• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Infectious Diseases Society of America/International Society of Anti-Infective Pharmacology/ Food and Drug Administration Co-Sponsored Antimicrobial Drug Development Workshop

Thursday April 15, 2004

 

9:00 a.m.                     Opening Remarks

Moderator: John E. Edwards, Jr., M.D. (UCLA School of Medicine) 

 

I.        Progress Report Since Last Workshop 

 

9:05 a.m.                           IDSA 

                                                Speaker: W. Mike Scheld, M.D. (University of Virginia

Health System)

9:20 a.m.                           FDA

                                                Speaker: Edward Cox, M.D., M.P.H.

 

9:35 a.m.                     Discussion

 

II.      Continuing Discussion on Incentives for Drug Development

 

9:45 a.m.                           IDSA 

                                                Speaker: George Talbot, M.D. (Talbot Advisors LLC)

 

10:00 a.m.                        FDA

Speaker: Mark Goldberger, M.D., M.P.H.

 

10:15 a.m.                   Discussion

 

10:45 a.m.                   Break

 

 

III.     Microbiologic Surrogate Endpoints in Clinical Trials

 

11:00 a.m.                      IDSA 

Speaker: Sheldon Kaplan, M.D. (Baylor College of 

Medicine)

11:15 a.m.                   INDUSTRY

            Speaker: Barry Eisenstein, M.D. (Cubist Pharmaceuticals)

11:30 a.m.                      FDA

                                                Speaker: John Powers, M.D.

 

11:45 a.m.                   Discussion

 

12:45 p.m.                   Lunch 

 

 

IV.          Discussions about Bacteremia as an Indication/Issues with

Clinical Trials in Endocarditis

 

1:45 p.m.                          IDSA 

                                                Speaker: Ralph Corey, M.D. (Duke University)

2:00 p.m.                        INDUSTRY

            Speaker: Tim Henkel, M.D. (Vicuron)

2:15 p.m.                          FDA

Speaker: Dave Ross, M.D., Ph.D.

 

2:30 p.m.                     Discussion

 

3:30 p.m.                     Concluding Remarks

Moderator: John E. Edwards, Jr., M.D. (UCLA School of

Medicine)

  

Transcripts and slide presentations for this workshop will be posted at http://www.fda.gov/cder/drug/antimicrobial/default.htm

 

 

 

Friday April 16, 2004
Dose Selection in Antimicrobial Drug Development Incorporation of Pharmacokinetics and Pharmacodynamics

 

9:00 a.m.                     Opening Remarks

Moderator:      John E. Edwards, Jr., M.D. (UCLA School of Medicine)

9:05 a.m.                     Introduction 

                                                FDA:               John Lazor, Pharm.D.

 

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

 

9:20 a.m.                     Academic Perspective

                                                Speaker:          William A. Craig, M.D. (University of 

Wisconsin)

9:35 a.m.                     Industry Perspective

Speaker:          Mike Dudley, Pharm.D. (Diversa Corporation)

9:50 a.m.                     FDA Perspective

                                                Speaker:          John Powers, M.D.

 

10:05 a.m.                   Discussion

 

II. In Vitro/Animal Models to Support Dose Selection

 

10:15 a.m                    Academic perspective

                            Speaker:          Dave Andes, M.D. (University of Wisconsin)

10:30 a.m                    Industry perspective

                            Speaker:          Lisa Benincosa, Ph.D. (Pfizer Inc.)

10:45 a.m                    FDA perspective

                                   FDA Speaker: Chuck Bonapace, Pharm.D.

11:00 a.m                    Break

 

11:15 a.m.                   Discussion

 

12 noon                       Lunch

 

III. Current Status of Dose Selection in Antimicrobial Drug Development Programs

 

1:00 p.m.                     Academic Perspective

                                   Speaker:      George L. Drusano, M.D. (Albany Medical College)

1:15 p.m.                     Industry Perspective

                            Speaker:          Dennis Grasela, Pharm.D., Ph.D. (Bristol-Myers Squibb)

1:30 p.m.                     FDA Perspective

                                   Speaker:          Frank Pelsor, Pharm.D.

 

IV. Improvement in Dose Selections through Clinical Applications of PK-PD in

Antimicrobial Drug Development Programs

 

1:45 p.m                      Academic Perspective

Speaker:          Harmut Derendorf, Ph.D. (University of Florida )

2:00 p.m                      Industry Perspective

                                                Speaker:          Greg Winchell, M.D. (Merck)

2:15 p.m                      FDA Perspective

                                                Speaker:          Jenny J. Zheng, Ph.D.

 

2:30 p.m                      Discussion 

 

3:30 p.m                      Concluding Remarks

Moderator:      John E. Edwards, Jr., M.D. (UCLA School of Medicine)

 

Transcripts and slide presentations for this workshop will be posted at http://www.fda.gov/cder/drug/antimicrobial/default.htm