Monthly Archives: December 2019

Genetics

Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive…

BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN) today announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The submission is based on the results of HER2CLIMB, a randomized pivotal trial comparing tucatinib added to trastuzumab and capecitabine versus trastuzumab and capecitabine alone. HER2CLIMB trial results were presented on December 11, 2019 at the 2019 San Antonio Breast Cancer Symposium and published in the New England Journal of Medicine. Tucatinib is an oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2.

Tucatinib was recently granted Breakthrough Therapy designation by the FDA in combination with trastuzumab and capecitabine, for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been treated with trastuzumab, pertuzumab, and T-DM1. This designation was based on data from the HER2CLIMB trial.

Todays submission marks another important milestone for Seattle Genetics and tucatinib, and a potential advance for patients with either locally advanced or metastatic HER2-positive breast cancer, including those with and without brain metastases, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. We look forward to working with the FDA on the review of this application.

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the aggressive spread of cancer cells. An estimated 271,270 new cases of invasive breast cancer will be diagnosed in the U.S. in 2019.1 Between 15 and 20 percent of breast cancer cases worldwide are HER2-positive.2 Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.2, 3, 4 In patients with metastatic breast cancer, the most common site of first metastasis is in bone, followed by lung, brain, and liver.5, 6 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.2, 7 Despite recent treatment advances, there is still a significant need for new therapies that can impact metastatic disease, especially brain metastases. There are currently no approved therapies demonstrating progression-free survival or overall survival benefit for the treatment of patients with HER2-positive metastatic breast cancer after progression on T-DM1.8, 9, 10

About HER2CLIMB

HER2CLIMB is a multinational randomized (2:1), double-blind, placebo-controlled, active comparator, pivotal clinical trial comparing tucatinib in combination with trastuzumab and capecitabine compared with trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer who were previously treated with trastuzumab, pertuzumab, and T-DM1. The primary endpoint of the trial was PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by blinded independent central review (BICR) in the first 480 patients enrolled in the trial. HER2CLIMB enrolled a total of 612 patients to support the analyses of key secondary endpoints, including overall survival, PFS per BICR in patients with brain metastases at baseline, and confirmed objective response rate. Safety data were evaluated throughout the study.

About Tucatinib

Tucatinib is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR. Inhibition of EGFR has been associated with significant toxicities, including skin rash and diarrhea. Tucatinib has shown activity as a single agent and in combination with both chemotherapy and other HER2 targeted agents such as trastuzumab.1, 2 Studies of tucatinib in these combinations have shown activity both systemically and in brain metastases. HER2 is a growth factor receptor that is overexpressed in multiple cancers, including breast, colorectal, and gastric cancers. HER2 mediates cell growth, differentiation, and survival. Tucatinib has been granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.

In addition to HER2CLIMB, tucatinib is being evaluated in a randomized, double-blind, placebo-controlled, multi-center phase 3 trial of tucatinib in combination with T-DM1 compared to T-DM1 alone, in patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have had prior treatment with a taxane and trastuzumab. The primary endpoint is progression-free survival per RECIST criteria. Secondary endpoints include overall survival, objective response rate, and duration of response. The trial is being conducted in North America and is expected to enroll approximately 460 patients. More information about the phase 3 trial, including enrolling centers, is available at http://www.clinicaltrials.gov.

Tucatinib is also being evaluated in a multi-center, open-label, single-arm phase 2 clinical trial known as MOUNTAINEER, which is evaluating tucatinib in combination with trastuzumab in patients with HER2-positive, RAS wildtype metastatic, or unresectable colorectal cancer. The primary endpoint of the trial is objective response rate by RECIST criteria. Progression-free survival, duration of response, overall survival, and safety and tolerability of the combination regimen are secondary objectives. Results for 26 patients were evaluated in an analysis and presented at the European Society for Medical Oncology (ESMO) 2019 Congress. Enrollment is ongoing. More information about the MOUNTAINEER trial, including enrolling centers, is available at http://www.clinicaltrials.gov.

About Seattle Genetics

Seattle Genetics, Inc. is a global biotechnology company that discovers, develops, and commercializes transformative medicines targeting cancer to make a meaningful difference in peoples lives. ADCETRIS (brentuximab vedotin) and PADCEV (enfortumab vedotin-ejfv) use the companys industry-leading antibody-drug conjugate (ADC) technology designed to bring a powerful medicine directly to cancer cells. ADCETRIS is approved for the treatment of several types of CD30-expressing lymphomas, and PADCEV is approved to treat adults with metastatic urothelial cancer. In addition, investigational agent tucatinib, a small molecule tyrosine kinase inhibitor, is in late-stage development for HER2-positive metastatic breast cancer, and in clinical development for metastatic colorectal cancer. The company is headquartered in Bothell, Washington, and has offices in California, Switzerland, and the European Union. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

Forward Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting; the therapeutic potential of tucatinib, including its possible efficacy, safety and therapeutic uses and anticipated development activities including ongoing and future clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that the New Drug Application submission based on the HER2CLIMB trial may not be accepted for filing by, or ultimately approved by, the FDA in a timely manner or at all or with the requested label; the difficulty and uncertainty of pharmaceutical product development; the risk of adverse events or safety signals; and the possibility of disappointing results in ongoing or future clinical trials despite earlier promising clinical results. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

References:

View original post here:
Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive...

