Evidentiary Considerations for Integration of Biomarkers in Drug Development Symposium

Evidentiary Considerations for Integration of Biomarkers in Drug Development Symposium

On August 21st, the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI),
the U.S Food and Drug Administration (FDA), and the Critical Path Institute co-sponsored a symposium titled
“Evidentiary Considerations for Integration of Biomarkers in Drug Development” at the University of Maryland School of Pharmacy.

The objective of the symposium was to begin to define and ultimately codify the scientific and regulatory expectations
for the qualification of biomarkers.
Two types of biomarker were discussed:

  • Safety biomarkers
  • Biomarkers used for trial enrichment

The symposium format was designed to elicit participant feedback on defining evidentiary standards based on hypothetical
biomarker qualification projects with varying contexts of use.

The one-day symposium brought together leading scientists and researchers from industry, academia, and the FDA, and provided
a unique opportunity for participants to gain a greater perspective on biomarker development and application of biomarkers
in preclinical and clinical research. Topics covered included:

  • An overview of biomarkers in drug development
  • Biomarker qualification
  • Evidentiary considerations for biomarker utilization in drug development

Tom Benthin summarized the sessions graphically during the Symposium and you may view these images here .

Proceedings from the symposium are available here.


Agenda Presentation Videos

  • Welcome – Dr. James Polli and Dr. Natalie D. Eddington
  • Keynote Address – Dr. Janet Woodcock

Session 1: Overview of Biomarkers in Drug Development (Chair: Dr. Shashi Amur)

Session 2: Evidentiary Considerations for Clinical Safety Biomarkers (Chair: Dr. John-Michael Sauer)

Session 3: Evidentiary Considerations for Biomarker-Based Enrichment of Clinical Study Populations to Increase Efficacy or Safety of Drugs (Chairs: Dr. Klaus Romero and Dr. Arlene Chapman)

Session 4: Roundtable Discussion (CERSI/FDA)