This workshop pertains to the development of rabies monoclonal antibody products to be used in conjunction with licensed rabies vaccine as part of a rabies post-exposure prophylaxis (PEP) regimen. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders on various aspects of development efforts pertaining to animal models, laboratory assays, and clinical trials. The input from this public workshop will also help FDA in developing topics for future discussion.
Monday, July 17, 2017
8:30 a.m. to 5:00 p.m.
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 Public Meetings at the FDA White Oak Campus
To register electronically, please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone by July 12, 2017 to RabiesWorkshop2017@fda.hhs.gov. 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. 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, midnight Eastern Time. If selected for presentation, any presentation materials must be emailed to RabiesWorkshop2017@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.
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.
The agenda, speaker slides and other meeting materials will be posted and/or updated 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. Transcripts will be posted here approximately 45 days after the workshop.
- Rabies Workshop Final Panel Questions (PDF - 114KB)
- Rabies Workshop Final Agenda (PDF - 140KB)
- Rabies Workshop Affiliations and Disclosures (PDF - 19KB)
- Transcript: Monday, July 17, 2018 (PDF - 776KB)
- Connelly, Sarah, MD. Opportunities and Challenges for Development of Monoclonal Antibodies for Use in Rabies Post-Exposure Prophylaxis
- Taylor, Louise. GARC. Rabies Epidemiology and Vectors
- Dorothy, Scott, MD. Scientific Basis for Approval of Human Rabies Immune Globulin in Combination with Rabies Vaccine
- Wilde, Henry, MD. Worldwide Rabies Deaths
- Sparrow, Erin. Rabies monoclonal antibodies WHO Perspective
- Desai, Samir, RabiMabs A novel monoclonal antibody cocktail for post-bite prophylaxis against Rabies virus
- Gunale, Bhagwat, MD Rabies mAb for PEP: Clinical development experience
- Quiambao, Beatriz P.MD, Perspectives on Rabies mAb Development: Example from Academic experience
- Ellison, James, PhD. Use of Animal Models in Rabies Product Development
- Moore, Susan M.PhD, MS, HCLD(ABB), MT(ASCP)SBB Use of Serologic Assays in Rabies Product Development
- Bell, Tanvir, MD; Valappil, Thamban, PhD. FDA Perspective on Rabies mAb Clinical Trials Challenges
- Taylor, Holly.PhD, MPH Ethical Considerations in Rabies mAb Development