Society for Neuroscience—and yet only a handful of biomarkers are available. Focused attention is needed in neuroscience biomarker research and development, yet it is often difficult to categorize which areas are the most ripe for investment and should be further pursued.
Given the promising potential and high need for neuroscience biomarkers, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened a workshop in Washington, DC, on February 26 and 27, 2007. The workshop brought together experts in various areas to discuss the most promising and practical arenas in neuroscience in which novel biomarkers will have the greatest near-term impact on the rate at which new treatments are brought forward for psychiatric and neurological disorders.
Several themes, including the following needs and opportunities, were highlighted by workshop participants:3
a better understanding of the Food and Drug Administration (FDA) evaluation and qualification process to help promote and increase neuroscience biomarker submission;
opportunities for public-private partnerships in a precompetitive space (i.e., the ability of organizations, including companies, sponsors, and developers, to work together on research and development without jeopardizing their intellectual property);
combined tools and technologies in arenas such as proteomics, genomics, and imaging to refine specificity within findings;
deconstruction of certain aspects of current characterizations and diagnostic criteria (e.g., Diagnostic and Statistical Manual [DSM] categorizations);
standardization and pooling of resources and data, especially from current and completed clinical trials, including reporting of negative results; and
development that draws upon successful models and lessons learned from outside fields.