NON-GLP DOSE-RANGE FINDING AND GLP TOXICITY STUDIES AND IN VITRO DRUG-DRUG INTERACTION STUDIES FOR A SMALL PEPTIDE

Battelle Centers/Pub Hlth Res & Evaluatn, Columbus OH

Investigators

Abstract

The BPN-Biologics Services Indefinite delivery, indefinite quantity (IDIQ) contract provides neuroscience product developers/innovators with a full range of industry-style, biologic drug-development services and expertise for their development of biological therapeutics for neurological diseases. These product developers/researchers are funded through other programs at the National Institutes of Health (NIH) but may lack the entire suite of capabilities necessary to advance their candidate product to a phase I clinical trial. Therefore, this contract augments the progress of the candidate product by providing the support required at the specific stage of its development and optimization path. The services offered through this contract are assay development, pharmacokinetics, manufacturing, formulation, fill-finish, investigational new drug (IND)-enabling toxicological studies, and support through phase I clinical trial.