Drugs

CDER Biomarker Qualification Case Studies

These fictional case studies are part of an educational series on qualifying biomarkers for use in drug development, including the Biomarker Qualification Program. The case studies are intended to help patients, patient advocacy groups, health professionals, small businesses, and pharmaceutical and clinical innovators learn more about the role of biomarkers and biomarker qualification in drug development. They provide “real-world” examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies, and patient advocates to qualify innovative biomarkers.

Biomarker Qualification—Developing and Obtaining Regulatory Acceptance of a New Biomarker

FDA Case Study 1

A researcher discovers a promising biomarker of drug-induced kidney injury in rats. His results suggest the biomarker might be useful for monitoring drug-induced kidney injury during clinical trials of new drugs. This case study explores how he partnered with researchers and engaged with FDA early in the biomarker development process to get the data to support biomarker qualification.

Learning Objectives:

  • Understand the role of biomarker qualification in drug development.
  • Understand the validation studies necessary to support the qualification of a biomarker for use in drug development.
  • Understand the collaborative efforts involved in qualification of a biomarker for a specific context of use.

Download the Biomarker Qualification—Developing and Obtaining
Regulatory Acceptance of a New Biomarker
case study (PDF - 944 KB).

Biomarker Qualification—Collaborative Effort to Qualify a Drug Development Tool

FDA Case Study 2

When a woman’s husband is diagnosed with osteoporosis, she sets out to learn how she can help. This case study follows her as she works with other patient advocates, researchers, and FDA to qualify a biomarker that will make clinical trials on new osteoporosis drugs more efficient. Along the way, she learns about the Biomarker Qualification Program and speaks to patients, advocacy groups, and drug developers about the potential of biomarkers to improve the drug development process.

Learning Objectives:

  • Understand the potential benefits of biomarker qualification in drug development.
  • Understand the collaborative efforts involved in the qualification of a biomarker and the role that patient advocates can play in the process.

Download Biomarker Qualification—Collaborative Effort to Qualify a Drug Development Tool case study (PDF - 186 KB).

Page Last Updated: 06/16/2017
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