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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Appendix B

Workshop Agenda

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

June 6–7, 2017

AGENDA

National Academy of Sciences Building, Kavli Auditorium
2101 Constitution Avenue, NW, Washington, DC 20418

WORKSHOP OBJECTIVES

  • Discuss the roles and efforts of the federal government and relevant stakeholders who have an interest in building and maintaining a national medical countermeasure (MCM) monitoring and assessment capability for public health emergencies.
  • Discuss federal monitoring and assessment efforts and opportunities for future work in areas including electronic health record capabilities, big data, clinical networks, and operations for response.
  • Help inform the development of strategic MCM monitoring and assessment plans for public health emergencies.

June 6, 2017

8:30 am OPENING REMARKS
Boris Lushniak, Dean and Professor, School of Public Health, University of Maryland
8:45 am KEYNOTE PRESENTATION: BACKGROUND ON FEDERAL MCM AND MONITORING/ASSESSMENT
Carmen T. Maher, Acting Assistant Commissioner for Counterterrorism Policy, U.S. Food and Drug Administration
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
AUDIENCE Q/A
Moderator: Boris Lushniak, Dean and Professor, School of Public Health, University of Maryland
9:30 am LIGHTNING PRESENTATIONS: ESTABLISHING DEFINITIONS OPERATIONS FOR RESPONSE
Boris Lushniak, Dean and Professor, School of Public Health, University of Maryland
ELECTRONIC HEALTH DATA
Richard Platt, Professor and Chair, Department of Population Medicine, Harvard Medical School
UNSTRUCTURED/BIG DATA
Suzanne Bakken, Alumni Professor of Nursing; Professor of Biomedical Informatics, Columbia University
CLINICAL NETWORKS
Perren Cobb, Professor of Clinical Surgery; Director, University of Southern California Critical Care Institute; Director, Keck Surgical Intensive Care Unit, University of Southern California
FACILITATED DISCUSSION
Laura Runnels, LAR Consulting
10:30 am BREAK
11:00 am PANEL DISCUSSION I: WHAT DATA ARE NEEDED TO MAKE DECISIONS?
Moderator: Yon C. Yu, Associate Director, Regulatory Affairs, National Center for Emerging and Zoonotic Infectious Diseases, U.S. Centers for Disease Control and Prevention
Quazi Ataher, Senior Director of Epidemiology in Worldwide Safety Strategy, Pfizer Inc.
Theresa Cullen, Associate Director, Global Health Informatics Program, Regenstrief Institute, Inc.
Alison Levy, Emergency Operations Manager, Public Health–Seattle and King County
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
Anita Patel, Senior Advisor, Lead, Pandemic Medical Care and Countermeasures Influenza Coordination Unit, National Center for Immunization and Respiratory Diseases, U.S. Centers for Disease Control and Prevention
Paul Petersen, Director, Emergency Preparedness Program, Tennessee Department of Health
Adam Wilcox, Professor, Biomedical Informatics and Medical Education, Chief Analytics Officer, University of Washington
FACILITATED DISCUSSION WITH AUDIENCE
Laura Runnels, LAR Consulting
12:30 pm LUNCH (on your own)
1:30 pm PANEL DISCUSSION II: EXISTING DATASETS AND CHALLENGES WITH THE SOURCES
Moderator: Laura Runnels, LAR Consulting
Rhona Cooper, Public Health Preparedness Clinical Coordinator, Philadelphia Department of Public Health
Henry “Skip” Francis, Director, Data Mining and Informatics Evaluation and Research, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Eva Lee, Director, Center for Operations Research in Medicine and HealthCare, H. Milton Stewart School of Industrial and Systems Engineering, Georgia Institute of Technology
Joe Vasey, Epidemiologist and Biostatistician, Practice Fusion
FACILITATED DISCUSSION WITH AUDIENCE
Laura Runnels, LAR Consulting
3:00 pm BREAK
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
3:30 pm PANEL DISCUSSION III: EXISTING SYSTEMS AND INFRASTRUCTURE FOR CLINICAL NETWORKS AND OPERATIONS FOR THREAT RESPONSE: ADVANTAGES AND CHALLENGES
Moderator: Laura Runnels, LAR Consulting
Jeff Brown, Associate Professor, Harvard Pilgrim Health Care Institute
John Grabenstein, Executive Director, Medical Affairs, Merck Vaccines
Elizabeth S. Higgs, Global Health Science Advisor, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Lou Ann Lance, Public Health Program Nurse, Clinical Operations, Bureau of Communicable Disease Control, New York State Health Department
Amanda Peppercorn, Senior Medical Director, Infectious Diseases Research and Development, GlaxoSmithKline
Scott Proestel, Director, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
FACILITATED DISCUSSION WITH AUDIENCE
Laura Runnels, LAR Consulting
5:00 pm RECAP AND REVIEW
Boris Lushniak, Dean and Professor, School of Public Health, University of Maryland
5:15 pm ADJOURN DAY 1
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

