BIOLOGICS IDIQ TASK ORDER- NON-GLP TOXICITY AND TOXICOKINETIC STUDIES IN RODENTS AND NON-RODENTS FOR A NOVEL, SUBCUTANEOUSLY-DOSED MODIFIED-HEPARIN DRUG

Battelle Centers/Pub Hlth Res & Evaluatn, Columbus OH

Investigators

Abstract

The objective of this Task Order (TO) is to perform non-GLP toxicity and toxicokinetic studies in support of a Helping End Addiction Long-term (HEAL) Pain Therapy Development Program (PTDP) project. This 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 diseases of the central nervous system. 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 has been put in place to augment 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.