Physiology

The technique, physiology and painkillers behind James Anderson’s longevity as 150th Test looms – The Telegraph

Bowling a cricket ball fast is essentially an exercise in contorting the human body into an unnatural and often painful shape, then delivering the ball with enough pace, accuracy and movement to try and get the batsman out. In Test cricket history, no pace bowler has undergone this task more than James Anderson. He has already delivered 32,359 balls, a number that will mushroom further from Boxing Day.

In Centurion, Anderson will become the ninth cricketer to play 150 Test matches. It is, most obviously, a testament to his multifarious skills. But it is, too, a testament to how Anderson, and England, have managed his body. In some ways this is the most remarkable part of Andersons career: simply...

Here is the original post:
The technique, physiology and painkillers behind James Anderson's longevity as 150th Test looms - The Telegraph

Physiology

Potatoes engineered to harm a major pest but leave other insects safe – New Scientist

By Michael Le Page

blickwinkel/Alamy

An ideal pesticide would kill only pests, leaving all other creatures unharmed. Now biologists have engineered potatoes to be lethal to a major pest called the Colorado potato beetle but harmless to other species, no pesticide required.

Ralph Bock of the Max Planck Institute of Molecular Plant Physiology in Germany has genetically modified potatoes to produce RNA molecules that, when eaten, shut down an important gene in the beetle. The approach is based on a technique known as gene silencing or RNA interference.

Currently theres a lot of excitement

See original here:
Potatoes engineered to harm a major pest but leave other insects safe - New Scientist

Physiology

Who was the man behind Pavlovs Dog? – Russia Beyond

Ivan Pavlov might be Russias most famous scientist, but for most foreigners he lives in the shadow of his famous experiments with dogs. But who was Pavlov, and what else did he contribute to the history of science?

Im told that the denizens of Koltushi, nestled just twenty kilometers outside St. Petersburg, are little aware of who planted the trees in the towns beloved park. Im there on a Saturday, and many are taking a stroll with family or friends. My guide, Irina Aktuganova, continues that not many would know that the wooden buildings scattered through the greenery form part of the regions UNESCO-protected heritage, an extended monument to Russias most famous scientist and first Nobel Laureate: Ivan Petrovich Pavlov.

When foreigners think of Ivan Pavlov, theyre more likely to think of his experiments with dogs than the parks he cultivated. In fact, they might not even think about the man at all a strange fate for a scientist whose name appears in high school textbooks the world over. Little is mentioned of the pond where the aging researcher would swim every morning, or the banya where hed invite guests for a good sweat, or about the beloved bicycle he bought in Sweden before Lenins revolution. Or how he survived the revolution, for that matter.

Ivan Pavlov (second right) in his laboratory. Leningrad, 1927

I had no idea before coming to Koltushi that the same hands that rang bells for dogs also cultivated whole orchards of apple trees, or that young chimpanzees used to clamor here between the trees and busts of scientists like Decartes, Mendel or Sechenov. Aktuganova, the curator of a new permanent exhibition of art and science located in the basement of Pavlovs historical lab, shares that it was the scientist himself who developed this land from a loose hamlet, once inhabited by the Finnish diaspora, into the countrys first official academic village.

Born in 1849 in what was still the Russian Empire, Pavlov was the eldest of eleven children raised by a Russian orthodox priest and his wife. Due to an early injury as a child, he was unable to start school until he was eleven years old. Despite this, he showed a high degree of intelligence and academic potential he was reading independently by the age of seven, and after switching from theology to physiology (moving his studies from Ryazan to St. Petersburg in order to do so) he won prestigious awards while still an undergraduate.

House-museum of academician Ivan Pavlov in the city of Ryazan where he was born

His greatest award, though, was yet to come. After leaving for a stint in Germany to receive his doctorate, he returned to St. Petersburg and was eventually invited to organize the Department of Physiology at the Institute of Experimental Medicine there in 1891, which he would go on to transform into a global center for physiological research. He was nominated for the Nobel Prize in Physiology or Medicine every year after 1901 until winning it in 1904, not for his work with dogs, but in recognition of his work on the physiology of digestion, through which knowledge on vital aspects of the subject has been transformed and enlarged.

It was on this base, however, that his most famous experiment would be made possible.

