AGENDA
March 26-27, 2015
Room 125 of the National Academy of Sciences Building
2101 Constitution Avenue, NW, Washington, DC 20418
Enabling Rapid Response and Sustained Capability
with Medical Countermeasures to Mitigate Risk of Emerging
Infectious Diseases:
An Institute of Medicine Workshop
Background:
Ensuring ready access to medical countermeasures (MCMs) for emerging infectious diseases such as pandemic influenza has been an issue accumulating national attention. 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. As the National Health Security Strategy states, “As the movement of people, goods, and services across borders increases, our national health security is increasingly dependent on global health security.” Though similar in some ways to intentional biological threats like anthrax, these naturally occurring threats present a unique challenge to the medical countermeasures enterprise given the persistent, dynamic,
and unpredictable nature of their epidemiological trajectories. Traditional means of risk assessment and mitigation may require novel approaches. Is rapid response with MCMs a reality now or in the future, if the MCM is not already in advanced development or available in stockpiles? Are public–private partnerships well positioned to respond in a timely manner?
Current operational and business models to build and sustain this capability are limited. Secure multiyear markets, a fundamental tenet of the public–private partnership for MCM advanced development and acquisition programs for intentional CBRN (chemical, biological, radiological, and nuclear threats) (e.g., Project BioShield), and the initial phase of pandemic preparedness have been dramatically reduced. In a Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) now dependent on annual appropriations, and with limited funding to support rapid response as evidenced in 2014 with the Ebola outbreak, these models face new challenges. PHEMCE in 2009 proposed new strategies and approaches to MCM development. However, it did not solve all challenges, and recent decreases in funding and shifts to annual appropriations may prove to negate some initial successes. Between events such as H1N1 influenza outbreaks, mission capabilities need to be sustained so capacity is not lost when the next event emerges. Additionally, many regulations and policies have been developed in response to past events, instead of looking forward to potential future needs and creating capabilities and partnerships in a systematic manner.
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.
Meeting Objectives:
- Discuss the nation’s capacity to provide rapid access to MCMs for EIDs (emerging infectious diseases), delineate preparedness gaps, and identify activities required by all stakeholders to improve capabilities.
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- Consider the impact of the current fiscal environment and reasonable expectations.
- Examine the sustainability of public–private partnerships.
- Examine the role of MCMs for emerging infectious disease threats as a national security issue.
- Discuss the ethical, economic, and global dimensions of these threats and the public–private partnerships required to establish robust capabilities.
- Discuss case studies of past incidents of emerging threats to understand government and private-sector decisions and lessons learned.
- 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 opportunities, and the value proposition to private-sector partners.
- Discuss the integration of One Health efforts into ongoing threat assessments prior to a declared emergency.
- Consider how to operationalize next steps for the public and private sectors to coordinate a more rapid and nimble response to global emerging threats.
- Discuss common elements across a range of threats.
- Consider the sustainability of business models to keep stakeholders invested.
March 26, 2015
8:30 a.m. | Welcome and Introductions: Workshop Co-Chairs |
RICHARD HATCHETT | |
Chief Medical Officer, Deputy Director Biomedical Advanced Research and Development (HHS/ASPR/BARDA) | |
MONIQUE K. MANSOURA | |
Head, Medical Countermeasures & Government Affairs, Americas | |
Novartis Influenza Vaccines | |
8:35 a.m. | Global Health Security Initiative Update |
VICTOR DZAU | |
President Institute of Medicine | |
8:55 a.m. | Opening Keynote |
JEREMY FARRAR | |
Director Wellcome Trust |
SESSION I: Framing Preparedness for Emerging Infectious
Diseases as a National Security Imperative
Session Objectives:
- Provide an overview of the current ability to have MCMs available to effectively respond to EIDs of high (national security) impact.
- Discuss budgetary and policy issues that have challenged rapid and nimble response.
- Identify barriers that might prevent a prospective framework for managing future needs.
