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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

REQUEST FOR ORAL PRESENTATIONS

During online registration you may indicate if you wish to present during the virtual 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. 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 April 13th, 2021. All requests to make oral presentations must be received by April 8th, 2021. If selected for presentation, any presentation materials must be emailed to [email protected] no later than  April 19th, 2021. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

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

Workshop Recording 

Transcript

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
To get a quick overview of the Connect Pro program, visit https://www.adobe.com/products/adobeconnect.html

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

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