The conditioned reflexes Pavlov is known for refers to how any organism with a sufficiently developed nervous system can develop special reflexes in response to its environment. To discover this, Pavlov designed soundproof chambers for the dogs to be kept in, where the only stimulus would be some food or the sound of a bell. The bell would be rung before the dog was given meat, and so the animals eventually learned to associate the bell with being fed. Using his experience with the digestive system, Pavlov was able to measure the dogs saliva levels to confirm that, yes, their glands would eventually produce saliva in response to the bell instead of to the sight or smell of food.

Ivan Pavlov watching an experiment with a dog, summer 1934

It was this discovery that led to his becoming a household name. Curiosity, combined with the mystery associated with his experiments, led to his laboratory complex being named the Tower of Silence. It was located in the center of the old imperial capital, on Petrogradsky island, but the forces of history wouldnt necessarily give Pavlov the silence he was looking for. The outbreak of World War I, and the revolution that followed, turned the city into a chaotic scene of disorder and violence.

Russias first scientific village

While Pavlov was open in his criticism of Soviet ideology, his work earned him the respect of none other than Vladimir Lenin. He couldnt work in disorder, Aktuganova tells me, and so, Pavlov wrote Lenin a letter that said give me a place to work in peace, or Ill emigrate. The plan worked, and the scientist received approximately one million rubles worth of gold to relocate his laboratory. With it he chose Koltushi.

He built a complex for experimental medicine and surrounded it with what became Russias first scientific village. This included his lab, a house (that he rarely used), a complex that included a hotel, cafeteria and club, five cottages for workers and, of course, kennels for the dogs, chimpanzees and other animals he worked with. This formed the core of a set of buildings that eventually expanded with the years, until it became a functional suburb of the ever-growing Leningrad (known now as St. Petersburg).

To look at the place now, Aktuganova tells me, you wouldnt think that a world-famous figure used to live here. With the UNESCO status, there should be more tourists and more infrastructure to support them [visiting].

But remembering Pavlov and his contributions wasnt on the highest list of national priorities after his death from pneumonia in 1936, support for the village continued until perestroika in the 1980s. A greater focus was then given to the humanities, which had faced various pressures over the past half century, and money typically invested in the hard sciences was redirected.

Ivan Pavlov in Koltushi, Leningrad Region

That said, a museum still exists here that tells of how Pavlov lived out the last years of his life. There are pictures of him with his wife Serafima, or Sara for short, and their children (two of which sadly died while Pavlov was still alive). Alongside them are photos of international visitors like Niels Bohr and H.G. Wells. Photos with famous local artists, like Ilya Repin, can also be found, confirming the age Pavlov lived in, as a time when art and science were not necessarily competitors. The permanent exhibition in the basement, a collaboration between young artists and scientists, seeks to revitalize this tradition.

Monument to Pavlov and his dog in Koltushi

Asteroids, lunar craters and scientific principles have since been named after him, but its become all too easy to hear about Pavlov without knowing anything about the man himself. That said, these buildings, much like his famous dogs, stand as a legacy that wont soon be forgotten. What remains is a testament to a remarkable scientist who changed the way we think about our behavior, our desires and the other secrets still locked inside our brains.

If using any of Russia Beyond's content, partly or in full, always provide an active hyperlink to the original material.

') }, error: function() { $email.val(''); alert('An unknown error occurred. Try later.'); } }); } }); }; initFormSubmit(); $completeButton.on('click', function (evt) { evt.preventDefault(); evt.window.location.reload(); }); }());

Excerpt from:
Who was the man behind Pavlovs Dog? - Russia Beyond

Physiology

PhysIQ Named One of the Most Innovative Companies of 2019 by PM360 – Business Wire

CHICAGO--(BUSINESS WIRE)--PM360, a leading trade magazine for marketing decision makers in the pharmaceutical, biotech, medical device, and diagnostics industries, has named physIQ as one of the most innovative Companies of 2019.

PhysIQs mission is to deliver on the promise of scalable personalized medicine by applying artificial intelligence to data collected from any wearable biosensor and transforming it into personalized insight. The physIQ solution provides clinicians with tools to proactively engage at-risk patients, as well as provide pharmaceutical companies with powerful data-driven support to demonstrate the efficacy of their products.

Using an AI-based approach to personalized physiology analytics, physIQ has been clinically validated, with multiple market-leading 510(k) clearances that include respiration rate, QRS detection, heart rate, heart rate variability, atrial fibrillation detection, and our personalized physiology change detection analytic.

Previously, physicians and clinical trial sponsors were limited in monitoring ambulatory patients with noisy and very sporadic point-measurement data. PhysIQ enables them to collect high quality continuous data to gain better insights and make better decisions for their patients, said physIQs CEO Gary Conkright. With physIQ, pharmaceutical companies will now have greater clarity on the impact clinical trials have on patients, allowing for new life saving therapies to reach the market faster. As a result, physicians will have a better chance to care for their patients in their own homes at the lowest possible cost while delivering the highest quality of life.

