IDSA/PhRma/FDA Working Group Meeting 
November 19-20, 2002

• Agenda
• Minutes Day1 and Day 2

IDSA/PhRma/FDA Working Group Mtg. Presentations:

1. Clinical Trials of Anti-Infectives for Highly Resistant Microorganisms by Richard P. Wenzel, M.D., M.Sc.
2. Drug Development for Resistant Pathogens by Francis P. Tally, M.D.
3. Developing Drugs for the Treatment of Infections due to Resistant Pathogens by Edward Cox, M.D., M.P.H.
4. Use of PK/PD to Facilitate Development of Drugs for Treatment of Resistant Pathogens by William A. Craig, M.D.
5. Use of PK/PD to Facilitate Development of Drugs for Treatment of Resistant Pathogens by James A. Poupard, Ph.D.
6. Exposure-Response: Application to Antimicrobial Drug Development by Philip Colangelo, Pharm.D., Ph.D
7. Antibiotic Resistance: Incentives for Antimicrobial Development by Mark J. Goldberger, M.D., M.P.H.
8. Incentives in Drug Development Biotech View by Frank Tally, M.D.
9. Regulatory and Other Incentives for Antibiotic Development by David M. Cocchetto, Ph.D.
10. Issues regarding non-Inferiority margins in Clinical Trials by George H. Talbot, M.D.
11. Non-Inferiority Margins: Implications, Challenges, and Opportunities by Christy Chuang-Stein, Ph.D.
12. Issues in Selection of Deltas in Non-Inferiority Trials by John H. Powers, M.D.
13. Bacterial Meningitis by John S. Bradley, M.D.
14. Clinical Trials in Acute Bacterial Meningitis by Roger M. Echols, M.D.
15. Antimicrobial Drug Development for Acute Bacterial Meningitis by Imo Ibia, M.D., M.P.H.
16. Are Antibiotics Useful in Exacerbations of Chronic Bronchitis? by JV Hirschmann, M.D.
17. Clinical Trials in AECB by Roger M. Echols, M.D.
18. Acute Exacerbation of Chronic Bronchitis - Issues in Drug Development by Susan D. Thompson, M.D.
19. Healthcare-Associated Pneumonia (HAP): Issues for Clinical Trials by Donald E. Craven, M.D.
20. Issues in Antibacterial Clinical Trials for Nosocomial Pneumonia by Richard Gesser, M.D.
21. Hospital Acquired Pneumonia (HAP) by Sary Beidas, M.D.

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