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OCR for page 81
Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
B
Public Workshop on Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships
Monday, February 26, 2007
Lecture Room
The National Academy of Sciences
2100 C Street, NW
Washington, DC
Workshop Objectives
Discuss the most promising, and practical, arenas in neuroscience in which novel biomarkers will have greatest near-term impact on the rate at which new treatments are brought forward for psychiatric and neurological disorders.
Discuss the necessary parameters for such a high-impact biomarker.
Discuss potential partnerships needed to advance the development of biomarkers and biosignatures.
8:00 a.m.
Continental Breakfast
8:30 a.m.
Welcome and Introductions
ALAN LESHNER
Forum Chair
Chief Executive Officer, AAAS
Executive Publisher, Science
OCR for page 82
Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
SESSION I:
BIOMARKER AND BIOSIGNATURE PRINCIPLES
8:40 a.m.
Workshop Objective: What parameters should be considered when developing a high-impact biomarker?
DENNIS CHOI, Workshop Chair
Professor of Pharmacology and Experimental Therapeutics
Boston University
8:50 a.m.
Introduction to the fNIH Biomarkers Consortium
TOM INSEL
Director
National Institute of Mental Health
9:10 a.m.
Lessons Learned from Alzheimer’s Disease and the NIA Alzheimer’s Disease Neuroimaging Initiative
WILLIAM POTTER
Vice President
Merck Research Laboratories
Clinical Neuroscience
SESSION II:
POTENTIAL TOOLS FOR BIOMARKER AND BIOSIGNATURE DEVELOPMENT
Session Objective: Discuss which tools and parameters should be considered when developing a high-impact biomarker for the neurological or psychiatric disorders.
ALAN BREIER, Session Chair
Vice President for Medical and Chief Medical Officer
Eli Lilly and Company
9:30 a.m.
What Impact Will the Genomics Field Have on the Immediate or the Near-Term Development of Biomarkers for Nervous System Diseases?
ALLEN ROSES
Senior Vice President
GlaxoSmithKline
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
9:50 a.m.
What Impact Will Proteomics, Including CSF Analysis, Have on the Near-Term Development of Biomarkers for Nervous System Diseases?
HOWARD SCHULMAN
Vice President
PPD Biomarker Discovery Sciences
10:10 a.m.
BREAK
10:30 a.m.
What Imaging Tools May Be Utilized for the Development of Biomarkers for Nervous System Diseases?
BRUCE ROSEN
Director
Athinoula A. Martinos Center for Biomedical Imaging
Massachusetts General Hospital
10:50 a.m.
Panel Discussion with Meeting Attendees
ALAN BREIER, Session Chair
11:30 a.m.
LUNCH
SESSION III:
PSYCHIATRIC DISEASES AND DRUG ADDICTION DISORDERS
Session Objective: Identify specific areas of psychiatric medicine where the development of a novel biomarker could have a high impact.
TOM INSEL, Session Chair
Director
National Institute of Mental Health
12:30 p.m.
Which Psychiatric Disorders Are Primed for Key Advances in Biomarker Development?
STEVEN HYMAN
Provost
Harvard University
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
12:45 p.m.
Current and Near-Term Impact of Biomarkers for Depression
HUSSEINI MANJI
Director, Mood and Anxiety Disorders Program
National Institute of Mental Health
1:05 p.m.
Current and Near-Term Impact of Biomarkers for Schizophrenia
DAVID LEWIS
Endowed Professor of Psychiatry
University of Pittsburgh Medical Center
1:25 p.m.
Current and Near-Term Impact of Biomarkers for Disorders of Addiction
NORA VOLKOW
Director
National Institute on Drug Abuse
1:45 p.m.
Panel Discussion with Meeting Attendees
TOM INSEL, Session Chair
2:15 p.m.
BREAK
SESSION IV:
NEUROLOGICAL AND EYE DISEASES
Session Objective: Discuss specific areas of neurological medicine where the development of a novel biomarker could have a high impact.
STORY LANDIS, Session Chair
Director
National Institute of Neurological Disorders and Stroke
2:30 p.m.
Which Neurological Diseases are Primed for Key Advances in Biomarker Development?
IRA SHOULSON
Professor of Neurology
University of Rochester
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
2:45 p.m.
Current and Near-Term Impact of Biomarkers for Multiple Sclerosis
GAVIN GIOVANNONI
Professor of Neurology
Institute of Cell and Molecular Science
Queen Mary, University of London
3:05 p.m.
Current and Near-Term Impact of Biomarkers for Stroke
STEVEN WARACH
Chief
Section on Stroke Diagnostics and Therapeutics
National Institute of Neurological Disorders and Stroke
3:25 p.m.
Current and Near-Term Impact of Biomarkers for SMA
MEG WINBERG
Research Director
Spinal Muscular Atrophy Foundation
3:45 p.m.
Current and Near-Term Impact of Biomarkers for Retinal Degeneration
PAUL SIEVING
Director
National Eye Institute
4:05 p.m.
Panel Discussion with Meeting Attendees
STORY LANDIS, Session Chair
SESSION V:
REGULATORY CONSIDERATIONS, NEXT STEPS, AND GENERAL DISCUSSION
4:35 p.m.
What Regulatory Considerations Are Important to Developing a Qualified Biomarker?
JANET WOODCOCK
Deputy Commissioner and Chief Medical Officer
Food and Drug Administration
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
4:55 p.m.
General Discussion
Which biomarkers have the greatest potential for near-term impact on the development of treatments or key diagnostics for nervous system diseases?
What partnerships are needed to move forward?
DENNIS CHOI, Workshop Chair
Professor of Pharmacology & Experimental Therapeutics
Boston University
5:30 p.m.
ADJOURN