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Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD | Small Molecules | News Channels -…

DetailsCategory: Small MoleculesPublished on Monday, 19 October 2020 10:33Hits: 608

Recommendation of triple-combination therapy based on positive results from ETHOS and KRONOS Phase III trials

LONDON, UK I October 19, 2020 I AstraZenecas Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been recommended for marketing authorisation in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist.

Trixeo Aerosphere, a triple-combination therapy, is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the ETHOS Phase III trial in which Trixeo Aerosphere showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate) over 52 weeks.1

The recommendation for approval was also supported by data from the KRONOS Phase III trial.2 In both trials, the safety and tolerability of Trixeo Aerosphere were consistent with the profiles of the dual comparators.1,2

Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, Director of the Department of Pneumology at Clinic Grosshansdorf, Germany, Lead Investigator of the ETHOS trial and National Co-ordinating Investigator of the KRONOS Phase III trial, said: Preventing exacerbations is central to the management of chronic obstructive pulmonary disease, as exacerbations may cause irreversible damage and disease progression. The triple-combination therapy, Trixeo Aerosphere, has demonstrated significant benefits in reducing moderate or severe exacerbations in patients suffering from this debilitating disease.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: Chronic obstructive pulmonary disease is now the third leading cause of death globally and affects approximately one in 10 adults over the age of 40 in Europe. Trixeo Aerosphere has demonstrated strong clinical benefit when compared with dual-combination therapies and this positive recommendation brings us closer to providing a much-needed new treatment to patients in Europe.

COPD

COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.3,4,5 It affects an estimated 384 million people6 and is the third leading cause of death globally.7 In Europe, approximately 10% of adults over the age of 40 have COPD.8 Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important treatment goals in the management of COPD.3 A single COPD exacerbation can have a negative impact on lung function,9,10 quality of life11 and increase the risk of hospitalisation.12 Additionally, even one COPD exacerbation that results in hospitalisation increases the risk of death.13,14

ATHENA clinical trial programme

The ETHOS and KRONOS Phase III trials are part of AstraZenecas ATHENA Phase III clinical trial programme for Trixeo Aerosphere, which included more than 15,500 patients globally across 11 trials.

ETHOS is a randomised, double-blinded, multi-centre, parallel-group, 52-week Phase III trial to assess the efficacy and safety of Trixeo Aerosphere in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. The primary endpoint was the rate of moderate or severe exacerbations.1 Results were published in The New England Journal of Medicine.1

KRONOS is a randomised, double-blinded, parallel-group, 24-week, chronic-dosing, multi-centre Phase III trial to assess the efficacy and safety of Trixeo Aerosphere in patients with moderate to very severe COPD regardless of whether or not they had an exacerbation in the previous year. The primary endpoints were lung function parameters.2 Results were published in The Lancet Respiratory Medicine.2

Trixeo Aerosphere

Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) is a single-inhaler, fixed dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a LAMA, with budesonide, an ICS, and delivered in a pressurised metered-dose inhaler.

Trixeo Aerosphere is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD.

AstraZeneca in Respiratory & Immunology

Respiratory & Immunology is one of AstraZenecas three therapy areas and is a key growth driver for the Company.

Building on a 50-year heritage,AstraZeneca is an established leader in respiratory care, across inhaled and biologic medicines. AstraZeneca aims to transform the treatment of asthma and COPD by eliminating preventable asthma attacks across all severities and removing COPD as a leading cause of death through earlier biology-led treatment. The Companys early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.

With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Companys growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential in rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZenecas ambition in immunology is to achieve disease control and ultimately clinical remission in targeted immune-driven diseases.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

References

1. Rabe KF, Martinez FJ, Ferguson GT, et al. Inhaled Triple Therapy at Two Glucocorticoid Doses in Moderate-to-Very Severe COPD. N Engl J Med 2020; 383: 35-48.

2. Ferguson GT, Rabe KF, Martinez FJ, et al. Triple combination of budesonide/glycopyrrolate /formoterol fumarate using co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, randomised controlled trial. Lancet Respir Med. 2018; 6: 747758.

3. GOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2020. [Online]. Available at: http://goldcopd.org. [Last accessed: October 2020].

4. Laviolette L, Laveneziana P; ERS Research Seminar Faculty. Dyspnoea: a multidimensional and multidisciplinary approach.Eur Respir J. 2014; 43 (6): 1750-1762.

5. May SM, Li JT. Burden of chronic obstructive pulmonary disease: healthcare costs and beyond.Allergy Asthma Proc. 2015; 36 (1): 4-10.

6. Adeloye D, Chua S, Lee C,et al. Global Health Epidemiology Reference Group (GHERG). Global and regional estimates of COPD prevalence: Systematic review and meta-analysis.J Glob Health. 2015; 5 (2): 020415.

7. Quaderi SA, Hurst JR. The unmet global burden of COPD.Glob Health Epidemiol Genom. 2018; 3: e4. Published 2018 Apr 6. doi:10.1017/gheg.2018.1.

8. European lung white book. 2013. Chapter 13 Chronic obstructive pulmonary disease. Available at: https://www.erswhitebook.org/chapters/chronic-obstructive-pulmonary-disease/ [Last accessed: October 2020].

9. Halpin DMG, Decramer M, Celli BR, et al. Effect of a single exacerbation on decline in lung function in COPD. Respiratory Medicine 2017; 128: 85-91.

10. Kerkhof M, Voorham J, Dorinsky P, et al. Association between COPD exacerbations and lung function decline during maintenance therapy.Thorax. 2020; 75 (9): 744-753.

11. Roche N, Wedzicha JA, Patalano F, et al. COPD exacerbations significantly impact quality of life as measured by SGRQ-C total score: results from the FLAME study.Eur Resp J.2017; 50 (Suppl 61): OA1487.

