Event Month: June

Virtual Meeting

Federal Register Notice

Webcast

• Link to webcast for Meeting (June 25, 2021)

Agenda

• NIH NExTRAC June 2021 Meeting Agenda

Minutes

• NIH NExTRAC June 2021 Meeting Minutes

Draft Report of the Gene Drives in Biomedical Research Working Group

• Draft Report of the Gene Drives in Biomedical Research Working Group

This is the draft report of the Gene Drives in Biomedical Research Working Group, which was prepared in response to the charge given by the NIH Director at the December 2019 NExTRAC meeting to:

• “Consider whether existing biosafety guidance is adequate for contained laboratory research utilizing gene drive technology
• Outline conditions (if any) under which NIH could consider supporting field release of gene drive modified organisms

and to provide advice on the following issues:

• Given the diverse applications and species that may be used in gene drive research with different risks, is the current landscape of biosafety guidance adequate for contained research?
• What knowledge and conditions should be in place to help ensure that field release research of gene drive modified organisms could be conducted safely and ethically?”

Additional Meeting Materials

This material contains content that is not fully supported by assistive technology. For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.

• NExTRAC Roster
• Gene Drives in Biomedical Research Working Group Roster
• NExTRAC Gene Drives in Biomedical Research Working Group, Cinnamon Bloss, Ph.D. and Zach Adelman, Ph.D. June 25, 2021
• Charge to the NExTRAC, Lawrence A. Tabak, D.D.S., Ph.D. June 25, 2021

Public Comments

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

This material contains content that is not fully supported by assistive technology. For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.

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

Virtual Meeting

Federal Register Notice

Webcast

• Link to webcast for Meeting (June 25, 2021)

Agenda

• NIH NExTRAC June 2021 Meeting Agenda (Needs Link)

Draft Report of the Gene Drives in Biomedical Research Working Group

• Draft Report of the Gene Drives in Biomedical Research Working Group (Needs Link)

This is the draft report of the Gene Drives in Biomedical Research Working Group, which was prepared in response to the charge given by the NIH Director at the December 2019 NExTRAC meeting to:

• “Consider whether existing biosafety guidance is adequate for contained laboratory research utilizing gene drive technology
• Outline conditions (if any) under which NIH could consider supporting field release of gene drive modified organisms

and to provide advice on the following issues:

• Given the diverse applications and species that may be used in gene drive research with different risks, is the current landscape of biosafety guidance adequate for contained research?
• What knowledge and conditions should be in place to help ensure that field release research of gene drive modified organisms could be conducted safely and ethically?”

Additional Meeting Materials

This material contains content that is not fully supported by assistive technology. For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.

• NExTRAC Roster (Needs Link)
• Gene Drives in Biomedical Research Working Group Roster (Needs Link)
• NExTRAC Gene Drives in Biomedical Research Working Group, Cinnamon Bloss, Ph.D. and Zach Adelman, Ph.D. June 25, 2021 (Needs Link)
• Charge to the NExTRAC, Lawrence A. Tabak, D.D.S., Ph.D. June, 25 2021 (Needs Link)

Public Comments (Needs Link)