A multistep validation process of biomarkers for preclinical drug development

W. M. Freeman, G. V. Bixler, R. M. Brucklacher, C. M. Lin, K. M. Patel, H. D. Vanguilder, K. F. Lanoue, S. R. Kimball, A. J. Barber, D. A. Antonetti, T. W. Gardner, S. K. Bronson

Research output: Contribution to journalArticlepeer-review

24 Scopus citations

Abstract

Biomarkers that can be measured in preclinical models in a high-throughput, reproducible manner offer the potential to increase the speed and efficacy of drug development. Development of therapeutic agents for many conditions is hampered by the limited number of validated preclinical biomarkers available to gauge pharmacoefficacy and disease progression, but the validation process for preclinical biomarkers has received limited attention. This report defines a five-step preclinical biomarker validation process and applies the process to a case study of diabetic retinopathy. By showing that a gene expression panel is highly reproducible, coincides with disease manifestation, accurately classifies individual animals and identifies animals treated with a known therapeutic agent, a biomarker panel can be considered validated. This particular biomarker panel consisting of 14 genes (C1inh, C1s, Carhsp1, Chi3l1, Gat3, Gbp2, Hspb1, Icam1, Jak3, Kcne2, Lama5, Lgals3, Nppa, Timp1) can be used in diabetic retinopathy pharmacotherapeutic research, and the biomarker development process outlined here is applicable to drug development efforts for other diseases.

Original languageEnglish (US)
Pages (from-to)385-395
Number of pages11
JournalPharmacogenomics Journal
Volume10
Issue number5
DOIs
StatePublished - Oct 2010

All Science Journal Classification (ASJC) codes

  • Molecular Medicine
  • Genetics
  • Pharmacology

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