Chapter 4. Biomarkers and Surrogate Markers in Drug Development

  1. Neal R. Cutler M.D. President CEO1,
  2. John J. Sramek Pharm. D. Director1,
  3. Michael F. Murphy M.D., Ph.D. Chief Medical and Scientific Officer2,
  4. Henry Riordan Sr Ph.D. Chief Medical and Scientific Officer3,
  5. Peter Bieck M.D., Ph.D. Vice President4 and
  6. Angelico Carta M.D. President5

Published Online: 5 MAR 2010

DOI: 10.1002/9781444318579.ch4

Critical Pathways to Success in CNS Drug Development

Critical Pathways to Success in CNS Drug Development

How to Cite

Cutler, N. R., Sramek, J. J., Murphy, M. F., Riordan, H., Bieck, P. and Carta, A. (2010) Biomarkers and Surrogate Markers in Drug Development, in Critical Pathways to Success in CNS Drug Development, Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444318579.ch4

Author Information

  1. 1

    Worldwide Clinical Trials Beverly Hills, CA, USA

  2. 2

    Worldwide Clinical Trials King of Prussia, PA, USA

  3. 3

    VP Medical and Scientific Affairs, Worldwide Clinical Trials King of Prussia, PA, USA

  4. 4

    Worldwide Clinical Trials Indianapolis, IN, USA

  5. 5

    Worldwide Clinical Trials Europe London, UK

Publication History

  1. Published Online: 5 MAR 2010
  2. Published Print: 9 APR 2010

ISBN Information

Print ISBN: 9781444330649

Online ISBN: 9781444318579

SEARCH

Keywords:

  • Biomarker;
  • surrogate;
  • clinica;
  • validation;
  • schizophrenia;
  • anxiety;
  • depression;
  • Alzheimer's;
  • compound;
  • efficacy

Summary

Animal models provide a good starting point for identifying a compound's safety and efficacy, but do not always mirror results in humans. Early indicators of efficacy in humans are needed to minimize costs and time required for clinical trials, by providing reliable information on whether a novel compound warrants further development. Biomarkers provide early data in humans on whether a compound is reaching its intended target or modifying its intended disease pathway. Unfortunately, biomarkers represent a “wild-west” in drug development; few are fully validated, and research on their utility and what they truly represent is often conflicting. In addition, new biomarkers with unknown parameters are constantly being developed and added to the fray. This chapter reviews the most utilized biomarkers of efficacy, and the most promising new biomarkers being developed, in four major CNS indications: Alzheimer's disease, anxiety disorder, depression, and schizophrenia.