Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop (2015)
Chapter: 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 |
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 |
Panelists
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 |
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) |
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 |
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
Q&A Discussion (45 minutes) |
10:00 | Session 9: Summary Discussions Moderator: Harvey Fineberg The rapporteurs will report on the main ideas collected on each of the following topics:
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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
Moderated Discussion (approximately 2 hours) |
1:30 | Session 11: Chairman’s Summary of Meeting Highlights |
2:00 | Adjourn |
