|By PR Newswire||
|January 29, 2014 11:36 AM EST||
CFAST Develops Processes to Accelerate Understanding of Alzheimer's disease and Asthma
AUSTIN, Texas, Jan. 29, 2014 /PRNewswire-USNewswire/ -- The Clinical Data Interchange Standards Consortium (CDISC), Critical Path Institute (C-Path) and TransCelerate BioPharma Inc. ("TransCelerate") announced today that version 1.0 of the Asthma Therapeutic Area (TA) User Guide (UG) and version 2.0 of the Alzheimer's TAUG are now available for implementers on the CDISC website. These user guides and the new standards development process through which they were formed are expected to further accelerate the development of additional TA standards. This is expected to streamline the process of developing new therapies for patients.
The release of these two standards marks the first time that TA standards have been fully developed through the CFAST partnership using the enhanced CDISC standards development process. CFAST is a joint initiative of CDISC and C-Path, with partners such as TransCelerate, the U.S. Food and Drug Administration (FDA) and the National Institute of Health's (NIH) National Cancer Institute – Enterprise Vocabulary Services (NCI-EVS), and with participation and input from many other organizations. An aim of the CFAST effort is to support the goals of the FDA's Therapeutic Area Standards (TAS) Initiative Project Plan.
Version 2.0 of the Alzheimer's TAUG provides guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent Alzheimer's data in regulatory submissions. This User Guide describes the most common research concepts relevant to studies of Alzheimer's disease and mild cognitive impairment, and gives guidance on the necessary metadata to represent in a way that is consistent with CDISC standards. The goal of this project was to expand upon v1.0, including a broader set of concepts for Alzheimer's clinical trials and research, using the Alzheimer's Disease Neuroimaging Initiative (ADNI) as the primary source of input. Substantive additions from version 1.0 include 10 new clinical scales of cognition/function, cerebrospinal fluid (CSF) biomarkers sample handling and processing, and imaging biomarkers including volumetric MRI, amyloid PET imaging and FDG-PET imaging.
"This project would not have been possible without the generous support of and the many contributions by clinicians, scientists, C-Path and CDISC members, staff and volunteers. This team worked closely with subject matter experts to enhance the AD data standard which is now being used to develop new tools to analyze aggregated data and better understand Alzheimer's disease progression," said Martha Brumfield, C-Path President and CEO.
It is anticipated that the process followed for the Asthma standard will serve as a model for the development of many more TA standards through the CFAST initiative. The Asthma TA data standard specifically includes variables being collected in clinical research studies in support of therapies for asthma in adults.
"The development of the first data standard created entirely within the CFAST initiative is a landmark achievement," stated Diane Wold, Director of Data Standards at GlaxoSmithKline, member of TransCelerate and CDISC Clinical Data Standards teams and CFAST Asthma team member. "We are looking forward to applying what we learned during the Asthma project to future TA standards development projects."
CDISC is a 501(c)(3) global non-profit charitable organization, with over 300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can significantly decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research. For more information, please visit the CDISC website.
An independent, non-profit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the U.S. Food and Drug Administration (FDA), C-Path's mission is to improve human health and well-being by developing new technologies and methods to accelerate the development and review of medical products. An international leader in forming collaborations, C-Path has established global, public-private partnerships that currently include 1,000+ scientists from government regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies. For more information, please visit the C-Path website.
About TransCelerate BioPharma Inc.
TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies. The organizations' mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines. TransCelerate evolved from discussions at various forums for executive R&D leadership to debate current issues facing the industry, and examine solutions for addressing agreed-upon common challenges. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Astellas Pharma Inc., Biogen Idec, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.), Medgenics, Inc., Shionogi & Co., Ltd. and UCB.
Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research & Development operations. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com.
SYS-CON Events announced today that FalconStor Software® Inc., a 15-year innovator of software-defined storage solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. FalconStor Software®, Inc. (NASDAQ: FALC) is a leading software-defined storage company offering a converged, hardware-agnostic, software-defined storage and data services platform. Its flagship solution FreeStor®, utilizes a horizonta...
Feb. 13, 2016 02:30 PM EST
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 13, 2016 02:00 PM EST Reads: 251
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
Feb. 13, 2016 01:30 PM EST Reads: 140
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 13, 2016 01:30 PM EST Reads: 277
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 13, 2016 12:45 PM EST Reads: 469
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 13, 2016 12:00 PM EST Reads: 442
The Quantified Economy represents the total global addressable market (TAM) for IoT that, according to a recent IDC report, will grow to an unprecedented $1.3 trillion by 2019. With this the third wave of the Internet-global proliferation of connected devices, appliances and sensors is poised to take off in 2016. In his session at @ThingsExpo, David McLauchlan, CEO and co-founder of Buddy Platform, will discuss how the ability to access and analyze the massive volume of streaming data from mil...
Feb. 13, 2016 12:00 PM EST
SYS-CON Events announced today that Column Technologies will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Established in 1998, Column Technologies is a global technology solutions provider with over 400 employees, headquartered in the United States with offices in Canada, India, and the United Kingdom. Column Technologies provides “Best of Breed” technology solutions that automate the key DevOps principal...
Feb. 13, 2016 12:00 PM EST
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Feb. 13, 2016 12:00 PM EST Reads: 470
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
Feb. 13, 2016 11:45 AM EST Reads: 312
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Feb. 13, 2016 11:45 AM EST Reads: 271
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee...
Feb. 13, 2016 11:45 AM EST
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Feb. 13, 2016 11:30 AM EST Reads: 445
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
Feb. 13, 2016 11:30 AM EST Reads: 154
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
Feb. 13, 2016 11:30 AM EST Reads: 280