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U.S. Department of Health and Human Services

Animal & Veterinary

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Agenda - Pre-Approval Studies in Antimicrobial Resistance and Pathogen Load, February 22 – 24, 2000

February 22, 2000

Session 1: Objectives and background information

Chair: C. Lathers

8:00 Registration

8:30 Welcome; outline purpose and objectives of workshop [S. Sundlof]

8:45 Antibiotic use in ruminants - An Overview [G. Riddell]

9:05 Antibiotic use in poultry - An Overview [D. Wages]

9:25 Antibiotic use in swine - An Overview [R. Morrison]

9:45 Antibiotic use in aquaculture - An Overview [R. MacMillan]

10:05 Break

10:30 Antimicrobial drug discovery and development [J. Watts]

11:00 Antimicrobial new animal drug applications - Review process overview [D. Benz]

11:30 "558.15" studies: A historical perspective [J. Cooper]

12:00 Lunch (on your own)

Session 1 (continued)

1:00 Pre-approval assessment of microbial safety - General concepts [B. Flynn]

1:45 Resistance and pathogen load - Factors to consider [D. White]

2:30 Open Comment Period [Facilitator: J. Heslin]

3:00 Break


Session 2:
Study concepts for modeling resistance development and/or pathogen load changes

Chair: [D. White]

3:15 Introduction [D. White]

3:25 Use of animal studies [K. Ewert]

4:00 Review of an animal study and its relevance [D. Mevius]

4:35 Use of pharmacokinetics/pharmacodynamics [M. Papich]

5:15 Open Comment Period [Facilitator: J. Heslin]

5:30 Adjourn


February 23, 2000

Session 2 (continued):

Study concepts for modeling resistance development and/or pathogen load changes

8:30 Use of in vitro studies [S. Kotarski]

9:00 In vitro antimicrobial susceptibility data: Points to consider [T. Shryock]

9:25 Use of mathematical models [M. Lipsitch]

10:05 Break

10:30 Modeling changes in pathogen load [P. Cray]

11:15 Study concepts panel [K. Ewert, D. Mevius, M. Papich, T. Shryock,
S. Kotarski, M. Lipsitch, P. Cray, R. Singer]

  • Panel comments on questions/issues for breakout sessions
11:55 Open Comment Period [Facilitator: J. Heslin]
  • Questions for panel, comments, suggestions, and/or additional concepts
  • Additional questions for consideration by breakout groups
12:25 Description of afternoon breakout group process [A. Sindelar]
Questions for consideration by breakout groups:
  1. What are the positive aspects of study concepts presented What are the limitations Can the approach predict resistance development Can it predict changes in pathogen load
  2. What role could the various types of data play in evaluating microbial effects
  3. What factors should be considered when modeling resistance development and pathogen load changes in the Breakout Group species of interest
  4. What pathogen(s) should be the focus of pre-approval studies How should the appropriate pathogen(s) be selected Should surrogate organisms be used
5. Are there other alternative approaches/concepts that have not been considered
12:30 Lunch (on your own)


Session 3: Breakout group discussions (convene in breakout rooms)

2:00 Breakout sessions (according to following categories of food-producing species):
  • A. Ruminants: Regency Room [Moderator: G. Riddell]
  • B. Avian: Montrose Room [Moderator: D. Wages]
  • C. Monogastrics: Twinbrook Room [Moderator: R. Morrison]
  • D. Aquatics: Randolph Room [Moderator: R. MacMillan]

3:30 Break

4:00 Breakout groups (continued)

5:30 Adjourn


February 24, 2000

Session 3: Breakout group discussions (continued)

(convene in breakout rooms)

8:30 Breakout groups (continued)

10:00 Break

10:30 Breakout groups (continued)

12:00 Lunch (on your own)


Session 4: Discussion on breakout group summaries (convene in main meeting room)

Chair: [S. Thompson]

1:00 Spokesperson Panel [G. Riddell, D. Wages, R. Morrison, R. MacMillan]
  • Presentation of breakout group summaries
2:30 Open Comment Period [Facilitator: J. Heslin]
  • Comments on group summaries/additional perspectives

3:15 Next steps/closing comments [S. Thompson]

3:45 Adjourn Workshop