A new therapeutic agent with demonstrated activity in cell culture and in animal efficacy models requires many additional studies to convert it from a promising lead into a pharmaceutical agent suitable for evaluation in clinical trials. These product development (or "translational") activities are designed to generate the necessary pharmaceutical-grade materials and preclinical data needed to support submission of an Investigational New Drug application to the Food and Drug Administration (FDA). The types of preclinical studies required include scale-up synthesis of the therapeutic agent, development of analytical assays to detect and quantitate the therapeutic agent and its metabolites, development and manufacture of dosage formulations, and animal pharmacology and toxicology. Many of these studies require compliance with current FDA regulations regarding Good Manufacturing Practices and Good Laboratory Practices. NIAID administers contracts to conduct many of these translational activities for new therapeutic agents to treat HIV and its co-infections.
Last Updated July 21, 2015