A major impediment to the development of drugs for neglected tropical diseases has been support of the translational steps needed to move an optimized lead drug to clinical candidacy. If a new drug is being developed with an industrial partner, the translation of basic target discovery to a drug that can be taken by people is supported by the industry partner either directly or through outsourcing to contract research organizations worldwide. Because neglected tropical diseases, by definition, do not have an industry partner other options must be considered to meet this challenge.
The CDIPD is closely linked to the UCSD Drug Development Pipeline. This pipeline is carried out entirely by laboratories at UCSD or affiliated campuses. The pipeline includes in vitro ADME, snapshot pharmacokinetics, GLP-level pharmacodynamics and pharmacokinetic studies, and safety (toxicology) studies in both mice and beagle dogs. Movement of a lead compound through this pipeline should provide the information necessary for a pre-IND meeting with the US FDA.
The UCSD Drug Development Pipeline now has a Project Manager, Dr. Jeremiah Momper, who is Assistant Professor of Clinical Pharmacy in the Skaggs School of Pharmacy and Pharmaceutical Sciences where his research is focused on mechanistically understanding alterations in drug disposition and response in special populations. Prior to joining UCSD Dr. Momper worked at FDA and completed a Commissioner’s Fellowship (2011- 2013) in the Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.