AGENDA

• March 26-27, 2015
• Room 125 of the National Academy of Sciences Building
• 2101 Constitution Avenue, NW, Washington, DC 20418

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.
  • 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