Appendix A
Study Methods
At the request of the Office of the Assistant Secretary for Preparedness and Response (ASPR), the National Academies of Sciences, Engineering, and Medicine (the National Academies) convened the Committee on Reviewing the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). In addressing its charge and preparing its final report, the committee pursued several avenues for information collection and analysis. The committee held five virtual meetings, three of which included open public sessions that incorporated remarks from and discussion between invited stakeholders and experts. This appendix describes the committee’s study process in detail, including a summary of the written public comments received by the committee and copies of the three open-session agendas.
MEETINGS AND INFORMATION-GATHERING ACTIVITIES
The committee held five virtual meetings from August 2021 through September 2021. The first, second, and third meetings included portions open to the public. The agendas for these sessions are included at the end of this appendix. The remaining meetings were held entirely in closed session.
To inform its deliberations, the committee gathered information through a variety of mechanisms: (1) reviews of PHEMCE charter and process documents and materials shared by ASPR and (2) the first, second, and third committee meetings, which included sessions open to the public. All written information provided by external sources is available by request through the National Academies’ Public Access Records Office.
PHEMCE Charter and Process Materials
ASPR provided public documents that describe PHEMCE and some activities from approximately 2006 to 2015. Sharing these materials with the committee allowed deeper insight into PHEMCE during that time.
Charter documents primarily described the mission and organizational structure of PHEMCE, while process documents showcased activities such as requirements setting, development of Strategy and Implementation Plans (SIPs), and threat and preparedness assessments. ASPR also shared materials describing PHEMCE’s responsibilities with the U.S. Strategic National Stockpile (SNS), including the congressionally mandated annual reviews of the SNS. Lastly, ASPR provided a description of the current PHEMCE organizational structure.
Open Sessions
The first meeting’s open session provided an opportunity for the committee to hear the sponsors’ perspectives on the charge and scope of the study. This session afforded the members the chance to discuss anticipated challenges and points of clarification and define the project’s boundaries.
The second meeting’s open session allowed the committee to hear from former and current PHEMCE personnel on key issues related to the committee’s scope. The committee also had an opportunity to reengage with the sponsor to discuss PHEMCE materials shared by ASPR.
The third meeting’s open session heard perspectives on issues related to PHEMCE mission, ensuring defensible PHEMCE recommendations and enterprise-wide reviews, integrating external partners and stakeholders into PHEMCE decision making and activity execution, and best business practices of the industrial base, supply chain, and stockpiling/inventory management for medical countermeasures preparedness. Relevant stakeholders from federal, state, and local government; the industrial base; and the medical sector were able to share their perspectives on PHEMCE and what the committee should consider in its review.
PUBLIC AGENDAS
First Committee Meeting Public Agenda
Friday, August 6, 2021
3:00–5:00 p.m. ET
Meeting Objective
- Hold an open session to hear from the sponsor of the study regarding their perspectives on the charge to the committee and to hear from former PHEMCE personnel.
