Human Behavior

RTD mental health counselor meets people ‘exactly where they are’ – The Know

For a few tense moments, the situation at an RTD bus stop looked complicated.

A woman waiting for a bus was agitated and yelling at anyone who would listen. Other riders appeared bewildered and intimidated. The bus operator wondered whether to choose between declining a rider or inconveniencing all the other passengers. Security personnel thought the woman should cool off away from public transit.

It was a perfect situation to test the skills of the only mental health clinician in the nation assigned full-time to a transit agency licensed professional counselor Nicholas Runyan, who joined RTD last summer. Runyan, contracted by RTD through the Mental Health Center of Denver (MHCD), pairs up with a Transit Police officer when he ventures out in RTDs service area within Denver.

On this day, Runyan asked to have a moment to speak calmly with the agitated woman. He decided the real problem was the obvious one: The woman needed a ride home, and getting one would change her day. Once she learned she would be allowed on the bus she relaxed, and everything turned out fine, Runyan said.

We see people who are having their worst day, Runyan noted.

Runyans MHCD supervisor, Carleigh Sailon, observed that an individuals crisis affects not just that person, but also the larger community.

Theres not really a law enforcement solution to a lot of these crises, she said. And its wonderful that RTD reached out and saw this as something that really benefits their riders.

The work arrangement RTD has with Runyan follows the ride-along model of community mental health that has proven effective with the Denver Police Department, local emergency medical responders and other out-of-the-box situations. RTD sought out the MHCD partnership to help residents in need of extra services and to improve the ridership experience of its customers.

RTDs passengers display a broad range of human behavior expected in a metro region of nearly 3 million people. Transit can be affected more heavily than other institutions because people with mental health issues, substance abuse histories or legal involvement rely on public transportation. In addition, the metro areas homeless population uses transit spaces ranging from bus shelters to light rail elevators to waiting areas at high-traffic stops such as Civic Center Station and Union Station.

Runyan starts his days with RTD security officers at 6 a.m. Often their first contacts are with people who are homeless, sleeping on RTD property.

We meet people exactly where they are, both physically and mentally, said Runyan, speaking to the MHCD and RTD philosophy of the program. If they dont want to talk, we dont force it. Half the people I already know, from previous encounters.

Runyan can put them in touch with a variety of community resources, from emergency shelter to food to a mental health intake with MHCD. The mental health agency can send a counselor immediately to a bus stop to make an initial assessment and set up longer-term counseling services.

The teams carry an app with access to MHCDs records. I might ask, Are you in our system? Runyan said.

The counselors talk with law enforcement constantly about balancing safety and effective help, short-term versus long-term goals, Runyan said.

If somebody drinks beer at the same bus stop every day, putting him in jail isnt going to do anything, he noted.

When situations are dangerous, counselors have authority to place people on 72-hour behavioral holds. Its a rare occurrence but an important tool when someone poses a clear danger to themselves or others, Runyan said. To this point he has put holds on two people, both of whom were walking out into traffic.

While some days are a 10-hour road trip without multiple incidents, Runyan said, other days have been quite eventful. In one instance, he and his partner raced to the scene of a shooting near RTD property.

Its very different in person than in a book, Runyan said of his work. My respect for what police deal with has grown exponentially.

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RTD mental health counselor meets people 'exactly where they are' - The Know

Human Behavior

Faculty of Kinesiology and Recreation Management | Wearable systems’ applications in health research – UM Today

February 25, 2020

In the era of the Internet of Bodies, wearable systems are becoming ubiquitous tools to capture human behavior and function in health research. Wearable systems can be used for multiple functions (medical care, research, consumer health) under different forms (embedded in clothing, worn as an accessory, worn on the skin, implantable or edible) and applications (physiological measures, motion measures, location measures, environmental measures and multi-sensing measures).

Advances in sensor technologies and devices in commercially available wearable systems allow for the opportunity to measure various types of data and variables under real-life conditions for long periods of time. From the clinic to the home, data streams from wearable systems that include sensor measurements, activity logs and user-generated content, can be leveraged as outcome measures for use in digital phenotyping or to deliver and enhance intervention in the context of digital therapeutics.

The Faculty of Kinesiology and Recreation Management is pleased to welcome Dr. Patrick Boissy to the University of Manitoba Thursday, March 26 at 2:30 p.m. in 220 ALC to present Wearable Systems and their Applications in Health Research at the monthly Research Seminar Series.

Dr. Patrick Boissy

Boissy, a kinesiology graduate from the Universit de Sherbrooke and current professor at the Department of Surgery (orthopedic division) at the Faculty of Health and Sciences at Universit de Sherbrooke, has been actively involved in the Research Centre on Aging in the development and use of wearable systems for health research in aging and disease since 2005.

This presentation will provide an overview of the emergence of wearable systems and key concepts surrounding the use of wearable systems for health research. Use cases for wearable systems from ongoing research at the Research Centre on Aging will be illustrated. Specifically, mobility and activity monitoring of older adults using inertial sensing and location sensing. Choosing the right wearable system for your research and usability consideration when using wearable systems will be discussed.

The lecture is free and open to the public.

Garrick Kozier

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Faculty of Kinesiology and Recreation Management | Wearable systems' applications in health research - UM Today

Human Behavior

This Is the Impact of the Coronavirus on Business – BRINK

A passenger wears a protective mask as they ride in a nearly empty bus during rush hour in Beijing, China. The mobility and work disruptions have led to marked declines in Chinese consumption.

