CRO Support for NCATS In Vitro and In Vivo Toxicology Studies

The National Institutes of Health established this Master IDIQ with the National Center for Advancing Translational Sciences (NCATS) on April 20, 2017, to procure in vitro and in vivo toxicology studies supporting early-stage drug development and safety assessments for small molecules and biologics, with the last date to order on April 20, 2022—the vehicle is now closed to new orders and has not received task orders for nearly four years.

NCATS conducted 24 task orders totaling $34.5 million in combined potential value, of which $29.9 million (87 percent) has been obligated. All task orders are unrestricted competitions. Ordering peaked in 2020 with nine awards; activity tapered sharply thereafter, with two orders in 2022 and none since. All work funds NCATS programs except one order ($751 thousand) placed by the National Institute on Drug Abuse.

Five contractors hold all awards. IIT Research Institute dominates by both order count and value, capturing 11 of 24 orders and $14.1 million combined potential. Lovelace Biomedical Research Institute ranks second by value with $9.6 million across two orders despite fewer awards than Battelle Memorial Institute, which holds six orders valued at $8.6 million combined. Sri International and Lovelace Biomedical And Environmental Research Institute, Inc. hold the remainder.

Task orders are cost-plus-fixed-fee arrangements supporting non-clinical safety assessments of investigational compounds across multiple therapeutic areas: pain management, gene therapy, corneal dystrophy, sleeping sickness, fragile X syndrome, multiple sclerosis, and others. Work includes GLP-compliant in vivo studies in animal models (dogs, rats, minipigs, mice) and safety pharmacology studies. Order values span from $80 thousand to $6.8 million ceiling, with most awards in the $450 thousand to $4.7 million range. Obligated amounts often track ceiling values, indicating fixed-scope orders. Work is performed nationwide with no geographic concentration evident.

The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research in the area of human therapeutics development and aims to move small molecule and biologic drug candidates forward in the drug development pipeline, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients. The overall goal of this project is to support safety evaluations that are of interest to NCATS by conducting various toxicology studies. Specifically, to help identify, develop, and perform in-vitro and in-vivo IND/NDA/BLA-enabling safety studies for small and large molecules. In addition, in vitro tests and in-vivo exploratory studies will be carried out to aid therapeutic target evaluation, lead optimization, and compound selection processes on a case-by-case basis. To accomplish this goal, the Government plans to solicit proposals from offerors having in-house capability in one or more of the following technical areas: (1) Exploratory and Genetic Toxicology and (2) In-Vivo Toxicity Testing.