12. Rothnie KJ, Mllerov H, Smeeth L, Quint JK. Natural History of Chronic Obstructive Pulmonary Disease Exacerbations in a General Practice-based Population with Chronic Obstructive Pulmonary Disease. Am Jour of Resp Crit Care Med. 2018; 198 (4): 464-471.

13. Ho TW, Tsai YJ, Ruan SY, et al. In-Hospital and One-Year Mortality and Their Predictors in Patients Hospitalized for First-Ever Chronic Obstructive Pulmonary Disease Exacerbations: A Nationwide Population-Based Study. PLOS ONE. 2014; 9 (12): e114866.

14. Suissa S, DellAniello S, Ernst P. Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. Thorax. 2012; 67 (11): 957-63.

SOURCE: AstraZeneca

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Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD | Small Molecules | News Channels -...

Human Behavior

Add-On Psychotherapy a Win in Bipolar Disorder – Medscape

Adding psychotherapy to pharmacotherapy benefits patients with bipolar disorder (BD), particularly when delivered in family or group settings, results of a new meta-analysis confirms.

Outpatients with BD receiving drug therapy "should also be offered psychosocial treatments that emphasize illness management strategies and enhance coping skills; delivering these components in family or group format may be especially advantageous," the investigators, led by David Miklowitz, PhD, University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior, write.

The study was published online October 14 in JAMA Psychiatry.

It's increasingly recognized that drug therapy alone can't prevent recurrences of BD or fully alleviate post-episode symptoms or functional impairment, the researchers note in their article. Several psychotherapy protocols have been shown to benefit patients with BD when used in conjunction with drug therapy, but little is known about their comparative effectiveness, the authors point out.

To investigate, the researchers conducted a systematic review and component network meta-analysis of 39 randomized clinical trials (36 involving adults and three involving adolescents).

The trials involved 3863 patients with BD and compared pharmacotherapy used in conjunction with manualized psychotherapy (cognitive-behavioral therapy [CBT], family or conjoint therapy, interpersonal therapy, and/or psychoeducational therapy) with pharmacotherapy delivered in conjunction with a control intervention (supportive therapy or treatment as usual).

Across 20 two-group trials that provided usable information, manualized psychotherapies were associated with a lower probability of illness recurrence (the primary outcome) compared with control interventions (odds ratio [OR], 0.56; 95% CI, 0.43 0.74).

Psychoeducation with guided practice of illness management skills in a family or group format was superior to these strategies delivered in an individual format (OR, 0.12; 95% CI, 0.02 0.94).

Family or conjoint therapy and brief psychoeducation were associated with lower attrition rates than standard psychoeducation.

For the secondary outcome of stabilization of depressive or manic symptoms over 12 months, CBT and, with less certainty, family or conjoint therapy and interpersonal therapy were more effective than treatment as usual.

The investigators note that the findings are in line with a network meta-analysis published earlier this year that found that combining psychotherapy with pharmacotherapy is the best option for stabilizing episodes and preventing recurrences of major depression.

"[T]here is enough evidence from this analysis and others to conclude that health care systems should offer combinations of evidence-based pharmacotherapy and psychotherapy" to outpatients with BD, the researchers note.

"When the goals center on prevention of recurrences, patients should be engaged in family or group psychoeducation with guided skills training and active tasks to enhance coping skills (eg, monitoring and managing prodromal symptoms) rather than being passive recipients of didactic education," they write.

"When the immediate goal is recovery from moderately severe depressive or manic symptoms, cognitive restructuring, regulating daily rhythms, and communication training may be associated with stabilization," they add.

The coauthors of an editorial in JAMA Psychiatry note that the findings "further reinforce extant treatment guidelines recommending medication management and adjunctive evidence-based psychosocial treatments for individuals with BD."

The findings also "identify specific treatment components and formats most strongly associated with preventing relapse and addressing mood symptoms," write Tina Goldstein, PhD, and Danella Hafeman, MD, PhD, from Western Psychiatric Hospital, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.

The study "may further serve as a call to action to enhance availability and uptake of these treatments in the community. Unfortunately, data suggest substantially lower rates of psychotherapy receipt (26%50%) compared with medication management (46%90%) among adults with BD," they write.

Goldstein and Hafeman note future steps for the field include "demonstrating effectiveness of evidence-based treatment approaches for BD in the community, maximizing accessibility, and furthering knowledge that informs individualized treatment selection with substantial promise to optimize outcomes for individuals with BD."

The study was supported in part by a grant from the National Institute for Health Research (NIHR) Oxford Health Biomedical Research Centre. Miklowitz has received research support from the NIHR, the Danny Alberts Foundation, the Attias Family Foundation, the Carl and Roberta Deutsch Foundation, the Kayne Family Foundation, AIM for Mental Health, and the Max Gray Fund; book royalties from Guilford Press and John Wiley and Sons; and served as principal investigator on four of the trials included in this meta-analysis. Goldstein has received grants from the National Institute of Mental Health, the American Foundation for Suicide Prevention, the University of Pittsburgh Clinical and Translational Science Institute, and the Brain and Behavior Research Foundation and royalties from Guilford Press outside the submitted work. Hafeman has received grants from the National Institute of Mental Health, the Brain and Behavior Research Foundation, and the Klingenstein Third Generation Foundation.

JAMA Psychiatry. Published online October 14, 2020. Abstract, Editorial

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Add-On Psychotherapy a Win in Bipolar Disorder - Medscape

Human Behavior

Research in 11 countries: citizens fear the use of robots may lead to a society full of inequality – Innovation Origins

Robots and artificial intelligence (AI) appeal to the imagination of the general public. Research in eleven countries into peoples attitudes towards these technologies has shown that they feel uncomfortable with robots that look like humans and exhibit human behavior. A study of the SIENNA project shows that people assume that their lives and society will change as artificial intelligence and robotics are increasingly applied. They also expect the degree of inequality in society to increase as a result.

