TUCSON, Ariz., March 26, 2019 -- Critical Path Institute (C-Path) announced today that a formal consultation between its Predictive Safety Testing Consortium (PSTC) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has resulted in an agreement on a first-of-its-kind approach to compare the levels of eight novel urinary kidney safety biomarkers in healthy Japanese volunteers to data collected on these same biomarkers in healthy Western volunteers in a bridging study.Results from the project are expected to provide clinical evidence for PMDA evaluation to support utilization of these biomarkers to help guide decisions in early-stage clinical trials to ensure the safety of trial participants.The new study, to be conducted in Japan by PSTC member companies beginning in late 2019, will compare healthy Japanese volunteers with subjects enrolled in a similar U.S.-based study conducted by PSTC from 2011-2012 completed to support U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) submissions on these novel kidney safety biomarkers.Results from the Japanese study will inform subsequent work in Japan to be defined during future consultations between PSTC and PMDA.Biomarkers to be measured in Japanese subjects in this study include clusterin (CLU), cystatin C (CysC), kidney injury molecule-1 (KIM-1), N-acetyl-beta-D-glucosaminidase (NAG), neutrophil gelatinase-associated lipocalin (NGAL), osteopontin (OPN), albumin (ALB) and total protein."Drug-induced kidney injury is a serious issue that can occur during drug development," said John-Michael Sauer, Ph.D., C-Path Biomarkers Program Officer and Executive Director of PSTC.
America's first taste of Hyundai's new N Line trim came at the 2019 Detroit Auto Show, by way of the Elantra GT N Line.Europe had the similar i30 N Line before that, and now, there's a second addition to the stable on the other side of the Atlantic.On the outside, the Tucson N Line sports more aggressive bumpers with a dark grille pattern up front and dark chrome scattered about.The 19-inch alloy wheels are also dark, as are the mirror caps and the rear spoiler.Heck, even the headlights have a darker appearance than usual, but they also carry unique a running light design.The interior is a little less gussied up.
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TUCSON, Ariz., March 14, 2019 -- The Critical Path Institute's (C-Path) Predictive Safety Testing Consortium (PSTC) today announced availability of the User's Guide: Kidney Safety Composite Measure Biomarker for Use in Clinical Development.Authored by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium Kidney Safety Biomarker Project Team and PSTC's Nephrotoxicity Working Group, the Guide provides drug development companies with important information about implementing the first ever clinical safety biomarker qualified by the US Food and Drug Administration (FDA).The qualification applies to a single composite measure of six urine biomarkers, to be used in conjunction with traditional measures of kidney function, a major milestone that will improve the detection of drug-induced kidney injury in early phase drug development."Drug-induced kidney injury is a key safety issue that can slow the development of new therapies," explained John-Michael Sauer, Program Officer of C-Path's Biomarkers Program and PSTC Executive Director."While qualification of the composite measure kidney safety biomarker is an important accomplishment, its true impact will be realized as the biomarker is implemented by drug developers in Phase 1 clinical trials to inform clinicians and investigators in their work."Included in the User's Guide is information about why the biomarker is important, its context of use, how it should be used, how results should be interpreted, mode of measurement and methodologies drug developers can use to calculate and apply the biomarker to detect kidney injury during Phase 1 clinical trials.
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It was produced as part of the GEOEssential project funded by the EU's Horizon 2020 programme, with the coding done by Jurij Stare of Deneb Geoinformation Solutions.Satellites produce a great deal of data, so simply downloading the data can pose a challenge."Before this app was developed, if someone new wanted to analyse trends in light emissions for a specific region, I expect it would take them at least a full day to do it", says Christopher Kyba.With the "Radiance Light Trends" app, it is now possible for someone with no special training to produce a chart showing light trends in under a minute.This is particularly useful for interested citizens, environmentalists, or journalists, but also for municipal administrations and companies planning lighting measures.Greenhouse lights up, airport dims lighting
While we've already seen a bit of what automakers have to offer, there are more than a few things that we've only seen in teasers or heard about from the rumor mill.Considering how hungry the market is for crossovers, this is a great way to get Alfas in more driveways, especially in the US.Aston Martin Lagonda has something cool up its sleeve to one-up the brilliant concept that debuted in Geneva last year.From the teaser, we can surmise that the Lagonda All-Terrain will be a tall, sleek thing, rocking Lagonda's brilliant design language with an electric powertrain underneath.The latest iteration of Audi's compact hot hatch packs even sharper looks than before, part of a wide-reaching refresh that covers the whole TT lineup.But now, it has angrier bumpers and some mild changes to the interior.
TUCSON, Ariz. and DOWNINGTOWN, Penn., February 27, 2019 -- Critical Path Institute's (C-Path) Data Collaboration Center (DCC) and the Friedreich's Ataxia Research Alliance (FARA) today announced the launch of the Friedreich's Ataxia Integrated Clinical Database (FAICD).The new platform will enable collaborative research and data sharing to support the understanding of natural history, potential biomarkers and clinical endpoints, and promote research into novel clinical trial design in Friedreich's ataxia (FA).By making this data available to researchers, the organizations hope to enable the development of tools that will help design and interpret efficient clinical trials -- leading to effective treatments for FA as soon as possible."FA is a rare, progressive and fatal disease that affects multiple organ systems, and those living with the disease are in urgent need of effective treatments," explained FARA's Executive Director Jennifer Farmer."FAICD addresses this need by providing a platform to share data and making it available to qualified researchers to expedite the drug development process.All data contributed to this project is de-identified, mapped to standards defined by the Clinical Data Interchange Standards Consortium (CDISC) and curated by C-Path's DCC before inclusion in FAICD.