Photo: Kevin Frayer/Getty Images

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Pandemics top national risk-management frameworks in many countries. For example, pandemic influenza tops the natural hazards matrix of the UK National Risk Register, and emerging infectious diseases are tagged as of considerable concern. Seen as a medical problem, each outbreak of a potentially dangerous infection prompts authorities to ask a rational set of questions and dust off the menu of response options that can be implemented as needed in a phased manner.

Reality, however, is generally more disruptive, as national governments and supranational agencies balance health security and economic and social imperatives on the back of imperfect and evolving intelligence. Its a governance challenge that may result in long-term consequences for communities and businesses. On top of this, they also need to accommodate human behavior.

The 2019 coronavirus disease (COVID-19) is no exception. The disease an epidemic that could become a global pandemic emerged in a densely populated manufacturing and transport hub in central China and has since spread to 29 other countries and regions (as of February 20, 2020), carried along by Chinese New Year and international travel.

In contrast to the Western Africa Ebola emergency of 2013-2016 more deadly but less contagious, arguably more isolated, and eventually contained in part by richer countries putting money into Africa COVID-19 presents larger, more interdependent economies with management dilemmas. It has also surfaced at a time of eroding trust within and between countries, with national leadership under pressure from growing societal unrest and economic confrontations between major powers.

Effective governance of cross-border crises such as pandemics involves preparedness, response and recovery at local, national and international levels. Epidemic preparedness assessments show many countries, especially in regions where new pathogens might emerge, are not well-equipped to detect, report and respond to outbreaks.

Response strategies vary, for example: playing up or playing down crises and staying open for business as long as possible versus seeking to reopen quickly. COVID-19 has highlighted tendencies in many countries to deny or cover up red flags in order to avoid economic or political penalties, but this approach can misfire.

With tens of millions of workers now in quarantine and parts in short supply, China is struggling to get economic activity back on track. Countries with well-honed crisis risk-management arrangements are faring better at slowing the spread of infection, although that does not make them immune to political and economic pressures.

COVID-19 has also shown how governance failures may involve inaction or over-zealous action by ill-prepared authorities scrambling to maintain or regain stability. Both ends of the spectrum undermine trust and cooperation among citizens and countries. Centralized control measures may seem necessary to stop or delay the spread of the virus and compensate for weak individual and community resilience, but they may also cause harm.

Mass quarantines in cities or cruise ships stigmatize those under lockdown and increase mental health risks as people experience stress, anxiety and a sense of isolation and loss of control over their lives. Travel bans result in social, economic and political penalties, which can discourage individuals and government bodies from sharing information and disclosing future outbreaks. Weak or overwhelmed health systems struggle to limit the spread of infection or cope with surging care needs, further reducing confidence in the competence and character of the institutions and individuals in charge.

Social media poses a further challenge to trust: Panic spreads faster than pandemics, as global platforms amplify uncertainties and misinformation. Emotionally visceral content from anyone, such as data, anecdotes or speculation, that sparks fear can go viral and reach far more people than measured, reassuring advice from experts. Even in the absence of human or automated trolls seeking attention or disruption, well-meaning individuals can spread panic worldwide by escalating or misinterpreting early, provisional or context-free information. Such fear will fray citizens trust in governments ability to protect them from risk and increase the likelihood of psychologically defensive and societally damaging measures such as panic-buying and prejudice.

Where a stringent policy response is deemed necessary, business will inevitably be impacted, with both near-term effects and less-expected longer-run consequences.

Overall, Chinas GDP growth may slow by 0.5 percentage points this year, taking at least 0.1 percentage point off of global GDP growth. This will ripple through developed and emerging markets with high dependencies on China be that in the form of trade, tourism or investment. Some of these countries exhibit pre-existing economic fragilities, others (acknowledging an overlap) have weak health systems and thus lower resilience to pandemics. Many Asian and African countries lack surveillance, diagnostic and hospital capacities to identify, isolate and treat patients during an outbreak. Weak systems anywhere are a risk to health security everywhere, increasing the possibility of contagion and the resulting social and economic consequences.

Epidemics and pandemics are hence both a standalone business risk as well as an amplifier of existing trends and vulnerabilities. In the longer run, COVID-19 may serve as another reason besides protectionist regulations and energy-efficiency needs for companies to reassess their supply chain exposure to outbreak-prone regions and to reconfigure regionally.

Businesses may also have to contend with intensifying political, economic and health security risks for example, resumption of trade hostilities between China and the United States. A prolonged outbreak or economic disruption could fan public discontent in Hong Kong and mainland China, prompting repressive measures that stifle innovation and growth. Stumbling growth in emerging markets may fail to absorb fast-growing workforces, leading to societal unrest, political uncertainty and an inability to invest in health systems.

Beyond standard concerns related to business operational continuity, employee protection and market preservation, businesses and countries should take a fresh look at their exposure to complex and evolving interdependencies that could compound the effects of pandemics and other crises. Given the panic and neglect cycle of pandemic preparedness, once COVID-19 is contained, much of the world is likely to return to complacency and remain under-prepared for the inevitable next outbreak. Businesses that invest in strategic, operational and financial resilience to emerging global risks will be better positioned to respond and recover.

A version of this piece originally appeared on the World Economic Forums Agenda blog.

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This Is the Impact of the Coronavirus on Business - BRINK

Human Behavior

Transportation – The March to Digital Mobility – Lexology

Its not quite The Jetsons, but American streets and airways are starting to look eerily futuristic. Towns are seeing legions of new e-scooters; new-age cars are being introduced with autonomous features; and the skies are alight with drones whose agility and ease of use were unimaginable only a few years ago. Meanwhile, Crowell & Morings cutting-edge digital clients are testing unmanned delivery vehicles meant to travel sidewalks, drones of various sizes, smaller and lighter street vehicles, and fully autonomous cars and trucks.

