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The Forum on Neuroscience and Nervous System Disorders hosted a public workshop on June 21-22, 2010, bringing together key stakeholders, to present promising current and emerging technologies with potential as reliable glutamate biomarkers, and to outline strategies to accelerate development, validation, and implementation of these biomarkers as powerful tools to advance drug development for nervous system disorders associated with glutamatergic dysfunction.
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Workshop
·2011
Glutamate is the most pervasive neurotransmitter in the central nervous system (CNS). Despite this fact, no validated biological markers, or biomarkers, currently exist for measuring glutamate pathology in CNS disorders or injuries. Glutamate dysfunction has been associated with an extensive range o...
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Description
An ad hoc committee will organize and host a public workshop inviting participants from academia, the pharmaceutical industry, NIH and the FDA to present and discuss strategies to accelerate development, validation, and implementation of glutamate biomarkers as tools to advance drug development for nervous system disorders associated with glutamatergic dysfunction.
Specifically, workshop participants will be invited to:
- Briefly outline the need for glutamate-related biomarkers both for understanding the causes of neurological diseases associated with glutamatergic dysfunction, and for accelerating drug development and therapeutic decision-making for these disorders.
- Discuss the most promising current and emerging technologies and analytical methods for assessing glutamatergic neurotransmission, and identify the research gaps for their development into biomarkers.
- Outline approaches for biomarker validation in preclinical and clinical studies, including relevant animal models and translational challenges.
- Discuss the implementation and regulatory barriers to incorporating glutamatergic biomarkers into drug development for neurological disease and approaches to overcome them
- Identify the next steps to establish principles and procedures to accelerate biomarker development, validation, and implementation in clinical trials, including frameworks for partnerships andcollaboration
An individually authored summary of the workshop will be prepared in accordance with institutional policy and procedures.
Collaborators
Committee
Daniel C. Javitt
Co-Chair
Chi-Ming Lee
Co-Chair
Huda Akil
Member
Mark Bear
Member
John Dunlop
Member
Richard Frank
Member
Walter J. Koroshetz
Member
Menelas Pangalos
Member
William Z. Potter
Member
Rae Silver
Member
Nora Volkow
Member
Stevin H. Zorn
Member
Stephen Zukin
Member
Sponsors
Department of Health and Human Services
National Science Foundation
Private: For Profit
Private: Non Profit
Staff
Bruce Altevogt
Lead
Clare Stroud
Lead
Major units and sub-units
Health and Medicine Division
Lead
Institute of Medicine
Lead
Board on Health Sciences Policy
Lead