The Food and Drug Administration (FDA) is announcing this public workshop regarding the current state and further development of animal models for serious infections caused by Acinetobacter baumanii and Pseudomonas aeruginosa. FDA is conducting this workshop in order to facilitate the development of narrow-spectrum antibacterial drugs, such as those that are active against only a single species of bacteria that may not occur frequently. When the species occurs infrequently, performing clinical trials can be extremely challenging. Therefore, animal models of infection may be useful to explore the activity of a candidate antibacterial drug and may help to predict whether the drug will be efficacious in humans. A discussion of the additional scientific work needed to evaluate current animal models of infection and evaluate potential animal models that may predict response in humans could advance the development of antibacterial drugs targeting a single species. The input from this public workshop will also help in developing topics for future discussion. The Agency encourages health care providers, other U.S. Government Agencies, academic experts, contract research organizations, industry and other interested persons to attend this public workshop.
March 1, 2017, 8:30 AM to 5:00 PM
DoubleTree by Hilton Hotel Washington DC-Silver Spring, 8727 Colesville Rd, Silver Spring, MD 20910
Pinnacle Grand Ballroom (2nd floor)
Registration is free. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) to AnimalModelsInfectionWorkshop2017@fda.hhs.gov. Persons without access to the Internet can call 301-796-1300 to register. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability.
Requests for Oral Presentations:
During online registration you may indicate if you wish to present during a public comment session, and which topic(s) you wish to address. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. All requests to make oral presentations must be received by February 21, 2017. FDA will review all requests and will determine the amount of time allotted to each presenter and the approximate time each presentation is to begin. Participants will be notified of their selection on or before February 22, 2017. If selected for presentation, any presentation materials must be emailed to AnimalModelsInfectionWorkshop2017@fda.hhs.gov no later than February 27, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.
If further information is needed, please contact Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6221, Silver Spring, MD 20993-0002, 301-796-1300.
The agenda, speaker slides and other meeting material will be posted here prior to the workshop. Please note that only the agenda, affiliations and disclosures will be provided during the meeting. Please print/bring your own slides, as these will not be provided on the day of the meeting as printed copies.
- Agenda (PDF - 165KB)
- Panel Questions (PDF - 75KB)
- Panelist Affiliations and Disclosures (PDF - 42KB)
- Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa (PDF - 204KB) - Sumati Nambiar M.D. MPH
- Mouse Models for Antibacterial PK/PD (PDF - 1MB) - David Andes
- Pathogen-Specific, Novel Antibiotic for the Treatment of Infections due to P. aeruginosa in Patients with Nosocomial Pneumonia (PDF - 836KB) - Andreas Wallnöfer
- Animal Model Development In Barda’s Non-Clinical Network (PDF - 551KB) - David Boucher
- Rabbit Models of Pseudomonas Pneumonia (PDF - 551KB) - Binh Diep, Ph.D.
- Pathogenesis of Pseudomonas (PDF - 2MB) - Joanna B. Goldberg, Ph.D.
- Developing an Animal Model of Pneumonic Plague (PDF - 1.8MB) - Judy Hewitt, Ph.D.
- Development of a Non-Human Primate Model of Inhalational Tularemia (PDF - 378KB) - Julie A. Hutt, DVM, PhD, Dipl. ACVP
- Challenges with Clinical Trial Design for a Drug Targeting a Single Species of Bacteria:Acinetobacter baumannii (PDF - 1.8MB) - Robin Isaacs
- Mouse Model for Testing Therapeutics Against Pulmonary Pseudomonas Infection (PDF - 909KB) - Matthew Lawrenz
- Ventilated Pig Models of Pseudomonas aeruginosa Pneumonia (PDF - 909KB) - Gianluigi Li Bassi, M.D., Ph.D.
- Lessons Learned in Animal Model Development: Inhalational Anthrax (PDF - 547KB) - Gabriel Meister, Ph.D.
- NIAID Resources for Research and Development of Therapeutics and Animal Models (PDF - 1.5MB) - Tina Guina, Ph.D.
- Office of Antimicrobial Products Research Activities (PDF - 608KB) - Thushi Amini, Ph.D.
- Pathogenesis of Acinetobacter spp.: Resistance and Virulence Converge? (PDF - 2.6MB) - Robert A. Bonomo, M.D.
- Trial Design for Narrow-Spectrum Agents: Overview & Drug X-1 (PDF - 262KB) - John H. Rex, M.D.
- Current State and Further Development of Animal Models of Serious Infections Caused by A. baumannii and P. aeruginosa: A Clinician’s Perspective (PDF - 990KB) - Helen W. Boucher, M.D. FACP, FIDSA
- Animal models to test the safety and efficacy novel antibacterials against Acinetobacter baumannii (PDF - 14MB) - Daniel V. Zurawski, Ph.D.
Public Comments/Presentations (11:40-11:55 AM):
- Establishment and validation of rodent pneumonia models with P. aeruginosa and A. baumannii at GSK (PDF - 190KB) - Jennifer Hoover
- Open Public Comments (PDF - 43KB) - William Weiss
- P. aeruginosa and A. baumannii Infection Models (PDF - 198KB) - Lynn Miesel
- Open Public Comments (PDF - 124KB) - Craig Rayner
In order to listen to the workshop remotely and follow along with the slides being presented, please use the following information below:
To start this meeting
1. Provide your number when you join the meeting to receive a call back. Alternatively, you can call one of the following numbers:
toll free: 1-855-828-1770
2. Join as a Participant. Please remember to mute your phones during the meeting, especially as some speakers will be presenting via WebEx.
3. Follow the instructions that you hear on the phone.
Cisco Unified MeetingPlace meeting ID: 749 312 237