We live in dynamic times, and previous leaders in mobility have seized commanding market positions by launching first and seeking permission later. After all, what else can they do when law lags behind science? Startups that launch early similarly stand to gain the edge in publicity, funding, and user networks.

But unlike many digital developments, mobility solutions involve real people cruising hazardous streets and airways. Serious accidents can sink a product or a business. Even without mishaps, getting labeled as rogue by regulators and officials can imperil a companys brand and delay its license to operate in desired markets.

For mobility companies intent on staying on the right side of regulatory agencies, that requires rulesand, when it comes to digital mobility, rules are few and far between.

Rules and Contracts and Disruption, Oh My

Most safety regulations for transportation were written before the move from analog to digital, notes Cheryl Falvey, a partner in Crowell & Morings Mass Tort, Product, and Consumer Litigation Group and former general counsel of the Consumer Product Safety Commission. They tend to focus on the products and their components themselves, and not the new-age challenges that can arise when their connected ecosystem fails to operate as intended, such as through hacking or loss of interconnection.

In January 2019, one commissioner at the CPSC released a framework for safety for the Internet of Things intended to provide broad-based technology-neutral best practices to ensure consumer product safety. By the end of the year, however, the commission had not yet issued binding rules.

Meanwhile, the National Institute of Standards and Technology is hosting an interagency task force that includes representatives of the CPSC and the National Highway Traffic Safety Administration, which is discussing safety and cybersecurity in the Internet of Things. All government agencies are watching NIST because they keep coming out with more robust and targeted guidance on these topics, says Falvey. In July 2019, NIST finalized risk management guidance for the Internet of Things. Meanwhile, several states have mandated basic security on internet-connected devices.

Many emerging technologies are produced outside the U.S., but U.S. manufacturers and importers operating in the U.S. will be responsible for ensuring regulatory compliance, notes Rebecca Baden Chaney, a partner in Crowell & Morings Mass Tort, Product, and Consumer Litigation and Product Risk Management groups.

"U.S. manufacturers and importers operating in the U.S. will be responsible for regulatory compliance" of technologies produced outside the U.S.

Regulation aside, mobility players need their contracts to keep pace. When already-complex devices require connection with many other complex devices, the supply chain gets longer and potential sources of liability mushroom. As a constellation of new software and hardware companies join the mobility supply chain, contracts have to be entirely rethought, says Scott Winkelman, a partner in Crowell & Morings Mass Tort, Product, and Consumer Litigation Group. Major new suppliers are not traditional auto industry players and lack experience dealing with transportation safety agencies and negotiating terms in the industry. And Big Tech titans moving into mobility bring entirely new levels of leverage to contract negotiations. As if this werent complicated enough, trade wars, Brexit, climate change, and other global forces are disrupting transportation supply chains in ways rarely seen before.

One concrete measure of mobility that companies can take now is to embed in their contracts with software suppliers the right to see their source code if needed, says Falvey. If a safety incident might be traceable to defective or hacked software, then an immediate review of that source code may be necessaryand it may be difficult to access that proprietary information without a prior agreement in place.

Autonomous Vehicles: Waiting for Winners

Fans of autonomous vehicles have been feeling impatient recently, as some developers conclude that the artificial intelligence needed to handle all the edge cases presented by human behavior on the roads isnt quite ready for prime time.

Meanwhile, studies such as a feature in The Economist warn that China might beat the U.S. to widespread deployment of AVs. Thats because Chinese officials are using their overwhelming command-and-control authority to modify transportation infrastructure to be AV-friendly, limit liability for AV companies, and encourage development of 5G technology. As a result, Chinese AVs may soon be roaming the streets in environments custom-built for themeven if those vehicles lack the AI capabilities of American AVs.

In an ideal world, U.S. officials would develop a Marshall Plan for digital that would design digital-friendly policy in unified fashion around chosen technologies, says Crowell & Morings Scott Winkelman. Instead, theyve opted for what Winkelman calls the next best thing: an approach that is technology-neutral and focused less on means than on (safe) ends.

The NHTSA is a sterling example. It has convened stakeholder groupings that have collaborated on a series of autonomous driving guidelines that are measured, practical, and focused on safe driving and safe vehicles, Winkelman says. Guidelines released in 2018 declared that the NHTSA would reconsider safety standards to accommodate AV technologies. In 2019, the agency took comments on rules that could allow vehicles without manual controls to operate on public roadways.

Federal legislation that would allow for uniform treatment of autonomous vehicles nationwide remained stalled in 2019. If history is any guide, the wait could be long, Winkelman says, unless or until a significant safety incident occurs or a given state gets so far out ahead that the feds feel compelled to act.

New Roles and Responsibilities

Rentable e-scooters and autonomous drones and vehicles might not seem to have much in common, but they all involve new ownership and distribution models that bring up new challengesand opportunitiesin terms of safety, liability, and the public obligations of vehicle manufacturers.

For example, individual car and truck owners are generally expected to be primarily responsible for maintenance. But todays rentable vehiclesand many of tomorrows autonomous vehiclesare generally owned by the company putting them out on the streets. Now it is on that owner, not the consumer, to be accountable for safety, Falvey says. Officials and regulators are still working out what they expect those companies to do and what their legal authority to require it is. While the Federal Aviation Administration is clear on these expectations for aircraft, other agencies are still catching up, she adds.

