A
Study Methods and Public Meeting Agendas
At the request of the Administration for Strategic Preparedness and Response (ASPR), the National Academies of Sciences, Engineering, and Medicine (the National Academies) convened the Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures. In addressing its charge and preparing its final report, the committee pursued several avenues for information collection and analysis. This appendix describes the committee’s study process, including copies of the public meeting agendas.
MEETINGS AND INFORMATION-GATHERING ACTIVITIES
The committee held five virtual full committee meetings from November 2023 through February 2024. The committee held three meetings that included portions open to the public as well as one virtual public workshop. The agendas for these four open sessions are included at the end of this appendix.
To inform its deliberations, the committee gathered information through a variety of mechanisms including a review of literature from 2009 and were informed by reports and deliberations of the 154th session of the World Health Organization (WHO) Executive Board. Targeted literature reviews were conducted as novel issues arose throughout the committee’s deliberations. All written information provided to the committee from external sources is available by request through the National Academies’ Public Access Records Office.
PUBLIC AGENDAS
MEETING 1 AGENDA
Thursday, November 16, 2023
Purpose
- Hear from the sponsoring agency on their perspective of the statement of task and to hear from relevant stakeholders.
- Identify core issues to be addressed in the report.
OPEN SESSION
Sponsor Briefing: Discussion of the Committee’s Charge
Objectives: To hear from the sponsors of the study regarding their perspectives on the charge to the committee.
| 2:00 p.m. | Welcoming Remarks |
| LARRY GOSTIN, Committee Chair | |
| Distinguished University Professor and O’Neill Chair in Global Health Law | |
| O’Neill Institute for National and Global Health Law | |
| Georgetown University | |
| 2:05 p.m. | Sponsor Perspective on Charge to the Committee |
| Administration for Strategic Preparedness and Response (ASPR) | |
| 3:30 p.m. | ADJOURN |
MEETING 2 AGENDA
Friday, December 1, 2023
Purpose
- Hold an open session to hear from different U.S. government and international partners on key activities and perspectives relevant to the charge.
- Hear from subject matter experts on different issues related to variola and poxvirus research and medical countermeasure development.
OPEN SESSION
| 2:00 p.m. | Welcoming Remarks |
| LARRY GOSTIN, Committee Chair | |
| Distinguished University Professor and O’Neill Chair in Global Health Law | |
| O’Neill Institute for National and Global Health Law | |
| Georgetown University | |
| 2:05 p.m. | Variola Virus Research—Overview of Main Activities and Use of Live Virus |
| CHRISTY HUTSON | |
| Chief, Poxvirus and Rabies Branch | |
| Division of High Consequence Pathogens and Pathology | |
| U.S. Centers for Disease Control and Prevention (CDC) | |
| ROSAMUND LEWIS | |
| Head, WHO Smallpox Secretariat, | |
| Technical Lead for Orthopoxviruses | |
| World Health Organization (WHO) | |
| 3:15 p.m. | Perspectives from Prominent Poxvirus Researchers |
| BERNARD MOSS | |
| Chief, Genetic Engineering Section | |
| National Institute of Allergy and Infectious Diseases (NIAID) | |
| STUART ISAACS | |
| Associate Professor of Medicine | |
| Perelman School of Medicine | |
| University of Pennsylvania | |
| 4:00 p.m. | ADJOURN |
PUBLIC WORKSHOP AGENDA (DAY 1)
Thursday, December 14, 2023
Purpose
- Hold an open session to hear from different U.S. government partners on key activities relevant to the charge.
- Examine the current state of medical countermeasures (MCMs) for the diagnosis, prevention, and treatment of smallpox, including the continued role of live variola virus for research and public health purposes.
- Explore how lessons learned from COVID-19 and mpox can inform future preparedness and readiness.
- Examine potential scenarios and strategies that might inform future stockpiling of smallpox MCMs.
SESSION I Day 1 Opening Session
| 12:00 p.m. | Welcoming Remarks |
| LARRY GOSTIN, Committee Chair | |
| Distinguished University Professor and O’Neill Chair in Global Health Law | |
| O’Neill Institute for National and Global Health Law | |
| Georgetown University |
SESSION II U.S. Government Updates
Objectives: Hear briefings from federal stakeholders on current activities for smallpox medical countermeasures.
Guiding Questions:
- What is the current regulatory landscape for smallpox medical countermeasures?
- What is the current research and development landscape for smallpox medical countermeasures?
- What is the current state of stockpiling of smallpox medical countermeasures?
- What additional areas of research and development could be conducted to improve our MCMs?
