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Safety biomarker applications in drug development

Shelli Schomaker1, Shashi Ramaiah1, Nasir Khan1

  • 1Drug Safety R&D, Pfizer, Inc, CT, USA.

The Journal of Toxicological Sciences
|April 5, 2019
PubMed

Insights

Safety biomarkers are crucial for early drug development, aiding in monitoring organ toxicities like kidney and liver. Despite progress, gaps remain for other organs, necessitating further research and qualification for broader clinical trial application.

Area of Science:

  • Pharmacology
  • Toxicology
  • Biomarker Discovery

Background:

  • Translational safety biomarkers are essential for assessing drug safety in early clinical trials, particularly when therapeutic exposure margins are narrow.
  • While progress has been made in identifying biomarkers for kidney and liver toxicities, significant gaps persist for other organs such as the testis and pancreas.
  • Precompetitive consortia, including the Predictive Safety Testing Consortia (PSTC) and Innovative Medicines Initiative (IMI), are actively working to qualify biomarkers for broader use.

Purpose of the Study:

  • To discuss the complexities involved in the discovery, validation, and international regulatory qualification of novel safety biomarkers for clinical trial applications.
  • To highlight specific examples and insights from Pfizer Research and Development regarding safety biomarker implementation.
  • To emphasize the role of qualified safety biomarkers in accelerating drug development and facilitating therapeutic progression.

Main Methods:

  • Review of current landscape and challenges in safety biomarker development.
  • Discussion of precompetitive consortia efforts (PSTC, IMI) in biomarker qualification.
  • Presentation of case examples from pharmaceutical industry research (Pfizer R&D).

Main Results:

  • Progress in identifying and implementing safety biomarkers for certain organ toxicities (kidney, liver).
  • Identification of existing biomarker gaps for other critical organs (testis, pancreas).
  • Emphasis on the collaborative efforts of industry, academia, and regulatory bodies in biomarker qualification.

Conclusions:

  • Qualified safety biomarkers are increasingly vital for early clinical trials, enhancing decision-making processes.
  • The acceptance and qualification of safety biomarkers by regulatory agencies will accelerate the progression of promising therapeutics.
  • Addressing biomarker gaps and fostering collaborative efforts are key to advancing drug safety assessment.
Keywords:
Biomarker qualificationClinical translationSafety biomarker

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