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  4. Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States - 11/18/2019
  1. FDA Meetings, Conferences and Workshops

Workshop | In Person

Event Title
Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States
November 18 - 19, 2019

Date:
November 18 - 19, 2019

Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States public workshop Nov. 18-19, 2019

Date / Time:

  • Monday, November 18, 2019 8:30 AM – 5:30 PM EDT
  • Tuesday, November 19, 2019 8:30 AM – 1:00 PM EDT
  • Registration will be from 7:30AM - 8:30AM on both days

 
Cosponsors: U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), the Infectious Diseases Society of America (IDSA), the National Institute of Allergy and Infectious Diseases (NIAID) and The Pew Charitable Trusts (Pew)
 
Summary: The FDA, IDSA, NIAID and Pew are co-sponsoring this workshop to focus on Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States. This workshop will bring together a diverse array of subject matter experts in the fields of infectious diseases (ID), academics and industry and other government bodies to better understand the current state of U.S. based ID trials and how to enhance enrollment and research in such trials.
 
Main Goals/Objectives:

  • Review current state of antibacterial drug development  
  • Obtain stakeholder perspectives on what data would be informative from development programs for new antibacterial drugs
  • Evaluation of strategies to support generation of the desired data from antibacterial drug development programs
    • The role of novel endpoints
    • The role of novel statistical methods (e.g., Bayesian analytical techniques)
    • Ways to facilitate clinical trial conduct (e.g., enhancing enrollment, clinical trial networks)
    • Role of scientific journals in the dissemination of information/publication of data
    • Timely and regular updates of guidelines as new data emerge

 
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 November 14, 2019. Onsite registration will begin at 7:30 am the day of the meeting. Please plan to arrive 30 minutes prior for security processing.
 
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

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 November 6, 2019. 

All requests to make oral presentations must be received by the close of registration on November 1, 2019.  If selected for presentation, any presentation materials must be emailed to ONDPublicMTGSupport@fda.hhs.gov no later than November 12, 2019.  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 avaliable online by webcast at the following link: https://collaboration.fda.gov/nov2019/
 
If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
 
Webcast Recordings:

Day 1

Day 2


Transcripts:

Event Materials

Title File Type/Size
Speakers and Panelists pdf (64.80 KB)
NIH PEW Agenda pdf (185.75 KB)
Day 1_Albrecht pdf (1.64 MB)
Day 1_Baden pdf (1.00 MB)
Day 1_Bart pdf (617.68 KB)
Day 1_Boucher pdf (368.12 KB)
Day 1_Cosgrove pdf (320.49 KB)
Day 1_Dixon pdf (903.45 KB)
Day 1_Duffy pdf (1.36 MB)
Day 1_Farley pdf (125.74 KB)
Day 1_Kim pdf (564.38 KB)
Day 1_Leitman pdf (1.20 MB)
Day 1_Luthy_Formal Public Comment pdf (1.18 MB)
Day 1_Nambiar pdf (469.71 KB)
Day 1_Outterson pdf (689.34 KB)
Day 1_Sears pdf (736.18 KB)
Day 2_Dane.pdf pdf (451.06 KB)
Day 2_Evans_Stats pdf (1.16 MB)
Day 2_Fowler pdf (2.69 MB)
Day 2_Lewis pdf (582.91 KB)
Day 2_Rex_Morning pdf (256.82 KB)
Day 2_Rex_Wrap Up pdf (121.11 KB)
Day 2_Rubin pdf (130.31 KB)
Day 2_Tenaerts pdf (653.81 KB)
Day 2_Uchea pdf (1.17 MB)
Day 1: FDA-IDSA-NIH-Pew Public Workshop pdf (8.81 MB)
Day 2: FDA-IDSA-NIH-Pew Public Workshop pdf (4.36 MB)
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