocacy efforts around preventing sexual assault and racism, especially after Mike Polisky was initially chosen as the Universitys next athletic director, only to resign 10 days later.

Polisky came under fire because of his handling of complaints of sexual harassment and racism on NUs cheer team. He was also named a defendant in a lawsuit relating to his responses to sexual harassment complaints. As a result, the OWF released a statement on May 13 in response to Poliskys promotion.

[Read The Dailys February investigation into allegations of racism on the cheer team.]

The Universitys response to recent events and allegations regarding the cheer team is deeply problematic, illustrating the power dynamics that perpetuate sexist and racist harassment and contribute to a toxic climate for women faculty, staff, and students and members of minoritized groups, the statement read.

These minority communities arent just limited to cisgender women faculty and faculty members of color. Political science Prof. SB Bouchat said the University focuses too heavily on traditional conceptions of gender, and should acknowledge the different needs of gender non-conforming and transgender faculty.

There is a really acute and serious concern for people who have child care responsibilities, but I do think that leaves a lot of other aspects of gender out of the conversation, Bouchat said.

While administrators and advocates push for short- and long-term changes to advance gender equality at NU, its still hard for women to keep on top of teaching, research and personal responsibilities. Additionally, professors continue to support their students, make virtual learning gratifying and manage their personal lives.

However, Tilley said acknowledging the gaps and working toward closing them has helped people feel like someone has their back, even though systemic change is still necessary.

Quick thinking and flexibility can make a big difference in helping people feel like, even if there are not big institutional changes, theres a leadership that sees that theres a problem and recognizes a problem, Tilley said. That actually can make a big difference to morale.

Email: [emailprotected]

Twitter: @haley_fuller_

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Organization of Women Faculty talks equity amid COVID-19 with Provost, deans

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Skoda announces warranty extension and more for Covid-19 relief in India: Details explained – The Financial Express

Posted: at 8:04 am

Skoda Auto India has announced it has extended the warranty period for its customers. In light of the covid-19 pandemics second wave in India, customers may have been unable to make use of their service plans and product warranties due to the lockdown. It is why Skoda has decided to fulfil those warranties for an extended period of time. Product warranties, scheduled maintenance services and Skodas SuperCare Maintenance Plans which were to expire between April to June have been extended to July 31, 2021. The brands roadside assistance offers for those customers with plans to expire between April and May will be fulfilled till June 30.

Zac Hollis, Brand Director, KODA AUTO India commented; Our priority at koda Auto India is to provide continued support to our customers during such unprecedented times. Hence, we have decided to extend our warranty, Scheduled Maintenance Services and SuperCare Maintenance Plans, which were due between April and June, to July 31, 2021. We are also extending our roadside assistance policies, which would otherwise expire between April and May, until June 30, 2021.

Skoda Auto India was gearing up to launch its premium sedan the new-generation Octavia, along with its all-new c-segment SUV, the Kushaq, and the second import lot of the Karoq SUVs. However, due to the lockdown, the launch plans have been delayed. The Kushaq would rival the highly popular Hyundai Creta and Kia Seltos. Additionally, Skoda would also launch two more product in the Indian market the BS6 version of the Kodiaq and the all-new notchback based on the MQB-A0 IN platform. The Kodiaq has received its mid-life-cycle update in Europe. The updated model is now expected to be launched in India later this year to rival the Volkswagen Tiguan Allspace, Toyota Fortuner and Ford Endeavour.

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ASCO: Roche’s Tecentriq grabs I-O’s first win in post-surgery lung cancer, but it’s limitedand an FDA approval could be, too – FiercePharma

Posted: May 20, 2021 at 4:43 am

In early cancer thats amenable to surgery, a field viewed as the next battleground for PD-1/L1 immunotherapies, Roches Tecentriq has claimed the first post-operative win innon-small cell lung cancer. But the drugs role, at least in some patients, remains unclear.

Tecentriq slashed the risk of cancer recurrence or death after surgery by 34% in a studyslated for the virtual American Society of Clinical Oncology meeting next monthbut onlyin patients with stage II to IIIA disease whose tumors bore the PD-L1 biomarker.

Charles Fuchs, M.D., head of oncology andhematology product development at Roches Genentech, called the win a transformative step in helping patients with early-stage lung cancer.

Historically, improving a disease-free survival by 20% or 30% has been practice-changing and really meaningful when youre talking in a curative setting, Fuchs said in an interview.

But when all patients in the IMpower010 studyare counted, the number drops to 19%raising questions about how broad an FDA approval might be and whether doctors would actually use the drug for post-surgeryNSCLC.

