A step-by-step development pathway
Target Malaria is developing its innovative genetic technologies in a step-wise approach. Our phased development pathway follows the recommendations made by several expert groups, including the 2021 World Health Organisation (WHO) Guidance framework for testing of genetically modified mosquitoes (first and second editions), the 2016 National Academies of Sciences, Engineering and Medicine report Gene Drives on the Horizon, and, most recently, the 2018 Pathway to Deployment of Gene Drive Mosquitoes as a Potential Biocontrol Tool for Elimination of Malaria in Sub-Saharan Africa: Recommendations of a Scientific Working Group.
Our research is still at an early stage, and even though results so far have been promising, we still have a long way ahead of us. Our aim is to develop genetic technologies for vector control for malaria that will be sustainable and cost-effective to implement, as the mosquitoes themselves will help to control malaria transmission.
Target Malaria seeks to achieve excellence, creating a path for responsible research in the development of genetic technologies for vector control for malaria. In order to succeed, our research requires the participation of many people, as no single institution has the knowledge or research environment necessary to succeed alone. The sustainability of our research and the effectiveness of our tools depend on sharing knowledge and in investing in partnerships across disciplines and among institutions.
Our project’s ability to move through each evaluation phase is subject to securing regulatory approvals from national authorities in the countries where we operate. While these requirements may differ slightly between countries, we are committed to aligning our assessment activities with international guidelines and emerging recommendations and guidance from global, regional and national bodies to support evidence-based evaluations to present to regulatory authorities.
Safety is a foundational cornerstone of regulatory science, and we are constantly working to ensure that our approach to data and evidence gathering is informed by the most current body of peer reviewed science in all the steps along our development pathway.
We first test our mosquitoes extensively in our laboratories in the UK, USA and Italy before we apply to the national regulatory authority for a permit to import a genetically modified strain into containment in one of our African partner institution’s laboratories. Further studies in containment in partner laboratories will inform the decision whether to seek permission to undertake a small-scale field study in that country.
Regulatory dossiers for key phases in the research are submitted by our collaborating partners based in malaria-endemic countries. Just as we depend on the support and approval of communities and stakeholders, we are required to comply with national legislation and we only wish to operate within jurisdictions where we have the full confidence and appropriate authorisation of their national regulatory authorities.
Our approach to malaria control using mosquitoes would provide protection for everyone in the community, regardless of their education, wealth or ability to access healthcare services.
As the project’s research progresses, Target Malaria has been engaging with more groups, from the potential beneficiaries in local communities where we conduct our research activities to national, regional and global stakeholders. Our strategy is to focus on the communities that might benefit from the technology and that are directly affected by the research activities but also to have an ongoing, transparent dialogue with other stakeholders. The project uses ethically designed engagement best practices to empower these communities to make the most informed decisions about the project’s work and its activities.
Engagement is a two-way dialogue and reinforces our commitment to co-development. Target Malaria believes that engaging stakeholders can help improve our working processes and the technology we aim to develop. We can learn a lot from our stakeholders and they have a right to understand what we do and to decide whether to support us. We believe engagement will make our research better and help ensure what we develop is welcomed and useful.