NOREEN HYNES, Moderator, Committee Member
| 12:05 p.m. | U.S. Food and Drug Administration Panel |
| NOEL GERALD | |
| Branch Chief for Bacterial Respiratory and Medical Countermeasures | |
| Division of Microbiology Devices, Center for Devices and Radiological Health | |
| FDA | |
| 12:20 p.m. | Administration for Strategic Preparedness and Response Panel |
| STEVE ADAMS | |
| Director, Strategic National Stockpile | |
| ASPR | |
| DANIEL WOLFE | |
| Branch Chief, CBRN Vaccines | |
| BARDA | |
| KAREN MARTINS | |
| Branch Chief, CBRN Antivirals and Antitoxins | |
| BARDA | |
| MARGARET SLOANE | |
| Office of Strategy, Policy, and Requirements | |
| ASPR |
SESSION III Smallpox Medical Countermeasures Landscape
Objectives: (1) Examine current state of MCMs for the prevention and treatment of smallpox, and (2) explore how lessons learned from COVID-19 and mpox can inform future preparedness and readiness.
Guiding Questions:
- What is the current research and development landscape for smallpox medical countermeasures?
- How effective are the current MCMs for the diagnosis, prevention, and treatment of smallpox?
- What additional areas of research and development could be conducted to improve our MCMs?
- How did the mpox outbreak alter assumptions about the efficacy and utility of smallpox MCMs?
- How can the lessons from COVID-19 and mpox inform the U.S. preparedness and readiness posture?
| 2:05 p.m. | Vaccine Research and Development |
| RICK KENNEDY, Moderator, Committee Member | |
| PAUL CHAPLIN | |
| Chief Executive Officer | |
| Bavarian Nordic | |
| SETH LEDERMAN | |
| Co-Founder, Chief Executive Officer, and Chairman | |
| Tonix | |
| BRETT LEAV | |
| Head, Clinical Development, Public Health Vaccines | |
| Moderna | |
| CHRIS SINCLAIR | |
| Head of Global Preparedness Government Business | |
| Emergent BioSolutions | |
| 3:05 p.m. | Therapeutics Research and Development |
| INGER DAMON, Moderator, Committee Member | |
| CYRUS JAVAN | |
| Medical Officer | |
| Division of AIDS | |
| NIAID | |
| DENNIS HRUBY | |
| Chief Scientific Officer | |
| SIGA |
SESSION IV Scenario Planning and MCM Stockpiling Strategies
Objectives: (1) Explore how recent COVID-19 and mpox public health emergencies have altered assumptions about the U.S. preparedness, readiness, and MCMs stockpiling posture for smallpox, and (2) examine potential scenarios and strategies that might inform future stockpiling of smallpox MCMs.
Guiding Questions:
- How has the mpox outbreak altered our assumption about the availability of smallpox MCMs and the ability to meet potential global demand?
- How do advancements in biotechnology, life sciences research, and converging and enabling technologies alter approaches for scenario planning and stockpiling strategies?
- What options and strategies could be considered to inform the smallpox MCM stockpiling posture?
- How can the lessons from COVID-19 and mpox inform the U.S. preparedness and readiness posture?
| 3:45 p.m. | Scenario Planning and MCM Stockpiling Strategies |
| HENRY WILLIS, Moderator, Committee Member | |
| NATHANIEL HUPERT | |
| Associate Professor of Population Health Sciences | |
| Cornell University Weill Medical College | |
| CRYSTAL WATSON | |
| Senior Scholar and Associate Professor | |
| Johns Hopkins Center for Health Security | |
| KEVIN YESKEY | |
| Senior Advisor for Emergency Public Health | |
| MDB, Inc. |
SESSION V Wrap-Up and Closing Remarks
| 4:25 p.m. | Summary of Day 1 and Closing Remarks |
| LARRY GOSTIN, Committee Chair | |
| Distinguished University Professor and O’Neill Chair in Global Health Law | |
| O’Neill Institute for National and Global Health Law | |
| Georgetown University | |
| 4:30 p.m. | ADJOURN |
PUBLIC WORKSHOP AGENDA (DAY 2)
Friday, December 15, 2023
Purpose
- Discuss how the COVID-19 pandemic and the mpox multi-country outbreak can inform improvements to smallpox readiness and response.
- Explore how recent COVID-19 and mpox public health emergencies have altered assumptions about the U.S. stockpiling, preparedness, and readiness posture.
