Neuroscience Biomarkers and Biosignatures Converging Technologies, Emerging Partnerships: Workshop Summary (2008) / Chapter Skim
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1 Biomarker and Biosignature Principles
1 Biomarker and Biosignature Principles
Pages 15-26
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From page 15... ...
Biomarkers Consortium, which catalyzes new partnerships for the development of biomarkers that lie within the precompetitive space, was identified by participants as one potential mechanism that may facilitate additional collaboration and investment. Further, participants highlighted other models of public-private partnership that seek to accelerate development of new therapeutics, spanning effort across multiple areas of biomarker development, including the Alzheimer's Disease Neuroimaging Initiative (ADNI)
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From page 16... ...
Besides stimulating discussion on these important topics, it was the Forum's ambition to contribute specifically to accelerating the availability of at least one important nervous system biomarker, both for its intrinsic value and for its value in exploring modes of Forum engagement. Thus, a stated goal of the workshop was to identify at least one highimpact biomarker, suitable for public-private partnership and potentially accomplishable in the near term, whose development might be accelerated by the Forum by facilitating interactions among stakeholders.
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From page 17... ...
FOUNDATION FOR NIH BIOMARKERS CONSORTIUM To facilitate public-private partnerships for biomarker development, Dr. Insel, director of the National Institute of Mental Health, outlined one major new mechanism, the FNIH Biomarkers Consortium.
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From page 18... ...
For a single drug or device maker, biomarker development is too risky and removed from commercial payoff to justify the investment. The Consortium fills the gap by funding precompetitive projects that none of these entities would undertake on their own.
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From page 19... ...
However, one key issue, conflict of interest, is less relevant to the Biomarkers Consortium because all members have agreed that all work will be public and, as described above, in the precompetitive space. In addition, device manufacturers and diagnostic companies are not represented in the Consortium, eliminating those who may see the biomarkers discovered as within their intellectual property space and of considerable value.
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FDA became concerned about the lag in biomarker development, relative to a surge in therapeutic development, when it realized that many biomarkers are discovered but never submitted for regulatory review. They are developed in academic laboratories and published in the biomedical literature as case series.
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From page 21... ...
Qualification of any biomarker first requires analytic validation, a process that includes evaluation of test parameters such as stability of reagents, standardization of assays, assessment of sensitivity, specificity and predictive value of assays, and the biomarker's robustness in various sites. Analytic validation is the area where academia falls short, in part because academic scientists are not well compensated or rewarded in the academic sector for applied science.
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From page 22... ...
New biomarkers such as gene expression arrays in cancer or markers of inflammation in heart disease may be used to identify individuals at high risk for recurrence or myocardial infarction, respectively. Qualification of surrogate biomarkers requires great rigor, including evidence showing biological plausibility, statistical correlation with a clinical outcome, and success in clinical trials (Box 1-1)
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From page 23... ...
Regarding applications to nervous system disorders, Woodcock expressed optimism. Few nervous system biomarkers are available today because the disorders are marked by subjective diagnostic criteria, highly variable rates of responses, a high need for preventive interventions, and current therapeutic interventions with safety or adherence problems.
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From page 24... ...
William Potter, vice president, Franchise Integrator Neuroscience, at Merck Research Laboratories, the presenter who described the initiative and the lessons drawn thus far. The study seeks to identify biomarkers for the progression of mild cognitive impairment and early Alzheimer's disease.
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From page 25... ...
For the primary public partner, the NIA, the trial serves a crucial public health need to find a biomarker to stimulate development of new therapeutics. And that public health need is growing due to the demographic bulge of aging baby boomers.
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From page 26... ...
While many advances are coming from the analysis of the image data, Potter expressed that collection of CSF may turn out to be more important than imaging biomarkers. This contribution was made possible through the advisory committee's success in working with its public partner to modify the study design to collect CSF at much higher rates than initially called for in the protocol and by encouraging more patients, via an educational video, to willingly undergo lumbar puncture.
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