Plus, the 34% recurrence reduction rate Tecentriq achieved in the carved-out subgroup was way lower than the 83% AstraZenecas small-molecule drug Tagrisso accomplished in patients with EGFR-mutated stage II to IIIA disease in its own phase 3 Adaura trial.

While Tagrisso targets a niche population, physicians are benchmarking their interest in Tecentriqs post-surgery adjuvant use against the EGFR inhibitor data right now, becausedata hasntyet shownwhether either drug can help patients live longer.

RELATED:Roche's Tecentriq is the first I-O drug to claim a post-surgery win in lung cancer. But will doctors use it?

Fuchs acknowledged the field is evolving but stressed that Tagrissos impressive showing was in a small subset of patients, whereas PD-L1-positive disease makes up 40% to 50% of all NSCLC cases. So he called Tecentriqs 34% improvement as clinically meaningful and practice-changing.

The next question centers onTecentriqs benefit for PD-L1-negative patients. When those trial subjects were counted, Tecentriqs reduction of disease recurrence dropped to 21%, which is still statistically significant. Butthe rate fell below the statistical significance bar to 19% once all randomized patients, including those with stage IB disease, were included.

Fuchs suggests that data from the stage IB patientswho made up 12% of the total trial populationare immature at the interim analysis because those patients are healthier;it takes longer for that group to accrue recurrence cases.

RELATED:AstraZeneca's blockbuster Tagrisso gets major boost with FDA OK for early lung cancer use

During Roches first-quarter earnings call a few weeks ago, Roches pharma chief Bill Anderson put the size of the market for resectable lung cancer at between $2 billion and $3 billion. But he also acknowledged the uncertainty of whether Tecentriq is for only PD-L1-positive patients or for all patients. He said he expectsmore mature disease-free survival data to answer that question.

Roche isnow talking to the FDA and the European Medicines Agency to see what we collectively think is in the best interest of patients in terms of a potential label for Tecentriqs NSCLC adjuvant use, Fuchs said.

As Roche awaits key life extension data from the IMpower010 trial, a recent survey by Jefferies analyst Peter Welford suggested that almost all physicians would rather wait until that data emerge to consider using a PD-1/L1 therapy in that group.

One reason for caution is the uncertainty of whether PD-1/L1 inhibitors will work in metastatic cancer patients who were treatedwith one of the drugs early on. Its possible that physicians might reserve PD-1/L1 for more advanced disease; Mercks PD-1 inhibitor Keytruda combined with chemo has become the standard of care for front-line treatment of metastatic disease because its proven to help patients live longer.

The question of sequential PD-1/L1 use needs to be addressed, Fuchs said, but he stressed the importance of advancing the landscape of cancer immunotherapy beyond the PD-1/L1s.

Meanwhile, other PD-1/L1 players are also targeting adjuvant NSCLC. These include Ketyrudas Keynote-091 trial, which is expected to deliver data later this year.

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Mining Weekly Pitt punts more gas – Creamer Media’s Mining Weekly

Posted: at 4:43 am

PERTH (miningweekly.com) Federal Resources Minister Keith Pitt has thrown his support behind the development of further liquefied natural gas (LNG) projects, in Western Australia, saying they would be needed to support increased global demand.

Global gas demand is forecast to grow by 1.5% on average per year out to 2025, providing incentive to ensure our large gasfields like Scarborough and Browse are developed as soon as possible.

Australias large upcoming offshore gas developments such as the Scarborough, Browse and the Barossa projects, will create thousands of new high-wage jobs, including nearly 5 000 jobs during construction and more than 1 000 operational jobs, Pitt said this week.

The Scarborough gasfield, being developed by ASX-listed Woodside, is estimated to contain a contingent resource of some 11.1-trillion cubic feet.

Fellow-listed Santos took a final investment decision on its $3.6-billion Barossa gas and condensate project in March this year, also kick-starting a $600-million investment in the Darwin LNG life extension and pipeline tie-in projects, which will extend the facility life for around 20 years. The Santos-operated Darwin LNG plant has the capacity to produce approximately 3.7-million tonnes of LNG per annum.

Australia is ready to capitalise on the expected growth in global gas demand driven by Asian economies. The use of carbon capture and storage (CCS) is a critical enabler of emerging energy technologies, Pitt said this week.

I am pleased to note that Tuesdays Budget committed A$263.7-million over 10 years to fund the carbon capture utilisation and storage (CCUS) Hubs and Technology Program, building on the A$50-million previously announced in the CCUS Development Fund.

Pitt said the Yara Pilbara plant was a great example of using gas to add value to valuable commodities for farmers and the resources industry.

The Yara plant uses natural gas in the production of fertiliser ammonia, and the further processing into ammonium nitrate for use in the mining industry.

