Clinical Pharmacology Subcommittee

Meeting Agenda for Nov 3-4, 2004

(Draft on 9/30)



Day 1


8:00                 Call to order and opening remarks                 


8:15                 Tribute to Dr. Lew Sheiner                            


8:30                 Update on previous meeting discussions,

Introduction to the topics of this meeting      


Topic 1           Pharmacogenetics of Irinotecan:  Scientific and Clinical Impact of UGT Polymorphism


9:00                 Introduction               


9:15                 Scientific perspectives           


9:45                 Additional scientific and clinical perspectives           


10:15               Break 


10:45               Clinical perspectives: utility of genotyping                


11:00               Committee discussion


12:00               Lunch


1:00                 Public Hearing



Topic 2:          Drug-Drug Interaction Concept Paper: Issues Related to CYP/Transporter- and Induction-Based Interactions and Multiple-Inhibitor Drug Interaction Studies


1:30                 Relevant principles of drug interaction

concept paper                                                


2:15                 Industry perspective                                      


2:45                 Induction-based interactions                          


3:15                 Multiple inhibitor Studies                               


3:30                 Break


4:00                 Committee discussion                                    



5:30                 Wrap-up of Day 1                                          

5:45                 Adjourn



Day 2


8:00                 Call to order and opening remarks                 


Topic 3             Transition of Biomarkers to Surrogate Endpoints: A New Critical Path Initiative


8:05                 Introduction to the topic, background and                

                        project plan                                                    


8:20                 Framing the issues, what needs to be done

and how?                                                        


9:05                 What are industry’s expectations of the project and process?                                                                                                                        

9:50                 Opportunities, challenges

and some ways forward – how can academia-

industry-government collaborations facilitate

the development of biomarkers and surrogates?                                                                                                                               


10:20               Break


10:50               Committee discussion


12:00               Summary of recommendation s                      


12:30               Public Hearing


1:00                 Adjourn