June 7, 2017

8:30 am OPENING REMARKS
Boris Lushniak, Dean and Professor, School of Public Health, University of Maryland
8:45 am PANEL DISCUSSION IV: LAWS AND INCENTIVES TO PROMOTE ADOPTION AND STANDARDIZATION
Moderator: Laura Runnels, LAR Consulting
Ray Barishansky, Deputy Secretary of Health, Pennsylvania Department of Health
Jeff Coughlin, Senior Director, Federal and State Affairs, Healthcare Information Management and Systems Society
Deven McGraw, Deputy Director, Health Information Privacy, Office for Civil Rights, U.S. Department of Health and Human Services; Acting Chief Privacy Officer, Office of the National Coordinator for Health Information Technology
Amanda Fuller Moore, Public Health Preparedness and Response, Division of Public Health, North Carolina Department of Health and Human Services
J. Marc Overhage, Chief Health Informatics Officer, Cerner
FACILITATED DISCUSSION
Laura Runnels, LAR Consulting
10:15 am BREAK
10:45 am KEYNOTE PANEL DISCUSSION: INSPIRING COLLECTIVE ACTION
Moderator: Boris Lushniak, Dean and Professor, School of Public Health, University of Maryland
Stacey Arnesen, Chief, Disaster Information Management Research Center, Specialized Information Services, National Library of Medicine, National Institutes of Health
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
Greg Burel, Director, Division of Strategic National Stockpile, U.S. Centers for Disease Control and Prevention
Redonna Chandler, Deputy Director, Division of Clinical Innovation, National Center for Advancing Translational Sciences, National Institutes of Health
John Fleming, Deputy Assistant Secretary for Health Technology Reform, Office of the National Coordinator for Health Information Technology
Joseph Larsen, Deputy Director, Division of CBRN Medical Countermeasures, Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response
Carmen T. Maher, Acting Assistant Commissioner for Counterterrorism Policy, U.S. Food and Drug Administration
11:45 am ACTIVITY: PRIORITIZING ISSUES FOR STRATEGY BREAKOUTS
Laura Runnels, LAR Consulting
12:15 pm LUNCH (on your own)
1:15 pm BREAKOUT EXERCISE (Rooms to Be Announced)
Moderators:
Suzanne Bakken, Alumni Professor of Nursing; Professor of Biomedical Informatics, Columbia University
Perren Cobb, Professor of Clinical Surgery; Director, University of Southern California Critical Care Institute; Director, Keck Surgical Intensive Care Unit, University of Southern California
Boris Lushniak, Dean and Professor, School of Public Health, University of Maryland
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
Richard Platt, Professor and Chair, Department of Population Medicine, Harvard Medical School
3:30 pm BREAK
4:00 pm BREAKOUT EXERCISE—REPORT BACK
Suzanne Bakken, Alumni Professor of Nursing; Professor of Biomedical Informatics, Columbia University
Perren Cobb, Professor of Clinical Surgery; Director, University of Southern California Critical Care Institute; Director, Keck Surgical Intensive Care Unit, University of Southern California
Boris Lushniak, Dean and Professor, School of Public Health, University of Maryland
Richard Platt, Professor and Chair, Department of Population Medicine, Harvard Medical School
5:00 pm RECAP AND REVIEW
Boris Lushniak, Dean and Professor, School of Public Health, University of Maryland
5:15 pm ADJOURN DAY 2
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
Page 82
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
Page 83
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
Page 84
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
Page 85
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
Page 86
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
Page 87
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
Page 88
Next: Appendix C: Biographical Sketches of Workshop Speakers and Moderators »
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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.

As part of the United States’ scientific and research preparedness enterprise, there is an imperative to go “beyond the last mile” of MCM dispensing and administration to build and maintain a national capability to monitor and assess the use of MCMs (e.g., safety, compliance, clinical benefit) after they have been dispensed during PHEs. To further the discussion on this need, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 2-day public workshop, Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies. The workshop, sponsored by FDA, was held on June 6–7, 2017, in Washington, DC. Workshop participants discussed the roles and efforts of the federal government and of relevant stakeholders with an interest in building and maintaining a national PHE MCM active monitoring and assessment capability. This publication summarizes the presentations and discussions from the workshop.

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