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Appendix D: Public Meeting Agendas
Pages 143-154

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From page 143... ... Appendix D Public Meeting Agendas Committee on Vaccine Research and Development for Advancing Pandemic and Seasonal Influenza Preparedness and Response First Committee Meeting Agenda March 8 and 10, 2021 Orientation and Conflict of Interest Discussion: March 8, 7:00–9:30 PM EST Speaker Session: March 10, 7:00–10:00 AM EST Planning/Working Session: March 10, 3:30–6:30 PM EST Virtual Meeting Objectives • Conduct committee and staff introductions • Orient the committee to the National Academies consensus study process • Conduct the bias and conflict of interest discussion • Hold on open session to hear from sponsoring agency on its perspective of the Statement of Task and to hear from relevant stakeholders • Discuss the Statement of Task and work plan and agree on approach to completing the task • Identify information needs and future meeting topics 143 Read the entire page →
From page 144... ... 144 VACCINE RESEARCH AND DEVELOPMENT Monday, March 8, 2021 7:30–8:30 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY 8:30–9:00 PM EST OPEN SESSION 8:30 PM Sponsor Perspective on Charge to the Committee 8:45 PM Q&A for Sponsor 9:00–9:30 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY 9:30 PM Adjourn Wednesday, March 10, 2021 7:00–9:00 AM EST OPEN SESSION 7:00 AM Welcome and Opening Remarks 7:10 AM COVID-19 Response: Lessons Learned Nadine Rouphael Department of Medicine, Division of Infectious Diseases Emory University School of Medicine 7:30 AM Discussion with Committee 7:45 AM Regulatory Pathways in the United States to Facilitate Vaccine Availability Peter Marks Center for Biologics Evaluation and Research U.S. Food and Drug Administration 8:00 AM Discussion with Committee 8:10 AM Break Read the entire page →
From page 145... ... APPENDIX D 145 8:15 AM Overview of the Influenza Vaccines R&D Roadmap and the Universal Influenza Vaccine Technology Landscape Julie Ostrowsky Center for Infectious Disease Research and Policy University of Minnesota 8:40 AM Discussion with Committee 8:55 AM Break 9:00–10:00 AM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY 10:00 AM Adjourn Morning Session Wednesday, March 10, 2021 3:30–6:30 PM EST CLOSED SESSION Second Committee Meeting March 30, 2021 3:00–6:00 PM EST Virtual Meeting Objectives • Review key discussion points of previous meeting • Address the current state of basic/translational science of influenza vaccines • Address the implications of "lessons learned" from COVID-19 on basic/ translational science of influenza vaccines • Discuss the potential application of emerging technologies to seasonal or pandemic influenza outbreaks • Identify information needs and future meeting topics March 30, 2021 3:00–4:30 PM EST OPEN SESSION 3:00 PM Welcome, Review of Previous Session Read the entire page →
From page 146... ... 146 VACCINE RESEARCH AND DEVELOPMENT 3:10 PM Broadly Protective and Universal Influenza Virus Vaccines in Development Florian Krammer Professor in Vaccinology Department of Microbiology Icahn School of Medicine at Mount Sinai 3:25 PM Discussion with Committee 3:35 PM Perspective on Lessons from the COVID-19 Vaccine Experience Barney Graham Deputy Director, Vaccine Research Center Chief, Viral Pathogenesis Laboratory and Translational Science Core National Institutes of Health 3:50 PM Discussion with Committee 4:00 PM Vaccinating Against Influenza Viruses: Can New Memory Be Induced When Old Memory Is Recalled Annette Fox Senior Research Scientist World Health Organization Collaborating Centre for Reference and Research on Influenza University of Melbourne 4:15 PM Discussion with Committee 4:25 PM Break, End of Open Session 4:30–6:00 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY Read the entire page →
From page 147... ... APPENDIX D 147 Third Committee Meeting April 15, 2021 3:00–6:00 PM EST Virtual Meeting Objectives • Review key discussion points of previous meeting • Continue discussion of basic/translational science of vaccine research and development • Identify priority goals for future research and development, including potential timelines and actors • Discuss needs and mechanisms for global collaboration, highlighting issues of equity • Identify information needs and future meeting topics April 15, 2021 3:00–4:15 PM EST OPEN SESSION 3:00 PM Welcome, Review of Previous Session 3:10 PM Overview of Novel Platforms in Influenza Vaccine and Integrating Lessons from COVID-19 Rebecca Cox Professor of Medical Virology and Head of the Influenza Centre University of Bergen 3:25 PM Discussion with Committee 3:35 PM Lessons Learned from COVID-19 Vaccine Development Melanie Seville Director of Vaccine Development Coalition for Epidemic Preparedness Innovations 3:50 PM Discussion with Committee 4:10 PM Break, End of Open Session Read the entire page →
