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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 81
82 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES 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 Alzheimerâs Disease and the NIA Alzheimerâs 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
APPENDIX B 83 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
84 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES 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
APPENDIX B 85 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
86 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES 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
