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    Leadership Managing people
    From the January–February 2016 Issue
    Explore the Archive

    Executive Summary

    Collaboration is taking over the workplace. According to data collected by the authors over the past two decades, the time spent by managers and employees in collaborative activities has ballooned by 50% or more. There is much to applaud about these developments—but when consumption of a valuable resource spikes that dramatically, it should also give us pause.

    At many companies, people spend around 80% of their time in meetings or answering colleagues’ requests, leaving little time for all the critical work they must complete on their own. What’s more, research the authors have done across more than 300 organizations shows that the apportionment of collaborative work is often extremely lopsided. In most cases, 20% to 35% of value-added collaborations come from only 3% to 5% of employees. The avalanche of demands for input or advice, access to resources, or sometimes just presence in a meeting causes performance to suffer. Employees take assignments home, and soon burnout and turnover become real risks.

    Leaders must start to manage collaboration more effectively in two ways: (1) by mapping the supply and demand in their organizations and redistributing the work more evenly among employees, and (2) by incentivizing people to collaborate more efficiently.

    The Situation

    Over the past two decades, the amount of time managers and employees spend on collaborative work has ballooned. At many companies people now spend about 80% of their time in meetings or answering colleagues’ requests.

    The Problem

    Although the benefits of collaboration are well documented, the costs often go unrecognized. When demands for collaboration run too high or aren’t spread evenly through the organization, workflow bottlenecks and employee burnout result.

    The Solution

    Leaders must learn to better manage collaboration in their companies by mapping supply and demand, eliminating or redistributing work, and incentivizing people to collaborate more efficiently.

    Collaboration is taking over the workplace. As business becomes increasingly global and cross-functional, silos are breaking down, connectivity is increasing, and teamwork is seen as a key to organizational success. According to data we have collected over the past two decades, the time spent by managers and employees in collaborative activities has ballooned by 50% or more.

    Amid all of this, our best leaders have demonstrated objectivity through their commitment to present only balanced and fact-based analysis in the Oval Office, in the White House Situation Room, in congressional testimony, and in public hearings. They don’t shy away from delivering bad news or color judgments to support a particular policymaker narrative—they call it like they see it. That sometimes means providing brutally honest assessments when White House policies were failing (as was the case during the Vietnam War and, more recently, in Afghanistan), or pointing out when a policy seemed to be based more on hope than a tough-minded assessment of the underlying conditions at play.

    Although objectivity is crucial, it’s not always easy for a leader— whether in the intelligence community or elsewhere — to remain objective. Our newspapers are filled with stories of corporate finance departments and managers who have identified Golden Goose 20MM SUPER STAR EMBELLISHED SNEAKERS 7mp6U
    to manage earnings that downplay poor results. Similarly, we have all read accounts across multiple industries in which people facing tough Philippe model Sneakers ETOILE fabric flower pattern bulldog patch B2aJKbI
    have been observed exaggerating their performance.

    In intelligence, there is always a strong pull on our leaders to become part of the White House team. Just consider — these leaders are appointed by the president and interact with the senior White House staff regularly, so it’s natural to want to support the president’s foreign policy agenda, and to want to avoid always being the bearer of bad news when a policy is stumbling. After all, how many senior business executives would relish the opportunity to inform — frequently alone — the company’s CEO that his or her strategy is failing?

    In being critical of the effectiveness of a policy, intelligence community leaders can also be perceived as criticizing the people charged with implementing it. For example, I recall multiple instances during the Obama administration when, during debates about America’s Afghanistan strategy, the intelligence analysis of deteriorating political and security conditions in the country stood in sharp contrast to more upbeat assessments from U.S. officials in Kabul. At times, this placed intelligence leaders in the awkward position of appearing to criticize the performance of U.S military and diplomatic personnel operating in Afghanistan, even though the analysis itself focused on the shortcomings of Afghanistan’s political leaders and security forces.

    Against this backdrop, then, it’s fair to ask why and how the best leaders are so willing and able to take their lumps and to steadfastly remain objective. I’ll answer this based on my experience in the intelligence community, where it’s not an exaggeration to say that objectivity can be a life-or-death issue.

    First, these intelligence leaders recognize and embrace the principle that the intelligence community should be a, and not the, voice in the Oval Office or White House Situation Room, and recognize that the best policy decisions are always reached with input from multiple agencies of government. It’s at times easy for intelligence leaders to dominate policy discussions because of the community’s unique access to information and our deep analytic bench strength, but our best leaders work diligently to ensure that multiple voices are aired during policy meetings. They embrace the community’s historic role of informing and not making policy, and offering the president the best possible information with which to make decisions.

