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Glutamate-related Biomarkers in Drug Development for Disorders of the Nervous System – A Workshop

Completed

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.

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

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