Preclinical Pharmacology and Toxicology Studies 2012-2014

The Preclinical Pharmacology and Toxicology Studies 2012-2014 Master IDIQ, awarded by the National Institutes of Health's National Cancer Institute, supports comprehensive toxicological and pharmacological evaluations of potential cancer preventive agents. The contract vehicle is designed to facilitate preclinical research that prepares investigational compounds for regulatory submissions, specifically supporting Investigational New Drug (IND) applications and New Drug Applications (NDA) to the Food and Drug Administration. The primary objective is to conduct scientific assessments that determine appropriate first-in-human (FIH) dosing and safety profiles for emerging cancer prevention and treatment interventions.

Task orders under this IDIQ demonstrate a focus on specialized pharmacological and toxicological research, with values ranging from approximately $1,000 to $773,557. Contractors such as Battelle Memorial Institute and Southern Research Institute have been awarded delivery orders, predominantly involving preclinical safety evaluations and contract orientation meetings. The task orders consistently target nonclinical safety assessments, including toxicity studies of specific medical interventions like recombinant DNA vaccines and topical treatment compounds for conditions such as cervical intraepithelial neoplasia. All documented task orders were issued without specific small business set-aside designations, and they consistently employed firm fixed price or cost-plus fixed fee pricing structures. The contract vehicle operated from September 2012 to November 2015, with a shared ceiling value of $6,900,000, indicating a strategic approach to supporting advanced medical research through targeted, short-duration scientific investigations.