An ad hoc committee will organize a public workshop that will examine how to better enable rapid and nimble private sector engagement in the discovery, development, and translation of medical countermeasures (MCM). The workshop will explore what policies, guidance, and resources exist to guide decision making within the government and how the business and operational models employed by the private sector are impacted by policies and guidance (formal and informal) and available resources set forth by the U.S. government. Further, the workshop will explore what is needed to ensure that the private sector can respond in a rapid, nimble manner to ensure the availability of MCMs. The committee will develop the workshop agenda, select and invite speakers and discussants, and moderate the discussions. The workshop participants will:
• Explore advances made by the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to improve MCM development and translation.
o Consider successful public private partnership strategies and other challenges or opportunities that might help incentivize MCM product development.
o Consider implications of recent decreases in funding and the impact on whether gains made by the sector since the initial PHEMCE Strategy are able to be sustained.
o Discuss whether the establishment of a strategic reserve fund may further enable rapid and nimble MCM development for emerging diseases.
• Identify and discuss policy and regulatory issues that either enable or become barriers to an operational model with strong public-private partnerships.
o Discuss principles that would strengthen capability-based approaches instead of looking to past events for future direction.
• Explore what is needed from the private sector perspective in order to support this type of rapid response.
o Consider the need for formal guidance on the indicators and triggers that are used by the U.S. government to guide decisions.
For the workshop presentations the committee may use examples from recent emerging infectious diseases, such as Ebola Virus Disease (EVD), H7N9 Influenza, and MERS-CoV to help frame the discussions. An individually authored summary of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.