As regulators work these questions, theyre demanding data they can use to make safety-related decisions. Many startups dont realize they need to collect this data in the first place, Falvey says; in fact, they should be ready to provide it to regulators on short notice, accompanied by the necessary analysis. The data includes how often the vehicles are being used, maintenance schedules, which product issues are being reported, and how quickly the company responds.

Much of this data is also important for companies own internal use as they determine how best to keep their vehicles in safe working order, Falvey adds. Companies must understand the lifecycle of their vehicles and their components in real-life commercial use, because unlike the average individually owned car or bike, these items may be used dozens of times a day. They must also be willing and able to put the vehicles in maintenance mode so that they cant be used until theyve been repaired. These companies have innovated on the product side. Now they need to innovate throughout the products lifecycle, considering the maintenance and support needed out in the field, Falvey says.

"Now companies need to innovate throughout the product's lifecycle, considering the maintenance and support needed out in the field."

While startups are accustomed to testing products in controlled conditions, they must account for human factorsthat is, how having actual humans controlling and surrounding these vehicles affects operational safety, says Mary-Caitlin Ray, a counsel in Crowell & Morings Aviation Group and a former attorney in the Federal Aviation Administrations Office of the Chief Counsel. The analysis must consider not only the variability of humans but also how the vehicle affects its environment. How do pedestrians and drivers react to seeing a scooter on the street? How do people on the ground (or pilots in the air) react when they see a drone?

Drones: Delayed Liftoff

While micro-mobility options are proliferating, widespread adoption of autonomous drones appears farther off. The FAA has several rulemakings underway; the most hotly anticipated would develop standards for Remote ID, a technology that would allow unmanned aircraft to operate within a system similar to the air traffic control system now in place for manned aircraft. This technology is a critical piece in ensuring that drones are safely integrated into the National Airspace System, and it plays both safety and enforcement functions, Ray says. Electronic license plates would allow drones to see and communicate with each other and would identify the operator of the drone, providing law enforcement with actionable information in the event of an emergency or a rogue drone.

Though much delayed, the rulemaking process for Remote ID will be underway by early 2020. It will be followed by rulemakings allowing commercial operators to conduct more complex operations without obtaining special permission from the FAA. That would include operations beyond the operators line of sight and operations over peoplecrucial for tasks such as facility inspections as well as for deliveries.

For companies with an eye on commercial package delivery programs, a vast majority of these operations are forced to conform to regulatory requirements developed for manned aircraft, known as a Part 135 certificate. Thus, they must obtain exemptions for a host of requirements such as use of seat belts and on-board operations manuals. These requirements and others have made the Part 135 certificate time- and cost-prohibitive for many operators. For new entrants to the aerospace sector, the challenge will be getting to know the FAA and its unique language of trust and very specific safety culture, Ray says. Companies not steeped in the aviation space may find it a difficult language to learn.

Beyond deliveries, drone aficionados are excited about the potential of larger drones to carry heavier cargoes and even people, reducing costs and relieving traffic congestion. But until there is a clear path to certification specific to drone operators, Ray jests, drone-delivered pizza is just a pie in the sky.

"Until there is a clear path to certification specific to drone operators, drone-delivered pizza is just a pie in the sky."

The Time Is Now

As regulators race to catch up, the savviest mobility companies are taking matters into their own hands. Ensuring access to data, upgrading contracting practices to fit the digital era, maintaining relations of trust with regulators, diagnosing and improving supply chainsall this can be done without a single law enacted. Digital disruption will have winners and losers, Winkelman says. Would-be winners are the ones working to earn it now.

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Transportation - The March to Digital Mobility - Lexology

Human Behavior

From Evolution to Revolution – Thrive Global

Its difficult toimagine a world without social media. After all, its where we spend on averagefive years and four months of our lifetime. There are 3.397 billion active social media users on this planet. Onaverage, people have 5.54 social media accounts. The average daily time spent on social mediaper person is 2 hours a day and could beup to 9 hours for teenagers.

Social media has becomemore than just a place where we connect. Its where we share photos, where weget our news, where we go to be validated, and where we go to get ourvoices heard. Its also where were told what to buy, and even what to believe.

But its impact on ourwellbeing is just starting to surface. An entire generation Generation Z, oriGen, as its sometimes called is growing up under the influence of socialmedia. Theyre spending significantly less time at in-person social activities than previousgenerations. Studies have shown that the more time teens spend on social media,the higher their risk of being unhappy, developing depressive symptoms andanxiety, as well as loneliness.

The impact of socialmedia on mental health is not restricted to teenagers. 210 million people are estimated to suffer from social media and internetaddiction. Its a destructive behavior that has been likened to drug use and demonstrated to cause impaired decision-making.

How can we make socialmedia the connector it was meant to be without all the harmful side-effects?

The anatomy of words.And the effects of social media on our language

There was a time whenbeing social meant physically interacting with human beings, whether itwas playing sports, getting together with friends or having dinner with yourfamily.

Today, it seems thatface-to-face interaction is being traded for device interaction. Instead ofgenuine, real-life connections, we clamber for likes, claps, upvotes, shares,follows, and comments.

The word friendis now used more as a verb than a noun friending someone is somethingthat you do, often without thinking, with the push of a button.

And then theres theword like. It has become a measure of worth in business as well associal circles. Now, a like is something we count, something thatincreases our value. Just as we friend with a single click, we often likewithout much thought.

The effects of social media on our behavior the good and the bad

It would be unfair to talkabout social media without acknowledging its positive effects.