From page 148... ... 148 VACCINE RESEARCH AND DEVELOPMENT 4:15–6:00 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY Fourth Committee Meeting April 28, 2021 3:00–6:00 PM EST Virtual Meeting Objectives • Review key discussion points of previous meeting • Address the current state of clinical science of influenza vaccines • Address the implications of "lessons learned" from COVID-19 on clinical sci ence of influenza vaccines • Discuss the potential application of emerging technologies to seasonal or pandemic influenza outbreaks April 28, 2021 3:00–3:20 PM EST CLOSED SESSION 3:20–4:30 PM EST OPEN SESSION 3:20 PM Introduction to Open Session 3:30 PM Overview of Vaccine Clinical Trials in Lower- and Middle-Income Countries Milagritos Tapia Professor of Pediatrics and Medicine University of Maryland at Baltimore 3:45 PM Discussion with Committee 4:00 PM Influenza Vaccines in LMICs: Manufacturing and Feasibility Considerations Kathy Neuzil Director, Center for Vaccine Development University of Maryland School of Medicine Read the entire page →
From page 149... ... APPENDIX D 149 4:15 PM Discussion with Committee 4:25 PM Break, End of Open Session 4:30–6:00 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY Fifth Committee Meeting May 12, 2021 8:00–11:00 AM EST Virtual Meeting Objectives • Review key discussion points of previous meeting • Continue discussion of clinical science of vaccine research and development • Identify priority goals for future research and development, including potential timelines and actors • Discuss needs and mechanisms for global collaboration, highlighting issues of equity • Identify information needs and future meeting topics May 12, 2021 8:00–9:30 AM EST OPEN SESSION 8:00 AM Introduction to Open Session 8:10 AM Lessons from COVID-19 for Influenza Preparedness Jerome Kim Director General International Vaccine Institute 8:25 AM Discussion with Committee Read the entire page →
From page 150... ... 150 VACCINE RESEARCH AND DEVELOPMENT 8:35 AM Understanding Vaccine Effectiveness: Lessons from COVID-19 and Applications for Influenza Ben Cowling Professor of Epidemiology and Biostatistics School of Public Health The University of Hong Kong 8:50 AM Discussion with Committee 9:00 AM Successes and Challenges in Monitoring Vaccine Safety in the United States Grace Lee Professor of Pediatrics Stanford University School of Medicine 9:30 AM Break, End of Open Session 9:30–11:00 AM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY Sixth Committee Meeting May 26, 2021 3:00–6:00 PM EST Virtual Meeting Objectives • Address the current state of manufacturing and regulatory science of influ enza vaccines • Address the implications of "lessons learned" from COVID-19 on manufactur ing and regulatory science of influenza vaccines • Discuss the potential application of emerging technologies to seasonal and pandemic influenza outbreaks nationally and globally • Identify conclusions and recommendations for best practices in manufactur ing and regulatory science • Identify information needs and future meeting topics Read the entire page →
From page 151... ... APPENDIX D 151 May 26, 2021 3:00–4:30 PM EST OPEN SESSION 3:00 PM Welcome, Review of Previous Session 3:05 PM Successes in Technology Transfer and Manufacturing Partnerships: Lessons from COVID-19 and Applications for Influenza Maria Elena Bottazi Associate Dean and Professor Baylor College of Medicine 3:15 PM Discussion with Committee 3:25 PM Manufacturing Science of Influenza Vaccine Research and Development Robert Johnson Director, Influenza and Emerging Infectious Diseases Division and COVID-19 Incident Manager Biomedical Advanced Research Development Authority 3:35 PM Discussion with Committee Developing Vaccines in the Era of Genomics 3:45 PM Rino Rappuoli Chief Scientist and Head of External Research and Development GlaxoSmithKline 3:55 PM Discussion with Committee Manufacturing Science of Influenza Vaccine 4:05 PM R&D: Mind the Adjacencies David Kaslow Chief Scientific Officer PATH 4:15 PM Discussion with Committee 4:30 PM Break, End of Open Session Read the entire page →
From page 152... ... 152 VACCINE RESEARCH AND DEVELOPMENT 4:30 PM–6:00 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY Seventh Committee Meeting June 10, 2021 3:00–6:00 PM EST Virtual Meeting Objectives • Address the current state of regulatory science of influenza vaccines • Address the implications of "lessons learned" from COVID-19 on regulatory science of influenza vaccines • Discuss the potential application of emerging technologies to seasonal or pandemic influenza outbreaks nationally and globally • Identify conclusions and recommendations for best practices in regulatory science June 10, 2021 3:00–4:30 PM EST OPEN SESSION 3:00 PM Welcome 3:10 PM Opening Remarks by Joshua Sharfstein 3:15 PM Key Considerations for Vaccine Research and Development Phil Dormitzer Vice President and Chief Scientific Officer: Viral Vaccines Pfizer Inc. Key Considerations for Vaccine Research and 3:30 PM Development Rita Helfand Chair World Health Organization Global Advisory Committee for Vaccine Safety Read the entire page →
From page 153... ... APPENDIX D 153 3:25 PM Key Considerations for Vaccine Research and Development Nicole Lurie Director, Strategic Advisor to the Chief Executive Officer Coalition for Epidemic Preparedness Initiatives 3:30 PM Panel: Regulatory Science of Vaccine Development 4:30 PM Break, End of Open Session 4:30–6:00 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY Read the entire page →