PhysIQ was selected as part of PM360s 8th Annual Innovations Issue published each December. This issue was established to serve as a guide to the years most innovative Companies, Startups, Divisions, Products, Services, and Strategies from within the healthcare and life sciences industries. This comprehensive overview of the years most innovative achievements in these six categories helps other companies in the industry to find potential partners and offerings that can help them advance healthcare and life sciences.

For the past eight years, we have worked to help the industry identify the latest and most exciting advancements that facilitate change in the industry, how it operates, or offer new advancements that better serve patients, doctors, payers, and others involved, says Anna Stashower, CEO/Publisher of PM360. We hope this guide can serve as an important resource for the industry throughout 2020 as we all work to improve the healthcare experience for everyone involved.

PM360 received hundreds of submissions from across the healthcare and life sciences industries. The editorial staff of PM360 evaluated each submission and selected their picks for the most innovative, regardless of category. Ultimately, 60 total innovations were featured in the issue. Within the Company category, a total of 12 companies were featured.

All of this years selections can be found at: http://www.pm360online.com/pm360-presents-the-2019-innovators.

About physIQ

PhysIQ is a company dedicated to enabling proactive care delivery models through pinpointIQ, its highly scalable cloud-based platform for personalized physiology analytics. Our FDA 510(k)-cleared data analytics platform is designed to process multiple vital signs from wearable sensors to create a personalized dynamic baseline for each individual. By mapping vital sign relationships this way, physIQs analytics detect subtle deviations that may be a precursor to disease exacerbation or change in health. With applications in both healthcare and clinical trial support, physIQ is transforming continuous physiological data into insight for providers, health systems, payers and pharmaceutical and medical device companies. For more information, please visit http://www.physIQ.com. Follow us on Twitter and LinkedIn.

About PM360

PM360 is the premier, must-read magazine for marketing decision makers in the pharmaceutical, biotech, medical device, and diagnostics industries. Published monthly, PM360 is the only journal that focuses on delivering the full spectrum of practical information necessary for product managers and pharmaceutical marketing professionals to succeed in the complex and highly regulated healthcare environment.

The journals targeted and insightful editorial focuses on issues that directly impact critical decision making, including: Planning and implementation of cutting-edge strategies, trends, the latest technological advances, branding/marketing, advertising/promotion, patient/professional education, sales, market research, PR, and leadership. Additionally, the 360 in the title signifies the span of this critical, how-to info with personal and career insights for an enjoyable and thought-provoking read.

By providing the full circle of enriching content, PM360 is truly an indispensable tool for busy and productive marketing professionals to stay at the top of their game.

Read the original:
PhysIQ Named One of the Most Innovative Companies of 2019 by PM360 - Business Wire

Physiology

Israeli Researchers Isolate Brain Wave Patterns that Will Lead to Better Treatment of Kids with Autism – Breaking Israel News

Yaakovawoke from his sleep and said, SurelyHashemis present in this place, and I did not know it! Genesis 28:16 (The Israel Bible)

brainwaves (courtesy: Shutterstock)

The types of challenges posed by youngsters on the autism spectrum are very varies. They include repetitive behaviors; difficulty understanding, talking, reading, writing and following directions; limited interests; problems with social communication and interaction; and extreme sensitivity to certain sounds, smells or textures.

In addition, a large percentage of children with autism have a difficult time falling asleep, or they may wake up frequently in the middle of the night or early in the morning.

A new research study from the National Autism Research Center at Ben-Gurion University of the Negev in Beersheba shows that the brain waves of those on the spectrum are shallower particularly during the first part of the night, indicating difficulty falling into a deep, rejuvenating sleep.

Now that the team has identified the potential physiology underlying these sleep difficulties, they are planning several follow-up studies to discover ways to generate deeper sleep and larger brain waves from increasing physical activities during the day to behavioral therapies and pharmacological alternatives such as medical cannabis.

The study was just reported in Sleep, the leading journal in the field under the title Reduced Sleep Pressure in Young Children with Autism. While the disorder is as yet incurable, the discovery could lead in the future to improved treatments.

Previous studies have shown that 40% to 60% of children with autism have some form of sleep disturbance, which makes life difficult for the youngsters and for their families. Determining what causes these sleep disturbances is a first critical step in finding out how to mitigate them.

A team led by Prof. Ilan Dinstein, who heads the research and is a member of the universitys psychology department, examined the brain activity of 29 children on the spectrum and compared them to 23 children without autism. The childrens brain activity was recorded as they slept during an entire night in the sleep lab at Soroka University Medical Center, which is managed by Prof. Ariel Tarasiuk.

Normal sleep begins with periods of deep sleep that are characterized by high amplitude slow brain waves. The recordings revealed that the brain waves of children with autism are, on average, 25% weaker (shallower) than those of typically developing children, indicating that they have trouble entering deep sleep, which is the most critical aspect of achieving a restful and rejuvenating sleep experience.