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    Feb 13, 2017
    Zosano Pharma Announces 3.8mg Dose of M207, its Novel Transdermal Therapeutic, MeetsBoth Co-primary Endpoints in the ZOTRIP Pivotal Efficacy Trial in Migraine 28.8 KB
    Zosano Pharma Announces 3.8mg Dose of M207, its Novel Transdermal Therapeutic, MeetsBoth Co-primary Endpoints in the ZOTRIP Pivotal Efficacy Trial in Migraine

    41.5% of patients experienced freedom from pain at 2 hours vs. 14.3% for placebo (p < 0.0001)

    68.3% of patients experienced freedom from most bothersome symptom at 2 hours vs. 42.9% for placebo (p < 0.0009)

    26.8% of patients experienced freedom from pain at 1 hour vs. 10.4% for placebo (p < 0.0084)

    FREMONT, Calif., Feb. 13, 2017 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN) announces that its lead product candidate, M207, achieved both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours in therecently completed ZOTRIP trial. The ZOTRIP pivotal efficacy study was a multicenter, double-blind, randomized, placebo-controlled, dose-ranging trial comparing three doses (1.0mg, 1.9mg and 3.8mg) of M207, a novel transdermal therapeutic, to placebo for a single migraine attack. A total of 589 subjects were enrolled at 36 sites across the US. The 3.8mg dose achieved significance in the secondary endpoints of pain freedom at 45 minutes and 1 hour and showed durability of effect on pain freedom at 24 and 48 hours. Additionally, M207 was not associated with any Serious Adverse Events (SAEs).

    The 3.8mg dose of M207 achieved statistical significance for both co-primary endpoints at two hours:

    Furthermore, secondary endpoints measuring pain freedom at additional time points for the 3.8mg dose of M207 showed M207 superior to placebo with a nominal p-value less than 0.05:

    M207 was well-tolerated with no SAEs

    Stewart Tepper, MD, Professor of Neurology, Geisel School of Medicine at Dartmouth and Director of the Dartmouth Headache Clinic commented, "The ZOTRIP study was successful from the dual perspectives of meeting the co-primary endpoints and no serious adverse events. The study demonstrated a statistically significant 2-hour pain freedom response rate with a low placebo rate for the primary endpoint. The data also indicate a durability of effect at 24 and 48 hours, and meaningful pain freedom rate at 1 hour. If approved by the FDA, M207 has the potential to become an important treatment option for those suffering from migraine."

    A PDF accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/45722c3f-e41a-4c21-826c-4721615c30cd

    Overall, higher pain freedom rates were achieved on all doses after 60 minutes over placebo. While the 1.0mg and 1.9mg doses of M207 produced p-values less than 0.05 in pain freedom at two hours, they did not produce a p-value below 0.05 for the co-primary endpoint of freedom from most bothersome symptom at two hours.

    "ZOTRIP was designed to be a dose-ranging study, as well as a registration study. We are very pleased by the results for the 3.8mg dose, and look forward to continuing the development of M207 towards filing an NDA and working to bring this novel therapy to patients suffering from the incapacitating effects of migraines," said Konstantinos Alataris PhD, President and Chief Executive Officer of Zosano.

    The ZOTRIP Phase 3 Trial Design:

    The ZOTRIP pivotal efficacy study was a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. Subjects were enrolled in the ZOTRIP trial at 36 centers across the United States. Those recruited into the trial had a history of at least one year of migraine episodes with or without aura. Upon recruitment, the subjects entered a run-in period that ensured they met the key eligibility criteria of 2-8 migraine attacks per month, which was documented using an electronic diary or an app on their cell phone. Subjects also identified their most bothersome symptom and indicated the presence or absence of nausea, phonophobia or photophobia, during the episodes in the run-in period. Successfully screened subjects were then randomized into the treatment/dosing period in which they had 8 weeks to confirm and receive blinded treatment for a single migraine attack, termed "qualifying migraine." In which the most bothersome symptom had to be present.

    During a qualifying migraine, subjects scored the severity of pain on a 4-point scale, and the presence or absence of migraine associated symptoms (photophobia, phonophobia or nausea), starting pre-dose and then at several intervals over 48 hours post-dose.

