Forum on Neuroscience and Nervous System Disorders
Board on Health Sciences Policy

Neuroscience Biomarkers and Biosignatures:

Converging Technologies, Emerging Partnerships

Monday, February 26, 2007
 

Lecture Room
National Academy of Sciences Building
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

Session I: Biomarker and Biosignature Principles

8:40 a.m.          Workshop Objectives: What Parameters should be considered when developing a 
                        high-impact biomarker? 

Dennis Choi, Workshop Chair
Professor of Pharmacology & Experimental Therapeutics
Boston University

8:50 a.m.          Introduction to the fNIH Biomarkers Consortium

Tom Insel
Director
National Institute on 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 on the Near-term
                        Development of Biomarkers for Nervous System Diseases?

Allen Roses
Senior Vice President
GlaxoSmithKline

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
Associate 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 on Mental Health

12:30 p.m.        Which Psychiatric Disorders are Primed for Key Advances in Biomarker
                        Development?

Steven Hyman
Provost
Harvard University

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
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 for 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

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 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 for 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

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