Contemporary Designs for Early-Phase Clinical Trials

12:30 PM — 1:00 PM

Box Lunch Provided

1:00 PM — 2:35 PM

Model Based Methods

• Introduction
  Susan Halabi, PhD - Duke University Medical Center
  
  
• Case Presentation
  William K. Kelly, DO - Thomas Jefferson University
  
  
• Traditional Phase I Designs
  Gina Petroni, PhD - University of Virginia
  
  
• Model-Based Phase I Designs
  Xiabou Ye, MD, MS - Sidney Kimmel Comprehensive Cancer Center
  

2:35 PM — 2:45 PM

Break

2:45 PM — 5:00 PM

Partial Order and Adaptive Bayesian Methods

• Partial and Group Order Phase I Designs
  Mark Conaway - University of Virginia School of Medicine
  
  
• Practical Adaptive Bayesian Methods for Early Phase Clinical Trials
  Peter Thall, PhD - The University of Texas MD Anderson Cancer Center
  

7:00 AM — 7:30 AM

Continental Breakfast Provided

7:30 AM — 11:00 AM

Regulatory Perspective

• Biomarkers in Early Drug Development
  Sue-Jane Wang - U.S. Food and Drug Administration
  
  
• Innovative Designs: FDA Perspective
  Rajeshwari Sridhara, PhD - U. S. Food and Drug Administration
  
  
• Case Presentation
  William K. Kelly, DO - Thomas Jefferson University
  
  
• Panel Discussion on Phase I Trials