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Another autonomous-vehicle unicorn has joined the herd.Sina, operator of China’s biggest microblogging site Weibo, is one of TuSimple’s earliest investors.TuSimple launched when the burgeoning AV ecosystem of investors, academics turned entrepreneurs and early self-driving tech pioneers were focused more on the development of autonomous passenger vehicles, namely robotaxis.Then came the reveal of the Tesla Semi and the founding of several autonomous trucking startups, including Starsky Robotics and Embark.In late 2017, TuSimple raised $55 million with plans to use those funds to scale up testing to two full truck fleets in China and the U.S. By 2018, TuSimple started testing on public roads, beginning with a 120-mile highway stretch between Tucson and Phoenix in Arizona and another segment in Shanghai.After three years of intense focus to reach our technical goals, we have moved beyond research into the serious work of building a commercial solution,” TuSimple founder, president and CTO Xiaodi Hou said.
TUCSON, Ariz.–(BUSINESS WIRE)–February 12, 2019–DVI Equity Partners, LLC today announced an investment of capital and strategic growth expertise in mobile integration company Appdome.The Appdome platform offers no-code mobile implementation options for leading mobile security, mobility, mobile app management, mobile identity and threat defense vendors.“The leaders at Appdome recognized the need for multi-vendor app augmentation to fill a critical requirement in enterprise mobility management,” DVI Managing Partner Robert Griffin said.“Nearly 70 percent of all enterprise apps are created using third-party vendors.Providing a smart solution to the ongoing management of distinct apps has given Appdome an impressive leadership foothold in this market.”
Having previously promised a software update to address a mind-bogglingly huge privacy flaw in FaceTime, Apple today released iOS 12.1.4 and Mojave 10.14.3 (18D109) with patches to fix the issue.The updates are currently making their way through Apple’s software update servers, becoming fully available to all users throughout the day.Colloquially referred to as the “FacePalm” bug, the privacy flaw was reported to Apple in January by 14-year-old Grant Thompson and his attorney mother Michele, but remained unaddressed by the company for roughly a week.During a Fortnite session, Thompson discovered that initiating a Group FaceTime call enabled any FaceTime user to instantly begin hearing microphone audio from a ringing remote device, and under some circumstances would begin seeing video from the device, as well.After reports of the issue began to spread on social media, Apple issued a statement promising to fix its software last week, and disabled the Group FaceTime server that was impermissibly streaming audio and video.The company later apologized and delayed the software update until this week, while thanking users for their patience as the patch was tested.
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TUCSON, Ariz., and FLAGSTAFF, Ariz. -- Jan. 8, 2019 -- Critical Path Institute (C-Path) and TGen North -- the Pathogen and Microbiome Division of the Translational Genomics Research Institute (TGen) -- have received a Phase 1 Concept Validation grant from the Flinn Foundation of $400,000 over 12 months to develop and pilot a framework enabling the state institutions to be more responsive to antimicrobial resistance.Antimicrobial resistant (AMR) infections, caused by microbial pathogens including bacteria, viruses, fungi and parasites, can be deadly for humans and constitute a growing threat that jeopardizes modern medicine and healthcare in Arizona and across the globe."The increasing occurrence of dangerous -- and sometimes life-threatening -- infections caused by antimicrobial resistant pathogens has accelerated the need to develop and implement new tools and systems to detect outbreaks and manage an effective response," said C-Path President and Chief Executive Officer Dr. Martha Brumfield, Ph.D. "The Prevent HAARM system will effectively monitor and track the emergence and transmission of antimicrobial resistant pathogens throughout Arizona, and provide rapid feedback to clinicians, hospitals, epidemiologists and public health professionals.This, in turn, will allow critical intervention decisions to be implemented faster to effectively limit further spread of AMR clusters in Arizona."Prevent HAARM will be designed to leverage existing genomic, informatic, and database technology resources previously developed by C-Path and TGen to effectively respond to AMR threats in Arizona.With support from the Flinn Foundation, C-Path and TGen plan to engage with Arizona-based stakeholders to identify the most critical public health needs related to AMR, determine integration points into the existing healthcare and public health data infrastructure, and validate the utility of the existing genomic, informatic, and database technology as a proof of concept of the Prevent HAARM solution.
A little more than a year ago, autonomous trucking startup TuSimple —flush with a fresh round of venture capital — was preparing to scale up its testing to two full truck fleets in China and the U.S.TuSimple, a China-based company with an R facility in San Diego and test operations in Tucson, has put that money to use.The startup, which launched in 2015, is taking three to five fully autonomous trips per day for customers on three different routes in Arizona, TuSimple said Monday at CES 2019 in Las Vegas.All of these trips have two safety engineers, one who is behind the wheel, and another monitoring the data pouring in during each trip.That’s a milestone for TuSimple and the burgeoning autonomous trucking industry, which is getting increasingly crowded.TuSimple isn’t disclosing its customers.
FlixBus, the low-cost tech-forward bus service out of Europe that launched in U.S. this year, has added a VR experience to some long-distance routes to and from Las Vegas.For now, the FlixBus VR feature, which includes about 50 virtual reality games and travel experiences, is limited to routes from Tucson, Phoenix, Los Angeles and San Diego.Travelers who reserve a panoramic seat on these routes will get the VR experience for free.Once on board, passengers will receive VR headset loaded with content.The Pico Goblin 2 headsets are from Pico Interactive.Inflight VR provides the content and software updates of the VR platform.