SESSION VI Day 2 Opening Session
| 12:30 p.m. | Welcoming Remarks |
| LARRY GOSTIN, Committee Chair | |
| Distinguished University Professor and O’Neill Chair in Global Health Law | |
| O’Neill Institute for National and Global Health Law | |
| Georgetown University |
SESSION VII Synthetic Biology Opportunities and Risks
Objectives: (1) Hear briefing on advancements in synthetic biology related to smallpox, and (2) examine the opportunities and risks that these advancements pose to preparedness, readiness, and response capabilities and capacities.
Guiding Questions:
- What is the likelihood for advancements in synthetic biology to develop a poxvirus with pandemic potential?
- How do advancements in synthetic biology alter approaches to preparedness, readiness, and robust public health response to smallpox?
- What opportunities and risks do these advancements pose to preparedness and readiness capabilities and capacities of the United States?
| 12:35 p.m. | Synthetic Biology |
| DREW ENDY, Moderator, Committee Member | |
| CATHRYN MAYES | |
| Senior Biologist | |
| Sandia Laboratories |
SESSION VIII Lessons Learned and Future Considerations for Smallpox Preparedness and Readiness
Objectives: Explore how recent COVID-19 and mpox public health emergencies have altered assumptions about preparedness, readiness, and MCMs stockpiling posture for smallpox.
Guiding Questions:
- How has the 2022 mpox multi-country outbreak altered our assumption about the availability of smallpox medical countermeasures (MCMs) and the ability to meet potential demand?
- How can the lessons from COVID-19 and mpox inform the U.S. stockpiling, preparedness, and readiness posture?
- What additional areas of research and development could be conducted to improve our MCMs?
| 12:45 p.m. | Lessons Learned and Future Considerations |
| GEORGES BENJAMIN, Moderator, Committee Member | |
| MATTHEW HEPBURN | |
| Chief Medical Officer | |
| JPEO-CBRND | |
| EWA KING | |
| Chief Program Officer | |
| Association of Public Health Laboratories (APHL) | |
| MARCUS PLESCIA | |
| Chief Medical Officer | |
| Association of State and Territorial Health Officials (ASTHO) |
SESSION IX Wrap-Up and Closing Remarks
| 1:45 p.m. | Concluding Remarks |
| LARRY GOSTIN, Committee Chair | |
| Distinguished University Professor and O’Neill Chair in Global Health Law | |
| O’Neill Institute for National and Global Health Law | |
| Georgetown University | |
| 2:00 p.m. | ADJOURN |
MEETING 4 AGENDA
Friday, January 12, 2024
Purpose
- Engage in discussion with external subject matter experts on issues related to smallpox medical countermeasures, specifically diagnostics and therapeutics.
SESSION X Presentations and Discussion on Key Issues Related to Smallpox Diagnostics and Therapeutics
Objective: To hold a discussion with key subject matter experts on key issues related to the study charge.
| 2:30 p.m. | Welcoming Remarks |
| LARRY GOSTIN, Committee Chair | |
| Distinguished University Professor and O’Neill Chair in Global Health Law | |
| O’Neill Institute for National and Global Health Law | |
| Georgetown University | |
| 2:35 p.m. | DoD Presentations and Discussions on Smallpox Diagnostics and Therapeutics |
| NICOLE DORSEY | |
| Director, Advanced Technology Platforms and Clinical Evaluation (ATP) | |
| Joint Project Lead, CBRND Enabling Biotechnologies (JPL CBRND EB) | |
| MATTHEW CLARK | |
| Colonel, U.S. Army | |
| Joint Project Manager, CBRN Medical | |
| Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) | |
| 3:15 p.m. | Presentations and Discussions on Smallpox Diagnostics |
| GAVIN CLOHERTY | |
| Senior Research Fellow, Head of Infectious Disease Research | |
| Abbott Molecular Diagnostics |
| MANOJ GANDHI | |
| Senior Director for Medical and Scientific Affairs | |
| Abbott Molecular Diagnostics | |
| JOHN CONNOR | |
| Associate Professor of Virology, Immunology, and Microbiology | |
| Boston University | |
| 3:45 p.m. | Q&A with CDC |
| CHRISTY HUTSON | |
| Chief, Poxvirus and Rabies Branch | |
| Division of High Consequence Pathogens and Pathology | |
| U.S. Centers for Disease Control and Prevention (CDC) | |
| 3:55 p.m. | Wrap-Up and Closing Remarks |
| LARRY GOSTIN, Committee Chair | |
| Distinguished University Professor and O’Neill Chair in Global Health Law | |
| O’Neill Institute for National and Global Health Law | |
| Georgetown University | |
| 4:00 p.m. | ADJOURN |
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