Opportunities and challenges of safety biomarker qualification: perspectives from the predictive safety testing consortium

Eslie H. Dennis, Elizabeth G. Walker, Amanda F Baker, Richard T. Miller

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Preclinical Research Biomarkers hold tremendous promise to improve the drug development and evaluation process, advance patient care, and reduce health-care costs. However, understanding the characteristics of novel biomarkers and developing the robust evidentiary packages to support incorporating them into drug development and clinical practice is an enormous undertaking requiring significant resources and commitment from a wide range of stakeholders, including regulators, the biopharmaceutical industry, academia, governmental agencies, patients, and payors. The Predictive Safety Testing Consortium (PSTC) is a unique public-private partnership formed by Critical Path Institute (C-Path) in collaboration with the United States Food and Drug Administration (FDA) to identify new and improved drug safety testing methods and submit them for formal regulatory qualification by the FDA, the European Medicines Agency, and the Japanese Pharmaceuticals and Medical Devices Agency. In 2008, the PSTC obtained the first regulatory qualification of seven urinary renal preclinical safety biomarkers for use in rodent studies and on a case-by-case basis for inclusion into clinical development programs. These qualified biomarkers are now successfully informing drug discovery and development decisions. PSTC has expanded their qualification efforts into dogs, nonhuman primates, and humans and focuses on six areas of organ toxicity. The collaborative effort of multiple stakeholders through PSTC has resulted in significant cost savings and more rapid scientific consensus, leading to greater acceptance of these biomarkers by health authorities and pharmaceutical companies. Regulatory qualification of a biomarker for a defined context of use provides scientifically robust assurances to sponsors and regulators that should accelerate appropriate adoption of biomarkers into drug development and, ultimately, clinical practice.

Original languageEnglish (US)
Pages (from-to)112-126
Number of pages15
JournalDrug Development Research
Volume74
Issue number2
DOIs
StatePublished - Mar 2013
Externally publishedYes

Fingerprint

Biomarkers
Safety
Pharmaceutical Preparations
United States Food and Drug Administration
Public-Private Sector Partnerships
Drug Evaluation
Critical Pathways
Cost Savings
Drug Discovery
Health Care Costs
Primates
Rodentia
Patient Care
Industry
Dogs
Kidney
Equipment and Supplies
Health
Research

Keywords

  • biomarker
  • Critical Path Institute
  • drug development tool
  • novel methodology
  • Predictive Safety Testing Consortium
  • qualification
  • regulatory science

ASJC Scopus subject areas

  • Drug Discovery

Cite this

Opportunities and challenges of safety biomarker qualification : perspectives from the predictive safety testing consortium. / Dennis, Eslie H.; Walker, Elizabeth G.; Baker, Amanda F; Miller, Richard T.

In: Drug Development Research, Vol. 74, No. 2, 03.2013, p. 112-126.

Research output: Contribution to journalArticle

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