Zika Virus in the Americas: an HHS Expert Consultation To

Zika virus in the Americas: an HHS expert consultation to accelerate the development of countermeasures March 28-29, 2016 5601 Fishers Lane Conference Center Rockville, MD, USA

Goals of the Consultation:  Review the current information about the epidemiology and natural history (including potential link to microcephaly and other fetal malformations), clinical manifestations, modes of transmission and pathogenesis of Zika virus.

 Identify critical gaps in knowledge, technologies, research infrastructure and regulatory oversight needed to address the current epidemic.

 Discuss strategies to accelerate the development of vaccines, diagnostics, therapeutics and novel vector control methods.

This consultation is supported by NIAID, NICHD, ASPR/BARDA, CDC and FDA within the U.S. Department of Health and Human Services (NIAID/NIH/HHS).

MONDAY, 28 MARCH 2015, 12:00-18:30

11:00-12:00 Registration

OPENING REMARKS 12:00-12:30

Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health

Catherine Spong, M.D., Acting Director, National Institute of Child Health and Human Development, National Institutes of Health

Nicole Lurie, M.D., M.S.P.H., Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services

Beth P. Bell, M.D., M.P.H., Director, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention

Luciana Borio, M.D., Acting Chief Scientist, Food and Drug Administration

SESSION 1 Pathogenesis, Epidemiology, and Natural History Moderators: Name, Degree, Institution

12:30-12:50 Zika Virus Virology and transmission 1 Scott C. Weaver, Ph.D., University of Texas Medical Branch

12:50-13:10 Update of Zika Epidemic Lyle R. Petersen, M.D., Ph.D., Centers for Disease Control and Prevention

13:10-13:30 Epidemiology of Zika Infection and pregnancy in Brazil Federico Costa, Ph.D., Fiocruz,

13:30-13:30 Zika Infection with Neurological Outcome (Guillain-Barré Syndrome and Others) Jim J. Sejvar, M.D., Centers for Disease Control and Prevention

13:30-13:50 Clinical implications of Zika infection in pregnancy Peggy Honein, Ph.D., M.P.H., Centers for Disease Control and Prevention

13:50-14:05 Animal Models for Zika and Other Flaviviruses Pedro F.C. Vanconcelos, M.D., Ph.D., Instituto Evandro Chagas

14:05-14:20 Transmission Dynamics: Role of Asymptomatic Cases Thomas W. Scott, Ph.D., University of California, Davis

14:20-15:30 Pathogenesis, Epidemiology, and Natural History Panel Discussion  NICHD suggestions  Fernando Bozza, M.D., Ph.D., Fiocruz  Albert I. Ko, M.D., Yale School of Public Health  Ernesto T.A. Marquez, Jr., M.D., Ph.D., University of Pittsburgh  Duane J. Gubler, Sc.D., University of Hawaii, Mānoa  Erin Staples, M.D., Ph.D., Centers for Disease Control and Prevention  Sylvain Aldighieri, M.D., Pan American Health Organization

15:30-15:50 Break

SESSION 2 Vaccines Moderators: Name, Degrees, Institution

15:50-16:05 Flavivirus Vaccines: current status Thomas P. Monath, M.D., NewLink

16:05-16:20 Overview of Regulatory Considerations for Zika Vaccines Wellington Sun, M.D., FDA

16:20-17:50 Vaccines Panel Discussion  Barney Graham, M.D., Ph.D., National Institute of Allergy and Infectious Diseases  Stephen S. Whitehead, Ph.D., National Institute of Allergy and Infectious Diseases  Alexander R. Precioso, M.D., Ph.D., Instituto Butantan 2  Bruce Gellin, M.D., MPH, Director National Vaccine Program Office, HHS  Anvisa  SP and GSK

TUESDAY, 29 MARCH 2015, 08:30-17:00

SESSION 3 Diagnostics Moderators: Name, Degrees, Institution

08:30-08:50 Update on Existing Diagnostics for active infection and previous infections Robert S. Lanciotti, Ph.D., Centers for Disease Control and Prevention

08:50 -09:10 Blood Supply Monitoring Jay S. Epstein, M.D., Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

09:10-09:25 Diagnostics under Development Rosemary Humes, Biomedical Advanced Research and Development Authority

09:25-09:40 Regulatory Considerations Uwe Scherf, Ph.D., U.S. Food and Drug Administration

09:40-10:40 Diagnostics Panel Discussion  Jorge L. Muñoz-Jordán, Ph.D., Centers for Disease Control and Prevention  Michael S. Diamond, M.D., Ph.D., Washington University in St Louis  Industry  Ted C. Pierson, Ph.D., National Institute of Allergy and Infectious Diseases

10:40-11:00 Break

SESSION 4 Therapeutics Moderators: Name, Degrees, Institution

11:00- 11:15 Flavivirus Therapeutics: current status Pei Yong Shi, Ph.D., University of Texas Medical Branch

3 11:15 -11:30 Overview of Regulatory Considerations for Therapeutics – Especially Use of Therapeutics in Pregnancy Christine Nguyen, M.D., U.S. Food and Drug Administration

11:30-12:00 Therapeutics Panel Discussion  Justin Julander, Ph.D., Utah State University  Pharma

12:00-13:00 Lunch

SESSION 5 Vector Control Strategies Moderators: Name, Degrees, Institution

13:00-13:20 Utility of Traditional Vector Control Methods/ Current Limitations William Black, Ph.D., Colorado State University

13:20-14:40 Novel Approaches to Vector Control: Wolbachia and RIDL Luciano A. Moreira, Ph.D., FIOCRUZ

14:40-15:40 Vector Control Panel Discussion  Stephen L. Dobson, Ph.D., University of Kentucky  José M.C. Ribeiro, M.D., Ph.D., National Institute of Allergy and Infectious Diseases  Carolina V. Barillas-Mury, M.D., Ph.D., National Institute of Allergy and Infectious Diseases  Roberto Barrera, Ph.D., Centers for Disease Control and Prevention  Industry

15:40-16:00 Break

SESSION 6 Future Steps and Conclusion: What should HHS do in the immediate and longer term to accelerate research and development of countermeasures? Moderators: Name, Degrees, Institution

17:00 Meeting adjourns

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