Development of New Tuberculosis Drug Regimens-Scientific and Clinical Design Considerations

The Food and Drug Administration is holding a public workshop regarding scientific and clinical trial design considerations for development of new tuberculosis drug regimens. This public workshop is intended to provide information for and gain perspective pertaining to development efforts around new in vitro and in vivo models, new biomarkers and tuberculosis diagnostics, assessing the contribution of 2 or more new components used in combination for to a tuberculosis regimen and clinical trial design challenges.

Dates and Times:

Wednesday, July 19, 2017 from 8:30 a.m. to 5:00 p.m. Eastern Time

Location:

The public 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

Registration:

To register, please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone to TuberculosisWorkshop2017@fda.hhs.gov by July 14, 2017. Registrants will receive confirmation when they have been accepted. Persons without access to the Internet can call 301-796-1300 to register. Onsite registration on the day of the meeting will be provided 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. 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 July 11, 2017. All requests to make oral presentations must be received by July 10, 2017. If selected for presentation, any presentation materials must be emailed to TuberculosisWorkshop2017@fda.hhs.gov no later than July 13, 2017. 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 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.

Streaming Webcast:

This public workshop will also be Webcast at the following Web site: https://collaboration.fda.gov/tbdd071917.

If you have never attended a Connect Pro event before, please 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.

Meeting Materials:

The agenda, speaker slides and other meeting material will be posted here prior to the workshop. Please note that only printed copies of 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.

• TB Workshop Final Agenda (PDF - 152 KB)
• TB Workshop Panel Questions (PDF - 33 KB)
• TB Workshop Panel Affiliations and Disclosures (PDF - 21 KB)
• TB Transcript (PDF - 1.5 MB)

Webcast Recordings:

• https://collaboration.fda.gov/p1dzg8gom43/
• https://collaboration.fda.gov/p75pcx2ohdb/
• https://collaboration.fda.gov/p3c646glme0/
• https://collaboration.fda.gov/p9o3eauvesc/

Transcripts:

Transcript (PDF - 10.33MB)

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Presentations

• LoBue, Philip, MD. Landscape and Important Challenges
• Bansbach, Cathy, PhD. The TB Drug Landscape and Challenges
• Lessem, Erica. Need and Accessibility of New TB Drug Regimens
• Nuermberger, Eric, MD. What’s New in Pre-Clinical Tools Used for Evaluation of New Components of TB Regimens
• Peloquin, Charles, Pharm.D. Assessing Pharmacokinetics in Clinical Studies
• Nahid, Payam, MD, MPH. TB Biomarkers and Clinical Utility
• Schito, Marco. Approaches to Tuberculosis Diagnostics
• Hanna, Debrah. Critical Path to TB Drug Regimens Role in Facilitating TB Drug Development
• Wallis, Robert, MD, FIDSA, FRCPE. Month 2 culture and duration as predictors of TB relapse
• Higgins, Karen, Sc.D. Regulatory Overview of Adequate and Well-Controlled Studies in TB Regimen Development
• Spigelman, Mel. Approaches to TB Drug Development: (Past, Present, and Future)
• Wells, Charles, MD. Approaches to TB Drug Development :An Industry Perspective
• Vernon, Andrew. Tuberculosis Trials Consortium (TBTC): CDC Experience
• Starke, Jeffrey, MD. Trial Design Considerations in Pediatric Trials of Antituberculosis Drugs
• Lienhardt, Christian, MD, PhD. Lessons Learned from Completed TB Trials and Implications for Future Trials