|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
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
Dec. 9, 2016 10:30 PM EST Reads: 1,696
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, discussed how VPaaS enables you to move fast, creating scalable video experiences that reach your aud...
Dec. 9, 2016 10:00 PM EST Reads: 287
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...
Dec. 9, 2016 09:45 PM EST Reads: 2,003
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 9, 2016 09:30 PM EST Reads: 1,279
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
Dec. 9, 2016 08:00 PM EST Reads: 1,017
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for ...
Dec. 9, 2016 07:45 PM EST Reads: 716
IoT is rapidly changing the way enterprises are using data to improve business decision-making. In order to derive business value, organizations must unlock insights from the data gathered and then act on these. In their session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, and Peter Shashkin, Head of Development Department at EastBanc Technologies, discussed how one organization leveraged IoT, cloud technology and data analysis to improve customer experiences and effici...
Dec. 9, 2016 06:45 PM EST Reads: 5,145
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, discussed why and how ReadyTalk diverted from healthy revenue and mor...
Dec. 9, 2016 06:15 PM EST Reads: 1,765
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
Dec. 9, 2016 05:30 PM EST Reads: 2,370
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lead...
Dec. 9, 2016 05:30 PM EST Reads: 484
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
Dec. 9, 2016 05:15 PM EST Reads: 1,891
The Internet of Things (IoT) promises to simplify and streamline our lives by automating routine tasks that distract us from our goals. This promise is based on the ubiquitous deployment of smart, connected devices that link everything from industrial control systems to automobiles to refrigerators. Unfortunately, comparatively few of the devices currently deployed have been developed with an eye toward security, and as the DDoS attacks of late October 2016 have demonstrated, this oversight can ...
Dec. 9, 2016 05:15 PM EST Reads: 1,471
"MathFreeOn.com is a line coding platform for engineers and scientists. When they want to solve an engineering problem and they have to use software - they have to pay a lot of money for licenses - but with MathFreeOn you don't have to pay a lot of money. Just go to our site and write the code and you can check the result right away," explained Simon Lee, CMO of MathFreeOn, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Cla...
Dec. 9, 2016 05:15 PM EST Reads: 415
In his session at 19th Cloud Expo, Claude Remillard, Principal Program Manager in Developer Division at Microsoft, contrasted how his team used config as code and immutable patterns for continuous delivery of microservices and apps to the cloud. He showed how the immutable patterns helps developers do away with most of the complexity of config as code-enabling scenarios such as rollback, zero downtime upgrades with far greater simplicity. He also demoed building immutable pipelines in the cloud ...
Dec. 9, 2016 05:00 PM EST Reads: 2,075
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
Dec. 9, 2016 04:45 PM EST Reads: 1,869