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GeneConvene Snapshot

What is GeneConvene and what does it do?

The GeneConvene Global Collaborative is a program of the Foundation for the National Institutes of Health (FNIH), an independent not-for-profit organization that supports the mission of the U.S. National Institutes of Health (NIH). GeneConvene supports informed decision making about genetic biocontrol technologies, like gene drive mosquitoes. The program takes a neutral stance on these technologies and does not advocate for or against any stakeholder or technology. GeneConvene works with stakeholders to identify and address key questions, provide technical guidance, strengthen capacity and share information.

Mission

GeneConvene’s mission is to support coordination among stakeholders that enables the development and dissemination of scientific knowledge and agreed upon best practices and standards. It provides administrative, regulatory, and technical advice and training to advance responsible research and development and, if warranted, the responsible use of genetic biocontrol technologies to improve public health by reducing the transmission of diseases, like malaria.

History

GeneConvene was founded in July of 2020 as an initiative to advance the safe and responsible exploration of genetic biocontrol technologies, which are investigational public health tools that hold the potential to save lives by reducing the spread of malaria and other vector-borne illnesses.

Before GeneConvene was founded, several initiatives existed to generate discussion around the use of genetic biocontrol technologies. The FNIH was involved in the creation of the first edition of the Guidance Framework for Testing Genetically Modified Mosquitoes, published in 2014 by the World Health Organization (WHO) and partners, which would later be updated as a 2nd Edition in May of 2021, co-published by WHO and the FNIH/GeneConvene. FNIH co-sponsored the 2016 NASEM report, Gene Drives on the Horizon, which was a comprehensive analysis of the requirements for responsible research on this new technology.

Since its founding, GeneConvene has been involved in several initiatives to expand the conversation occurring around gene drive technology, including funding the African Genetic Biocontrol Consortium and co-authoring Regulatory and Policy Considerations for the Implementation of Gene Drive-Modified Mosquitoes to Prevent Malaria Transmission (2023).

Relationship to FNIH

The GeneConvene Global Collaborative is a program of the FNIH, which is a U.S. based not-for-profit organization working to advance biomedical discoveries. GeneConvene is governed by the FNIH Board of Directors, an expert Advisory Board and a Management Team.

GeneConvene Spokesperson Bios

  • Director

    Michael Santos, PhD

    Senior Vice President, Chief Population Health Science Officer

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    Michael Santos is Senior Vice President, Science Partnerships, and Chief Population Health Science Officer. He is responsible for a portfolio of programs supporting biomedical innovation to improve health and health equity globally. He also directs the GeneConvene Global Collaboration, an initiative advancing informed decision making about the development of genetic biocontrol technology for public health.

    Prior to joining the FNIH in 2019, Dr. Santos was at the Bill & Melinda Gates Foundation, where he served as a Deputy Director in the Global Health division accountable for strategy and operations across the Discovery & Translational Sciences, HIV, and TB programs. His responsibilities included developing investment strategies for emerging priorities, leading the team and processes that supported investment making and management, and reporting on team strategy and progress. He was also a Strategy Advisor on the Strategy, Innovation, and Impact team, developing perspectives on the philosophy of philanthropy.

    Previously Dr. Santos was a Principal at Boston Consulting Group, where he led projects on malaria, HIV, contraceptive technology, global health regulatory systems, and public radio and contributed to strategies in the energy and environment, health care, industrial goods, consumer, and retail sectors. His first career was astronomy: he holds a Ph.D. from Caltech and was a research fellow at the University of Cambridge and the Space Telescope Science Institute.

  • Director

    Brinda Dass, PhD

    Senior Technical Expert, Policy Lead for GeneConvene

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    Dr. Brinda Dass currently serves as Senior Technical Expert and Policy Lead for the GeneConvene Global Collaborative at the FNIH. Dr. Dass has a Ph.D. in cell and molecular biology, an MPH, and extensive experience in transgenic laboratory animal care and use, preclinical drug testing, clinical trial management, and review of new animal drug dossiers for genetically engineered products. Other special interests include the regulation of and policy development for engineered insects intended for population suppression, disease mitigation, and invasive species/environmental control.

    Their most recent contribution in the risk assessment space is as an expert member of the Convention on Biological Diversity Ad Hoc Technical Expert Group on Risk Assessment in March-April 2020 and Nov 2023.

    Prior to the FNIH and GeneConvene, Dr. Dass served as a Biologist for the FDA from 2012 to 2017. They have provided expert advice and guidance on a variety of topics related to the policy, regulation, and risk assessment of GM insects, especially mosquitos that spread human diseases such as Zika and Dengue, both within FDA as well as across US federal agencies, international organizations, and other stakeholder groups, including the public. They also represented the US FDA on various task forces related to the Zika health emergency, both at the national and international level. Additionally, they also represented the US government as an expert on an International Ad Hoc Expert Group organized by the Organization for Economic Cooperation and Development (OECD) for the preparation of the biology document on Aedes aegypti.

