Meeting

Biomarkers of Neuroinflammation – A Workshop


When: March 20, 2017 - March 21, 2017 (1:00 PM Eastern)

Topics Biomedical and Health Research, Substance Use and Mental Health, Diseases, Aging, Public Health, Quality and Patient Safety
Activity: Forum on Neuroscience and Nervous System Disorders
Board: Board on Health Sciences Policy

Background:

Innate and adaptive immunity have become very important areas of investigation for psychiatric disorders, neurologic disorders, neurodevelopmental disorders, and neurodegeneration resulting from traumatic brain injury. For example, compelling genetic and other biologic data are demonstrating critical roles of innate and adaptive immunity in Alzheimer’s disease pathogenesis. Several conferences and meetings are being held in this hot area, but it is not clear how best to translate recent findings to therapeutics; developing biomarkers that can be validated and used in clinical development and regulatory decision making is a critical step in this process. Many efforts are already underway to identify biomarkers of neuroinflammation, including biomarkers in cerebrospinal fluid and blood, as well as PET imaging agents for targets such as translocator protein (TSPO). Given the intense activity in academic research and private sector settings and across many nervous system disorders, there is an opportunity to take stock of current knowledge, provide a venue for coordination, and identify potential opportunities to advance work in this domain. This public workshop will bring together key stakeholders from government, academia, industry, and disease-focused organizations to explore and advance efforts to identify biomarkers of neuroinflammation that can be validated and used in clinical development and regulatory decision making.

Workshop Objectives:

Provide an overview of current knowledge on the role of neuroinflammation in nervous system disorders—including psychiatric and neurologic disorders, neurodevelopmental disorders, and neurodegeneration resulting from traumatic brain injury—discuss the various definitions of neuroinflammation in use across the field, and the contribution of the peripheral and CNS innate immune systems to normal brain function and disease pathophysiology.

Explore the state-of-the-science of neuroinflammation biomarkers and research needed to enable the use of these biomarkers at the individual level.  Do any biomarkers under development/validation implicate glia, neurons, immune cells, endothelial cells, should these be deployed singly or in combination, and where are the gaps in current approaches?

Facilitate coordination among consortia and companies that are developing biomarkers of neuroinflammation. How might a study be designed to establish the disease relevance or drug-development utility of a neuroinflammation biomarker? Are such studies underway, and if not, why not? If not, what more do we need to facilitate these, and are there opportunities for “add-on” studies to current clinical trials?

Highlight approaches, tools, and lessons learned that may apply across disorders and opportunities to advance the development of these biomarkers.





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