Bridging the Gap: Improving Clinical Development and the Regulatory Pathways for Health Products for Neglected Diseases

There has been tremendous progress over the last decade in the development of health products for neglected diseases. These include drugs, vaccines, and diagnostics for malaria and tuberculosis, which kill millions of people annually, plus other diseases like chagas and dengue fever, which may less familiar, but nonetheless exact a large and often lethal toll in the world’s poorest communities. Led by product development publicprivate partnerships (PDPs) and fueled by the support of the Bill & Melinda Gates Foundation, the National Institutes of Health, and other donors, there are now dozens of candidate products in the pipeline. Two substantial bottlenecks, however, threaten our capacity to bring these products to those in need. First, the research and regulatory capacity in many neglected disease-endemic settings is not adequate to support the clinical trials that need to occur there in order to complete the development of these products. Second, even with expected attrition in the pipeline, current levels of financing are insufficient to support the clinical development of these products under current cost assumptions. Addressing these related challenges requires not only increased funding for large scale clinical trials and capacity building, but also greater attention to how these trials and their regulatory pathways can be improved to reduce unnecessary costs, delays, and risks to trial subjects.