We are getting used to interacting with intelligent machines. We bring robot vacuum cleaners into our living rooms and ask Siri, Alexa, or Google to help us with the navigation when we drive our cars. Robotic dogs, such as the Sony Aibo, are used in the care of dementia patients. These developments are already visible. Society relies more and more on these technologies. Almost every day we use smart devices and intelligent software.

Also read: Service robots have to think like people, but theyll never become human

As part of the EUs SIENNA project, which is led by UTwente, research has been conducted among 11,000 adults from Germany, Greece, the Netherlands, Poland, Spain, Sweden, Brazil, South Africa, South Korea and the United States about their attitude towards these new technologies. In all countries where the research was carried out, respondents expect the rapid development of intelligent devices that could lead to artificial understanding and communication on a human level. Their expectation is that this will change society.

Half of the interviewees do not want robots to look and behave like humans.

80% of those questioned think that AI and rapid developments in robots will significantly change their country over the next 20 years. Less than half (46%) were positive about the impact these devices can have on their country, a third (30%) were even negative. The Dutch and South Koreans are the most positive (61% and 55%), the French the least positive (31%). More than half of those questioned (55%) think that these technologies give them less control over their own lives, only 13% think they have more control.

With respect to robotics, more than half of those questioned (52%) said that they did not want robots to look and behave like humans in their workplace or in the public space. Less than a third (29%) have no problem with it. The South Koreans accept this the most (52%), the French the least (17%). In none of the countries did more than a third of the participants find the idea of a robot as a romantic partner acceptable.

Unless everyone has equal access to technology, we run the risk of building a society of inequality.

Most people are open to robots and artificial intelligence, but they reject robots with human traits, says Philip Brey, professor of science philosophy at Twente University and coordinator of the SIENNA project. We know that interaction with machines can offer enormous advantages. But with increasing dependence on technology, we can also lose some of our autonomy. Unless everyone has equal access to technology, we run the risk of building a society in which inequality prevails.

According to Philip Brey, the research clearly shows that people see a greater degree of inequality as one of the dangers, with the result that individual autonomy is endangered. The data from these studies are a snapshot of what people know about technology and how they see the benefits and dangers, says Brey.

The SIENNA project (Stakeholder-informed ethics for new technologies with high socio-economic and human rights impact) was funded by the European Union in the framework of the H2020 research and innovation program. The project focuses on ethical and legal issues in three new technological areas under development: human genomics, human enhancement, and the interaction between man and machine. The SIENNA project is coordinated by the University of Twente and has 12 partners in Europe, Asia, Africa and North and South America.

The results of the SIENNA research are available at https://www.sienna-project.eu/publications/.

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Research in 11 countries: citizens fear the use of robots may lead to a society full of inequality - Innovation Origins

Human Behavior

What to Expect When You’re Expecting Robots – MIT News

As Covid-19 has made it necessary for people to keep their distance from each other, robots are stepping in to fill essential roles, such as sanitizing warehouses and hospitals, ferrying test samples to laboratories, and serving as telemedicine avatars.

There are signs that people may be increasingly receptive to robotic help, preferring, at least hypothetically, to be picked up by a self-driving taxi or have their food delivered via robot, to reduce their risk of catching the virus.

As more intelligent, independent machines make their way into the public sphere, engineers Julie Shah and Laura Major are urging designers to rethink not just how robots fit in with society, but also how society can change to accommodate these new, working robots.

Shah is an associate professor of aeronautics and astronautics at MIT and the associate dean of social and ethical responsibilities of computing in the MIT Schwarzman College of Computing. Major SM 05 is CTO of Motional, a self-driving car venture supported by automotive companies Hyundai and Aptiv. Together, they have written a new book, What to Expect When Youre Expecting Robots: The Future of Human-Robot Collaboration, published this month by Basic Books.

What we can expect, they write, is that robots of the future will no longer work for us, but with us. They will be less like tools, programmed to carry out specific tasks in controlled environments, as factory automatons and domestic Roombas have been, and more like partners, interacting with and working among people in the more complex and chaotic real world. As such, Shah and Major say that robots and humans will have to establish a mutual understanding.

Part of the book is about designing robotic systems that think more like people, and that can understand the very subtle social signals that we provide to each other, that make our world work, Shah says. But equal emphasis in the book is on how we have to structure the way we live our lives, from our crosswalks to our social norms, so that robots can more effectively live in our world.

Getting to know you

As robots increasingly enter public spaces, they may do so safely if they have a better understanding of human and social behavior.

Consider a package delivery robot on a busy sidewalk: The robot may be programmed to give a standard berth to obstacles in its path, such as traffic cones and lampposts. But what if the robot is coming upon a person wheeling a stroller while balancing a cup of coffee? A human passerby would read the social cues and perhaps step to the side to let the stroller by. Could a robot pick up the same subtle signals to change course accordingly?

Shah believes the answer is yes. As head of the Interactive Robotics Group at MIT, she is developing tools to help robots understand and predict human behavior, such as where people move, what they do, and who they interact with in physical spaces. Shes implemented these tools in robots that can recognize and collaborate with humans in environments such as the factory floor and the hospital ward. She is hoping that robots trained to read social cues can more safely be deployed in more unstructured public spaces.

Major, meanwhile, has been helping to make robots, and specifically self-driving cars, work safely and reliably in the real world, beyond the controlled, gated environments where most driverless cars operate today. About a year ago, she and Shah met for the first time, at a robotics conference.

We were working in parallel universes, me in industry, and Julie in academia, each trying to galvanize understanding for the need to accommodate machines and robots, Major recalls.

From that first meeting, the seeds for their new book began quickly to sprout.

A cyborg city

In their book, the engineers describe ways that robots and automated systems can perceive and work with humans but also ways in which our environment and infrastructure can change to accommodate robots.

