Rapid Medical Countermeasure Response to Infectious Diseases Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships: Workshop Summary (2016) / Chapter Skim
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D Agenda
Pages 115-128
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From page 115... ...
With the 2013 emergence and persistence of the H7N9 pandemic influenza threat, the 2014 Ebola outbreak affecting West Africa and several countries around the globe, and a recent surge in cases of Middle East respiratory syndrome coronavirus (MERS-CoV) in the Middle East, the real and present danger of these emerging infectious diseases, which know no borders, are increasingly a national security issue.
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This workshop, hosted by the Forum on Medical and Public Health Preparedness for Catastrophic Events; the Forum on Drug Discovery, Development, and Translation; and the Forum on Microbial Threats, will bring together public- and private-sector stakeholders to discuss how to achieve rapid and nimble MCM availability for new and emerging threats. Discussions will include real-world case studies to elucidate how past events were handled from a policy, budget, and operational standpoint, and contribute to a better aggregate picture of what capabilities and resources are needed moving forward.
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• Discuss case studies of past incidents of emerging threats to under stand government and private-sector decisions and lessons learned. o Evaluate potential strategies for rapid availability of needed MCMs; examine the operational and business models required to enable post-event rapid development, translation, and response in terms of regulatory pathways, financing and market opportu nities, and the value proposition to private-sector partners.
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PARKER, Vice President, Public Health Preparedness and Response, Texas A&M Health Science Center 9:25 a.m. Panel Discussion: Rapid MCM Response as a National Security Imperative National Security: ANDREW C
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U.S. Preparedness Perspective: Sustainability and Threat Assessment NICOLE LURIE Assistant Secretary for Preparedness and Response Department of Health and Human Services
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Panel Discussion: Fast-Track Development of Ebola Vaccines and Testing: Reviewing Successes and Under standing Remaining Barriers to a "Rapid" Response in Real Time ROBIN ROBINSON, Director, Biomedical Advanced Research and Development Authority (BARDA) MARK FEINBERG, Vice President and Chief Public Health and Science Officer, Merck Vaccines MARION GRUBER, Director, Office of Vaccines Re search and Review, Center for Biologics Evaluation and Research, Food and Drug Administration WOUTER LATOUR, CEO, Vaxart THOMAS A
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o Were there components of the response that worked well compared to prior emerging threat situations? • How did the evolving ethical considerations in per forming clinical trials impact your decisions?
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Panel Discussion: Opportunities and Challenges in Pre paredness and Response to Pandemic Influenza Threats JACQUELINE KATZ, Deputy Director (acting) , Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC)
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Welcome and Introductions RICHARD HATCHETT, Workshop Co-Chair Chief Medical Officer and Deputy Director Biomedical Advanced Research and Development Au thority (HHS/ASPR/BARDA)
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outbreak. • Discuss the need for ongoing threat and risk assessments and impli cations for MCM development before an outbreak reaches public health emergency threshold.
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11:20 a.m. LUNCH SESSION V: Sustainability and Maintenance of Business Models to Ensure Rapid and Nimble Response to Emerging Threats of National Security Concern Session Objectives: • Discuss internal and external ideas to mounting a rapid response to emerging threats that are presented by current business models and public–private partnerships in other sectors.
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Panel Discussion: Lessons Learned from Sectors and Potential Future Strategies for Infectious Diseases of Na tional Security Concern (5-10 min each) JOE LARSEN, Deputy Director, Division of CBRN Medical Countermeasures, Biomedical Advanced Re search Development Authority (BARDA)
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BREAK 2:30 p.m. Response Panel: Report Out from Discussions -- Common Elements and Priorities Identified Across Threats Evaluate potential strategies in terms of regulatory pathways, financing and market opportunities, and value proposition to private-sector partners.
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Discussion with Attendees: Potential Discussion Questions: • How can we create policies to support MCM devel opment across threat levels, countermeasure types, and funding cycles? • How can business models be created to engage the private sector and maintain interest of stakeholders across the MCM response spectrum?
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