  • Director

    Stephanie James, PhD

    Senior Scientific Advisor, Population Health Science

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    Dr. James is Senior Scientific Advisor at the FNIH, where she works with the GeneConvene Global Collaborative and advises on other programs on global health research. She has a Ph.D. in microbiology, a background in research on parasitic diseases, and more than 30 years of experience leading global health programs.

    Prior to joining FNIH in 2004, Dr. James served as Chief of the Parasitology and International Programs Branch in the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, US National Institutes of Health, and subsequently as Deputy Director and director of the Global Infectious Disease program at The Ellison Medical Foundation. At FNIH, she served as Director of the Grand Challenges in Global Health Initiative and Director of Science from 2008–2018; Acting Executive Director in 2012; and Senior Vice President for Science from 2018 to 2021. She was the founding Director of the GeneConvene Global Collaborative. Dr. James has served on multiple international advisory committees, including to the World Health Organization, the US Agency for International Development, the Burroughs Wellcome Fund, and the U.S.-Japan Cooperative Medical Sciences Program. In 1998, she was elected President of the American Society of Tropical Medicine and Hygiene, and is presently a Fellow of that society.

  • Director

    Royden Saah

    Senior Technical Expert for Scientific Partnerships at GeneConvene

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    Royden Saah serves as the Senior Technical Expert for Scientific Partnerships at GeneConvene. In his role, Royden utilizes his expertise in One-Health, infectious disease, and gene-drives to foster cooperation among governmental, academic, non-governmental, and transnational organizations. Working with partners including the African Union, WHO, and others, he promotes collaborations to build knowledge, capacity, and institutions in advance of technology intended to mitigate the impact of malaria.

    Prior to joining the FNIH, for 7 years he coordinated an international program to develop multiple, genetic biocontrol tools for use in preventing extinctions. In that role, he organized governments, universities and non-profits from the US, Australia, and New Zealand to formally work together as part of The Genetic Biocontrol of Invasive Rodents consortium (GBIRd). Previous to his environmental work, Royden spent 12 years in the NC Division of Public Health leading multiple laboratories dedicated to the prevention, detection and response to high-consequence pathogens. In 2020, he worked in the National Coordination Center as a WHO GOARN volunteer to increase the ability to detect and understand COVID-19 presence and spread in Papua New Guinea. In 2015 he worked with Médecins Sans Frontières (MSF) in Liberia to create biosafety processes and build a pediatric hospital. From 2008-2014, he conducted projects with the Guyana Ministry of Health, Centers for Disease Control and Prevention (CDC), and the Association of Public Health Labs to build infectious disease detection and response capacity in Guyana.

    Royden brings passion to his endeavors and remains a fierce advocate of public health, health equity, mental health, and social justice, working and volunteering on the ground and at policy level to reduce suffering globally.

Program Milestones

September 2022: Workshop on Use of Modeling Tools for Decision Making at Pan-African Mosquito Control Association

2021: Virtual Panel Series on Unsettled Ethical Issues and Stakeholder Engagement in Gene Drive Research

2020: Launch of The African Genetic Biocontrol Consortium

Frequently Asked Questions

About GeneConvene
Is GeneConvene affiliated with the NIH?

The GeneConvene Global Collaborative is a program of the Foundation for the National Institutes of Health (FNIH), a U.S. not-for-profit 501(c)3 charitable organization created to advance biomedical discoveries that lead to improved health outcomes.

Who funds GeneConvene?

As a program of the FNIH, GeneConvene is funded by its generous donors, primarily The Bill & Melinda Gates Foundation.

Does GeneConvene take a position on the use of gene drive mosquitoes for malaria control?

No. GeneConvene serves as a neutral convener to inform stakeholders about responsible decision making strategies for genetic biocontrol approaches and does not advocate for or against the use of gene drive mosquitoes.

Does GeneConvene oversee or conduct gene drive research?

No. As a neutral body, GeneConvene does not lead or conduct research. The program also does not fund research directly or make decisions for funders.

Which groups of stakeholders does GeneConvene work with on a regular basis?

GeneConvene works with stakeholders from the research community and funding agencies, product development professionals, regulators, and others from the academic, for-profit, government, and not-for-profit sectors who are interested in how gene drive technologies might be used for conservation, food security and agriculture, or public health.

About gene drive and genetic biocontrol
What is genetic biocontrol?

Biocontrol, short for biological control, refers to the use of living organisms to manage pest populations. Genetic biocontrol is a form of biocontrol using genetically modified forms of the target or pest species to reduce or eliminate the threat it poses (e.g., malaria).

What are gene drives?

