Section: Wednesday, May 27, 2015; 10:30 AM - 12:00 PM | EPI 260: Development and Approval of Drugs and Devices (Spring 2015)

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Activity since Wednesday, July 15, 2026, 4:45 AM

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Section outline

Discussion Seminar: Use of biomarkers in clinical development
The use of diagnostic biomarkers and surrogate biomarkers in drug development will be covered. Review of case studies of how these different types of biomarkers have been utilized in drug development.

Faculty: June Lee

Location: Mission Hall 1106
- Select activity Session Slides:
  
  Session Slides:
- Select activity Biomarker Lecture 2012 Final
  
  Biomarker Lecture 2012 Final File
- Select activity Session Audio/Video Recording (Access restricted t...
  
  Session Audio/Video Recording (Access restricted to registered students):
- Select activity Required Reading:
  
  Required Reading:
- Select activity Buyse M, Michiels S, Sargent DJ, Grothey A, Matheson A, de Gramont A. Integrating biomarkers in clinical trials. Expert Rev Mol Diagn. 2011 Mar;11(2):171-82.
  
  Buyse M, Michiels S, Sargent DJ, Grothey A, Matheson A, de Gramont A. Integrating biomarkers in clinical trials. Expert Rev Mol Diagn. 2011 Mar;11(2):171-82. File
- Select activity Frank R, Hargreaves R. Clinical biomarkers in drug discovery and development
  
  Frank R, Hargreaves R. Clinical biomarkers in drug discovery and development File
  
  Not available unless: Your ID number contains 02
- Select activity Assignment: Homework Assignment for this lectur...
  
  Assignment:
  
  Homework Assignment for this lecture is due: May 27, 2015. Go to: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html and download two of the documents, one of which should be E6, and another of your choice. You should read them, and discuss how the guidelines might 1) protect patient safety and 2) protect data integrity

July 2026

Section outline