IriSys Doubles Contract with NCI for Mfg. Clinical Trial Materials

IriSys, a San Diego, CA-based provider of contract pharmaceutical product development and manufacturing services, was awarded an increase in the ceiling of its five-year prime vendor contract, which was doubled to up to $6,000,000, by the National Cancer Institute (NCI)'s Developmental Therapeutics Program (DTP) of the Division of Cancer Treatment and Diagnosis (DCTD). The contract is for the pharmaceutical development and production of new therapeutic agents for use in clinical trials supported by NCI. It was initiated in June 2015 and will be in effect through June 2020.

Under this contract, IriSys will continue to manufacture oral, topical, and injectable dosage forms to be used in NCI-sponsored and/or investigator-initiated clinical trials in humans. IriSys is responsible for formulation studies, process optimization, manufacture of the clinical dosage forms, release testing, quality control and quality assurance. The significant increase in the contact amount threshold allows NCI to place new task orders with IriSys to satisfy their changing needs.

The manufacturing of pharmaceutical formulations for clinical trials and commercial pharmaceutical products under U.S. Current Good Manufacturing Practices (cGMP) regulations is one of IriSys' specialized services. The company produces materials in all dosage forms, including solid oral dosage forms such as tablets and capsules, as well as liquids, injectables, and topical ointments, creams and gels, in its state-of-the-art facility in San Diego.

"IriSys' consistent delivery of quality clinical trials materials to NCI on a timely basis is an example of our client-focused approach," said Gerald Yakatan, chairman and chief executive officer, IriSys. "Our highly experienced technical staff is responsible for IriSys' successful track record developing and manufacturing therapeutic agents of all classes and physicochemical properties. We look forward to producing additional material as needed by NCI for their important work."

This project has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN261201500009I.  The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.