Friday, August 6, 2021
OPEN SESSION
| SESSION Objectives: | Sponsor Briefing: Discussion of the Committee’s Charge 1) To hear from the sponsor of the study regarding their perspectives on the charge to the committee. 2) To introduce the committee to PHEMCE materials shared by ASPR, including available charters, memorandums of understanding, process documents, and other related documents to inform the committee’s understanding of past decision making, business practices, and other policy approaches. |
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| 3:00 p.m. | Welcome and Introductions | |
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Gigi Gronvall, Committee Co-Chair Senior Scholar Johns Hopkins Center for Health Security |
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Alan Leshner, Committee Co-Chair Chief Executive Officer Emeritus American Association for the Advancement of Science |
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| 3:05 p.m. | Sponsor Perspective on Charge to the Committee | |
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David (Chris) Hassell, Study Sponsor Deputy Assistant Secretary Senior Science Advisor Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services |
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Lara Lamprecht, Study Sponsor Branch Chief, PHEMCE Division of Requirements Office of Strategy, Policy, Planning, and Requirements Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services |
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Chad Hrdina, Study Sponsor Director, Division of Requirements Office of Strategy, Policy, Planning, and Requirements Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services |
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| 3:35 p.m. | Discussion with Committee | |
| 4:00 p.m. | Preview of Shared PHEMCE Materials | |
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Lara Lamprecht, Study Sponsor Branch Chief, PHEMCE Division of Requirements Office of Strategy, Policy, Planning, and Requirements Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services |
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Chad Hrdina, Study Sponsor Director, Division of Requirements Office of Strategy, Policy, Planning, and Requirements Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services |
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| 4:10 p.m. | Discussion with Committee | |
| SESSION Objective: | Discussion of PHEMCE Management and Operations 1) To gather information from former PHEMCE personnel on the management and operations of PHEMCE, including any challenges, major accomplishments, and recommendations for the future. |
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| 4:30 p.m. | Discussion of PHEMCE Management and Operations | |
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George Korch Director, National Biodefense Analysis and Countermeasures Center Former Senior Science Advisor to the ASPR Former Chair, Enterprise Executive Committee (2009–2017) |
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Joanna Prasher Senior Advisor, Centers for Disease Control and Prevention Center for Preparedness and Response Founder and Former Chief, PHEMCE Branch |
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| 4:45 p.m. | Discussion with Committee | |
| 5:00 p.m. | ADJOURN OPEN SESSION | |
Second Committee Meeting Public Agenda
Friday, August 13, 2021
2:00–4:30 p.m. ET
Meeting Objectives
- Gather information from former and current PHEMCE personnel on key issues
- Continue discussion with ASPR on shared PHEMCE materials
Friday, August 13, 2021
OPEN SESSION
| 2:00 p.m. | Welcome and Introductions | |
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Gigi Gronvall, Committee Co-Chair Senior Scholar Johns Hopkins Center for Health Security |
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Alan Leshner, Committee Co-Chair Chief Executive Officer Emeritus American Association for the Advancement of Science |
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| SESSION Objective: |
Discussions with PHEMCE Personnel 1) To gather information from former and current PHEMCE personnel on the following issues:
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| 2:15 p.m. | Views of Former and Current PHEMCE Personnel (7–10 minutes) | |
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Robert Kadlec Former U.S. Department of Health and Human Services Assistant Secretary for Preparedness and Response |
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Stephen Redd Former Director of the Office of Public Health Preparedness and Response Centers for Disease Control and Prevention |
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Michael Mair Acting Assistant Commissioner for Counterterrorism Policy Acting Director of the Office of Counterterrorism and Emerging Threats U.S. Food and Drug Administration |
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Michael Kurilla Director, Division of Clinical Innovation National Center for Advancing Translational Sciences Former Director, Office of Biodefense Research Affairs National Institute of Allergy and Infectious Diseases National Institutes of Health |
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Richard Hatchett CEO Coalition for Epidemic Preparedness Innovations Former Acting Director of the Biomedical Advanced Research and Development Authority |
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| 3:15 p.m. | Discussion with Committee | |
| SESSION Objective: | Discussion of Shared PHEMCE Materials 1) To review, engage, and understand more in depth the materials (such as available charters, MOUs, process documents, and other related documents) provided by ASPR. |
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| 4:00 p.m. | Q&A with ASPR on Shared PHEMCE Materials | |
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David (Chris) Hassell, Study Sponsor Deputy Assistant Secretary Senior Science Advisor Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services |
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Lara Lamprecht, Study Sponsor Branch Chief, PHEMCE Division of Requirements Office of Strategy, Policy, Planning, and Requirements Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services |
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Chad Hrdina, Study Sponsor Director, Division of Requirements Office of Strategy, Policy, Planning, and Requirements Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services |
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| 4:30 p.m. | ADJOURN OPEN SESSION | |
Third Committee Meeting Public Agenda
Thursday, August 19, 2021
1:30–6:00 p.m. ET
Meeting Objective
- To hear perspectives on issues related to PHEMCE mission, ensuring defensible PHEMCE recommendations and enterprise-wide reviews, the integration of external partners and stakeholders into PHEMCE decision making and activity execution, and best business practices of the industrial base, supply chain, and stockpiling/inventory management for medical countermeasures preparedness.