With the help of socialmedia, weve been able to raise awareness about important topics that wereseldom talked about before. Social media has been instrumental in movementslike Black Lives Matter, MeToo, among others, and in helping to mobilize rescueefforts and community support for disaster relief. It has allowed us to stay intouch with friends and relatives, introduced new marketing channels forbusinesses, aided us in finding jobs, and enhanced our social experience inmany other ways.

Where did we go wrong?

Social media began as afast and easy way to connect with others, and as it evolved, it became avehicle for our voices, a way to get our message across, a platform to promoteproducts and services, etc. Pretty quickly though, things started to go wrong.

As social media startedgathering data on us, they built psychological profiles on what we like anddislike. The advertisers learned that outragegot peoples attention and made them share. But more importantly, they knowwhat outrages each of us individually and as groups. Trolls, bots andalgorithms were created to feed the outrage machine.

The result is social media has negativelyimpacted our ability to deeply connect with other people in real life. Many ofus lack the social intelligence and social skills that enable us to communicate our thoughts andfeelings, and as a result, our relationships suffer.

Weve changed in endless ways, but now its timeto reassert control over our minds and our online wellbeing.

The Revolution

Around 2014, people beganto question the ethics of social media platforms, along with the ad-drivenbusiness model, also known as the Stalker Economy or Surveillance Capitalism.

The Cambridge Analytica Scandal was just the beginning of a growing publicdiscontent that we now call techlash (a term coined by the Economist in 2017).A quiet revolution has begun in an effort to hold BigTech players like Facebookaccountable for the negative effects that have become difficult to overlook.

Weve been told by ex-leaders and supporters of big tech companies thatcontinuing to use certain free services is dangerous not only because ofcountless data breaches and the threat to your psychological wellbeing but alsofor the health of our democratic societies.

The good news is, amovement is underway. People are demanding alternative solutions, and legislationlike GDPR and CCPA are meant to give us control over our identities online. Privacyis a human right in our digital world, as well as our physical one.

By reasserting ourrights online, just maybe, we can get back to a world where social media is onceagain a vehicle for meaningful connection and leave the toxicity behind.

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From Evolution to Revolution - Thrive Global

Immunology

What Happens With AbbVie If Its Allergan Buyout Is Blocked? – Motley Fool

A deal isn't done until the ink dries on the paper. And for AbbVie's (NYSE:ABBV) pending acquisition of Allergan (NYSE:AGN), the ink hasn't dried yet.

AbbVie first announced plans to buy Allergan in June 2019. CEO Rick Gonzalez stated in the company's Q4 conference call earlier this month that the deal was on track to close in the first quarter of 2020.

But now there's a threat that could prevent the transaction from receiving regulatory clearance from the U.S. Federal Trade Commission (FTC). What happens for AbbVie if its Allergan buyout is blocked?

Image source: Getty Images.

A coalition of consumer groups and trade unions representing over 10 millions subscribers and members oppose AbbVie's takeover of Allergan. These organizations sent a letter to the director of the FTC's Bureau of Competition on Feb. 18, stating that Allergan's sale ofbrazikumab to AstraZenecaisn't enough to address the anti-competitive impact of the acquisition.

AstraZeneca initially developedbrazikumab. The drug is currently in mid-stage clinical studies for treating Crohn's disease and ulcerative colitis. Allergan's divestiture of the immunology drug enabled AstraZeneca to recover its full commercialization rights.

But the allied consumer groups and trade unions are concerned that AstraZeneca won't be able to compete against AbbVie's immunology juggernaut. These groups pointed out in the letter to the FTC that AstraZeneca wasn't able to bringbrazikumab to the market in the past and doesn't have the immunology infrastructure in place to be successful against AbbVie.

The consumer groups and unions are also worried that AbbVie will gain increased bargaining leverage with payers by picking up Allergan's lineup of drugs. Allergan claims current blockbuster products including Botox and a fast-rising star in antipsychotic drug Vraylar.

What would AbbVie's backup plan be if the FTC blocks its acquisition of Allergan? For one thing, the company wouldn't probably walk away from the deal without putting up a fight. It's spent too much time and money trying to make the acquisition happen to immediately throw in the towel.

If, however, the transaction does fall apart, it seems likely that AbbVie would go back to the drawing board to identify other potential transformative acquisitions. The problem is that if the FTC scuttles the Allergan buyout, it would probably be opposed to nearly any major deal that AbbVie might want to make.

One possible candidate that would be an intriguing pick for AbbVie is Vertex Pharmaceuticals (NASDAQ:VRTX). The only significant overlap between the two companies' pipelines and product lineups is in cystic fibrosis (CF). But AbbVie's CF drugs are only in early-stage development, while Vertex claims four FDA-approved CF drugs.

Vertex and Allergan have similar market caps. However, the price tag for AbbVie to acquire Vertex would probably have to be well above what it plans to pay for Allergan because of Vertex's strong growth prospects. It's also doubtful that Vertex would be interested in an acquisition at this point.

Another potential plan B strategy for AbbVie would be to go with the "string-of-pearls" approach and scoop up multiple smaller biotech stocks. The problem with this, though, is that AbbVie is looking for reliable revenue to reduce its dependence on Humira. A string-of-pearls shopping spree wouldn't likely achieve the big drugmaker's objective.

AbbVie could also go back to its roots and acquire a medical device maker instead of a biopharmaceutical company. Before it was a stand-alone company, AbbVie was part of Abbott Labs, which ranks as one of the biggest medical device makers in the world. The chances that AbbVie would take this course of action, though, are probably really low.

