Battelle has been awarded a five-year, Indefinite Delivery/Indefinite Quantity (IDIQ) contract, with a potential value of $19 million, by the National Cancer Institute (NCI). Under the Preclinical Toxicology of Drugs Developed for Cancer Patients contract, Battelle will bid for task orders to support NCI’s program to develop and advance emerging cancer therapeutics to clinical trials.
The goal of the NCI program is to evaluate new drugs intended for the treatment of cancer. Battelle will be working directly with NCI to perform toxicology studies for a variety of drug candidates, including both small molecules and biologics. Data gathered from studies conducted under the contract may serve as the basis for filing for an IND (investigational new drug) application. MaryEllen Lynch, the Battelle Program Manager for the contract, explains, “Battelle has collaborated successfully with NCI for nearly 30 years. We have an experienced, full-service toxicology and safety pharmacology assessment team standing ready to help NCI get products through required preclinical studies and into the clinics where they are needed.”
The 2016 IDIQ is one of many awarded to Battelle by NCI since 1980. Over the years, researchers at Battelle have conducted numerous toxicology studies for cancer therapeutics. Under this new contract, Battelle may provide NCI with a full spectrum of services, including:
- general toxicology services;
- chemical and analytical support, including bioanalytical capabilities to perform pharmacokinetic (PK), pharmacodynamics (PD), bioavailability and bioequivalence studies; and
- a broad range of safety pharmacology assessment services.
Battelle has been conducting preclinical drug development programs for global regulatory submissions for the pharmaceutical industry and the government for more than 35 years. In the past five years, the Battelle toxicology team has successfully conducted more than 1,000 relevant studies supporting preclinical development, including safety pharmacology, analytical and bioanalytical method development and validation, efficacy animal model development, efficacy studies, validation and analysis of biomarkers, and Good Laboratory Practices (GLP) and non-GLP toxicology in multiple species and in multiple routes of administration.
The NCI is the federal government's principal agency for cancer research and training. It is part of the National Institutes of Health (NIH), under the Department of Health and Human Services (HHS). Originally established under the National Cancer Institute Act of 1937, NCI now coordinates the National Cancer Program, which conducts and supports research, training, health communications, and other programs related to the diagnosis, prevention and treatment of cancer.
Battelle is pleased to continue support for NCI’s mission to bring new cancer treatments to clinics and cancer patients.