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Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
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Appendix C


Agenda

Potential Risks and Benefits of Gain-of-Function Research
Symposium Agenda
National Academy of Sciences Building
2101 Constitution Avenue NW
Washington, DC 20036
December 15–16, 2014

Monday, December 15

7:30 am

Registration

(coffee and tea will be served)

8:00

Welcome

Harvey Fineberg, Chair of Symposium Planning Committee, Moderator

Ralph Cicerone, President, National Academy of Sciences and Chairman, National Research Council

Victor Dzau, President, Institute of Medicine

8:15

Session 1: Opening Remarks

Moderator: Harvey Fineberg

Goals of the Symposium: Discussion of Potential Benefits and Risks of Gain-of-Function (GoF) Research and Identification of Key Principles and Considerations for Risk/Benefit Assessment (10 minutes)

Harvey Fineberg

Summary of Recent European Meetings on GoF Research (5 minutes)

Harvey Fineberg

Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×

Current U.S. Government Policy on GoF Research Proposals and Charge to the Academies (15 minutes)

Andrew Hebbeler, Assistant Director for Biological and Chemical Threats, Office of Science and Technology Policy, The White House

Mary Groesch, Senior Policy Advisor, National Institutes of Health (NIH)

Summary of and Response to October 22, 2014, National Science Advisory Board for Biosecurity (NSABB) Meeting (15 minutes)

Samuel Stanley, Chair of the NSABB

Moderated Discussion (15 minutes)

To clarify or expand on key issues that emerge from the presentations

9:15

Session 2: Overview

Moderator: Harvey Fineberg

Purpose: To provide a brief introduction to the current scientific and technical approaches to virology research and the study of pandemic avian influenza, Severe Acute Respiratory Syndrome (SARS), and Middle East Respiratory Syndrome (MERS).

Speaker: Kanta Subbarao, National Institute of Allergy and Infectious Diseases (NIAID)/NIH (20 minutes)

Virology: What impact does virological research typically have on the viruses being studied? Where does virology cross the line into GoF research as defined by the U.S. government? Explanation of types of GoF research.

What do we know or not know about flu, SARS, and MERS and can GoF research help fill the gaps?

Moderated panel discussion (20 minutes)

To clarify or expand on key issues that emerge from the presentations

Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×

Panelists

  • Thomas Briese, Columbia University
  • Michael Imperiale, University of Michigan

Q&A Discussion (20 minutes)

10:15

Session 3: What Are the Main Points of the Debate on the Potential Risks and Benefits of GoF Research?

Moderator: Harvey Fineberg

Two Views (15 minutes each)

What are the key issues on benefits that need to be addressed in the assessments that the NIH will undertake?

Yoshihiro Kawaoka, University of Wisconsin-Madison

What are the key issues on risks that need to be addressed in the assessments that the NIH will undertake?

David Relman, Stanford University

Respondent: Robert Webster, member of Symposium

Planning Committee (15 minutes)

To probe and explore the evidence for the statements made by speakers above.

Q&A Discussion (30 minutes)

11:30

Break

12:00 pm

Session 4: Potential Benefits of GoF Research I: Surveillance, Detection, and Prediction

Moderator: Philip Dormitzer, member of Symposium Planning Committee

Focus: Potential for contributions to public health and biosecurity (early detection and identification of dangerous strains) as well as design and operation of disease surveillance or pandemic modeling systems.

Surveillance of emerging zoonotic diseases (10 minutes)

Stacey Schultz-Cherry, St. Jude Children’s Research Hospital

Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×

Modeling of potential pandemics (10 minutes)

Christophe Fraser, Imperial College, London

Respondent: Colin Russell, University of Cambridge

Q&A Discussion (30 minutes)

1:00

Lunch

(boxed lunches will be provided)

2:00

Session 5: Potential Benefits of GoF Research II: Treatment and Response

Moderator: Baruch Fischhoff, member of Symposium Planning Committee

Focus: Potential for GoF research to accelerate vaccine and antiviral development and potential impact of GoF regulations on vaccine and antiviral development.

Panel of Academic, Government, and Industry

Representatives (5 minutes each)

Philip Dormitzer, Novartis Vaccines—synthetic influenza vaccine viruses

Ralph Baric, University of North Carolina—vaccines targeting coronaviruses

George Kemble, 3-V Biosciences (formerly Medimmune)—GoF and live attenuated influenza viruses

Jerry Weir, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration—regulatory perspective on viral manipulation for biologics

Mark Denison, Vanderbilt University—GoF research and countermeasures against SARS and MERS

Moderated Discussion (15 minutes)

To clarify or expand on key issues that emerge from the presentations

Q&A Discussion (30 minutes)

Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×

3:15

Session 6: Potential Risks of GoF Research I: Biosafety

Moderator: Alta Charo, member of Symposium Planning Committee

Focus: Potential for inadvertent releases, laboratory acquired infections, environmental health issues, and risk mitigation for pathogen research in general and as related to GOF research.

