Advancing Animal Models for Antibacterial Drug Development March 5, 2020

Workshop | Mixed

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• Date: March 5, 2020
• Location: White Oak Campus: The Great Room; Conference Center; 10903 New Hampshire Ave; Building 31, Room 1503; Silver Spring, MD 20993; United States

Summary: The Food and Drug Administration is holding a public workshop entitled “Advancing Animal Models for Antibacterial Drug Development.” The purpose of the public workshop is to discuss progress and challenges in the development and advancement of various animal models for serious infection funded by FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA). This workshop is a follow up to the FDA public workshop held on March 1, 2017.

Date and Time: The public workshop will be held on March 5, 2020, from 8:30 AM. to 4:00 PM. Same day registration will be from 7:30 AM – 8:30 AM.

Location: The workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Building 31 Great Room, Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to Public Meetings at the FDA White Oak Campus

Main Goals/Objectives:

• Review the progress and challenges in the development of small and large animal models of serious bacterial infections funded by FDA, BARDA, and NIH.
• Understand the pharmacokinetic considerations in animal model development.
• Understand the role that animal models currently play in antibacterial drug development.
• Determine potential priorities for future research and development in this area.

Registration: Those who are interested in attending this public workshop either in-person or by web viewing must register here by 11:59 pm on March 2, 2020. Onsite registration will begin at 7:30 am the day of the meeting. Please plan to arrive 30 minutes prior for security processing.

Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions.

Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will select and notify participants by February 25, 2020.

All requests to make oral presentations must be received by February 21, 2020. If selected for presentation, any presentation materials must be emailed to ONDPublicMTGSupport@fda.hhs.gov no later than March 2, 2020. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

Contact: If further information is needed, please contact the OND Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov

Streaming Webcast: This public workshop will be available online by webcast at the following link: Animal Model Development Workshop

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Webcast Recordings:

• Webcast 1
• Webcast 2
• Webcast 3
• Webcast 4

Transcripts:

• Transcript (PDF - 5 MB)

Meeting Presentations

• Waack, Ursula, MS, PhD. Assessing Animal Models of Bacterial Pneumonia Used in Investigational New Drug Applications for the Treatment of Bacterial Pneumonia (PDF – 538 KB)
• Joshi, Abhay, PhD.  Pharmacokinetic Considerations in Advancing Animal Models for Antibacterial Drug Development  (PDF – 396 KB)
• Hewitt, NIAID, Preclinical Services at NIAID (PDF -728KB)
• Guina, Tina, PhD.  CARB-X Portfolio: Accelerating Innovation in Antibacterial Drug Development. (PDF – 762 KB)
• Miesel, Lynn, PhD. Development of a Murine Model of Pseudomonas aeruginosa Lung Infection (PDF – 565 KB)
• Luna, Brian, PhD Development and PK Challenges of a Murine Model for Acinetobacter baumannii infection (PDF – 3618 KB)
• Lawrenz, Matthew.  Mouse Model for Testing Therapeutics Against Pulmonary Pseudomonas Infection (PDF – 965KB)
• Hope, William  Development and PK Challenges of a Rabbit Meningocephalitis Model (PDF – 478 KB)
• Walsh, Thomas J. MD, PhD. Development and Challenges of a Rabbit Model System of Pneumonia (PDF – 2863 KB)
• Diep, Binh, PhD.  Development of Rabbit Models of Acute Pneumonia (Non-Ventilated) and Ventilator-Associated Pneumonia (PDF – 5941 KB)
• Phipps, Andrew DVM, PhD. Porcine Animal Model of Ventilator-Associated Bacterial Pneumonia Caused by Pseudomonas aeruginosa or Acinetobacter baumannii (PDF – 418 KB)
• Weinstein, Edward MD, PhD. Summary Remarks (PDF -236 KB)

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Event Materials

Title	File Type/Size
Federal Register Notice_2020-02159	pdf (274.12 KB)
WorkshopAgendaFinal2020_03_05	pdf (164.70 KB)
Waack_pdf	pdf (537.44 KB)
Joshi_pdf	pdf (395.60 KB)
Hewitt_pdf	pdf (727.12 KB)
Guina_pdf	pdf (761.28 KB)
Miesel_pdf	pdf (564.75 KB)
Luna_pdf	pdf (3.53 MB)
Lawrenz_pdf	pdf (964.90 KB)
Hope_pdf	pdf (477.93 KB)
Walsh_pdf	pdf (2.80 MB)
Diep_pdf	pdf (5.80 MB)
Phipps_pdf	pdf (417.83 KB)
Weinstein_pdf	pdf (235.01 KB)
Advancing Animal Models for Antibacterial Drug Development_March 5, 2020 Workshop Transcript	pdf (15.20 MB)
Speakers and Panelists	pdf (26.50 KB)