All material from NBDA Workshop 1 are available, information from Workshops 2-5 will be available in September to individuals and organizations that join the NBDA as Partners, Collaborators or Members.
Over the past 18 months, the NBDA has undertaken a process to address the daunting challenges of defining and understanding the major technical and other barriers in biomarker development that are in the aggregate responsible for their dismal success rates. This challenge has not heretofore been met, despite numerous isolated efforts. To achieve this goal, the NBDA has assembled (and continues to assemble) experts from all sectors through well-designed workshops that focus on intensive analysis of each phase of biomarker development to identify the technical and other barriers that are negatively impacting biomarker development. Moreover, this ongoing “think tank” process is providing an unprecedented learning system to create and test solutions to the problems identified. Through these “solutions forums,” the operating requirements and necessary management structure for the NBDA has evolved to ensure relevance and a responsive problem-solving construct.
Through the NBDA workshops, affected stakeholders are addressing the Food and Drug Administration’s (FDA) clear position as stated by Dr. Janet Woodcock: “It is not the FDA’s job to develop guidelines and standards to enable biomarker development, it is the job of the affected communities.” This process, which requires unrelenting focus on the targeted area of biomarker discovery and validation will continue to be an integral part of the NBDA’s operations. For without an approach that is current in terms of the rapidly evolving landscape of Biomarker Research and Development (R&D), the NBDA will still be solving old (last century) problems. From these workshops the mission of the NBDA has emerged as follows: “To collaboratively create the NBDA Standards* required for end-to-end, systems- based biomarker development to advance precision (personalized) medicine.” This will not be an easy mission and is one that will most surely require significant resources and the dedicated effort of NBDA staff and the affected communities. The strategies needed to fully capture the input from all of the stakeholders will be synthesized through the dialogue and consensus building which characterizes the NBDA workshops.
*NBDA Standards includes but is not limited to: “official existing standards”, guidelines, principles, standard operating procedures (SOP), and best practices.