Over the next several months, the NBDA will undertake a series of projects to determine how the use of NBDA Standards* affects the outcomes of specific elements of early and translatable discovery, assay development and performance and biomarker qualification and clinical validation. The results of these demonstration projects will also serve to assemble existing information and data into responsive NBDA Standards as well as research and development efforts where needed. During the course of NBDA’s “due diligence” to understand in depth the barriers/issues that are responsible for the dismal success of biomarkers, several specific concepts for demonstration projects have emerged. Examples of potential demonstration projects include:
Nucleic Acid Biomarkers: Setting standards for assessing (measuring) more common genomic changes (translocations, deletions and mutations) and their value in targeted therapy. The goal of these demonstration projects will be to identify the NBDA Standards* needed to reproducibly show that a genetic rearrangement can serve to predict the therapeutic response in a cancer subtype. In essence, such demonstration projects will demonstrate the value of standards in developing high value genomic biomarkers for use in the clinic.
Protein Biomarkers: In the coming months, the NBDA will convene groups of experts to review the myriad SOPs in proteomics for everything from biospecimen collection to standards for metadata. From these consensus conferences, the NBDA will set “gold standards” for the strategic elements of proteomics biomarker research and development, including a “meets NBDA Guidelines” certification approach. The NBDA is also undertaking the planning for the construction of a protein biomarker database. This goal is to take steps to ensure that the database be of extremely high value (e.g., including both successful protein biomarkers and those that have failed at late stages in the biomarker development process). The database will be publicly available. The NBDA is planning a demonstration project to determine what specifically is required to develop a prognostic protein biomarker (e.g., biomarkers to assess transition from pre-diabetes to type 2 diabetes).
Imaging Biomarkers: Imaging biomarkers are of high interest to the NBDA. NBDA plans to undertake demonstration projects consensus conference to prove the value of magnetic resonance imaging (MRI) as a biomarker for disease response and/or presence of targets.
“Complex” Biomarkers: NBDA’s is planning a demonstration project directed at decision algorithms for biomarkers. Specifically algorithms that integrate two or more measurements (e.g., imaging and molecular biomarker) to produce a composite score for use in guiding clinical decision-making will be evaluated. The goal is to determine what standards/guidelines, etc. are needed to ensure that the composite score predicts response accurately.
*NBDA Standards includes but is not limited to: “official existing standards”, guidelines, principals, standard operating procedures (SOP), and best practices.
(Standards refers to NBDA Standards unless otherwise noted)