Neuroscience Biomarkers and Biosignatures Converging Technologies, Emerging Partnerships: Workshop Summary (2008) / Chapter Skim
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While many advances have been made in the development of biomarkers for disorders other than those of the nervous system, e.g., cancer biology, advances in establishing biomarkers for disorders of the nervous system have been disappointing, given escalating research investment. This is a result of a combination of many factors, including, but not limited to, complexity of the nervous system, access to tissue and the blood brain barrier, and incentives for industry and academia, causing development to fall between the cracks of academic, government, and industry research programs.
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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)
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The Consortium promotes public-private partnerships by facilitating collaborative research among the National Institutes of Health (NIH) , academia, industry, and other foundations and patient advocacy groups to accelerate discovery, development, and qualification of biomarkers.
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The success of the ADNI project is that it lies within the precompetitive space, allowing for broad applicability in future clinical trials and, in addition, fostering communication within otherwise proprietary realms in this area of research. Although ADNI is one example of a successful public-private partnership, there are many others that have been established that are also demonstrating similar successes; however, these were not discussed in detail at the workshop.
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The ADNI project addressed this challenge by pointing out that attitude toward lumbar puncture was suggested to be improved as a result of subjects viewing an educational video that profiled the low risks associated with lumbar punctures. Imaging Technologies Imaging tools are being used to discover surrogate biomarkers, guide therapeutic development, and detect and track disease progression; there is further hope in new, increasingly sophisticated technologies.
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FUTURE DIRECTIONS Several future directions and next steps for biomarker development were identified by various workshop participants: • Biomarker development should follow a process similar to drug development, with the same scientific rigor applied to analyzing and qualifying biomarkers. This suggests creating standardization in reporting and analysis, patient selection, and specimen and assay characterization.
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Schizophrenia: A few promising biomarkers utilize electrophysiology technologies to help detect cognitive dysfunction and working memory in the brain and have led to a few small clinical trials. The value of electrophysiology as a pathway to biomarker development for schizophrenia encompasses many opportunities that include a greater understanding of the neurocircuitry, including imaging, of psychiatric disorders and increased specificity for cognitive and behavioral tests.
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Stroke: A promising biomarker for acute ischemic stroke, using MRI technology, may hold the key to applications for stroke clinical trials. The field of stroke research needs a formal way to share clinical trial and observational studies data, specifically during Phase II trials, which would help to standardize and optimize MRI data and patient selection and outcomes.
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