The Bill & Melinda Gates Medical Research Institute is a non-profit organization dedicated to the development and effective use of novel biomedical interventions addressing substantial global health concerns, for which investment incentives are limited. The institute works through collaborating partners and organizations, coordinating and driving the full spectrum of biopharmaceutical development activities, including pre-clinical development, full clinical development (from phase 1 through to and including phase 3), and global regulatory interactions. The institute focuses on programs aimed at reducing the burden of TB, malaria, diarrheal diseases, and maternal, newborn, and child illnesses worldwide. As an affiliate of the Bill & Melinda Gates Foundation, the institute’s programs are focused on disease and health areas of primary focus at the foundation. The interventions under study and development are derived from sources both within and external to the foundation.