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IriSys Wins $14.4M NCATS Contract

To provide research services to support the development, manufacture, and stability studies of therapeutics

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By: Kristin Brooks

Managing Editor, Contract Pharma

IriSys, LLC, a San Diego-based provider of pharmaceutical product development and manufacturing services, has been awarded a new “CRO Support for Drug Product Development, Manufacture, and Stability Studies” contract by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). The contract, valued at $14.4 million, runs from August 1, 2017 through July 31, 2022.

NCATS studies and supports translational science, supporting collaborations across traditionally separate scientific disciplines and organizations. The Center convenes teams with diverse expertise as part of an effort to reduce or bypass significant bottlenecks across the drug development cycle. Contracted organizations provide manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to NCATS to assist with assay development, lead selection and optimization, and Investigational New Drug – or New Drug Application/Biologic License Application-directed studies.

“IriSys is very pleased to be selected by NCATS to receive this significant contract,” said Gerald Yakatan, Ph.D., chairman, chief executive officer and founder of IriSys. “The objective of the contract is for IriSys to provide research services to support the development, manufacture, and stability studies of both oral and injectable dosage forms of experimental therapeutics. IriSys’ successful track record developing and manufacturing dosage forms for therapeutic agents of all classes and physicochemical properties makes us well-suited to successfully carry out the defined activities.”

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