Panel Discussion (10 minutes each)

Barbara Johnson, Biosafety Biosecurity International

Rob Weyant, Division of Select Agents and Toxins, U.S. Centers for Disease Control and Prevention

Rebecca Moritz, Biosecurity Task Force, University of Wisconsin-Madison

Marc Lipsitch, Harvard University

Q&A Discussion (30 minutes)

4:30

Session 7: Potential Risks of GOF Research II: Biosecurity

Moderator: Ronald Atlas, member of Symposium Planning Committee

Focus: Potential for misuse of research for biocrimes or bioterrorism or to develop new biological weapons, as well as the potential for deliberate release or sabotage.

Speakers (10 minutes each)

Gregory Koblentz, George Mason University

Carol Linden, Biomedical Advanced Research and Development Authority

Gigi Kwik Gronvall, University of Pittsburgh Medical Center (UPMC) Center for Health Security

Q&A Discussion (30 minutes)

5:30

Adjourn for the day

Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×

Tuesday, December 16

7:45 am

Welcome

(continental breakfast will be provided)

8:00

Session 8: Models for Risk/Benefit Assessment, Risk Mitigation, and Engaging the Public

Moderator: Charles Haas, member of the Symposium Planning Committee

What can risk/benefit assessment do and what can it not do? What have we learned from the past about strategies, pitfalls, and limitations of risk and benefit assessments? (15 minutes)

Baruch Fischhoff, member of the Symposium Planning Committee

The role of human factors (15 minutes)

Gavin Huntley-Fenner, Huntley-Fenner Advisors

Ensuring public engagement (15 minutes)

Monica Schoch-Spana, UPMC Center for Health Security

What, if any, special considerations about GoF research need to be taken into account in the risk/benefit assessment? (30 minutes)

Ralph Baric, member of the Symposium Planning Committee

Robert Lamb, Northwestern University

  • - Reversibility/mitigation?
  • - Special considerations about alternative research methods with less risk?
  • - Differences among organisms?
  • - Exactly what functionality is being gained or lost?
  • - Are transmissibility, virulence, growth, and functionality (necessary for vaccine production) all similar in terms of GOF objectives?

Q&A Discussion (45 minutes)

Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×

10:00

Session 9: Summary Discussions

Moderator: Harvey Fineberg

The rapporteurs will report on the main ideas collected on each of the following topics:

  • - Potential risks
  • - Potential benefits
  • - Considerations/challenges for analysis of potential risks and benefits to Inform broader assessments
  • - Policy implications

11:00

Break (substantial snacks will be served, because there will be no lunch break)

11:30

Session 10: Finding Common Ground

Moderator: Harvey Fineberg

  • What are the major areas of agreement on risks and benefits?
  • What are the major areas of disagreement on risks and benefits?
  • How should the risks be weighed against the benefits?
  • What approaches may be available to diminish risks and achieve benefits
    simultaneously?
  • What are the key principles and issues that the NIH’s risk and benefit assessments need to include?

Moderated Discussion (approximately 2 hours)

1:30

Session 11: Chairman’s Summary of Meeting Highlights

2:00

Adjourn

Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×

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Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×
Page 95
Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×
Page 96
Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×
Page 97
Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×
Page 98
Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×
Page 99
Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×
Page 100
Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×
Page 101
Suggested Citation:"Appendix C: Agenda." Institute of Medicine and National Research Council. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21666.
×
Page 102
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On October 17, 2014, spurred by incidents at U.S. government laboratories that raised serious biosafety concerns, the United States government launched a one-year deliberative process to address the continuing controversy surrounding so-called "gain-of-function" (GOF) research on respiratory pathogens with pandemic potential. The gain of function controversy began in late 2011 with the question of whether to publish the results of two experiments involving H5N1 avian influenza and continued to focus on certain research with highly pathogenic avian influenza over the next three years. The heart of the U.S. process is an evaluation of the potential risks and benefits of certain types of GOF experiments with influenza, SARS, and MERS viruses that would inform the development and adoption of a new U.S. Government policy governing the funding and conduct of GOF research.

Potential Risks and Benefits of Gain-of-Function Research is the summary of a two-day public symposia on GOF research. Convened in December 2014 by the Institute of Medicine and the National Research Council, the main focus of this event was to discuss principles important for, and key considerations in, the design of risk and benefit assessments of GOF research. Participants examined the underlying scientific and technical questions that are the source of current discussion and debate over GOF research involving pathogens with pandemic potential. This report is a record of the presentations and discussion of the meeting.

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