|By PR Newswire||
|January 13, 2014 12:01 AM EST||
The NBDA Intends to Change the Dismal Success Rate of Biomarkers by Creating Evidence Based, End-to-End Biomarker Development Processes
A Collaborative Network-Based, Non-Profit Organization, the NBDA Will Create Standards to Successfully Develop Biomarkers Needed for Precision (personalized) Medicine
WASHINGTON, Jan. 13, 2014 /PRNewswire-USNewswire/ -- The launch of a new independent, non-profit organization, the National Biomarker Development Alliance (NBDA), broadly engaging leaders in industry, academia, patient groups and government from across the country, was announced today at the National Press Club by the Research Collaboratory at Arizona State University (ASU). The mission of the NBDA is to address the complex and urgent challenge of creating the standards needed to support end-to-end evidence-based biomarker development in order to significantly advance precision (personalized) health care.
Effective high quality biomarkers are critical to ultimately realizing the promise of precision (personalized) medicine. The NBDA, will be disease "agnostic" and is the first independent trans-sector organization that brings together key stakeholders from academia, the private sector, payers and patients/advocates to ultimately change the current dismal success rate of biomarker discovery, development and validation. "Creating the standards and systems for successful biomarker development is complex but achievable through a new generation of networks of stakeholders that integrate knowledge to solve critical problems of this scale," stated Dr. Anna Barker, President, Director and Co-Founder of the NBDA, Co-Director of Complex Adaptive Systems and Professor at ASU, and former Deputy Director of the National Cancer Institute. "The NBDA was developed not just to relegate the flawed and fragmented approaches to biomarker development processes to history but also to serve as a working example of what purposeful convergence of scientific knowledge and multi-sector collaboration can accomplish," said Barker.
The NBDA will achieve its goals through a management construct and systems-based approach that integrates and leverages biomarker knowledge networks from all of these stakeholder communities. "We were pleased to enable the development of the NBDA," stated Dr. Rick Shangraw, Chief Executive Officer of the Arizona State University Foundation (ASUF). "Increasingly transformative ideas will be accomplished through new organizational constructs such as NBDA that facilitate the convergence of knowledge to address major societal problems."
Biomarkers are signals, or indicators (markers) of normal or disease-related processes or measures of pharmacologic response to therapy. They are the key to realizing a future in which patients are treated based on identifying molecular changes in their disease. These molecular profiles will empower physicians to select targeted therapies using molecular diagnostics versus today's one "size fits all." Currently, too many drugs and biomarkers fail in late stages of regulatory review, as most explicitly evidenced by the disturbing historical lack of success of many phase III clinical trials for cancer.
Powered by advanced genomic and other technologies, biomarker discovery has become a major focus for investigators working in nearly all areas of biomedical research. "Reflecting on the 150,000 papers that documented thousands of biomarker discoveries," Dr. George Poste, interim Chief Science Officer of the NBDA, Co-Director of Complex Adaptive Systems and Regents Professor at ASU and Former President of Research & Development for SmithKline Beecham (now GlaxoSmithKline), stated that "a discovery" does not mean that the technical process was robust, that the findings could be independently reproduced, or that they measure a meaningful change in biology that addresses clinically meaningful questions."
Unfortunately, in the face of this tsunami of biomarker discovery, the approval of protein biomarkers has changed little since the 1990s, with less than 1.5 approved per year by the Food and Drug Administration (FDA). Moreover, less than 100 biomarkers are used routinely in the clinic today. Failure to develop and implement standards based end-to-end systems approaches for biomarker development has also essentially stalled the advancement of the diagnostics industry, especially smaller biotechnology companies focused on molecular diagnostics. The explosion of genomics-based assays and other non-regulated laboratory developed tests (LDTs) discourages companies from pursuing more rigorous, uncertain and expensive FDA biomarker/diagnostic approval pathways. The undervaluation of biomarkers and reimbursement ambiguities further discourages investment in the field. "The NBDA is a potentially transformative approach to not just identifying and advancing successful biomarkers, but it will also serve to energize and support the development of the diagnostics industry," stated Mara Aspinall, CEO, Ventana Medical Systems and Co-Founder, DxInsights.
The NBDA is well underway in setting up demonstration projects to develop standards and/or create ideal pathways for four "classes" of biomarkers: genomics, proteomics, imaging and complex biomarkers (e.g., biosignatures). In addition, the NBDA is assembling a database of all guidelines, standard operation procedures and standards developed to date on the collection, stewardship and management of biospecimens. Once assembled, NBDA will organize a consensus conference to define "standards" for the field that can be agreed to by the stakeholder communities. Dr. Carolyn Compton, NBDA's Chief Medical Officer, Professor at ASU, and former President and CEO of the Critical Path Institute will lead this effort. "I know from long experience, that this is not an easy task, but I believe that we already have a great deal of the information needed to get this done and identification of critical knowledge gaps will guide needed research," said Dr. Compton.
"Creating and broadly implementing the standards (guidelines, standard-operating procedures, best practices, etc.) needed to successfully discover and develop the effective biomarkers we need is not the job of the FDA, but it is the job of the affected stakeholders. A successful NBDA promises to reduce health care costs by accelerating drug development, empowering the diagnostics industry and improving patient engagement and outcomes," said Barker. "Continuing to tolerate the failure of biomarkers means that the promise of precision medicine will never materialize for patients and that would be tragic and costly."