It appears that autistic children and especially those whose parents reported serious sleep problems do not tire themselves out enough during the day or develop enough pressure to sleep and dont sleep as deeply, said Dinstein. We also found a clear relationship between the severity of sleep disturbances as reported by the parents and the reduction in sleep depth. Children with more serious sleep issues showed brain activity that indicated more shallow and superficial sleep.

Original post:
Israeli Researchers Isolate Brain Wave Patterns that Will Lead to Better Treatment of Kids with Autism - Breaking Israel News

Anatomy

Anatomy of the biggest comeback in Bengals history – The Athletic

MIAMI What happened Sunday afternoon at Hard Rock Stadium was both the most ridiculous, improbable thing ever, and the most yawnably predictable.

The Bengals lost. Again. Just like anyone who watched them drop 13 of their previous 14 thought they would. Just like the majority of even their staunchest fans hoped they would in order to clinch the No. 1 draft pick.

They were being boat-raced by a bad Dolphins team that also was in play for the leagues worst record and top pick, outclassed to the extent that with 11:12 still remaining, in-game analytics gave the Bengals an infinitesimal 0.1 percent chance of winning.

The Bengals trailed by 23 points at that time. Four minutes later, the only thing that changed was a win likelihood that shrunk to single-grain-of-sand-on-South-Beach level.

Which is why what followed was the wildest, weirdest, wackiest stretch in 52 seasons of Bengals football, and something not likely to be replicated during the...

Continued here:
Anatomy of the biggest comeback in Bengals history - The Athletic

Anatomy

Anatomy of a protest – The Shillong Times

Along with the rest of the country Meghalaya too protested the passage of the Citizenship Amendment Bill in the Rajya Sabha last week. In a democracy, to protest is a fundamental right; to be violent and commit arson are not. A protest may be organised by one or two groups and people who feel strongly about the issue under protest like to affiliate themselves with that group even if they are not members. However, every protest also has its share of agent provocateurs. These might enter a protest rally after carefully studying the behaviour of the group thats calling the protest. They are part of the protest just to incite violence so that the cause of the protestors is defeated. On Thursday after the Meghalaya Assembly had passed a resolution to invoke the Inner Line Permit (ILP) in Meghalaya as a deterrent to the CAA, hundreds of people on two wheelers rode past Police Bazar, vandalizing shops, beating unsuspecting passers-by and generally creating fear psychosis in the city. In fact, in the week-long protests, vandals were seen targeting certain localities and trying to set ablaze vehicles or breaking their windows. This senseless violence has been part of the culture of protest in Shillong. Hence the Government law and order machinery cannot claim to have been caught unawares.

This unprovoked violence has very pernicious effects on young people from Meghalaya, studying and working outside the state. Video clips of the violence in Police Bazar on Thursday have gone viral. These would have reached people across the country by now. They create anger and resentment against all tribal people of Meghalaya living outside. This cycle of violence will take long to break. So far no earnest efforts have been made to resolve the conflicts and heal the emotional fractures. Those in their twenties and thirties today would not be able to relate to the events of 1979 when a cycle of violence shattered the harmony between the tribals and non-tribals. The disruption in social harmony is difficult to repair. It will take an evolved kind of social engineering to repair the faultlines that are, unfortunately, not given enough time to mend. Every time there is social unrest over small or big issues the non-tribals residing here, including those whose ancestors have come here over a century ago, become soft targets. They are alienated and treated like interlopers who have no right to their living space. So much so they dont feel that sense of belongingness and stake-holdership for this city. Its time for the elders from all communities to come together and build bridges of peace and understanding.

Continue reading here:
Anatomy of a protest - The Shillong Times

Anatomy

Augmedics Announces FDA 510K Clearance and U.S. Launch of xvision, the First Augmented Reality Guidance System for Surgery – Business Wire

CHICAGO--(BUSINESS WIRE)--Augmedics, a pioneer in augmented reality surgical image guidance, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the U.S. launch of its groundbreaking xvision Spine system (XVS), the first AR guidance system to be used in surgery. xvision Spine allows surgeons to visualize the 3D spinal anatomy of a patient during surgery as if they had x-ray vision, and to accurately navigate instruments and implants while looking directly at the patient, rather than a remote screen.

The xvision consists of a transparent near-eye-display headset and all elements of a traditional navigation system. It accurately determines the position of surgical tools, in real time, and a virtual trajectory is then superimposed on the patient's CT data. The 3D navigation data is then projected onto the surgeons retina using the headset, allowing him or her to simultaneously look at the patient and see the navigation data without averting his or her eyes to a remote screen during the procedure. The system is designed to revolutionize how surgery is done by giving the surgeon better control and visualization, which may lead to easier, faster and safer surgeries.

