WORKSHOP GOALS

Organized by an independent planning committee, the Forum hosted a public workshop on biomarkers for nervous system diseases, inviting experts from industry, academia, government, and advocacy groups. The goal of the workshop was to discuss strategies to identify a high-impact biomarker, including a proof of concept, and provide a framework for how the Forum may facilitate its future dialogue and interactions among academia, government, and the private sector. Each speaker was asked to present data and stimulate discussion on the following questions:

  • What processes can be used to accelerate scientific advances relevant to biomarker development?

  • What models of public/private/academic partnerships have been successful in this and other arenas?

  • What disciplines should be brought to bear? How can interdisciplinary perspectives be promoted?

  • What tools are available? What tools are needed?

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 high-impact 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. It was recognized that to be suitable for public-private partnership, a biomarker would need to be useful to therapeutic development in industry context.

The chairman of the workshop’s planning committee, Dr. Dennis Choi, described the workshop’s goals in greater detail. He underscored the importance of setting realistic expectations for biomarker development, considering that few biomarkers (of varying qualification levels) besides risk genes have been developed for nervous system diseases to date. He and other members of the planning committee noted that biomarkers that reflected disease activity, drug safety,1 or effectiveness were most likely to be of value in aiding clinical trials and, hence, to be of interest to industry. Yet a disease risk biomarker could also have quick im-

1

A safety biomarker can be used to identify patients at high risk for serious side effects, to monitor early signs of toxicity, or to predict the likelihood for severe toxicity.



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