About the National Biomarker Development Alliance (NBDA)
The mission of the National Biomarker Development Alliance (NBDA) is to collaboratively create the standards to support evidence-based, end-to-end biomarker development – to advance precision medicine. The NBDA was established as an independent non-profit organization by the Research Collaboratory of Arizona State University in 2013 following two years of study and planning by the founders and informed by a large and diverse group of biomarker experts through ongoing think tanks and workshops. The NBDA is creating needed "standards" (inclusive of best practices, guidelines, standard operating procedures, etc.) through trans-sector networks to support new models of end-to-end biomarker development. The Alliance will integrate existing relevant knowledge and identify and address need for new research and make its data, processes and standards publicly available. The NBDA is disease agnostic and will examine how lessons in biomarker development from one disease can be translated to others. The NBDA will also undertake efforts to build unique resources to serve the biomarker communities including: a national biomarker biorepository; a network to reproduce selected biomarker resullts; and a common biomarker database. Overall, the NBDA is dedicated to moving high quality, effective biomarkers through all phases of discovery, development and validation more rapidly so that the promise of precison (molecularly based) medicine can produce meaningful gains for patients.
Anne Marie Geary
National Biomarker Development Alliance
Fax: (480) 884-2040
Teleconference (listen only) dial-in number:
800-747-5150 access code is 6627545
SOURCE National Biomarker Development Alliance
SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points of presence, SoftLayer provides infrastructure as a service to leading-edge customers ranging from Web startups to global enterprises. SoftLayer's modular architecture, full-featured API, and sophisticated automation provide unparalleled performance and control. Its flexible unified platform seamlessly spans physical and virtual devices linked via a world...
May. 26, 2016 04:30 AM EDT Reads: 1,818
SYS-CON Events announced today TechTarget has been named “Media 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. TechTarget is the Web’s leading destination for serious technology buyers researching and making enterprise technology decisions. Its extensive global networ...
May. 26, 2016 04:30 AM EDT Reads: 3,077
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...
May. 26, 2016 04:15 AM EDT Reads: 2,790
SYS-CON Events announced today that BMC Software has been named "Siver 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. BMC is a global leader in innovative software solutions that help businesses transform into digital enterprises for the ultimate competitive advantage. BMC Digital Enterprise Management is a set of innovative IT solutions designed to make digital business fast, seamless, and optimized from mainframe to mo...
May. 26, 2016 04:00 AM EDT Reads: 1,906
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 18th International CloudExpo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York, 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.
May. 26, 2016 03:45 AM EDT Reads: 2,127
SYS-CON Events announced today BZ Media LLC has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. BZ Media LLC is a high-tech media company that produces technical conferences and expositions, and publishes a magazine, newsletters and websites in the software development, SharePoint, mobile development and Commercial Drone markets.
May. 26, 2016 03:00 AM EDT Reads: 3,429
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
May. 26, 2016 02:00 AM EDT Reads: 1,091
SYS-CON Events announced today that MangoApps 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. MangoApps provides modern company intranets and team collaboration software, allowing workers to stay connected and productive from anywhere in the world and from any device. For more information, please visit https://www.mangoapps.com/.
May. 26, 2016 12:45 AM EDT Reads: 566
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, wh...
May. 26, 2016 12:00 AM EDT Reads: 1,893
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discuss how businesses can gain an edge over competitors by empowering consumers to take control through IoT. We'll cite examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He'll also highlight how IoT can revitalize and restore outdated business models, making them profitable...
May. 25, 2016 10:45 PM EDT Reads: 2,637
Many banks and financial institutions are experimenting with containers in development environments, but when will they move into production? Containers are seen as the key to achieving the ultimate in information technology flexibility and agility. Containers work on both public and private clouds, and make it easy to build and deploy applications. The challenge for regulated industries is the cost and complexity of container security compliance. VM security compliance is already challenging, ...
May. 25, 2016 10:00 PM EDT Reads: 1,096
SYS-CON Events announced today that ContentMX, the marketing technology and services company with a singular mission to increase engagement and drive more conversations for enterprise, channel and SMB technology marketers, has been named “Sponsor & Exhibitor Lounge Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York. “CloudExpo is a great opportunity to start a conversation with new prospects, but what happens after the...
May. 25, 2016 10:00 PM EDT Reads: 911
The pace of innovation, vendor lock-in, production sustainability, cost-effectiveness, and managing risk… In his session at 18th Cloud Expo, Dan Choquette, Founder of RackN, will discuss how CIOs are challenged finding the balance of finding the right tools, technology and operational model that serves the business the best. He will discuss how clouds, open source software and infrastructure solutions have benefits but also drawbacks and how workload and operational portability between vendors...
May. 25, 2016 09:00 PM EDT Reads: 1,787
The essence of data analysis involves setting up data pipelines that consist of several operations that are chained together – starting from data collection, data quality checks, data integration, data analysis and data visualization (including the setting up of interaction paths in that visualization). In our opinion, the challenges stem from the technology diversity at each stage of the data pipeline as well as the lack of process around the analysis.
May. 25, 2016 08:30 PM EDT Reads: 1,246
As machines are increasingly connected to the internet, it’s becoming easier to discover the numerous ways Industrial IoT (IIoT) is helping to shape the business world. This is exactly why we have decided to take a closer look at this pervasive movement and to examine the desire to connect more things! Now if you need a refresher on IIoT and how it is changing the world, take a moment and listen to Greg Gorbach with ARC Advisory Group. Gorbach believes, "IIoT will significantly change the worl...
May. 25, 2016 08:00 PM EDT Reads: 1,838