FNIH has been at the forefront of scientific developments in genetic biocontrol technology, including the development of gene drive mechanisms to address challenges such as the eradication
of insect-borne diseases


Perspectives of African Stakeholders on Gene Drives for Malaria Control and Elimination: A Multi-Country Survey

This multi-country study explores the insights and recommendations of key stakeholders across Africa on the potential of gene drive-modified mosquitoes for malaria control and elimination in the continent.

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Regulatory and Policy Considerations for Implementation of Gene Drive Mosquitoes

The current early stage of development is an opportune time to begin to consider the potential regulatory requirements for eventual implementation of gene drive technologies in national or regional public health programs.

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Independent Risk Assessment for Release of Genetically Modified Mosquitoes in Africa

FNIH sponsored an assessment by a neutral third party, CSIRO, of risks associated with release of genetically modified mosquitoes by the Target Malaria project.

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Requirements for Market Entry of Gene Drive-Modified Mosquitoes for Control of Vector-Borne Diseases: Analogies to Other Biologic and Biotechnology Products

It is important to begin now to consider approval procedures and market entry strategies for the eventual implementation of gene drive-modified mosquitoes.


Side Event on Capacity Strengthening for Risk Assessment at the 15th Conference of Parties of the Convention on Biological Diversity

Participants learned about tools and methods currently available to support decision making and risk assessment in the context of new genetic biocontrol technologies.

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Inaugural Gordon Research Conference 
on Genetic Biocontrol Technologies

A five-day conference 
explored genetic biocontrol as 
an approach for controlling or eliminating specific organisms that threaten public health, food security and biodiversity.

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Guidance for Containment of Gene Drive Arthropods

Updated guidance from the American Committee of Medical Entomology provides recommendations on containment practices for arthropods modified with engineered transgenes capable of gene drive.

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Workshop on Use of Modeling Tools for Decision-Making at Pan-African Mosquito Control Association

A three-day workshop, held 
in conjunction with the PAMCA annual conference, provided experience with tools and strategies to enhance in decision-making capacity.

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Points to Consider for Biosafety Approval of Genetic Biocontrol Products

This paper provides a generalizable tool for developers of genetic biocontrol products to understand the safety data and information likely to be required within the regulatory dossier.

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Series on Ethical 
Issues and Stakeholder Engagement in Gene Drive Research

The Gene Drive Research Forum provides a unique environment for interaction among a broad spectrum of stakeholders for engineered gene drive technologies.

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Guidance Framework 
for Testing Genetically Modified Mosquitoes, 2nd Edition

This updated WHO guidance recommends standards for quality and consistency among processes for testing and regulating new genetically modified mosquito technologies, including those incorporating gene drive.

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Participation in the Expert Advisory Group on Risk Assessment for the Convention on Biological Diversity

The FNIH participated in an ad hoc technical advisory group established by Parties to the Cartagena Protocol to consider specific issues regarding risk assessment of living modified organisms containing gene drives.

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Definition of Safety and Efficacy Criteria for Gene Drive Mosquitoes

A summary of discussions on efficacy and safety characteristics that must be met for an investigational gene drive-modified mosquito product to move from contained testing to field release.

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Launch of the African Genetic Biocontrol Consortium

The FNIH supported creation of the AGBC to provide a platform for interaction among African experts for technical capacity strengthening, knowledge exchange, and deliberation about new genetic biocontrol technologies.

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Launch of GeneConvene Global Collaborative

GeneConvene offers technical information, advice, training, and coordination for research on gene drive and other genetic biocontrol technologies – technologies that use genetic variants of a target species, like a disease-transmitting mosquito, to control its undesirable impacts.

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Workshop on Regulatory Science for Gene Drive Modified Insects

FNIH hosted a workshop to provide a deliberative space for international experts in regulatory science and risk assessment to consider whether gene drive products would present any new issues that are not addressed by regulatory frameworks.

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Inaugural Course on Gene Editing Technologies for Africa

This course provided an opportunity for African scientists to extend their professional expertise by obtaining a rigorous understanding of gene editing technologies and their underlying mechanisms.

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Independent Risk Assessment for Release 
of Genetically Modified Mosquitoes in Africa

FNIH sponsored an assessment by a neutral third party, CSIRO, of risks associated with release of genetically modified mosquitoes by the Target Malaria project.

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Guidance on Engaging Stakeholders in Research on Novel Vector Control Methods

These recommendations 
on practices for stakeholder engagement build on the knowledge and experience of practitioners and subject-matter experts from a large variety of fields.

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Consensus Recommendations for Safe and Ethical Testing of Gene Drive Mosquitoes for Malaria Control

The FNIH supported an international working group to develop recommendations describing the development pathway for gene drive-modified mosquitoes to control malaria in Africa.

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Problem Formulation for Gene Drive Mosquitoes Designed to Reduce Malaria Transmission in Africa: Results from Four Regional Consultations 2016–2018

A summary of deliberations from four regional consultative workshops to engage African stakeholders in considering protection goals and pathways relevant to the use of gene drive mosquitoes for malaria control.

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Guiding Principles for Gene Drive Research

This report, a product of the Gene Drive Research Forum, issues recommendations aimed at researchers, funders, and policy makers on actions important for minimizing potential risks of gene drive technologies and earning the confidence and support of the public.

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First Problem Formulation Workshop on Use of Gene Drive Mosquitoes

A report from the first international workshop organized to consider potential risks related to the use of gene drives in Anopheles gambiae for malaria control in Africa.

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Inaugural Meeting of 
the Gene Drive Research Forum

The Gene Drive Research Forum provides a unique environment for interaction among a broad spectrum of stakeholders for engineered gene drive technologies

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NASEM Report on Responsible Conduct of Research on Gene Drive Technologies

Recommendations from an FNIH-sponsored independent study on principles for responsible practices of gene drive research pertaining to technology development, ethics, public engagement, and risk assessment.

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Roundtable on Genetic Biocontrol for Malaria with African Academy of Science

The African Academy of Sciences and the FNIH co-hosted a roundtable discussion in Nairobi, Kenya, on the use of gene drive technology for malaria control.


Guidance Framework 
for Testing Genetically Modified Mosquitoes, 
1st Edition

Jointly commissioned by WHO and FNIH, this was the first comprehensive effort to summarize knowledge and best practices for safety and efficacy testing, stakeholder engagement and regulatory evaluation of genetically modified mosquitoes.

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Progress and Prospects for the Use of Genetically Modified Mosquitoes to Inhibit Disease Transmission

A report from an international technical consultation co-sponsored by WHO and FNIH to assess current progress and future development of genetically modified mosquito technologies for public health.

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Guidance for Contained Field Trials of Vector Mosquitoes Engineered 
to Contain a Gene Drive System

Recommendations of a scientific working group on the design and implementation of contained field trials to test the safety and efficacy of gene drive-modified mosquitoes.

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