Augmedics successfully completed a percutaneous laboratory study with the xvision Spine at Rush University Medical Center with investigators Frank Phillips, M.D., Camilo Molina, M.D., Kornelis Poelstra, M.D., Ph.D., Larry Khoo, M.D., and Matthew Colman, M.D. Ninety-three screws were positioned in the thoracic and sacro-lumbar areas of five different cadavers. The study was conducted as evidence to the FDA to evaluate the accuracy of the xvision Spine system by comparing the actual screw tip position and trajectory versus the virtual. The result of overall clinical accuracy, analyzed by two independent neuro-radiologists, was 98.9 percent using the Heary (thoracic) and Gertzbein (lumbar) scales. This study adds to the evidence of accuracy and usability found last year in another cadaver study performed by two surgeons from Johns Hopkins Medicine, Daniel Sciubba, M.D., and Timothy Witham, M.D., one surgeon from Sheba Tel-Hashomer, Israel, Ran Harel, M.D., and one from Assaf Harofeh, Israel, Yigal Mirovsky. The study last year was conducted at Vista Labs, an independent lab in Baltimore, with results published in the Journal of Neurosurgery: Spine.

The ability that Augmedics xvision provides to visualize the patients spinal anatomy in 3D, coupled with live CT images as a retina display, is game changing, said Frank Phillips, M.D., Professor of Orthopaedic Surgery, Rush University Medical Center. The efficiency and accuracy this augmented reality technology enables in placing spinal implants without looking away from the surgical field - as well as the ability to "see the spine" through the skin in minimally invasive procedures - differentiates the xvision from conventional spinal navigation platforms. The economics of the xvision system are also compelling in both the hospital and the surgicenter environment.

Augmedics mission is to give surgeons more control by creating technological advances that cater to their needs and fit within their workflow, said Nissan Elimelech, founder and CEO of Augmedics. xvision is our first product of many to follow that will revolutionize surgery, as it gives surgeons the information they need, directly within their working field of sight, to instill technological confidence in the surgical workflow and help them do their jobs as effectively and safely as possible.

xvision is now available for sale in the United States, with headset distribution expected to begin in early 2020. Augmedics plans to explore additional surgical applications for xvision beyond spinal surgery. The systems small footprint, economical cost and compatibility with current instrumentation is designed to allow easy integration into any surgical facility nationwide.

About Augmedics

With Augmedics, the future of surgery is within sight. The Chicago-based company aims to improve healthcare by augmenting surgery with cutting edge technologies that solve unmet clinical needs and instill technological confidence in the surgical workflow. Its pioneering xvision system, the first augmented reality guidance system for surgery, allows surgeons to see the patients anatomy through skin and tissue as if they have x-ray vision, and to accurately navigate instruments and implants during spine procedures. Augmedics is backed by Terra Venture Partners and AO Invest, a venture arm of the AO Foundation. The AO is a medically guided, not-for-profit organization, a global network of surgeons, and the world's leading education, innovation, and research organization for the surgical treatment of trauma and musculoskeletal disorders. For more information, visit http://www.augmedics.com.

See the original post here:
Augmedics Announces FDA 510K Clearance and U.S. Launch of xvision, the First Augmented Reality Guidance System for Surgery - Business Wire

Anatomy

Grey’s Anatomy’s Jaicy Elliot on the Station 19 Crossover Event and Helm Falling In Love With Herself! – TV Fanatic

It has been an eventful season of Grey's Anatomy.

The series is in its sweet 16th season, and it shows no signs of slowing down.

It celebrated another milestone with its 350th episode, which served as an ode to Meredith Grey and the series and all it has offered.

The series is about to fully expand its universe by choosing to meld the Grey's Anatomy world with that of its spinoff Station 19.

It's an exciting venture, and it'll bring some of our favorite actors and characters from both series together more.

One of whom we had the privilege to speak with about what's coming up with the series and her character.

We caught up with Jaicy Elliot best known as Taryn "Hellmouth" Helm, and discussed the upcoming crossover event when the series returns, the trajectory of her character, and why Helm shouldn't be "the New Meredith Grey."

It's Elliot's first television role, but she has a background in theater. She was a big fan of the show, but she mentioned it was a friend of hers who recommended she audition for the role of Helm.

She mentioned that she sees a lot of herself in Taryn and the character resonated with her.

She joked that she hoped she wasn't as sarcastic as the woman she played, but while Taryn can at times come across a bit cold and sarcastic, Elliot is all warmth and friendliness.

She's passionate about her craft and this character, and she's so thoughtful in how she speaks about and understands Taryn.

We discussed how she ushered in a more diverse batch of interns -- the most diverse bunch we've seen to date.

It included Vik, their first notable South Asian character on the series, Dahlia who, notably wore a hijab, Sam, who was a DACA kid, Levi, of course, the first gay male series regular on the series, transgender veteran Casey, and Taryn, of course, who plays a driven woman who likes women.

