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             262 *   
         
        
             Tue, 8/4/2020,
                1:00 PM -
                2:50 PM  
         
        
            
            
                
                    Virtual 
                
             
         
     
    
        
            The FDA Complex Innovative Trial Design Pilot Program: Learning from Case Examples and Simulations for the Public Good — Topic Contributed Papers 
         
     
    
        
            Biopharmaceutical Section , ENAR, Section on Bayesian Statistical Science 
         
     
    
    
        
            Organizer(s): Dionne  L Price, Food and Drug Administration 
         
     
    
    
        
            Chair(s): Dionne  L Price, Food and Drug Administration 
         
     
    
                    
                        
                            1:05 PM 
                         
                        
                            An Overview of Innovative Designs and Statistical Considerations: Lessons Learned 
                            
                             
                            Laura Lee  Johnson, FDA  
                         
                     
                
                    
                        
                            1:25 PM 
                         
                        
                            A Bayesian Adaptive Trial in Duchenne Muscular Dystrophy 
                            
                             
                            Stephen   Lake, WAVE Life Sciences ; Melanie  Quintana, Berry Consultants; Scott  Berry, Berry Consultants; Jennifer  Panagoulias, Wave Life Sciences; Michael A. Panzara, Wave Life Sciences 
                         
                     
                
                    
                        
                            1:45 PM 
                         
                        
                            The Design, Challenges, and Benefits of Evaluating Multiple Assets and Disease Types in a Master Protocol 
                            
                             
                            JonDavid  Sparks, Eli Lilly and Company ; Saptarshi  Chatterjee, Eli Lilly and Co; Karen L Price, Eli Lilly and Company 
                         
                     
                
    
        2:05 PM
     
    
        Floor Discussion