Draft Agenda – FDA/IDSA/ISAP Workshop
April 15, 2004

9:00                              Opening Remarks 

Progress Report Since Last Workshop  

9:00 – 9:15                         IDSA
                                                Speaker  = Mike Scheld (University of Virginia Health System)

9:15 – 9:30                         FDA
                                                Speaker = Ed Cox

9:30 – 9:45                                Discussion

Microbiologic Surrogate Endpoints in Clinical Trials

9:45 – 10:00                       IDSA
                                                Speaker  = Sheldon Kaplan (Baylor College of Medicine)

10:00  – 10:15                   INDUSTRY
                                                Speaker  = Barry Eisenstein (Cubist Pharmaceuticals)

10:15 – 10:30                    FDA
                                                Speaker  = John Powers

10:30 – 10:45                Break

10:45 – 12:00                Discussion

12:00 – 1:00                  Lunch

 Discussions about Bacteremia as an Indication/Issues with Clinical Trials in Endocarditis

1:15 – 1:30                         IDSA                                               
                                                Speaker  = Ralph Corey (Duke University)

1:30  – 1:45                        INDUSTRY
                                                Speaker  = Tim Henkel (Vicuron)

1:45 – 2:00                         FDA
                                                Speaker  = Dave Ross

2:00 – 3:15                    Discussion

3:15 – 3:30                    Break

 Continuing Discussion on Incentives for Drug Development

3:30 – 3:45                         IDSA
                                                Speaker  = George Talbot (Talbot Advisors LLC)

3:45 – 4:00                         FDA
                                                Speaker  = Mark Goldberger

4:30 – 4:55                    Discussion

4:55                               Concluding Remarks

 Draft Agenda – FDA/IDSA/ISAP Workshop
April 16, 2004

 Dose Selection in Antimicrobial Drug Development
Incorporation of pharmacokinetics and pharmacodynamics

 9:00                            Introduction – use of PK/PD in clinical development programs

                                    FDA = John Lazor

9:10 -                          I. Overview of use of PK-PD in streamlining drug development

15 minutes                   Academic Perspective
                                                Speaker  = Bill Craig (University of Wisconsin)

15 minutes                   Industry Perspective
                                                Speaker  = Mike Dudley (Diversa Corporation)

15 minutes                   FDA Perspective
                                                Speaker  = John Powers

15 minutes                   Discussion                                           

10:10 -                                                II. Current Status of Dose Selection in Antimicrobial Drug Development Programs

15 minutes                   Academic Perspective
                                                Speaker  = George Drusano (Albany Medical College)

15 minutes                   Industry Perspective
                                                Speaker  = Dennis Grasela (Bristol-Myers Squibb)

15 minutes                   FDA Perspective
                                                Speaker = Frank Pelsor

15 minutes                   Break

60 minutes                   Discussion

12:10 (1 hour)             Lunch

1:10 -                          II. In Vitro/Animal Models to Support Dose Selection

15 minutes                   Academic perspective
                                                Speaker = Dave Andes (University of Wisconsin)

15 minutes                   Industry perspective
            Speaker  = Amarnath Sharma (Pfizer, Inc.)

15 minutes                   FDA perspective
            FDA Speaker  = Chuck Bonapace

60 minutes                   Discussion

2:55 -                          III. Improvement in Dose Selections through Clinical
                                    Applications of PK-PD in Antimicrobial Drug Development Programs

15 minutes                   Academic Perspective
                                                Speaker  = Harmut Derendorf (University of Florida)

15 minutes                   Industry Perspective
                                                Speaker  = Greg Winchell (Merck)

15 minutes                   FDA Perspective
                                                Speaker  = Jenny Zheng

15 minutes                   Break

60 minutes                   Discussion

4:55 - 5pm                  Concluding Remarks and Adjournment

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Date created: April 1, 2004

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