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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Public Workshop - Agenda for the Development and Evaluation of Next-Generation Smallpox Vaccines

AGENDA

8:00-8:15Welcome and Overview of Meeting
Karen Midthun, M.D., Director, CBER
8:15-8:45Overview of Orthopoxviruses and the Diseases They Cause
Bernard Moss, M.D., Ph.D., Chief, Laboratory of Viral Diseases
NIAID/NIH

I. Regulatory Challenges for Next-Generation Smallpox Vaccines and the Animal Rule
Moderator: CAPT Tim Nelle, Ph.D.

8:45-9:15Considerations for Licensure of Next Generation Smallpox Vaccines
CAPT Tim Nelle, Ph.D., Team Leader, Regulatory Review Branch 2,
DVRPA/OVRR/CBER
9:15-9:45Live Variola Virus to Support Less Reactogenic Vaccine Development:
Continued Evaluation of "Third" Generation Vaccines

Inger K. Damon, M.D., Ph.D., Chief, Poxvirus and Rabies Branch, CDC
9:45-10:00BREAK
10:00-10:30Antibody Responses to Smallpox Vaccines
Stuart Isaacs, M.D., Associate Professor of Medicine,
University of Pennsylvania
10:30-11:00Assessment of the Effectiveness of Smallpox Vaccines: Immunogenicity Assay Considerations
Freyja Lynn, Consumer Safety Officer, Division of Bacterial, Parasitic
and Allergenic Products, OVRR/CBER
11:00-12:00PANEL:
Speakers - B. Moss, T. Nelle, I. Damon, S. Isaacs, F. Lynn
Drusilla Burns, Ph.D., Deputy Director, Division of Bacterial, Parasitic
and Allergenic Products, OVRR/CBER
Gerry R. Kovacs, Ph.D., Director, Division of CBRN Countermeasures,
BARDA/ASPR/HHS
12:00-1:00LUNCH

II. Animal Models of Orthopoxvirus Infection and Disease
Moderator: Inger K. Damon, M.D., Ph.D.

a. Non-Human Primate Models

1:00-1:30Variola Virus Challenge Models
Jennifer A. Cann, D.V.M., Ph.D., DACVP, Integrated Research Facility
NIAID/NIH
1:30-2:00NIAID Sponsored I.V. and Respiratory Models
Mark Challberg, Ph.D., Program Officer, Virology Branch NIAID/NIH
2:00-2:30Susceptibility of Marmosets (Callitrix Jacchus) to Monkeypox Virus
Eric Mucker, M.S., Ph.D. Candidate, Microbiologist, Viral Therapeutics
Department, USAMRIID
2:30-2:45BREAK

b. Rabbit/Rodent Models

2:45-3:15Development of Aerosol Animal Model for Rabbitpox in New Zealand White Rabbits
Aysegul Nalca, M.D., Ph.D., Chief, USAMRIID
3:15-3:45Mousepox (Ectromelia Virus) Challenge Model
R. Mark Buller, Ph.D., Professor, Department of Molecular Microbiology
and Immunology, St. Louis University School of Medicine
3:45-4:45PANEL:
Speakers - J. Cann, M. Challberg, E. Mucker, A. Nalca, M. Buller
Ed Nuzum, D.V.M., Ph.D., Chief, Biodefense Vaccines and Other
Biological Products Development Section, Office of Biodefense Research
Affairs, DMID/NIAID/NIH
Jerry P. Weir, Ph.D., Director, Division of Viral Products, OVRR/CBER
4:45-5:00Wrap-up and Recommendations
Norman Baylor, Ph.D., Director, Office of Vaccines Research and Review,
CBER