Welcome!

News Feed Item

Launch of a Transformative Health Care Initiative: The National Biomarker Development Alliance (NBDA)

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.

(Logo: http://photos.prnewswire.com/prnh/20140113/DC44690LOGO)

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.

MEDIA CONTACT
Mollie Roth
(202) 280-5887
Anne Marie Geary
(480) 884-1070
National Biomarker Development Alliance
[email protected]
Fax: (480) 884-2040
Teleconference (listen only) dial-in number:
800-747-5150 access code is 6627545

SOURCE National Biomarker Development Alliance

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that Venafi, the Immune System for the Internet™ and the leading provider of Next Generation Trust Protection, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Venafi is the Immune System for the Internet™ that protects the foundation of all cybersecurity – cryptographic keys and digital certificates – so they can’t be misused by bad guys in attacks...
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market? In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, explored the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences between wh...
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
In his session at Cloud Expo, Robert Cohen, an economist and senior fellow at the Economic Strategy Institute, will provide economic scenarios that describe how the rapid adoption of software-defined everything including cloud services, SDDC and open networking will change GDP, industry growth, productivity and jobs. This session will also include a drill down for several industries such as finance, social media, cloud service providers and pharmaceuticals.
Security, data privacy, reliability, and regulatory compliance are critical factors when evaluating whether to move business applications from in-house, client-hosted environments to a cloud platform. Quality assurance plays a vital role in ensuring that the appropriate level of risk assessment, verification, and validation takes place to ensure business continuity during the migration to a new cloud platform.
SYS-CON Events announced today the Kubernetes and Google Container Engine Workshop, being held November 3, 2016, in conjunction with @DevOpsSummit at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA. This workshop led by Sebastian Scheele introduces participants to Kubernetes and Google Container Engine (GKE). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, students learn the key concepts and practices for deploying and maintainin...
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
StackIQ has announced the release of Stacki 3.2. Stacki is an easy-to-use Linux server provisioning tool. Stacki 3.2 delivers new capabilities that simplify the automation and integration of site-specific requirements. StackIQ is the commercial entity behind this open source bare metal provisioning tool. Since the release of Stacki in June of 2015, the Stacki core team has been focused on making the Community Edition meet the needs of members of the community, adding features and value, while ...
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
In addition to all the benefits, IoT is also bringing new kind of customer experience challenges - cars that unlock themselves, thermostats turning houses into saunas and baby video monitors broadcasting over the internet. This list can only increase because while IoT services should be intuitive and simple to use, the delivery ecosystem is a myriad of potential problems as IoT explodes complexity. So finding a performance issue is like finding the proverbial needle in the haystack.
"We host and fully manage cloud data services, whether we store, the data, move the data, or run analytics on the data," stated Kamal Shannak, Senior Development Manager, Cloud Data Services, IBM, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, discussed how research has demonstrated the value of Machine Learning in delivering next generation analytics to imp...
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, 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 opportuni...