The impetus for the biomarkers workshop arose out of the scientific and therapeutic import of discovering and developing neuroscience biomarkers or biosignatures—more specifically biomarkers that are not currently being aggressively pursued but that hold the potential of near-term impact. The workshop drew upon experts from various fields to inform and provide discussion for the Institute of Medicine (IOM) Forum on Neuroscience and Nervous System Disorders about the challenges and opportunities in identifying biomarker targets that are not currently being aggressively pursued but that could be developed to practicality within the next 5 years by public-private partnerships. The goal of the workshop was focused consideration of potential biomarker, or biosignature, opportunities, including the current state of biomarker development and the resources needed to carry this effort forward.

Contents

• The National Academies
• Biomarkers Planning Committee
• Forum on Neuroscience and Nervous System Disorders
• Board on Health Sciences Policy
• Reviewers
• Summary
  • Workshop Goals and Objectives
  • Regulatory Considerations
  • Public-Private Partnership
  • POTENTIAL TOOLS
  • FUTURE DIRECTIONS
• Introduction
  • BACKGROUND ON BIOMARKERS
  • PUBLIC-PRIVATE PARTNERSHIPS
• 1. Biomarker and Biosignature Principles
  • WORKSHOP GOALS
  • FOUNDATION FOR NIH BIOMARKERS CONSORTIUM
  • REGULATORY CONSIDERATIONS FOR BIOMARKER DEVELOPMENT
  • LESSONS LEARNED FROM A SUCCESSFUL PARTNERSHIP TO PROMOTE BIOMARKER DEVELOPMENT FOR ALZHEIMER’S DISEASE
• 2. Potential Tools for Biomarker and Biosignature Development
  • IMPACT OF GENOMICS
  • IMPACT OF PROTEOMICS
  • IMPACT OF IMAGING TOOLS
• 3. Psychiatric and Drug Addiction Disorders
  • OVERVIEW
  • BIOMARKERS FOR DEPRESSION
  • THE ROLE OF GENES IN TREATMENT RESPONSE
  • BIOMARKERS FOR SCHIZOPHRENIA
  • BIOMARKERS OF ADDICTION
• 4. Neurological and Eye Diseases
  • LESSONS FROM FAILED CLINICAL TRIALS
  • BIOMARKERS OF MULTIPLE SCLEROSIS
  • BIOMARKERS OF STROKE
  • BIOMARKERS FOR SPINAL MUSCULAR ATROPHY
  • BIOMARKERS FOR NEURODEGENERATIVE DISEASES OF THE RETINA
  • PROMISING TOOLS FOR USE IN OTHER APPLICATIONS
• Appendixes
  • A References
  • B Public Workshop on Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships
  • C Workshop Attendees
  • D Biographical Sketches of Invited Speakers, Committee Members, and Staff

Rapporteurs: Miriam Davis, Sarah Hanson and Bruce Altevogt

This project was supported by contracts between the National Academy of Sciences and the Alzheimer's Association; Amgen, Inc.; AstraZeneca Pharmaceuticals, Inc.; the Department of Health and Human Services’ National Institutes of Health (Contract No. N01-OD-4-2139) through the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Aging (NIA), the National Institute on Drug Abuse (NIDA), the National Eye Institute (NEI), the NIH Blueprint for Neuroscience Research, the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS); Eli Lilly and Company; GE Healthcare, Inc.; GlaxoSmithKline, Inc.; Johnson & Johnson Pharmaceutical Research and Development, LLC; Merck Research Laboratories, Inc.; the National Multiple Sclerosis Society; the National Science Foundation (Contract No. OIA-0647541); Pfizer Global Research and Development, Inc.; and the Society for Neuroscience.

Suggested citation:

Institute of Medicine. 2008. Neuroscience biomarkers and biosignatures: Converging technologies, emerging partnerships, workshop summary. Washington, DC: The National Academies Press.

The views presented in this publication are those of the editors and attributing authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.