- August 20 - 21, 2018
Summary:The Food and Drug Administration is holding a public workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections." The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.
Date and Time: The public workshop will be held on August 21, 2018 from 8:30 a.m. to 4:30 p.m and August 22, 2018 from 8:30 a.m. to 12 p.m.
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
Registration: To register, please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone to NonTraditionalTherapiesWorkshop2018@fda.hhs.gov by August 14, 2018. Registrants will receive email 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 or request time for a joint presentation. 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 August 10, 2018. All requests to make oral presentations must be received by the close of registration on August 6, 2018. If selected for presentation, any presentation materials must be emailed to NonTraditionalTherapiesWorkshop2018@fda.hhs.gov no later than August 14, 2018. 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 site: https://collaboration.fda.gov/dcontpfbi/ 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.
Meeting Materials: The agenda, speaker slides and other meeting material will be posted here a few days 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.
Webcast Recordings: A recording(s) of the workshop will be posted here shortly after the completion of the workshop.
Part 1: https://collaboration.fda.gov/p69g5de97gc/
Part 2: https://collaboration.fda.gov/p22sr2fhdj0/
Part 3: https://collaboration.fda.gov/p6ftughm30s/
Part 4: https://collaboration.fda.gov/p4fim5gr7o4/
Transcripts: Transcripts will be posted here approximately 45 days after the workshop.
Day 1 Non Traditional Therapies: Transcript
Day 2 Non Traditional Therapies: Transcript
Public Comment Slides
- Grint, Dr. Paul Unique Challenges Transitioning from Preclinical to Clinical Development with Self-replicating Antibacterials
- Lajaunias, S. CAL02: A BROAD-SPECTRUM ANTI-TOXIN AGENT; Combioxin
- Leininger - Aridis - Public Comments
- Mannino, R. Matinas Development of Non-Traditional Therapies for Bacterial Infections
- Wagner, EnBiotix Linear Peptide Antibiotics
General Presentation: Session 1
- Rex, J. Outterson, K. Development of Non-Traditional Therapies for Bacterial Infections
- Wei, X. Development of Non-Traditional Therapies for Bacterial InfectionsClinical Pharmacology Considerations
- Suvarna, K. Microbiology Considerations in the Development of Nontraditional Therapies for Bacterial Infections
- McMaster, O. Development of Non-Traditional Therapies for Bacterial Infections Pharmacology and Toxicology considerations
- Boucher, H. Nontraditional Therapies:A Clinicianâs Perspective
General Presentation: Session 2
- Ghosh, M. Drug X-1: Hypothetical case of a monoclonal antibody for prevention of a bacterial disease
General Presentation: Session 3
- Rex, H. Z-3: Reducing risk of infection due to an MBL-producing organism by preventing acquisition of same
- Gopinath, R. Drug Z-2 for Prevention of C. difficile Infection by Minimizing Disruption of the Gut Microbiome