- November 18-19, 2019
08:30 AM - 01:00 PM EST
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.
- 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
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. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview.
Webcast Recordings: Transcripts of the workshop will be posted here approximately 30-45 days after the completion of the workshop.
Transcripts: Transcripts of the workshop will be posted here approximately 30-45 days after the completion of the workshop.
The event materials, including the agenda will be added shortly. Please check back before the meeting for any updates.