A cyborg-friendly city, engineered to manage and direct robots, could avoid scenarios such as the one that played out in San Francisco in 2017. Residents there were seeing an uptick in delivery robots deployed by local technology startups. The robots were causing congestion on city sidewalks and were an unexpected hazard to seniors with disabilities. Lawmakers ultimately enforced strict regulations on the number of delivery robots allowed in the city a move that improved safety, but potentially at the expense of innovation.

If in the near future there are to be multiple robots sharing a sidewalk with humans at any given time, Shah and Major propose that cities might consider installing dedicated robot lanes, similar to bike lanes, to avoid accidents between robots and humans. The engineers also envision a system to organize robots in public spaces, similar to the way airplanes keep track of each other in flight.

In 1965, the Federal Aviation Agency was created, partly in response to a catastrophic crash between two planes flying through a cloud over the Grand Canyon. Prior to that crash, airplanes were virtually free to fly where they pleased. The FAA began organizing airplanes in the sky through innovations like the traffic collision avoidance system, or TCAS a system onboard most planes today, that detects other planes outfitted with a universal transponder. TCAS alerts the pilot of nearby planes, and automatically charts a path, independent of ground control, for the plane to take in order to avoid a collision.

Similarly, Shah and Major say that robots in public spaces could be designed with a sort of universal sensor that enables them to see and communicate with each other, regardless of their software platform or manufacturer. This way, they might stay clear of certain areas, avoiding potential accidents and congestion, if they sense robots nearby.

There could also be transponders for people that broadcast to robots, Shah says. For instance, crossing guards could use batons that can signal any robot in the vicinity to pause so that its safe for children to cross the street.

Whether we are ready for them or not, the trend is clear: The robots are coming, to our sidewalks, our grocery stores, and our homes. And as the books title suggests, preparing for these new additions to society will take some major changes, in our perception of technology, and in our infrastructure.

It takes a village to raise a child to be a well-adjusted member of society, capable of realizing his or her full potential, write Shah and Major. So, too, a robot.

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What to Expect When You're Expecting Robots - MIT News

Human Behavior

Clearing the record on Holiday Inn – Columbia Daily Tribune

JohnGlascock| Columbia Daily Tribune

On Tuesday, we learned that the management of the Holiday Inn Executive Center, a staple in the Columbia hotel and convention industry for over 30 years, would transfer from Executive Hotel Management to Driftwood Hospitality Management.

The new management company has indicated they are excited to become part of Columbias hotel and convention providers and announced there would be no closure of the facility. Driftwood manages more than 70 hotels under 20 brands across the United States.

Ed and Kathy Baker, who are part of the management team for Executive Hotel Management, also announced they would no longer retain a residence at the Executive Center. We appreciate Ed and Kathys contributions to our community and we wish them the very best in their future endeavors.

On Tuesday afternoon, Boone County Commissioner Fred Parry posted to his Facebook account a lengthy commentary regarding the closure of the Executive Center and made a number of statements which I would like to correct or add context too. Much of the post centered around the health orders currently in place to protect our community from the highly infectious coronavirus, forwhich there is no vaccine or approved therapeutic drugs.

To be clear, the pandemic has been very difficult for hotels and convention centers to navigate locally as well as across our state and country. While some industries were able to adapt to local health regulations and changes in human behavior due to the pandemic, the lodging industry simply must rely on people being present to conduct business.

I am proud of the cooperative agreement the city of Columbia and Boone County entered into many years ago to have a world-class accredited public health department providing direction and services to Columbia and Boone County. I am also proud of how our health and human services teams have worked with large and small businesses in Columbia and Boone County to find solutions which allow businesses to operate, with some restrictions, while protecting the health of the community and the employees of those businesses.

Since the pandemic was declared, Columbia/Boone County Public Health and Human Services (PHHS) has issued 13 health orders for both Columbia and Boone County. While the City Council and Boone County Commission do not vote to adopt each order, I am told Commissioner Parry has supported each order.

Since the initial emergency order was enacted on March 16, our Columbia/Boone County Public Health and Human Services department has conducted almost 1,500 interactions with local businesses to provide guidance. These interactions include phone calls, meetings, emails and site visits to ensure each business has ample access to make safe business plans.

It is important to note that 11 of those interactions were directly with the management of the Holiday Inn Executive Center. One of the largest events since the start of the pandemic was held at the Executive Center in July, when the Missouri Bar Association administered the bar exam to more than 600 people. This event alone involved dozens of hours of interactions, including site visits to the Executive Center by PHHS so the exam could be conducted safely.

For Commissioner Parry to suggest we did not work with the management of the Executive Center is simply wrong. In addition to providing business guidance when requested, the Columbia Chamber of Commerce hosted a meeting with local health officials and leaders. The Columbia Hospitality Association invited health officials to one of their meetings as well. The Executive Center was represented in at least one of those meetings by a member of the management team. The Convention and Visitors Bureau is hosting another meeting this week where health department leaders will be present.

At the request of Commissioner Parry, Scott Clardy, assistant director of Public Health and Human Services, reached out to Mr. Baker to discuss his concerns with the local health ordinance. Unfortunately, Mr. Baker did not return Mr. Clardys call. Mr. Baker did not reach out personally to me or Mayor Brian Treece requesting a meeting. Had he done so, we would have met with him to discuss his concerns.

Commissioner Parry also stated that Columbia Public Schools would lose almost $300,000 in property taxes remitted by the Executive Center. This is also incorrect. The facility remains open, and even if it closed, the owner would be responsible for paying the property taxes, regardless of who they are. The Executive Center remits to the City of Columbia, on average, $30,000 a month in combined utilities. In reviewing the account, that continues to be the case despite the downturn in business.

Commissioner Parry seemingly indicated he feels that PHHS has overreacted with the health orders as they pertain to local business. I am told that Commissioner Parry has not voiced objections to each of the 13 health orders, although the County Commission does not take a formal vote like the Columbia City Council does. Its interesting to me that in theColumbia Missourians candidate Q&A, Commissioner Parry gave PHHS an A+ for their handling of the COVID-19 crisis.

