The AAPS Journal

, Volume 13, Issue 2, pp 274–283

Translational Biomarkers: from Preclinical to Clinical a Report of 2009 AAPS/ACCP Biomarker Workshop

Authors

    • Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration
  • Robert Bell
    • Drug & Biotechnology Development, LLC
  • ShaAvhree Buckman
    • Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration
  • Gilbert J. Burckart
    • Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration
  • Hans-Georg Eichler
    • EMEA, Canary Wharf
  • Kenneth C. Fang
    • XDx Expression Diagnostics
  • Federico M. Goodsaid
    • Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration
  • William J. Jusko
    • University of Buffalo, State University of New York
  • Lawrence L. Lesko
    • Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration
  • Bernd Meibohm
    • University of Tennessee
  • Scott D. Patterson
    • Amgen Inc
  • Oscar Puig
    • Merck & Co, Inc.
  • Jeffrey B. Smerage
    • University of Michigan
  • Barbara J. Snider
    • Washington University in St. Louis
  • John A. Wagner
    • Merck & Co, Inc.
  • Jingsong Wang
    • Hospital of the University of Pennsylvania
    • Bristol-Myers Squibb
  • Marc K. Walton
    • Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration
  • Russell Weiner
    • Bristol-Myers Squibb
Meeting Report

DOI: 10.1208/s12248-011-9265-x

Cite this article as:
Bai, J.P.F., Bell, R., Buckman, S. et al. AAPS J (2011) 13: 274. doi:10.1208/s12248-011-9265-x

Abstract

There have been some successes in qualifying biomarkers and applying them to drug development and clinical treatment of various diseases. A recent success is illustrated by a collaborative effort among the US Food and Drug Administration, the European Medicines Agency, and the pharmaceutical industry to provide a set of seven preclinical kidney toxicity biomarkers for drug development. Other successes include, but are not limited to, clinical biomarkers for cancer treatment and clinical management of heart transplant patients. The value of fully qualified surrogate endpoints in facilitating successful drug development is undisputed, especially for diseases in which the traditional clinical outcome can only be assessed in large, multi-year trials. Emerging biomarkers, including chemical genomic or imaging biomarkers, and measurement of circulating tumor cells hold great promise for early diagnosis of disease and as prognostic tests for managing treatment of chronic diseases such as osteoarthritis, Alzheimer disease, cardiovascular disease, and cancer. To advance the success of treating and managing these diseases, efforts are needed to establish the temporal relationship between changes in inflammatory or imaging biomarkers with the progression of the chronic disease, and in the case of cancer, between the extent of circulating cancer cells and tumor progression or remission.

KEY WORDS

biomarkers diagnostic diseases gene expression imaging

Copyright information

© American Association of Pharmaceutical Scientists 2011