Preclinical Pharmacology and Toxicology Studies 2012-2014

The National Institutes of Health, National Cancer Institute awarded this Master IDIQ on September 20, 2012 to conduct preclinical toxicology and pharmacology evaluations of potential cancer preventive agents in support of FDA Investigational New Drug applications, New Drug Applications, and first-in-human dose determinations. Ordering closed on November 9, 2015, making this vehicle inactive for over a decade.

The vehicle is no longer viable for new pursuits. All $950 thousand in combined potential value has been obligated across six task orders, the last awarded in September 2014. Activity concentrated heavily at vehicle inception—four orders in 2012—with only one order each in 2013 and 2014. No new orders have been issued since the vehicle's ordering window closed.

Work contracted under the vehicle consisted of nonclinical safety and toxicokinetic evaluations of specific therapeutic candidates: a recombinant DNA vaccine, a vaginal cream formulation, and other investigational agents. Most orders were firm-fixed-price toxicology studies, with two small administrative/orientation meetings issued on a cost-plus-fixed-fee basis.

Sri International dominated the vehicle by value, holding two orders worth $777 thousand combined. IIT Research Institute also received two orders totaling $166 thousand. Southern Research Institute and Battelle Memorial Institute each held one order of nominal value. All work was unrestricted (no set-aside designations), and all orders funded National Cancer Institute programs exclusively.

Task orders ranged from $1,148 to $773,557, with the largest being a safety evaluation of a recombinant DNA vaccine awarded to Sri International. Completion dates extended to March 2018, meaning all contracted work has long concluded. The vehicle's $6.9 million shared ceiling was substantially underutilized relative to actual task-order awards.

Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI) has awarded a Master IDIQ to support the conduct of toxicological and pharmacological evaluations of potential cancer preventive agents for Investigational New Drug (IND) applications to the Food and Drug Administration (FDA) for phase 0, 1-3 clinical studies; New Drug Applications (NDA) to the FDA; and to determine appropriate first-in-human (FIH) doses.