The city of Columbia values the health and well-being of all of our residents, visitors, students and businesses. Additionally, we know our small and locally owned businesses are vital to our communitys success. We work tirelessly to protect the public health of everyone while balancing that with the short-term economic impact. We want our community and businesses to be able to remain open and not have to revert back to another stay at home order or full closure.

We are a resilient community. We will get through this together.

John Glascock is Columbia's city manager.

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Clearing the record on Holiday Inn - Columbia Daily Tribune

Human Behavior

NIH awards over $100 million to examine biomarkers of Alzheimer’s disease in adults with Down syndrome – UCI News

Irvine, Calif., Oct. 22, 2020 The Alzheimers Biomarkers Consortium Down Syndrome (ABC-DS), a multi-institution research team, co-led by members from the University of California, Irvine, has been awarded an unprecedented five-year, $109 million grant by the National Institutes of Health (NIH), to expand research on the biomarkers of Alzheimers disease in adults with Down syndrome.

UCI principal investigators Elizabeth Head, PhD, professor and vice chair for research in the Department of Pathology & Laboratory Medicine, and Mark Mapstone, PhD, professor in the Department of Neurology, both at the UCI School of Medicine, are renowned researchers in the area of aging and Alzheimers disease in Down syndrome. Together, they will co-lead the international project, along with their colleagues from the University of Pittsburgh and the University of Wisconsin, aimed at improving the quality of life of our aging population through advancing progress toward effective prevention and treatment of Alzheimers disease (AD).

Its an honor to be involved in this landmark study and to participate in an historic opportunity to collaborate with world-class researchers across the world in an effort to better understand Down syndrome and aging, said Head. Not to mention, the timing of this announcement couldnt be more appropriate, considering October is Down Syndrome Awareness Month.

Other members of the team include Ira T. Lott, MD, professor emeritus in the Departments of Pediatrics and Neurology at the UCI School of Medicine. Lott is an award-winning pediatric neurologist who initiated the Down Syndrome Program through UCIs Alzheimer Disease Research Center 25 years ago. Eric Doran, MS, manager of the UCI Down syndrome research program, follows people with Down syndrome as they age. Other UCI schools participating in the cross-disciplinary team include the School of Biological Sciences and UCI Institute for Memory Impairments and Neurological Disorders (MIND). David Keator, PhD, research professor in the UCI Department of Psychiatry & Human Behavior, and Michael Yassa, PhD, director of the UCI Center for Neurolobiology of Learning and Memory, and professor in the Department of Neurobiology & Behavior at the UCI School of Biological Sciences, both have critical roles in the ABC-DS program overseeing the neuroimaging component of the study.

Its tremendously encouraging to see this kind of support for Alzheimers disease and Down syndrome research, said Michael J. Stamos, dean for the UCI School of Medicine. The awareness is building on a national scale and is certainly reflected in the environment at UCI, where we recently approved a new Center for Down syndrome research that will get underway in the coming months.

Down syndrome is the most common neurodevelopmental disorder affecting over 250,000 individuals in United States. People with Down syndrome have a very high risk of developing Alzheimers disease and nearly all have the brain pathology (amyloid plaques) of Alzheimers at death.

Their risk is thought to come from the fact that they have three copies of chromosome 21, where a key gene that produces amyloid is found. Because they have three copies of the gene, instead of two, they overproduce amyloid which is the key pathology of Alzheimers disease, said Mapstone.By expanding our research and increasing our studies involving Alzheimers risk in people with Down syndrome, we have a tremendous opportunity to better understand the development of the disease. This may lead us to new preventative therapies and treatments for Alzheimers in people with Down syndrome and the general population.

Funding support for this award is provided by NIHs National Institute on Aging, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) project. The INCLUDE project seeks to investigate conditions that affect individuals with Down syndrome and the general population, such as Alzheimers disease, autism, cataracts, celiac disease, congenital heart disease and diabetes.

Alzheimers Biomarkers Consortium Down Syndrome (ABC-DS) includes a cross-disciplinary team from the University of California, Irvine, along with other research teams from the University of Pittsburgh School of Medicine, University of Wisconsin-Madison, University of Cambridge, Columbia University Irving Medical Center, New York State Institute for Basic Research in Developmental Disabilities, University of Kentucky, John Hopkins Bloomberg School of Public Health, Massachusetts General Hospital, Washington University School of Medicine in St. Louis, University of North Texas Health Science Center, University of Southern Californias Mark and Mary Stevens Neuroimaging and Informatics Institute and the Alzheimers Therapeutic Research Institute at the Keck School of Medicine of USC.

The research teams will assess and examine a wide range of data from biofluid biomarkers to genetic factors, neuroimaging, and everyday cognitive and psychological function. Researchers will see participants every 16 months for up to four visits.

This research will be funded by NIH grant U19AG068054. For more information, visit: https://www.nia.nih.gov/health/abc-ds-information-patients-and-families.

About the UCI School of Medicine: Each year, the UCI School of Medicine educates more than 400 medical students, and nearly 150 doctoral and masters students. More than 700 residents and fellows are trained at UCI Medical Center and affiliated institutions. The School of Medicine offers an MD; a dual MD/PhD medical scientist training program; and PhDs and masters degrees in anatomy and neurobiology, biomedical sciences, genetic counseling, epidemiology, environmental health sciences, pathology, pharmacology, physiology and biophysics, and translational sciences. Medical students also may pursue an MD/MBA, an MD/masters in public health, or an MD/masters degree through one of three mission-based programs: the Health Education to Advance Leaders in Integrative Medicine (HEAL-IM), the Leadership Education to Advance Diversity-African, Black and Caribbean (LEAD-ABC), and the Program in Medical Education for the Latino Community (PRIME-LC). The UCI School of Medicine is accredited by the Liaison Committee on Medical Accreditation and ranks among the top 50 nationwide for research. For more information, visit som.uci.edu.