Elliot stated she is proud to be part of such an inclusive series.

She came in at a rewarding time, both participating in Greys Anatomy: B-Team, the Emmy nominated digital series short about the new interns' first day, and she was able to celebrate two big milestones for the series.

She described the experience of celebrating the 350th episode as exciting.

Grey's Anatomy Season 16 Episode 8 served as an ode to Meredith Grey after half of the season was dedicated to Meredith taking on a flawed healthcare system.

Elliot had nothing but praise for the series for exploring these pitfalls in the healthcare system and wanting to address them.

She herself is a celebrity ambassador for Valley Community Healthcare, whose primary goal is to provide quality healthcare for all, especially those who cannot always afford it.

Taryn is known for being the biggest Meredith fangirl out of the bunch, so Meredith being fired from the hospital had an effect. "Many of these residents, they came to learn from Meredith Grey. She's an idol -- they look to her as a mentor."

We delved into Helm's well-known crush on Meredith, and it has more to do with who Helm aspires to be as a doctor than simply romantic, according to Elliot. Meredith is why Helm is at Grey Sloan. She went there to work with the best, and for her, Meredith is the best.

Meredith's absence was hard on Helm because of her inability to work with her mentor. It also caused some tension between Helm and Levi. The two of them are great friends.

I asked her about the unfortunate manner in which Levi was being treated by the others, and while she admits that Levi was doing his job "there's a loyalty at Grey Sloan."

She mentioned how fundamental loyal seems to be at this hospital with these people. It's "part of the culture," and "Taryn is loyal. She's not wavering. She's always firmly in support of Meredith."

It seems Taryn's loyalty to her mentor supersedes even her friendship to Levi, but from the sounds of it, it's nothing the two can't get past.

Elliot admits that Helm's Meredith crush stems from Taryn's admiration of who Meredith is as a person.

Meredith is passionate about her job "and doing what she feels is right. She's not afraid to fight for what's right, and that's something I think Taryn appreciates and respects."

It's a fine line between wanting to be with Meredith and be Meredith, but Helm's feelings for Meredith are leaning more toward the aspirational.

As we can recall with that famous "New Meredith Grey" line, Taryn wants to model her career trajectory off of someone like Meredith, and they share similar values.

Taryn has been making some great strides this season. For starters, she had her first major surgery opportunity. "She was the first to perform such an advanced surgery. I was so excited for her."

It was a standout moment for Taryn, but it didn't exactly go according to plan.

"Taryn was a bit full of herself --um, too self-assured, maybe. She got too confident. She couldn't succeed in it outright, but it was humbling. Taryn has a naivete, and she needed that experience -- it was an important reality check."

But Elliot is excited about what the second half of the season has in store for us.

They've been working hard on the series, and from the sounds of it, when the show returns, it's going to be crazy insane!

With Kristen Vernoff at the helm of both Grey's Anatomy and Station 19 now, we can expect both series to blend into each other more.

They'll be linked more than ever. Jaicy reminded us that it wasn't uncommon for characters from both shows to pop up here and there, but they'll be working more cohesively hand in hand now.

It sounds like the timelines will match up more now compared to before. The world of Grey's Anatomy and Station 19 will become one universe for our enjoyment.

And the second half of the season promises more mixes and matches with character interactions and more.

We discussed it further along with her thoughts on exploring Taryn's romantic/personal life and much more.

When the series returns, there's going to be a crossover event. It seems like we're headed more into bridging the Grey's Anatomy world with the Station 19 world.

What's it like working with both sets? Does it feel different working between the two? The crossover seems like it's going to be very action-packed, so what's that like shooting?

Jaicy: Usually, they include a lot of people and a lot of hours onset. Because, you know, everyone's there. It takes longer and it's more intricate, and there's a feeling of like, of, we're really in the thick of it and working long hours. So there's a very exciting aspect to it. I always feel like a child when I'm on set.

Because I'm like, it's like stepping into Disneyland because of all these sets and all these people. We can talk and hang out, and act, and, you know, it's always a great time. To shoot these scenes it feels kind of like a boot camp, we have a lot of fun.

It sounds like it. It looks like you guys have a blast!

Mhmm.

Now, do you think we're going to learn more about Helm's personal life? Do you think she's going to get a romance? Is it something you'd like to see? Because some people would like to see it and others don't.

I mean, I would love for Taryn to fall in love, um, and it sounds super corny, but I think I would like her to fall in love with herself first, and I think that might go along with her blooming into the doctor that she wants to be.

Every time we learn a little bit more about Taryn and who she is and where she comes from and all of that, I feel like she's so focused in her work, I want her to get a little break from that, a little success in that and find a little confidence.

I think any relationship that might trigger, like, somebody's interest or her being interested in someone who is a little more accessible, but she's also like so fully committed to Meredith that I don't see her being interested in anyone else, but I'm -- I would be excited for her to find someone, but one step at a time.