Gene drive is a phenomenon that increases the likelihood that certain genes will be passed on to an organism’s offspring. There are many forms of gene drive, which is an umbrella term, and gene drives can occur naturally in some organisms. Gene drives enable certain genes and genetic traits to become highly common in a population in a relatively short period.

How do you make a gene drive mosquito and is CRISPR involved?

To make a gene drive mosquito, the mosquito needs to have a gene drive sequence in its DNA. One way to do this is to micro-inject DNA containing the information for a gene drive into a mosquito egg using a fine glass needle. Some of the time the gene drive DNA will integrate into the mosquito s DNA and that mosquito and its offspring will have the gene drive. Some gene drive sequences include the CRISPR/Cas gene editing system, but gene drive is also engineered with other approaches.

How do gene drives spread throughout a mosquito population?

Through genetic engineering, mosquito DNA is modified so that the genes passed on to offspring no longer follow the typical rules of inheritance. Instead, the gene drive mosquito passes the altered gene to its offspring readily so that all, or most of, the individuals in a population will carry the modified DNA within a short period of time.

What are the potential benefits of using gene drive technologies as public health tools?

Genetic biocontrol and gene drive technology can be applied to various disease vectors, in addition to mosquitoes, potentially offering an opportunity to protect individuals from a wide array of vector-borne diseases.

How can gene drives reduce the spread of malaria?
How do gene drives help reduce the spread of malaria?

Gene drives can help reduce the spread of malaria in one of two ways:

  1. By reducing the population of malaria-transmitting mosquitoes, or
  2. By reducing the mosquito’s ability to pass the malaria parasite to humans.
What is the difference between population modification and population suppression?

Population modification, sometimes called population replacement, refers to the process of altering a
population trait, like reducing the ability to transmit malaria, for example. Population suppression means reducing the size of the population of the mosquitoes that transmit malaria.

Combined with malaria vaccines and existing malaria interventions, like bed nets, could gene drive mosquitoes be the missing piece of the puzzle that will enable the world to achieve zero malaria status?

Some research suggests that it is possible malaria could be locally eliminated in low-to-moderate transmission areas. By increasing the variety of tools available to reduce the incidence of malaria, we are likely to see swifter progress toward the goal of zero malaria.

Are there risks involved in the use of gene drive mosquitoes?
What are the risks, and will risk mitigation measures be in place before gene drive mosquitoes are released?

There are risks associated with the uncertainties of releasing any new technology into the environment, and risk assessments will be conducted during the decision making process that will take place prior to the use of gene drive mosquitoes. In theory, there could be an effect on organisms other than the target mosquito population, for example. The World Health Organization (WHO) recommends that risk analysis be performed on a case-by-case basis so that it can be tailored to the specific circumstances involved (e.g., the specific version of gene drive-modified mosquitoes being used). It is important for assessments of this technology to pay particular attention to legal considerations, socioeconomic effects and the biosafety of all individuals and locations that may be exposed.

Are gene drives irreversible?

Not necessarily. There are different types of gene drives, and some are designed to stop working after a period of time; these are called self-limiting drives. Another type of gene drive, called self-sustaining, is meant to be permanent. As a precautionary measure, scientists are working on ways to halt or reverse the effects of self-sustaining gene drives. While these methods have not yet been perfected, this is an area of recognized need and active research.

Are gene drive mosquitoes meant to cause species extinctions?

No, gene drive mosquitoes are not intended to cause species extinctions.

Could the release of gene drive mosquitoes have unintended harmful effects on the local ecology?

The main malaria-transmitting mosquito, Anopheles gambiae, makes up only a small percentage of the entire African mosquito population. Additionally, experts do not consider Anopheles gambiae a keystone species, or one that an ecosystem greatly depends on. While the potential field implementation of gene drive mosquitoes to combat the spread of malaria would involve ecological considerations, it would be unlikely to cause a drastic change in an ecosystem.

Where are gene drive mosquitoes in use and how are governments regulating them?
Where are gene drive mosquitoes currently in use?

As of December 2023, gene drive mosquitoes are still being tested in laboratories and have not been released into the field. The technical and regulatory groundwork is being laid to support informed decisions about the potential field-testing of gene drive technologies.

How is the use of gene drive mosquitoes being addressed from a regulatory and policy standpoint?

The regulation of gene drive-modified mosquitoes likely will involve multiple government agencies. In countries that follow the Cartagena Protocol on Biosafety, genetically modified organisms must be reviewed under national biosafety laws. Ministries of Health, Ministries of Environment, and possibly other agencies are likely to be involved.

In the US, which does not follow the Cartagena Protocol, genetically modified mosquitoes for population suppression are currently regulated by the Environmental Protection Agency, while genetically modified mosquitoes for population modification to reduce the mosquito’s ability to transmit disease are regulated by the Food and Drug Administration.

GeneConvene in the Media

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