About the University of California, Irvine: Founded in 1965, UCI is the youngest member of the prestigious Association of American Universities. The campus has produced three Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UCI has more than 36,000 students and offers 222 degree programs. Its located in one of the worlds safest and most economically vibrant communities and is Orange Countys second-largest employer, contributing $5 billion annually to the local economy. For more on UCI, visit http://www.uci.edu.

Media access: Radio programs/stations may, for a fee, use an on-campus ISDN line to interview UCI faculty and experts, subject to availability and university approval. For more UCI news, visit news.uci.edu. Additional resources for journalists may be found at communications.uci.edu/for-journalists.

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NIH awards over $100 million to examine biomarkers of Alzheimer's disease in adults with Down syndrome - UCI News

Human Behavior

New model of human brain networks sheds light on how the brain functions – News-Medical.Net

Reviewed by Emily Henderson, B.Sc.Oct 20 2020

A team of Indiana University neuroscientists has built a new model of human brain networks that sheds light on how the brain functions.

The model offers a new tool for exploring individual differences in brain networks, which is critical to classifications of brain disorders and disease, as well as for understanding human behavior and cognitive abilities.

The model highlights different brain structures -- cells, groups of cells or specific regions -- and the ongoing, overlapping series of "conversations" between those structures, which are tracked on a more precise time scale than has been previously afforded by other approaches.

"The model gives us a new perspective on the brain that adds clarity to what we already know about how the brain functions," said Richard Betzel, senior author of a new study in Nature Neuroscience. Betzel is a professor in the IU Bloomington College of Arts and Sciences' Department of Psychological and Brain Sciences. "It highlights new organizational features that we hope to use down the road as diagnostic tools or as biomarkers for certain disorders."

Because the new model vividly depicts individual differences in brain networks -- the idiosyncratic signature or fingerprint that distinguishes one person's brain networks from another -- the researchers believe it could be useful for classifying brain disorders and disease.

Betzel's lab has begun to use the model in classifications of autism spectrum disorder with IU psychological and brain sciences autism researcher Dan Kennedy.

Working with researchers at the Indiana Alzheimer's Disease Research Center at the IU School of Medicine, IU neuroscientist Olaf Sporns has begun to use the model in the context of dementia, memory tasks and executive tasks, to see if they can find a marker for those at risk for Alzheimer's disease.

The model can also help researchers understand how brain networks correlate to certain kinds of behavior or abilities regarding cognitive tasks.

"We've only scratched the surface," said Sporns, Betzel's collaborator on the study. "This is what makes the project so exciting: There's a sense of something new."

Using three large pre-existing datasets, the researchers constructed their model by drawing on the theoretical work of IU network scientist Yong Yeol Ahn, an associate professor in the IU Luddy School of Informatics, Computing and Engineering. Instead of modeling the interactions among network "nodes," each of which represents a different brain structure, the researchers built a model of the brain where "edges" -- the connections between the nodes -- were front and center.

By taking this step, "we shifted the focus onto how pairs of brain regions converse and communicate across time," Betzel said.

Instead of saying that activations in two parts of the brain are correlated, we get a signal of the conversation itself. Our networks are telling us about co-activity, the conversations, which nobody has done before."

Richard Betzel, Study Senior Author and Professor, Department of Psychological and Brain Sciences, Bloomington College of Arts and Sciences, Indiana University

Continuing the analogy, Sporns, "One way we think about these edge communities is as patterns of how brain regions talk to each other, as snippets of conversation in a crowded room."

The shift from nodes to edges adds layers of complexity not present in the old model. The new edge-centric approach used a total of 200 nodes, or 200 brain structures, with 19,900 connections between them and looks at the links between these connections. The links between those 19,990 connections is well over 150 million.

"While it's more complicated to keep track of so many numbers, and requires more powerful computers, looking at the data through this new lens uncovers a lot of connections we couldn't previously see," said Joshua Faskowitz, a collaborator and graduate student in Sporns' lab. "It uncovers relationships that the traditional node-centric approach wouldn't have been sensitive to before."

As Betzel put it, "We have a different lens through which to look at the brain."

A key advantage to the model is the view it provides of "pervasive overlap," the extent to which each brain structure participates in multiple ongoing conversations. The new model represents the multifunctionality of brain regions, with every part of the brain participating in several functions.

"We're arguing that this pervasive overlap may be a fundamental feature of the brain," Betzel said. "We're painting a picture of the brain where there's a lot more interaction than we had seen before."

Source:

Journal reference:

Faskowitz, J., et al. (2020) Edge-centric functional network representations of human cerebral cortex reveal overlapping system-level architecture. Nature Neuroscience. doi.org/10.1038/s41593-020-00719-y.

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New model of human brain networks sheds light on how the brain functions - News-Medical.Net

Human Behavior

Adolescents’ Impulsive and Risky Behaviors – The Great Courses Daily News

By Mark Leary, Ph.D., Duke University Adolescents choose risky behaviors because of a brain function that dominates their decisions: socioemotional network. (Image: Motortion Films/Shutterstock)

Impulsive and risky behaviors are commonly associated with adolescence. In the United States and most other Western countries, people in their teens and early twenties show the highest rates of risky behaviors. Risky behaviors range from alcohol and drug abuse to criminal actions.

The common belief is that adolescents think of themselves as invulnerable. However, research shows that adolescents perceive risks not that differently from adults. They also have almost equal judgments of how much risk is involved in various behaviors, and how severe the consequences can be.

At the same time, the peak of crime, drug and alcohol use, automobile accidents and fatalities, and rates of sexually transmitted diseases are all in the late teenage years and drop sharply after the beginning of the 20s. Why do they do that, despite all the warnings and correct judgments?

Learn more about why adolescents dont behave like adults.

