Virtual | Virtual
Event Title
Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea
April 23, 2021
- Date:
- April 23, 2021
- Time:
- 9:00 AM - 5:00 PM ET
DESCRIPTION/SUMMARY
This public workshop is currently being scheduled and planned as a virtual meeting. The Food and Drug Administration, NIAID and CDC are announcing the following public virtual workshop entitled "Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea." The purpose of the public virtual workshop is to discuss the nonclinical and clinical pharmacology data and clinical trial design considerations regarding developing antimicrobial drugs for the treatment of gonorrhea.
ABOUT THE PUBLIC WORKSHOP
FDA, NIAID and CDC are announcing a public workshop regarding the development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will focus on the current state and nonclinical and clinical trial design considerations regarding antimicrobial drug development for gonorrhea and include the following topic areas:
- Animal models
- Clinical pharmacology considerations
- Trial design considerations for gonorrhea, such as enrollment strategies, choice of comparators and site of infection.
REGISTRATION
This meeting will be held in virtual format only. Registration is required for online attendance and will be available until 5pm on April 21st, 2021
To register for this workshop, visit https://www.eventbrite.com/e/antimicrobial-drugs-for-the-treatment-of-gonorrhea-public-workshop-tickets-146615921167
MEETING MATERIALS
A full agenda will be available before the workshop. All other meeting materials, including speaker slides and transcripts, will be also available here before and after the workshop. Please visit this page for any updates and posting of materials before and after the meeting.
Presentations
Session 1
- Marrazzo, J. Gonorrhea Treatment Strategies: Needs & Emerging Data to Address Future Challenges (PDF - 622.91KB)
- Wi, TE. Antibiotic Resistant Gonorrhoea : Policy Consideration and Implication for Drug Development (PDF - 2.65MB)
- Bachmann, L. Treatment of Gonorrhea: Current State and Future Considerations (PDF - 1.68MKB)
- Unemo, M. and Drusano, G. Antimicrobial resistance in Neisseria gonorrhoeae (NG) and pharmacokinetic/pharmacodynamic (PK/PD) considerations (PDF - 2.29MB)
- Jerse, A. Animal models for pre-clinical testing of antibiotics against gonorrhea: Established and new models under development (PDF - 1.92MB)
- Hiltke, T. Preclinical efforts to support gonorrhea drug development (PDF - 1.2MB)
- Duffy, E. Funding Efforts to Support Gonorrhea Drug Development (PDF - 1.61MB)
- Reno, H. and McNeil, C. STI Clinic + Public Health Perspective (PDF - 1.47MB)
- Wang, S and Ofunseitan, O. Antibiotic-Resistant Gonorrhea Among Adolescents and Young Adults: Need for Early Education (PDF - 635.96KB)
Session 2
- Hiruy, H. Development of Antibacterial Drugs for Uncomplicated Gonorrhea: A Regulatory Perspective (PDF - 203.31KB)
- Sato, J. Development of Antimicrobial agents for Gonorrhea in Japan (PDF - 504.22KB)
- Botgros, R. EU Regulatory Perspectives on Development of Antibacterial Medicines for Gonorrhoea (PDF - 1.76MB)
- Cammarata, S. Overview of Drug Development Considerations for Uncomplicated Urogenital Gonorrhea a Tale of Two Recent Trials.(PDF - 167.01KB)
- Chaves, R. Development of novel drugs for NG: translational challenges (PDF - 806.52KB)
- Perry, C. Developers Perspective on Lessons Learned and Recent Challenges (PDF - 141.2KB)
- O'Brien, S. Development of treatments for gonorrhoea : Addressing the global public health need Current and future challenges (PDF - 485.69KB)
- Gelone, S. Development Considerations for a Syndromic Approach to Uncomplicated Urethritis/Cervicitis (PDF - 736.43KB)
- Hook, E. Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea: Investigator Perspectives (PDF - 143.65KB)
ONLINE ATTENDANCE (WEBCAST)
This meeting will be available for online viewing, on the day of the meeting via the following link: https://collaboration.fda.gov/cderond042321/
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
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EVENT POINT OF CONTACT
Lori Benner and/or Antoinette Ziolkowski, 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
Event Materials
| Title | File Type/Size |
|---|---|
| Agenda FDA-CDC-NIAID Virtual Public Workshop Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea | pdf (147.59 KB) |
| Speakers and Panelists: Affiliations and Disclosures - Developmental Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea | pdf (67.93 KB) |
| Sato_Session2 | pdf (504.22 KB) |
| Session2_Perry | pdf (141.20 KB) |
| Session2_O'Brien | pdf (485.69 KB) |
| Session_2_Hook | pdf (143.65 KB) |
| Session_2_Hiruy | pdf (203.31 KB) |
| Session_2_Gelone | pdf (736.43 KB) |
| Session_2_Chaves | pdf (806.52 KB) |
| Session_2_Cannarata | pdf (167.01 KB) |
| Session_2_Botgros | pdf (1.76 MB) |
| Session_1_Wi | pdf (2.65 MB) |
| Session_1_Unemo_Drusano | pdf (3.79 MB) |
| Session_1_Reno_McNeil | pdf (1.47 MB) |
| Session_1_PublicComment_SarahWang | pdf (635.96 KB) |
| Session_1_Marrazzo | pdf (622.91 KB) |
| Session_1_Jerse | pdf (1.92 MB) |
| Session_1_Hitke | pdf (1.20 MB) |
| Session_1_Duffy | pdf (1.61 MB) |
| Session_1_Bachmann | pdf (1.68 MB) |
| FDA GC Workshop Transcript April 23 2021 | pdf (447.12 KB) |