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Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies: A Workshop

Completed

During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to affected populations to help mitigate the human health impact of the threat. The optimal MCMs determined for use during an emergency might be U.S. Food and Drug Administration (FDA) approved but used in unapproved ways (e.g., in a new age group or against a new agent); FDA approved using animal models because human efficacy testing is not ethical or feasible; or not yet FDA approved for any indication.

Description

An ad hoc committee will organize a 2-day public workshop in Washington, D.C. Through this workshop, the committee will convene experts representing a selection of government, academia and other researchers, the private sector, and public health and health care stakeholders and organizations currently involved with, or who have an interest in the concept of, building a national capability to monitor and assess public health emergency medical countermeasure (MCM) use after dispensing/administration during public health emergencies. The workshop will focus on the topics of Electronic Health Record (EHR) capabilities, the role of big data (i.e. large, complex, and unstructured datasets often precluded from conventional approaches to analysis that could be used for identifying patterns and associations), clinical trials networks, and concepts of operations for threat response and the utility of each to actively monitor and assess MCM use during actual or potential public health emergency responses.
The workshop will address the following objectives:
• Discuss the roles and efforts (both current and future) of the federal government and of relevant stakeholders with an interest in building and maintaining a national public health emergency MCM active monitoring and assessment capability;
• Discuss federal monitoring and assessment efforts (completed and ongoing) and opportunities for future work in areas including:
o Electronic Health Record (EHR) Capabilities
o The Role of Big Data
o Clinical Trial Networks
o Concept of Operations for Threat Response
• Help inform the development of MCM active monitoring and assessment strategic plans for public health emergencies.
The committee will develop the agenda for workshop sessions, select and invite speakers and discussants, and moderate the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.

Collaborators

Committee

Boris D. Lushniak

Chair

Phyllis Arthur

Member

Suzanne Bakken

Member

Jeremy Brown

Member

Sam Butler

Member

J. P. Cobb

Member

Jeffrey R. Coughlin

Member

Daniel R. Masys

Member

Dan O'Hair

Member

Amamda Peppercorn

Member

Richard Platt

Member

Kimberley Ricketts

Member

Paul J. Seligman

Member

Umair A. Shah

Member

Yon C. Yu

Member

Justin Snair

Staff Officer

Sponsors

Department of Health and Human Services

Staff

Justin Snair

Lead

Scott Wollek

Lead

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