The most likely scenario of all for AbbVie is that it doesn't have to find a plan B at all. AbbVie has already obtained a green light from the European Union for its buyout of Allergan. Allergan soldZenpep in addition tobrazikumab to grease the wheels for the EU's blessing. It also sold pancreatic enzymeViokace as a sweetener to gain FTC approval.

It's still possible that the FTC could block AbbVie's acquisition of Allergan. However, any arguments that the deal will significantly boost the company's competitive position in immunology or oncology don't appear to be compelling ones. Look for the ink to dry on the $63 billion transaction sooner rather than later.

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What Happens With AbbVie If Its Allergan Buyout Is Blocked? - Motley Fool

Immunology

Flow Cytometry Market, Forecast to 2027 – Growing Research Activities in Stem Cells, Adoption of Recombinant DNA Technology for Antibody Production -…

Dublin, Feb. 26, 2020 (GLOBE NEWSWIRE) -- The "Flow Cytometry Market by Product and Solution (Consumables, Instrument, Software, Service), Technology (Cell-based, Bead-based), Application (Cancer, Immunology, Hematology), and End-user (Pharmaceutical, Biotech, Academia) - Global Forecast to 2027" report has been added to ResearchAndMarkets.com's offering.

The global flow cytometry market is expected to grow at a CAGR of 8.2% from 2019 to 2027 to reach $6.36 billion by 2027.

The growth in the overall flow cytometry market is mainly attributed to rising global incidence and prevalence of chronic diseases, increasing adoption of flow cytometry techniques in research and academia, and growing initiatives in the field of immunology and immuno-oncology researches. In addition, evolving pipeline for stem cell research and adoption of recombinant DNA technology for antibody production will further provide significant opportunities for the various stakeholders in this market.

The overall flow cytometry market is mainly segmented by product and solution (instruments, software, accessories, services), technology (cell-based flow cytometry, bead-based flow cytometry), application (research, clinical, and industrial), end user (research and academic institutes, diagnostic laboratories, pharmaceutical & biotechnology companies), and geography.

On the basis of technology, bead-based technology segment is expected to grow at the highest CAGR during the forecast period. Procedural advantages offered by this technology over other cell-based technologies (such as ELISA and western blot), including its capacity to detect multiple analytes, high reproducibility, stability, and speed are expected to propel its growth.

On the basis of product and solution, the consumables and reagents segment accounted for the largest share of the overall flow cytometry market in 2019. Frequent utilization of application-specific reagents and assays by the end users is supporting the growth of this segment.

On the basis of application area, drug discovery segment held the largest share of the overall flow cytometry market in 2019. A wide variety of flow cytometry methods with the implementation of multi-parameter intracellular flow cytometric analysis have been employed at different stages of drug discovery and development. The growing demand for such advanced technologies used during drug discovery processes to simplify complicated cell analysis procedures is expected to drive the growth of this segment.

Based on end user, the pharmaceutical and biotechnology companies segment accounted for the largest share of this market in 2019. Increasing chronic cases leading to the development of new drugs and rise in R&D expenditure by companies is contributing to the growth of this segment.

An in-depth analysis of the geographical scenario of the flow cytometry market provides detailed qualitative and quantitative insights about the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region. North America commanded the largest share of the global flow cytometry market in 2019, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

The key players operating in the global flow cytometry market are Agilent Technologies, Inc. (U.S.), Thermo Fisher Scientific Inc. (U.S.), Apogee Flow Systems Ltd. (U.K.), Sysmex Partec GmbH (Germany), Luminex Corporation (U.S.), Miltenyi Biotec GmbH (Germany), Bio-Rad Laboratories, Inc. (U.S.), bioMerieux S.A. (France), Cytonome/ST LLC (U.S.), Beckman Coulter, Inc. (U.S.), and Becton, Dickinson and Company (U.S.) among others.

Key Topics Covered

1. Introduction1.1. Market Definition1.2. Market Ecosystem1.3. Currency1.4. Key Stakeholders

2. Research Methodology

3. Executive Summary

4. Market Dynamics4.1. Introduction4.2. Drivers4.2.1. Rising Incidence and Prevalence of Chronic Diseases4.2.2. Growing Initiatives in the Field of Immunology and Immuno-Oncology Researches4.2.3. Adoption of Flow Cytometry Techniques in Research and Academia4.2.4. Flow Cytometry Based Technological Advancements4.3. Restraint4.3.1. Lack of Skilled Professionals4.4. Opportunities4.4.1. Growing Research Activities in Stem Cells4.4.2. Emerging Markets4.4.3. Adoption of Recombinant DNA Technology for Antibody Production4.5. Challenges4.5.1. Inadequate Research infrastructure across Emerging Countries4.5.2. Complexities Related to Reagent Development

5. Flow Cytometry Market, by Product & Solution5.1. Introduction5.2. Consumables and Reagents5.3. Instruments5.3.1. Cell Analyzers5.3.2. Cell Sorters5.4. Software5.5. Accessories5.6. Services

6. Flow Cytometry Market, by Technology6.1. Introduction6.2. Cell-Based Flow Cytometry6.3. Bead-Based Flow Cytometry

7. Flow Cytometry Market, by Application7.1. Introduction7.2. Research Applications7.2.1. Drug Discovery7.2.2. Stem Cell Research7.2.3. Immunology7.2.4. Cell Sorting7.2.5. Apoptosis7.2.6. Other Research Applications7.3. Clinical Applications7.3.1. Cancer7.3.2. Organ Transplantation7.3.3. Immunodeficiency Diseases7.3.4. Hematology7.3.5. Other Clinical Applications7.4. Industrial Applications

