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

AGENDA

8:00-8:15	Welcome and Overview of Meeting Karen Midthun, M.D., Director, CBER
8:15-8:45	Overview 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.

8:45-9:15	Considerations for Licensure of Next Generation Smallpox Vaccines CAPT Tim Nelle, Ph.D., Team Leader, Regulatory Review Branch 2, DVRPA/OVRR/CBER
9:15-9:45	Live 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
9:45-10:00	BREAK
10:00-10:30	Antibody Responses to Smallpox Vaccines Stuart Isaacs, M.D., Associate Professor of Medicine, University of Pennsylvania
10:30-11:00	Assessment of the Effectiveness of Smallpox Vaccines: Immunogenicity Assay Considerations Freyja Lynn, Consumer Safety Officer, Division of Bacterial, Parasitic and Allergenic Products, OVRR/CBER
11:00-12:00	PANEL: 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
12:00-1:00	LUNCH

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

a. Non-Human Primate Models

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

b. Rabbit/Rodent Models

2:45-3:15	Development of Aerosol Animal Model for Rabbitpox in New Zealand White Rabbits Aysegul Nalca, M.D., Ph.D., Chief, USAMRIID
3:15-3:45	Mousepox (Ectromelia Virus) Challenge Model R. Mark Buller, Ph.D., Professor, Department of Molecular Microbiology and Immunology, St. Louis University School of Medicine
3:45-4:45	PANEL: 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
4:45-5:00	Wrap-up and Recommendations Norman Baylor, Ph.D., Director, Office of Vaccines Research and Review, CBER