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Future State of Smallpox Medical Countermeasures (2024)

Chapter: Appendix A: Study Methods and Public Meeting Agendas

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Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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Page 147
Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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Page 148
Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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Page 149
Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×
Page 150
Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×
Page 151
Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×
Page 152
Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×
Page 153
Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×
Page 154
Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×
Page 155
Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×
Page 156
Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×
Page 157
Suggested Citation:"Appendix A: Study Methods and Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×
Page 158

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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 Cur- rent 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 Novem- ber 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. 147

148 FUTURE STATE OF SMALLPOX MEDICAL COUNTERMEASURES PUBLIC AGENDAS MEETING 1 AGENDA Thursday, November 16, 2023 Purpose • Hear from the sponsoring agency on their perspective of the state- ment 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 perspec- tives 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.

APPENDIX A 149 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

150 FUTURE STATE OF SMALLPOX MEDICAL COUNTERMEASURES PUBLIC WORKSHOP AGENDA (DAY 1) Thursday, December 14, 2023 Purpose • Hold an open session to hear from different U.S. government part- ners 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 in- form 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 small- pox medical countermeasures? • What is the current state of stockpiling of smallpox medical countermeasures? • What additional areas of research and development could be con- ducted to improve our MCMs? NOREEN HYNES, Moderator, Committee Member

APPENDIX A 151 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 Administration for Strategic Preparedness and 12:20 p.m. 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 treat- ment 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 small- pox 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 con- ducted 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?

152 FUTURE STATE OF SMALLPOX MEDICAL COUNTERMEASURES 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.

APPENDIX A 153 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

154 FUTURE STATE OF SMALLPOX MEDICAL COUNTERMEASURES 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 emergen- cies have altered assumptions about the U.S. stockpiling, prepared- ness, 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 pre- paredness, readiness, and robust public health response to smallpox? • What opportunities and risks do these advancements pose to prepared- ness 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

APPENDIX A 155 SESSION VIII Lessons Learned and Future Considerations for Smallpox Preparedness and Readiness Objectives: Explore how recent COVID-19 and mpox public health emer- gencies have altered assumptions about preparedness, readiness, and MCMs stockpiling posture for smallpox. Guiding Questions: • How has the 2022 mpox multi-country outbreak altered our as- sumption about the availability of smallpox medical countermea- sures (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 con- ducted 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

156 FUTURE STATE OF SMALLPOX MEDICAL COUNTERMEASURES MEETING 4 AGENDA Friday, January 12, 2024 Purpose • Engage in discussion with external subject matter experts on issues related to smallpox medical countermeasures, specifically diagnos- tics 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

APPENDIX A 157 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

Next: Appendix B: Committee and Staff Biographical Sketches »
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At the request of the Administration for Strategic Preparedness and Response, the National Academies convened a committee to examine lessons learned from the COVID-19 pandemic and mpox multi-country outbreak to inform an evaluation of the state of smallpox research, development, and stockpiling of medical countermeasures (MCM). In the resulting report, the committee presents findings and conclusions that may inform U.S. Government investment decisions in smallpox MCM readiness, as well as the official U.S. position on the disposition of live viral collections at future World Health Assembly meetings.

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