8. Flow Cytometry Market, by End-user8.1. Introduction8.2. Pharmaceutical & Biotechnology Companies8.3. Diagnostic Laboratories8.4. Research & Academic institutes

9. Global Flow Cytometry Market, by Geography9.1. Introduction9.2. North America9.2.1. U.S.9.2.2. Canada9.3. Europe9.3.1. Germany9.3.2. France9.3.3. U.K.9.3.4. Italy9.3.5. Spain9.3.6. Rest of Europe9.4. Asia-Pacific9.4.1. Japan9.4.2. China9.4.3. India9.4.4. Rest of Asia-Pacific9.5. Latin America9.6. Middle East & Africa

10. Competitive Landscape10.1. Introduction10.2. Key Growth Strategies10.3. Competitive Benchmarking10.4. Market Share Analysis (2018)

11. Company Profiles(Business Overview, Financial Overview, Product Portfolio, Strategic Developments)11.1. Agilent Technologies Inc.11.2. Thermo Fisher Scientific Inc.11.3. Becton, Dickinson & Company11.4. bioMerieux S.A.11.5. Beckman Coulter Inc. (Subsidiary of Danaher Corporation)11.6. Bio-Rad Laboratories Inc.11.7. Luminex Corporation11.8. Cytonome/St, LLC11.9. Apogee Flow Systems Ltd.11.10. Sysmex Partec GmbH (Subsidiary of Sysmex Corporation)11.11. Miltenyi Biotec B.V. & Co. KG

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Flow Cytometry Market, Forecast to 2027 - Growing Research Activities in Stem Cells, Adoption of Recombinant DNA Technology for Antibody Production -...

Immunology

Is It Too Late to Buy High-Flying Galapagos? – Motley Fool

Galapagos(NASDAQ:GLPG) galloped to all-time highs heading into this week. Although a pullback in the overall market has caused the biotech to give up some of its gains, Galapagos is still up close to 20% year to date and up around 150% over the past 12 months.

Some investors could view Galapagos as valued at a steep premium after its big run-up. But is it really too late to buy the high-flying biotech stock?

Image source: Getty Images.

The primary catalyst behind Galapagos' meteoric rise over the last year was its major collaboration deal signed with Gilead Sciences (NASDAQ:GILD) in July last year. Gilead forked over $5.1 billion for the 10-year agreement, with a $3.95 billion upfront payment and a $1.1 billion equity investment in Galapagos.

Gilead and Galapagos were already partnering on immunology drug filgotinib. The new deal gave Gilead the rights to Galapagos' other late-stage pipeline candidate, idiopathic pulmonary fibrosis (IPF) drug GLPG1690. In addition, Gilead can exercise an option to license any of Galapagos' other candidates.

You can attribute Gilead's interest in Galapagos to the tremendous promise for filgotinib. The experimental drug sailed through late-stage clinical studies targeting rheumatoid arthritis with flying colors. Gilead and Galapagos filed for U.S. and European regulatory approvals for filgotinib in treating rheumatoid arthritis in 2019. Approvals are anticipated later this year in the indication.

And that could be just the start. Gilead and Galapagos are also evaluating filgotinib in other late-stage clinical studies in treating Crohn's disease, psoriatic arthritis, and ulcerative colitis. It's also in phase 2 clinical studies targetingankylosing spondylitis and other inflammatory diseases.

Just how successful filgotinib could be if it wins approval remains to be seen. But peak annual sales of close to $3 billion in treating rheumatoid arthritis and another $3 billion in treating other immunology indications could be possible. Filgotinib's safety profile and convenience (it's an oral medication instead of an injection) could boost its commercial success.

That kind of market potential might make Galapagos' current market cap of under $16 billion seem like a steal. However, it's important to remember that the biotech won't rake in all of the money that filgotinib could make.

Galapagos will market filgotinib on its own inBelgium,the NetherlandsandLuxembourg. It willsplit profits generated by filgotinib equally with Gilead in France,Germany,Italy,Spain, and theUnited Kingdom. In other countries, Galapagos stands to receive tiered royalties between 20% and 30%.

Based on AbbVie'sexperience with blockbuster drug Humira prior to it losing exclusivity in Europe, I expect somewhere around two-thirds of filgotinib's sales will be made in the U.S. If we use a peak annual sales estimate of $6 billion, that would give Galapagos a maximum of $1.2 billion from U.S. sales of the drug. Outside of the U.S., my back-of-the-napkin estimate is that Galapagos would make a little under $1 billion annually.

It's more difficult to predict the financial impact for Galapagos' other drugs. Galapagos thinks that the global market for IPF could be $5 billion by 2025. If we assumedGLPG1690 could capture half of that market, Galapagos would probably make around $750 million annually at peak sales due to its licensing deal with Gilead.

My numbers are admittedly very rough. However, I think that peak revenue from filgotinib andGLPG1690 could bring in somewhere in the ballpark of $3 billion for Galapagos in the future. The company's other earlier-stage programs could boost its sales. In addition, Galapagos is eligible to receive some hefty milestone payments from Gilead if all goes well.

Still, though, we're looking at a stock that currently trades at more than five times sales that it might achieve sometime in the future. I like the potential for Galapagos' products. However, I think that there are other biotech stocks with more room to run. My view is that it is a little too late to jump on the Galapagos bandwagon.

