Strengthening Regulatory Systems
The push to improve global health depends on having reliable sources of high-quality medical products—including vaccines, drugs, and diagnostics—at prices that are affordable for people in developing countries. Many of those countries, as well as multilateral organizations such as Gavi, UNICEF, and UNITAID, require that the medical products they buy meet standards set by the World Health Organization (WHO).
We work to reduce the time needed for a novel medical product to achieve WHO prequalification and other regulatory approval, by taking the guesswork out of the process and fostering an ecosystem in which products can more quickly proceed through the regulatory pipeline. We also strive to improve monitoring and surveillance of medical products after they have been licensed for use, in order to identify any adverse reactions.
Data Analytics for Decision Making
We provide data analysis support to other foundation programs and to our partners and grantees to inform their decision making. One key effort is an initiative that integrates massive amounts of existing data—covering 12 million children in 34 countries—about risk factors affecting birth, growth, and neurodevelopment. Researchers can analyze this data set to generate insights and facilitate rapid progress.
We apply this same data-driven approach to our model-informed drug development platform and our dose-selection platform for vaccines and therapeutic drugs. Another key initative is our support for data collection and research on infecting Aedes aegypti mosquitos with Wolbachia bacteria, which renders them less able to transmit dengue, chikungunya, and Zika. Other projects include support for development of long-acting oral and inhaled drugs, including contraceptives.
Chemistry, Manufacturing, and Controls
We provide technical expertise to other foundation programs on manufacturing, delivering, and seeking regulatory approval for drug candidates, with the aim of accelerating timelines and increasing the probability of success. We also work with the foundation’s country offices to facilitate partnerships with low-cost regional manufacturers and invest in promising low-cost manufacturing technologies. In addition, we make grants to support the development of technologies that aid in drug discovery and low-cost drug manufacturing and drug delivery devices.