|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
Grape Up is a software company, specialized in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market across the USA and Europe, we work with a variety of customers from emerging startups to Fortune 1000 companies.
Apr. 27, 2017 10:45 PM EDT Reads: 2,418
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Analytic. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
Apr. 27, 2017 10:30 PM EDT Reads: 1,269
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
Apr. 27, 2017 10:30 PM EDT Reads: 2,441
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Apr. 27, 2017 10:15 PM EDT Reads: 1,448
Cloud Expo, Inc. has announced today that Aruna Ravichandran, vice president of DevOps Product and Solutions Marketing at CA Technologies, has been named co-conference chair of DevOps at Cloud Expo 2017. The @DevOpsSummit at Cloud Expo New York will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and @DevOpsSummit at Cloud Expo Silicon Valley will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Apr. 27, 2017 10:15 PM EDT Reads: 2,639
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Apr. 27, 2017 10:15 PM EDT Reads: 9,224
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 20th Cloud Expo, which will take place on June 6-8, 2017 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 add...
Apr. 27, 2017 10:00 PM EDT Reads: 2,040
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
Apr. 27, 2017 09:45 PM EDT Reads: 884
Translating agile methodology into real-world best practices within the modern software factory has driven widespread DevOps adoption, yet much work remains to expand workflows and tooling across the enterprise. As models evolve from pockets of experimentation into wholescale organizational reinvention, practitioners find themselves challenged to incorporate the culture and architecture necessary to support DevOps at scale. In his session at @DevOpsSummit at 20th Cloud Expo, Anand Akela, Senior...
Apr. 27, 2017 09:30 PM EDT Reads: 1,888
Join IBM November 2 at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA, and learn how to go beyond multi-speed it to bring agility to traditional enterprise applications. Technology innovation is the driving force behind modern business and enterprises must respond by increasing the speed and efficiency of software delivery. The challenge is that existing enterprise applications are expensive to develop and difficult to modernize. This often results in what Gartner calls ...
Apr. 27, 2017 09:15 PM EDT Reads: 3,271
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Apr. 27, 2017 09:15 PM EDT Reads: 7,292
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Apr. 27, 2017 09:15 PM EDT Reads: 1,265
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
Apr. 27, 2017 09:15 PM EDT Reads: 9,103
Multiple data types are pouring into IoT deployments. Data is coming in small packages as well as enormous files and data streams of many sizes. Widespread use of mobile devices adds to the total. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists will look at the tools and environments that are being put to use in IoT deployments, as well as the team skills a modern enterprise IT shop needs to keep things running, get a handle on all this data, and deli...
Apr. 27, 2017 08:45 PM EDT Reads: 2,487
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Apr. 27, 2017 08:15 PM EDT Reads: 724