Toxicology of Drugs Developed for Cancer Patients

The National Institutes of Health, through the National Cancer Institute's Development Therapeutics Program, established this Master IDIQ on July 1, 2016 to procure preclinical toxicology studies of cancer-targeted drugs, with a shared ceiling of $19 million — but ordering closed on June 30, 2021 and no new task orders may be placed.

The vehicle is no longer active. The last task order awarded was April 9, 2021; the ordering period has been closed for over five years. This IDIQ is archived and cannot support new work.

For context on its operational period: the vehicle issued 17 task orders between July 2016 and April 2021. Work concentrated heavily in the first year (eight orders in 2016), with declining activity thereafter (three orders in 2017, four in 2018, one in 2020, and one in 2021). Combined task-order potential value reached $6.3 million, of which $4.3 million (68%) has been obligated. Task orders funded NCI programs exclusively.

IIT Research Institute dominated the vehicle, holding five orders with $4.3 million combined potential value — more than two-thirds of all awards by value. The remaining four primes each received three orders: University of Illinois ($761 thousand), Sri International ($500 thousand), Southern Research Institute ($376 thousand), and Battelle Memorial Institute ($366 thousand). All 17 orders carried no set-aside designation.

Task orders were cost-plus-fixed-fee or firm-fixed-price, ranging from initial administrative charges under one thousand dollars to substantive studies with ceiling values near or exceeding $2 million (notably, an EIF4A inhibitor toxicology study with a $2.425 million ceiling awarded September 2020). Typical periods of performance spanned 12 to 24 months. Work included tissue cross-reactivity studies, embryo-fetal developmental studies in animal models, pharmacokinetic and toxicology profiling of antibodies and small-molecule oncology candidates, and reproductive toxicology assessments — all supporting FDA Investigational New Drug Application submissions.

The Development Therapeutics Program (DTP) of the National Cancer Institute (NCI) Division of Cancer Treatment and Diagnosis (DCTD) is soliciting preclinical toxicology of drugs developed for cancer patients. Investigations that profile and characterize the toxicological risk of these compounds to healthy organs are essential to the preclinical development phase for potential new drugs. Data generated from these studies are evaluated in light of potential human toxicity risk and additionally, form a major portion of the information required by the Food and Drug Administration for an Investigational New Drug Application (IND). Such laboratory investigations comprise the primary responsibility of this concept and of the Toxicology & Pharmacology Branch (TPB) within the DTP.