Strengthening Capacity and Sharing Information

The GeneConvene Global Collaborative provides technical and regulatory capacity strengthening activities through developing and executing educational training programs and discussion-based workshops.

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To make well-informed decisions about new genetic biocontrol tools, regulatory authorities need to understand the technology, and product developers need to understand the applicable regulatory frameworks. For regulatory authorities to make well-informed decisions about gene drive-modified mosquitoes, they need to develop familiarity with the new tools of genetic biocontrol; determine how risk assessments for these organisms will be done; and determine whether changes in the existing regulatory frameworks of their respective countries and regions are necessary to effectively evaluate these organisms. GeneConvene provides technical information for understanding the technology. Conversely, for researchers and developers to create products that meet the regulatory requirements, they need to understand regulatory requirements of the country(ies) for which the product is destined and to take these into account during project planning phases. GeneConvene provides an understanding of regulatory science and regulatory goals overall, and the regulatory landscape for particular potential field sites.

Key Examples

An Introduction to Regulatory Considerations for Moving Research from the Laboratory to Field Trials

The FNIH held a workshop in 2019 that provided an introduction to the fundamentals of regulatory science and decision-making procedures (in the United States and internationally) for researchers who have limited experience with regulatory processes.

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Participants learned of the differences in goals and approaches between research science and regulatory science, about frameworks within which regulators work, and the utility of understanding regulatory needs and requirements and engaging regulatory systems early in the product development process.

 

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Regulatory Consultative Workshops

Principles for gene drive researchWorking with the African Union Development Agency (AUDA-NEPAD), GeneConvene has provided technical support for regional consultative workshops for regulatory authorities that are designed to build awareness of gene drive technologies.

Three workshops have been held to-date: 1) 16-18 October 2018 in Dakar, Senegal; 2) 4-6 March 2019 in Entebbe, Uganda; and 3) 6-8 August 2019, in Maputo, Mozambique.

Gene Editing Technologies and Their Application in the Life Sciences and Medicine in Africa

Principles for gene drive research

The FNIH held a mini-course on gene editing technologies in June 2019 at the International Centre for Insect Physiology and Ecology (ICIPE) in Nairobi, Kenya. This course, co-sponsored by ICIPE and TReND in Africa, provided an opportunity for established researchers and academics to extend their professional expertise by obtaining a rigorous understanding of gene editing technologies and their underlying mechanisms.

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Notable applications of these technologies with direct relevance to Africa, such as malaria eradication, crop improvement and gene therapy, were studied. This course was the first in a series to be offered over the next four years that are intended to strengthen the capacity of African scientists to participate in discussions regarding the use of contemporary genetic technologies to address challenges to the health and welfare of Africans.

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Second African Biosafety Leadership Summit: Gene Drive Technology as a Potential Biocontrol Tool for Vector-borne Diseases in Sub-Saharan Africa and Relevant Issues to be Discussed at COP-MOP

Principles for gene drive researchSecond African Biosafety Leadership Summit, 2018, Kenya

In 2018, the FNIH supported a meeting hosted by the National Biosafety Authority, Kenya that brought together biosafety and health regulators, policy makers and other professionals to share experiences, to analyze the key capacity building needs, to share existing country laws and past experience on regulation of vector control or GM mosquitoes.

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These discussions considered how existing frameworks may be applied to research and deployment of gene drive technologies in Africa, and opportunities for developing consensus regulatory and institutional frameworks for regulating gene drive and synthetic biology in countries and in the African region.

 

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Talking About Gene Drive: Communications Workshop

The FNIH organized a one-day workshop in November 2017 in Baltimore, MD, attended by more than 70 researchers conducting or interested in gene drive research for public health, conservation and agriculture applications.

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The workshop was designed to create an opportunity for participants to think collectively about how to discuss gene drive technology productively with the public.

 

Roundtable Discussion, Malaria Control in Africa through Genetic Modification of Malaria Vectors

On October 11, 2016, 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. A group of about 20 scientists from across Africa with expertise in infectious diseases, entomology and public health participated in the meeting.

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Discussions focused on approaches to decrease the number of malaria-carrying mosquitoes in Africa. Meeting participants raised questions on safety and efficacy aspects of the technology. Participants also noted the importance of initiating engagement activities with various diverse groups of stakeholders early in the research and development process. Given the potential for transboundary movement of gene drive-modified mosquitoes, all participants agreed that early engagement at the regional level should be a priority. Finally, participants discussed the opportunities and challenges that new technologies, such as gene drive, create for African scientists and institutions. Technology transfer and capacity strengthening (scientific and regulatory) were seen as essential to ensure successful development, testing, and, if appropriate, implementation of gene drive products, and African leadership in these activities was emphasized as critical.

 

 

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