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
7:30am 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
Amy Patterson, Associate Director for Biosecurity and Biosecurity Policy, 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
• 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 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 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 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 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)
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, as 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 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