NEUROSCIENCES I—NEURODEGENERATIVE AND NEUROPSYCHIATRIC DISORDERS

Objectives

• Define biomarker, intermediate endpoint, and surrogate endpoint
• Consider how to approach identification and validation of a biomarker or set of markers for complex diseases in which the pathophysiology is unknown (markers of disease state, progression, severity, diagnostic and epidemiological issues)
• Evaluate how to identify and validate predictive treatment response biomarkers
• Develop an understanding of:
  • the advantages and disadvantages of including biomarkers in clinical trials
  • the use of biomarkers to select patient subpopulations for clinical studies and clinical trials
  • statistical and modeling issues for validating biomarkers and surrogate markers for use in clinical studies and clinical trials

Agenda

Introduction/Overview of Session Objectives
Linda S. Brady, Ph.D.

Overview of Statistical and Modeling Issues for Evaluating Biomarkers
Scott L. Zeger, Ph.D., Johns Hopkins University School of Hygiene and Public Health

Session I. Neuroimaging Markers

Magnetic Resonance Imaging in Multiple Sclerosis Revealing In Vivo Pathology
Donald W. Paty, M.D., Vancouver Hospital and Health Sciences Center

Novel Brain Imaging Techniques and Drug Development in Schizophrenia
Marc Laruelle, M.D., New York State Psychiatric Institute

Discussant: Mony J. de Leon, Ed.D., New York University School of Medicine

Open Discussion 

Break   

Session II. Behavioral and Genetic Markers

Biomarkers for Cerebrovascular Diseases
Justin A. Zivin, M.D., Ph.D., University of California, San Diego, School of Medicine

Cognitive Markers of Alzheimer's Disease and Schizophrenia
Richard C. Mohs, Ph.D., Mount Sinai School of Medicine

Biochemical and Neuroendocrine Markers in Psychiatric Disorders
Stanley J. Watson, Jr., M.D., Ph.D., University of Michigan School of Medicine

Linking Genetic Markers to Disease Patterns
Kathleen Merikangas, Ph.D., Yale University

Discussant: Scott L. Zeger, Ph.D.

Summary of Session Recommendations

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