in MCM development by noting that definition of metrics is challenging. He commented that there is limited opportunity to assess the true public health benefit of an MCM; success cannot simply be measured by the number of MCM approvals (as not all products will or should succeed). Participants offered a variety of suggestions for metrics, from a goal of adding a defined number of new, approved MCMs to the SNS within a defined time period; to smaller, incremental steps such as developing an assay that solves a key problem, thereby reducing time and/or cost of development;to finalizing MCM-related FDA guidance documents; to approving a product under the Animal Rule. It was repeated throughout the workshop that providing a clear regulatory pathway forward can foster innovation and enhance the quality of sponsor submissions;this, it is hoped, would lead to increased speed of review and success of applications.

From a defense perspective, U.S. troops face threats around the globe, not just traditional biothreats, but endemic diseases as well. It is important to remember that MCM development must include not only vaccines and therapeutics, but also point-of-care diagnostics (for both organism identification and drug resistance profile). An ongoing challenge for both civilian and military populations is getting “the right product, in the right place, at the right time, for the right individuals.” In this regard there was discussion of pre-positioning tools (such as diagnostics or mobile manufacturing capability).

Rex added that in the end, for any countermeasures to be effective, the public must accept and use them. In this regard, there is a need to educate the public about advances in regulatory science (e.g., approval and use of products that have not been tested in humans, benefit versus risk during an emergency versus routine medical care). There was interest in leveraging social networks and developing educational apps.

BENEFIT AND RISK

Carl Peck of the University of California, San Francisco, emphasized that in all processes, there needs to be a change in mindset or a “reset” regarding benefit-risk criteria. Benefit-risk assessments must take into account the fact that MCMs are intended for use in extreme public health emergencies (not for treatment of, for example, chronic, nonfatal conditions). Hatchett added that the development of rapid diagnostics could help facilitate the reset of benefit-risk assessments, allowing FDA to better define for whom the use of a product would outweigh potential risk (e.g., only to be used for those who test positive).

Participants discussed whether this reset of benefit-risk assessments would mean setting a level of safety that is not necessarily the same as the



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