national health security. However, certain structural, strategic, and technical elements of the enterprise continue to impede research, development, and production of medical countermeasures. The presentations and discussions at this workshop are intended to assist federal officials in conducting a thorough review of the “pipeline through approval” spectrum of our national programs and to assist in the ultimate goal of improving the efficiency and effectiveness of the countermeasures enterprise.
Identify and discuss strategies to optimize the federal public health emergency medical countermeasures enterprise, and explore resources and/or other supporting components needed for accomplishing goals of countermeasure discovery, development, approval, and production.
Examine strategies to further enhance the translation of early phase investments in basic science into potential public health interventions.
Identify and discuss models for enhancing current partnerships and establishing new ones among federal programs, innovators, and the commercial marketplace to enhance our nation’s capabilities to meet public health emergency preparedness goals.
Consider market forces acting on the advanced development biodefense community (pharma/biotech) that incentivize/disincentivize efforts to develop and license products in support of the national response.
Examine ways the regulatory oversight process for public health emergency medical countermeasures might evolve and identify ways to enable more efficient approval and use.
Review the innovative approaches being used to advance drug development for orphan diseases (i.e., rare, neglected, or tropical diseases) or any other area that does not have a ready and sustainable commercial market (e.g., oncology therapeutics), and identify the shared challenges and opportunities for strategies that might be adopted by the Enterprise.