The socioemotional network is a part of the brain concerned with processing information about rewards, and especially social rewards. The socioemotional and reward system are located in the areas of the brain that handle emotion and motivation, such as the limbic system.

The hormone changes remodel the socioemotional network neurologically during puberty. When puberty begins, the reward centers in the brain change in a way that teenagers pay more attention to potentially rewarding actions. These brain changes can be seen in other mammals too.

This is a transcript from the video series Understanding the Mysteries of Human Behavior. Watch it now, on The Great Courses Plus.

The network becomes more active and interconnected with other parts, also the one responsible for processing social information. Thus, social factors and social rewards get highlighted in a teenagers life.

The cognitive control network plays a vital role in executive processes, which involve functions such as thinking ahead, planning, and controlling ones impulses. The core component of this network is the prefrontal cortex, but it is distributed throughout the brain. This network takes much longer than the socioemotional network to mature.

Hormones do not change the cognitive control network as they do in the case of the socioemotional network. The cognitive control network matures gradually during adolescence and into young adulthood.

Learn more about why self-control is so hard.

In the bigger picture, there is one system that makes a teenager want to do exciting things that involve social reward. The other system that should stop risky or bad decisions, however, is not as mature as the first yet, and it takes longer to mature.

In other words, the first network pushes adolescents toward risky behaviors because of the social reward involved. The second network, on the other hand, is not strong enough to brake. Another interesting point is that the social and emotional factors take the lead.

When there is no social reward, such as peer attention, teenagers can make good decisions with less risk. When the social and emotional stimuli emerge, the socioemotional system makes dangers look fun to gain social reward afterward. This explains why teenagers are mature when they are alone, but as soon as the friends come over, they turn into the reckless adolescent.

It also explains why studies showed that adults and adolescents perceive risks equally. The studies are done under conditions that do not activate the socioemotional network. As a result, teenagers are in their mature mood, and there is no social reward to hunt. So many of the adolescents risky behaviors occur in groups.

Learn more about why we care what others think of us.

Peer pressure comes from the dominance of the socioemotional network. It is not always that teenagers do dangerous things under pressure. They are convinced by the socioemotional network that what they do is cool, not dangerous.

The social reward coming from committing risky behaviors in a group of peers motivates risky behavior. The maturity of the cognitive networks pushes the adolescents into the more logical phase, where the socioemotional network does not control everything anymore.

Peer influences are also affected by the growth of cognitive network and susceptibility to peer pressure change with age. Further, the influence of peer pressure changes as well. For example, in one study, teenagers took twice as many risks in a video driving game when peers were present than when they played that game by themselves. Among college students, the presence of peers increased risk-taking only half as much as it did among younger teens. And among adults, having peers present had no effect on the risks they took.

Teenagers take risks not because they are less able to analyze situations, or they feel a kind of pressure to look cool, they just have not developed the cognitive brakes yet.

Teenagers know the dangers of risky behavior, yet they take more risks than adults because their cognitive control is not mature enough to help them fully perceive dangers.

Teenagers show risky behaviors because their cognitive control is maturing, and they cannot perceive dangers as adults do. Also, the social surrounding and social rewards always is a great incentive for them.

No. many studies have shown that merely informing teenagers about risky behaviors and their results does not stop them.

Yes, teenagers tend to show more risky behaviors when there is social reward or attention from their peers.

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Adolescents' Impulsive and Risky Behaviors - The Great Courses Daily News

Human Behavior

Halting the hogs | UDaily – UDaily

Feral hogs are one of the most damaging, invasive animals that you probably havent heard of. University of Delawares Center for Experimental and Applied Economics researcher Sean Ellis hadnt heard about them either. But, after his economics research on these hogs and how to address the many problems they present, hes unexpectedly become a hog expert. Along with UDs Kent Messer, Ellis is a co-author of new feral hog research published this October in Applied Economic Perspectives and Policy.

When you think feral hogs, dont think of cute pigs playing around in a barnyard. Think wild boars nine million and growing quickly eating and trampling agricultural crops, damaging streams and spreading disease to livestock and humans.

Controlling feral hogs is very expensive. For farmers, its not just about the risk of what feral hogs can do to their property, its also about the costs of spending money to control them, said Ellis, a postdoctoral researcher. Most farmers are small business owners operating on a thin margin of profit. They have to be very smart about directing their resources to the most impactful areas of their business.

Like many other invasive pests, these hogs run amuck due to a lack of natural predators to control the population. In the United States, they cost estimated $1.5 billion in damages and control costs annually. Genetically, feral hogs are a blend of domestic swine and the Eurasian wild boar; theyve taken the strongest characteristics from each thick fur, a strong sense of smell and superior intelligence making them a prolific species. And the hogs are a carrier of more diseases than a typical wild animal, a topic of which the world is more cognizant than ever given the possible origins of the coronavirus (COVID-19). Now in the U.S. across 35 states, the problem has reached epidemic levels in states across the southeast and spreading north. Highly affected states are more vulnerable to transmission of exotic parasites from these hogs, which can have a dangerous effect on a humans immune system.

Farmers, landowners and public land managers alike are working to combat populations of these swine; like a chain, efforts to stop their spread are only as strong as the weakest link. For example, if one landowner scares the hogs off her property, these resourceful pigs will move next door to another farm or public lands.

There is very little economics research on this issue, but ultimately its an economic problem involving human behavior, said Ellis. Solving the problem requires coordinated community action, but the members of the community face varying levels of risk. The financial loss from feral hog damage and the opportunity cost of investing limited financial resources into solving this problem, instead of elsewhere.

Controlling the hogs is not as simple as sending out hunting parties. Efforts to trap or shoot the wild hogs are often thwarted as these opportunistic omnivores are clever and adaptable. Groups of hogs, known as sounders, move across large areas. Once hunted, they learn to hide or lie still in the presence of humans. They also can become exclusively nocturnal and often change or expand their home range. Feral hog control is also difficult because of the species high fertility. A sounders size can double in four months. A pregnant sow can reproduce as early as six months of age, typically bearing four to twelve piglets per year.