    Five hundred and eighty nine subjects were enrolled in this study, of which 365 were randomized. Of those randomized, 333 subjects treated and are included in the safety analysis, and 321 qualified for the modified intent-to-treat (mITT) population. 51% of the subjects randomized were found to have severe migraine pain pre-treatment. Also at the time of treatment, 70% reported nausea, 37% aura, and 51% waking up with their migraine (morning migraine). With the multiple doses and multiple endpoints in the trial, a sequential testing procedure was used beginning with the highest dose and the co-primary endpoints. Since statistical significance was not achieved for most bothersome symptom in the 1.9 mg group, p-values for secondary endpoints should be considered nominal p-values.

    About Migraine

    Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. An estimated 36 million American adults suffer from migraine. Migraine can be extremely disabling and costly, accounting for more than an estimated $20 billion in direct (e.g., doctor visits, medications) and indirect (e.g., missed work, lost productivity) expenses each year in the United States.

    About M207

    M207 is Zosano's proprietary zolmitriptan-coated microneedle patch that is designed to rapidly deliver zolmitriptan during a migraine attack. In a phase 1 trial, M207 demonstrated markedly faster absorption kinetics compared to oral zolmitriptan. The Company presented these results at the 2016 annual meeting of the American Headache Society.

    Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company's proprietary intracutaneous delivery system. The Company's goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications. The Company believes that its intracutaneous delivery system offers rapid and consistent drug delivery combined with ease of use. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies. Zosano Pharma anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com .

    This press release contains forward-looking statements regarding the timing of expected clinical development milestones, the likelihood that M207 is approved by the FDA and, if approved, the potential of M207 as a treatment for migraine and other future events and expectations. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading "Risk Factors" in our 2015 Annual Report on Form 10-K, as filed with the Securities Exchange Commission on March 29, 2016. In addition, the results of the M207 pivotal trial are not necessarily predictive of results in future trials. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.

    About Zosano Pharma

    We found that NIf HVC neurons were spontaneously active during quiescent non-singing periods and increased their firing rates before song onsets ( Fig 1A–1C ). In two juvenile birds that started their songs with either one of several types of introductory notes or calls, NIf HVC neurons fired highly distinct spike patterns prior to these different onsets, ranging from almost no spikes prior to some note/call onsets, up to a high-frequency burst of more than four spikes prior to other onsets, revealing differential coding of song onset type.

    Fig 1. NIf firing rates increase prior to song onsets and return to baseline prior to song offsets.

    A. Song oscillogram (top) and raw extracellular trace of a NIf HVC cell (bottom) depict baseline and song-related NIf HVC firing. The insets show close-ups of spike bursts. The shaded gray area highlights time intervals during which the root-mean square (RMS) voltage exceeds a threshold of one standard deviation. B. Spike raster plot of a single NIf HVC cell aligned with song onsets (example derivative sound spectrogram shown on top), revealing no anticipatory firing when the first syllable is a short call (black rasters), but distinctive bursts before songs starting with a long call (red rasters) or an introductory note (blue rasters). Example onset syllables are shown on the left, framed in corresponding colors. Average firing rate curves, in corresponding colors, are shown at the bottom. C. The onset-related firing rate averaged over n = 16 NIf HVC cells (black full line) exceeds a threshold (red line) of three jackknife standard deviations above baseline, already firing 70 ms before song onset and peaking coincidently with song onset. D. Spike raster of same unit as in B, but aligned with song offset. The neuron fires at baseline rates already toward the middle of the last syllable. E. Aligned with song offsets, the average firing rate of n = 16 NIf HVC cells falls below baseline threshold (three standard deviations, red), already 30 ms before song offset. All data can be downloaded as part of the supporting information files ( S1 Data ).

    https://doi.org/10.1371/journal.pbio.2000317.g001

    On average, NIf HVC firing rates gradually increased before song onset and significantly deviated from pre-song baseline firing (greater than 3 jackknife standard deviations) already 70 ms prior to song onset ( Frank Wright ORLOV Smart slipons biscuit 4gHPAPBWk
    ). The firing rate during song of 37 Hz (averaged from -70 to +160 ms of song onsets) was much higher than the 8 Hz baseline firing rate (averaged from -300 to -100 ms before song onset, p = 0.0005 Wilcoxon signed rank test, n = 16 NIf HVC cells, excluding four cells in which we did not record sufficient amounts of baseline activity prior to song onsets). NIf HVC firing also returned to baseline prior to song offsets ( Fig 1D ). On average, NIf HVC firing rates were indistinguishable from post-song baseline firing (less than three jackknife standard deviations, n = 16 cells) already 34 ms prior to song offset ( Fig 1E ). Thus, HVC receives excessive NIf input long before song onset, and this input wanes before song offset.

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