From page 143...

... Appendix D Public Meeting Agendas Committee on Vaccine Research and Development for Advancing Pandemic and Seasonal Influenza Preparedness and Response First Committee Meeting Agenda March 8 and 10, 2021 Orientation and Conflict of Interest Discussion: March 8, 7:00–9:30 PM EST Speaker Session: March 10, 7:00–10:00 AM EST Planning/Working Session: March 10, 3:30–6:30 PM EST Virtual Meeting Objectives • Conduct committee and staff introductions • Orient the committee to the National Academies consensus study process • Conduct the bias and conflict of interest discussion • Hold on open session to hear from sponsoring agency on its perspective of the Statement of Task and to hear from relevant stakeholders • Discuss the Statement of Task and work plan and agree on approach to completing the task • Identify information needs and future meeting topics 143

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From page 144...

... 144 VACCINE RESEARCH AND DEVELOPMENT Monday, March 8, 2021 7:30–8:30 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY 8:30–9:00 PM EST OPEN SESSION 8:30 PM Sponsor Perspective on Charge to the Committee 8:45 PM Q&A for Sponsor 9:00–9:30 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY 9:30 PM Adjourn Wednesday, March 10, 2021 7:00–9:00 AM EST OPEN SESSION 7:00 AM Welcome and Opening Remarks 7:10 AM COVID-19 Response: Lessons Learned Nadine Rouphael Department of Medicine, Division of Infectious Diseases Emory University School of Medicine 7:30 AM Discussion with Committee 7:45 AM Regulatory Pathways in the United States to Facilitate Vaccine Availability Peter Marks Center for Biologics Evaluation and Research U.S. Food and Drug Administration 8:00 AM Discussion with Committee 8:10 AM Break

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From page 145...