And the hogs arent just staying put on rural lands. Theyre making suburban communities home, especially across the South. While the hogs have reached central Pennsylvania, Delaware has, so far, been spared. From 2014 to 2018, the National Feral Swine Damage Management Program spent more than $1 million in the Keystone State to control the hogs in counties like Lancaster and York. But, given their prodigious birth rates, that doesnt mean populations wont rebound.

Many parts of the country are becoming more suburban. That increases the number of interactions between feral hogs and people, said Ellis. Since they carry a lot of diseases and are physically large animals, that is a concern.

So how can we stop the spread? Like weve seen in the fight against COVID-19, it takes a coordinated community effort. Ellis says farmers and public land managers must work in concert. Even if all area property owners work together, without a local feral hog control program, the hogs will retreat to safer areas like the deep woods or river bottoms, re-populate and come back as strong as before. Conversely, public land managers in highly affected areas have feral hog control programs, but the program cannot stop these animals without participation of surrounding landowners.

While new federal funding has recently become available for feral hog management through the 2018 Farm Bill, how best to spend this money is not well understood. This research is designed to help ensure that these funds are used in a manner that effectively addresses the problem.

One of the most effective methods of controlling feral hogs is a remotely operated trap. However, they come at a hefty cost. For their research, Ellis, Messer and their co-authors at Albany State University and Johns Hopkins University developed a cost-share program to see if they could increase adoption. Landowners could bid in actual auctions around the country for trapping systems that boasted remote monitoring and gate closure features. Included in the price of the trap was a year of cellular service for remote monitoring, as well as delivery, setup and training provided by a Jager Pro contractor.

Our results show that landowners require substantial financial assistance when implementing control efforts with high upfront costs, such as remotely operated traps, said Messer, S. Hallock du Pont Professor and director of the Center for Experimental and Applied Economics. Some landowners may even require a financial incentive to use methods like trapping, as they ultimately cost money to maintain and operate. This research suggests that landowners are reluctant to invest in these traps, if they dont believe that their neighbors will do their part in controlling the hogs.

Through collaboration of researchers from UD, Albany State University, Johns Hopkins University, and the Center for Behavioral and Experimental Agri-Environmental Research (CBEAR), the study was funded by the U.S. Department of Agriculture National Institute of Food and Agriculture.

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Halting the hogs | UDaily - UDaily

Physiology

Staying informed: Michigan Tech Thursday town halls cover wide range of pandemic-related topics – Marquette Mining Journal

By RYAN SPITZA

Journal Staff Writer

MARQUETTE COVID-19 has impacted millions of people across the globe.

From China, to Europe, the United States, Michigan and right down to the Upper Peninsula, the coronavirus is present and has shown no signs of slowing down anytime soon.

Thats why Michigan Technological University is working to inform U.P. residents about the virus through the U.P. COVID-19 Community Town Hall Series, a virtual 12-week program organized by MTUs Health Research Institute and Center for Educational Outreach.

The series started with the first town hall on Sept. 3. The town halls take place Thursday evenings from 7 p.m. to 8 p.m. Each town hall focuses on a different aspect of COVID-19 and the public is encouraged to tune in via Zoom, Facebook Live and Keweenaw-area radio station 97.7 The Wolf.

The goal of the town hall series is to increase awareness about COVID-19 and how it impacts health and society, Dr. Steven Elmer, associate professor in MTUs Department of Kinesiology and Integrative Physiology, said in a news release. Viewers from across the Upper Peninsula have tuned in. Some of the weekly topics discussed so far include the role of public health in protecting the community, virus transmission, testing, tracing and vaccines, and acute care of hospitalization of COVID-19.

Elmer is one of the moderators for each of the town halls, along with Dr. Kelly Kamm, assistant professor of kinesiology and integrative physiology at MTU.

Elmer and Kamm are joined by clinicians, public health officials, researchers and community experts each week to discuss a range of COVID-19 topics and answer any questions the public may have.

Last weeks town hall was titled How to Stay Physically Active during the Pandemic, and guests on the panel included University of Michigan family and sports medicine physician Dr. Keri Denay, U.P. Health System-Portage health and fitness manager Angela Luskin and Steve Short, physical therapist for the Denver Nuggets.

An important message was to find simple ways to move more and sit less because exercise is one of the best forms of medicine to promote good health, prevent disease and bolster immune function, organizers said in the release. Additionally, the audience was encouraged to follow the four Ws, wear a mask, wash hands, watch your distance and walk to stay active.

MTU graduate student Jamie Phillips also joined last weeks panel to introduce UP and Moving, a program Phillips and his colleagues created which aims to help U.P. and northern Wisconsin residents stay active throughout the pandemic through a free virtual exercise series.

The next town hall is scheduled for today at 7 p.m. and will cover the Impact of COVID-19 on Mental Health.

Joining the panel this week will be Leslie Griffith, outpatient program director for Copper Country Community Mental Health, MTU director of student health and well-being Dr. Amber Bennett, MTU assistant professor in cognitive and learning science Dr. Kevin Trewartha and one additional community guest.

Other upcoming topics include Teaching and Learning on Oct. 29, How to Work Safely and Productively on Nov. 5, Michigan Tech Response to COVID-19 and Student Involvement on Nov. 12, COVID-19 Impact on Economics on Nov. 19 and COVID-19 Exacerbation of Health Disparities on Dec. 3.

To download and view previous town halls, a schedule of the remaining town halls and links to view or listen to the remaining town halls, visit http://www.mtu.edu/health-research/covid19townhall/.

Ryan Spitza can be reached at 906-228-2500, ext. 248. His email address is rspitza@miningjournal.net.

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Staying informed: Michigan Tech Thursday town halls cover wide range of pandemic-related topics - Marquette Mining Journal