I think I would be more excited to see her as a good surgeon first.

Right. Right. I know everyone cracked jokes about her when she said the line about being the new Meredith Grey, but my first instinct when she said that was "learn to be a badass Taryn first."

Right, yeah!

I mean, it's not really about Meredith in the end for Taryn. It's about finding out who you are and going through that, and I agree, I think that would be a really great journey for her.

I do like how laser-focused and committed she is. Now, you were a fan of the series before, so have fans ever made the comparisons between your character and any of the previous interns?

Um, not that I've seen multiple times. I've definitely had little moments where I've said "Oh, that feels like something that person would say" but it feels to me like Taryn is very a mix of a lot of different things.

You know, for a long time I felt like Taryn was a little cold, and this one scene when she sees, I think it was last year when she showed this vulnerability, and it sort of made her into a different person.

As I'm finding out more about her, I'm seeing that she's very much her own person. I'm having kind of a hard time comparing her to anyone that has been on the show. I mean, I know for a while I was hoping that she would be a little bit of a Cristina, but she doesn't feel like a Cristina to me.

She has a little Cristina in her with the dedication, but I agree.

Yeah, she does have a little bit of that, but she does come out as her own person.

And I love how, you guys have so many -- you guys have such a huge cast, and there are so many storylines, but you do see the growth, and development, and the characterization of your character. I love her journey she's taken from when she first arrived. She has, as you said, mellowed out a lot. And you can see her journey.

Yeah, and I feel like that's kinda been my experience this year.

At first, she came in a little, um, how can I say this, a little bit full of herself, not full of herself, but naive in a sense that she thought that she would come in a rule the day.

But she comes in now, and she's like, OK, let's just do the day to day work and then eventually I'll get to a place where I'm comfortable. She feels a little bit this year like she knows what she's doing.

When you're scared, it's very easy to act like you're not being affected, or you're a certain way, and I feel like now she's a little bit more like an actual human being.

[Laughs]Yeah, she's still confident, but I think she lost some of the arrogant edge now that she has more experience.

Arrogant. Arrogant is what I was looking for, thank you.

Yeah. She's more grounded now than when she first came in. You said you brought a lot of yourself to the role, do you have any similarities to her?

Oh yeah, we have tons of similarities. Sometimes I wonder if the writers are just telling me how to live my life ...

[Laughs]

Or if they're actually basing the character off of me. But from like starting this show too, we [Jaicy and Taryn] started the huge, new job at the same time, so that in itself, we were both put into this same situation.

We both had to adapt and learn how to deal with our own emotions, like maybe dealing with feeling intimidated and not really knowing how to stand, or when to do something, so from our experience to like, traits that we have.

I think she has a lot of compassion, and I like to think that it's something I have in my life that the writers wanted to add to the character. Um, we also, like. she's a little more sarcastic than I am.

Which, I hope that I'm not as cut and dry as she is, but we have that, and I know the writers, we talk a lot about that. Some of her personality, maybe they've grown these traits into making her more of a defined person. I feel very close to her like maybe she can be my cousin or my sister.

Sometimes I feel like I have split personalities ... And she gives me advice, and I give her advice, and it can be very confusing. But yeah, she's very close to me, and I have a lot of compassion for her.

That's so cool. I always find that so fascinating. The process of playing someone, you know? How much of it is you, and how much of it is what you aspire to be or what you don't aspire to be, you know what I mean?

Oh yeah, I understand. And also, they make her very funny, and like, I hope I'm funny, but like, I don't have as much repartee as she has? {Laughs}You know?

[Laughs].OK, I don't want to get you in any trouble with giving out spoilers.

Right!

But basically, to sum it up, when Grey's returns it's going to be huge, and exciting, and we won't want to miss it, right?

I think the main idea for the next half of the season is that, um, we're really merging Station 19 and Grey's. And I think, if you think about what that might bring, it means new stories and a lot more ground to work with, and that's really kind of the main event.

And then it's everyone has their own little evolutions. For Taryn, again, I think this year is going to be a defining year in the sense that she's, I feel like she thinks she's finally part of the hospital.

With Grey's there's always drama, and there is DEFINITELY drama in the next part of the season for everyone, and also for Taryn.

Well, it wouldn't be Grey's without the drama!

Yup!

Grey's Anatomy returns with a two-hour crossover special with Station 19 on January 23.

Until then, if you need a refresher, you can watch Grey's Anatomy online.

Also, if you haven't checked out the spinofff yet, you can watch Station 19 online too, right here on TV Fanatic!

Edit Delete

Jasmine Blu is a senior staff writer for TV Fanatic. Follow her on Twitter.

Read more from the original source:
Grey's Anatomy's Jaicy Elliot on the Station 19 Crossover Event and Helm Falling In Love With Herself! - TV Fanatic