... APPENDIX D 145 8:15 AM Overview of the Influenza Vaccines R&D Roadmap and the Universal Influenza Vaccine Technology Landscape Julie Ostrowsky Center for Infectious Disease Research and Policy University of Minnesota 8:40 AM Discussion with Committee 8:55 AM Break 9:00–10:00 AM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY 10:00 AM Adjourn Morning Session Wednesday, March 10, 2021 3:30–6:30 PM EST CLOSED SESSION Second Committee Meeting March 30, 2021 3:00–6:00 PM EST Virtual Meeting Objectives • Review key discussion points of previous meeting • Address the current state of basic/translational science of influenza vaccines • Address the implications of "lessons learned" from COVID-19 on basic/ translational science of influenza vaccines • Discuss the potential application of emerging technologies to seasonal or pandemic influenza outbreaks • Identify information needs and future meeting topics March 30, 2021 3:00–4:30 PM EST OPEN SESSION 3:00 PM Welcome, Review of Previous Session

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From page 146...

... 146 VACCINE RESEARCH AND DEVELOPMENT 3:10 PM Broadly Protective and Universal Influenza Virus Vaccines in Development Florian Krammer Professor in Vaccinology Department of Microbiology Icahn School of Medicine at Mount Sinai 3:25 PM Discussion with Committee 3:35 PM Perspective on Lessons from the COVID-19 Vaccine Experience Barney Graham Deputy Director, Vaccine Research Center Chief, Viral Pathogenesis Laboratory and Translational Science Core National Institutes of Health 3:50 PM Discussion with Committee 4:00 PM Vaccinating Against Influenza Viruses: Can New Memory Be Induced When Old Memory Is Recalled Annette Fox Senior Research Scientist World Health Organization Collaborating Centre for Reference and Research on Influenza University of Melbourne 4:15 PM Discussion with Committee 4:25 PM Break, End of Open Session 4:30–6:00 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY

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From page 147...

... APPENDIX D 147 Third Committee Meeting April 15, 2021 3:00–6:00 PM EST Virtual Meeting Objectives • Review key discussion points of previous meeting • Continue discussion of basic/translational science of vaccine research and development • Identify priority goals for future research and development, including potential timelines and actors • Discuss needs and mechanisms for global collaboration, highlighting issues of equity • Identify information needs and future meeting topics April 15, 2021 3:00–4:15 PM EST OPEN SESSION 3:00 PM Welcome, Review of Previous Session 3:10 PM Overview of Novel Platforms in Influenza Vaccine and Integrating Lessons from COVID-19 Rebecca Cox Professor of Medical Virology and Head of the Influenza Centre University of Bergen 3:25 PM Discussion with Committee 3:35 PM Lessons Learned from COVID-19 Vaccine Development Melanie Seville Director of Vaccine Development Coalition for Epidemic Preparedness Innovations 3:50 PM Discussion with Committee 4:10 PM Break, End of Open Session

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From page 148...

... 148 VACCINE RESEARCH AND DEVELOPMENT 4:15–6:00 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY Fourth Committee Meeting April 28, 2021 3:00–6:00 PM EST Virtual Meeting Objectives • Review key discussion points of previous meeting • Address the current state of clinical science of influenza vaccines • Address the implications of "lessons learned" from COVID-19 on clinical sci ence of influenza vaccines • Discuss the potential application of emerging technologies to seasonal or pandemic influenza outbreaks April 28, 2021 3:00–3:20 PM EST CLOSED SESSION 3:20–4:30 PM EST OPEN SESSION 3:20 PM Introduction to Open Session 3:30 PM Overview of Vaccine Clinical Trials in Lower- and Middle-Income Countries Milagritos Tapia Professor of Pediatrics and Medicine University of Maryland at Baltimore 3:45 PM Discussion with Committee 4:00 PM Influenza Vaccines in LMICs: Manufacturing and Feasibility Considerations Kathy Neuzil Director, Center for Vaccine Development University of Maryland School of Medicine

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From page 149...