Day 1: Thursday, August 19, 2021
OPEN SESSION
| 1:30 p.m. | Welcoming Remarks | |
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Gigi Gronvall, Committee Co-Chair Senior Scholar Johns Hopkins Center for Health Security |
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| SESSION I Objective: |
What Is the Value of PHEMCE? 1) To hear perspectives on the following issues related to the PHEMCE mission:
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| 1:35 p.m. | Re-envisioned PHEMCE Mission, Operating Structure, and Authorities | |
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Nicole Lurie U.S. Director Coalition for Epidemic Preparedness Innovations Former Assistant Secretary for Preparedness and Response |
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Prabhavathi Fernandes Chairperson National Biodefense Science Board |
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| 2:00 p.m. | Discussion with Committee | |
| SESSION II Objective: |
Business Practices for Defensible PHEMCE Recommendations 1) To hear perspectives on the following issues related to the ensuring defensible PHEMCE recommendations and enterprise-wide reviews:
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| 2:30 p.m. | Threat Assessments, National Security Considerations, and Operation Warp Speed | |
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Daniel Gerstein Senior Policy Researcher RAND Corporation |
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Andrew Kilianski Senior Director for Emerging Infectious Diseases IAVI |
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Tara O’Toole Senior Fellow and Executive Vice President In-Q-Tel |
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Matthew Hepburn (joining at 3 p.m.) Director, COVID Vaccine Development U.S. Department of Health and Human Services-U.S. Department of Defense Countermeasures Acceleration Group (formerly Operation Warp Speed) |
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| 2:40 p.m. | Decision Making, Workflows, Technology, and Processes | |
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Valerie Karplus Associate Professor, Engineering and Public Policy Carnegie Mellon University |
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| 2:50 p.m. | Discussion with Committee | |
| 3:15 p.m. | 30-Minute Break | |
| SESSION III Objective: |
Integration of Partners into PHEMCE 1) To hear perspectives on the following issues related to the integration of external partners and stakeholders into PHEMCE decision making and activity execution:
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| 3:45 p.m. | State and Local Perspectives | |
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Karen Smith Former State Public Health Officer and Director California Department of Public Health |
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David Gruber Associate Commissioner for Regional and Local Health Operations Texas Department of State Health Services |
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John Hick Deputy Chief Medical Director Hennepin EMS Medical Director for Emergency Preparedness Hennepin Healthcare |
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Mary Grealy President Healthcare Leadership Council |
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James Lawler Associate Professor, Department of Internal Medicine Director, International Programs and Innovation, Global Center for Health Security Director, Clinical and Biodefense Research University of Nebraska Medical Center |
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| 4:00 p.m. | Business Partners and Industry | |
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Phyllis Arthur Vice President, Infectious Diseases and Diagnostics Policy Biotechnology Innovation Organization |
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Mary Kosinski Chief of Staff and Deputy Vice President for Science and Regulatory Advocacy PhRMA |
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Bruce Altevogt Vice President and Head External Medical Engagement Pfizer |
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Edward Cox Vice President Regulatory Affairs Regeneron |
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Patrick Lucy President and CEO Lykan Bioscience |
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| 4:15 p.m. | Discussion with Committee | |
| SESSION IV Objective: |
Industrial Base, Supply Chain, and Stockpiling 1) To hear perspectives on the following issues related to best business practices of the industrial base, supply chain, and stockpiling/inventory management for medical countermeasures preparedness:
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| 5:00 p.m. | Industrial Base, Supply Chain, and Stockpiling | |
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Robert Handfield Bank of America University Distinguished Professor of Supply Chain Management Executive Director, Supply Chain Resource Cooperative North Carolina State University |
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Nicolette Louissaint Executive Director Healthcare Ready |
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Jon Mogford Chief Operating Officer and Senior Vice President Texas A&M Health |
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| 5:15 p.m. | Discussion with Committee | |
| 5:45 p.m. | Summary of Public Workshop Presentations | |
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Gigi Gronvall, Committee Co-Chair Senior Scholar Johns Hopkins Center for Health Security |
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| 6:00 p.m. | ADJOURN PUBLIC WORKSHOP | |
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