CRO Support for NCATS Drug Substance Development and Manufacture

This National Institutes of Health Master IDIQ for chemistry, manufacturing, and control services supporting the National Center for Advancing Translational Sciences drug development program closed to new orders on March 31, 2022, and is no longer available for pursuit.

The vehicle was established in March 2017 to procure Active Pharmaceutical Ingredients and formulated drug products for IND-enabling, preclinical, and clinical studies across three technical areas: small-molecule manufacture and analysis, synthetic peptides and oligonucleotides, and biopharmaceuticals. The combined potential value across 13 task orders totals $13.8 million, with $12.7 million already obligated (92% of available value). The final task order was awarded in September 2023, more than two years ago, reflecting residual activity after the ordering window closed.

Curia Global Inc. dominates the prime contractor base, holding 4 orders valued at $7.3 million combined potential. Bachem Americas Inc. follows with 3 orders worth $2.5 million, while Mriglobal secured 3 orders for $879 thousand. The Regents of the University of Minnesota and Advanced Bioscience Laboratories Inc. each hold smaller positions. All 13 task orders are unrestricted, non-set-aside awards.

Funding is concentrated within HHS-NIH: the National Center for Advancing Translational Sciences placed 9 orders worth $10.6 million combined potential, while the National Institute on Drug Abuse funded 4 orders for $3.3 million. Typical task orders ranged from approximately $130 thousand to $3.4 million, with durations extending through 2028. Work included drug-substance manufacturing in current Good Manufacturing Practice specifications, stability studies, analytical method development, and process development supporting candidates such as mitragynine, metarrestin, and ketamine metabolites. Since ordering closed in March 2022, this vehicle is closed to new work.

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 proposed project is to support the DPI drug development program by contracting for Chemistry, Manufacturing, and Control services. Specifically, this proposed project is designed to ensure DPI receives Active Pharmaceutical Ingredients and formulated Drug Product of sufficient quality and quantity to support IND-enabling, pre-clinical, and clinical studies. 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) Manufacture and Analysis of Small Molecules; (2) Manufacture and Analysis of Synthetic Peptides, Oligonucleotides, and Related Substances; and (3) Manufacture and Analysis of Biopharmaceuticals.