Parenteral Dosage Forms for Clinical Studies

The National Institutes of Health National Cancer Institute awarded a Master IDIQ on September 20, 2013, to develop and produce parenteral dosage forms of promising cancer therapeutic agents for Phase I and II clinical trials, with a last date to order of September 19, 2018—ordering closed in September 2018 and the vehicle is no longer active.

The vehicle is closed to new task orders. All three task orders on record were awarded on the establishment date itself and completed by November 29, 2013, each valued at $1 thousand and designated as Partial Small Business set-asides. Combined potential value across all task orders was $3 thousand, with $3 thousand obligated (100% of potential value). The single customer, the National Cancer Institute, placed all three orders.

Scope centered on development and production of parenteral formulations for clinical studies, with batch sizes ranging from small batches of 100–200 units to intermediate batches of 1,000–5,000 or more units for Phase I and II trials. The three awarded task orders were kick-off webinar activities rather than production orders, indicating the vehicle was structured to initiate contractor engagement before substantive development work.

Competition was fragmented across three primes—Eurofins Advantar Laboratories, Inc., Curirx, Inc., and Piramal Pharma Solutions Inc.—each receiving one order of equal value. No prime dominated the portfolio. All three orders carried Partial Small Business designations.

The vehicle's combined ceiling value was stated as $8,463,789, but actual obligated spend was $3 thousand across three initial activities. The vast gap between ceiling and obligations, combined with closure of the ordering period seven years ago, indicates the vehicle either saw minimal subsequent activity after the 2013 kick-off events or was superseded by successor vehicles. The vehicle is unsuitable for current pursuit.

The Development Therapeutics Program (DTP) of the National Cancer Institute (NCI) Division of Cancer Treatment and Diagnosis (DCTD) has awarded a Master IDIQ to develop and produce pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer. Certain agents selected by the NCI, DCTD will be assigned for development and production as parenteral products. Batch sizes shall range from small batches (100 - 200 units) to intermediate size batches to be used in Phase I and II trials (1,000 - 5,000 or more units).