The Yara Pilbara facilities are a great example of downstream uses of natural gas, with the company exporting fertiliser to help grow crops and feed the world from the nearby Port of Dampier, Pitt said.

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Sustainable Startup Apeel Acquires ImpactVision To Use Its AI Imaging Tech To Tackle Food Waste – Green Queen Media

Posted: at 4:43 am

Edible peel startup Apeel, which works to eliminate food waste and plastic pollution, has acquired AI hyperspectral imaging tech company ImpactVision, and by integrating this new tech into their application systems at supplier locations around the world, they will be able to help food suppliers and retailers in extending the shelf life of their fresh produce on a larger scale.

California-based food tech firm Apeel acquired ImpactVision for an undisclosed amount to use the latters imaging technology enabling suppliers to literally look inside their produce and understand the interior quality of the items.

Before this, Apeel had developed an edible peel technology which helps extend the shelf-life of fresh produce and was recently used by retail giantWalmart to trial plastic-free cucumbers given that the former uses leftover food materials like peel or skin of avocados, limes, apples, etc. and produces a blend that creates a protective layer for the produce. This results in the produce lasting 2x longer than it normally would as the peel slows down the water loss and oxidation that could make the produce go bad.

Now with this new technology, the company will be able to assess the quality of products by collecting quantifiable data on ripeness, freshness, nutritional density, and other indicators of the quality of the produce. To understand this, let us take the example of avocadoes. Usually, depending on how they look or feel when squeezed, suppliers and consumers access the ripeness. However, with the new hyperspectral imaging, the technology will be able to collect information from light the human eye cant see revealing its firmness and dry matter. This helps Apeel to frame a real-time prediction model for avocadoes red, yellow, green, from ripest to least ripe.

This first acquisition will facilitate the company in its plans of quantifying and digitizing produce quality data for its partners as well as for the entire global food system.

In a press release seen by Green Queen, CEO of Apeel, James Rogers, said: Our journey began with Apeels plant-based protection an invisible peel that addresses the challenge of global food waste by bringing more time to fresh produce before it spoils. Now, were expanding our technology to bring to light the previously invisible characteristics of produce, including internal quality, phytonutrient content, and environmental impact.

Were expanding our existing technology to bring to light the previously invisible characteristics of produce, including internal quality, phytonutrient content, and environmental impact

Given that its plant-based protection is in use throughout packing and distribution centers across North America, South America and Europe, the imaging technology will be added to the application systems to gather high-quality data images as the produce travels along the conveyance lines.

Founder of ImpactVision, Abi Ramanan, said that its companys technology can predict the internal quality of food products from hyperspectral images. When this ability to see beyond the borders of human vision is combined with Apeels shelf-life extension technology, the potential to fundamentally transform produce supply chains to reduce post-harvest loss, optimize distribution and lengthen shelf-life is enormous.

At the moment, 40% of the food grown globally goes to waste and hence, by continuously expanding into new produce categories and geographies, Apeel aims to collect category-wide datasets in a presently data-poor food landscape and by providing the largest and most comprehensive database of objective fresh produce insights aims to reduce food waste and strengthen the fresh fruit and vegetable supply chains.

When this ability to see beyond the borders of human vision is combined with Apeels shelf-life extension technology, the potential to fundamentally transform produce supply chains to reduce post-harvest loss, optimize distribution and lengthen shelf-life is enormous

For instance, fresh produce suppliers can use this data and know the exact ripening window for all their items, say if a produce supplier sees that an avocado is set to ripen tomorrow while another one will take 4 days to ripen, they know that one has more time to travel and should be sent to the retailer that is further away, ensuring that the best quality reaches consumers.

Presently, Apeel has 30 supplier integrations, with plans to double this number by end of this year.

Rogers added that using the insights made available through Apeels imaging technology, its partners will be able to effectively see inside of every fruit and vegetable. This will help quantify quality as never before so that the distribution of fresh food can be optimized. For our partners, this will mean less waste and an immediate bottom-line improvement, and ultimately, the ability to one day differentiate produce by making freshness and nutritional content visible to the consumer.

Elsewhere, China has introduced a new legislation to tackle food waste that bans online binge-eating videos and fines people that leave excess uneaten food in restaurants to enable a resource-conserving society.

Another company that is using its tech to enhance the shelf-life of products is Hazel Technologies, whose product offering is a sachet that releases shelf-life enhancing vapours in bulk produce cartons and recently received US$70 million in an oversubscribed Series C financing round to expand this technology.

Elsewhere, Barry Callebaut, which manufactures chocolate and cocoa products unveiled a sustainable brand Cabosse Naturals that is made from one single ingredient cacao which otherwise is wasted as only 30% of the entire pod is used in conventional products leading to unnecessary food waste.

Lead image courtesy of Apeel.

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