Virtual Meeting

Federal Register Notice

Webcast

• Link to webcast for Day 1 (November 9, 2020)
• Link to webcast for Day 2 (November 10, 2020)

Agenda

• NExTRAC November 2020 Meeting Agenda

Meeting

• NExTRAC November 2020 Meeting Minutes

Draft Report of the Working Group to Establish a NExTRAC Framework

• Draft Report of the Working Group to Establish a NExTRAC Framework
• The draft report of the Working Group to Establish a NExTRAC Framework was prepared in response to the charge given by the NIH Director at the December 2019 NExTRAC meeting to:
  • “Describe effective approaches for prospectively identifying emerging biotechnologies or specific applications with reasonable potential to have important scientific, safety, or ethical considerations
  • Conceptualize a framework for NExTRAC deliberation of issues surrounding emerging biotechnologies and applications, including:
    • Guiding principles for when an emerging biotechnology or its applications would significantly benefit from further public deliberation
    • A potential process by which the NExTRAC will consider or evaluate any given emerging biotechnology or its applications”

Additional Meeting Materials

• NExTRAC Roster
• Gene Drives in Biomedical Research Working Group Roster
• Working Group to Establish a NExTRAC Framework Roster
• NExTRAC Member and Working Group Member Bios
• Speaker Bios

Slides

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SESSION I: GENE DRIVES IN BIOMEDICAL RESEARCH

• Overview of Charge to the Gene Drives in Biomedical Research Working Group, Zach Adelman, Ph.D. and Cinnamon Bloss, Ph.D. November 9, 2020
• Overview of Gene Drive Technologies and Applications, Anthony James, Ph.D. November 9, 2020

SESSION II: BIOSAFETY GUIDANCE FOR CONTAINED RESEARCH

• Overview: NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and Biosafety in Microbiological and Biomedical Laboratories (BMBL), Kathryn Harris, Ph.D., RBP, November 9, 2020
• Biosafety Guidance for Contained Research with Arthropod Vector Species, Lyric Bartholomay, Ph.D. November 9, 2020
• Biosafety Guidance for Contained Research with Gene Drive Modified Organisms – A Biosafety Officer’s Perspective, David Gillum, MS RBP, November 9, 2020
• Contained Insectary of PoloGGB Terni, Italy, Ruth Müller, Ph.D. November 9, 2020

SESSION III: SCIENCE OF BIOLOGICAL AND ENVIRONMENTAL RISK MITIGATION APPROACHES

• Science of Biological and Environmental Risk Mitigation Approaches, Antoinette Piaggio, Ph.D. November 9, 2020
• State of the Art Strategies for Gene Drive and Biological Risk Mitigation, Omar Akbari, Ph.D. November 9, 2020
• Not All Gene Drives Are Created Equal, Fred Gould, Ph.D. November 9, 2020
• Prospects and Limitations of Modeling in the Assessment of Gene Drive Systems, Philipp Messer, Ph.D. November 9, 2020

SESSION IV: STRATEGIES FOR ASSESSING RISK AND BENEFIT FOR GENE DRIVE FIELD RELEASE

• Strategies for Assessing Risk and Benefit for Gene Drive Field Release, Keith Hayes, Ph.D. November 9, 2020
• Risk Assessment for Native vs. Invasive Species, Limited Gene Drive Spread, Gene Flow, Raul Medina, Ph.D. November 9, 2020

SESSION V: US AND INTERNATIONAL POLICY DISCUSSIONS AND OVERSIGHT FRAMEWORKS FOR RESEARCH INVOLVING GENE DRIVE FIELD RELEASE

• Overview of the Recommendations from the 2016 National Academies’ Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values, Elizabeth Heitman, Ph.D. November 10, 2020
• Advances in Gene Drive Policy and Oversight, Stephanie James, Ph.D. November 10, 2020
• Overview of International Oversight – Experiences with CBD and Other Discussions of Gene Drives, Wadzanayi Mandivenyi, MS. November 10, 2020
• Moving Towards Gene Drive Field Trials? (Who, What, When, Where and Why), Todd Kuiken, Ph.D. November 10, 2020

SESSION VI: PUBLIC ENGAGEMENT- INPUT FROM LOCAL COMMUNITIES

• Large Scale Releases of Wolbachia Infected Aedes aegypti Male Mosquitoes in Residential Communities, Steve Mulligan, November 10, 2020

SESSION VII: STRATEGIES FOR STAKEHOLDER AND PUBLIC ENGAGEMENT

• Strategies for Stakeholder and Public Engagement, Abdoulaye Diabaté, Ph.D. November 10, 2020
• Linking Analysis and Public Deliberation: Lessons from Environmental Assessment and Decision Making, Thomas Dietz, Ph.D. November 10, 2020
• Public Engagement in Biotechnology Governance, Jennifer Kuzma, Ph.D. November 10, 2020

SESSION VIII: DRAFT REPORT OF THE WORKING GROUP TO ESTABLISH A NEXTRAC FRAMEWORK

• NExTRAC Framework Working Group, Margaret Riley, JD and Gigi Gronvall, Ph.D. November 10, 2020

Public Comments