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Is It Too Late to Buy High-Flying Galapagos? - Motley Fool

Immunology

What’s Behind Mallinckrodt’s Better-Than-Expected Q4 Results – Motley Fool

Investors could be experiencing whiplash from the big up-and-down swings forMallinckrodt(NYSE:MNK). There have been at least half a dozen moves of at least 20% for the stock in just the first two months of 2020.

Mallinckrodt announced its 2019 fourth-quarter and full-year results before the market opened on Tuesday. And the stock had yet another big jump. Here are the highlights from the company's Q4 update.

Image source: Getty Images.

Mallinckrodt announced Q4 revenue of $804.9 million, down from the $834.9 million reported in the same quarter of the previous year. This result topped the average analysts' revenue estimate of $772.52 million.

The company reported a net loss in the fourth quarter of $1.2 billion, or $13.76 per share, based ongenerally accepted accounting principles (GAAP). This reflected considerable improvement from the GAAP net loss of $3.7 billion, or $44.64 per share, in the prior-year period.

Mallinckrodt's non-GAAP adjusted bottom line looked much better, though. The company posted adjusted net income of $2.40 per share, up 10% year over year. It also easily beat the Wall Street consensus earnings estimate of $2.05 per share.

The drugmaker's biggest segment didn't perform very well in Q4. Net sales for Mallinckrodt's specialty brands segment slipped 6.3% year over year to $611.4 million. Sales for Acthar Gel sank 17.8% to $232.6 million due to continued reimbursement headwinds. Net sales for Amitiza fell 21.2% to $50.9 million in the wake of increased competition.

There were some bright spots, though. Net sales for Inomax climbed 3.7% year over year to $143.8 million. Ofirmev's net sales jumped 28.2% to $111.8 million. Net sales for the Therakos immunology platform increased by 11.1% year over year to $63.3 million.

Mallinckrodt's specialty generics segment also performed relatively well. Fourth-quarter net sales for the segment rose 6% year over year to $193.5 million.

The company's GAAP bottom line improved significantly from the prior-year period, primarily due to a bigger non-restructuring impairment charge in the fourth quarter of 2018. This was partially offset, however, by a $1.64 million opioid litigation settlement charge in Q4 of 2019.

Mallinckrodt's biggest news of the day wasn't its Q4 results. The company also announced an agreement in principle to settle all remaining opioid claims against it and its subsidiaries. This agreement involves Mallinckrodt's specialty generics businesses filing for Chapter 11 bankruptcy. Mallinckrodt would pay $1.6 billion over eight years and fork over warrants that would allow a trust set up as part of the agreement to buy 19.99% of the company's outstanding shares.

Investors liked the deal, with the pharma stock rising as much as 51.7% on Tuesday at one point. The agreement would enable Mallinckrodt to finally remove the dark cloud that's been hovering over its head related to opioid litigation. It would also allow the company's specialty brands business to avoid bankruptcy.

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What's Behind Mallinckrodt's Better-Than-Expected Q4 Results - Motley Fool

Immunology

Severe, Difficult-to-Treat Asthma Benefits From Systematic Assessment – Pulmonology Advisor

The majority of patients with severe and difficult-to-treat asthma who underwent systematic assessment improved significantly in at least one key asthma outcome, but with few reliable predicators of response, according to the results of an uncontrolled, observational study published in the Journal of Allergy and Clinical Immunology: In Practice.

In fact, about one-thirdof patients who require maintenance oral corticosteroids may be able todiscontinue steroid use completely after systematic evaluation.

Investigators sought to examine which patients with asthma would respond to systematic assessment and whether the oral corticosteroid burden can be reduced independent of the use of monoclonal biologic agents. They undertook a responder analysis for improvements in the following 4 domains: symptom control, quality of life, disease exacerbations, and airflow obstruction, all of which were evaluated 6 months after the initial assessment. To identify predictors of response, multivariate analyses were conducted for each of these domains. Changes in oral corticosteroid burden were measured as well, stratified by monoclonal biologic use initiated during the assessment.

Of 161 patients who wereassessed systematically, 64% exhibited a reduction in disease exacerbations,54% attained minimum clinically important differences regarding both symptomcontrol and quality of life, and 40% increased their forced expiratory volumein 1 second by 100 mL. Overall, 87% of the participants with asthmademonstrated improvement in at least one of the domains.

The most consistentpredictor of response across all of the domains was poorer baseline asthmastatus. A significant decrease in mean chronic oral corticosteroid dose wasobserved (from 11 mg to 5 mg; n=46; P <.001),even after the exclusion of 7 individuals who initiated monoclonal biologictherapy (from 11 mg to 5.6 mg; n=39; P <.001).

The study results may havebeen limited by the lack of follow-up duration, as the researchers did not assessresponse beyond 6 months.

The investigators concluded that the use of systematic assessment in patients with severe or difficult-to-treat asthma is beneficial for most of these individuals. However, [n]o single outcome was sufficient to assess patient response to interventions, and a combination of measures remains necessary in this area, the researchers added.

Disclosure: Several study authors declared affiliations with thepharmaceutical industry. Please see the original reference for a full list ofauthors disclosures.

Reference

Denton E, Lee J, Tay TR, et al. Systematic assessment for difficult and severe asthma improves outcomes and halves oral corticosteroid burden independent of monoclonal biologic use [published online January 15, 2020]. J Allergy Clin Immunol Pract. doi:10.1016/j.jaip.2019.12.037

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Severe, Difficult-to-Treat Asthma Benefits From Systematic Assessment - Pulmonology Advisor