... APPENDIX D 149 4:15 PM Discussion with Committee 4:25 PM Break, End of Open Session 4:30–6:00 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY Fifth Committee Meeting May 12, 2021 8:00–11:00 AM EST Virtual Meeting Objectives • Review key discussion points of previous meeting • Continue discussion of clinical science of vaccine research and development • Identify priority goals for future research and development, including potential timelines and actors • Discuss needs and mechanisms for global collaboration, highlighting issues of equity • Identify information needs and future meeting topics May 12, 2021 8:00–9:30 AM EST OPEN SESSION 8:00 AM Introduction to Open Session 8:10 AM Lessons from COVID-19 for Influenza Preparedness Jerome Kim Director General International Vaccine Institute 8:25 AM Discussion with Committee

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From page 150...

... 150 VACCINE RESEARCH AND DEVELOPMENT 8:35 AM Understanding Vaccine Effectiveness: Lessons from COVID-19 and Applications for Influenza Ben Cowling Professor of Epidemiology and Biostatistics School of Public Health The University of Hong Kong 8:50 AM Discussion with Committee 9:00 AM Successes and Challenges in Monitoring Vaccine Safety in the United States Grace Lee Professor of Pediatrics Stanford University School of Medicine 9:30 AM Break, End of Open Session 9:30–11:00 AM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY Sixth Committee Meeting May 26, 2021 3:00–6:00 PM EST Virtual Meeting Objectives • Address the current state of manufacturing and regulatory science of influ enza vaccines • Address the implications of "lessons learned" from COVID-19 on manufactur ing and regulatory science of influenza vaccines • Discuss the potential application of emerging technologies to seasonal and pandemic influenza outbreaks nationally and globally • Identify conclusions and recommendations for best practices in manufactur ing and regulatory science • Identify information needs and future meeting topics

Read the entire page →

From page 151...

... APPENDIX D 151 May 26, 2021 3:00–4:30 PM EST OPEN SESSION 3:00 PM Welcome, Review of Previous Session 3:05 PM Successes in Technology Transfer and Manufacturing Partnerships: Lessons from COVID-19 and Applications for Influenza Maria Elena Bottazi Associate Dean and Professor Baylor College of Medicine 3:15 PM Discussion with Committee 3:25 PM Manufacturing Science of Influenza Vaccine Research and Development Robert Johnson Director, Influenza and Emerging Infectious Diseases Division and COVID-19 Incident Manager Biomedical Advanced Research Development Authority 3:35 PM Discussion with Committee Developing Vaccines in the Era of Genomics 3:45 PM Rino Rappuoli Chief Scientist and Head of External Research and Development GlaxoSmithKline 3:55 PM Discussion with Committee Manufacturing Science of Influenza Vaccine 4:05 PM R&D: Mind the Adjacencies David Kaslow Chief Scientific Officer PATH 4:15 PM Discussion with Committee 4:30 PM Break, End of Open Session

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From page 152...

... 152 VACCINE RESEARCH AND DEVELOPMENT 4:30 PM–6:00 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY Seventh Committee Meeting June 10, 2021 3:00–6:00 PM EST Virtual Meeting Objectives • Address the current state of regulatory science of influenza vaccines • Address the implications of "lessons learned" from COVID-19 on regulatory science of influenza vaccines • Discuss the potential application of emerging technologies to seasonal or pandemic influenza outbreaks nationally and globally • Identify conclusions and recommendations for best practices in regulatory science June 10, 2021 3:00–4:30 PM EST OPEN SESSION 3:00 PM Welcome 3:10 PM Opening Remarks by Joshua Sharfstein 3:15 PM Key Considerations for Vaccine Research and Development Phil Dormitzer Vice President and Chief Scientific Officer: Viral Vaccines Pfizer Inc. Key Considerations for Vaccine Research and 3:30 PM Development Rita Helfand Chair World Health Organization Global Advisory Committee for Vaccine Safety

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From page 153...

... APPENDIX D 153 3:25 PM Key Considerations for Vaccine Research and Development Nicole Lurie Director, Strategic Advisor to the Chief Executive Officer Coalition for Epidemic Preparedness Initiatives 3:30 PM Panel: Regulatory Science of Vaccine Development 4:30 PM Break, End of Open Session 4:30–6:00 PM EST CLOSED SESSION -- COMMITTEE MEMBERS ONLY

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Appendix D: Public Meeting Agendas Pages 143-154

Appendix D: Public Meeting Agendas
Pages 143-154