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