NIH Analysis of Anti-Cancer Chemicals 2017-2022

The National Institutes of Health awarded this Master IDIQ on July 31, 2017, for analytical chemistry services supporting the National Cancer Institute's anti-cancer drug development pipeline, with the ordering period closed as of July 31, 2022 — no new task orders may be issued against this vehicle.

The vehicle is now inactive and of historical interest only. Ordering closed nearly four years ago, with the most recent task order awarded in February 2022. The combined potential value across all 15 task orders issued was $367 thousand, fully obligated. Ordering momentum was light and irregular: 4 orders in 2018, 1 in 2019, 4 in 2020, 1 in 2021, and 1 in 2022, trailing to zero after mid-2022.

Work performed under the vehicle consisted of bulk drug substance and formulated drug product analysis — release testing (appearance, proton NMR, infrared, HPLC assay and impurity analysis, moisture content, residual solvents, heavy metals, residue on ignition), stability studies, and developmental studies — with analytical data supplied to the FDA as part of Investigational New Drug filings. Task orders typically ranged from roughly $7 thousand to $70 thousand and were priced on a cost-plus-fixed-fee basis.

Competition was concentrated among three primes. Sri International captured 60% of awarded orders (9 of 15) and 63% of combined potential value ($232 thousand). Mriglobal held 33% of orders (5 of 15) and 37% of potential value ($134 thousand). Research Triangle Institute received a single administrative task order. All task orders were unrestricted competitive awards. The National Cancer Institute was the sole customer across all 15 task orders.

The Pharmaceutical Resources Branch (PRB), Developmental Therapeutics Program (DTP), Division Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking services for the analysis of bulk drug substances and formulated drug products. Reports of these analyses will be used as a basis for assessing the suitability of these materials for use in biological activity screening, pharmacological studies, toxicological studies, formulation studies and clinical trials. Data provided in these analytical reports will be supplied to the Food and Drug Administration (FDA) as part of the Investigational New Drug (IND) filings for new anti-tumor agents.