Path Drug Solutions

Programs: Essential medicines: pds partnered with colleagues in bangladesh to help launch the diarrhea innovations group, a global network committed to reducing child deaths from diarrheal disease. The group's primary goal is to accelerate the development and adoption of new diagnostic and therapeutic technologies with the greatest potential to reduce child deaths from diarrheal disease in countries with the highest disease burden. To address cryptosporidium infection, one of the leading causes of diarrheal disease among young children in low-resource settings, pds worked with academic researchers and others to advance research and development of drug candidates to reduce mortality and morbidity. To combat malaria worldwide, pds continued work to ensure that sufficient sources and quantities of artemisinin, a key ingredient in gold-standard malaria treatments, are available to fully support current and future use of artemisinin-based combination therapy in global malaria control and elimination programs. Pds also continued to advance a long-acting injectable drug that may help prevent infection with hiv when used before exposure (an approach called "pre-exposure prophylaxis, or "prep"). Pds provided regulatory sponsorship of a phase 2 trial to evaluate the safety and acceptability of intramuscular injections. By early 2016, all four clinical trial sites in the united states, south africa, and zimbabwe had completed enrollment of participants, and pds had conducted site visits to confirm site quality and compliance with the study protocol.

international development: in 2016, pds continued work to reduce the burden of visceral leishmaniasis (vl), also known as kala-azar. Vl is a parasitic disease common in africa and asia and is almost always fatal if untreated. In collaboration with partners in bangladesh and nepal, pds continued work to strengthen national pharmacovigilance (pv) programs for vl elimination. The pv programs aim to improve patient safety and care associated with the use of vl drugs, and have been acclaimed by the governments of nepal and bangladesh. Pds also advanced a post kala-azar dermal leishmaniasis (pkdl)/vl relapse observation study in bangladesh. Pkdl surveillance is especially important because the disease serves as a significant vector for overall vl transmission. Interim data for the monotherapy treatment arms were disseminated in 2016 with an observation of a strong relationship between pkdl/vl relapse incidence and the current primary vl treatment. To build clinical research capacity in india, pds worked to further develop and implement a clinical research training and mentorship program. This work was done in collaboration with three national clinical research resource centers specializing in pharmacovigilance, research ethics, and data management.