Biomarkers of Neuroinflammation – A Workshop
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.
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.