9:15 a.m. | Session Chair: Introduction and Overview of Objectives |
GERALD W. 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. WEBER, Deputy Coordinator for Ebola Response, Department of State | |
Biosecurity Strategy: TARA O’TOOLE, Senior Fellow, In-Q-Tel, Inc. |
Department of Defense/Warfighter Perspective: CDR FRANCA JONES, Medical Director, Office of the Deputy Assistant Secretary of Defense for Chemical and Biological Defense Programs | |
Economics: ROBERT SHAPIRO, Co-founder and Chairman, Sonecon, LLC, former Undersecretary of Commerce for Economic Affairs | |
Global Risk Report: SURESH KUMAR, Senior Partner, Oliver Wyman Public Sector and Health & Life Sciences Practice, Marsh & McLennan Companies | |
Industry Perspective: DANIEL J. ABDUN-NABI, President and CEO, Emergent BioSolutions, Inc. | |
Ethical Considerations: LISA M. LEE, Executive Director, Presidential Commission for the Study of Bioethical Issues | |
10:40 a.m. | BREAK |
11:00 a.m. | Facilitated Discussion with Attendees (1 hr) |
Potential Discussion Questions “In your experience…”: | |
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12:00 p.m. | U.S. Preparedness Perspective: Sustainability and Threat Assessment |
NICOLE LURIE Assistant Secretary for Preparedness and Response Department of Health and Human Services |
12:30 p.m. | LUNCH |
SESSION II: 2014 Ebola Outbreak Response
Session Objectives:
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1:15 p.m. | Session Chair: Introduction and Overview of Objectives |
MICHAEL T. OSTERHOLM, McKnight Presidential Endowed Chair in Public Health Director, Center for Infectious Disease Research & Policy (CIDRAP), University of Minnesota | |
1:25 p.m. | Panel Discussion: Fast-Track Development of Ebola Vaccines and Testing: Reviewing Successes and Understanding 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 Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration | |
WOUTER LATOUR, CEO, Vaxart | |
THOMAS A. DUNN, Program Manager for the Next Generation Diagnostics System Increment 1, Joint |
Project Management Office for Medical Countermeasures Systems (JPM-MCS) | |
2:15 p.m. | Facilitated Discussion with Attendees (1 hr) |
“In your experience…”: | |
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3:15 p.m. | BREAK |
SESSION III: Pandemic Influenza
Session Objectives:
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3:30 p.m. | Session Chair: Introduction and Overview of Objectives |
ANDREW PAVIA, George and Esther Gross Presidential Professor, Chief, Division of Pediatric Infectious Diseases, University of Utah | |
3:40 p.m. | Panel Discussion: Opportunities and Challenges in Preparedness 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) | |
RICK BRIGHT, Director of the Influenza Division, Biomedical Advancement Research and Development Authority (BARDA) | |
LOUIS FRIES III, Vice President, Chief Medical Officer, Novavax | |
MONIQUE K. MANSOURA, Head, Medical Countermeasures & Government Affairs, Americas, Novartis Influenza Vaccines | |
DAVID W. VAUGHN, Head of External R&D, North America, GSK Vaccines |
4:30 p.m. | Facilitated Discussion with Attendees (1 hr) |
“In your experience…”: | |
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5:30 p.m. | ADJOURN |
March 27, 2015
8:30 a.m. | Welcome and Introductions |
RICHARD HATCHETT, Workshop Co-Chair Chief Medical Officer and Deputy Director Biomedical Advanced Research and Development Authority (HHS/ASPR/BARDA) | |
MONIQUE K. MANSOURA, Workshop Co-Chair Head, Medical Countermeasures & Government Affairs, Americas | |
Novartis Influenza Vaccines |
8:35 a.m. | Opening Remarks |
RAJEEV VENKAYYA President, Global Vaccine Business Unit Takeda Pharmaceuticals |
SESSION IV: Developing Vaccines and Therapeutics to Emerging
Infectious Diseases Prior to the Emergency Threshold: Coronaviruses
Session Objectives:
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9:00 a.m. | Session Chair: Introduction and Overview of Objectives (10 min) |
TOM INGLESBY, Director, UPMC Center for Health Security | |
9:10 a.m. | Panel Discussion: Challenges and Opportunities in Responding to Coronaviruses: Past and Present (10 min each) |
DAVID SWERDLOW, Associate Director for Science, National Center for Immunization and Respiratory Diseases (NCIRD), CDC | |
FRED CASSELS, former SARS Program Officer, current Chief of Enteric and Hepatic Diseases Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases | |
JEFFREY ULMER, Global Head, External Research, GSK Vaccines |
MICHAEL WONG, Senior Medical Director for Infectious Diseases, Sarepta Therapeutics | |
PETER DASZAK, President, EcoHealth Alliance | |
10:00 a.m. | BREAK |
10:20 a.m. | Facilitated Discussion with Attendees (1hr) |
“In your experience…”: | |
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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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- Consider opportunities for companies to collaborate in pre-competitive areas and solve antitrust issues and perceptions.
- Discuss ways to better leverage public–private partnerships for future emerging threats.
- Consider how to operationalize next steps for the public and private sectors to coordinate a more rapid and nimble response to global emerging threats.
- Discuss common elements across a range of threats.
- Consider the sustainability of business models to keep stakeholders invested.
12:20 p.m. | Session Chair: Introduction and Overview of Objectives |
JOHN REX, Senior Vice President and Head of Infection, Global Medicines Development, Astrazeneca | |
12:30 p.m. | Panel Discussion: Lessons Learned from Sectors and Potential Future Strategies for Infectious Diseases of National Security Concern (5-10 min each) |
JOE LARSEN, Deputy Director, Division of CBRN Medical Countermeasures, Biomedical Advanced Research Development Authority (BARDA) | |
ROBERT GARRY, Program Manager, Viral Hemorrhagic Fever Consortium, Tulane University | |
MEGHAN MAJOROWSKI, Global Health Director, FSG | |
DEBRA HANNA, Executive Director for the Critical Path to TB Drug Regimens Consortium, Critical Path Institute | |
1:10 p.m. | Facilitated Discussion with Attendees (1 hr) |
“In your experience…”: | |
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2:10 p.m. | 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. How can we get to the next level? | |
Session Chairs: | |
GERALD W. PARKER, Texas A&M Health Science Center |
MICHAEL T. OSTERHOLM, CIDRAP | |
ANDREW PAVIA, University of Utah | |
TOM INGLESBY, UPMC Center for Health Security | |
JOHN REX, Astrazeneca | |
3:15 p.m. | Discussion with Attendees: |
Potential Discussion Questions: | |
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4:15 p.m. | Next Steps: Key Takeaway Messages |
4:30 p.m. | ADJOURN |